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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02736461
Other study ID # 1-104-05-124
Secondary ID
Status Completed
Phase N/A
First received March 18, 2016
Last updated October 12, 2017
Start date July 2016
Est. completion date October 12, 2017

Study information

Verified date October 2017
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date October 12, 2017
Est. primary completion date October 12, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Floor repair surgery


Locations

Country Name City State
Taiwan Tri-Service General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Bartoli D, Fadda MT, Battisti A, Cassoni A, Pagnoni M, Riccardi E, Sanzi M, Valentini V. Retrospective analysis of 301 patients with orbital floor fracture. J Craniomaxillofac Surg. 2015 Mar;43(2):244-7. doi: 10.1016/j.jcms.2014.11.015. Epub 2014 Nov 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Strabismus happening Number of participants suffered from strabismus happening at 6 months after operation and their characteristics. 6 months after orbital floor fracture repair surgery
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