Comparing Computer-Optimized Glasses to Routine Clinical Glasses for Children With Down Syndrome Aged 5 to 12

What this Trial Is About

Researchers are evaluating whether glasses prescriptions based on detailed computer analysis of eye images can improve vision outcomes for children with Down syndrome compared to prescriptions determined by standard clinical methods. This phase II clinical trial uses a randomized, crossover design involving 24 children aged 5 to 12 years with Down syndrome. The study aims to compare visual acuity improvements using metric-derived spectacle prescriptions based on wavefront aberration measurements versus routine clinical prescriptions. Participants will undergo an enrollment exam measuring eye refraction, pupil size, and wavefront aberrations. Two types of spectacles will be made for each child metric-optimized spectacles based on wavefront data and routine clinical spectacles from standard eye exams. Each participant will wear each type of glasses for two months in random order, with a Smart Button data logger recording wear time. After both periods, the best spectacles will be selected for continued use, followed by a six-month follow-up visit to assess further vision changes. Throughout the study, participants will attend five visits over 12 months, including enrollment, dispensing, two two-month wearing periods, and a final follow-up. Visual acuity, binocular function, and spectacle wear time will be assessed using objective measures and surveys completed by parents or guardians. Safety checks will ensure no worsening of vision or eye alignment before dispensing spectacles. The main outcome is adapted distance visual acuity after two months of wear, with additional measures including near visual acuity, compliance, and participant feedback.

Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome