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Visual Outcomes and Accommodative Response of the Lumina Accommodative Intraocular Lens
Abstract
Purpose:
To compare visual acuity, accommodation, and contrast sensitivity of the AkkoLens Lumina accommodative intraocular lens (AkkoLens Clinical b.v., Breda, The Netherlands) with a standard monofocal intraocular lens (IOL).
Design:
Randomized clinical trial.
Methods:
The study enrolled 86 eyes with cataract that all required cataract surgery and IOL implantation. The study group included 61 eyes that were implanted with the Lumina. The control group included 25 eyes that were implanted with an Acrysof SA60AT (Alcon, Fort Worth, TX, USA) monofocal IOL. The distance and near visual acuities, contrast sensitivity, and accommodation were measured over a 1-year follow-up period. Accommodation was measured subjectively, using defocus curves, and objectively, with an open-field autorefractor.
Results:
Uncorrected (UDVA) and corrected (CDVA) distance visual acuities did not differ significantly between the groups (P ≥ .21) over the 12 months. However, the uncorrected near visual acuity (UNVA) was 0.07 ± 0.08 logRAD for the Lumina group and 0.37 ± 0.19 logRAD for the control group (P < .01) and the corrected distance near visual acuity (CDNVA) was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from -4.50 to -0.50 diopters (D) (P < .01) with significantly higher visual acuities for the Lumina group. Subjective accommodation, as determined from defocus curves, was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and 3.67 ± 0.75 D for the control group at visual acuities of 0.10, 0.20, and 0.4 logMAR for both groups, respectively. The objective accommodation, measured by an open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, 0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group and 0.10 ± 0.15, 0.12 ± 0.15, -0.06 ± 0.09 and 0.07 ± 0.10 D for the control group at accommodation stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast sensitivity was the same for both groups (P ≥ .26).
Conclusions:
The Lumina accommodative IOL effectively restores the visual function, accommodation, and contrast sensitivity after cataract surgery with no influence on the postoperative contrast sensitivity.
... Alio et al. assessed the characteristics of the Lumina accommodating lens (AkkoLens, e Netherlands). e UDVA was 0.04 (±0.11) logMAR, and 100% of eyes achieved a BCDVA of 0.1 logMAR after 12 months [23]. In a comparative study of 4 types of IOLs, Pedrotti et al. evaluated VA in 55 patients with TecnisSymfony ZXR00 lens (Abbott Medical Optics, USA). ...
... In the study by Kohnen et al., binocular trifocal lens implantation led to mean binocular UNVA of 0.04 (±0.1) logMAR [22]. UNVA of 0.07 (±0.08) logMAR and BCNVA of 0.1 logMAR were obtained in 90.32% of eyes at 12 months after cataract surgery and binocular Lumina accommodative lens implantation [23]. ...
... Contrast sensitivity in patients with 1CU lenses and monofocal lenses did not differ significantly in randomized studies by Harman et al. and Kamppeter et al. [30,31]. Similar results were obtained by other authors [23,32]. Alio et al. also compared the quality of vision between three groups of binocularly implanted multifocal lenses, i.e., bifocal refractive-diffractive AT Lisa IOL (Carl Zeiss), trifocal AT Lisa IOL (Carl Zeiss), and apodized bifocal IOL ReSTOR (Alcon). ...
Purpose:
Long-term evaluation of the visual refractive outcomes and the quality of life after implantation of the WIOL-CF (Medicem, Czech Republic) in both eyes.
Design:
retrospective, nonrandomized noncomparative case series.
Methods:
50 eyes of 25 patients, including 11 women (44%) and 14 men (56%). The age range of the patients was 38 to 77 years (mean age 55.48 ± 10.97 years). All patients underwent bilateral implantation of the WIOL-CF. Exclusion criteria were previous ocular surgeries except for cataract surgery and refractive lens exchange, irregular corneal astigmatism of >1.0 diopter, and ocular pathologies or corneal abnormalities. Postoperative examinations were performed at 14 days and 3, 6, 12 months of surgery; the last follow-up was between 24 and 36 months after the procedure. All exams included manifest refraction, monocular uncorrected visual acuity (UCVA) and distance-corrected visual acuity (DCVA) in 5 m (Snellen), monocular uncorrected visual acuity in 70 cm and 40 cm (Jeager) and binocular UCVA, DCVA in 5 m, 70 cm, and 40 cm, binocular contrast sensitivity (CS) under photopic conditions, binocular defocus curves, high-order aberrations, quality-of-vision VF-14 questionnaire, and spectacle independence.
Results:
Significant improvement in monocular visual acuity at all distances was demonstrated; the mean postoperative spherical equivalent was 0.32 ± 0.45D. The postoperative means of binocular distance UCVA and BCVA were also improved (p < .001) and so were the mean uncorrected intermediate VA (2.053 ± 1.268) and near uncorrected VA (2.737 ± 1.447). There was a significant improvement in contrast sensitivity at all spatial frequencies and higher-order aberration, compared to preoperative results.
Conclusions:
The evaluation of a WIOL-CF showed good distance, intermediate, and near visual acuity. Contrast sensitivity increased after surgery in all spatial frequencies. Patient satisfaction was high despite some optical phenomena. The rate of postoperative spectacle independence also turned out high. Financial Disclosure. No author has a financial or proprietary interest in any material or method mentioned.
... Of these, 15 were further excluded, leaving a total of 17 articles eligible to be included in the present meta-analysis. Finally, 17 studies [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] with 1764 eyes were incorporated into the current meta-analysis. ...
... Ten trials [25,27,28,[30][31][32][33][36][37][38] with 747 eyes were included in analysis of CDVA. No significant difference between the 2 groups (WMD = 0.03, 95% CI = À0.01 to 0.06, P heterogeneity < 0.001, I 2 = 76.1%; ...
... Recently, Ong et al [14] conducted a meta-analysis, which involved 256 eyes from 5 studies. Compared with Ong's work, we identified 12 additional eligible studies [24][25][26]28,30,[32][33][34][35][36][37][38] and our study involved 1764 eyes from 17 studies. Our study also reported pilocarpine-induced IOL shift that was not reported in meta-analysis by Ong et al and found that AC-IOLs were associated with significantly greater anterior lens shift than MF-IOLs. ...
Introduction:
We performed a systematic review and meta-analysis to evaluate whether accommodative intraocular lenses (AC-IOLs) are superior for cataract patients compared with monofocal IOLs (MF-IOLs).
Methods:
Pubmed, Embase, Cochrane library, CNKI, and Wanfang databases were searched through in August 2018 for AC-IOLs versus MF-IOLs in cataract patients. Studies were pooled under either fixed-effects model or random-effects model to calculate the relative risk (RR), weighted mean difference (WMD), or standard mean difference (SMD) and their corresponding 95% confidence interval (CI). Distance-corrected near visual acuity (DCNVA) was chosen as the primary outcome. The secondary outcomes were corrected distant visual acuity (CDVA), pilocarpine-induced IOL shift, contrast sensitivity, and spectacle independence.
Results:
Seventeen studies, involving a total of 1764 eyes, were included. Our results revealed that AC-IOLs improved DCNVA (SMD = -1.84, 95% CI = -2.56 to -1.11) and were associated with significantly greater anterior lens shift than MF-IOLs (WMD = -0.30, 95% CI = -0.37 to -0.23). Furthermore, spectacle independence was significantly better with AC-IOLs than with MF-IOLs (RR = 3.07, 95% CI = 1.06-8.89). However, there was no significant difference in CDVA and contrast sensitivity between the 2 groups.
Conclusion:
Our study confirmed that AC-IOLs can provide cataract patients with DCNVA and result in more high levels of spectacle independence than MF-IOLs. Further studies with larger data set and well-designed models are required to validate our findings.
... Recently, our research team conducted an investigation to evaluate the first clinical results of patients implanted with this type of IOL [36]. In the study, a total of 61 eyes implanted with the Lumina AIOL were assessed during a follow up period of one year. ...
... Table 3 summarizes the visual and refractive results found in the study. In addition, when compared with a monofocal IOL, the Lumina AIOL also showed significantly better results in terms of uncorrected near and distance corrected near visual acuity (p <0.01) [36]. After 1 year of follow up, more than 90% of those patients implanted with the Lumina AIOL showed a distance corrected near visual acuity of 0.8 in the decimal scale with 70% of the patients having a spherical equivalent of ± 1 D [36]. ...
... In addition, when compared with a monofocal IOL, the Lumina AIOL also showed significantly better results in terms of uncorrected near and distance corrected near visual acuity (p <0.01) [36]. After 1 year of follow up, more than 90% of those patients implanted with the Lumina AIOL showed a distance corrected near visual acuity of 0.8 in the decimal scale with 70% of the patients having a spherical equivalent of ± 1 D [36]. ...
Presbyopia still remains the last frontier of refractive surgery. Its surgical management is under constant evolution due to the limitations that exist today with respect to its management, which is probably in relation with the multifactorial basis in which presbyopia is clinically developed in the human. Until currently, virtually all surgical techniques that have been proposed for its correction are based on the induction of pseudoaccommodation in the presbyopic eye, including multifocality. However, the real restoration of accommodation is more complex, and it has been tried by the use of different, so called, “accommodative” pseudophakic intraocular lenses (AIOL). Overall, the reported results with these lenses by independent authors have been modest in relation with the restoration of the accommodative power of the eye and these modest benefits are usually lost with time due to the long term changes in the capsular bag. This fact made these lenses to be almost abandoned in the last few years, but there are currently other AIOL models being used with innovative mechanisms of action and different anatomical support outside the capsular bag that offer encouraging preliminary results that could bring a new potential of application to these types of lenses.
In this article, we will update the modern refractive surgeon about the fundamentals and provide updated information about the outcomes of AIOLs by reviewing the concept of accommodation, the different attempts that have been accomplished in the past, their demonstrated published results in human clinical trials, and the future alternatives that may arrive in the near future.
... 74,83 The AkkoLens Lumina AIOL (Akkolens International B.V., Netherlands) slides on the plane perpendicular to the optical axis to provide a continuous variable-focus lens (Table S7). 84 A previous study showed that Luminas produced significantly better UIVA and UNVA than MIOLs at a 1-year follow-up, without compromising contrast sensitivity. 84 Fluidvision (Powervision, United States), another clinically available AIOL, changes the refractive index through fluid displacement. ...
... 84 A previous study showed that Luminas produced significantly better UIVA and UNVA than MIOLs at a 1-year follow-up, without compromising contrast sensitivity. 84 Fluidvision (Powervision, United States), another clinically available AIOL, changes the refractive index through fluid displacement. When the haptics are subject to accommodative forces, silicone oil is pushed into the optic through fluid channels that connect the haptics to the optic, changing the AIOL's refractive index, which provides much better biocompatibility with the uvea and lens capsule than a single-optic AIOL. ...
Background
Presbyopia has become a global disease affecting the world's aging population. Among various treatments, cataract extraction and intraocular lens (IOL) implantation have become the most popular and common methods of presbyopia correction. During the twentieth century, IOLs have underwent significant innovation and advancements to meet the patients' high demands for functional vision at all distances.
Main body
To meet the increasing needs for excellent near and intermediate vision for daily activities, some premium IOLs with more than one focus have been developed, for example, the refractive MfIOLs, diffractive MfIOLs, extended depth of field (EDOF) IOLs, and accommodating IOLs (AIOLs) were introduced to meet this need. In addition, the add-on MfIOLs have been explored as promising supplementary IOLs for pseudophakic presbyopia. When selecting the MfIOLs, the IOLs' features, patients’ characteristics, preoperative eye conditions, and treatment expectations should be considered.
Conclusion
In this review, we focus on the multifocal IOLs (MfIOLs) commonly used for presbyopia correction and systematically summarized their optical designs and clinical outcomes. More evidence-based studies are required to provide guidelines for MfIOL selection, provide maximum visual benefits, and develop personalized visual solutions in the future.
... The IOL power selected was targeted to emmetropia. The Lumina AkkoLens accommodative IOL was implanted in the context of an independent clinical trial (P16-006-V1) [16,17]. ...
... The AkkoLens Lumina consists of two optical elements, which move one over the other in a plane perpendicular to the optical axis, aiming to produce a continuous variable-focus lens and change the dioptric Fig. 1 PSF Strehl ratio with and without low-order aberration for each group, obtained with a pyramidal wavefront sensor-based aberrometer, and level of significance compared to the monofocal spherical control group. *P < 0.05, **P < 0.001 power of the system while they change their position [16,17]. We found a good level of PSFw2 Strehl ratio, even though significantly lower when compared to the monofocal spherical group (0.32 ± 0.11 and 0.23 ± 0.16 at 3.0 and 4.0 mm, respectively; P < 0.0001). ...
Background:
To study and compare the clinical optical image quality following implantation with different premium IOLs by analysing the point spread function (PSF) Strehl ratio using a pyramidal wavefront sensor (PWS)-based aberrometer.
