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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Watany Research and Development Center, Watany Eye Hospital
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Dr. Heba Fuoad, MD, PhD Ophthalmology
• Email: hebamfouad@watanyeyehospitals.com
• Phone: +2012260616112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.