Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children

NCT07323953 | Recruiting

• 1 other identifier: AFX-PCT-EG-2025
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Outcomes will be compared against a retrospective cohort of patients of the same age range previously treated with standard occlusion (patching) at the same clinic. A total of 33 participants will be enrolled, allowing for up to 15% attrition to ensure at least 28 evaluable completers at Week 24. Eligible participants must have unilateral amblyopia with amblyopic-eye best-corrected visual acuity (BCVA) between 0.3 and 1.3 logMAR and an interocular difference of at least 0.2 logMAR, with stable refractive correction for at least 16 weeks prior to enrollment. The primary outcome is the change in amblyopic-eye BCVA (logMAR) from baseline to Week 24, assessed under standardized Snellen or ETDRS protocol by certified, masked outcome assessors. Secondary outcomes include adherence (captured via in-software usage logs), safety (BCVA worsening ≥2 lines and ocular adverse events), and patient-reported outcomes (acceptability, usability, satisfaction). An interim analysis will be conducted at Week 6 and at Week 12 to review early efficacy and safety, with the option to recommend early termination if robust evidence of non-inferiority is demonstrated. In addition to the primary study population of unilateral amblyopia, an exploratory subgroup of 3 or more participants with bilateral amblyopia may be enrolled for observational evaluation. Treatment will initially target the eye with worse BCVA as selected in the AmblyoFix software. Upon sufficient improvement, as determined by the Principal Investigator, treatment may be switched to the other eye within the software settings. Data from the bilateral exploratory cohort will be analyzed descriptively and reported separately. These data will not contribute to the primary non-inferiority analysis. Participants and caregivers cannot be blinded due to the nature of the intervention; however, outcome assessors and statisticians will remain masked to study objectives and comparator data to minimize bias. Follow-up assessments will occur at baseline, Week 6, Week 12, and Week 24, with no additional amblyopia treatment permitted during the study unless clinically required. This trial is designed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to patching, with the potential to improve adherence, usability, and acceptability in real-world amblyopia therapy.

Conditions

Amblyopia

Keywords

Amblyopia Treatment

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. 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.

  From enrollment to the end of treatment at 24 Weeks

Secondary Outcomes (2)

• Adherence to AmblyoFix

  From enrollment to the end of treatment at 24 Weeks

• Safety of Amblyofix

  From enrollment to the end of treatment at 24 Weeks

Study Arms (1)

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.

Behavioral: AmblyoFix binocular digital therapy

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.

AmblyoFix

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-12 years.
• Unilateral amblyopia secondary to anisometropia and/or mild strabismus.
• 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).
• Parent/guardian consent and child assent (7+ 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
• Al Watany Eye Hospital: collaborator

Study Sites (1)

Watany Research and Development Center, Watany Eye Hospital

Cairo, Egypt

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

Dr. Heba Fuoad, MD, PhD Ophthalmology

CONTACT

+2012260616112; hebamfouad@watanyeyehospitals.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)