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

NCT07622576 | Not Yet Recruiting

• 1 other identifier: 2026-0200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Amblyopia; Amblyopia Unilateral

Keywords

Amblyopia; Dichopitc treatment; Binocular treatment; Patching; Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stereoacuity

  From enrollment to the end of treatment at 12 weeks

• Binocular balance

  From enrollment to the end of treatment at 12 weeks

• Contrast sensitivity function

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (2)

• Adverse events

  From enrollment to the end of treatment at 12 weeks

• Adherence

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Dichoptic treatment

EXPERIMENTAL

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

Patching

OTHER

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

Interventions

Augmented Reality glasses DEVICE

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.

Dichoptic treatment

Eye patch DEVICE

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.

Patching

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• 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 (△).
• Individuals who are willing to enroll in this study and are able to complete the entire trial protocol.

You may not qualify if:

• 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.
• Individuals diagnosed with tumors, cardiac diseases, hypertension, or epilepsy.
• Individuals with implanted electronic devices such as cardiac pacemakers.
• Individuals presenting with severe ocular inflammation, photophobia, or lacrimation in either eye.
• 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.
• Individuals with severe mental disorders or poor treatment adherence.
• Individuals currently using or planning to use medications that may affect visual function (mydriatic eye drops for refraction examination such as atropine are excluded).
• Individuals with diplopia or inability to achieve binocular fusion during augmented reality-based amblyopia training.
• Individuals who received any amblyopia treatments except spectacle lenses within 2 weeks prior to screening.
• Individuals who enrolled in other clinical drug trials within 3 months or other medical device trials within 1 month before recruitment.
• Individuals who are unable to attend regular ophthalmological examinations.
• Individuals deemed ineligible by the investigators.

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China 2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Amblyopia; Bites and Stings

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; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Xiajing Tang, M.D.

CONTACT

+86 13732227517; xiajingtang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)