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.
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