Augmenting Patching Treatment for Amblyopia With Physical Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2020-11-19

Brief Summary

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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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Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Physical Exercise in addition to Patching

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No