Methods:
This study included 194 eyes implanted with: (a) 19 AcrySof SA60AT (control group); (b) 19 Miniwell; (c) 24 LENTIS Mplus LS-313 MF30; d) 33 LENTIS Mplus LS-313 MF15; (e) 17 AkkoLens Lumina; (f) 31 AT LISA Tri 839MP; (g) 20 Precizon Presbyopic; (h) 20 AcrySof IQ PanOptix; (i) 11 Tecnis Eyhance. Main outcome measures were PSF Strehl ratio, PSF Strehl ratio excluding second-order aberrations (PSFw2), total root mean square (RMS), low-order aberration (LOA) and high-order aberration (HOA) RMS measured by PWS aberrometer.
Results:
AT LISA Tri had the highest PSFw2 Strehl ratio at both 3.0- and 4.0-mm pupil size (0.52 ± 0.14 and 0.31 ± 0.10; P < 0.05), followed by SA60AT (0.41 ± 0.11 and 0.28 ± 0.07) and PanOptix (0.4 ± 0.07 and 0.26 ± 0.04). AT LISA Tri was found to provide a significantly better retinal image quality than PanOptix at both 3.0 mm (P < 0.0001) and 4.0 mm (P = 0.004). Mplus MF15 was found to be significantly better than Mplus MF30 at both 3.0 mm (P < 0.0001) and 4.0 mm (P = 0.002). Total RMS, LOA RMS, HOA RMS, PSF Strehl ratio and PSFw2 varied significantly between the studied groups (P < 0.001).
Conclusions:
Far distance clinical image quality parameters measured by PWS aberrometer differed significantly according to the technology of the implanted lens. AT LISA Tri, SA60AT and PanOptix showed the highest values of far distance retinal image quality, while the lowest PSFw2 Strehl ratios were displayed by Miniwell, Mplus MF30 and Precizon Presbyopic.
... Multifocal IOLs can be divided into the following categories according to the number of focal points: bifocals (which incorporate a far and a near focus), trifocal IOLs (which include an additional intermediate distance point), and extended depth of focus IOLs (which boast an extended far focus area that reaches intermediate distances). According to the optical design and physical principles applied, multifocal IOLs employ diffractive optics, offer zones of differing refractive power, or induce spherical aberration [43]. A diffractive IOL generates multifocality based on light interference. ...
... The IC-8 IOL (AcuFocus, Inc., Irvine, CA, USA) creates an extended and continuous range of functional vision, similar to as done by the KAMRA corneal inlay (AcuFocus, Inc., Irvine, CA, USA). An accommodative IOL attempts to adjust the focus for different distances by way of an axial shift of a fixed-power lens, change of lens curvature, or variable-focus optics with two optical elements [43]. An alternative to multifocal and accommodative IOLs for reducing spectacle dependence is monovision, where the distant eye is targeted for emmetropia, and the non-dominant eye for myopia. ...
Purpose
Cataract surgery has evolved into a procedure that generally yields the best postoperative refractive result attainable. Patients with multifocal intraocular lenses (IOLs) present higher rates of spectacle independence, although reduced intermediate vision, dysphotopsias, and a loss of image quality might also be experienced. The aim of the study was to review the methods for assessing quality of life and vision in patients undergoing lens refractive surgery in randomized controlled trials.
Methods
We reviewed the PubMed web platform to identify relevant studies using the following keywords: quality of life, quality of vision, lens surgery, lens exchange, refractive lens exchange, cataract, cataract surgery, intraocular lens, IOL, multifocal, and monovision.
Results
An increasing number of studies have focused on patient-reported outcomes (PROs). Only a few of the available visual function questionnaires can be regarded as useful in lens refractive surgery with multifocal IOL implantation. Many self-developed questionnaires have emerged that have not been adequately validated or found to feature properly evaluated repeatability, hampering the possibility of comparing outcomes.
Conclusions
This review describes the existing PROs instruments and informs the choice of an appropriate measure in lens refractive surgery. Rasch-developed tools should be utilized for measuring quality of life and vision in patients undergoing lens refractive surgery and there is a number of highly robust tools available.
... После проведения транссекции ИОЛ фемтосекундным лазером в зоне воздействия лазера при электронной микроскопии была выявлена шероховатая поверхность с углублениями от 6 до 25 мкм, расположенными рядами (рис. 4,5). ...
... Кроме того, быстрое развитие и совершенствование ИОЛ приводит к созданию ИОЛ со сложным дизайном, которые могут увеличить потребность и сложность эксплантации различных видов ИОЛ [4]. ...
... This lens has to be implanted at the sulcus, and its size is customized based on the sulcus to sulcus diameter, measured by an OCT at the 12 o'clock meridian. [119] This lens is not yet commercially available. ...
... It has been proven through subjective and objective methods that the Lumina IOL improves near, intermediate and far vision without affecting contrast sensitivity, with an accommodative power between 1.5 and 6.0D. [119] Authors' comments ...
Presbyopia results from loss or insufficiency of the eye's accommodative ability, and clinically manifests as the inability to focus near objects on the retina. It is one of the most common causes of visual impairment worldwide especially in adults of productive or working age. Various means of compensating for the loss of accommodative ability have been devised from optical tools such as spectacles and contact lenses, to topical medications and to surgical procedures. A comprehensive search on journal articles about topical and surgical correction of presbyopia was undertaken. The various techniques for presbyopia correction, as enumerated in these articles, are discussed in this paper with the addition of our personal experience and perspective on the future of these techniques.
... The near visual properties of our patients, particularly the ability to read, can be affected by many eye diseases. Since the treatment of eye diseases could be significantly improved, and patients who suffer from sight-threatening eye disease share a desire to regain a comfortable reading ability, it is evident that there is increasing clinical interest in well-standardized, calibrated reading charts [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]. Accordingly, this review gives an overview of the history and background of modern logarithmically progressing reading charts that can be considered calibrated for the assessment of functional vision [16,17]. ...
... Clinical outcome studies using calibrated reading charts began appearing in 2002 [1], when the reading performance obtained with a diffractive multifocal IOL was compared to that of a refractive IOL with the RADNER Reading Charts. Since then, a number of studies performed with these standardized logarithmic reading charts have shown that it is possible to obtain detailed information about the reading performance achieved with bi-and multifocal IOLs [1][2][3][4][5][6][7][8][9], monofocal IOLs [9, 10], or following LASIK/LASEK [11] or refractive laser treatment for presbyopia [12][13][14]. In addition, the reading performance of patients with different types of cataracts [67] has been analyzed, and the potential for using such reading charts to discriminate among visual impairments caused by cataracts and age-related maculopathy has also been demonstrated [68]. ...
A new generation of logarithmic reading charts has sparked interest in standardized reading performance analyses. Such reading charts have been developed according to the standards of the International Council of Ophthalmology. The print size progression in these calibrated charts is in accordance with the mathematical background of EN ISO 8596. These reading charts are: the Bailey–Lovie Word Reading Chart, the Colenbrander English Continuous Text Near Vision Cards, the Oculus Reading Probe II, the MNREAD Charts, the SKread Charts, and the RADNER Reading Charts. The test items used for these reading charts differ among the charts and are standardized to various extents. The Bailey–Lovie Charts, MNREAD Charts, SKread Charts, and RADNER Charts are also meant to measure reading speed and allow determination of further reading parameters such as reading acuity, reading speed based on reading acuity, critical print size, reading score, and logMAR/logRAD ratio. Such calibrated reading charts have already provided valuable insights into the reading performance of patients in many research studies. They are available in many languages and thus facilitate international communication about near visual performance. In the present review article, the backgrounds of these modern reading charts are presented, and their different levels of test-item standardization are discussed. Clinical research studies are mentioned, and a discussion about the immoderately high number of reading acuity notations is included. Using the logReading Acuity Determination ([logRAD] = reading acuity equivalent of logMAR) measure for research purposes would give reading acuity its own identity as a standardized reading parameter in ophthalmology.
... The Lumina accommodative IOL is specifically designed to provide accommodation by moving the optic forward. A study assessing the visual outcomes and accommodative response of the Lumina IOL found that the IOL effectively restored visual function, accommodation, and contrast sensitivity after cataract surgery [95]. However, the efficacy of this IOL design is limited to providing pseudoaccommodation [96,97]. ...
Cataracts, an inevitable consequence of aging, affect people worldwide [1]. This age-related condition is accompanied by another visual problem, presbyopia, the gradual decline in near vision [2]. Projections estimate that the global prevalence of presbyopia will reach approximately 1.8 billion people by 2050 [3]. While eyeglasses serve as the traditional solution for presbyopia, a growing number of people are seeking a more comprehensive solution.
... A dual optic design allows for a larger accommodative range (approximately 2.5 D/mm movement compared to < 2 D/mm with a mono-optic IOL) [109] from separation of the high plus-powered anterior and negative posterior optics [110], and was found to give stable reading performance [111] and an average range of focus of approximately 3.5 D [112], slightly outperforming a hinge optic IOL [113]. Variable focus IOLs based on lateral shifts of two lenses with cubic-type surfaces (such as the Alvarez design) have also been conceived [114] and tested [115,116]. ...
Cataract surgery including intraocular lens (IOL) insertion, has been refined extensively since the first such procedure by Sir Harold Ridley in 1949. The intentional creation of monovision with IOLs using monofocal IOL designs has been reported since 1984. The first reported implantation of multifocal IOLs was published in 1987. Since then, various refractive and or diffractive multifocal IOLs have been commercialised. Most are concentric, but segmented IOLs are also available. The most popular are trifocal designs (overlaying two diffractive patterns to achieve additional focal planes at intermediate and near distances) and extended depth of focus designs which leave the patient largely spectacle independent with the reduced risk of bothersome contrast reduction and glare. As well as mini-monovision, surgical strategies to minimise the impact of presbyopia with IOLs includes mixing and matching lenses between the eyes and using IOLs whose power can be adjusted post-implantation. Various IOL designs to mimic the accommodative process have been tried including hinge optics, dual optics, lateral shifts lenses with cubic-type surfaces, lens refilling and curvature changing approaches, but issues in maintaining the active mechanism with post-surgical fibrosis, without causing ocular inflammation, remain a challenge. With careful patient selection, satisfaction rates with IOLs to manage presbyopia are high and anatomical or physiological complications rates are no higher than with monofocal IOLs.
... [127][128][129] Accommodative IOLs are intended to allow IOL movement toward the cornea or variablefocus optics; however, studies on these IOLs report a variable degree of improvement of accommodative abitlity. 130,131 Pure EDOF IOLs, which are EDOFs with continuous optical profiles, might, for example, increase the DOF by increasing the spherical aberration of the eye or by employing the pinhole effect. 3,132 Multifocal IOLs have two or more distinct foci at different distances within their optical zone. ...
Purpose
To discuss factors influencing corneal aberrations that might influence the optical quality after intraocular lens (IOL) implantation.
Methods
PubMed and Scopus were the main resources used to search the medical literature. An extensive search was performed to identify relevant articles concerning factors influencing the level of corneal aberrations as of August 27, 2023. The following keywords were used in various combinations: corneal, aberrations, defocus, astigmatism, spherical aberration, coma, trefoil, quadrafoil, intraocular lens, and IOL.
Results
Conclusive evidence is lacking regarding the correlation between age and changes in corneal aberrations. Patients with astigmatism have greater corneal higher-order aberrations than those with minimal astigmatism, particularly concerning trefoil and coma. Increased levels of corneal higher-order aberrations are noted following contact lens wear, in patients with dry eye disease, and with pterygium. Increased higher-order aberrations have been reported following corneal refractive surgery and for 3 months following trabeculectomy; regarding intraocular lens surgery, the results remain controversial.
Conclusions
Several factors influence the level of corneal higher-order aberrations. Multifocal and extended depth-of-focus IOLs can share similarities in their optical properties, and the main difference arises in their design and performance with respect to spherical aberration. Preoperative evaluation is critical for proper IOL choice, particularly in corneas with risk of high levels of aberrations.
[ J Refract Surg . 2024;40(6):e420–e434.]
... The Lumina accommodative intraocular lens is based on the Alvarez principle which implements 2 lenses being translated perpendicular to the optical axis [1,2]. The mechanism is driven by direct action from the ciliary body. ...
Aims/Purpose: To develop a method for measuring the exact dimensions of the ciliary sulcus in order to improve the predictability of accommodative intraocular lens sizing.
Methods: Patients scheduled for cataract surgery have been pre‐operatively examined with the anterior segment optical coherence tomographer (AS‐OCT) CASIA2 (Tomey, Nagoya, Japan). Optimized scan protocols were defined to improve the image quality of the ciliary structures. The horizontal scan from 0° to 180° was taken to represent the space where a sulcus‐fixated accommodative intraocular lens (IOL), whose diameter must agree with that of the ciliary sulcus, may be placed. The images were corrected for the optical distortion induced by the cornea's refraction. The sulcus‐to‐sulcus (STS) size as well as the depth of the sulcus plane (SPD) was measured using the integrated software calliper by two independent raters. Inter‐rater variability and correlation were evaluated. In addition, STS measurements were compared to other ocular diameter measures, such as angle‐to‐angle (ATA) and anterior chamber width (ACW). Data were analysed by means of correlation coefficient R ² and Bland–Altmann analysis.
