An interventional study of Binocular games for treatment of amblyopia in Amblyopia, sponsored by Retina Foundation of the Southwest. Recruiting at 1 site in United States. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Retina Foundation of the Southwest · Not applicable, Interventional, and Treatment
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.
wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
Exclusion Criteria:
Other: Binocular games for treatment of amblyopia
Other: Binocular games for treatment of amblyopia
Other: Binocular games for treatment of amblyopia
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
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
Time frame: baseline vs 8 weeks
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
Time frame: baseline vs 2, 4, 6, and 12 weeks
Change in stereoacuity
Randot Preschool Stereoacuity Test
Time frame: baseline vs 2, 4, 6, 8, 12 weeks
Change in suppression
Dichoptic Letter Chart
Time frame: baseline vs 2, 4, 6, 8, 12 weeks
Change in accommodation
Accuracy of accommodation to a near target (Grand Seiko)
Time frame: baseline vs 8 week
Change in motion perception
Motion-defined form
Time frame: baseline vs 8 weeks
Change in fixation stability
Bivariate contour ellipse area
Time frame: baseline vs 8 weeks
Reading speed
Reading speed in wpm
Time frame: baseline vs 4 and 8 weeks
Fine motor skills
M-ABC
Time frame: baseline vs 4 and 8 weeks
Self-perception
self-perception questionnaire
Time frame: baseline vs 8 weeks
Plan to share: No — we will only share aggregated data
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Retina Foundation of the Southwest