AmblyopiaNCT04086524
A Patch Free Treatment for Young Children With Amblyopia
A study testing Binocular cartoon treatment at home, Patching and Binocular cartoon treatment in office in people with Amblyopia and Binocular Vision Disorder, run by University of Waterloo at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 83 months
- Conditions the study is for
- Amblyopia, Binocular Vision Disorder
- What is being tested?
- Binocular cartoon treatment at home, Patching and Binocular cartoon treatment in office
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jan 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Retina Foundation of the Southwest
Dallas, Texas, 75231
Australia1 site
Queensland University of Technology
Brisbane, Queesnland, 4000
About this study
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.
Read the 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
- Being tested
- Binocular cartoon treatment at home, Patching, Binocular cartoon treatment in office
- Keywords
- Amblyopia, Binocular treatment, Visual acuity, Stereopsis, Motor function
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular cartoon treatment at homeOther
see arm description.
PatchingOther
Also called occlusion therapy, penalization
see arm description
Binocular cartoon treatment in officeOther
see arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Binocular cartoon treatment in office |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Change in visual acuity, measured in logMAR using an electronic HOTV test
Measured: 2 weeks
Secondary outcomes (11)
Visual acuity
Change in visual acuity, measured in logMAR an electronic HOTV test
Measured: 4 weeks
Motor function
Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)
Measured: 2 weeks
Stereopsis
Change in stereopsis, measured using the Randot Preschool Stereoacuity Test
Measured: 2 weeks
Treatment adherence
Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time
Measured: 4 weeks
Treatment adherence
Self-reported amount of time spent viewing the cartoon or patching compared to amount of prescribed time
Measured: 2 weeks
Stereopsis
Change in stereopsis, measured using the Randot Preschool Stereoacuity Test
Measured: 4 weeks
Motor function
Change in motor function, measured using the Movement Assessment Battery for Children-2 (version 2)
Measured: 4 weeks
Interocular suppression
Change in interocular suppression measured using the Worth 4 dot test
Measured: 2 weeks
Interocular suppression
Change in interocular suppression measured using the Worth 4 dot test
Measured: 4 weeks
Interocular contrast balance
Change in interocular contrast balance measured using a dichoptic letter chart
Measured: 2 weeks
Interocular contrast balance
Change in interocular contrast balance measured using a dichoptic letter chart
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start13 Jan 2020
- Primary completion1 May 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- TREATMENT = 2 weeks of treatment (additional 2 weeks if they agree) CONTROL = 2 weeks patching, 2 weeks treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Retina Foundation of the Southwest, McGill University, Queensland University of Technology
- Responsible party
- Principal investigator, Ben Thompson, University of Waterloo
- Investigators
- Ben Thompson, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086524
- Sponsor's protocol ID
- 12345
- Other IDs
- 3600-105
- Status last verified
- Mar 2024
- First submitted
- 9 Sep 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jost RM, Birch EE, Wang YZ, Dao LM, Stager D, Luu B, Beauchamp CL, Giridhar P, Brin TA, Baldwin AS, Hess RF, Thompson B. Patch-free streaming contrast-rebalanced dichoptic cartoons versus patching for treatment of amblyopia in children aged 3 to 5 years: a pilot, randomized clinical trial. J AAPOS. 2024 Oct;28(5):103991. doi: 10.1016/j.jaapos.2024.103991. Epub 2024 Sep 11.
PubMed 39270746Jost 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.
PubMed 37619861
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patch Free Treatment for Young Children With Amblyopia
- ClinicalTrials.gov ID
- NCT04086524
- Acronym / sponsor ID
- 12345
- Conditions
- Amblyopia, Binocular Vision Disorder
- Keywords
- Amblyopia, Binocular treatment, Visual acuity, Stereopsis, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Retina Foundation of the Southwest, McGill University, Queensland University of Technology
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- TREATMENT = 2 weeks of treatment (additional 2 weeks if they agree) CONTROL = 2 weeks patching, 2 weeks treatment
| Arm | Type | Receives |
|---|---|---|
| Binocular cartoon treatment at home | Experimental | Other: Binocular cartoon treatment at homeParticipants 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. |
| Control group | Active comparator | Other: PatchingParticipants 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. |
| Binocular cartoon treatment in office | Experimental | Other: Binocular cartoon treatment in officeParticipants 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. |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular cartoon treatment at homesee arm description. | Other | Binocular cartoon treatment at home |
| PatchingAlso: occlusion therapy, penalizationsee arm description | Other | Control group |
| Binocular cartoon treatment in officesee arm description. | Other | Binocular cartoon treatment in office |
Primary outcome
Visual acuity
Time frame: 2 weeks
Change in visual acuity, measured in logMAR using an electronic HOTV test
11 secondary outcomes
Visual acuity
Time frame: 4 weeks
Motor function
Time frame: 2 weeks
Stereopsis
Time frame: 2 weeks
Treatment adherence
Time frame: 4 weeks
Treatment adherence
Time frame: 2 weeks
Stereopsis
Time frame: 4 weeks
Motor function
Time frame: 4 weeks
Interocular suppression
Time frame: 2 weeks
Interocular suppression
Time frame: 4 weeks
Interocular contrast balance
Time frame: 2 weeks
Interocular contrast balance
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39270746Jost RM, Birch EE, Wang YZ, Dao LM, Stager D, Luu B, Beauchamp CL, Giridhar P, Brin TA, Baldwin AS, Hess RF, Thompson B. Patch-free streaming contrast-rebalanced dichoptic cartoons versus patching for treatment of amblyopia in children aged 3 to 5 years: a pilot, randomized clinical trial. J AAPOS. 2024 Oct;28(5):103991. doi: 10.1016/j.jaapos.2024.103991. Epub 2024 Sep 11.
- Derived from this study: PubMed 37619861Jost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Thompson, PhD principal investigator
University of Waterloo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular cartoon treatment at home, Patching and Binocular cartoon treatment in office in people with Amblyopia and Binocular Vision Disorder, run by University of Waterloo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.