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In vitro optical quality assessment of a monofocal intraocular lens sutured to an artificial iris
Abstract
Purpose:
To assess whether the combined implantation of a monofocal intraocular lens (IOL) and an artificial iris has an effect on the IOL's optical performance.
Setting:
David J. Apple International Laboratory for Ocular Pathology, Heidelberg, Germany.
Design:
In vitro laboratory study.
Methods:
IOL optical quality was assessed using an OptiSpheric IOL Pro II to measure the IOL's modulation transfer function (MTF) at 3.0 mm pupil size and spatial frequency of 100 lp/mm. Three ASPIRA-aAY IOLs with different base powers, 10.0 diopter (D) (IOL A), 20.0 D (IOL B), and 30.0 D (IOL C) were measured before and after suturing the IOL to an ArtificialIris (AI). The degree of lens decentration in respect to the center of the AI was also evaluated.
Results:
The mean MTF values prior to suturing were 0.57, 0.65, and 0.63 for IOLs A, B, and C, respectively. After suturing to the AI, the mean MTF values were 0.52, 0.54, and 0.55 for IOLs A, B, and C, respectively. The decentration values in vertical direction were 0.20 mm, 0.00 mm, and 0.02 mm for IOLs A, B, and C. In horizontal direction, the decentration values were 0.42 mm, 0.10 mm, and 0.03 mm for IOLs A, B, and C.
Conclusions:
The MTF decreased slightly in all 3 IOLs after they were sutured to the AI. The small differences, however, should be clinically irrelevant. This laboratory assessment showed that suturing of the IOL to the AI can be done in a reliable and reproducible manner without deteriorating optical quality.
... 8 It has been previously shown that the suturing of an IOL to the AI does not impair the optical quality. 19 Combined implantation of an IOL and Artificial Iris provides predictable postoperative refraction without the need for a correction factor. 20 A range of complications have been reported after AI implantation including decentration of the implant, macular edema, decreased visual acuity, worsening or onset of glaucoma, corneal decompensation and retinal detachment. ...
Purpose
We present the case of a severe golf related ocular injury that affected the anterior and posterior segment. Treatment included primary surgical closure of the traumatic wound and secondary reconstruction of the iris-lens-diaphragm to correct aphakia and traumatic mydriasis and iridodialysis.
Observations
A 62-year-old woman presented to our clinic with severe ocular contusion after she had been hit by a golf ball in the right eye. We observed iridodialysis, traumatic mydriasis and luxation of the crystalline lens into the vitreous body as well as Berlin's edema and retinal tears. The patient underwent primary surgical closure of the traumatic wound and, 6 months later, combined Intraocular lens (IOL) and Customflex ArtificialIris (AI, HumanOptics, Erlangen, Germany) implantation. Uncorrected distance visual acuity was hand movement after primary surgical closure of the traumatic wound. After secondary reconstruction of the iris-lens-diaphragm, corrected distance visual acuity increased to 0.30 logMAR. Subjective impairment from glare could effectively be reduced and the patient was very satisfied with the aesthetic result.
Conclusions and Importance
Combined AI and IOL implantation can successfully restore visual acuity and reduce sensitivity to glare while providing an excellent aesthetic result in patients with a history of severe blunt ocular trauma, even in cases with a poor visual acuity prognosis.
... Alternativ kann die IOL auch auf die AI aufgenäht und beide Implantate können kombiniert eingenäht werden [1,4,5]. An der optischen Bank konnte gezeigt werden, dass auch das Zusammennähen beider Implantate die optische Qualität nur unwesentlich beeinflusst [6]. Die Implantation kann -je nach Ausgangssituation -auch in den Kapselsack oder Sulcus ciliaris ohne Nahtfixierung erfolgen [1]. ...
Zusammenfassung
Ziel
Wir berichten über den Fall eines Patienten mit traumatischem Irisdefekt, der sich 4 Monate nach dem initialen Trauma im Rahmen eines Fahrradunfalls einer chirurgischen Irisrekonstruktion mit einer CUSTOMFLEX Artificial Iris (AI, HumanOptics AG, Erlangen, Deutschland) unterzog.
Beobachtungen
Bei der Erstvorstellung zeigte sich eine gedeckte Bulbusruptur, die notfallmäßig mittels Vorderkammerspülung, Vitrektomie, Skleranaht und C 3 F 8 Gastamponade versorgt wurde. Nach extern durchgeführter sekundärer IOL-Implantation klagte der Patient über eine erhöhte Blendempfindlichkeit und Visusminderung am rechten Auge. Der bestkorrigierte Fernvisus betrug 1,4 logMAR für das rechte Auge und 0,10 logMAR für das linke Auge. Die klinische Untersuchung zeigte einen großen Irisdefekt mit Restirisgewebe von 4 bis 8 Uhr. Beide Augen waren pseudophak, der fundoskopische Befund war unauffällig. Der Patient unterzog sich einer AI-Implantation v. a. zur Linderung seiner Blendempfindlichkeit am rechten Auge. Die Sehschärfe stieg auf 0,30 logMAR an. Die subjektive Blendempfindlichkeit verbesserte sich deutlich. Die Kontrastempfindlichkeit, gemessen mit einer Pelli-Robson-Tafel, stieg von 0,15 logarithmischen Einheiten präoperativ auf 1,05 logarithmische Einheiten postoperativ.
Schlussfolgerungen
Wir beobachteten nach chirurgischer Irisrekonstruktion mit einer künstlichen Iris ein sehr gutes ästhetisches und funktionelles Ergebnis mit hoher Patientenzufriedenheit. Dieser Fall demonstriert, wie die Reduktion der Blendempfindlichkeit gleichzeitig auch zu einer deutlichen Verbesserung der Funktion mit Anstieg von Sehschärfe und Kontrastsehen führen kann.
... Die kombinierte Implantation einer monofokalen Intraokularlinse und einer künstlichen Iris wird inzwischen routinemäßig zur Behandlung von Patienten mit Aphakie und Aniridie durchgeführt [15,33]. Es wurde bereits in vitro an der optischen Bank (OptiSpheric IOL Pro II, Trioptics, Wedel, Deutschland) gezeigt, dass ein Annähen der IOL an die AI die optische Qualität nicht in einem relevanten Ausmaß reduziert [16]. ...
