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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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
Retina Foundation of the Southwest
Dallas, Texas, United States
RECRUITINGChange 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
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