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Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia

RecruitingNAAges 18 Years - 40 YearsAllPolytechnic Institute of Porto
NCT07819552 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate a home-based augmented reality-based binocular therapy designed to improve visual function in adults aged 18 to 40 years with unilateral anisometropic amblyopia, commonly called "lazy eye." The therapy is designed to be used during everyday activities, allowing visual training to be integrated into the participant's normal home routine. The main questions this study aims to answer are: * Does the Ambly4Home augmented reality-based binocular therapy improve visual acuity in the amblyopic eye and binocular vision compared with placebo visual training? * Are any improvements in visual function maintained 6 months after the treatment has ended? * Is the treatment associated with changes in other measures of visual function, retinal structure and function, and visual brain function? Participants will be randomly assigned to receive either acti

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 40 years. * Diagnosis of anisometropic amblyopia, defined as unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity (BCVA), with BCVA worse than 20/32 in the more affected eye. Exclusion Criteria: * Amblyopia other than anisometropic amblyopia. * Bilateral amblyopia. * Ophthalmologic or neuro-ophthalmologic disease other than amblyopia. * Neurological disease, chronic pharmacological therapy, or implanted medical devices. * Any ocular surgery or ocular treatment within the previous year. * Significant media opacities that may prevent fundus examination. * Inability to provide informed consent.
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What it tests

  • Active Augmented Reality-Based Binocular Therapy
  • Placebo Augmented Reality-Based Visual Training
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Where

2 sites
Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), University of Coimbra
Coimbra, Portugal
RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
Porto, Portugal
🤝 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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