Effect of Dual-Focus Soft Contact Lens Wear on Axial Myopia Progression in Children
ABSTRACT To test the efficacy of an experimental Dual-Focus (DF) soft contact lens in reducing myopia progression.
Prospective, randomized, paired-eye control, investigator-masked trial with cross-over.
Forty children, 11-14 years old, with mean spherical equivalent refraction (SER) of -2.71 ± 1.10 diopters (D).
Dual-Focus lenses had a central zone that corrected refractive error and concentric treatment zones that created 2.00 D of simultaneous myopic retinal defocus during distance and near viewing. Control was a single vision distance (SVD) lens with the same parameters but without treatment zones. Children wore a DF lens in 1 randomly assigned eye and an SVD lens in the fellow eye for 10 months (period 1). Lens assignment was then swapped between eyes, and lenses were worn for a further 10 months (period 2).
Primary outcome was change in SER measured by cycloplegic autorefraction over 10 months. Secondary outcome was a change in axial eye length (AXL) measured by partial coherence interferometry over 10 months. Accommodation wearing DF lenses was assessed using an open-field autorefractor.
In period 1, the mean change in SER with DF lenses (-0.44 ± 0.33 D) was less than with SVD lenses (-0.69 ± 0.38 D; P < 0.001); mean increase in AXL was also less with DF lenses (0.11 ± 0.09 mm) than with SVD lenses (0.22 ± 0.10 mm; P < 0.001). In 70% of the children, myopia progression was reduced by 30% or more in the eye wearing the DF lens relative to that wearing the SVD lens. Similar reductions in myopia progression and axial eye elongation were also observed with DF lens wear during period 2. Visual acuity and contrast sensitivity with DF lenses were not significantly different than with SVD lenses. Accommodation to a target at 40 cm was driven through the central distance-correction zone of the DF lens.
Dual-Focus lenses provided normal acuity and contrast sensitivity and allowed accommodation to near targets. Myopia progression and eye elongation were reduced significantly in eyes wearing DF lenses. The data suggest that sustained myopic defocus, even when presented to the retina simultaneously with a clear image, can act to slow myopia progression without compromising visual function.
Proprietary or commercial disclosure may be found after the references.
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- "Such lenses not only include the plethora of commercially available bi-and multifocal contact lenses but also novel lens designs, including the marketed myopia control contact lens MiSight, which features a large central distance zone surrounded by alternating concentric distant and near zones. Various commercial and novel multifocal contact lenses have been assessed for the capacity to retard myopia progression     , however, few studies have assessed the visual performance of multifocal contact lenses in non-presbyopic myopic eyes   . The accumulated evidence from these studies indicates some degradation of visual performance is likely to occur when contact lenses with multiple refractive zones are worn. "
ABSTRACT: To assess visual performance of single vision and multifocal soft contact lenses. At baseline, forty-four myopic participants (aged 18-35 years) were fitted bilaterally with a control lens (AirOptix Aqua). At the four follow-up visits, a total of 16 study lenses (5 single vision, 11 multifocal lenses) were fitted contralaterally. After 1h of lens wear, participants rated (scale 1-10) vision clarity (distance, intermediate and near), magnitude of ghosting at distance, comfort during head movement, and overall comfort. Distance high contrast visual acuity (HCVA), central refraction and higher order aberrations, and contact lens centration were measured. For single vision lenses, vision ratings were not significantly different to the control (p>0.005). The control outperformed Acuvue Oasys, Clariti Monthly and Night and Day in HCVA (mean VA: -0.10±0.07 logMAR, p<0.005). Most refraction and higher order aberration measures were not different between lenses. The Night and Day lens showed greatest differences compared to the control, i.e., C[4, 0] was more positive (p<0.005) at distance (Δ=0.019μm) and near (Δ=0.028μm). For multifocal lenses, the majority of vision ratings (84%) were better with the control (p<0.005). HCVA was better with the control (p<0.005). Proclear Multifocal lenses showed greatest differences for M, C[3, -1] and C[4, 0] at distance and near, and were inferiorly de-centered (p<0.005). Design differences between single vision lenses had a small impact on visual performance. Lenses featuring multifocality decreased visual performance, in particular when power variations across the optic zone were large and/or the lens was significantly de-centered. Copyright © 2015. Published by Elsevier Ltd.Contact lens & anterior eye: the journal of the British Contact Lens Association 07/2015; DOI:10.1016/j.clae.2015.07.005 · 2.00 Impact Factor
