A Patch Free Treatment for Young Children With Amblyopia

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.

Study Overview

• Status: Completed
• Conditions: Amblyopia; Binocular Vision Disorder
• Intervention / Treatment: Other: Binocular cartoon treatment at home; Other: Patching; Other: Binocular cartoon treatment in office

Detailed Description

This is a prospective study with study sites in Ontario, Canada (University of Waterloo); Quebec, Canada (University of McGill); Texas, United States of America (Retina Foundation of the Southwest); and Queensland, Australia (Queensland University of Technology). There are three study conditions. 1) binocular treatment at home, 2) binocular treatment in office and, 3) standard patching therapy.

Participants will be recruited from university-affiliated clinics and local clinical practices. Following full informed consent, participants will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, stereopsis, interocular suppression and motor function. Eligible participants will then be randomized to either binocular treatment or patching.

The treatment consists of dichoptically presented children's animations with all characters seen by the amblyopic eye and only a subset of characters seen by the fellow eye. Images shown to the amblyopic eye will be presented at 100% contrast and images presented to the fellow eye will be presented at 20% contrast on session 1 and contrast will increment by 10% of the prior session's contrast level for each subsequent session. Participants will complete 4 x 1-hour sessions per week for two weeks. After 2 weeks of treatment, participants will be offered the opportunity to complete an additional 2 weeks (8 hours) of treatment. Treatment will take place in the home or in-office depending on the study site.

The control group will patch for 2 hours every day, at home, for 2 weeks. A calendar will be provided (to both groups) in order for parents to track compliance. After 2 weeks of patching, participants in the control group have the option to crossover to the treatment group for an additional 2 weeks.

The primary analysis will compare visual acuity improvements from baseline between the binocular treatment and patching groups after 2 weeks of treatment. Secondary analyses will include comparisons of binocular vision and motor function outcomes between the binocular treatment and patching groups, comparisons of at-home vs. in-office binocular treatment outcomes and an evaluation of crossover effects.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queesnland
    • Brisbane, Queesnland, Australia, 4000
      • Queensland University of Technology
• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 3-5.9 years old (36-83 months at the time of registration)
• Confirmed diagnosis of amblyopia
• Best-corrected visual acuity of 20/32 - 20/100 in the amblyopic eye
• Best-corrected visual acuity of 20/16 - 20/40 in fellow eye for ages 3-4, and 20/16-20/32 for ages 5-5.9
• Interocular difference in visual acuity of 3 lines or greater
• If anisometropic, anisometropia (≥1.00D)
• Wearing glasses for 8+ weeks + no change in VA w/ glasses for 4-6 weeks
• Must be able to experience simultaneous perception when viewing the binocular treatment stimuli with an appropriate interocular contrast offset
• Doctor and parent must be willing to forego patching/drops for 4 week study period

Exclusion Criteria:

• strabismus
• Diagnosed eye disease or visual disorder other than amblyopia or anisometropia
• >8 weeks premature
• Diagnosed or suspected developmental delay (eg. learning disability, autism, Down syndrome)
• Diagnosed systemic disease (eg. diabetes, lupus, albinism)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Binocular cartoon treatment at home; Participants will view a dichoptic binocular cartoon (provided by BBC) on the Nintendo 3DS-XL at home. They will continue to watch the cartoon for 60 minutes, 4 times a week, for 2 weeks. After 2 weeks, they will be given the option to continue for an additional 2 weeks (total of 4 weeks). Watching the cartoon does not require any special glasses. They will discontinue patching during this time.	Other: Binocular cartoon treatment at home; see arm description.
Active Comparator: Control group; Participants will patch for 2 hours every day at home. After 2 weeks, they will be given the option to crossover to the teratment group for an additional 2 weeks (total of 4 weeks). Patching is a common treatment for amblyopia, often considered the "golden standard." It is the most common comparison as a "control" group in amblyopia and vision therapy literature.	Other: Patching; see arm description; Other Names: occlusion therapy; penalization
Experimental: Binocular cartoon treatment in office; Participants will view a dichoptic binocular cartoon (provided by BBC) on the Nintendo 3DS-XL in office. They will continue to watch the cartoon for 60 minutes, 4 times a week, for 2 weeks. After 2 weeks, they will be given the option to continue for an additional 2 weeks (total of 4 weeks). Watching the cartoon does not require any special glasses. They will discontinue patching during this time.	Other: Binocular cartoon treatment in office; see arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Change in visual acuity, measured in logMAR using an electronic HOTV test	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Change in visual acuity, measured in logMAR an electronic HOTV test	4 weeks
Motor function	Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)	2 weeks
Stereopsis	Change in stereopsis, measured using the Randot Preschool Stereoacuity Test	2 weeks
Treatment adherence	Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time	4 weeks
Treatment adherence	Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time	2 weeks
Stereopsis	Change in stereopsis, measured using the Randot Preschool Stereoacuity Test	4 weeks
Motor function	Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)	4 weeks
Interocular suppression	Change in interocular suppression measured using the Worth 4 dot test	2 weeks
Interocular suppression	Change in interocular suppression measured using the Worth 4 dot test	4 weeks
Interocular contrast balance	Change in interocular contrast balance measured using a dichoptic letter chart	2 weeks
Interocular contrast balance	Change in interocular contrast balance measured using a dichoptic letter chart	4 weeks

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: McGill University; Retina Foundation of the Southwest; Queensland University of Technology
• Investigators: Principal Investigator: Ben Thompson, PhD, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Amblyopia; Motor function; Visual acuity; Stereopsis; Binocular treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements); 3600-105 (Other Grant/Funding Number: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No