Results: 55 eyes of 28 patients were included in the study. The optimized scan protocols improved overall image quality and subjective visibility of ciliary anatomy compared to the default protocol. STS ranged from 10.66 mm to 12.89 mm, ACW from 10.76 mm to 12.74 mm and ATA from 10.69 to 12.46 mm. SPD ranged from 3.73 mm to 5.0 mm, while ATA depth was between 2.74 mm and 3.95 mm. Readings of both raters were highly correlated ( R ² > 0.98). Manual readings of STS correlated poorly with automated ACW and ATA measurements ( R ² < 0.66). The mean difference was 0.018 mm for STS and −0.011 mm for SPD. The levels of agreement were within [−0.109; +0.145] mm for STS and [−0.112; +0.091] mm for SPD.
Conclusions: Despite the absorption of light by the iris pigment, the infrared light from the AS‐OCT is able to penetrate the posterior chamber to some degree. Therefore, the new AS‐OCT method for sulcus‐to‐sulcus and ciliary dimensions measurements seems to be feasible, reliable and is less bothersome for the patients compared to ultrasound bio‐microscopy. This approach could be useful for sulcus fixated accommodative IOLs and for sizing determination of posterior chamber phakic IOLs.
... Despite the differences in spherical aberration of the Art40 and Art70, the values of contrast sensitivity are similar for all spatial frequencies and comparable with monofocal IOLs. 31 Our findings disclose high patient satisfaction with the Art40/Art70 combination in terms of glasses independence and photic phenomena. The majority of the patients (71.4%) were completely independent of glasses. ...
Purpose
To evaluate visual performance, spectacle independence, and quality of vision of new intraocular lenses (IOLs) for presbyopia correction with an aspheric inverted meniscus optical design (ArtIOLs; Voptica SL) in patients undergoing bilateral cataract surgery.
Methods
In this prospective study, 60 eyes from 30 patients implanted bilaterally with Art40 and Art70 IOLs were included. These new IOLs were designed with an inverted meniscus shape to improve the peripheral performance and with aspheric surfaces to induce different amounts of negative spherical aberration in each IOL model. Distance-corrected and uncorrected through-focus visual acuities and contrast sensitivity were measured 1 to 3 months after surgery. Twenty-eight patients answered Patient Reported Spectacle Independence (PRSIQ) and Quality of Vision (QoV) questionnaires.
Results
Mean monocular (Art40 and Art70) and binocular (Art40/70) corrected distance visual acuities (CDVA) were zero logMAR (20/20). Binocular uncorrected distance visual acuity (UDVA) at far, intermediate (66 cm), and near (40 cm) distances was 0.00 ± 0.01, 0.01 ± 0.03, and 0.09 ± 0.09 logMAR, respectively. Spectacle independence was achieved by 24 (85.7%) patients for far and intermediate vision and 20 patients (71.4%) for near vision. The number of patients never reporting experiencing glare, halos, and starbursts was 28, 27, and 26 (100%, 96.4%, and 92.9%), respectively.
Conclusions
The binocular combination of two ArtIOLs models (Art40 and Art70) significantly extended the depth of focus up to at least 40 cm. This combination resulted in a full range of vision with a high level of spectacle independence and without the compromise of halos or dysphotopsias.
[ J Refract Surg . 2023;39(9):582–588.]
... 3e5 Although Duane had to rely solely on subjective measures, recent developments such as accommodating intraocular lenses (IOLs) with a shifting focal point brought up the need for objective measures of accommodation. 6 Before this study, several approaches to objectively measure accommodation with inherent advantages and disadvantages have been proposed. An overview is presented in Table 1. ...
Purpose
The objective measurement of binocular accommodation remains a challenge. The Dynamic Stimulation Aberrometry System (DSA) uses wavefront measurements to dynamically assess accommodation. In this study, we sought to introduce this method in a large number of patients of varying age and compare it to the subjective push-up method as well as historical results of Duane.
Design
This study is an evaluation of diagnostic technology.
Subjects
91 patients aged 20 to 67 years (70 healthy, phakic eyes and 21 myopic eyes after phakic intraocular lens implantation) were enrolled at a tertiary eye hospital.
Methods
All patients underwent DSA measurements, the accommodative amplitude of 13 patients chosen at random was additionally examined using the subjective push-up method introduced by Duane. DSA measurements were also compared to Duane’s historical results.
Main outcome measures
Accommodative amplitude, dynamic parameters of accommodation and near pupil motility.
Results
DSA allowed the objective measurement of binocular accommodation which decreased with age (e.g. 30-39 year olds vs >50 years old 3.8 +/- 0.9 dpt and 0.1 +/- 0.4 dpt, respectively). Dynamic parameters, such as the time delay of the commencement of accommodation after near target presentation, increased with age (0.26s +/- 0.14 for 20-30-year-olds and 0.43s +/- 0.15 for 40-50-year-olds, p=0.0002). The objective accommodative amplitude was significantly smaller compared to Duane’s historic results (p=0.001) as well as the subjective push-up method. DSA records pupil motility dynamically in parallel to wavefront measurements. Maximum pupil motility during accommodation significantly decreased with age (p=0.0002). Maximum pupillary speed did not correlate significantly with age.
Conclusion
DSA allows the objective, dynamic, binocular measurement of accommodation and pupil motility with a high time-resolution in subjects with accommodative amplitudes up to 7 dpt. This article introduces the method in a large study population and may serve as a control for further studies.
... There are reports in the literature that lens placement in the sulcus improves visual outcome [15], thus representing the better location for lens placement than the capsular bag [13] [16] [17]. However, this aspect is controversial [16], as sulcus placement may cause a potential outflow obstruction [18]. ...
... However, the multifocal diffractive lenses are affected by the same source of bias and, in this way, the IOLs of this group can be compared among themselves. It is the same with refractive lenses, and less affected by the light dispersion that affects the diffractive models and does not affect the accommodative lens analysed in this group and which has been the subject of previous publications [4,5]. ...
... Single-optic AIOL have flexible supporting elements to transmit ciliary muscle contraction into an anterior displacement of the lens optic, resulting in increased dioptric power of the eye to improve near vision [173]. Experimental evidence suggests that beyond 6 months, the emptied capsular bag is unable to provide any significant dynamic force to an intracapsular located device [174], suggesting that sulcus placement of AIOLs may be needed [175][176][177]. A dual-optic lens design essentially consists of two separate optics: a high-powered 'plus' anterior optic of fixed dioptric power and a 'minus' posterior optic, coupled by spring haptics [178]. ...
Refractive surgery refers to any procedure that corrects or minimizes refractive errors. Today, refractive surgery has evolved beyond the traditional laser refractive surgery, embodied by the popular laser in situ keratomileusis or ‘LASIK’. New keratorefractive techniques such as small incision lenticule extraction (SMILE) avoids corneal flap creation and uses a single laser device, while advances in surface ablation techniques have seen a resurgence in its popularity. Presbyopic treatment options have also expanded to include new ablation profiles, intracorneal implants, and phakic intraocular implants. With the improved safety and efficacy of refractive lens exchange, a wider variety of intraocular lens implants with advanced optics provide more options for refractive correction in carefully selected patients. In this review, we also discuss possible developments in refractive surgery beyond 2020, such as preoperative evaluation of refractive patients using machine learning and artificial intelligence, potential use of stromal lenticules harvested from SMILE for presbyopic treatments, and various advances in intraocular lens implants that may provide a closer to ‘physiological correction’ of refractive errors.
... Other optical concepts such as the pinhole effect [41] or light sword optical element [42] might be employed. Accommodating IOLs may change their curvature, or have a fixed-power presenting axial shift in order to restore accommodation ( Fig. 3.2d) [43]. Ametropia following cataract surgery can be treated by performing a corneal refractive enhancement. ...
Cataract surgery is the most common surgical procedure performed in medicine. In the 2015 over 20 million surgeries were carried out worldwide, of which 3.6 million in the United States of America and 4.2 million in the European Union. The progress in technology enabled cataract surgery to be the safest and most predictable eye surgery. On the other hand, the increase in life expectancy and quality of life result in higher surmises regarding the outcomes. Currently, individuals over 70 years of age might be declared inactive or retired, however, still wish to maintain an active lifestyle, including driving a car and performing sports. Subsequently, there is a demand for techniques that are even more perfect. New encounters include surgeries performed on patients with dementia and other comorbidities related with ageing. The anticipated duration of intraocular lens in the eye has significantly increased. Thus physico-chemical characteristics and endurance should allow the lens to keep its’ optical properties for up to three decades. The most significant advances in cataract surgery will be briefly discussed within this chapter.
... Bardzo dobre wyniki daje wszczepienie soczewek akomodujących AkkoLens Lumina, o dwóch elementach optycznych, do rowka ciała rzęskowego podczas operacji zaćmy[13]. W grupie 61 pacjentów, u których wszcze- piono tę soczewkę, uzyskano średnią akomodację na po- ziomie 0,63-1,27 Dsph, po stymulacji bodźcem akomo- dacyjnym 2,0-4,0 D. Coraz częściej wykonywane są na świecie zabiegi refrak- cyjnej wymiany soczewki (RLE, refractive lens exchange). Z definicji pacjenci poddani RLE mają przezierną so- czewkę własną, brak zaćmy, a także odmienną budowę gałki ocznej, będącą wskazaniem do RLE ...
W ostatnich latach obserwujemy intensywny rozwój technik chirurgicznej korekcji prezbiopii. Monowizja jest metodą powszechnie stosowaną w chirurgii refrakcyjnej oraz chirurgii zaćmy, polegającą na celowym wytworzeniu różnowzroczności. W procedurach chirurgii refrakcyjnej korekcja prezbiopii może być uzyskana poprzez zastosowanie mikro- lub minimonowizji, wytworzenie stref o różnej mocy optycznej, a także zwiększenie głębi ostrości poprzez indukcję aberracji sferycznej. W chirurgii zaćmy stosowane są soczewki jedno-, dwu-, trzy- oraz wieloogniskowe refrakcyjne lub dyfrakcyjne, w tym soczewki o zwiększonej głębi ostrości. Możliwe jest również wykonanie refrakcyjnej wymiany soczewki lub wszczepienie soczewki wewnątrzgałkowej fakijnej, zwłaszcza przy współistniejącej dużej wadzie refrakcji.
... 71 Accommodation is a reflex increase in the dioptric power of the lens that allows focus from far to near. Objective measurements of accommodation are important to evaluate treatments such as accommodative intraocular lenses (IOLs) and scleral expansion techniques that claim to restore accommodation 7,46,72 and to determine the extent to which near-vision performance may be increased by mechanisms other than a real accommodative gain (pseudoaccommodation). Subjective tests of near-and intermediate-vision performance are more relevant to patient satisfaction, but there is no current agreed standard for methods used or test distances. ...
... The AkkoLens Lumina (AkkoLens Clinical, Breda, The Netherlands) (Fig. 2) The AkkoLens is a dual optic hydrophilic acrylic lens that sits in the sulcus. Alio et al. [11] showed the lens can provide a statistically significant improvement in distance-corrected near vision (0.11 ± 0.12 logRAD) which is nearly 20/25, compared with Alcon SN60AT monofocal control (0.37 ± 0.19 logRAD), which is closer to 20/40 (p < 0.01), without a significant difference in UDVA, CDVA (p ≥ 0.21), or contrast sensitivity (p ≥ 0.26). There are theoretical concerns about this being a sulcus IOL; however, these data seem promising. ...
Purpose of Review
The aim of this paper is to provide an overview of published literature evaluating new refractive intraocular lenses (IOLs).
Recent Findings
Six categories of refractive IOLs are either currently commercialized in various regions (notably Europe) or under investigation for the treatment of presbyopia. No single category has emerged as a clear market leader, re-emphasizing the need for surgeons to individualize their treatment approaches.
Summary
The newest refractive IOLs provide good outcomes with minimal complications. However, the categories studied each have their own strengths and weaknesses. Despite advancements, there are still significant opportunities to meet the unmet refractive needs through additional research and development in intraocular lenses.
... Harman et al (43) reported that 19.0% of the 1CU group were completely spectacle independent, compared to none of the monofocal group, and that a higher proportion of the monofocal group, 72.2%, required glasses for all reading tasks, compared with 23.8% of the 1CU group (p = 0.049). One RCT compared the Lumina lens to a monofocal and reported no difference in contrast sensitivity (82). Results from case-control and cohort-control studies were similar. ...
Purpose
Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium options including premium intraocular lens implants (IOLs) or laser-assisted cataract surgery (LACS). This report provides a systematic review evaluating patient-centered and visual quality outcomes comparing standard monofocal IOLs to premium cataract surgery options.
