Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
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