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NCT07622576

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

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

View on ClinicalTrials.gov

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?

Key Details

Gender

All

Age Range

12 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2027-05-31

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Amblyopia Amblyopia Unilateral

Interventions

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.

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.

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.

Locations (1)

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

Hangzhou, Zhejiang, China