Background
Patients with iris defects suffer from severe visual impairment, especially increased glare sensitivity, and cosmetic disturbances. This can constitute a great psychological strain for patients. In the recent past the treatment consisted of iris print contact lenses, sunglasses and simple iris prostheses. The indications for surgical treatment are colobomas of the iris, aniridia, traumatic iris defects and persistent mydriasis. The aim of this review article is to investigate the surgical approaches, complications, functional and aesthetic outcome after implantation of an individual artificial iris prosthesis made from silicone.Objective
Analysis of the literature on the topic of surgical iris reconstruction with an artificial iris in combination with the own experience in more than 120 patients treated by the author in the last 10 years.Material and methodsThe custom-made flexible silicone iris prosthesis ArtificialIris (HumanOptics, Erlangen, Germany) assessed in this review is an innovative and versatile option for surgical treatment of iris defects. Patients were examined before and after iris reconstruction with respect to feasibility, complications and outcome.ResultsChange of best corrected visual acuity, intraocular pressure, pupillary opening, glare, contrast sensitivity, endothelial cell count, anterior chamber depth, anterior chamber angle and patient satisfaction were assessed. Furthermore, complications and color match to the residual and fellow iris were assessed.Conclusion
The implantation of an artificial iris is an effective option for the treatment of extensive traumatic iris defects and leads to an individual aesthetically appealing and good functional outcome as well as high patient satisfaction; however, this is an intervention that should not be underestimated because of a flat learning curve and various complications that can occur.
... Nonetheless, the ArtificialIris generally offers the possibility to simultaneously correct aphakia or cataract in aniridia when required, which substantially improves vision. A previous laboratory assessment also showed that suturing of the IOL to the AI can be done in a reliable and reproducible manner without deteriorating optical quality [18]. ...
Background:
To assess the functional outcomes after combined iris and intraocular lens (IOL) repair in aniridia patients.
Methods:
Retrospective observational study in 59 aniridic and aphakic eyes for ArtificialIris (AI) and IOL reconstruction. The iris prostheses were placed together with the IOL in the capsular bag using an injection system or were fixed by transscleral suturing of the IOL and AI. The primary outcomes measured were visual acuity, contrast and glare sensitivity (Pelli-Robson chart for photopic and dark adaptometer for mesopic conditions), intraocular pressure, endothelial cell density (ECD) and patient impairment.
Results:
Blunt trauma (37 eyes) and penetrating injuries (16 eyes) were observed more frequently than congenital aniridia (1 eye), iatrogenic causes (1 eye), aniridic state after severe iritis (2 eyes) or iris tumor (2 eyes). Monocular CDVA improved significantly (p < 0.0001) from median 0.7 logMAR (0.0-1.98) to 0.3 logMAR (- 0.08-2.0). Median pupillary area could significantly (p < 0.0001) be reduced by 79.3% from 51.27 mm2 (17.91 to 98.23) to 8.81 mm2 (4.16 to 8.84). Median ECD decreased from 2646.0 mm2 to 2497.5 mm2 (p = 0.007). Contrast and glare sensitivity improved significantly (p = 0.008) in photopic light conditions from 0.9 (0.0-1.95) to 1.35 (0.0-1.8). Patients reported to be highly satisfied with the functional improvement.
Conclusion:
The flexible ArtificialIris seems to be a safe and effective iris prosthesis in combination with an IOL having functionally and cosmetically exceptional reconstruction options.
... Mayer et al. previously reported good functional results with this technique. [8,18] In a prospective study, functional outcome of 37 consecutive cases of iris reconstruction using the AI were presented. Whereas best-corrected visual acuity did not change significantly, Pelli-Robson contrast sensitivity and impairment through glare improved three months after surgery. ...
Patients with large iris defects not only suffer from functional disadvantages but also from aesthetic limitations. The aim of this study was to evaluate the aesthetic outcome of iris reconstruction using an artificial iris (AI). In this study, 82 eyes of 79 consecutive patients with mostly traumatic partial or total aniridia that underwent iris reconstruction surgery using a custom-made silicone AI (HumanOptics, Erlangen, Germany). Pre- and postoperative photographs of 66 patients were analysed subjectively and objectively. Subjective evaluation was based questionnaires. Objective evaluation included measurement of pupil centration and iris colour analysis. Averaged hues from iris areas were transferred to numerical values using the LAB-colour-system. Single parameters and overall difference value (ΔE) were compared between AI and remaining iris (RI), as well as AI and fellow eye iris (FI). Patients, eye doctors and laymen rated the overall aesthetic outcome with 8.9 ±1.4, 7.7 ±1.1 and 7.3 ±1.1 out of 10 points, respectively. Mean AI decentration was 0.35 ±0.24 mm. Better pupil centration correlated with a higher overall score for aesthetic outcome (p<0.05). The AI was on average 4.65 ±10 points brighter than RI and FI. Aniridia treatment using a custom-made artificial iris prosthesis offers a good aesthetic outcome. Pupil centration was a key factor that correlated with the amount of aesthetic satisfaction. The AI was on average slightly brighter than the RI and FI.
Purpose:
To determine in vitro, using a translational research approach before realizing the procedure in a patient with iatrogenic aphakia and partial aniridia, whether suturing a trifocal intraocular lens (IOL) to an artificial iris degrades the IOL's optical quality.
Methods:
Optical quality was analyzed by measuring the modulation transfer function (MTF) at a 3-mm aperture and at 50 and 100 lp/mm spatial frequencies. The FineVision Pod F GF IOL (PhysIOL) was assessed in two powers: two +20.00 diopters (D) (20A and 20B IOLs) and two +30.00 D (30A and 30B IOLs). The IOLs' decentration in relation to the artificial iris's center was evaluated. The laboratory results provided empirical evidence in the informed consent for surgical intervention in a patient with iatrogenic aphakia and iris defect in one eye. Clinical results were measured using the parameter of corrected distance visual acuity plus a patient self-assessment of the cosmetic appearance of the operated eye.
