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Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia
Sponsor: Eyesight Electronics
Summary
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. The registered inclusion criteria specified amblyopic-eye BCVA of 0.3 to 1.3 logMAR and an interocular difference of at least 2 lines. Because visual acuity at the study site was recorded in decimal Snellen notation and the threshold was incorrectly converted at screening, participants with amblyopic-eye BCVA of 0.1 to 0.2 logMAR were also enrolled. In addition, for these participants an interocular difference of 1 line was accepted instead of the protocol-specified 2 lines. The 0.3 logMAR threshold had been set because, over the planned 24-week treatment period, participants with milder amblyopia might reach normal acuity before treatment ended; as the trial was terminated with follow-up at 4 weeks, this concern is less relevant to the reported results. The deviation was identified after trial termination and reported to the ethics committee, which on 20 April 2026 (ref. 251/NP/2026) approved inclusion of these participants' data in the analysis.
Official title: Randomized Controlled Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children, Teenagers and Young Adults Aged 8-19
Key Details
Gender
All
Age Range
8 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-01
Completion Date
2026-02-24
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
AmblyoFix binocular digital therapy
AmblyoFix is a binocular vision therapy delivered through specialized software on a laptop computer in combination with red-blue anaglyph glasses. The program uses interactive, gamified visual tasks designed to stimulate the amblyopic eye while maintaining binocular viewing conditions. Each participant undergoes a standardized calibration process to ensure screen specifications are validated before starting therapy. The prescribed regimen is 90 minutes per day, six days per week, for 24 weeks. The software incorporates adaptive difficulty adjustment, automated compliance logging with timestamped usage data, and a daily lockout feature to prevent overuse. Therapy adherence and performance are monitored remotely, and caregivers receive structured training materials to support session supervision and troubleshooting.
Occlusion therapy (Patching)
Standard occlusion therapy involves patching of the non-amblyopic (fellow) eye to stimulate visual function in the amblyopic eye. Participants are prescribed patching for 2 hours per day, six days per week, over a 24-week treatment period, while continuing to wear their full-time spectacle correction. Caregivers are trained to correctly apply the patch, supervise adherence, and recognize signs of intolerance. Daily patching logs are maintained by caregivers to record hours patched and any issues encountered, and these logs are reviewed by investigators at scheduled follow-up visits.
Locations (1)
Nour Pajouhan Shargh Eye Specialist Clinic
Zahedan, Sistan & Balouchestan, Iran