Novel Amblyopia Treatment With Virtual Reality Games
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Optical Correction alone Optical correction alone (16 weeks) (Each participant will complete both study conditions.) |
Device: Optical Correction
Optical correction (if needed)
|
| 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.) |
Device: Optical Correction
Optical correction (if needed)
Device: Therapeutic Dichoptic Virtual Reality Games
Virtual Reality Game play for amblyopia treatment
|
Outcome Measures
Primary Outcome Measures
- Difference in Mean Change in Amblyopic Eye Visual Acuity [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 Outcome Measures
- Difference in Change in Stereoacuity/Binocularity [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.
- Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity [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).
- Difference in Mean Change in Attention [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.
- Difference in Mean Change in reading eye movements [Baseline to 16 weeks versus 16 weeks to 32 weeks]
Optical correction worn for testing with Readalyzer eye tracker.
- Difference in Mean Change in visual-motor integration [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
- Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ) [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)
Eligibility Criteria
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
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Age normal VA in the nonamblyopic eye
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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)
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Interocular difference of ≥ 3 lines
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No amblyopia treatment in the past 2 weeks
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An interpupillary distance of 52-72 mm (inclusive)
Exclusion Criteria:
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Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
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Previous intraocular or refractive surgery.
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Previous dichoptic treatment > 2 weeks in duration
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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).
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Diplopia more than once per week over the last week prior to enrollment by parental report.
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Down syndrome or cerebral palsy.
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Light-induced seizures
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Known simulator sickness
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ohio State University College of Optometry | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Marjean Kulp
- Beta Sigma Kappa - College of Optometrists in Vision Development
- VividVision
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023H0013