Actively Recruiting

Phase Not Applicable
Age: 5Years - 55Years
All Genders
ID06498206

Dichoptic Augmented Reality Training Versus Patching for Unilateral Amblyopia in Children and Adults

Led by Eye & ENT Hospital of Fudan University · Updated on 2025-04-10

114

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

E

Eye & ENT Hospital of Fudan University

Lead Sponsor

F

First Affiliated Hospital of Fujian Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of augmented reality (AR) training compared to traditional patching for treating unilateral amblyopia in children and adults aged 5 to 55 years. This trial addresses challenges with patching, such as poor adherence and limited improvement in visual functions, by using an innovative binocular therapy based on neural deficits seen in amblyopia. The study aims to compare improvements in visual acuity and other visual functions between the two treatments. The trial involves two groups: one receiving dichoptic AR training using a dual-pathway push-pull method targeting specific neural pathways, and the other undergoing conventional patching therapy. AR training requires patients to perform 2 hours of visual exercises daily at home using a device that presents different images to each eye, while the patching group patches the fellow eye for 2 hours daily at home. The study is conducted across multiple centers and based on advanced neural processing theories to rebalance visual pathways and binocular interaction. Participants will be assessed over 13 weeks with multiple evaluations at 2, 4, 9, and 13 weeks to monitor changes in visual acuity, stereopsis, contrast sensitivity, and treatment compliance. Safety reports are also collected regularly. The main outcome measured is the total effective rate at 13 weeks. Participants need to attend visits and complete treatments as scheduled to contribute to the study’s findings on improving visual outcomes in amblyopia.

CONDITIONS

Brief Title

AR Training Versus Patching in Unilateral Amblyopia

Who Can Participate

Age: 5Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 5-55 years (including 5 and 55 years)
  • Best-corrected visual acuity worse than 20/30 but no worse than 20/200 in the amblyopic eye
  • Interocular difference of 2 or more lines
  • Better eye within normal vision range
  • Wearing optical refractive correction for more than 3 months
  • Ability to attend visits and complete treatment
  • Normal binocular alignment or intermittent exotropia within -15 to 0 prism diopters
Not Eligible

You will not qualify if you...

  • Organic eye diseases preventing good vision (e.g., ptosis, media opacity, nystagmus, keratitis, glaucoma, retinal diseases)
  • Brain lesions preventing good vision (e.g., cortical visual impairment)
  • Having implantable electronic devices
  • History of eye surgery (except strabismus surgery) affecting vision
  • History of eye trauma affecting vision
  • Receiving amblyopia therapy (except glasses) within 2 weeks before study
  • History of epilepsy, mental illness, or cognitive defects
  • Taking medications affecting vision or needing them during study
  • Inability to comply with treatments or follow-ups
  • Participation in drug trials within 3 months or device trials within 30 days before study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 13 weeks

Participants undergo either augmented reality training or conventional patching therapy for unilateral amblyopia at home.

Visits at 2 weeks, 4 weeks, 9 weeks, and 13 weeks for assessments

Trial Site Locations

Total: 1 location

1

Eye & ENT Hospital of Fudan University

Shanghai, China

Actively Recruiting

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Research Team

W

Wen Wen, MD, PhD

Y

Yulian Zhou, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial