NCT02736461

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

March 18, 2016

Last Update Submit

October 12, 2017

Conditions

Orbital FracturesStrabismus

Keywords

Orbital fracturesStrabismusPredicting factorsorbital floor fractures

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

Floor repair surgeryPROCEDURE
Group 1- With strabismusGroup 2- Without strabismus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

Related 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.

    PMID: 25547215RESULT

MeSH Terms

Conditions

Orbital FracturesStrabismus

Condition Hierarchy (Ancestors)

Maxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and InjuriesOcular Motility DisordersCranial Nerve DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 13, 2016

Study Start

July 1, 2016

Primary Completion

October 12, 2017

Study Completion

October 12, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

TW(1)