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

NCT07819552 | Recruiting

• 2 other identifiers: ORT-2026-003COMPETE2030-FEDER-01469700
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Amblyopia; Anisometropic Amblyopia

Keywords

Adult Amblyopia; Anisometropic Amblyopia; Dichoptic Therapy; Binocular Therapy; Interocular Suppression; Interocular Contrast Modulation; Augmented Reality; Home-Based Visual Rehabilitation

Outcome Measures

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.

  Baseline and Week 10

Secondary Outcomes (13)

• Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 6-Month Follow-up

  Baseline and 6 months after treatment completion

• Change From Baseline in Near Stereoacuity at Week 10

  Baseline and Week 10

• Change From Baseline in Near Stereoacuity at 6-Month Follow-up

  Baseline and 6 months after treatment completion

• Change From Baseline in Interocular Suppression at Week 10

  Baseline and Week 10

• Change From Baseline in Interocular Suppression at 6-Month Follow-up

  Baseline and 6 months after treatment completion

Study Arms (2)

Active Augmented Reality-Based Binocular Therapy

EXPERIMENTAL

Participants will receive active augmented reality-based binocular therapy for 10 weeks, with 40-minute sessions four times per week, initially in a clinical setting and subsequently at home.

Device: Active Augmented Reality-Based Binocular Therapy

Placebo Augmented Reality-Based Visual Training

PLACEBO COMPARATOR

Participants will receive placebo augmented reality-based visual training for 10 weeks, with 40-minute sessions four times per week, using the same mixed-reality device and training schedule as the active group.

Device: Placebo Augmented Reality-Based Visual Training

Interventions

Active Augmented Reality-Based Binocular Therapy DEVICE

Active 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.

Active Augmented Reality-Based Binocular Therapy

Placebo Augmented Reality-Based Visual Training DEVICE

Placebo 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.

Placebo Augmented Reality-Based Visual Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polytechnic Institute of Porto: lead
• OPTIMIZER - Serviços e Consultadoria Informática, Lda.: collaborator
• LINOVT - Engenharia Software, Lda.: collaborator
• University of Coimbra: collaborator

Study Sites (2)

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

Coimbra, Coimbra District, 3000-548, Portugal

RECRUITING

RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto

Porto, Porto District, 4200-072, Portugal

RECRUITING

Related Publications (8)

• Wang M, Ding J, Levi DM, Cooper EA. The Effect of Interocular Contrast Differences on the Appearance of Augmented Reality Imagery. ACM Transactions on Applied Perception. 2024;21(1):1-23. doi:10.1145/3617684.

  BACKGROUND

• Bui Quoc E, Kulp MT, Burns JG, Thompson B. Amblyopia: A review of unmet needs, current treatment options, and emerging therapies. Surv Ophthalmol. 2023 May-Jun;68(3):507-525. doi: 10.1016/j.survophthal.2023.01.001. Epub 2023 Jan 18.

  PMID: 36681277 BACKGROUND

• Thompson B, Concetta Morrone M, Bex P, Lozama A, Sabel BA. Harnessing brain plasticity to improve binocular vision in amblyopia: An evidence-based update. Eur J Ophthalmol. 2024 Jul;34(4):901-912. doi: 10.1177/11206721231187426. Epub 2023 Jul 10.

  PMID: 37431104 BACKGROUND

• Tan F, Yang X, Fan Y, Liao Y. The Study of Short-Term Plastic Visual Perceptual Training Based on Virtual and Augmented Reality Technology in Amblyopia. J Ophthalmol. 2022 Sep 1;2022:2826724. doi: 10.1155/2022/2826724. eCollection 2022.

  PMID: 36091575 BACKGROUND

• Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.

  PMID: 28659140 BACKGROUND

• Hess RF, Thompson B. Amblyopia and the binocular approach to its therapy. Vision Res. 2015 Sep;114:4-16. doi: 10.1016/j.visres.2015.02.009. Epub 2015 Apr 20.

  PMID: 25906685 BACKGROUND

• Levi DM. Rethinking amblyopia 2020. Vision Res. 2020 Nov;176:118-129. doi: 10.1016/j.visres.2020.07.014. Epub 2020 Aug 28.

  PMID: 32866759 BACKGROUND

• Pineles SL, Aakalu VK, Hutchinson AK, Galvin JA, Heidary G, Binenbaum G, VanderVeen DK, Lambert SR. Binocular Treatment of Amblyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Feb;127(2):261-272. doi: 10.1016/j.ophtha.2019.08.024. Epub 2019 Oct 13.

  PMID: 31619356 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Catarina A Mateus, PhD

CONTACT

+351 913474780; cms@ess.ipp.pt

Rúben Magalhães, MSc

CONTACT

+351 968918180; rjcm@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized in a 1:1 ratio to two parallel groups, with stratification by amblyopia severity, age, and gender. Both groups will use the same mixed-reality device for 10 weeks and follow the same home-based visual training schedule. One group will receive active binocular therapy with selective contrast reduction in the dominant eye, while the other will receive placebo visual training without significant active interocular contrast rebalancing.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)