Methods
PubMed and EMBASE were searched for publications published between January 1, 1980, and September 18, 2016, on multifocal, accommodative, and toric IOLs, monovision, and LACS, which reported on 1) dysphotopsias, 2) contrast sensitivity, 3) spectacle independence, 4) vision-related quality of life or patient satisfaction, and 5) IOL exchange.
Results
Multifocal lenses achieved higher rates of spectacle independence compared to monofocal lenses but also had higher reported frequency of dysphotopsia and worse contrast sensitivity, especially with low light or glare. Accommodative lenses were not associated with reduced contrast sensitivity or more dysphotopsia but had only modest improvements in spectacle independence compared to monofocal lenses. Studies of monovision did not target a sufficiently myopic outcome in the near-vision eye to achieve the full potential for spectacle independence. Patients reported high levels of overall satisfaction regardless of implanted IOL. No studies correlated patient-reported outcomes with patient expectations.
Conclusions
Studies are needed to thoroughly compare patient-reported outcomes with concomitant patient expectations. In light of the substantial patient costs for premium options, patients and their surgeons will benefit from a better understanding of which surgical options best meet patients’ expectations and how those expectations can be impacted by premium versus monofocal—including monovision—options.
... As the IOL spring is bent by the capsula lentis, the position of the IOL changes, resulting in a change in the lens' focus. Akkolens International BV have proposed an IOL called Lumina IOL [7] that is also set in the capsula lentis. This IOL contains two lenses that slide by deformation of the capsula lentis upon contraction of the ciliary muscle. ...
An ion polymer–metal composite (IPMC) actuator has unique performance characteristics that were applied in this study for use within the eye. Cataracts are a common eye disease causing clouding of the lens. To treat cataracts, surgeons replace clouded lenses with intraocular lenses (IOLs). However, patients who receive this treatment must still wear reading glasses for tasks requiring close-up vision. We suggest a new voltage-controlled accommodating IOL consisting of an IPMC actuator to change the lens’ focus. We examined the relationship between the displacement performance of an IPMC actuator and the accommodating range of the IOL using in vitro experiments. We show that this system has an accommodating range of approximately 1.15 D under an applied voltage of ±1.2 V. By Lagrange interpolation, we estimate that with an IPMC actuator displacement of 0.14 mm, we can achieve a refractive power of 4 D, which is equivalent to the accommodating range of a 40 year old person.
Purpose
To report the outcomes of a Phase III Clinical Study with the sulcus-based Lumina accommodative intraocular lens (IOL) (Akkolens, Clinical BV) with 12 months of postoperative follow-up.
Methods
This was a prospective, interventional, non-comparative, longitudinal and consecutive study developed at the Cornea, Cataract, and Refractive Surgery Unit at Vissum, Grupo Miranza, Alicante, Spain. It was composed of 25 patients who were bilaterally implanted with the Lumina accommodative IOL and had undergone a 12-month postoperative evaluation including visual and refractive variables, defocus curve, objective accommodation, contrast sensitivity function, retinal optical quality assessment, and patient-reported outcome measures (PROMs). The Wilcoxon test was applied for all longitudinal comparisons.
Results
All distance and near visual acuities improved after the surgery ( P < .05). Distance and near mean postoperative uncorrected visual acuities were 0.06 ± 0.15 and 0.27 ± 0.15 logarithm of the minimum angle of resolution (logMAR), respectively. The defocus curve exhibited a corrected vision of −0.01 ± 0.06 at distance, 0.18 ± 0.11 at intermediate, and 0.38 ± 0.13 at near vision. The subjective depth of focus, as determined from the defocus curve, was 1.37 ± 0.74, 2.05 ± 0.75, and 3.63 ± 0.68 diopters (D) for visual acuities of 0.10, 0.20, and 0.40 logMAR. The mean objective accommodation was −0.65 ± 0.69 D. The contrast sensitivity function exhibited better results than normal values and the optical quality revealed a mean point spread function of 0.23 μm. In the PROMs, more than 87% of patients reported mild or no difficulties in uncorrected near vision. The complication rate was low; only posterior capsule opacity and epithelial type were common but being successfully treated by laser capsulotomy improved the uncorrected near vision ( P = .018). PROMs also revealed a perceived good functional result in far and near vision performance, with minimal or negative abnormal light visual phenomena.
Conclusions
The Lumina sulcus-based accommodative IOL provides generally good distance vision maintaining a suitable contrast sensitivity and optical quality. Near vision also was restored conveniently. The lens demonstrated both accommodative and pseudoaccommodative functions. The lack of complications other than posterior capsular opacity confirms the adequate performance of this implant and the preservation of accommodation after capsulotomy.
[ J Refract Surg . 2025;41(4):e374–e381.]
Purpose
To explore the features of the dominant and non-dominant eyes in patients with cataracts and predict ocular dominance shift (ODS) based on preoperative indicators.
Design
and setting: This prospective, observational study was conducted in Changsha Aier Eye Hospital in Changsha, Hunan province, China.
Methods
Patients with age-related cataracts who underwent unilateral cataract surgery were enrolled in this study. Before the procedure, uncorrected visual acuity (UCVA) was assessed, and non-cycloplegic subjective refraction evaluations were conducted to determine best-corrected visual acuity (BCVA). Total astigmatism, corneal astigmatism, and intraocular astigmatism were measured using OPD-Scan III. Cataract type was assessed using slit-lamp biomicroscopy based on the Lens Opacities Classification System III (LOCS III). Ocular dominance (OD) was determined under corrected conditions using the hole-in-card test. Follow-up visits occurred at 1 day, 1 week, and 1-month post-surgery. After 1 month, OD was re-evaluated, and participants completed the Catquest-9SF questionnaire.
Results
94 patients (188 eyes) were enrolled in the study. The analysis showed that the ODS rate of unilateral cataract surgery was 40.4%. In addition, age, uncorrected visual acuity of non-dominant eye, posterior subcapsular cataract and total astigmatism are risk factors for ODS. Besides, no difference in vision-related quality of life was detected between patients who had ODS and those who did not.
Conclusions
We identified several preoperative parameters as potential risk factors of ODS after cataract surgery. These findings provide guidance for predicting changes in the dominant eye, thus improve the precise selection of intraocular lenses and the implementation of monovision strategies.
Clinical, prospective, open label, single-arm study to evaluate the efficacy (visual data), function (accommodative power), Patient-reported outcome measures (PROMs)
and to compare pre- and postoperative clinical results in different phases of the follow-up
Presbyopia occurs when the physiologically normal age-related reduction in the eyes focusing range reaches a point, when optimally corrected for distance vision, that the clarity of vision at near is insufficient to satisfy an individual’s requirements. Hence, it is more about the impact it has on an individual’s visual ability to function in their environment to maintain their lifestyle than a measured loss of focusing ability. Presbyopia has a significant impact on an individual’s quality of life and emotional state. While a range of amelioration strategies exist, they are often difficult to access in the developing world and prescribing is generally not optimal even in developed countries. This review identified the need for a standardised definition of presbyopia to be adopted. An appropriate battery of tests should be applied in evaluating presbyopic management options and the results of clinical trials should be published (even if unsuccessful) to accelerate the provision of better outcomes for presbyopes.
Importance
A bayesian network meta-analysis (NMA) can help compare the various types of multifocal and monofocal intraocular lenses (IOLs) used in clinical practice.
Objective
To compare outcomes of presbyopia-correcting IOLs frequently recommended in clinical practice through a bayesian NMA based on a systematic review.
Data Sources
Medline (PubMed) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched on May 15, 2021, from inception.
Study Selection
Based on the research question, randomized clinical trials assessing multifocal IOLs in patients who underwent bilateral cataract extraction were searched. Nonrandomized studies, studies in patients with unilateral or contralateral cataract extractions, duplicated studies, conference abstracts, and nonpeer-reviewed articles were excluded.
Data Extraction and Synthesis
Descriptive statistics and outcomes were extracted. The NMA was conducted to compare different types of IOLs. The mean differences for continuous variables, odds ratios for binary variables, 95% credible intervals (CrIs), and ranks of interventions were estimated.
Main Outcomes and Measures
The outcomes examined included binocular visual acuities by distance and optical quality, including glare, halos, and spectacle independence.
Results
This NMA included 27 studies comprising 2605 patients. For uncorrected near visual acuity, trifocal IOLs (mean difference, −0.32 [95% CrI, −0.46 to −0.19]) and old bifocal diffractive IOLs (mean difference, −0.33 [95% CrI, −0.50 to −0.14]) afforded better visual acuity than monofocal IOLs. Regarding uncorrected intermediate visual acuity, extended depth-of-focus IOLs provided better visual acuity than monofocal IOLs. However, there were no differences between extended depth-of-focus and trifocal diffractive IOLs in pairwise comparisons. For uncorrected distant visual acuity, all multifocal IOLs were comparable with monofocal IOLs. There were no statistical differences between multifocal and monofocal IOLs regarding contrast sensitivity, glare, or halos.
Conclusions and Relevance
For patients considering a multifocal IOL due to presbyopia, bilateral implantation of a trifocal IOL might be an optimal option for patients without compromising distant visual acuity.
Accommodation is a reflex increase in the power of the lens that allows focus from far to near; as we age there is a gradual loss of the amplitude of accommodation, and around age 40 presbyopia becomes clinically manifest. Presbyopia is associated with a decreased quality of life because patients become spectacle dependent for performing daily activities like reading, working on a computer or seeing the car dashboard. Unlike other refractive errors, presbyopia remains a challenge for the refractive surgeon. There are many approaches for its correction but there is not a “gold standard” mainly because it is a progressive condition and we have not yet achieved the restoration of accommodation. In this chapter we will describe the different approaches to presbyopia correction.
Background: Posterior capsule opacification (PCO) is a clouding of the posterior part of the lens capsule, a skin-like transparent structure, which surrounds the crystalline lens in the human eye. PCO is the most common postoperative complication following modern cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The main symptoms of PCO are a decrease in visual acuity, 'cloudy', blurred vision and reduced contrast sensitivity. PCO is treated with a neodymium:YAG (Nd:YAG) laser to create a small opening in the opaque capsule and regain a clear central visual axis. This capsulotomy might cause further ocular complications, such as raised intraocular pressure or swelling of the central retina (macular oedema). This procedure is also a significant financial burden for health care systems worldwide. In recent decades, there have been advances in the selection of IOL materials and optimisation of IOL designs to help prevent PCO formation after cataract surgery. These include changes to the side structures holding the lens in the centre of the lens capsule bag, called IOL haptics, and IOL optic edge designs.
To date, nanotechnology has increasingly been identified as a promising and efficient means to address a number of challenges associated with public health. In the past decade, two-dimensional (2D) biomaterials, as a unique nanoplatform with planar topology, have attracted explosive interest in various fields such as biomedicine due to their unique morphology, physicochemical properties and biological effect. Motivated by the progress of graphene in biomedicine, dozens of types of ultrathin 2D biomaterials have found versatile bio-Applications, including biosensing, biomedical imaging, delivery of therapeutic agents, cancer theranostics, tissue engineering, as well as others. The effective utilization of 2D biomaterials stems from the in-depth knowledge of structure-property-bioactivity-biosafety-Application-performance relationships. A comprehensive summary of 2D biomaterials for biomedicine is still lacking. In this comprehensive review, we aim to concentrate on the state-of-The-Art 2D biomaterials with a particular focus on their versatile biomedical applications. In particular, we discuss the design, fabrication and functionalization of 2D biomaterials used for diverse biomedical applications based on the up-To-date progress. Furthermore, the interactions between 2D biomaterials and biological systems on the spatial-Temporal scale are highlighted, which will deepen the understanding of the underlying action mechanism of 2D biomaterials aiding their design with improved functionalities. Finally, taking the bench-To-bedside as a focus, we conclude this review by proposing the current crucial issues/challenges and presenting the future development directions to advance the clinical translation of these emerging 2D biomaterials. This journal is
Background:
Posterior capsule opacification (PCO) is a clouding of the posterior part of the lens capsule, a skin-like transparent structure, which surrounds the crystalline lens in the human eye. PCO is the most common postoperative complication following modern cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The main symptoms of PCO are a decrease in visual acuity, 'cloudy', blurred vision and reduced contrast sensitivity. PCO is treated with a neodymium:YAG (Nd:YAG) laser to create a small opening in the opaque capsule and regain a clear central visual axis. This capsulotomy might cause further ocular complications, such as raised intraocular pressure or swelling of the central retina (macular oedema). This procedure is also a significant financial burden for health care systems worldwide. In recent decades, there have been advances in the selection of IOL materials and optimisation of IOL designs to help prevent PCO formation after cataract surgery. These include changes to the side structures holding the lens in the centre of the lens capsule bag, called IOL haptics, and IOL optic edge designs.
Objectives:
To compare the effects of different IOL optic edge designs on PCO after cataract surgery.
