Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPolytechnic Institute of Porto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Amblyopia other than anisometropic amblyopia.
Bilateral amblyopia.
Ophthalmologic or neuro-ophthalmologic disease other than amblyopia.
Neurological disease, chronic pharmacological therapy, or implanted medical devices.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Augmented Reality-Based Binocular Therapy
DeviceActive augmented reality-based binocular therapy will be delivered using a Meta Quest 3 mixed-reality headset operating in passthrough mode. Participants will complete 40-minute sessions four times per week for 10 weeks, initially learning to use the system in a clinical setting and subsequently continuing the training at home. The real-world scene presented to the amblyopic eye will remain close to natural viewing, while the contrast presented to the dominant eye will be selectively reduced. This controlled contrast reduction gives the amblyopic eye a relative visual advantage, encouraging its more active contribution during binocular viewing and promoting binocular integration. The degree of contrast modulation will be adjusted according to visual performance over the course of treatment.
Placebo Augmented Reality-Based Visual Training
DevicePlacebo augmented reality-based visual training will be delivered using the same Meta Quest 3 mixed-reality headset operating in passthrough mode, with the same session duration, training schedule, and home-based setting as the active intervention. Participants will view and interact with their real-world surroundings while carrying out similar visual activities. Unlike the active intervention, the contrast presented to the dominant eye will not be selectively reduced. The visual information presented to both eyes will remain equivalent or will be only minimally and symmetrically modified, without providing active binocular rebalancing or a therapeutic visual advantage to the amblyopic eye.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Augmented Reality-Based Binocular TherapyExperimental treatment 1 intervention
Group B: Placebo Augmented Reality-Based Visual TrainingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at Week 10
Best-corrected visual acuity of the amblyopic eye will be assessed monocularly using a standardized ETDRS chart and recorded as the number of letters correctly identified. Higher ETDRS letter scores indicate better visual acuity. Change from baseline will be calculated as the Week 10 letter score minus the baseline letter score. A positive change indicates an improvement in visual acuity.
Time frame
Baseline and Week 10Secondary outcomes
1
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 6-Month Follow-up
Best-corrected visual acuity of the amblyopic eye will be assessed monocularly using a standardized ETDRS chart and recorded as the number of letters correctly identified. Higher ETDRS letter scores indicate better visual acuity. Change from baseline will be calculated as the 6-month follow-up letter score minus the baseline letter score. A positive change indicates an improvement in visual acuity.
Time frame
Baseline and 6 months after treatment completion2
Change From Baseline in Near Stereoacuity at Week 10
Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc. Measurable stereoacuity ranges from 400 to 20 seconds of arc. Lower values indicate better stereoacuity. Change from baseline will be calculated as the Week 10 value minus the baseline value. A negative change indicates an improvement. Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.
Time frame
Baseline and Week 103
Change From Baseline in Near Stereoacuity at 6-Month Follow-up
Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc. Measurable stereoacuity ranges from 400 to 20 seconds of arc. Lower values indicate better stereoacuity. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value. A negative change indicates an improvement. Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.
Time frame
Baseline and 6 months after treatment completion4
Change From Baseline in Interocular Suppression at Week 10
Interocular suppression will be assessed under binocular viewing conditions using a standardized suppression test. The outcome will be the filter level at which binocular perception changes. Change from baseline will be calculated as the Week 10 value minus the baseline value.
Time frame
Baseline and Week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Polytechnic Institute of Porto
Lead sponsor
OPTIMIZER - Serviços e Consultadoria Informática, Lda.
Collaborator
LINOVT - Engenharia Software, Lda.
Collaborator
University of Coimbra
Collaborator
Source ClinicalTrials.gov