Recruiting

Vivid Vision Therapeutic

Sponsor:

Marjean Kulp

Code:

NCT06049459

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Optical Correction

Therapeutic Dichoptic Virtual Reality Games

Study Details

Brief summary:

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

Amblyopia

Study ID

NCT06049459

Start date

Mar 14, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients ages 5 to 17 years of age

  • Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
  • Age normal VA in the nonamblyopic eye
  • Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
  • Interocular difference of ≥ 3 lines
  • No amblyopia treatment in the past 2 weeks
  • An interpupillary distance of 52-72 mm (inclusive)

Exclusion Criteria:

  • Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
  • Previous intraocular or refractive surgery.
  • Previous dichoptic treatment > 2 weeks in duration
  • Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
  • Diplopia more than once per week over the last week prior to enrollment by parental report.
  • Down syndrome or cerebral palsy.
  • Light-induced seizures
  • Known simulator sickness
  • Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.

Study Design

Enrollment

8 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Optical Correction alone

Optical correction alone (16 weeks) (Each participant will complete both study conditions.)

experimental: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)

Interventions

Optical Correction

Optical correction (if needed)

Therapeutic Dichoptic Virtual Reality Games

Virtual Reality Game play for amblyopia treatment

Primary outcome measure

  • Difference in Mean Change in Amblyopic Eye Visual Acuity [ Time Frame: Baseline to 16 weeks versus 16 weeks to 32 weeks ]

Central Contacts and Locations

Central contacts

Marjean T Kulp, OD, MS

614-688-3336kulp.6@osu.edu

Locations

The Ohio State University College of Optometry

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Marjean T Kulp, OD, MS

614-688-3336kulp.6@osu.edu

More Information

Sponsor

Marjean Kulp

Last update posted

Jul 22, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marjean Kulp on 2025-07-22.