Clinical trial NCT03288948: Binocular Amblyopia Treatment
Official title: Binocular Amblyopia Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Lead sponsor: Retina Foundation of the Southwest
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2017-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Detailed description: 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.

Eligibility criteria: 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

  * 4 weeks apart.
* 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:

* prematurity ≥8 weeks
* coexisting ocular or systemic disease
* developmental delay
* strabismus \>5pd
* any binocular amblyopia treatment in the past 3 months

Primary outcomes:
measure: Change in visual acuity of the amblyopic eye
timeFrame: baseline vs 8 weeks
Secondary outcomes:
measure: Change in visual acuity of the amblyopic eye
timeFrame: baseline vs 2, 4, 6, and 12 weeks
measure: Change in stereoacuity
timeFrame: baseline vs 2, 4, 6, 8, 12 weeks
measure: Change in suppression
timeFrame: baseline vs 2, 4, 6, 8, 12 weeks
Other outcomes:
measure: Change in accommodation
timeFrame: baseline vs 8 week
measure: Change in motion perception
timeFrame: baseline vs 8 weeks
measure: Change in fixation stability
timeFrame: baseline vs 8 weeks
measure: Reading speed
timeFrame: baseline vs 4 and 8 weeks
measure: Fine motor skills
timeFrame: baseline vs 4 and 8 weeks
measure: Self-perception
timeFrame: baseline vs 8 weeks
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
References:
citation: 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.