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A Patch Free Treatment for Young Children With Amblyopia

Primary Purpose

Amblyopia, Binocular Vision Disorder

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Binocular cartoon treatment at home
Patching
Binocular cartoon treatment in office
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Binocular treatment, Visual acuity, Stereopsis, Motor function

Eligibility Criteria

36 Months - 83 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Retina Foundation of the Southwest
  • Queensland University of Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Binocular cartoon treatment at home

Control group

Binocular cartoon treatment in office

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Visual acuity
Change in visual acuity, measured in logMAR using an electronic HOTV test

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2019
Last Updated
September 21, 2023
Sponsor
University of Waterloo
Collaborators
Retina Foundation of the Southwest, McGill University, Queensland University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04086524
Brief Title
A Patch Free Treatment for Young Children With Amblyopia
Official Title
A Patch Free Treatment for Young Children With Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Waterloo
Collaborators
Retina Foundation of the Southwest, McGill University, Queensland University of Technology

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Binocular Vision Disorder
Keywords
Amblyopia, Binocular treatment, Visual acuity, Stereopsis, Motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
TREATMENT = 2 weeks of treatment (additional 2 weeks if they agree) CONTROL = 2 weeks patching, 2 weeks treatment
Masking
Outcomes Assessor
Masking Description
Study team members measuring outcome variables will be masked to treatment group.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Binocular cartoon treatment at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Binocular cartoon treatment in office
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Binocular cartoon treatment at home
Intervention Description
see arm description.
Intervention Type
Other
Intervention Name(s)
Patching
Other Intervention Name(s)
occlusion therapy, penalization
Intervention Description
see arm description
Intervention Type
Other
Intervention Name(s)
Binocular cartoon treatment in office
Intervention Description
see arm description.
Primary Outcome Measure Information:
Title
Visual acuity
Description
Change in visual acuity, measured in logMAR using an electronic HOTV test
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Change in visual acuity, measured in logMAR an electronic HOTV test
Time Frame
4 weeks
Title
Motor function
Description
Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)
Time Frame
2 weeks
Title
Stereopsis
Description
Change in stereopsis, measured using the Randot Preschool Stereoacuity Test
Time Frame
2 weeks
Title
Treatment adherence
Description
Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time
Time Frame
4 weeks
Title
Treatment adherence
Description
Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time
Time Frame
2 weeks
Title
Stereopsis
Description
Change in stereopsis, measured using the Randot Preschool Stereoacuity Test
Time Frame
4 weeks
Title
Motor function
Description
Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)
Time Frame
4 weeks
Title
Interocular suppression
Description
Change in interocular suppression measured using the Worth 4 dot test
Time Frame
2 weeks
Title
Interocular suppression
Description
Change in interocular suppression measured using the Worth 4 dot test
Time Frame
4 weeks
Title
Interocular contrast balance
Description
Change in interocular contrast balance measured using a dichoptic letter chart
Time Frame
2 weeks
Title
Interocular contrast balance
Description
Change in interocular contrast balance measured using a dichoptic letter chart
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Thompson, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Queensland University of Technology
City
Brisbane
State/Province
Queesnland
ZIP/Postal Code
4000
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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A Patch Free Treatment for Young Children With Amblyopia

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