Augmenting Patching Treatment for Amblyopia With Physical Exercise

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

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Exercise in addition to Patching

Other

Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jan 30, 2019
Registry last updated: Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed