Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia

NCT07240311 | Recruiting

• 1 other identifier: AFX-RCT-IRN-2025
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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 35 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 86 participants will be enrolled (43 per arm). 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. An interim analysis will be performed at 12 weeks, with the option to stop the trial early if sufficient improvement in BCVA is demonstrated. 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 will occur at baseline, 4, 8, 12, 16, 20 and 24 weeks, with no additional amblyopia treatment permitted during the study unless clinically required. This trial aims 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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• 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 8-35 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 will occur at baseline and at follow-up visits scheduled every 4 weeks during the 24-week intervention period, to monitor durability of treatment effects.

  From enrollment to the end of treatment at 24 Weeks

Secondary Outcomes (4)

• Adherence to AmblyoFix

  From enrollment to the end of treatment at 24 Weeks

• Adherence to occlusion therapy

  From enrollment to Week 24

• Safety of Amblyofix

  From enrollment to the end of treatment at 24 Weeks

• Patient Satisfaction

  From enrollment to the end of treatment at 24 Weeks

Study Arms (2)

AmblyoFix

EXPERIMENTAL

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

Patching (standard occlusion)

ACTIVE COMPARATOR

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)

Interventions

AmblyoFix binocular digital therapy BEHAVIORAL

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.

AmblyoFix

Occlusion therapy (Patching) BEHAVIORAL

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.

Patching (standard occlusion)

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-35 years.
• Unilateral amblyopia secondary to anisometropia, strabismus, or mixed.
• BCVA in amblyopic eye between 20/40-20/400 (0.3-1.3 logMAR); fellow eye ≥20/32 (≤0.2 logMAR).
• Interocular difference ≥2 lines (≥0.2 logMAR).
• Stable refractive correction for ≥16 weeks or \<0.1 logMAR change across two visits ≥8 weeks apart.
• Cycloplegic refraction within 7 months meeting anisometropia criteria (e.g., hyperopia ≥+2.50 D).
• Access to a suitable home environment (laptop and internet) for AmblyoFix arm.
• Parent/guardian consent and child assent (8+ year olds).

You may not qualify if:

• Atropine use within 2 weeks before starting treatment
• Prior amblyopia treatment beyond refractive adaptation.
• Myopia \>-6.00 D SE, previous ocular surgery, or other ocular pathology.
• Severe cognitive/developmental delay impeding compliance.
• History of light-induced seizures.
• Inability/unwillingness to comply with digital monitoring.
• Any condition compromising safety or trial integrity.

Sponsors & Collaborators

• Eyesight Electronics: lead
• Nour Pajouhan Shargh Eye Specialist Clinic: collaborator

Study Sites (1)

Nour Pajouhan Shargh Eye Specialist Clinic

Zahedan, Sistan & Balouchestan, Iran

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Faiz Mohammad Rigi, Ophthalmologist

CONTACT

+985433448869; faizrigi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 20, 2025
• Study Start: September 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)