A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
ATS 23
What is the goal of the study?
To determine if dichoptic therapy using Luminopia is confirmed to be non- inferior to stardard part-time patching for best- corrected visual acuity, this study will have provided evidence to support Luminopia as a reasonable alternative to patching in young children. Accessing treatment impact and quality of life to provide data on whether there are advantages to Luminopia.
Who can participate in the study?
Age 4 to 7 years • Amblyopia associated with anisometropia, strabismus (<=5∆ at distance and near by spct or both. 8226 no more than 2 weeks cumulative prior dichoptic treatment 8226 no treatment with cycloplegic eyedrops e.g. atropine in the last 2 weeks 8226 spectacles contact lens correction if required worn for at least 18 weeks or demonstrated stability of amblyopic eye va><1-line change by the same testing method measured on 2 exams at least 9 weeks apart 8226 visual acuity in the amblyopic eye of 20 40 to 20 200 inclusive by ats-hotv 8226 interocular difference in va of 3 logmar lines or more by ats-hotv. 8226 age normal va in the fellow eye 20 40 or better if age 4 20 32 or better if 5-6 20 25 or better if age 7 by ats-hotv 8226 no diplopia by parental report defined as no more than once per week 8226 no myopia greater than -6.00d se in either eye 8226 interpupillary distance of 52mm to 72mm inclusive 8226 history of light-induced seizures>