Search methods:
We searched CENTRAL, Ovid MEDLINE, Ovid Embase, Latin American and Caribbean Health Sciences Literature Database (LILACS), the ISRCTN registry, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to 17 November 2020.
Selection criteria:
We included randomised controlled trials (RCTs) that compared different types of IOL optic edge design. Our prespecified primary outcome was the proportion of eyes with Nd:YAG capsulotomy one year after surgery. Secondary outcomes included PCO score, best-corrected distance visual acuity (BCDVA) and quality of life score at one year. Due to availability of important long-term data, we also presented data at longer-term follow-up which is a post hoc change to our protocol.
Data collection and analysis:
We used standard methods expected by Cochrane and the GRADE approach to assess the certainty of the evidence.
Main results:
We included 10 studies (1065 people, 1834 eyes) that compared sharp- and round-edged IOLs. Eight of these studies were within-person studies whereby one eye received a sharp-edged IOL and the fellow eye a round-edged IOL. The IOL materials were acrylic (2 studies), silicone (4 studies), polymethyl methacrylate (PMMA, 3 studies) and different materials (1 study). The studies were conducted in Austria, Germany, India, Japan, Sweden and the UK. Five studies were at high risk of bias in at least one domain. We judged two studies to be at low risk of bias in all domains. There were few cases of Nd:YAG capsulotomy at one year (primary outcome): 1/371 in sharp-edged and 4/371 in round-edged groups. The effect estimate was in favour of sharp-edged IOLs but the confidence intervals were very wide and compatible with higher or lower chance of Nd:YAG capsulotomy in sharp-edged compared with round-edged lenses (Peto odds ratio (OR) 0.30, 95% CI 0.05 to 1.74; I2 = 0%; 6 studies, 742 eyes). This corresponds to seven fewer cases of Nd:YAG capsulotomy per 1000 sharp-edged IOLs inserted compared with round-edged IOLs (95% CI 9 fewer to 7 more). We judged this as low-certainty evidence, downgrading for imprecision and risk of bias. A similar reduced risk of Nd:YAG capsulotomy in sharp-edge compared with round-edge IOLs was seen at two, three and five years but as the number of Nd:YAG capsulotomy events increased with longer follow-up this effect was more precisely measured at longer follow-up: two years, risk ratio (RR) 0.35 (0.16 to 0.80); 703 eyes (6 studies); 89 fewer cases per 1000; three years, RR 0.21 (0.11 to 0.41); 538 eyes (6 studies); 170 fewer cases per 1000; five years, RR 0.21 (0.10 to 0.45); 306 eyes (4 studies); 331 fewer cases per 1000. Data at 9 years and 12 years were only available from one study. All studies reported a PCO score. Four studies reported the AQUA (Automated Quantification of After-Cataract) score, four studies reported the EPCO (Evaluation of PCO) score and two studies reported another method of quantifying PCO. It was not possible to pool these data due to the way they were reported, but all studies consistently reported a statistically significant lower average PCO score (of the order of 0.5 to 3 units) with sharp-edged IOLs compared with round-edged IOLs. We judged this to be moderate-certainty evidence downgrading for risk of bias. The logMAR visual acuity score was lower (better) in eyes that received a sharp-edged IOL but the difference was small and likely to be clinically unimportant at one year (mean difference (MD) -0.06 logMAR, 95% CI -0.12 to 0; 2 studies, 153 eyes; low-certainty evidence). Similar effects were seen at longer follow-up periods but non-statistically significant data were less fully reported: two years MD -0.01 logMAR (-0.05 to 0.02); 2 studies, 311 eyes; three years MD -0.09 logMAR (-0.22 to 0.03); 2 studies, 117 eyes; data at five years only available from one study. None of the studies reported quality of life. Very low-certainty evidence on adverse events did not suggest any important differences between the groups.
Authors' conclusions:
This review provides evidence that sharp-edged IOLs are likely to be associated with less PCO formation than round-edged IOLs, with less Nd:YAG capsulotomy. The effects on visual acuity were less certain. The impact of these lenses on quality of life has not been assessed and there are only very low-certainty comparative data on adverse events.
Clinical relevance: Ultrasound biomicroscopy is an objective method for assessing changes in anterior segment biometry. There is a paucity of data on the reliability of this method. A reliable method for assessing anterior segment changes during physiologically driven accommodation can be a useful tool for clinicians, researchers, and industry.
Background: To assess the test–retest reliability of ultrasound biomicroscopy for measurements of change in anterior chamber depth during a distance to near fixation task in pseudophakic subjects.
Methods: Subjects were adults with monofocal intraocular lenses implanted in both eyes who completed a 6-month post-operative period and had monocular uncorrected distance visual acuity of 6/15 (0.4 logMAR) or better. The change in anterior chamber depth during a distance to near fixation task was measured with a 35-MHz VuMAX HD ultrasound biomicroscopy device (Sonomed Escalon, New Hyde Park, NY) during two separate visits. An asymmetrical vergence paradigm allowed evaluation of anterior segment biometry at 22-µm axial resolution in one eye, while the fellow eye fixated on the target. To assess the test–retest reliability, 2-sided 95% CI from a paired t test was calculated for the difference in anterior chamber depth change from distance to near between visits.
Results: The mean (standard deviation) near-focused anterior chamber depth measured by ultrasound biomicroscopy was 4.331 (0.237) and 4.333 (0.241) mm at visits 1 and 2, respectively. In response to a change in fixation from distance (4 m) to near (40 cm), the mean anterior chamber depth change was −0.012 (0.038) and 0.003 (0.039) mm at visits 1 and 2, respectively. Analysis of the difference in the change in anterior chamber depth between visits was −0.015 mm (95% CI, −0.035 to 0.003).
Conclusion: Ultrasound biomicroscopy is a repeatable, objective method for assessing change in anterior segment biometry during physiological changes in fixation from distance to near.
Over the last couple of years, cataract surgery – already an intervention of high efficiency and safety – has undergone further refinement, not least because of new IOL technologies that have entered the market. In this overview, innovative IOL designs will be presented, some of which are already in clinical use (though sometimes primarily at specialized centers) while others will be introduced shortly. Based on our own clinical experience and without any claims to completeness (there are many innovations currently under development of which we know little), we will focus on technologies like IOLs that can be adjusted postoperatively, on lenses that strive to treat presbyopia (the so-called final frontier in refractive surgery), on small-aperture and EDOF lenses. Some IOL innovations will have a positive impact way beyond cataract surgery like the lens/sensor that is going to benefit the not so small number of patients who suffer simultaneously from cataract and glaucoma.
While intraocular lenses (IOL) are used to restore visual acuity in cataract patients, they are limited in their development as no clinically available lens can effectively mimic the accommodative function of the eye's natural lens. The optoelectronic properties of 2D transition metal carbides and/or nitrides (MXenes), including high electronic conductivity, optical transparency, flexibility, biocompatibility, and hydrophilicity, suggest potential use within an accommodating IOL. This study investigates the use of Ti3C2Tx (MXene) as a transparent, conductive electrode to allow changes in optical power. Ti3C2Tx is synthesized and spin‐coated on hydrophobic acrylate IOLs, achieving a sheet resistance ranging from 0.2–1.0 kΩ sq−1 with 50–80% transmittance in the visible region. Human lens epithelial and monocytic cells show no cytotoxic nor inflammatory response to the coated lenses. An adjustable focus test cell is fabricated using a liquid crystal (LC) layer sandwiched between Ti3C2Tx coatings on a solid support. Molecular reorientation of the LC layer, through an applied electric field, results in changes in optical power as objects viewed through the test cell appeared in and out of focus. This study is the first step toward the use of Ti3C2Tx within an accommodative IOL design through demonstration of reversible, controlled, adjustable focus. The development of intraocular lenses, used to treat cataracts, is limited as no clinically available lens has the ability to mimic the accommodative function of the eye's natural lens. Here, an optoelectronic approach to lens accommodation is investigated. The unique properties of the 2D transition metal carbides (MXenes) suggest their suitability for use within an accommodating lens design.
An improved understanding of ammetropia and its effect on visual quality have led to the latest developments in refractive surgery. Eyedrops for presbyopia target the crystalline lens to improve accommodation. Corneal inlays alter the curvature of the cornea to enhance vision at all distances. Diffractive and refractive multifocal intraocular lenses—which aim light at several discrete foci—and extended depth of focus intraocular lenses—which aim light in a continuous plane—improve vision at all distances. Accommodating intraocular lenses change power with accommodative effort. Corneal refractive surgeries like PRK and LASIK have been joined by Small Incision Lenticule Extraction (SMILE)—an all femtosecond laser flapless procedure. Phakic intraocular lens implantation is indicated for a wider range of refractive errors than corneal refractive procedures. These techniques allow for safer and more effective correction of refractive errors, and adequate monitoring of visual quality at all distances for new refractive surgery techniques.
The correction of presbyopia is still one of the major challenges that face the ophthalmologist in their daily practice. Several medical and surgical proposals have been developed, but none of them have showed the efficacy of restoring accommodation. Formulations of topical instilled medication, corneal excimer laser surgery, scleral devices, and intraocular lenses are among the different options that have been proposed for presbyopia correction. Nowadays, multifocal IOL are the most popular and accepted option for presbyopia correction, but this technology does not restore accommodation and induce photic phenomena that in some circumstances might be a serious limitation situation for the patient. With the aim of restoring accommodation and avoid disadvantages of multifocal IOL, accommodative IOL were developed several years ago. Nevertheless, some of the technologies proposed for this type of IOL have not shown to be effective in restoring accommodation. New advances in material and technologies have brought new designs that are in continuous development and may overcome the difficulties observed with previous types of accommodative IOLs.
Purpose: To present the refractive outcomes, comparative defocus curves, proposed mechanisms of action, and methods to mitigate IOL-specific complications of the Crystalens intraocular lens.
Purpose:
To compare objective and subjective accommodation and visual acuities with a new accommodative intraocular lens (IOL) (Lumina; AkkoLens Clinical BV, Rijswijk, The Netherlands) with a monofocal IOL and young phakic eyes.
Methods:
In this prospective, randomized controlled clinical investigation, patients aged 51 to 85 years with symptomatic cataract were enrolled in the study. A total of 25 eyes were implanted with the accommodative IOL and 18 eyes received the monofocal Acrysof SA60AT IOL (Alcon Laboratories, Inc., Fort Worth, TX). Each group included 4 bilateral patients. An additional 20 phakic eyes of young patients aged 19 to 29 years were used to assess the restoration of accommodation. Subjective and objective accommodative amplitudes were evaluated by defocus curves and the WAM-5500 open-field Auto Ref/Keratometer (Grand Seiko, Tokyo, Japan), respectively.
Results:
The 1-year postoperative examination showed significantly better visual acuities with the accommodative IOL compared to the monofocal IOL, over a defocus range of -0.50 to -5.00 diopters (D) (P < 10-5), and revealed more than 50% of the visual acuities of the young phakic eyes at up to -3.50 D defocus. The depth of focus of the accommodative group exceeded that of the monofocal group by 2.52 ± 0.03 D in a visual acuity range of 0.3 to 0.8 (decimal) (20/63 to 20/25 Snellen). Compared with the monofocal IOL, the accommodative IOL resulted in a similar uncorrected distance visual acuity of 0.99 ± 0.12 (20/20 Snellen) (P > .79) and a significantly better uncorrected near visual acuity of 0.91 ± 0.11 (20/22 Snellen) (P < 2.7 × 10-6). A significant correlation of 0.51 (P < 1.3 × 10-7) was found between the objective and subjective accommodative amplitudes with the accommodative IOL.
Conclusions:
Eyes implanted with the accommodative IOL showed similar amounts of objective and subjective accommodation. [J Refract Surg. 2018;34(2):78-83.].
With an explosive increase in the worldwide prevalence of presbyopia, development of an accommodating intraocular lens with expansive accommodative amplitude remains the holy grail in lens-based refractive surgery. A dynamic change in the dioptric power of the eye can be accomplished by various strategies alone or in combination, including changes in the position, shape, or refractive index of a single- or dual- optic intraocular lens (IOL). This article reviews the cumulative advances in these various lens designs, along with clinical outcomes and complications of those that have been implanted. The challenges that remain in each category are also highlighted.
Multifocal intraocular lenses (MfIOLs) are increasingly used in the management of pseudophakic presbyopia. After MfIOL implantation, most patients do not need spectacles or contact lenses and are pleased with the result. Complications, however, may affect the patient's quality of life and level of satisfaction. Common problems with multifocal lenses are blurred vision and photic phenomena associated with residual ammetropia, posterior capsule opacification, large pupil size, wavefront anomalies, dry eye, and lens decentration. The main reasons for theseare failure to neuroadapt, lens dislocation, residual refractive error, and lens opacification. To avoid patient dissatisfaction after MfIOLs implantation, it is important to considerer preoperatively the patient's life style, perform an exhaustive examination including biometry, topography and pupil reactivity, and explain the visual expectations and possible postoperative complications .
