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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

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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04086524