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NCT Number: NCT06049459

Novel Amblyopia Treatment With Virtual Reality Games

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

Recruiting

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Marjean T Kulp, OD, MS

CONTACT

[email protected]

614-688-3336

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical Correction

Device

Optical correction (if needed)

Therapeutic Dichoptic Virtual Reality Games

Device

Virtual Reality Game play for amblyopia treatment

Primary outcomes

  1. Difference in Mean Change in Amblyopic Eye Visual Acuity

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older

Secondary outcomes

  1. Difference in Change in Stereoacuity/Binocularity

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.

  2. Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).

  3. Difference in Mean Change in Attention

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.

  4. Difference in Mean Change in reading eye movements

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing with Readalyzer eye tracker.

  5. Difference in Mean Change in visual-motor integration

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15

  6. Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)

    Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks

    Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)

Study contacts

Contact information is provided by the study sponsor or research team.

Marjean T Kulp, OD, MS

CONTACT

[email protected]

614-688-3336

Sponsors and collaborators

Lead sponsor

Marjean Kulp

Other

Collaborators

  • Beta Sigma Kappa - College of Optometrists in Vision Development
  • VividVision

Registry information

Official study title

Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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