Dichoptic Video Treatment for Amblyopia

NCT03825107 | Completed

• 1 other identifier: Dichoptic Video for Amblyopia
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children
2. 2.To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• Change in visual acuity of the amblyopic eye

  HOTV (preferred) or picture chart

  Baseline vs 2 weeks

Secondary Outcomes (3)

• Change in visual acuity of the amblyopic eye

  Baseline vs 4 weeks, 6 weeks, and 8 weeks

• Change in Stereoacuity

  Baseline vs 2, 4, 6, 8 weeks

• Change in Contrast Balance Index

  Baseline vs 2, 4, 6, 8 weeks

Study Arms (2)

Patching

ACTIVE COMPARATOR

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

Other: patching

Dichoptic Videos

EXPERIMENTAL

watching 6 dichoptic videos during each 2 week period

Other: Dichoptic videos

Interventions

patching OTHER

covering the fellow eye with an eyepatch to force use of the amblyopic eye

Also known as: occlusion therapy

Patching

Dichoptic videos OTHER

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

Dichoptic Videos

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Retina Foundation of the Southwest: lead

Study Sites (1)

Eileen E Birch

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23.

  PMID: 37619861 DERIVED

• 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.

  PMID: 35264692 DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eileen E Birch, PhD

  Retina Foundation of the Southwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Parallel for primary outcome; crossover for longterm effectiveness

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: January 31, 2019
• Primary Completion: July 6, 2021
• Study Completion: August 31, 2021
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)