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New treatment option for Amblyopia
Official title Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
ClinicalTrials.gov ID: NCT07323953
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 12
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.