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.
Aims To compare methods to measure time outdoor and light levels, two possible predictors of myopia, in Singapore children. Methods Outdoor time from a diary and portable light meter over a 1-week period was compared in 117 Singapore children aged 6-12 years with and without myopia. All children wore a (HOBO Pendant temp/light Part # UA-002-64) light meter for 1 week and the parents filled the 7-day outdoor diary to track the outdoor activity. Results Mean outdoor time from diary and time with light levels was 5.44 hours per week and 7.91 hours per week, respectively, during school term and school holidays. Time spent with light levels of 41000 Lux from the light meter were 7.08 h per week and 9.81 h per week, respectively, during school term and school holidays. The intraclass correlation coefficients were 0.21 and 0.28 for outdoor time from the diary and light meter (1000 Lux cut-off) during the school term and holidays, respectively. The correlation coefficient was 0.34 (95% CI 0.05, 0.58) for a weekday during school holidays, 0.17 (À0.14, 0.45) for a weekday during school term, 0.07 (À0.16, 0.29) for a weekday during school term, and 0.25 (0.02, 0.46) for a weekend during school term. Conclusions The agreement between the light meter and 1-week diary was poor to fair. Both instruments measure different parameters, time outdoors and light intensity, and could therefore capture different aspects of risk in future myopia studies.
PurposeMyopia is rising in prevalence in many locations, and there is evidence that outdoor light exposure is a major environmental factor playing a role in myopia development. This study examined the patterns of daily light exposure in similarly aged children from two geographic locations (Australia and Singapore) known to exhibit differences in myopia prevalence.MethodsWearable light sensors were used to assess daily light exposure in 69 Singaporean children aged 8 to 12 years (mean, 9.2 ± 1.1) and 43 Australian children aged 10 to 12 years (mean, 11.3 ± 0.6). The mean daily time exposed to bright outdoor light (>1000 lux) and the number and duration of daily episodes of outdoor exposure were examined.ResultsPatterns of daily outdoor light exposure differed substantially between Australia and Singapore. Australian children (105 ± 42 min/d) experienced significantly longer daily outdoor light exposure than Singaporean children (61 ± 40 min/d; P = 0.005), with the largest differences found on weekdays during school hours. Australian children (6.9 ± 1.5 episodes per day) had more frequent daily episodes of outdoor light exposure compared with Singaporean children (4.6 ± 1.5; P = 0.02); however, there was no significant difference in the mean duration of these episodes between countries (P = 0.54).ConclusionsChildren living in Singapore were exposed to significantly less daily outdoor light than Australian children, and these differences may be one of several factors contributing to the differences in myopia prevalence typically found between these populations.Translational RelevanceKnowledge of these light exposure patterns may assist in the design of outdoor interventions, including school programs, to increase outdoor time in urban Asian populations.
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