Strabismus Clinical Trial
Official title:
Factors Associated With Postoperative Strabismus After Floor Fracture Repair
| Verified date | October 2017 |
| Source | Tri-Service General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Tri-Service General Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Tri-Service General Hospital |
Taiwan,
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
| 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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