AmblyoFix for one-eye (unilateral) amblyopia in children 7–12 years

Prospective Clinical Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children

This will test whether AmblyoFix, an at-home binocular digital therapy, can improve the weaker eye's vision in children aged 7–12 with unilateral amblyopia compared with past patching treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 7 Years to 12 Years
• Sex: All
• Sponsor: Eyesight Electronics (industry)
• Locations: 1 site (Cairo)
• Trial ID: NCT07323953 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, non-inferiority trial testing AmblyoFix binocular digital therapy delivered at home and comparing outcomes to a retrospective cohort previously treated with patching. Thirty-three children aged 7–12 with unilateral amblyopia and specified visual acuity and refractive stability will be enrolled to allow for at least 28 completers at Week 24. The primary outcome is change in amblyopic-eye best-corrected visual acuity (logMAR) from baseline to Week 24 measured under standardized Snellen or ETDRS protocols by certified, masked outcome assessors. Therapy adherence, safety, and vision outcomes will be monitored with digital logging and clinic visits.

Who should consider this trial

Good fit: Children aged 7–12 with unilateral amblyopia, amblyopic-eye BCVA between 0.3 and 1.3 logMAR, an interocular difference of ≥0.2 logMAR, stable refractive correction, and access to a laptop with internet are the ideal candidates.

Not a fit: Children with prior amblyopia treatment beyond refractive adaptation, severe ocular pathology or high myopia, significant cognitive/developmental delay, a history of light-induced seizures, or no suitable home computer/internet are unlikely to benefit or qualify.

Why it matters

Potential benefit: If successful, AmblyoFix could provide an effective at-home alternative to patching that improves vision in the amblyopic eye for older children.

How similar studies have performed: Previous trials of binocular digital therapies for amblyopia have shown mixed but promising results—some matched patching while others did not—so the approach has partial supporting evidence but is not yet definitive.

Eligibility criteria

Inclusion Criteria:

* 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).

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.

Where this trial is running

Cairo

• Watany Research and Development Center, Watany Eye Hospital — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Dr. Heba Fuoad, MD, PhD Ophthalmology

Conditions: Amblyopia, Amblyopia Treatment