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Joe Rappon, Jill Woods, Debbie Jones, Lyndon William Jones; Tolerability of novel myopia control spectacle designs. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5845. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Myopia is a global epidemic that is increasing in both prevalence and severity, and high myopia (>5-6 D) leads to vision-threatening retinal complications later in life. Treatments to prevent myopia progression are urgently needed, particularly treatments amenable for young children (<10 years). We conducted a prospective, randomized, subject-masked, 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
Participants were healthy, myopic (-1.00 to -4.00 DS) children, aged 6-12 years. Twenty-one habitual spectacle wearers were randomized to one of three lens designs for 2 weeks. Each lens design had a clear central aperture and peripheral patterns designed to modulate peripheral contrast to three different levels. The primary outcome variables were distance visual acuity, contrast sensitivity, and subjective responses of acceptability assessed using a questionnaire. Other outcome variables included a parent questionnaire, near visual acuity, and axial length measurements.
All 21 eligible subjects completed the study. High-contrast distance visual acuity in both high and low room illumination were at high levels, not different to refraction acuity levels (p>0.05). There were no differences between any of the lens designs for high-contrast, high-illumination distance and near acuity; high-contrast, low-illumination distance acuity or contrast sensitivity. Results from the subject questionnaire indicated that the experience with lens designs 1 and 2 were similar to each other and to their habitual spectacles. By some measures related to vision clarity and cosmesis, subjects preferred their habitual spectacles to lens design 3. Results from the parent questionnaire supported that wearing lens design 3 posed more difficulties for the children in some areas compared to the other designs. All three lens designs showed a trend toward reduction in axial length over the 2 weeks of lens wear, with lens design 1 reaching statistical significance in both eyes (p<0.05).
All three lens designs provided similarly high levels of distance and near visual acuity and contrast sensitivity and were tolerable for the study duration. Based on patient-reported subjective data, lens designs 1 and 2 performed better than lens design 3. The axial length reductions noted is consistent with a therapeutic effect of slowing myopia progression, and merits further investigation.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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