Binocular Amblyopia Treatment
Primary Purpose
Amblyopia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Binocular games for treatment of amblyopia
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia
Eligibility Criteria
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
Sites / Locations
- Retina Foundation of the SouthwestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard Contrast Increment
Reduced Contrast Increment
No Contrast Increment
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change in stereoacuity
Randot Preschool Stereoacuity Test
Change in suppression
Dichoptic Letter Chart
Full Information
NCT ID
NCT03288948
First Posted
September 18, 2017
Last Updated
June 13, 2023
Sponsor
Retina Foundation of the Southwest
1. Study Identification
Unique Protocol Identification Number
NCT03288948
Brief Title
Binocular Amblyopia Treatment
Official Title
Binocular Amblyopia Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Foundation of the Southwest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Contrast Increment
Arm Type
Active Comparator
Arm Title
Reduced Contrast Increment
Arm Type
Experimental
Arm Title
No Contrast Increment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Binocular games for treatment of amblyopia
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in visual acuity of the amblyopic eye
Description
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
Time Frame
baseline vs 8 weeks
Secondary Outcome Measure Information:
Title
Change in visual acuity of the amblyopic eye
Description
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
Time Frame
baseline vs 2, 4, 6, and 12 weeks
Title
Change in stereoacuity
Description
Randot Preschool Stereoacuity Test
Time Frame
baseline vs 2, 4, 6, 8, 12 weeks
Title
Change in suppression
Description
Dichoptic Letter Chart
Time Frame
baseline vs 2, 4, 6, 8, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in accommodation
Description
Accuracy of accommodation to a near target (Grand Seiko)
Time Frame
baseline vs 8 week
Title
Change in motion perception
Description
Motion-defined form
Time Frame
baseline vs 8 weeks
Title
Change in fixation stability
Description
Bivariate contour ellipse area
Time Frame
baseline vs 8 weeks
Title
Reading speed
Description
Reading speed in wpm
Time Frame
baseline vs 4 and 8 weeks
Title
Fine motor skills
Description
M-ABC
Time Frame
baseline vs 4 and 8 weeks
Title
Self-perception
Description
self-perception questionnaire
Time Frame
baseline vs 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reed Jost, MS
Phone
2143633911
Ext
113
Email
reedjost@retinafoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Krista Kelly, PhD
Phone
2143633911
Ext
113
Email
kkelly@rfsw.org
Facility Information:
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pediatric Laboratory
Phone
214-363-3911
Ext
113
First Name & Middle Initial & Last Name & Degree
Eileen E Birch, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
we will only share aggregated data
Citations:
PubMed Identifier
33045374
Citation
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.
Results Reference
derived
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Binocular Amblyopia Treatment
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