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NCT02570555 Clinical Trial

Strabismus Surgery and Driving Ability

Strabismus Clinical Trial

Official title:
Strabismus Surgery and Driving Ability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02570555
Other study ID # 5503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date January 2018

Study information
Verified date August 2019
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Strabismus

- Age > 18 yrs old

- Driving license

Exclusion Criteria:

- Inability to driving under French law

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Sevice d'ophtalmologie Les hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effectiveness of strabismus surgery on driving ability by using a Performance score (number of errors, braking velocity, speed variations of the vehicle position). 6 months
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