SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS: Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs.-1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.
Corneal astigmatism less than 1.25 D was present in most cataract surgery candidates; it was higher in about 22%, with slight differences between the various age ranges. This information is useful for intraocular lens (IOL) manufacturers to evaluate which age ranges concentrate the parameters most frequently needed in sphere and cylinder powers and for surgeons to evaluate which IOLs provide the most effective power range.
PURPOSE. We defined the theoretical oxygen tension behind modern scleral contact lenses (CLs) made of different rigid gas permeable (RGP) materials, assuming different thickness of the tear layer behind the lens. A second goal was to show clinically the effect of the postlens tear film on corneal swelling. METHODS.We simulated the partial pressure of oxygen across the cornea behind scleral CLs made of different lens materials (oxygen permeability Dk, 75-200 barrer) and different thickness (T av , 100-300 lm). Postlens tear film thicknesses (T post-tear ) ranging from 150 to 350 lm were considered. Eight healthy subjects were fitted randomly with a scleral lens with a thin and a thick postlens tear layer in two different sessions for a period of 3 hours under open-eye conditions.RESULTS. The CLs with less than 125 barrer of Dk and a thickness over 200 lm depleted the oxygen availability at the lens-cornea interface below 55 mm Hg for a postlens tear film of 150 lm. For a postlens tear film thickness of 350 lm, no combination of material or lens thickness will meet the criteria of 55 mm Hg. Our clinical measures of corneal edema showed that this was significantly higher (P < 0.001, Wilcoxon signed ranks test) with the thicker compared to the thinner T post-tear (mean 6 SD, 1.66 6 1.12 vs. 4.27 6 1.19%).CONCLUSIONS. Scleral RGP CLs must be comprised of at least 125 barrer of oxygen permeability and up to 200 lm thick to avoid hypoxic effects even under open eye conditions. Postlens tear film layer should be below 150 lm to avoid clinically significant edema.
A survey in 2015 identified a high level of eye care practitioner concern about myopia with a reported moderately high level of activity, but the vast majority still prescribed single vision interventions to young myopes. This research aimed to update these findings 4 years later. Methods: A self-administrated, internet-based questionnaire was distributed in eight languages, through professional bodies to eye care practitioners globally. The questions examined: awareness of increasing myopia prevalence, perceived efficacy of available strategies and adoption levels of such strategies, and reasons for not adopting specific strategies. Results: Of the 1336 respondents, concern was highest (9.0 ± 1.6; p < 0.001) in Asia and lowest (7.6 ± 2.2;
CLs were reported to be well accepted, consistent, and safe methods to address myopia regulation in children. Corneal refractive therapy (orthokeratology) is so far the method with the largest demonstrated efficacy in myopia regulation across different ethnic groups. However, factors such as patient convenience, the degree of initial myopia, and non-CL treatments may also be considered. The combination of different strategies (i.e., central defocus, peripheral defocus, spectral filters, pharmaceutical delivery, and active lens-borne illumination) in a single device will present further testable hypotheses exploring how different mechanisms can reinforce or compete with each other to improve or reduce myopia regulation with CLs.
SIGNIFICANCE:Treatment of myopic children with a dual-focus soft contact lens (DFCL; MiSight 1 day) produced sustained slowing of myopia progression over a 6-year period. Significant slowing was also observed in children switched from a single vision control to treatment lenses (3 years in each lens).PURPOSE: This study aimed to evaluate the effectiveness of DFCLs in sustaining slowed progression of juvenileonset myopia over a 6-year treatment period and assess myopia progression in children who were switched to a DFCL at the end of year 3. METHODS: Part 1 was a 3-year clinical trial comparing DFCLs with a control contact lens (Proclear 1 day) at four investigational sites. In part 2, subjects completing part 1 were invited to continue for 3 additional years during which all children were treated with MiSight 1 day DFCLs (52 and 56 from the initially treated [T6] and control [T3] groups, respectively). Eighty-five subjects (45 [T3] and 40 [T6]) completed part 2. Cyclopleged spherical equivalent refractive errors (SEREs) and axial lengths (ALs) were monitored, and a linear mixed model was used to compare their adjusted change annually.RESULTS: Average ages at part 2 baseline were 13.2 ± 1.3 and 13.0 ± 1.5 years for the T6 and T3 groups, respectively. Slowed myopia progression in the T6 group observed during part 1 was sustained throughout part 2 (mean ± standard error of the mean: change from baseline SERE [in diopters], −0.52 ± 0.076 vs. −0.51 ± 0.076; change in AL [in millimeters], 0.28 ± 0.033 vs. 0.23 ± 0.033; both P > .05). Comparing progression rates in part 2 for the T6 and T3 groups, respectively, indicates that prior treatment does not influence efficacy (SERE, −0.51 ± 0.076 vs. −0.34 ± 0.077; AL, 0.23 ± 0.03 vs. 0.18 ± 0.03; both P > .05). Within-eye comparisons of AL growth revealed a 71% slowing for the T3 group (3 years older than part 1) and further revealed a small subset of eyes (10%) that did not respond to treatment.CONCLUSIONS: Dual-focus soft contact lenses continue to slow the progression of myopia in children over a 6-year period revealing an accumulation of treatment effect. Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.
Purpose. To show the distribution of ocular dominance as measured with sensory and eye sighting methods and its potential relationship with high and low contrast LogMAR visual acuity in presbyopic subjects. Method. Forty-four presbyopes (48.5 ± 3.5 years) participated in this study. Ocular dominance was determined by eye sighting (hole-in-card) and sensorial (+1.50 D lens induced blur) methods. According to the dominance detected with each method (RE: right eye or LE: left eye), patients were classified in dominance type 1 (RE/RE), type 2 (RE/LE), type 3 (LE/RE) and type 4 (LE/LE). Results. Baseline refractive error (MSE) was RE:−0.36 ± 1.67 D and LE:−0.35 ± 1.85 D (P = 0.930). RE was the dominant eye in 61.4% and 70.5% of times as obtained from sensorial and sighting methods, respectively. Most frequent dominance was of type 1 (52.3%), in this case the RE showed statistically significant better distance low contrast LogMAR VA (0.04 LogMAR units) compared to the LE (P < 0.05). Conclusions. The dominance was more frequent in RE in this sample. The eye sighting and sensorial methods to define ocular dominance agreed in more than half of cases. Amount of MSE was not significantly different between dominant and non-dominant eye. But in case of right dominance, the RE presented better distance low contrast VA compared to the LE.
First described during the 18th century, the cause of night myopia remains a controversial topic. Whereas several explanations have been suggested in the literature, particularly related with accommodation or chromatic shift in scotopic light conditions, no definitive explanation for its aetiology has been provided. We describe an experiment in which ocular refractive state was objectively and subjectively measured while viewing two kind of stimulus: letters on a bright background and a punctual source of light in a dark background. We found that under photopic conditions the optimum refractive state of the accommodating eye is significantly more myopic when maximizing perceived quality of a point source on a dark background compared to a conventional letter chart with black letters on a white background. Optical modeling suggested this difference in refractive state is due to spherical aberration. Since isolated point sources are more likely encountered at night, whereas extended objects are more likely encountered in the daytime, our results suggest that a significant part of the night myopia phenomenon is determined by the nature of the visual stimulus and the visual task used to assess ocular refractive state.
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