Factors Associated With Postoperative Strabismus After Floor Fracture Repair

• Sponsor: Tri-Service General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02736461
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Duration (Months): 15.4
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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	Phase
Orbital Fractures; Strabismus	Procedure: Floor repair surgery

Study Design

• 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: Jul 1, 2016
• Actual Primary Completion Date: Oct 12, 2017
• Actual Study Completion Date: Oct 12, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Strabismus happening [6 months after orbital floor fracture repair surgery]

   Number of participants suffered from strabismus happening at 6 months after operation and their characteristics.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Service General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Tri-Service General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ke-Hung Chien, Ophthalmologist, Tri-Service General Hospital
• ClinicalTrials.gov Identifier: NCT02736461
• Other Study ID Numbers: 1-104-05-124
• First Posted: Apr 13, 2016
• Last Update Posted: Oct 13, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Ke-Hung Chien, Ophthalmologist, Tri-Service General Hospital: Orbital fractures; Strabismus; Predicting factors; orbital floor fractures
• Additional relevant MeSH terms: Strabismus; Orbital Fractures; Fractures, Bone

Study Results

No Results Posted as of Oct 13, 2017