Augmenting Patching Treatment for Amblyopia With Physical Exercise

Amblyopia Clinical Trial

Official title:

Augmenting Patching Treatment for Amblyopia With Physical Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822806
• Other study ID #: 18-010474
• Status: Completed
• Phase: N/A
• Start date: January 21, 2018
• Est. completion date: November 19, 2020

Study information

• Verified date: January 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month (3 weeks to 8 weeks) after initiating game play

External Links

•   Mayo Clinic Clinical Trials