Orbital FracturesNCT02736461
Factors Associated With Postoperative Strabismus After Floor Fracture Repair
An observational study of Orbital Fractures and Strabismus, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orbital Fractures, Strabismus
- What is being tested?
- Floor repair surgery
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2016to 12 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.
Who may be able to join
- Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.
Who cannot join
- Prior ocular surgeries
- Multiple facial trauma or facial bone fractures
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Orbital Fractures, Strabismus
- Being tested
- Floor repair surgery
- Keywords
- Orbital fractures, Strabismus, Predicting factors, orbital floor fractures
- Medical subject headings
- Orbital Fractures, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floor repair surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1- With strabismus | Study group with strabismus happening after floor fracture repair Receives: Procedure: Floor repair surgery | |
| Group 2- Without strabismus | No strabismus happening after floor fracture repair Receives: Procedure: Floor repair surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strabismus happening
Number of participants suffered from strabismus happening at 6 months after operation and their characteristics.
Measured: 6 months after orbital floor fracture repair surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Hung Chien, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736461
- Sponsor's protocol ID
- 1-104-05-124
- Status last verified
- Oct 2017
- First submitted
- 18 Mar 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
Publications
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.
PubMed 25547215
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Postoperative Strabismus After Floor Fracture Repair
- ClinicalTrials.gov ID
- NCT02736461
- Acronym / sponsor ID
- 1-104-05-124
- Conditions
- Orbital Fractures, Strabismus
- Keywords
- Orbital fractures, Strabismus, Predicting factors, orbital floor fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Jul 2016
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- With strabismus | – | Procedure: Floor repair surgeryStudy group with strabismus happening after floor fracture repair |
| Group 2- Without strabismus | – | Procedure: Floor repair surgeryNo strabismus happening after floor fracture repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.
Key inclusion criteria (1 listed)
- Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.
Key exclusion criteria (2 listed)
- Prior ocular surgeries
- Multiple facial trauma or facial bone fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floor repair surgery | Procedure or surgery | Group 1- With strabismus, Group 2- Without strabismus |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Results publication: PubMed 25547215Bartoli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Fractures and Strabismus, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strabismus happening (time frame: 6 months after orbital floor fracture repair surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.