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Dichoptic Video Treatment for Amblyopia

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
patching
Dichoptic videos
Sponsored by
Retina Foundation of the Southwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 3 to 7 years old
  • Amblyopic eye visual acuity 20/32-20/125
  • Fellow eye visual acuity 20/16-25
  • Interocular visual acuity difference of at least 2 lines
  • Anisometropia or corrected strabsimus (<5pd)
  • in glasses at least 8 weeks or no change in visual acuity over two visits
  • no prior binocular treatment
  • must be able to see full video screen

Exclusion Criteria:

  • prematurity of 8 weeks or more
  • coexisting ocular or systemic disease
  • developmental delay
  • poor ocular alignment (>=5 pd)

Sites / Locations

  • Eileen E Birch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patching

Dichoptic Videos

Arm Description

2 hours per day 7 days per week patching of the fellow eye

watching 6 dichoptic videos during each 2 week period

Outcomes

Primary Outcome Measures

Change in visual acuity of the amblyopic eye
HOTV (preferred) or picture chart

Secondary Outcome Measures

Change in visual acuity of the amblyopic eye
HOTV (preferred) or picture charts
Change in Stereoacuity
Randot Preschool Stereoacuity test
Change in Contrast Balance Index
Dichoptic Letter chart

Full Information

First Posted
January 29, 2019
Last Updated
October 20, 2021
Sponsor
Retina Foundation of the Southwest
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1. Study Identification

Unique Protocol Identification Number
NCT03825107
Brief Title
Dichoptic Video Treatment for Amblyopia
Official Title
Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

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 determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)
Detailed Description
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 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
Model Description
Parallel for primary outcome; crossover for longterm effectiveness
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patching
Arm Type
Active Comparator
Arm Description
2 hours per day 7 days per week patching of the fellow eye
Arm Title
Dichoptic Videos
Arm Type
Experimental
Arm Description
watching 6 dichoptic videos during each 2 week period
Intervention Type
Other
Intervention Name(s)
patching
Other Intervention Name(s)
occlusion therapy
Intervention Description
covering the fellow eye with an eyepatch to force use of the amblyopic eye
Intervention Type
Other
Intervention Name(s)
Dichoptic videos
Intervention Description
watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
Primary Outcome Measure Information:
Title
Change in visual acuity of the amblyopic eye
Description
HOTV (preferred) or picture chart
Time Frame
Baseline vs 2 weeks
Secondary Outcome Measure Information:
Title
Change in visual acuity of the amblyopic eye
Description
HOTV (preferred) or picture charts
Time Frame
Baseline vs 4 weeks, 6 weeks, and 8 weeks
Title
Change in Stereoacuity
Description
Randot Preschool Stereoacuity test
Time Frame
Baseline vs 2, 4, 6, 8 weeks
Title
Change in Contrast Balance Index
Description
Dichoptic Letter chart
Time Frame
Baseline vs 2, 4, 6, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3 to 7 years old Amblyopic eye visual acuity 20/32-20/125 Fellow eye visual acuity 20/16-25 Interocular visual acuity difference of at least 2 lines Anisometropia or corrected strabsimus (<5pd) in glasses at least 8 weeks or no change in visual acuity over two visits no prior binocular treatment must be able to see full video screen Exclusion Criteria: prematurity of 8 weeks or more coexisting ocular or systemic disease developmental delay poor ocular alignment (>=5 pd)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen E Birch, PhD
Organizational Affiliation
Retina Foundation of the Southwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eileen E Birch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35264692
Citation
Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9.
Results Reference
derived

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Dichoptic Video Treatment for Amblyopia

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