Results:
The 20A and 20B IOLs demonstrated a mean MTF reduction of up to 1.1%, whereas the 30A and 30B IOLs showed a decrease of up to 5.2% for both spatial frequencies. All lenses showed good centration levels. In the clinical case, the patient showed corrected distance visual acuity, distance-corrected near visual acuity, and distance-corrected intermediate visual acuity of 0.20, 0.20, and 0.22 logMAR, respectively. The patient was satisfied with the cosmetic outcome.
Conclusions:
There was merely a slight reduction in trifocal IOL optical quality after it was sutured to an artificial iris. Clinically, the combined implantation of the artificial iris and FineVision IOL provided good functional and cosmetic outcomes. [J Refract Surg. 2022;38(1):61-68.].
Zusammenfassung
Hintergrund
Es können 3 Gruppen an Irisprothesen zur chirurgischen Versorgung von Irisdefekten unterschieden werden: (1) segmentale Irisimplantate, (2) kombinierte Irisblenden-Intraokularlinsen (IOL) und (3) reine Irisimplantate. Die meisten Irisrekonstruktionen gehen zusätzlich mit einer Aphakiekorrektur durch sekundäre Linsenimplantation einher. Auch wenn primäre Ziele die Herstellung einer Pupille sowie die Besserung des Blendungsempfindens, der Kontrastsensitivität und der Sehschärfe sind, spielt das ästhetische Ergebnis eine nicht zu vernachlässigende Rolle.
Ziel der Arbeit
Dargestellt werden funktionelle und ästhetische Ergebnisse nach Austausch von Aniridie-IOL-Implantaten gegen eine individuell angefertigte künstliche Iris in Kombination mit einer IOL.
Material und Methoden
In dieser retrospektiven Studie mit 7 Augen von 7 Patienten wurde eine Irisblenden-IOL (Morcher GmbH, Stuttgart) aus medizinischen Gründen (Subluxation) gegen eine individuell hergestellte künstliche Iris aus Silikon (Artificial Iris , HumanOptics, Erlangen) in Kombination mit einer angenähten IOL ausgetauscht. Die Nachbeobachtungszeit betrug mindestens 3 Monate. Bestkorrigierter Fernvisus (BCVA), Endothelzellzahl (ECC), Komplikationen, Blendungsempfinden, das ästhetische Ergebnis und die Patientenzufriedenheit wurden evaluiert.
Ergebnisse
BCVA und ECC zeigten keine statistisch signifikante Änderung zwischen prä- und postoperativ ( p > 0,05). Es zeigte sich eine Dezentrierung des Iris-IOL-Implantats von 0,27 ± 0,19 mm 3 Monate postoperativ. Auf einer visuellen Analogskala (VAS) von 1 bis 10 (1 = gar nicht bis 10 = extrem zufrieden) wurde die Zufriedenheit mit dem Gesamtergebnis mit 8,6 ± 2,5 bewertet. Das subjektive Blendungsempfinden besserte sich auf 5,6 ± 3,5 und die subjektive ästhetische Beeinträchtigung auf 2,4 ± 2,0 auf der VAS (1 = gar nicht bis 10 = extrem stark). Die postoperativen Komplikationen umfassten eine vorübergehende intraokulare Hypotonie in zwei, einen Druckanstieg in zwei, eine Netzhautablösung und eine transiente Glaskörperblutung jeweils in einem Auge. Sechs von sieben Patienten würden den Eingriff wiederholen.
Schlussfolgerung
Im Vergleich zu einem starren Aniridie-IOL-Implantat bietet der Austausch gegen eine individuell angefertigte künstliche Iris in Kombination mit einer IOL neben einem guten funktionellen gleichzeitig auch ein ästhetisch ansprechendes Ergebnis.
Purpose:
To assess the biometry and postoperative refraction in iris repair using ArtificialIris in combination with an intraocular lens (IOL).
Setting:
Department of Ophthalmology, University Hospital Heidelberg, University of Heidelberg, Germany.
Design:
Retrospective observational study.
Methods:
We included 44 aniridic and aphakic eyes for IOL implantation in combination with iris prosthesis reconstruction. The iris prostheses were either sutured into the ciliary sulcus and fixed by transscleral suturing or were implanted together with a capsular tension ring and the IOL in the capsular bag. The primary outcomes measured were pre- and postoperative best corrected visual acuity (CDVA), objective and subjective refraction, anterior chamber depth and optical biometry comparing common IOL formulae.
Results:
Reasons for surgery were trauma (39 eyes), iatrogenic causes (1 eye), aniridic state after severe iritis (2 eyes) or iris tumor (2 eyes). Monocular CDVA improved significantly (p<0.0001) from median 0.55 logMAR (0.0 to 1.98) to 0.16 logMAR (-0.08 to 2.0). There were no significant differences between the postoperative target refraction calculated by the formulae "Haigis", "Hoffer-Q", "SRK/T" and "Holladay 1" (p=0.68). The absolute deviation from target refraction did not differ significantly between the formulae (p=0.87). Median target refraction was -0.42 D (-4.0 to 1.68). Postoperatively median spherical equivalent was 0.00 D (-5.38 to 2.38). Median absolute deviation from target refraction after 5 months of follow-up was 0.98 D (0.06 to 5.17).
Conclusion:
Postoperative refraction using common techniques and using preoperative biometry revealed a well predictable postoperative refraction. There is no correction factor needed.
Purpose
Patients who have suffered an ocular trauma may present with varying degrees of injury to the anterior segment. In this retrospective interventional case series, we report the outcome of seven patients who underwent complete anterior segment reconstruction in a single surgery.
Methods
All patients with posttraumatic corneal decompensation or scar, aphakia, and iris defect underwent human donor corneal graft transplantation and implantation of an intraocular lens combined with a flexible silicone iris prosthesis. Postoperative examinations included assessment of best corrected distance visual acuity, objective refraction, and intraocular pressure. Sensitivity to glare and subjective discontent with the eye’s appearance was rated on a scale from 1 to 10, with 1 standing for low and 10 for high severity.
