Binocular Amblyopia Treatment

• Sponsor: Retina Foundation of the Southwest (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03288948
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 69.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amblyopia	Other: Binocular games for treatment of amblyopia	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Binocular Amblyopia Treatment
• Actual Study Start Date: Aug 31, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Change in stereoacuity [baseline vs 2, 4, 6, 8, 12 weeks]

   Randot Preschool Stereoacuity Test

3. Change in suppression [baseline vs 2, 4, 6, 8, 12 weeks]

   Dichoptic Letter Chart

Other Outcome Measures

1. Change in accommodation [baseline vs 8 week]

   Accuracy of accommodation to a near target (Grand Seiko)

2. Change in motion perception [baseline vs 8 weeks]

   Motion-defined form

3. Change in fixation stability [baseline vs 8 weeks]

   Bivariate contour ellipse area

4. Reading speed [baseline vs 4 and 8 weeks]

   Reading speed in wpm

5. Fine motor skills [baseline vs 4 and 8 weeks]

   M-ABC

6. Self-perception [baseline vs 8 weeks]

   self-perception questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Foundation of the Southwest	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Retina Foundation of the Southwest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eileen Birch, Senior Research Scientist, Retina Foundation of the Southwest
• ClinicalTrials.gov Identifier: NCT03288948
• Other Study ID Numbers: 062010-105
• First Posted: Sep 20, 2017
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Jun 21, 2022