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Dichoptic Video Treatment for Amblyopia

Sponsor
Retina Foundation of the Southwest (Other)
Overall Status
Completed
CT.gov ID
NCT03825107
Collaborator
(none)
65
Enrollment
1
Location
2
Arms
31
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children

  2. To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)

Condition or Disease Intervention/Treatment Phase
  • Other: patching
  • Other: Dichoptic videos
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel for primary outcome; crossover for longterm effectivenessParallel for primary outcome; crossover for longterm effectiveness
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
Actual Study Start Date :
Jan 31, 2019
Actual Primary Completion Date :
Jul 6, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patching

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

Other: patching
covering the fellow eye with an eyepatch to force use of the amblyopic eye
Other Names:
  • occlusion therapy

    		•
    Experimental: Dichoptic Videos

    watching 6 dichoptic videos during each 2 week period

    Other: Dichoptic videos
    watching contrast-rebalanced dichoptic videos to allow the two eyes to work together

    Outcome Measures

    Primary Outcome Measures

    1. Change in visual acuity of the amblyopic eye [Baseline vs 2 weeks]

      HOTV (preferred) or picture chart

    Secondary Outcome Measures

    1. Change in visual acuity of the amblyopic eye [Baseline vs 4 weeks, 6 weeks, and 8 weeks]

      HOTV (preferred) or picture charts

    2. Change in Stereoacuity [Baseline vs 2, 4, 6, 8 weeks]

      Randot Preschool Stereoacuity test

    3. Change in Contrast Balance Index [Baseline vs 2, 4, 6, 8 weeks]

      Dichoptic Letter chart

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eileen E Birch Dallas Texas United States 75231

    Sponsors and Collaborators

    • Retina Foundation of the Southwest

    Investigators

    • Principal Investigator: Eileen E Birch, PhD, Retina Foundation of the Southwest

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eileen Birch, Senior Research Scientist, Retina Foundation of the Southwest
    ClinicalTrials.gov Identifier:
    NCT03825107
    Other Study ID Numbers:
    • Dichoptic Video for Amblyopia
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Oct 28, 2021
    Last Verified:
    Oct 1, 2021
    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 Oct 28, 2021