New treatment for amblyopia using virtual reality games
Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
This study is testing if playing virtual reality games can help children with amblyopia see better when compared to just wearing glasses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06049459 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a 16-week treatment using Vivid Vision Therapeutic Virtual Reality Games compared to traditional optical correction (glasses) alone in children aged 5-17 with amblyopia. Participants will undergo two treatment periods: the first period will involve continued use of glasses, while the second period will incorporate virtual reality games for approximately 25 minutes a day, six days a week. The study will assess improvements in visual acuity, binocularity, contrast sensitivity, attention, oculomotor function, visual-motor integration, and overall quality of life. Each participant will serve as their own control, allowing for a direct comparison of the two treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 17 with moderate to severe unilateral amblyopia and specific visual acuity criteria.
Not a fit: Patients with significant myopia, previous ocular surgeries, or certain ocular co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual outcomes and quality of life for children with amblyopia.
How similar studies have performed: While this approach is innovative, similar studies using virtual reality for amblyopia treatment have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Columbus, Ohio
- The Ohio State University College of Optometry — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Marjean T Kulp, OD, MS
- Email: kulp.6@osu.edu
- Phone: 614-688-3336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.