Bewertung von AmblyoFix zur Behandlung von unilateraler Amblyopie bei Kindern

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.