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

NCT07622576 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622576 on ClinicalTrials.gov