Results
Mean best corrected distance visual acuity (BCDVA) was 1.51 ± 0.26 logMAR preoperatively and 1.29 ± 0.36 logMAR postoperatively. Mean IOP was 15.71 ± 8.94 mmHg pre-surgery and 13.57 ± 6.52 mmHg post-surgery. The mean sensitivity to glare was reduced from 7.17 ± 2.91 to 3.80 ± 3.43 and subjective cosmetic disfigurement was reduced from 5.33 ± 3.35 to 1.80 ± 1.60.
Conclusions
A single surgery technique for entire anterior segment reconstruction in trauma patients can effectively reduce glare and patient discontent with the eye’s appearance.
Purpose:
Patients with traumatic aniridia, aphakia and retinal complications can require silicone oil endotamponade. In the absence of compartmentalization, there is a risk of silicone oil migrating to the anterior chamber which can cause long-term complications. We report a two-step procedure in trauma cases, using sutures for silicone oil retention in primary care and subsequently prior to secondary artificial iris (AI) and intraocular lens (IOL) implantation, to achieve a reconstruction of the anterior and posterior chamber.
Material and methods:
Seven patients with loss of the iris-lens-diaphragm after an ocular trauma and the need for silicone oil endotamponade underwent a primary intervention including wound closure, placement of silicone oil retention sutures and silicone oil filling. Four of those underwent secondary reconstruction with silicone oil removal and AI and IOL implantation and could be included in this retrospective observational study. All main outcome measures were evaluated after the first and after the second surgery. The main outcome measures were morphological findings, subjective impairment from glare, subjective cosmetic disfigurement, patient satisfaction and intraocular pressure (IOP) as well as best-corrected distance visual acuity and objective refraction.
Results:
The retention sutures could effectively prevent silicone oil migration into the anterior chamber in the first surgery. Silicone oil emulsifications in the anterior chamber were observed in one patient. In two patients, pigment deposition at the sutures was seen. Subjective impairment from glare and subjective cosmetic disfigurement could be reduced after the second surgery compared to the evaluation after the first surgery. IOP and best-corrected distance visual acuity remained stable. No eye needed silicone oil refilling after the secondary reconstruction surgery.
Conclusion:
Our two-step approach is viable and provides good functional and aesthetic results. We observed a high patient satisfaction.
Purpose
To report the clinical outcomes after implantation of a small-aperture intraocular lens (IOL) and a partial aniridia ring in three patients with traumatic iris defects.
Observations
The corrected distance visual acuity (CDVA), irregular astigmatism, and glare improved in all patients. In one patient, the monocular defocus curve showed a visual acuity (VA) of 0.30 logMAR or better from 1.0 to −1.5 D, and the halo size and intensity were 5 and 10 (on a scale from 0 to 100), respectively, and the glare size and intensity were 23 and 16 (on a scale from 0 to 100), respectively.
Conclusions and importance
The pinhole effect of the small-aperture IOL helped considerably decrease irregular astigmatism and improve visual acuity. The partial aniridia implant also contributed to the reduction of the glare symptoms, while allowing a sufficient fundus assessment. The combined implantation of the small-aperture IOL and the partial aniridia device, therefore, presents an effective option for improvement of the visual symptoms in patients with traumatic iris defects.
Purpose
Evaluation of postoperative artificial iris prosthesis-related complications.
Design
Retrospective cohort study.
Methods
Fifty-one consecutive patients underwent pupillary reconstruction using an artificial iris implant made from silicone between 2011 and 2015. Quantity and quality of complications were subclassified into three groups including mild, moderate, and severe complications. Their management and the learning curve were evaluated.
Results
In total, 13 (25.5%) of 51 included artificial iris implantations showed unexpected events in various degrees: mild complications: recurrent bleeding (n=1, 2.0%), slight but stable iris deviation (n=1, 2.0%), capsular fibrosis (n=2, 3.9%); moderate complications: suture cutting through the residual iris (n=1, 2.0%), glaucoma (n=3, 5.9%), and corneal decompensation (n=3, 5.9%); severe complications: artificial iris suture loosening (n=2, 3.9%) and dislocation (n=3, 5.9%), synechiae (n=2, 3.9%), glaucoma (n=2, 3.9%), and corneal decompensation (n=5, 9.8%) with the need for surgery, cystoid macular edema (n=3, 5.9%) and retinal detachment (n=1, 2.0%). The complication rate decreased from 83.3% (5 of 6 implantations) in the first year to 13.3% (2 of 15 implantations) in the 4th year. Nineteen of 45 evaluated patients showed a significant gain in best-corrected visual acuity (BCVA) from 1.09 ± 0.56 logMAR to 0.54 ± 0.48 logMAR (p < 0.001), and 13 of 45 eyes had a significant BCVA loss from 0.48 ± 0.39 logMAR to 0.93 ± 0.41 logMAR after surgery (p < 0.001).
Conclusions
The artificial iris is a feasible option in the treatment of iris defects with a wide spectrum of postoperative complications. The significant reduction of complications after twelve implantations implicates that the procedure is not to be recommended in low volume settings.
Background
With recent advances in technology and introduction of new intraocular lens (IOL) models, surgeons today have the opportunity to choose from various optical designs, which can influence the postoperative quality of vision. In our laboratory study, we compared the optical quality of three different IOLs that use the identical platform and are produced by the same manufacturer. The study included two diffractive multifocal IOLs, a bifocal and a trifocal one, as well as a monofocal IOL.
Methods
Three IOL models: monofocal CT ASPHINA 409 M, diffractive bifocal AT LISA 809 M, and diffractive trifocal AT LISA Tri 839MP (Carl Zeiss Meditec AG, Germany) were assessed for optical quality by measuring modulation transfer function (MTF) and Strehl Ratio (SR) values at pupil sizes of 3.0 and 4.5 mm on the OptiSpheric® IOL PRO (Trioptics GmbH, Germany). The United States Air Force (USAF) Target images were also recorded to comfirm the optical performance qualitatively.
