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Clinical Trial

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

NCT: NCT07819552 · RECRUITING

NCT IDNCT07819552
StatusRECRUITING
Start Date2026-05-01
Completion2028-01-31
SponsorPolytechnic Institute of Porto (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia is a clinical trial registered under NCT07819552. Current status: RECRUITING.

What is the status of NCT07819552?

The current status of NCT07819552 (Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia) is: RECRUITING.

When did Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia start?

Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia started on 2026-05-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.