A Study to Assess the Effect of Exercise on Patching Treatment for Children with Amblyopia
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010474
NCT ID: NCT03822806
Sponsor Protocol Number: 18-010474
About this study
The purpose of this study is to establish whether moderate physical exercise enhances treatment benefit when patching 2 hours a day for residual amblyopia in children.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Erick Bothun, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available