Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia

NCT ID: NCT07240311

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AmblyoFix

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.

Group Type: EXPERIMENTAL

AmblyoFix binocular digital therapy

Intervention Type: 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.

Patching (standard occlusion)

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.

Group Type: ACTIVE_COMPARATOR

Occlusion therapy (Patching)

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nour Pajouhan Shargh Eye Specialist Clinic

UNKNOWN

Sponsor Role: collaborator

Eyesight Electronics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nour Pajouhan Shargh Eye Specialist Clinic

Zahedan, Sistan & Balouchestan, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Faiz Mohammad Rigi, Ophthalmologist

Role: CONTACT

faizrigi@gmail.com

+985433448869

Facility Contacts

Muhammad Reza Rouhani, Ophthalmologist

Role: primary

info@irannps.org

+985433448869

Other Identifiers

AFX-RCT-IRN-2025

Identifier Type: -

Identifier Source: org_study_id