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Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children

RecruitingNAAges 7 Years - 12 YearsAllEyesight Electronics
NCT07323953 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, assesse

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📋 Eligibility rules (as published)
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.
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What it tests

  • AmblyoFix binocular digital therapy
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Where

1 site
Watany Research and Development Center, Watany Eye Hospital
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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