Results
For far focus at 50 lp/mm and 3.0 mm pupil size, MTF value of the monofocal lens (MTF = 0.798) was 1.8-fold and 2.1-fold better than the bifocal (MTF = 0.446) and the trifocal (MTF = 0.382) IOLs, respectively. For near focus, bifocal IOL (MTF = 0.265) was 1.4-fold better than trifocal IOL (MTF = 0.187), while for intermediate focus, the trifocal IOL (MTF = 0.148) was 1.7-fold better than the bifocal IOL (MTF = 0.086). For the same pupil size, total sum of light loss amounted to 5.2% for the monofocal, 16.0% for the bifocal and 6.0% for the trifocal IOL. For a larger pupil, the amount of light loss increased significantly for the multifocal IOLs.
Conclusions
The monofocal IOL performed the best for far, the bifocal IOL for near and the trifocal IOL for intermediate focus. While the monofocal IOL created the least amount of light loss for both pupil sizes, the trifocal IOL created less than half the amount of light loss than the bifocal IOL for small pupil. For large pupil, however, less light scatter was observed for the bifocal than the trifocal IOL.
Congenital iris defects may usually present either as subtotal aniridia or colobomatous iris defects. Acquired iris defects are secondary to penetrating iris injury, iatrogenic after surgical excision of iris tumours, collateral trauma after anterior segment surgery, or can be postinflammatory in nature. These iris defects can cause severe visual disability in the form of glare, loss of contrast sensitivity, and loss of best corrected visual acuity. The structural loss of iris can be reconstructed with iris suturing, use of prosthetic iris implants, or by a combination of these, depending on the relative amount of residual iris stromal tissue and health of the underlying pigment epithelium. Since the first implant of a black iris diaphragm posterior chamber intraocular lens in 1994, advances in material and design technology over the last decade have led to advances in the prosthetic material, surgical technique, and instrumentation in the field of prosthetic iris implants. In this article, we review the classification of iris defects, types of iris prosthetic devices, implantation techniques, and complications.
Soft opaque contact lenses may be useful in certain recalcitrant vision problems. When the full central area is opaque, contact lenses eliminate the visual image, provide acceptable cosmesis, and may be useful in cases of intractable diplopia as well as in the treatment of amblyopia. Artificial iris contact lenses eliminate para-axial rays in monocular diplopia, aniridia, and albinism.
Purpose:
To assess the preliminary safety and efficacy of custom silicone artificial iris implantation.
Setting:
Stein Eye Institute.
Design:
Prospective consecutive case series.
Methods:
Review of medical records of patients implanted with the artificial iris and followed for 1 year. Safety measures included corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell count (ECC), surgical complications, secondary interventions, and adverse events (AEs). Efficacy measures included CDVA with glare, subjective daytime and nighttime glare graded from 0 to 10 (very significant), and subjective cosmetic appearance graded from 0 to 10 (very satisfied).
Results:
Twenty eyes (19 patients) were implanted. Safety data were mixed. CDVA improved in 13 eyes and worsened in 6. ECC decreased from 1918 ± 870 to 1405 ± 705 cells/mm (P = 0.02). Eight eyes experienced postoperative complications. There were 4 IOP elevations, 2 corneal decompensations, 1 case of cystoid macular edema, and 1 device dislocation. Four eyes underwent secondary surgical interventions including 2 AEs (1 glaucoma surgery, 1 device dislocation). Efficacy outcomes were excellent. CDVA with glare improved from 1.5 ± 0.6 to 0.7 ± 0.8 logMAR (P < 0.01). Mean subjective daytime glare decreased from 8.9 ± 1.8 to 2.7 ± 2.6 (P < 0.01) and nighttime glare decreased from 7.9 ± 1.8 to 2.5 ± 2.7 (P < 0.01). Mean cosmesis improved from 2.2 ± 1.6 to 8.8 ± 2.1 (P < 0.01).
Conclusion:
Custom artificial iris implantation was moderately risky but very effective at reducing light and glare sensitivity and improving ocular cosmesis.
Purpose:
The use of monochromatic light in the assessment of intraocular lenses (IOLs) has been criticized for not representing the real-world situation. This study aimed to measure and compare the image quality of 3 extended depth-of-focus (EDOF) IOL models in monochromatic and polychromatic light.
Setting:
David J Apple Laboratory, Heidelberg, Germany.
Design:
In vitro study.
Methods:
An optical metrology instrument was used to study image quality metrics of diffractive IOLs with chromatic aberration correction (Symfony and AT Lara) and a refractive lens (Mini Well). The modulation transfer function (MTF) was measured in green and polychromatic light at a 2.0 mm, 3.0 mm, and 4.0 mm aperture. The EDOF IOL's tolerance to defocus was tested against a monofocal lens.
Results:
The mean MTF of the EDOF IOL at far distance was decreased in polychromatic compared with monochromatic light. The largest effect was found in the refractive lens; however, at intermediate distance, only small differences occurred. In their tolerance to defocus, the EDOF IOLs were superior to the monofocal IOL. The diffractive IOL had higher MTFs than that of the refractive IOL at 2 primary foci, the refractive IOL's optical quality varied less with defocus at 3.0 mm. The refractive lens was the most susceptible to changes in aperture size.
Conclusion:
The diffractive EDOF IOL was more resistant to chromatic effects than the refractive IOL. The EDOF IOLs provided an extended through-focus performance compared with the monofocal IOL, but differences in optical design, particularly pupil dependency, should be considered when refining IOL selection for patients.
Purpose:
To compare the effect of intraocular lens (IOL) decentration on the optical quality in patients with implantation of three IOLs: monofocal, extended depth of focus (EDOF), and bifocal.
Methods:
Patients had cataract surgery with implantation of one of the three above-mentioned IOLs. Higher order aberrations (HOAs), modulation transfer function (MTF), point spread function (PSF), retinal straylight, and dysphotopsia phenomena were evaluated 3 months after surgery. IOL decentration was quantified as the distance between the visual axis center and the IOL center using the OPD-Scan III aberrometer (Nidek Co., Ltd., Gamagori, Japan). The patients who received each IOL type were then divided into two subgroups (decentration of ⩽ 0.25 or > 0.25 mm) to analyze the effect of IOL decentration on these optical qualities.
