Eye-tracking Based Amblyopia Training

Plain-language summary

An Eye-Tracking-Based Binocular Amblyopia Technology Improves Both Visual Acuity and Binocularity Screening A child is considered for the study after undergoing a standard of care and study-specific eye examinations (by a study investigator as part of the standard of care) that identify amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent (s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care. On screening visit, eligibility assessment, medical history, Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing, Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional). All eligible subjects enrolled in the study will be followed for 24 weeks of training followed by 52 weeks of follow-up. 24 weeks: Binocular treatment 90 minutes per day, 5 days per week for 12 weeks followed by 90 minutes per day, 3 days per week for an additional 12 weeks Follow up visits * Visit 1: 4 weeks ± 1 week * Visit 2: 8 weeks ± 1 week * Visit 3: 12 weeks ± 1 week * Visit 4: 24 weeks ± 1 week (primary endpoint) * Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)

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Trial details