A Comparative Study of the Efficacy of AR Based Amblyopia Training Therapy and Occlusion Therapy in Older Children and Adults With Amblyopia

The goal of this clinical trial is to investigate the efficacy and safety of dichoptic treatment based on Augmented Reality (AR) technology in treating monocular amblyopia aged 12 to 55 years, and compare dichoptic AR treatment with the standard patching therapy. The main questions it aims to answer are:

Does dichoptic AR treatment safely and effectively improve visual acuity and other monocular/binocular visual functions in older children and adults with amblyopia? Is binocular therapy superior to occlusion therapy?

Study Overview

• Status: Not yet recruiting
• Conditions: Amblyopia; Amblyopia Unilateral
• Intervention / Treatment: Device: Augmented Reality glasses; Device: Eye patch

Detailed Description

Amblyopia is the most prevalent developmental visual disorder in children, characterized by a reduction in best-corrected visual acuity in one or both eyes that cannot be attributed to optical anomalies or organic ocular pathologies. Epidemiological investigations have demonstrated that the prevalence of amblyopia among children ranges from 3% to 6%, rendering it one of the leading causes of unilateral visual impairment in pediatric populations. Beyond reduced visual acuity, amblyopia may also induce deficits in stereopsis, oculomotor coordination, and cognitive function, which substantially compromise patients' daily activities. Current mainstream clinical interventions for amblyopia primarily include refractive correction, occlusion therapy, penalization therapy, and visual function training.

Given the existence of a critical period for the development of the visual cortex in children, the treatment of amblyopia is constrained by a distinct therapeutic time window. Earlier intervention yields a higher probability of visual acuity recovery. Conversely, patients treated beyond the critical period of visual development generally exhibit a poor response to conventional therapies. Accordingly, amblyopia in older children and adults remains a major clinical challenge. With advancing research on the binocular pathogenesis of amblyopia-such as binocular imbalance induced by binocular contrast gain control and impairment of the parvocellular visual pathway originating from the lateral geniculate nucleus (LGN)-novel therapeutic strategies for amblyopia have been continuously developed.

Visual perceptual learning, which involves repeated training on near-threshold visual tasks to strengthen relevant neural pathways and elicit long-term improvements in visual function, has achieved favorable clinical outcomes in amblyopic patients. Since this approach can facilitate cortical plasticity, adult amblyopes who fail to respond to conventional treatments also show marked therapeutic responses. In recent years, dichoptic training, which delivers distinct visual stimuli to each eye simultaneously to promote binocular coordination and rehabilitate the parvocellular pathway, has exhibited promising efficacy in ameliorating monocular and binocular visual functions and shortening treatment duration in amblyopic patients.

Augmented Reality (AR) has attracted considerable attention due to its immersive interactive properties. By superimposing virtual visual stimuli onto the real-world environment, AR provides an innovative modality for amblyopia management. Compared with traditional therapies, AR systems enable real-time modulation of stimulus parameters (e.g., spatial frequency, contrast, and binocular balance), thereby supporting personalized and precise treatment. Preliminary studies have verified that AR-based training can significantly enhance contrast sensitivity and stereoscopic vision in adult amblyopes. Additionally, the gamified design of visual tasks remarkably improves patient adherence to treatment.

Nevertheless, existing studies on AR-based amblyopia training are mostly confined to laboratory settings or short-term interventions. Large-scale real-world evidence is still lacking to validate its long-term safety and general applicability. Furthermore, the assessment of visual function improvements after treatment mainly relies on visual acuity measurements, which represents a limited evaluation framework; comprehensive and systematic assessment systems remain underdeveloped.

In addition, amblyopia in individuals over 12 years of age (older children and adults) constitutes a difficult-to-treat cohort in clinical practice. These patients present low cortical plasticity and poor responses to occlusion therapy. Although dichoptic training is capable of inducing cortical plasticity, systematic real-world studies on this intervention are still insufficient. Therefore, the present study conducted in routine clinical settings targeting this specific population not only possesses important clinical implications, but also provides theoretical and practical evidence for the establishment of novel therapeutic regimens for amblyopia.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiajing Tang, M.D.; Phone Number: +86 13732227517; Email: xiajingtang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China 2nd Affiliated Hospital, School of Medicine
      • Contact: Phone Number: 18757755101; Email: ling.gong@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals aged 12 to 55 years (12 ≤ age ≤ 55 years). Written informed consent shall be obtained from participants aged 18 years and above, or their legal guardians for those aged 12 to 17 years.
2. Unilateral amblyopia with the following criteria: the best-corrected visual acuity (BCVA) of the dominant eye ≥ 0.8, and an interocular BCVA difference of two or more lines. Participants shall have confirmed amblyopia with relevant risk factors and no organic ocular diseases.
3. For Individuals with refractive errors: the spherical equivalent (SE) measured via cycloplegic autorefraction or phoropter refraction ≤ -6.00 D. All participants shall have received optical refractive correction for more than 3 months, with stable visual acuity (acuity change < 1 line) within the latest 2 months.
4. Individuals with orthotropic eye position, including patients with strabismic amblyopia after strabismus correction. The distance manifest deviation measured at 6 m using the prism and alternate cover test shall be within 5 prism diopters (△).
5. Individuals who are willing to enroll in this study and are able to complete the entire trial protocol.