Results:
The study included 54 eyes (54 patients), with 18 eyes in each IOL group. The distance of IOL decentration did not differ significantly among the three groups. With a decentration of more than 0.25 mm, MTF, PSF, and coma were only significantly deteriorated in the bifocal IOL (ZMB00; Abbott Medical Optics, Santa Ana, CA). HOAs, coma, PSF, and glare perception were better in the monofocal and EDOF IOLs than those in the ZMB00 IOL when decentration was more than 0.25 mm. Furthermore, IOL decentration was significantly correlated with HOAs, coma, MTF, and PSF in the ZMB00 IOL.
Conclusions:
The monofocal and EDOF IOLs are more immune to optical quality degradation caused by IOL decentration than the ZMB00 IOL. [J Refract Surg. 2019;35(8):484-492.].
Purpose:
To compare the effect of decentration and tilt on the optical performance of 6 aspheric intraocular lens (IOL) designs in a model eye.
Setting:
Department of Ophthalmology, Graduate School of Medicine, Dokkyo Medical University, Tochigi, Japan.
Design:
Experimental study.
Methods:
In theoretical simulations, the amount of spherical aberration in the IOL was varied to produce residual ocular spherical aberration (range -0.15 to 0.30 μm) at a 6.0 mm entrance pupil. Wavefront aberration analyses were performed with the ZEMAX optical design program (version August 20, 2014) to obtain the ocular root-mean-square values of astigmatism, coma, trefoil, and higher-order aberrations (HOAs) when the IOL was centered on the insertion position and misaligned at a 4.0 mm entrance pupil. The retinal visual images were calculated using the same conditions. Six 20.0 diopter (D) aspheric IOLs and one 20.0 D spherical IOL were used for the experimental studies. Each IOL was inserted in the model eye. The actual alignments were measured using a Scheimpflug camera (EAS-1000). The wavefront aberrations and visual images were gauged using a wavefront analyzer (KR-1W) at several IOL alignments.
Results:
Intraocular lens decentration and tilt increased wavefront aberrations and degraded optical performance. Astigmatism, coma, and HOAs generated by misaligned IOLs were related to the amount of spherical aberration correction of the IOLs. The extent of spherical aberration remained unchanged by the amount of misalignment. Experimental model eye results showed trends similar to theoretical results.
Conclusions:
The spherical aberration correction amount in the aspheric IOL design was critical for the astigmatism, coma, and HOAs generated by the IOL misalignment. Additional spherical aberration corrections led to a more sensitive optical performance degradation resulting from IOL misalignment.
Purpose:
To evaluate the effect of an artificial iris implant on the remnant iris.
Design:
Interventional case series METHODS: Setting: single-centre PATIENT POPULATION: 42 consecutive patients OBSERVATION PROCEDURES: Morphological evaluation over 24±14 months MAIN OUTCOME MEASURES: Remnant pupillary aperture, iris colour, visual acuity, intraocular pressure and endothelial cell count.
Results:
In 7 of 42 cases (16.7%), the residual iris aperture dilated from 36.6±15.4 mm2 preoperatively to 61.1±12.5 mm2 one year postoperatively (66.9% increase). In 5 of 7 affected eyes the artificial iris had been implanted into the ciliary sulcus, in 2 eyes it had been sutured to the sclera. 4 of the 7 patients presented with remarkable complications: 2 eyes needed glaucoma shunt surgeries due to pigment dispersion; 1 suffered from recurrent bleedings and in 1 case artificial iris explantation was performed due to chronic inflammation. Anterior chamber depth and angle, endothelial cell count and visual acuity did not change in this cohort. Changes in color were not observed in the remnant iris.
Conclusions:
The implantation of an artificial iris prosthesis can lead to a residual iris retraction syndrome. It is likely that residual iris is trapped in the fissure between the artificial iris and the anterior chamber angle, preventing further pupil constriction. Another possibility could be a constriction or atrophy of the residual iris. A scleral-sutured implant or an implantation in the capsular bag were both found to prevent the iris retraction. The study group number is inadequate to allow statistical comparison of these different implantation methods. As the use of artificial irises increases, we may expect more patients with iris retraction syndrome in the future.
Purpose:
To assess the influence of decentration and aperture size on the optical quality of different intraocular lenses (IOLs) of the same material, body design, and refractive power using standardized optical bench testing.
Methods:
Using an optical bench set-up, an aspheric monofocal (CT ASPHINA 409M; Carl Zeiss Meditec, Jena, Germany), an aspheric diffractive bifocal (AT LISA 809M; Carl Zeiss Meditec), and an aspheric diffractive trifocal (AT LISA 839M; Carl Zeiss Meditec) intraocular lens (IOL) were evaluated, each with the same distance power, body design, and material. Modulation transfer function (MTF) values were measured at spatial frequencies of 50 lp/mm and aperture sizes of 3 and 4.5 mm. Each IOL was measured while centered, then decentered by 0.25, 0.5, 0.75, and 1 mm.
Results:
MTF values for the monofocal IOL at far focus with 3- and 4.5-mm aperture size were 0.80/0.80 with maximum reduction to 0.77/0.73 for 1-mm decentration, respectively. Centered IOL MTFs of the bifocal and trifocal IOLs were lower for the far focus at 0.46/0.41 and 0.39/0.26, with reduction at 1-mm decentration to 0.35/0.25 and 0.25/0.18, respectively. Values for near focus of the bifocal and trifocal IOLs reduced from 0.27/0.31 and 0.19/0.18 to 0.2/0.21 and 0.12/0.13, respectively. The trifocal intermediate focus MTF reduced from 0.15/0.10 to 0.12/0.08. MTF values of all three lenses decreased significantly under all conditions with decentration of 0.5 to 0.75 mm.
Conclusions:
Monofocal lenses were least negatively affected by decentration, with mean optical quality reduction of less than 10% for 1-mm decentration at physiological pupil sizes. For diffractive bifocal and trifocal lenses, optical quality at all distances was significantly reduced if decentration exceeded 0.75 mm, with intermediate focus showing the least reduction. [J Refract Surg. 2017;33(12):808-812.].
