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Augmented Reality Training for Amblyopia After Congenital Cataract Surgery

NCT07693790 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-07-09

No results posted yet for this study

Summary

This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children.

Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.

The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.

Conditions

  • Deprivation Amblyopia
  • Congenital Cataract

Interventions

DEVICE

Augmented Reality Amblyopia Training

Participants assigned to the experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will present visual training tasks and record training duration, task completion, and adherence data.

BEHAVIORAL

Conventional Patching

Participants assigned to the control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits.

Sponsors & Collaborators

  • Shenzhen Eye Hospital

    collaborator OTHER

  • Zhengzhou Second Hospital

    collaborator UNKNOWN

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-01-31
Completion
2028-01-31

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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 NCT07693790 on ClinicalTrials.gov