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Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults

RecruitingNAAges 18 Years - 40 YearsAllPolytechnic Institute of Porto
NCT07752433 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 learn whether adding noninvasive brain stimulation to augmented reality-based vision therapy can improve vision in adults aged 18 to 40 years with unilateral anisometropic amblyopia, commonly called "lazy eye." Anisometropic amblyopia develops during childhood when the two eyes have different focusing powers and the brain relies more on one eye than the other. The main questions this study aims to answer are: * Does active high-definition transcranial direct current stimulation (HD-tDCS) improve best-corrected visual acuity in the amblyopic eye and depth perception more than sham stimulation? * Does the combined treatment improve contrast sensitivity, suppression between the eyes, and measures of retinal and visual brain function? All participants will receive the same augmented reality-based dichoptic therapy. This therapy presents different visu

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 40 years. * Diagnosis of anisometropic amblyopia. * Unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity, with visual acuity worse than 20/32 in the worse-seeing eye. Exclusion Criteria: * Any type of amblyopia other than anisometropic amblyopia. * Bilateral amblyopia. * Ophthalmological or neuro-ophthalmological disease other than amblyopia. * Neurological disease. * Chronic pharmacological treatment. * Presence of an implanted medical device. * Any ocular surgery or treatment within the previous year. * Significant ocular media opacities. * Previous treatment with transcranial direct current stimulation or another non-invasive brain stimulation technique. * Pregnancy or planning to become pregnant during the study period. * Inability to provide informed consent. * History of head trauma, seizures, or frequent headaches. * Electrical or electronic implants, such as a cardiac pacemaker. * Metallic objects or implants in the head, except dental implants.
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What it tests

  • Active High-Definition Transcranial Direct Current Stimulation
  • Sham High-Definition Transcranial Direct Current Stimulation
  • Augmented Reality-Based Dichoptic Therapy
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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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