NCT02570555

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

4.2 years

First QC Date

February 12, 2013

Last Update Submit

August 19, 2019

Conditions

StrabismusEsotropiaExotropia

Keywords

driving

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with strabismus tested before and after the eye surgery Control patients.

You may qualify if:

  • Strabismus
  • Age \> 18 yrs old
  • Driving license

You may not qualify if:

  • Inability to driving under French law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevice d'ophtalmologie Les hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

StrabismusEsotropiaExotropia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Arnaud Sauer, MDPHD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

October 7, 2015

Study Start

November 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

FR(1)