A Patch Free Treatment for Young Children With Amblyopia

NCT04086524 | Completed

• 2 other identifiers: 123453600-105
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 2

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.

Conditions

Amblyopia; Binocular Vision Disorder

Keywords

Amblyopia; Binocular treatment; Visual acuity; Stereopsis; Motor function

Outcome Measures

Primary Outcomes (1)

• Visual acuity

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

  2 weeks

Secondary Outcomes (11)

• Visual acuity

  4 weeks

• Motor function

  2 weeks

• Stereopsis

  2 weeks

• Treatment adherence

  4 weeks

• Treatment adherence

  2 weeks

Study Arms (3)

Binocular cartoon treatment at home

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Binocular cartoon treatment in office

EXPERIMENTAL

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

Interventions

Binocular cartoon treatment at home OTHER

see arm description.

Binocular cartoon treatment at home

Patching OTHER

see arm description

Also known as: occlusion therapy, penalization

Control group

Binocular cartoon treatment in office OTHER

see arm description.

Binocular cartoon treatment in office

Eligibility Criteria

• Age: 36 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Waterloo: lead
• Retina Foundation of the Southwest: collaborator
• McGill University: collaborator
• Queensland University of Technology: collaborator

Study Sites (2)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Queensland University of Technology

Brisbane, Queesnland, 4000, Australia

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Amblyopia

Interventions

Working Conditions

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

Intervention Hierarchy (Ancestors)

Workplace; Employment; Socioeconomic Factors; Population Characteristics; Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Ben Thompson, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study team members measuring outcome variables will be masked to treatment group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: TREATMENT = 2 weeks of treatment (additional 2 weeks if they agree) CONTROL = 2 weeks patching, 2 weeks treatment

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: January 13, 2020
• Primary Completion: May 1, 2023
• Study Completion: November 30, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1)