Augmenting Patching Treatment for Amblyopia With Physical Exercise

January 27, 2021 updated by: Erick D. Bothun, Mayo Clinic
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Exercise in addition to Patching
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).
Other: Physical Exercise in addition to Patching
Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month (3 weeks to 8 weeks) after initiating game play

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Erick Bothun, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2018

Primary Completion (Actual)

November 19, 2020

Study Completion (Actual)

November 19, 2020

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-010474

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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