Actively Recruiting

Phase Not Applicable
Age: 5Years - 55Years
All Genders
NCT06498206

AR Training Versus Patching in Unilateral Amblyopia

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

114

Participants Needed

1

Research Sites

65 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

This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia. Specific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia. Specific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.

CONDITIONS

Official 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 to 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 with the better eye within normal range
  • Have used optical refractive correction for more than 3 months
  • Able to attend visits and complete treatment
  • Normal binocular alignment, including strabismic amblyopia with orthotropia after surgical correction, or intermittent exotropia between -15 and 0 prism diopters
Not Eligible

You will not qualify if you...

  • Organic eye diseases preventing good vision (e.g., ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation, optic nerve or retinal diseases)
  • Brain lesions preventing good vision (e.g., cortical visual impairment)
  • Implantable electronic device
  • History of ocular surgery affecting vision except strabismus surgery
  • History of ocular trauma affecting vision
  • Receiving amblyopia treatment other than glasses within 2 weeks before study
  • History of epilepsy, mental illness, or cognitive defects
  • Taking medications that may affect vision during the study
  • Unable to comply with treatment or follow-up visits
  • Participation in drug clinical trials within 3 months or device trials within 30 days before study

AI-Screening

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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

CONTACT

Y

Yulian Zhou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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