An interventional study of AmblyoFix binocular digital therapy and Occlusion therapy (Patching) in Amblyopia, sponsored by Eyesight Electronics. Terminated at 1 site in Iran. Open to participants aged 8 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Eyesight Electronics · Not applicable, Interventional, and Treatment
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Eyesight Electronics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants assigned to this arm will undergo binocular vision therapy using the AmblyoFix software on a laptop, in combination with red-blue anaglyph glasses. Prior to therapy initiation, a calibration process will be completed and validated by the study team to ensure device screen specifications meet protocol requirements. Treatment consists of interactive, gamified visual tasks designed to stimulate the amblyopic eye under binocular viewing conditions. Participants will complete 90 minutes of therapy per day, six days per week, for 24 weeks. The software includes adaptive difficulty adjustments, automated usage logging for compliance monitoring, and a daily lockout feature to prevent overuse. Parents/guardians will receive training materials to support session supervision and problem reporting.
Behavioral: AmblyoFix binocular digital therapy
Participants assigned to this arm will receive standard occlusion therapy consisting of patching the non-amblyopic eye for 2 hours per day, six days per week, over a 24-week period, while continuing to wear spectacles full time. Caregivers will be trained to correctly apply and monitor patching, maintain daily patching logs documenting hours patched and any issues, and identify signs of intolerance. Patching logs will be reviewed by investigators during scheduled follow-up visits.
Behavioral: Occlusion therapy (Patching)
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.
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.
Change in BCVA in the amblyopic eye from baseline to Week 24
The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials, particularly for the study's target population of individuals aged 8-19 years. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized. Assessments were conducted at baseline and at 4 weeks, representing the time points with complete and reliable data across enrolled participants.
Time frame: From enrollment to 4 Weeks
Adherence to AmblyoFix
Adherence will be objectively measured through the AmblyoFix software's built-in time-tracking functions, which automatically record session frequency and duration. Adherence will be calculated as the total minutes of active use per week compared with the prescribed target duration. Mean weekly adherence will be derived over the available treatment period. Unit of Measure: Total minutes of active use per week (minutes/week)
Time frame: From enrollment to 4 Weeks
Adherence to occlusion therapy
Adherence will be monitored via parental reporting and a standardized compliance questionnaire administered at clinical visits. Parents will record the average number of hours per day that the prescribed occlusion therapy (eye patching) was completed. A mean reported adherence value will be calculated for each participant, expressed as the ratio of completed to prescribed hours per day. This questionnaire was developed for this study and has not been previously validated. Unit of Measure: Mean hours of occlusion per day (hours/day)
Time frame: From enrollment to 4 Weeks
Safety of Amblyofix
Safety will be evaluated by recording all adverse events (AEs) and serious adverse events (SAEs) throughout the available intervention period. Particular attention will be paid to ocular health, including reports of visual discomfort, diplopia, or any unexpected effects potentially related to digital therapy or occlusion. All safety data will be reviewed and summarized by the study investigators at each follow-up visit and at study completion. Unit of Measure: Number of participants with adverse events.
Time frame: From enrollment to 4 Weeks
Patient Satisfaction
Patient satisfaction will be assessed using a custom 10-item questionnaire developed for this study. Each item is rated on a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied). The questionnaire evaluates four domains: acceptability, comfort, ease of use, and overall satisfaction. Scores will be averaged to produce a total satisfaction score, with higher values indicating greater satisfaction. This instrument was developed specifically for this trial and has not been previously validated. Due to early trial termination, the patient satisfaction questionnaire was not administered to participants in either arm, as the study did not progress to the scheduled assessment stage at which this measure was to be collected.
Time frame: From enrollment to the end of treatment at 24 Weeks
Plan to share: No
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Ran from Sep 2025 to primary completion in Feb 2026, 5 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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