Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
NCT06049459

Novel Amblyopia Treatment With Virtual Reality Games

Led by Marjean Kulp · Updated on 2025-07-22

8

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

M

Marjean Kulp

Lead Sponsor

B

Beta Sigma Kappa - College of Optometrists in Vision Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

CONDITIONS

Official Title

Novel Amblyopia Treatment With Virtual Reality Games

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients ages 5 to 17 years of age
  • Moderate to severe unilateral amblyopia with logMAR best corrected visual acuity 0.3 to 1.3
  • Amblyopia associated with anisometropia and/or strabismus of 45 prism diopters or less
  • Normal vision in the nonamblyopic eye for age
  • Worn spectacle correction for at least 16 weeks or until stable visual acuity demonstrated (less than 0.1 logMAR change on 2 exams at least 8 weeks apart)
  • Interocular difference of 3 or more lines
  • No amblyopia treatment in the past 2 weeks
  • Interpupillary distance between 52 and 72 mm inclusive
Not Eligible

You will not qualify if you...

  • Myopia greater than -6.00 diopters spherical equivalent in either eye
  • Previous intraocular or refractive surgery
  • Previous dichoptic treatment longer than 2 weeks
  • Ocular conditions that may reduce visual acuity, except nystagmus if visual acuity criteria are met
  • Diplopia more than once per week in the last week before enrollment
  • Diagnosis of Down syndrome or cerebral palsy
  • History of light-induced seizures
  • Known simulator sickness
  • Severe developmental delay interfering with treatment or evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ohio State University College of Optometry

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

M

Marjean T Kulp, OD, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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