A Patch Free Treatment for Young Children With Amblyopia

NCT04086524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-03-12

No results posted yet for this study

Summary

The purpose of this study is to test whether a binocular treatment can improve vision and motor function in young children with amblyopia. The proposed treatment is an animation series that has been modified so that different characters in the animation are presented to each eye. The contrast of the images shown to the amblyopic eye is higher than the contrast of the images shown to the fellow eye. The aim of the treatment is to promote co-operation between the two eyes and improve visual and motor outcomes. We will compare the benefits of this binocular treatment to patching, whereby the better eye is occluded with an eye patch for two hours per day to force the usage of the weaker eye. We hypothesize that the binocular treatment will improve vision and motor outcomes in young children with amblyopia, and that these improvements will be superior to any effects of patching.

Conditions

  • Amblyopia
  • Binocular Vision Disorder

Interventions

OTHER

Binocular cartoon treatment at home

see arm description.

OTHER

Patching

see arm description

OTHER

Binocular cartoon treatment in office

see arm description.

Sponsors & Collaborators

  • Retina Foundation of the Southwest

    collaborator OTHER
  • McGill University

    collaborator OTHER
  • Queensland University of Technology

    collaborator OTHER
  • University of Waterloo

    lead OTHER

Principal Investigators

  • Ben Thompson, PhD · University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
36 Months
Max Age
83 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2023-05-01
Completion
2023-11-30

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086524 on ClinicalTrials.gov