Binocular Amblyopia Treatment

Not Applicable

Recruiting

• Conditions: Amblyopia
• Interventions: Other: Binocular games for treatment of amblyopia

• Registration Number: NCT03288948
• Lead Sponsor: Retina Foundation of the Southwest

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.

Study Timeline

• Study Start: 2017-08-31
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced Contrast Increment	Binocular games for treatment of amblyopia	-
Standard Contrast Increment	Binocular games for treatment of amblyopia	-
No Contrast Increment	Binocular games for treatment of amblyopia	-

Primary Outcome Measures

Name	Time	Method
Change in visual acuity of the amblyopic eye	baseline vs 8 weeks	ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity of the amblyopic eye	baseline vs 2, 4, 6, and 12 weeks	ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
Change in stereoacuity	baseline vs 2, 4, 6, 8, 12 weeks	Randot Preschool Stereoacuity Test
Change in suppression	baseline vs 2, 4, 6, 8, 12 weeks	Dichoptic Letter Chart

Trial Locations

Locations (1)

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States