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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03906994
Other study ID # 19-000212
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date December 2021

Study information

Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1
Completed NCT02003235 - Assessment of Device for Treatment of Amblyopia N/A

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