To study the mechanical dynamics between the zonuli-capsular complex and an accommodating intraocular lens mechanics simulator using pharmacological stimulation of the ciliary body in a primate eye.
Following phacoemulsification removal of the lens, force/movement gauges simulating the accommodating intraocular lens mechanics were implanted in 8 primate eyes (4 positioned in-the-bag and 4 on-the-bag). The gauge readings were taken under full effect of pilocarpine 4% or atropine 1% starting 6 weeks after surgery and following 3-month intervals for 30 months.
An average movement of 390 µm for on-the-bag gauges and 145 µm for in-the-bag gauges was documented at 3 months postoperatively. The mechanical compliance of in-the-bag gauges rapidly deteriorated with capsular fibrosis developing inside the gauge and the capsular bag shrinking around it. On-the-bag gauges remained functional but the initial compliance was compromised over time by the pressure build up caused by the fibrotic capsular bag.
Following phacoemulsification, capsular fibrosis causes disappearance of the mechanical forces detected by an in-the-bag gauge. An on-the-bag gauge detects active forces at the sulcus lasting at least 5 years, although the contracting capsule pressure compromises its compliance. These findings have important implications for future accommodating intraocular lens designs. [J Refract Surg. 2015;31(2):124-128.].
Copyright 2015, SLACK Incorporated.
To evaluate retinal straylight and patient complaint scores 18 months after implantation with the AcrySof ReSTOR diffractive multifocal intraocular lens (IOL) (Alcon Laboratories Inc).
Retinal straylight was measured with the C-Quant (Oculus Optikgeräte GmbH) system in 40 eyes implanted with the AcrySof ReSTOR IOL (SA60D3) and in 40 eyes implanted with the AcrySof SA60AT monofocal IOL. Complaint scores were assessed by a questionnaire in both groups of patients at three different lighting conditions--day light, dimmed light, and at night.
Seventy-five percent of eyes (30/40) of the ReSTOR group and 80% of eyes (32/40) of the SA60AT control group showed a retinal straylight value within or better than the normal range. No statistically significant differences between groups were found (P = .790). Patients of the ReSTOR group showed significantly more complaint scores at all assessed lighting conditions: increasing factors were 1.53, 2.02, and 2.66, for day light, dimmed light, and night, respectively (P < .0001). Comparing the amount of straylight, the multifocal group had 20% more straylight, albeit not significant at the 1% level.
The AcrySof ReSTOR IOL showed similar retinal straylight values compared to the monofocal IOL. Subjectively, patients with the diffractive IOL claimed significantly more glare for all light conditions, especially at night.
We present a new accommodative intraocular lens based on a two-element varifocal Alvarez lens. The intraocular lens consists of (1) an anterior element combining a spherical lens for refractive power with a cubic surface for the varifocal effect, and (2) a posterior element with a cubic surface only. The focal length of the IOL lens changes when the superimposed refractive elements shift in opposite directions in a plane perpendicular to the optical axis. The ciliary muscle will drive the accommodation by a natural process of contraction and relaxation. Results of ray-tracing simulations of the model eye with the two-element intraocular lens are presented for on-axis and off-axis vision. The configuration of the lens is optimized to reduce refractive errors as well as effects of misalignment. A prototype with a clear aperture of ~5.7 mm is manufactured and evaluated in air with a Shack-Hartmann wave-front sensor. It provides an accommodation range of ~4 dioptres in the eye at a ~0.75-mm lateral displacement of the optical elements. The experimentally measured on-axis optical performance of the IOL lens agrees with the theoretically predicted performance.
Purpose
To use anterior segment optical coherence tomography (AS-OCT) to evaluate the clinical effectiveness of Implantable Collamer Lens posterior chamber phakic intraocular lens (PC pIOL) sizing based on measurement of the distance from the iris pigment end to the iris pigment end.
Setting
S. Fyodorov Eye Microsurgery Federal State Institution, Moscow, Russia.
Design
Evaluation of diagnostic test or technology.
Methods
Stage 1 was a prospective study. The sulcus-to-sulcus (STS) distance was measured using ultrasound biomicroscopy (UBM) (Vumax 2), and the distance from iris pigment end to iris pigment end was assessed using a proposed AS-OCT algorithm. Part 2 used retrospective data from patients after implantation of a PC pIOL with the size selected according to AS-OCT (Visante) measurements of the distance from iris pigment end to iris pigment end. The PC pIOL vault was measured by AS-OCT, and adverse events were assessed.
Results
Stage 1 comprised 32 eyes of 32 myopic patients (mean age 28.4 years ± 6.3 [SD]; mean spherical equivalent [SE] −13.11 ± 4.28 diopters [D]). Stage 2 comprised 29 eyes of 16 patients (mean age 27.7 ± 4.7 years; mean SE −16.55 ± 3.65 D). The mean STS distance (12.35 ± 0.47 mm) was similar to the mean distance from iris pigment end to iris pigment end distance (examiner 1: 12.36 ± 0.51 mm; examiner 2: 12.37 ± 0.53 mm). The PC pIOL sized using the new AS-OCT algorithm had a mean vault of 0.53 ± 0.18 mm and did not produce adverse events during the 12-month follow-up. In 16 of 29 eyes, the PC pIOL vault was within an optimum interval (0.35 to 0.70 mm).
Conclusion
The new measurement algorithm can be effectively used for PC pIOL sizing.
Financial Disclosure
No author has a financial or proprietary interest in any material or method mentioned.
To compare visual acuity, intraocular lens (IOL) movement, and depth of focus with the Crystalens HD single-optic accommodating IOL and the Tecnis ZCB00 aspheric monofocal IOL.
St. Thomas' Hospital, London, United Kingdom.
Prospective randomized controlled trial.
Patients with bilateral symptomatic cataract had bilateral sequential cataract surgery within 6 weeks with randomized implantation of the accommodating or monofocal IOL in both eyes. Exclusion criteria included other ocular conditions and corneal astigmatism greater than 2.00 diopters. The primary outcome was uniocular distance-corrected near visual acuity (DCNVA). Secondary measures were IOL movement, depth of focus, intermediate and distance vision, objective refraction, and pupil size at distance and near fixation. Results from 3 months postoperatively are presented.
Three months postoperatively, 64 patients (32 in each group) were available for study. The distance vision was not statistically significantly different between the accommodating IOL and monofocal IOL (mean 0.05 logMAR versus 0.06 logMAR). The mean DCNVA (0.48 logMAR ± 0.15 [SD] versus 0.61 ± 0.13 logMAR) and intermediate visual acuity (0.08 ± 0.1 logMAR versus 0.20 ± 0.09 logMAR) were significantly better with the accommodating IOL (P<.001). Neither IOL had clinically significant movement, and near vision did not directly correlate with movement of the accommodating IOL. The accommodating IOL provided greater depth of focus.
Near and intermediate acuities were better with the accommodating IOL. This effect was not directly linked to IOL movement but was at least partly due to depth of focus.
To evaluate refractive and visual parameters related to distance, intermediate, and near vision after cataract surgery and the optical quality of a new diffractive trifocal intraocular lens (IOL).
Vissum Instituto Oftalmologico de Alicante, Alicante, Spain.
Case series.
Patients had bilateral refractive lens exchange and multifocal diffractive IOL (AT Lisa tri 839 MP) implantation. A complete ophthalmology examination was performed preoperatively and postoperatively. The follow-up was 6 months. The main outcome measures were uncorrected distance (UDVA) and corrected distance (CDVA), intermediate, and near visual acuities; keratometry; manifest refraction; and aberrations (total, corneal, internal).
The study comprised 60 eyes of 30 patients (mean age 57.9 years ± 7.8 [SD]; range 42 to 76 years). There was significant improvement in UDVA, uncorrected intermediate visual acuity, uncorrected near visual acuity, CDVA, and distance-corrected intermediate and near visual acuity. The postoperative refractive status was within the range of +1.00 to -1.00 diopter. Total internal aberrations decreased significantly (P<.001).
The trifocal IOL improved near, intermediate, and distance vision in presbyopic patients. The use of 3 foci provided significant intermediate visual results without sacrificing near or distance vision.
No author has a financial or proprietary interest in any material or method mentioned.
To evaluate the visual outcomes of patients with a new diffractive trifocal intraocular lens (IOL).
A trifocal diffractive Fine Vision IOL (Physiol, Liege, Belgium) was implanted after microincision cataract surgery (MICS) in 40 eyes of 20 patients with bilateral cataract. The monocular and binocular visual performance and the refractive status were assessed, as well as the defocus curve and contrast sensitivity at 1 and 6 months postoperatively.
The monocular visual outcomes (logMAR) at 6 months postoperatively were uncorrected distance visual acuity 0.18 ± 0.13, uncorrected near visual acuity 0.26 ± 0.15, and uncorrected intermediate visual acuity 0.20 ± 0.11. With the best distance correction, the visual outcomes were 0.05 ± 0.06 for corrected distance visual acuity, 0.16 ± 0.13 for distance corrected near visual acuity, and 0.17 ± 0.09 for distance corrected intermediate visual acuity. Binocular defocus curve at 6 months shows a wide range of useful vision with 0.19 ± 0.08 (logMAR) at -1.50 diopter defocus. The monocular contrast sensitivity under scotopic conditions (3 cd/m(2)) was within normal range for a population older than 60 years.
The trifocal Fine Vision IOL can restore vision at different distances after cataract surgery, specifically intermediate and near vision. [J Refract Surg. 2013;29(11):756-761.].
To compare visual and optical quality of the Crystalens HD intraocular lens (IOL) with that of a monofocal IOL.
The wavefront aberration patterns of the monocular Akreos Adapt AO IOL and the single-optic accommodating Crystalens HD IOL were measured in a model eye. The Crystalens IOL was measured in its nonaccommodative state and then, after flexing the haptic to produce 1.4 mm of movement, in its accommodative state. Using an adaptive optics system, subjects' aberrations were removed and replaced with those of pseudophakes viewing with either lens. Monocular distance visual acuity (DVA) at high (100%), medium (50%), and low (10%) contrast and contrast sensitivity (CS) were measured for both IOL optics. Near VA (NVA) and CS were measured for the Crystalens HD IOL in its accommodative state. Depth of focus around the distance and near focus was also evaluated for the Crystalens HD IOL. Modulation transfer function (MTF), point spread function (PSF), and Strehl ratio were also calculated. All measures were taken for 3- and 5-mm pupils.
The MTF, PSF, and Strehl ratio showed comparable values between IOLs (p > 0.05). There were no significant differences in DVA and CS between IOLs for all contrasts and pupils (p > 0.05). When spherically focused, mean DVA and NVA with the Crystalens HD IOL were ≥20/20 at 100 and 50% contrasts for both pupils. Monocular DVA, NVA, and CS were slightly better with 3- than 5-mm pupils, but without statistically significant differences. The Crystalens HD IOL showed about 0.75 and 0.50 D of depth of focus in its accommodative state and nonaccommodative state, respectively.
The optical and visual quality with the nonaccommodatied Crystalens HD IOL was comparable to that of a monofocal IOL. If this lens can move 1.4 mm in the eye, it will provide high-quality optics for near vision as well.
Unlabelled:
This literature review looks at the current status of multifocal intraocular lenses (IOLs) in cataract surgery. The results of implantation of multifocal IOLs of diffractive, refractive, and hybrid diffractive-refractive design are described with regard to uncorrected near and distance visual acuity and spectacle independence. The occurrence of photic phenomena and contrast sensitivity loss with multifocal IOLs are also addressed.
Financial disclosure:
Neither author has a financial or proprietary interest in any material or method mentioned.
PURPOSE: To compare near vision and quality of vision after controlling for pseudoaccommodation in patients with single-optic accommodating intraocular lenses (IOLs) or monofocal IOLs targeted for mini-monovision. SETTING: Clinical practice. DESIGN: Prospective randomized controlled clinical trial. METHODS: Patients were randomized to bilateral implantation of the Crystalens HD silicone accommodating IOL, the Tetraflex acrylic accommodating IOL, or the Tecnis 1-piece monofocal (nonaccommodating) control IOL. The target refraction for the control group was mini-monovision (-0.25 diopter [D] and -0.75 D). In the accommodating IOL groups, manufacturer recommendations were followed; that is, a target refraction of mini-monovision (-0.25 D and -0.75 D) in the acrylic accommodating group and +0.25 D in the silicone accommodating group. Pupil size and anterior corneal spherical aberration were measured preoperatively. Main outcome measures were binocular target refraction corrected near vision and contrast sensitivity 3 months postoperatively. RESULTS: There were no statistically significant differences between the 3 groups in age, photopic or mesopic pupil size, anterior corneal spherical aberration, corneal astigmatism, or the power of the IOLs implanted. Binocular distance visual acuity at 4 m was 20/20(-) in all groups, intermediate vision was approximately 20/25, and near vision was 20/40 to 20/50. There were no statistically significant differences between the 3 groups in visual acuity or contrast sensitivity. CONCLUSION: Single-optic accommodating IOLs did not offer a significant advantage in near visual acuity over mini-monovision with a monofocal (nonaccommodating) IOL. FINANCIAL DISCLOSURE: Dr. Beiko received research support for this study from Abbott Medical Optics, Inc. and Lenstec, Inc.
