Binocular Amblyopia Treatment

Retina Foundation of the Southwest

Status: Enrolling

Conditions: Amblyopia

Treatments: Other: Binocular games for treatment of amblyopia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03288948

062010-105

R01EY022313 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Standard Contrast Increment

Active Comparator group

Treatment:

Other: Binocular games for treatment of amblyopia

Reduced Contrast Increment

Experimental group

Treatment:

Other: Binocular games for treatment of amblyopia

No Contrast Increment

Experimental group

Treatment:

Other: Binocular games for treatment of amblyopia