Exclusion Criteria:

1. Participants with other organic ocular disorders, including media opacities, nystagmus, eccentric fixation, acute inflammatory conditions such as keratitis, optic neuropathy, including glaucoma, retinal lesions, and cortical visual impairment.
2. Individuals diagnosed with tumors, cardiac diseases, hypertension, or epilepsy.
3. Individuals with implanted electronic devices such as cardiac pacemakers.
4. Individuals presenting with severe ocular inflammation, photophobia, or lacrimation in either eye.
5. Individuals with a history of ocular surgery that affects visual function, excluding congenital cataract extraction combined with intraocular lens implantation, strabismus correction and blepharoptosis repair.
6. Individuals with severe mental disorders or poor treatment adherence.
7. Individuals currently using or planning to use medications that may affect visual function (mydriatic eye drops for refraction examination such as atropine are excluded).
8. Individuals with diplopia or inability to achieve binocular fusion during augmented reality-based amblyopia training.
9. Individuals who received any amblyopia treatments except spectacle lenses within 2 weeks prior to screening.
10. Individuals who enrolled in other clinical drug trials within 3 months or other medical device trials within 1 month before recruitment.
11. Individuals who are unable to attend regular ophthalmological examinations.
12. Individuals deemed ineligible by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dichoptic treatment; The AR smart glasses are connected to a video playback device, and participants watch cartoons, movies, or daily videos during training. The system performs real-time dichoptic processing on visual contents: high spatial frequency images are presented to the amblyopic eye, while low-contrast images are delivered to the dominant eye. The scheduled daily training duration is 1.5 hours, which can be divided into multiple sessions with a minimum single-session duration of 30 minutes. The total intervention period lasts for 3 months.	Device: Augmented Reality glasses; Dichoptic Augmented Reality (AR) treatment uses the smart glasses connected to a video playback device, and participants watch cartoons, movies, or daily videos during training. The system performs real-time dichoptic processing on visual contents: high spatial frequency images are presented to the amblyopic eye, while low-contrast images are delivered to the dominant eye.
Other: Patching; Opaque eye patches were used to cover the fellow eye (dominant eye), forcing participants to view objects with their amblyopic eye. The total daily occlusion duration was 4 hours, which could be split into separate sessions with a minimum duration of 2 hours per session. The intervention lasted for 3 months in total.	Device: Eye patch; Opaque eye patches were used to cover the fellow eye (dominant eye), forcing participants to view objects with their amblyopic eye. The total daily occlusion duration was 4 hours, which could be split into separate sessions with a minimum duration of 2 hours per session. The intervention lasted for 3 months in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	BCVA was measured with optimal refractive correction (if needed) and without cycloplegia, using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol.	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stereoacuity	Stereoacuity was measured by the RandomDot test and a disparity detection task.	From enrollment to the end of treatment at 12 weeks
Binocular balance	Binocular balance point is measured by binocular orientation task.	From enrollment to the end of treatment at 12 weeks
Contrast sensitivity function	Contrast sensitivity function is measured by the contrast sensitivity detection task at different spatial frequencies.	From enrollment to the end of treatment at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events captured by an administering protocol-defined questionnaire regarding their symptoms and diplopia	From enrollment to the end of treatment at 12 weeks
Adherence	The percentage of prescribed treatment completed (adherence) is computed using the ratio of the completed and prescribed hours of treatment. The completed treatment duration is recorded by the devices (dichoptic treatment) or self-reported calendars.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Occlusion; Amblyopia; Patching; Binocular treatment; Dichopitc treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Eye Diseases; Chemically-Induced Disorders; Vision Disorders; Sensation Disorders; Poisoning; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bites and Stings; Amblyopia
• Other Study ID Numbers: 2026-0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No