Augmenting Patching Treatment for Amblyopia With Physical Exercise

Not Applicable

Completed

• Conditions: Amblyopia
• Interventions: Other: Physical Exercise in addition to Patching

• Registration Number: NCT03822806
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-21
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Primary Completion: 2020-11-19
• Study Completion: 2020-11-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical Exercise in addition to Patching	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).

Primary Outcome Measures

Name	Time	Method
Visual Acuity	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States