We describe 6 surgical techniques used to implant a silicone iris prosthesis: sector-shaped iris segments that require suturing, injector-assisted sulcus fixation, injector-assisted capsular bag fixation with an intraocular lens (IOL) and capsular tension ring, folded iris tissue implanted with a forceps and sutured to the sclera with a scleral-fixated IOL, “sandwich” or “backpack” implantation with an IOL, and open-sky implantation with a perforating keratoplasty. The results of the techniques performed in 51 patients are discussed. Sector-shaped iris segments required longer surgery because of the complexity of intracameral sutures and carried risks for knots to loosen and sutures to cut through residual iris tissue. The combined implantation of an iris and IOL proved complex and lengthy but solved lens and iris abnormalities in 1 procedure and provided long-lasting stable conditions. The procedures that implanted a complete iris in pseudophakic eyes were shorter and required smaller incisions, a sutureless approach, and injector-assisted implantation.
Purpose:
Patients with iris defects suffer from severe visual impairment, especially increased glare sensitivity and cosmetic disturbances. This constitutes a great psychological strain for those patients. Until recently, possible treatment options were iris print contact lenses, sunglasses, and simple iris prostheses. The aim of this study was to investigate structural and functional outcome parameters and patient satisfaction after implantation of this new artificial iris prosthesis.
Design:
Prospective case series investigating functional results and patient satisfaction after surgical iris reconstruction.
Participants:
Thirty-seven consecutive patients with traumatic iris defects presenting from 2011 through 2014 underwent pupillary reconstruction with a new artificial iris implant at the Department of Ophthalmology, Technical University Munich.
Methods:
The custom-made, flexible silicone iris prosthesis ArtificialIris (HumanOptics, Erlangen, Germany) used in this study is a novel and innovative device in the surgical treatment of iris defects. Patients were examined before and after iris reconstruction with the iris implant placed in the ciliary sulcus.
Main outcome measures:
Change of best-corrected visual acuity (BCVA), intraocular pressure (IOP), pupillary aperture, glare, contrast sensitivity, endothelial cell density, anterior chamber depth, anterior chamber angle, and patient satisfaction were assessed.
Results:
Thirty-two eyes of 32 patients (mean age, 52.9±16.0 years) were included. After implantation and during follow-up, BCVA and IOP did not change significantly (BCVA, 0.77±0.62 logarithm of the minimum angle of resolution [logMAR] preoperatively vs. 0.68±0.64 logMAR 1 month postoperatively [P = 0.792]; IOP, 14.94±3.55 mmHg preoperatively vs. 17.72±5.88 mmHg 1 month postoperatively [P = 0.197]). The pupillary aperture was reduced significantly (42.11±20.1 mm(2) to 8.7±0.3 mm(2); P < 0.001). Contrast sensitivity increased significantly (0.80±0.51 to 0.93±0.49; P = 0.014). Endothelial cell count revealed a significant decrease postoperatively (1949±716 per 1 mm(2) to 1841±689 per 1 mm(2); P = 0.003). Anterior chamber depth (4.03±1.06 mm preoperatively vs. 4.29±0.70 mm postoperatively; P = 0.186) and angle (43.2±13.5° preoperatively vs. 40.5±10.8° postoperatively; P = 0.772) showed no significant differences. Subjective impairment through glare (9.12±1.62 preoperatively vs. 3.07±2.29 postoperatively; P < 0.001) and cosmetic disturbance (6.33±3.21 preoperatively vs. 1.58±0.86 postoperatively; P < 0.001) improved significantly. Patient satisfaction with the overall result was 8.91±1.51 of 10 points on an analog scale.
Conclusions:
The implantation of the artificial iris is a new and effective therapeutic option for the treatment of distinctive traumatic iris defects and results in an individual, aesthetically appealing, and good functional outcome in addition to high patient satisfaction.
The article presents clinical and functional results of model C iris-lens diaphragm (ILD) implantation to patients with aniridia or large iris defects. Modification of the supporting elements and new grooves at their base provide better adaptation of the diaphragm to individual eye sizes and reduces the impact exert upon reactive ocular structures. The new model shows good self centration and enables sutureless implantation in patients with aniridia if lens capsule or other supporting structures of the anterior chamber are present. Owing to design changes and lesser thickness of the new diaphragm, injection implantation onto the lens capsule is now possible.
Purpose:
To discuss limitations and benefits of a custom-made foldable artificial iris (Artificialiris) in the management of acquired iris defects.
Setting:
Hochkreuzklinik Eye Hospital, Bonn, and the Department of Ophthalmology, University of Cologne, Germany.
Design:
Case series.
Methods:
We reviewed the clinical course and surgical management in eyes with sight-compromising complications after phakic anterior chamber implantation of synthetic iris devices between November 2011 and January 2012.
Results:
Three eyes of 2 patients were reviewed. One patient developed cataract and corneal decompensation after anterior chamber artificial iris implantation in the left eye to treat post-uveitic mydriasis. Further treatment included artificial iris removal, cataract surgery, iridoplasty, and Descemet membrane endothelial keratoplasty (DMEK). By the 6-month follow-up, visual acuity had increased from 20/50 to 20/25. The second patient presented with bilateral secondary glaucoma, cataract, corneal edema, and iris atrophy after implantation of Newiris devices for cosmetic reasons. He consecutively had binocular explantation of the cosmetic devices, cataract surgery, artificial iris implantation, and DMEK in both eyes and Ahmed valve implantation in the right eye. During the 6-month follow-up, the intraocular pressure remained sufficiently adjusted in both eyes. Photophobia was eliminated, and visual acuity improved to 20/32 in the right eye and 20/20 in the left eye.
Conclusions:
In patients with major iris defects ineligible for pupilloplasties, the artificial iris allows functionally and esthetically satisfactory anterior segment reconstruction. To prevent secondary complications, the artificial iris should only be implanted in aphakic or pseudophakic eyes and placed in the posterior chamber.
