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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY022313 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.
Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Contrast Increment | Active Comparator |
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| Reduced Contrast Increment | Experimental |
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| No Contrast Increment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binocular games for treatment of amblyopia | Other | playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity of the amblyopic eye | ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years | baseline vs 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity of the amblyopic eye | ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years | baseline vs 2, 4, 6, and 12 weeks |
| Change in stereoacuity | Randot Preschool Stereoacuity Test |
| Measure | Description | Time Frame |
|---|---|---|
| Change in accommodation | Accuracy of accommodation to a near target (Grand Seiko) | baseline vs 8 week |
| Change in motion perception | Motion-defined form |
Inclusion Criteria:
age 4-10 y
male and female
strabismic, anisometropic, or combined mechanism amblyopia
amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
fellow eye best-corrected visual acuity ≤0.1 logMAR
interocular visual acuity difference ≥0.3 logMAR
wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
parent's informed consent
child must demonstrate understanding and ability to play binocular games
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reed Jost, MS | Contact | 2143633911 | 113 | reedjost@retinafoundation.org |
| Krista Kelly, PhD | Contact | 2143633911 | 113 | kkelly@rfsw.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Foundation of the Southwest | Recruiting | Dallas | Texas | 75231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37619861 | Derived | Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23. | |
| 33045374 | Derived | Jost RM, Kelly KR, Hunter JS, Stager DR Jr, Luu B, Leffler JN, Dao L, Beauchamp CL, Birch EE. A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment. J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9. |
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we will only share aggregated data
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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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| baseline vs 2, 4, 6, 8, 12 weeks |
| Change in suppression | Dichoptic Letter Chart | baseline vs 2, 4, 6, 8, 12 weeks |
| baseline vs 8 weeks |
| Change in fixation stability | Bivariate contour ellipse area | baseline vs 8 weeks |
| Reading speed | Reading speed in wpm | baseline vs 4 and 8 weeks |
| Fine motor skills | M-ABC | baseline vs 4 and 8 weeks |
| Self-perception | self-perception questionnaire | baseline vs 8 weeks |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |