Augmenting Patching Treatment for Amblyopia With Physical Exercise

NCT03822806 | Completed

• 1 other identifier: 18-010474
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Physical Exercise in addition to Patching

EXPERIMENTAL

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

Interventions

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

Physical Exercise in addition to Patching

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Amblyopia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erick Bothun, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: January 21, 2018
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (1)