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| Name | Class |
|---|---|
| Beta Sigma Kappa - College of Optometrists in Vision Development | UNKNOWN |
| VividVision | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical Correction alone | Active Comparator | Optical correction alone (16 weeks) (Each participant will complete both study conditions.) |
|
| Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction | Experimental | Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Correction | Device | Optical correction (if needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean Change in Amblyopic Eye Visual Acuity | 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 | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in Stereoacuity/Binocularity | 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. |
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Inclusion Criteria:
Patients ages 5 to 17 years of age
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjean T Kulp, OD, MS | Contact | 614-688-3336 | kulp.6@osu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.
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Outcomes assessor will be masked to past performance and adherence.
| Therapeutic Dichoptic Virtual Reality Games | Device | Virtual Reality Game play for amblyopia treatment |
|
| Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity | 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). | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Difference in Mean Change in Attention | 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. | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Difference in Mean Change in reading eye movements | Optical correction worn for testing with Readalyzer eye tracker. | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Difference in Mean Change in visual-motor integration | Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15 | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ) | 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) | Baseline to 16 weeks versus 16 weeks to 32 weeks |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |