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Factors Associated With Postoperative Strabismus After Floor Fracture Repair

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ClinicalTrials.gov Identifier: NCT02736461
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ke-Hung Chien, Tri-Service General Hospital

Brief Summary:
In patients suffered from floor fractures, there are 21.9% complaining about diplopia before fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4% had similar conditions. Investigators are planned to find predicting factors to prevent such conditions from happening.

Condition or disease Intervention/treatment
Orbital Fractures Strabismus Procedure: Floor repair surgery

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Factors Associated With Postoperative Strabismus After Floor Fracture Repair
Study Start Date : July 2016
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Group 1- With strabismus
Study group with strabismus happening after floor fracture repair
Procedure: Floor repair surgery
Group 2- Without strabismus
No strabismus happening after floor fracture repair
Procedure: Floor repair surgery



Primary Outcome Measures :
  1. Strabismus happening [ Time Frame: 6 months after orbital floor fracture repair surgery ]
    Number of participants suffered from strabismus happening at 6 months after operation and their characteristics.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.
Criteria

Inclusion Criteria:

  • Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.

Exclusion Criteria:

  • Prior ocular surgeries
  • Multiple facial trauma or facial bone fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736461


Locations
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Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Tri-Service General Hospital

Publications of Results:
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Responsible Party: Ke-Hung Chien, Ophthalmologist, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02736461     History of Changes
Other Study ID Numbers: 1-104-05-124
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Ke-Hung Chien, Tri-Service General Hospital:
Orbital fractures
Strabismus
Predicting factors
orbital floor fractures
Additional relevant MeSH terms:
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Strabismus
Orbital Fractures
Fractures, Bone
Wounds and Injuries
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Skull Fractures