Amblyopia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 visual information to each eye and lowers the contrast seen by the stronger eye. This gives the weaker, amblyopic eye a visual advantage and encourages both eyes to work together while participants carry out normal daily activities. During the first 2 weeks, participants will also receive either active HD-tDCS or sham stimulation immediately before the augmented reality therapy. Active HD-tDCS delivers a weak electrical current through small electrodes placed on the scalp. Sham stimulation uses the same equipment and procedures, but the current is applied only briefly at the beginning. Comparing the two groups will help researchers determine whether active brain stimulation provides additional benefits beyond those of augmented reality therapy alone. Participants will: * Complete 40-minute augmented reality therapy sessions four times per week for 10 weeks. * Receive eight 20-minute sessions of active or sham HD-tDCS during the first 2 weeks, immediately before the augmented reality therapy. * Attend assessment visits before treatment, after 2 weeks, and after 10 weeks. These visits will include vision tests, retinal imaging, tests of retinal function, and brain imaging.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Age between 18 and 35 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.

Locations
Other Locations
Portugal
RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
RECRUITING
Porto
Contact Information
Primary
Catarina A Mateus, PhD
cms@ess.ipp.pt
+351 962662157
Backup
Rúben J Magalhães, MSc
rjcm@ess.ipp.pt
+351 968918180
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 80
Treatments
Experimental: Active HD-tDCS + AR-Based Dichoptic Therapy
Participants will receive augmented reality-based dichoptic therapy for 10 weeks, with 40-minute sessions four times per week. During the first 2 weeks, participants will also receive eight 20-minute sessions of active HD-tDCS applied to the primary visual cortex immediately before the augmented reality-based dichoptic therapy.
Sham_comparator: Sham HD-tDCS + AR-Based Dichoptic Therapy
Participants will receive the same augmented reality-based dichoptic therapy for 10 weeks, with 40-minute sessions four times per week. During the first 2 weeks, participants will also receive eight 20-minute sessions of sham HD-tDCS immediately before the augmented reality-based dichoptic therapy. Sham stimulation will use the same equipment, electrode placement, and initial ramping procedure as active stimulation, but no sustained current will be delivered.
Related Therapeutic Areas
Sponsors
Leads: Polytechnic Institute of Porto
Collaborators: University of Coimbra

This content was sourced from clinicaltrials.gov