Binocular Amblyopia Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Other: Binocular games for treatment of amblyopia

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reed Jost, MS; Phone Number: 113 2143633911; Email: reedjost@retinafoundation.org
• Study Contact Backup: Name: Krista Kelly, PhD; Phone Number: 113 2143633911; Email: kkelly@rfsw.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Retina Foundation of the Southwest
      • Principal Investigator: Eileen E Birch, PhD
      • Contact: Pediatric Laboratory; Phone Number: 113 214-363-3911

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Contrast Increment	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
Experimental: Reduced Contrast Increment	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
Experimental: No Contrast Increment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline vs 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline vs 2, 4, 6, and 12 weeks
Change in stereoacuity	Randot Preschool Stereoacuity Test	baseline vs 2, 4, 6, 8, 12 weeks
Change in suppression	Dichoptic Letter Chart	baseline vs 2, 4, 6, 8, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in accommodation	Accuracy of accommodation to a near target (Grand Seiko)	baseline vs 8 week
Change in motion perception	Motion-defined form	baseline vs 8 weeks
Change in fixation stability	Bivariate contour ellipse area	baseline vs 8 weeks
Reading speed	Reading speed in wpm	baseline vs 4 and 8 weeks
Fine motor skills	M-ABC	baseline vs 4 and 8 weeks
Self-perception	self-perception questionnaire	baseline vs 8 weeks

Collaborators and Investigators

• Sponsor: Retina Foundation of the Southwest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: 062010-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we will only share aggregated data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No