To compare the visual and ocular optical performance in eyes with a single-optic or a dual-optic accommodating intraocular lens (IOL) with particular attention to near-vision outcomes.
Vissum Instituto Oftalmológico de Alicante, Miguel Hérnandez University, Alicante, Spain.
Prospective consecutive nonrandomized interventional comparative clinical study.
Eyes with cataract were divided into 2 groups. Group A had implantation of a single-optic accommodating IOL (Crystalens HD) and Group B, of a dual-optic accommodating IOL (Synchrony). Distance and near visual acuities, contrast sensitivity, ocular aberrations, reading performance, and the defocus curve were evaluated over a 6-month postoperative follow-up.
Group A comprised 27 eyes and Group B, 26 eyes. The patient age ranged from 59 to 82 years. Uncorrected and corrected distance visual acuities were significantly better in Group B (P≤.04). There were no significant between-group differences in near or intermediate visual vision (P≥.13). In the defocus curve, Group B had significantly better visual acuities at several levels of defocus (P≤.04). The ocular Strehl ratio and contrast sensitivity were also significantly better in Group B (P≤.04). Group A had higher postoperative total and higher-order root-mean-square aberrations (P≤.01). The incidence of posterior capsule opacification was significantly higher in Group A (40.7%) than in Group B (11.5%).
Both IOLs restored distance visual function after cataract surgery with limitations in near visual outcomes. Eyes with the dual-optic IOL had significantly better ocular optical quality.
To compare the visual outcomes and intraocular optical quality in patients with a low-addition (add) power multifocal refractive intraocular lens (IOL) with rotational asymmetry and a single-optic accommodating IOL.
Vissum Instituto Oftalmológico de Alicante, Miguel Hérnandez University, Alicante, Spain.
Prospective comparative nonrandomized consecutive case series.
Consecutive cataract patients had implantation of a low-add-power refractive multifocal IOL with rotational asymmetry (Lentis-Mplus LS-312 MF15) (multifocal group) or a single-optic accommodating IOL (Crystalens HD) (accommodating group). Distance and near visual acuities were evaluated. Ocular optical quality, intraocular aberrations, defocus curve, and contrast sensitivity were evaluated postoperatively.
Of the 66 eyes (40 patients; age 61 to 81 years), 31 were in the multifocal group and 35 were in the accommodating group. Postoperatively, both groups had a significant improvement in the uncorrected and corrected distance visual acuities and uncorrected (UNVA) and corrected near (CNVA) near visual acuities (P <.01). Distance-corrected near visual acuity was significantly better in the multifocal group postoperatively (P ≤.04). No significant differences in UNVA and CNVA were detected postoperatively (P ≥.09). In the defocus curve, the multifocal group had significantly better visual acuities at several defocus levels. The accommodating group had better contrast sensitivity under photopic conditions at all spatial frequencies (P ≤.04). The multifocal group had significantly higher postoperative intraocular tilt (P <.01).
Both IOLs restored distance vision. The refractive multifocal IOL provided better near visual rehabilitation.
The correction of presbyopia and restoration of true accommodative function to the ageing eye is the focus of much ongoing research and clinical work. A range of accommodating intraocular lenses (AIOLs) implanted during cataract surgery has been developed and they are designed to change either their position or shape in response to ciliary muscle contraction to generate an increase in dioptric power. Two main design concepts exist. First, axial shift concepts rely on anterior axial movement of one or two optics creating accommodative ability. Second, curvature change designs are designed to provide significant amplitudes of accommodation with little physical displacement. Single-optic devices have been used most widely, although the true accommodative ability provided by forward shift of the optic appears limited and recent findings indicate that alternative factors such as flexing of the optic to alter ocular aberrations may be responsible for the enhanced near vision reported in published studies. Techniques for analysing the performance of AIOLs have not been standardised and clinical studies have reported findings using a wide range of both subjective and objective methods, making it difficult to gauge the success of these implants. There is a need for longitudinal studies using objective methods to assess long-term performance of AIOLs and to determine if true accommodation is restored by the designs available. While dual-optic and curvature change IOLs are designed to provide greater amplitudes of accommodation than is possible with single-optic devices, several of these implants are in the early stages of development and require significant further work before human use is possible. A number of challenges remain and must be addressed before the ultimate goal of restoring youthful levels of accommodation to the presbyopic eye can be achieved.
To compare the visual acuity outcomes and the ocular and intraocular optical quality in patients with a monofocal intraocular lens (IOL) or a new-generation single-optic accommodating IOL.
Vissum Corporation, Alicante, Spain.
Comparative case series.
Consecutive eyes of bilateral cataract patients were divided into 2 groups. One group had implantation of a monofocal IOL (Acri.Smart 48S) and the other group, of a single-optic accommodating IOL (Crystalens HD). Distance and near visual acuities were evaluated preoperatively and postoperatively. In addition, postoperative ocular optical quality, intraocular aberrations, and defocus curves were evaluated.
The 20 patients included in the study ranged in age from 50 to 87 years. The monofocal IOL group comprised 24 eyes and the accommodating IOL group, 16 eyes. In both groups, the uncorrected and corrected distance visual acuities improved significantly from preoperatively to postoperatively (P ≤ .03). The distance-corrected near visual acuity also improved significantly in both groups (P ≤ .03); the difference between groups was at the limit of statistical significance (P = .05). The uncorrected near visual acuity was significantly better in the accommodating IOL group (J5 versus J3; P = .01). The defocus curves showed significantly better visual acuity in the accommodating IOL group at several levels of defocus. There were no statistically significant differences between the 2 groups in any intraocular aberrometric coefficient (P ≥ .06).
The new-generation single-optic accommodating IOL restored distance visual function after cataract surgery and improved near vision. The optical quality with the accommodating IOL was similar to that with the conventional monofocal IOL.
To evaluate long-term contrast sensitivity (CS) and visual acuity following implantation of monofocal, accommodating, refractive and diffractive multifocal intraocular lenses (IOLs) in patients with unilateral cataract.
In this prospective non-randomized clinical trial, 87 patients with unilateral cataract were enrolled in four groups for phacoemulsification and IOL implantation in Ophthalmology Department of Goztepe Training and Research Hospital. Twenty-four patients had monofocal (Alcon Acrysof; group 1), 21 patients accommodating (Human Optics 1CU; group 2), 22 patients diffractive multifocal (Tecnis ZM900; group 3) and 20 patients refractive multifocal (AMO Rezoom; group 4) IOL implantations. Ages of patients were between 40 and 70. Parameters analysed at the 18th postoperative month were subjective refractions, monocular and binocular distance and near photopic CSs, visual acuities.
Near visual acuities were statistically better in group 3 than the other groups (P < 0.05). At low spatial frequencies, mean monocular distance CSs of group 1 and mean monocular near CSs of groups 1 and 2 were statistically higher than those of group 4 (P < 0.05). There was no significant difference between binocular CSs of group 4 and the other groups at low spatial frequencies. At high spatial frequencies, monocular and binocular CSs of groups 1 and 2 were statistically higher than those of groups 3 and 4 (P < 0.05). Near CSs was better in group 3 than group 4.
In patients with unilateral cataract, monofocal, accommodating and partially diffractive multifocal IOL provided higher CS scores when compared with refractive multifocal IOL and in multifocal IOL groups binocular CSs were better than monocular CSs when compared with other groups.
A clinical evaluation of the Grand Seiko Auto Ref/Keratometer WAM-5500 (Japan) was performed to evaluate validity and repeatability compared with non-cycloplegic subjective refraction and Javal-Schiotz keratometry. An investigation into the dynamic recording capabilities of the instrument was also conducted.
Refractive error measurements were obtained from 150 eyes of 75 subjects (aged 25.12 +/- 9.03 years), subjectively by a masked optometrist, and objectively with the WAM-5500 at a second session. Keratometry measurements from the WAM-5500 were compared to Javal-Schiotz readings. Intratest variability was examined on all subjects, whilst intertest variability was assessed on a subgroup of 44 eyes 7-14 days after the initial objective measures. The accuracy of the dynamic recording mode of the instrument and its tolerance to longitudinal movement was evaluated using a model eye. An additional evaluation of the dynamic mode was performed using a human eye in relaxed and accommodated states.
Refractive error determined by the WAM-5500 was found to be very similar (p = 0.77) to subjective refraction (difference, -0.01 +/- 0.38 D). The instrument was accurate and reliable over a wide range of refractive errors (-6.38 to +4.88 D). WAM-5500 keratometry values were steeper by approximately 0.05 mm in both the vertical and horizontal meridians. High intertest repeatability was demonstrated for all parameters measured: for sphere, cylinder power and MSE, over 90% of retest values fell within +/-0.50 D of initial testing. In dynamic (high-speed) mode, the root-mean-square of the fluctuations was 0.005 +/- 0.0005 D and a high level of recording accuracy was maintained when the measurement ring was significantly blurred by longitudinal movement of the instrument head.
The WAM-5500 Auto Ref/Keratometer represents a reliable and valid objective refraction tool for general optometric practice, with important additional features allowing pupil size determination and easy conversion into high-speed mode, increasing its usefulness post-surgically following accommodating intra-ocular lens implantation, and as a research tool in the study of accommodation.
To evaluate visual outcomes and accommodative gains 1 year after implantation of the NuLens accommodating intraocular lens (IOL).
Department of Refractive Surgery, Vissum Corp., Alicante, Spain.
This study comprised patients with cataract and atrophic macular degeneration. In each patient, the accommodating IOL was implanted in the eye with the worse visual acuity. At the 12-month follow-up visit, visual acuity and accommodation were measured to determine the efficacy of the IOL. Ultrasound biomicroscopy was used to measure accommodative amplitude.
Ten eyes of 10 patients were evaluated. The mean number of lines patients could read increased from 1.0 preoperatively to 3.8 lines 6 months postoperatively, indicating improvement in uncorrected near visual acuity after IOL implantation. The mean change in cross-section measurements of the IOL was 0.06 mm at 1 month; the value peaked at 3 months (0.21 mm), after which it decreased steadily, becoming stable at 9 months (0.09 mm, which is equivalent to 10.00 diopters [D] of accommodation). Corrected near visual acuity improved slightly (0.7 Jaeger lines) at 12 months, with the best reading distance at 10 cm. These results suggest that the near and distance visual acuities were approximately equal and, therefore, the IOL can produce accommodation of 10.00 D.
The accommodation mechanism of the IOL can produce an ocular power variation of 10.00 D. Near visual acuity improved without compromising distance visual acuity.
To analyze the reasons for patient dissatisfaction after phacoemulsification with multifocal intraocular lens (IOL) implantation and the outcomes after intervention.
Emory Eye Center, Atlanta, Georgia, USA.
This retrospective review comprised eyes of patients dissatisfied with visual outcomes after multifocal IOL implantation. Outcomes analyzed included type of visual complaint, treatment modality for each complaint, and degree of clinical improvement after intervention.
Thirty-two patients (43 eyes) reported unwanted visual symptoms after multifocal IOL implantation, including in 28 eyes (65%) with an AcrySof ReSTOR IOL and 15 (35%) with a ReZoom IOL. Thirty patients (41 eyes) reported blurred vision, 15 (18 eyes) reported photic phenomena, and 13 (16 eyes) reported both. Causes of blurred vision included ametropia (12 eyes, 29%), dry eye syndrome (6 eyes, 15%), posterior capsule opacification (PCO) (22 eyes, 54%), and unexplained etiology (1 eye, 2%). Causes of photic phenomena included IOL decentration (2 eyes, 12%), retained lens fragment (1 eye, 6%), PCO (12 eyes, 66%), dry-eye syndrome (1 eye, 2%), and unexplained etiology (2 eyes, 11%). Photic phenomena attributed to PCO also caused blurred vision. Thirty-five eyes (81%) had improvement with conservative treatment. Five eyes (12%) did not have improvement despite treatment combinations. Three eyes (7%) required IOL exchange.
Complaints of blurred vision and photic phenomena after multifocal IOL implantation were effectively managed with appropriate treatment. Few eyes (7%) required IOL exchange. Neodymium:YAG capsulotomy should be delayed until it has been determined that IOL exchange will not be necessary.
To evaluate the optical and visual performance after implantation of refractive or apodized diffractive multifocal intraocular lenses (IOLs).
Military Health Service Institute, Warsaw, Poland.
Uncorrected distance visual acuity, best distance-corrected visual acuity, best distance-corrected near visual acuity, distance contrast sensitivity under photopic conditions (CSV-1000), residual refractive error, and wavefront aberrations (LADARWave Hartmann-Shack wavefront analyzer) were measured in 23 patients who had bilateral implantation of the AcrySof ReSTOR SN60D3 IOL and 23 patients who had bilateral implantation of the ReZoom IOL....
