Treating Amblyopia in Adults With Interactive Video Games | NCT03906994

Studies
Treating Amblyopia in Adults With Interactive Video Games

NCT03906994

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jan 12, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Amblyopia

Interventions

Video game Mario Kart Wii

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Original study PI left institution and the new PI elected not to proceed with the study.

Expanded Access Info

Start Date

Oct 1, 2019Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 5, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2021

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with Amblyopia	Experimental	Adult amblyopia subjects will play the video game Mario Kart Wii	Other: Video game Mario Kart Wii

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video game Mario Kart Wii	Other	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	Subjects with Amblyopia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Erick Bothun, MD	Mayo Clinic	Principal Investigator

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000550	Amblyopia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders

Browse Leaves

Not provided

Browse Branches

Not provided