NCT03906994

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

2.2 years

First QC Date

April 5, 2019

Last Update Submit

December 23, 2021

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Subjects with Amblyopia

EXPERIMENTAL

Adult amblyopia subjects will play the video game Mario Kart Wii

Other: Video game Mario Kart Wii

Interventions

Video game Mario Kart WiiOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erick Bothun, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

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

April 5, 2019

First Posted

April 8, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share