Binocular Amblyopia Treatment

Amblyopia Clinical Trial

Official title:

Binocular Amblyopia Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03288948
• Other study ID #: 062010-105
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Retina Foundation of the Southwest
• Contact: Reed Jost, MS
• Phone: 2143633911
• Email: reedjost[@]retinafoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

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

Locations

Country	Name	City	State
United States	Retina Foundation of the Southwest	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Retina Foundation of the Southwest

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in accommodation	Accuracy of accommodation to a near target (Grand Seiko)	baseline vs 8 week
Other	Change in motion perception	Motion-defined form	baseline vs 8 weeks
Other	Change in fixation stability	Bivariate contour ellipse area	baseline vs 8 weeks
Other	Reading speed	Reading speed in wpm	baseline vs 4 and 8 weeks
Other	Fine motor skills	M-ABC	baseline vs 4 and 8 weeks
Other	Self-perception	self-perception questionnaire	baseline vs 8 weeks
Primary	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	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
Secondary	Change in stereoacuity	Randot Preschool Stereoacuity Test	baseline vs 2, 4, 6, 8, 12 weeks
Secondary	Change in suppression	Dichoptic Letter Chart	baseline vs 2, 4, 6, 8, 12 weeks