Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07819552

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

Conditions: Amblyopia, Anisometropic Amblyopia

Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Polytechnic Institute of Porto

Location: Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), University of Coimbra Coimbra Coimbra District

Summary

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 active binocular therapy or placebo visual training. Both groups will use the same mixed-reality device, follow the same training schedule, and carry out similar daily activities while viewing their real-world surroundings through the device. In the active treatment, the image presented to the amblyopic eye will remain close to the natural scene, while the contrast of the image presented to the stronger eye will be selectively lowered. This gives the amblyopic eye a relative visual advantage, helping to rebalance the input from the two eyes and encouraging them to work together. In the placebo group, participants will use the same device under the same conditions, but without the selective contrast reduction used in the active treatment. This comparison will allow researchers to isolate the specific effect of selectively lowering the contrast seen by the stronger eye. Participants will: * Complete 40-minute training sessions four times per week for 10 weeks. * Learn how to use the system in a clinical setting before continuing the training at home. * Attend assessment visits before treatment, after 10 weeks of treatment, and 6 months after treatment has ended. * Complete tests of visual acuity, depth perception, suppression between the eyes, and contrast sensitivity, as well as retinal imaging, retinal function testing, and brain imaging.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07819552). StuddyBuddy aggregates publicly available trial information.