Brain Stimulation Combined with Augmented Reality Vision Therapy for Adults with Lazy Eye
Led by Polytechnic Institute of Porto · Updated on 2026-08-07
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether combining noninvasive brain stimulation with augmented reality-based vision therapy can improve vision in adults aged 18 to 40 years who have unilateral anisometropic amblyopia, also known as lazy eye. This condition occurs when the eyes have different focusing powers, causing the brain to rely more on one eye. The study aims to determine if active high-definition transcranial direct current stimulation HD-tDCS enhances visual acuity and depth perception more than a sham stimulation alongside augmented reality therapy.
Participants will undergo the same augmented reality-based dichoptic therapy for 10 weeks, involving 40-minute sessions four times weekly. During the first 2 weeks, they will receive either active or sham HD-tDCS delivered immediately before the augmented reality therapy. Active HD-tDCS involves applying a weak electrical current through electrodes on the scalp targeting the primary visual cortex for 20 minutes, while sham stimulation mimics the procedure without sustained current.
Throughout the study, participants will attend assessment visits before treatment, after 2 weeks, and after 10 weeks to undergo vision tests, retinal imaging, retinal function assessments, and brain imaging. Researchers will measure changes in best-corrected visual acuity, depth perception, contrast sensitivity, interocular suppression, retinal structure, retinal cell function, and brain organization. The study will also explore neural changes associated with treatment response and the potential for enhanced adult visual plasticity.
CONDITIONS
Brief Title
Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults
Research Team
C
Catarina A Mateus, PhD
R
Rúben J Magalhães, MSc
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Unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity
Visual acuity worse than 20/32 in the weaker eye
You will not qualify if you...
Any 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 other non-invasive brain stimulation
Pregnancy or planning pregnancy 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 10 weeks
Participants receive augmented reality-based dichoptic therapy for 10 weeks with 40-minute sessions four times per week. During the first 2 weeks, they also receive eight 20-minute sessions of either active or sham high-definition transcranial direct current stimulation immediately before the therapy.
Four sessions per week for 10 weeks and eight brain stimulation sessions in the first 2 weeks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Combined therapy of bilateral transcranial direct current stimulation and ocular occlusion improves visual function in adults with amblyopia, a randomized pilot study.
Raul Castillo-Astorga, Lucia Del Valle-Batalla, Juan José Mariman...
Anodal transcranial direct current stimulation transiently improves contrast sensitivity and normalizes visual cortex activation in individuals with amblyopia.
Daniel P Spiegel, Winston D Byblow, Robert F Hess...