- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02570555
Strabismus Surgery and Driving Ability
August 19, 2019 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Sevice d'ophtalmologie Les hôpitaux Universitaires de Strasbourg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with strabismus tested before and after the eye surgery Control patients.
Description
Inclusion Criteria:
- Strabismus
- Age > 18 yrs old
- Driving license
Exclusion Criteria:
- Inability to driving under French law
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effectiveness of strabismus surgery on driving ability by using a Performance score (number of errors, braking velocity, speed variations of the vehicle position).
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arnaud Sauer, MDPHD, Les Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2013
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
February 12, 2013
First Submitted That Met QC Criteria
October 6, 2015
First Posted (Estimate)
October 7, 2015
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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