AmblyopiaNCT03906994
Treating Amblyopia in Adults With Interactive Video Games
A study testing Video game Mario Kart Wii in people with Amblyopia, run by Mayo Clinic.
Trial summary
Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amblyopia
- What is being tested?
- Video game Mario Kart Wii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >17 years old
- Refraction within past year and wearing updated glasses or contact lenses
- Diagnosis of strabismic, anisometropic or combined amblyopia (> 2 lines inter-ocular difference)
- Stable visual acuity as defined as <1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks
Who cannot join
- Monovision and unwilling to wear corrective glasses
- Allergy to adhesive bandages
- Women who are currently pregnant
About this study
Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).
Read the detailed description
The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play.
Study participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period.
The primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.
- Conditions
- Amblyopia
- Being tested
- Video game Mario Kart Wii
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game Mario Kart WiiOther
Subjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Amblyopia | Experimental | Adult amblyopia subjects will play the video game Mario Kart Wii Receives: Other: Video game Mario Kart Wii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity
Measured: Baseline, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Oct 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Original study PI left institution and the new PI elected not to proceed with the study.
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
- 0 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
- NCT03906994
- Sponsor's protocol ID
- 19-000212
- Status last verified
- Dec 2021
- First submitted
- 5 Apr 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Amblyopia in Adults With Interactive Video Games
- ClinicalTrials.gov ID
- NCT03906994
- Acronym / sponsor ID
- 19-000212
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original study PI left institution and the new PI elected not to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Apr 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.
Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).
Detailed description
The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play.
Study participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period.
The primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Amblyopia | Experimental | Other: Video game Mario Kart WiiAdult amblyopia subjects will play the video game Mario Kart Wii |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >17 years old
- Refraction within past year and wearing updated glasses or contact lenses
- Diagnosis of strabismic, anisometropic or combined amblyopia (> 2 lines inter-ocular difference)
- Stable visual acuity as defined as <1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks
Key exclusion criteria (3 listed)
- Monovision and unwilling to wear corrective glasses
- Allergy to adhesive bandages
- Women who are currently pregnant
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 |
|---|---|---|
| Video game Mario Kart WiiSubjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior | Other | Subjects with Amblyopia |
Primary outcome
Change in visual acuity
Time frame: Baseline, one month
measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Erick Bothun, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Video game Mario Kart Wii in people with Amblyopia, run by Mayo Clinic.
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 4 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: withdrawn, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in visual acuity (time frame: Baseline, one month). 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 12 Jan 2022.