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Augmenting Patching Treatment for Amblyopia With Physical Exercise

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Exercise in addition to Patching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Exercise in addition to Patching

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2019
Last Updated
January 27, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03822806
Brief Title
Augmenting Patching Treatment for Amblyopia With Physical Exercise
Official Title
Augmenting Patching Treatment for Amblyopia With Physical Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
November 19, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Exercise in addition to Patching
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physical Exercise in addition to Patching
Intervention Description
Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game
Primary Outcome Measure Information:
Title
Visual Acuity
Description
The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.
Time Frame
1 month (3 weeks to 8 weeks) after initiating game play

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick Bothun, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Augmenting Patching Treatment for Amblyopia With Physical Exercise

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