This case report describes the one-year results of the implantation of a sectorial and foldable artificial iris in a phakic eye. To our knowledge, this is the first such report with a follow-up of 1 year. No perioperative or postoperative complications were seen. Corrected distance visual acuity remained unchanged (left eye, 1.5/10), the subjective complaints of glare and photophobia improved considerably, and the patient was very satisfied with the aesthetic result.
To study artificial iris intraocular lens (IOL) or ring specially designed for correction of aniridia or iris deficiencies associated with cataract or aphakia.
Nine patients with partial or total aniridia underwent the surgical procedure. A black (Morcher 67F) or brown (Ophtec 311) diaphragm intraocular lens was used for the seven patients with aphakia. Morcher 50C rings were used for the patients with cataract.
The esthetic results were satisfactory. Photophobia was reduced in all cases. Postoperative complications included one case of transient hypertony and one case of retinal detachment.
We recommend the use of artificial iris IOL or rings in aniridia associated with cataract or aphakia.
To determine the impact of spherical and aspheric foldable intraocular lens (IOL) tilt and decentration on optical quality after cataract surgery in an intraindividual comparative study.
Department of Ophthalmology, Goethe-University, Frankfurt am Main, Germany.
Randomized implantation of a spherical IOL (Sensar AR40e) was performed in 1 eye and of an aspheric IOL with negative spherical aberration (Tecnis Z9000) in the contralateral eye. Three to 4 months postoperatively, the wavefront was measured and higher-order aberrations (HOAs) were calculated for virtual pupil diameters of 3.5 mm and 6.0 mm. Tilt and decentration of the IOLs were measured using Scheimpflug photography. The tilt and decentration, HOAs, and best corrected visual Strehl ratio of the optical transfer function (BCVSOTF) calculated from the wavefront aberration were compared. The effect of tilt and decentration on HOAs and optical quality was assessed using multiple regression analysis.
The mean optic tilt was 2.89 degrees +/- 1.46 (SD) for the spherical IOL and 2.85 +/- 1.36 degrees for the aspheric IOL. The mean optic decentration was 0.19 +/- 0.12 mm and 0.27 +/- 0.16 mm, respectively. No significant intergroup differences in IOL tilt or decentration were found. Tilt and decentration did not significantly affect the BCVSOTF with either IOL.
The amounts of tilt and decentration of both IOLs were not large enough to cause deterioration of optical quality. Thus, when IOL tilt and decentration are within normal limits, they do not compromise the correction of spherical aberration by the aspheric IOL.
Aniridia is a rare panocular disorder affecting the cornea, anterior chamber, iris, lens, retina, macula and optic nerve. It occurs because of mutations in PAX6 on band p13 of chromosome 11. It is associated with a number of syndromes, including Wilm's tumour, bilateral sporadic aniridia, genitourinary abnormalities and mental retardation (WAGR) syndrome. PAX6 mutations result in alterations in corneal cytokeratin expression, cell adhesion and glycoconjugate expression. This, in addition to stem-cell deficiency, results in a fragile cornea and aniridia-associated keratopathy (AAK). It also results in abnormalities in the differentiation of the angle, resulting in glaucoma. Glaucoma may also develop as a result of progressive angle closure from synechiae. There is cataract development, and this is associated with a fragile lens capsule. The iris is deficient. The optic nerve and fovea are hypoplastic, and the retina may be prone to detachment. Aniridia is a profibrotic disorder, and as a result many interventions--including penetrating keratoplasty and filtration surgery--fail. The Boston keratoprosthesis may provide a more effective approach in the management of AAK. Guarded filtration surgery appears to be effective in glaucoma. Despite our increasing understanding of the genetics and pathology of this condition, effective treatment remains elusive.
A method for measuring the tilt and decentration of intraocular lenses (IOLs) in the static eye using the Purkinje image locations is presented. The patient fixates on a target that is coaxial with the camera or is at a predetermined angle with the camera axis. A telecentric stop is introduced in the camera so the positions of the Purkinje images on the film are independent of their distance from the camera. Measurements of the image locations on the film are used with anterior chamber depth and corneal curvature measurement to calculate the tilt and decentration of the IOL. In a group of 14 randomly selected patients with posterior chamber IOLs, 13 gave Purkinje images that could be measured. The average tilt was 7.8 degrees and the average decentration was 0.7 mm.
To study the theoretical optical performance of 3 intraocular lens (IOL) designs in the presence of IOL decentration.
Optics Center, Bausch & Lomb, Rochester, New York, USA.
A ray-tracing program was used to evaluate the effect of IOL decentration on the optical performance of 3 silicone IOLs (LI61U, Bausch & Lomb; Tecnis Z9000, Advanced Medical Optics; and a new aberration-free IOL [SofPort AO, Bausch & Lomb]) in an experimental model eye. The study was done using pupil diameters of 3.0 mm, 4.0 mm, and 5.0 mm and IOL decentrations of 0 mm, 0.25 mm, 0.50 mm, 0.75 mm, and 1.00 mm. The modulation transfer functions were computed and plotted. A Monte Carlo simulation analysis with 1000 trials with IOL decentration randomly varying for each pupil size was performed.
Decentration of LI61U and Tecnis Z9000 IOLs led to asymmetrical higher-order aberrations that adversely affected the optical performance of the model eye; performance was not affected with the aberration-free IOL because it lacks inherent spherical aberration. Optical performance with the aberration-free IOL was better than with the LI61U IOL as the former has less spherical aberration and did not introduce other aberrations when decentered. Performance with the aberration-free IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.15 mm, 0.30 mm, and 0.38 mm, respectively. Performance with the LI61U IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.3 mm, 0.5 mm, and 0.5 mm, respectively. Monte Carlo simulations showed the expected postoperative results of the LI61U IOL and aberration-free IOL would be repeatable and predictable, whereas the outcomes with the Tecnis Z9000 IOL would vary widely.
The optical performance of the model eye was not affected by decentration of an aspheric IOL designed to have no inherent spherical aberration. With decentration, the performance with the new IOL was better than with a conventional spherical IOL and an aspheric IOL designed to offset the spherical aberration of an average cornea.
[Surgical treatment with an artificial iris] [German]
- Mayer