A Patch Free Treatment for Young Children With Amblyopia

NCT ID: NCT04086524

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2023-11-30

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.

Conditions

Amblyopia; Binocular Vision Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Binocular cartoon treatment at home

Intervention Type: OTHER

see arm description.

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.

Group Type: ACTIVE_COMPARATOR

Patching

Intervention Type: OTHER

see arm description

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.

Group Type: EXPERIMENTAL

Binocular cartoon treatment in office

Intervention Type: OTHER

see arm description.

Interventions

Binocular cartoon treatment at home

see arm description.

Intervention Type: OTHER

Patching

see arm description

Intervention Type: OTHER

Binocular cartoon treatment in office

see arm description.

Intervention Type: OTHER

Other Intervention Names

occlusion therapy; penalization

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)

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 83 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Retina Foundation of the Southwest

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Queensland University of Technology

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Ben Thompson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

Retina Foundation of the Southwest

Dallas, Texas, United States

Queensland University of Technology

Brisbane, Queesnland, Australia

Countries

United States; Australia

References

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.

Reference Type: DERIVED

PMID: 37619861 (View on PubMed)

Other Identifiers

3600-105

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12345

Identifier Type: -

Identifier Source: org_study_id