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- "CLAE-753; No. of Pages 6 2 D.P. Lopes-Ferreira et al. / Contact Lens & Anterior Eye xxx (2014) xxx–xxx dual-focus contact lens has been proved to be effective in reducing myopia progression by up to 34% in children over a 10-month period . Kollbaum et al. recently evaluated the quality of vision of center-distance design and bifocal contact lenses for presbyopia and compared them to dual-focus lenses to determine the potential use of such lenses to control myopia . "
ABSTRACT: Purpose: To evaluate the impact of eye and head rotation in the measurement of peripheral refraction with an open-field autorefractometer in myopic eyes wearing two different center-distance designs of multifocal contact lenses (MFCLs). Methods: Nineteen right eyes from 19 myopic patients (average central M +/- SD = -2.67 +/- 1.66 D) aged 20-27 years (mean +/- SD = 23.2 +/- 3.3 years) were evaluated using a Grand-Seiko autorefractometer. Patients were fitted with one multifocal aspheric center-distance contact lens (Biofinity Multifocal D (R)) and with one multi-concentric MFCL (Acuvue Oasys for Presbyopia). Axial and peripheral refraction were evaluated by eye rotation and by head rotation under naked eye condition and with each MFCL fitted randomly and in independent sessions. Results: For the naked eye, refractive pattern (M, JO and J45) across the central 60 degrees of the horizontal visual field values did not show significant changes measured by rotating the eye or rotating the head (p > 0.05). Similar results were obtained wearing the Biofinity D, for both testing methods, no obtaining significant differences to M, JO and J45 values (p > 0.05). For Acuvue Oasys for presbyopia, also no differences were found when comparing measurements obtained by eye and head rotation (p > 0.05). Multivariate analysis did not showed a significant interaction between testing method and lens type neither with measuring locations (MANOVA, p > 0.05). There were significant differences in M and JO values between naked eyes and each MFCL. Conclusion: Measurements of peripheral refraction by rotating the eye or rotating the head in myopic patients wearing dominant design or multi-concentric multifocal silicone hydrogel contact lens are comparable.Contact Lens & Anterior Eye 12/2014; 38(2). DOI:10.1016/j.clae.2014.11.201 · 2.00 Impact Factor
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- "CLAE-726; No. of Pages 6 manufactured in soft materials  . However, the potential of rigid gas permeable (RGP) lens materials should not be neglected as their surfaces are not easily distorted by the underlying corneal topography. "
ABSTRACT: Purpose To evaluate the performance of two experimental contact lenses (CL) designed to induce relative peripheral myopic defocus in myopic eyes. Methods Ten right eyes of 10 subjects were fitted with three different CL: a soft experimental lens (ExpSCL), a rigid gas permeable experimental lens (ExpRGP) and a standard RGP lens made of the same material (StdRGP). Central and peripheral refraction was measured using a Grand Seiko open-field autorefractometer across the central 60° of the horizontal visual field. Ocular aberrations were measured with a Hartman-Shack aberrometer, and monocular contrast sensitivity function (CSF) was measured with a VCTS6500 without and with the three contact lenses. Results Both experimental lenses were able to increase significantly the relative peripheral myopic defocus up to −0.50 D in the nasal field and −1.00 D in the temporal field (p < 0.05). The ExpRGP induced a significantly higher myopic defocus in the temporal field compared to the ExpSCL. ExpSCL induced significantly lower levels of Spherical-like HOA than ExpRGP for the 5 mm pupil size (p < 0.05). Both experimental lenses kept CSF within normal limits without any statistically significant change from baseline (p > 0.05). Conclusions RGP lens design seems to be more effective to induce a significant myopic change in the relative peripheral refractive error. Both lenses preserve a good visual performance. The worsened optical quality observed in ExpRGP was due to an increased coma-like and spherical-like HOA. However, no impact on the visual quality as measured by CSF was observed.Contact Lens & Anterior Eye 09/2014; 37(6). DOI:10.1016/j.clae.2014.08.001 · 2.00 Impact Factor