At the 6-month postoperative visit, the mean photopic uncorrected distance acuity was 0.03+/-0.05 (SD) in the ReSTOR group and 0.02+/-0.06 logMAR in the ReZoom group (both approximately 20/20) (P= .569). In all patients, the mean photopic best distance-corrected acuity was 0.00 logMAR (approximately 20/20) and the mean photopic best distance-corrected near acuity at 35 cm was 0.10 logMAR. The photopic contrast sensitivity was within the standard normal range in both IOL groups. The difference in photopic contrast sensitivity between groups was statistically significant (P<.001). Higher-order aberrations, in particular coma and spherical aberrations, were significantly higher in the ReZoom group (all P<.001).
AcrySof ReSTOR SN60D3 and ReZoom IOLs provided good visual performance at distance and near under photopic conditions. Optical quality measures were significantly worse in patients with ReZoom IOLs.
To evaluate visual acuity, depth of focus, contrast sensitivity, and glare disability in eyes with an Array SSM 26-NB three-piece, five-zone multifocal intraocular lens (IOL).
University Eye Clinic, Vienna, Austria.
Fourteen eyes with an AMO Array IOL were evaluated for uncorrected and best corrected distance and near visual acuity. The reading distance produced by the near focus of the lens was varied with convex glasses of less power. Reading at distance focus was evaluated by adding +3.50 diopters (D) to the distance correction. Depth of focus was measured from -3.00 to +6.00 D. Contrast sensitivity and glare disability were also measured using the Brightness Acuity Tester with stationary sinusoidal gratings at 0.5, 1, 3, 6, 11.4, and 22.8 cycles/degree.
Mean uncorrected distance acuity (Snellen) was 0.79 +/- 0.17 (SD), which increased to 0.94 +/- 0.14 with best correction. Near acuity was J2.75 +/- 1.35 and J2.59 +/- 1.10, respectively. When near focus was tested for reading distance, a mean of +0.54 +/- 0.02 D was accepted for improvement of near vision of J1.71 +/- 0.94. Near acuity with a distance focus addition of +3.50 D was J1.08 +/- 0.28. Contrast sensitivity and glare disability were lower than in 13 eyes with a monofocal poly(methyl methacrylate) IOL and 16 normal phakic eyes.
Eyes with the Array IOL had full distance function. Reading performance could be improved with a near focus of more than +3.50 D. Full near vision could be achieved with the distance focus and conventional reading glasses. Depth of focus was sufficient but visual acuity was limited at intermediate and near distance. Although contrast sensitivity was relatively low, it was not beyond the reference range.
To evaluate the safety and effectiveness of a zonal-progressive multifocal silicone intraocular lens (IOL).
Prospective, nonrandomized, fellow eye comparative trial.
Four hundred fifty-six subjects were enrolled at 14 investigational sites in the United States; 400 subjects achieved 1-year follow-up. A subset of 123 subjects (102 at 1 year) were enrolled in a monofocal fellow eye control substudy; subjects were implanted with the multifocal IOL in one eye and a comparable monofocal IOL in the fellow eye.
Cataract extraction and implantation of a zonal-progressive multifocal silicone IOL was performed using the surgeon's standard technique. Subjects were followed at six postoperative examination intervals through 1 year.
The key efficacy measures were mean uncorrected and corrected distance and near visual acuity at 1 year after surgery.
In the monofocal fellow eye control substudy, the multifocal eyes showed a mean 2-line increase over monofocal eyes for uncorrected and distance-corrected near visual acuity (P < 0.0001). Mean uncorrected distance visual acuity was similar between multifocal and monofocal eyes (P = 0.116). A significantly higher proportion of bilateral multifocal subjects reported that they could function comfortably without glasses at near (81%, 96 of 118) compared with multifocal/monofocal subjects (56%; 93 of 165; P < 0.001) and unilateral multifocal subjects (58%; 56 of 97; P < 0.001). Low-contrast visual acuity was reduced in multifocal eyes by approximately 1 Snellen line. However, no perceived disadvantages attributable to the reduction in low-contrast acuity were found. Although the perception of halos and glare increased in the multifocal eyes, good visual function remained, and nearly all subjects were satisfied with the results of their surgery.
In a large study that included a subset of subjects with paired eye compared with those with monofocal lenses, this zonal-progressive multifocal lens provided a high level of uncorrected and corrected distance vision, improved uncorrected and distance-corrected near vision, reduced spectacle dependency, and a high level of patient satisfaction despite some loss of low-contrast visual acuity and increased reports of halos and glare.
To calculate the diameter of halos perceived by patients with multifocal intraocular lenses (IOLs) and to stimulate halos in patients with refractive multifocal IOLs in a clinical experiment.
Calculations were done to show the diameter of halos in the case of the bifocal intraocular lens. 24 patients with a refractive multifocal IOLs and five patients with a monofocal IOL were asked about their subjective observation of halos and were included in a clinical experiment using a computer program (Glare & Halo, FW Fitzke and C Lohmann, Tomey AG) which simulates a light source of 0.15 square degrees (sq deg) in order to stimulate and measure halos. Halo testing took place monoculary, under mesopic conditions through the distance and the near focus of the multifocal lens and through the focus of the monofocal lens.
The halo diameter depends on the pupil diameter, the refractive power of the cornea, and distance focus of the multifocal IOL as well as the additional lens power for the near focus. 23 out of 24 patients with a refractive multifocal IOL described halos at night when looking at a bright light source. Only one patient was disturbed by the appearance of halos. Under test conditions, halos were detected in all patients with a refractive multifocal IOL. The halo area testing through the distance focus was 1.05 sq deg +/- 0.41, through the near focus 1.07 sq deg +/- 0.49 and in the monofocal lens 0.26 sq deg +/- 0.13.
Under high contrast conditions halos can be stimulated in all patients with multifocal intraocular lenses. The halo size using the distance or the near focus is identical.
To evaluate contrast sensitivity at distance and near after multifocal intraocular lens (IOL) implantation.
Ophthalmologic Institute of Alicante, University Miguel Hernández, Alicante, Spain.
Contrast sensitivity was measured with the Stereo Optical Functional Acuity Contrast Test at distance and near in 21 patients with a refractive multifocal IOL (Array SA-40N, AMO). A control group with a monofocal IOL (SI-40NB, AMO) was also studied to allow comparison of results. Contrast sensitivity was measured 1, 3, 6, 12, and 18 months after IOL implantation.
There was a statistically significant greater reduction in contrast sensitivity at distance at all spatial frequencies in the multifocal group than in the monofocal group during the first month. At 3 months, contrast sensitivity at 12 and 18 cycles per deg remained reduced in the multifocal group; contrast sensitivity at the other frequencies did not differ from that in the monofocal group (P > 0.1). At 6, 12, and 18 months, contrast sensitivity at all spatial frequencies was not significantly different between groups (P > 0.1). There was a statistically significant greater reduction in near contrast sensitivity in the multifocal group than in the monofocal group at all spatial frequencies during the first and third month after surgery (P <.01). No statistically significant differences were found between groups after 6 months (P > 0.1). Contrast sensitivity at distance and near in the multifocal group improved over time (P <.01).
The Array IOL provided contrast sensitivity at distance comparable to that obtained with the monofocal IOL between 3 and 6 months after implantation. Near contrast sensitivity improved over time but was always lower than at distance and in the monofocal near-corrected patients, which is acceptable to avoid near visual function degradation.
To assess the visual effects of multifocal intraocular lenses (IOLs) compared with the current standard treatment of monofocal IOL implantation.
Systematic literature review and meta-analysis of randomized controlled trials.
The study was performed according to the Cochrane Collaboration methodology. Computer database and manual searches were made to identify all randomized trials comparing multifocal IOL implantation with a monofocal control group. Data were extracted using a standardized form and analyzed using Review Manager software. When study reporting allowed meaningful comparison, meta-analysis was performed. The chi-square test was used to examine heterogeneity between studies. Odds ratios were calculated for dichotomous outcomes and standardized mean differences for continuous variables.
There is no single outcome measure that can be thought of as summarizing the efficacy of an IOL. A number of different outcomes had to be examined. The primary outcomes for this review were distance and near visual acuity (unaided and corrected) and spectacle dependence. The secondary outcomes for this review included depth of field, contrast sensitivity, glare, subjective assessment of quality of life or visual function, and surgical complications.
Eight trials were identified. There was significant variability among the trials in the outcomes reported. Distance acuity was similar in multifocal and monofocal IOLs. Unaided near vision tended to improve with the multifocal IOL. This resulted in decreased spectacle dependence with use of the multifocal IOL. Adverse effects included reduced contrast sensitivity and the subjective experience of halos around lights.
Multifocal IOLs are effective at improving near vision relative to monofocal IOLs. Whether that improvement outweighs the adverse effects of multifocal IOLs will vary between patients, with motivation to achieve spectacle independence likely to be the deciding factor.
To report the safety and effectiveness of the AcrySof ReSTOR apodized diffractive intraocular lens (IOL), model MA60D3, when implanted into the capsular bag.
Multicenter European study including university clinics, eye hospitals, and private ophthalmic surgical centers.
One hundred twenty-seven subjects implanted in cataractous eyes in an open multicenter study.
After phacoemulsification, the foldable 3-piece hydrophobic acrylic apodized diffractive IOL was implanted in the capsular bag using a Monarch injector with an A-cartridge. The mean preoperative patient age was 68.4+/-12 years. Intraocular lens implant power ranged from 18.0 to 25.0 diopters (D) in 0.5-D increments.
Distance visual acuity (VA), near VA, spectacle dependence, unwanted visual symptoms, and patient satisfaction.
At the 6-month postoperative visit, binocular (both eyes simultaneously) mean uncorrected distance and near logarithm of the minimum angle of resolution VAs for the MA60D3 were 0.04+/-0.14 and 0.09+/-0.12 (n = 118), respectively. In addition, 88.0% and 84.6% of ReSTOR subjects achieved spectacle independence for distance and near vision, respectively. Glare and halos were reported as severe by only 8.5% and 4.2% of patients, respectively. Ninety-two percent of patients stated that they would choose to have the same lens implanted again after the first implant, and 95.7% answered likewise after the second implant.
The AcrySof ReSTOR MA60D3 IOL demonstrated excellent near VA without compromising distance vision. Spectacle independence and patient satisfaction were high, whereas unwanted photic phenomena were clinically acceptable.
A clear understanding of the anatomy of accommodative structures, the mechanism of accommodation, and the causes of presbyopia is necessary to understand whether accommodation may be restored to the presbyopic eye. Not withstanding the significant challenges that are faced owing to age-related changes in the eye, theoretically, it may be possible to restore accommodation to a presbyopic eye with an artificial accommodative intraocular lens.
To evaluate the 12-month U.S. phase II clinical trial results of the Crystalens AT-45 (eyeonics, Inc.) intraocular lens (IOL) used to provide uncorrected distance, intermediate, and near visual acuities in patients having cataract extraction and to compare in a substudy the contrast sensitivity and near visual acuity in patients with the Crystalens AT-45 IOL and those receiving a standard IOL.
Fourteen clinical sites throughout the U.S. for efficacy and 3 non-U.S. sites for safety and efficacy.
Patients 50 years or older had small-incision cataract extraction with implantation of the Crystalens AT-45 IOL. Unilateral implantation was followed by fellow-eye implantation. Postoperatively, uncorrected distance, near, and intermediate visual acuities were determined. Near and intermediate visual acuities were tested through a distance correction to eliminate potential pseudoaccommodative effects of residual myopia and corneal cylinder. A substudy tested contrast sensitivity under mesopic conditions with and without glare, as well as visual acuity in a subset of Crystalens AT-45 patients and a control group receiving a standard IOL.
A total of 263 patients participated in the U.S. clinical trial and had 1 year of follow-up. Near visual acuities through the distance correction of 20/40 (J3) or better, monocularly and bilaterally, respectively, were seen in 90.1% and 100%; intermediate near visual acuities were seen in 99.6% and 100%. More than half the bilaterally implanted Crystalens AT-45 patients achieved uncorrected near acuity of 20/25 (J1) or better through the distance correction, and 84% achieved 20/32 (J2) or better. In the substudy, monocular near vision through the distance correction of 20/25 (J1) or better was seen in 50.4% with the Crystalens AT-45 IOL and in 4.7% with the standard IOLs. Mesopic contrast sensitivity results with and without glare for the Crystalens AT-45 were similar to those with standard monofocal IOLs. Nearly all patients (74 patients; 97.3%) who bilaterally were within 0.50 diopter of plano postoperatively achieved 20/32 (J2) or better uncorrected near, intermediate, and distance visual acuities.
The Crystalens AT-45 accommodating IOL provided good uncorrected near, intermediate, and distance vision in pseudophakic patients. Contrast sensitivity with the Crystalens AT-45 was not diminished relative to standard monofocal IOLs, and near and intermediate visual performance was significantly better than with standard IOLs.