AmblyopiaNCT03822806
Augmenting Patching Treatment for Amblyopia With Physical Exercise
A study testing Physical Exercise in addition to Patching in people with Amblyopia, run by Mayo Clinic at 1 site in United States.
Trial summary
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Physical Exercise in addition to Patching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2018to 19 Nov 2020
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5 to < 17 years old
- Cycloplegic refraction within past year
- Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous
- Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment.
- Stable visual acuity as defined by <1 LogMAR change over 2 visits
- Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system with a version of Just Dance® already in the home.
Who cannot join
- Known problems with exercise tolerance
- No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home
- Current atropine treatment for amblyopia
Trial locations and contacts
1 site in 1 country.
About this study
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.
- Conditions
- Amblyopia
- Being tested
- Physical Exercise in addition to Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise in addition to PatchingOther
Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise in addition to Patching | Experimental | Patch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise). Receives: Other: Physical Exercise in addition to Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.
Measured: 1 month (3 weeks to 8 weeks) after initiating game play
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start21 Jan 2018
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick D. Bothun, Mayo Clinic
- Investigators
- Erick Bothun, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822806
- Sponsor's protocol ID
- 18-010474
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Patching Treatment for Amblyopia With Physical Exercise
- ClinicalTrials.gov ID
- NCT03822806
- Acronym / sponsor ID
- 18-010474
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 30 Jan 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.
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise in addition to Patching | Experimental | Other: Physical Exercise in addition to PatchingPatch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise). |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 5 to < 17 years old
- Cycloplegic refraction within past year
- Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous
- Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment.
- Stable visual acuity as defined by <1 LogMAR change over 2 visits
Key exclusion criteria (3 listed)
- Known problems with exercise tolerance
- No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home
- Current atropine treatment for amblyopia
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 |
|---|---|---|
| Physical Exercise in addition to PatchingPatch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game | Other | Physical Exercise in addition to Patching |
Primary outcome
Visual Acuity
Time frame: 1 month (3 weeks to 8 weeks) after initiating game play
The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.
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 28 Jan 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Erick Bothun, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in addition to Patching in people with Amblyopia, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 3 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: 1 month (3 weeks to 8 weeks) after initiating game play). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.