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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04086524




Registration number
NCT04086524
Ethics application status
Date submitted
9/09/2019
Date registered
11/09/2019
Date last updated
12/03/2024

Titles & IDs
Public title
A Patch Free Treatment for Young Children With Amblyopia
Scientific title
A Patch Free Treatment for Young Children With Amblyopia
Secondary ID [1] 0 0
3600-105
Secondary ID [2] 0 0
12345
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amblyopia 0 0
Binocular Vision Disorder 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Binocular cartoon treatment at home
Other interventions - Patching
Other interventions - Binocular cartoon treatment in office

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.

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.

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 interventions: Binocular cartoon treatment at home
see arm description.

Other interventions: Patching
see arm description

Other interventions: Binocular cartoon treatment in office
see arm description.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual acuity
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Visual acuity
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Motor function
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Stereopsis
Timepoint [3] 0 0
2 weeks
Secondary outcome [4] 0 0
Treatment adherence
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Treatment adherence
Timepoint [5] 0 0
2 weeks
Secondary outcome [6] 0 0
Stereopsis
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Motor function
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Interocular suppression
Timepoint [8] 0 0
2 weeks
Secondary outcome [9] 0 0
Interocular suppression
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Interocular contrast balance
Timepoint [10] 0 0
2 weeks
Secondary outcome [11] 0 0
Interocular contrast balance
Timepoint [11] 0 0
4 weeks

Eligibility
Key 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
Minimum age
36 Months
Maximum age
83 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2023
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
Queesnlan
Recruitment hospital [1] 0 0
Queensland University of Technology - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Waterloo
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Retina Foundation of the Southwest
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
McGill University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Queensland University of Technology
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04086524
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Thompson, PhD
Address 0 0
University of Waterloo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04086524