Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia

This is a prospective, randomized, parallel-group, assessor-masked, non-inferiority clinical trial designed to compare the efficacy, safety, and adherence of AmblyoFix binocular digital therapy with standard occlusion (patching) for the treatment of unilateral amblyopia in children and young adults aged 8 to 19 years. In the event that adequate recruitment within this age range is not feasible, the age range may be modified, subject to appropriate ethical approval and protocol amendment procedures. A total of 40 participants were enrolled. Eligible participants will be randomized in a 1:1 ratio to receive either AmblyoFix or patching, stratified by age group and amblyopia severity. Randomization will be implemented using the sealed opaque envelope method, with allocation concealment maintained through sequentially numbered, tamper-proof envelopes. The primary outcome is the change in amblyopic-eye best-corrected visual acuity (BCVA, logMAR) from baseline to 24 weeks, assessed under standardized Snellen or ETDRS protocol. Secondary outcomes include adherence, safety, and patient-reported outcomes. No interim analysis was conducted, as the trial concluded prior to reaching the 12-week time point. Participants and caregivers cannot be blinded due to the nature of the interventions; however, outcome assessors and statisticians will remain blinded to treatment allocation to minimize bias. Follow-up assessments were conducted at baseline and 4 weeks, representing the time points with complete and reliable data across enrolled participants. This trial aimed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to standard patching, with the potential to improve adherence and acceptability in amblyopia therapy.

NCT Number	NCT07240311
Lead Sponsor	Eyesight Electronics Collaborators: Nour Pajouhan Shargh Eye Specialist Clinic
Conditions	Amblyopia
Enrollment	40 participants
Start Date	2025-09-01
Primary Completion	2026-02-18 (estimated)
Study Completion	2026-02-24 (estimated)
Updated on ClinicalTrials.gov	2026-04-06