Treating Amblyopia in Adults With Interactive Video Games

Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).

Study Overview

• Status: Withdrawn
• Conditions: Amblyopia
• Intervention / Treatment: Other: Video game Mario Kart Wii

Detailed Description

The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play.

Study participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period.

The primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged >17 years old
• Refraction within past year and wearing updated glasses or contact lenses
• Diagnosis of strabismic, anisometropic or combined amblyopia (> 2 lines inter-ocular difference)
• Stable visual acuity as defined as <1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks

Exclusion Criteria:

• Monovision and unwilling to wear corrective glasses
• Allergy to adhesive bandages
• Women who are currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with Amblyopia; Adult amblyopia subjects will play the video game Mario Kart Wii	Other: Video game Mario Kart Wii; Subjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity	measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity	Baseline, one month

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Erick Bothun, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: 19-000212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No