Orbital Fractures Registry (OFx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03887988|
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : November 22, 2019
|Condition or disease||Intervention/treatment|
|Orbital Fractures Blow Out Fracture of Orbit||Procedure: Primary "early" reconstruction Other: Nonsurgical Procedure: Primary "delayed" reconstruction Procedure: Secondary reconstruction|
Approximately 300 patients presenting with a displaced orbital fracture (OFx) in the floor and/or medial wall (blow-out fracture) will be enrolled prospectively in this registry. All patients, surgically and nonsurgical treated will be followed-up (FU) within the registry. FU period for all patients will include assessments post-treatment at 6 weeks, 3 months and 6 months as corresponding with the local standard (routine) visit schedule at each participating clinic.
Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (ie, complications). Computer Tomography (CT) scans or Cone Beam-CT (CBCT) scans taken as per standard of care will be collected within the registry.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Patients with dislocated fracture of the inferior and/or medial orbital wall
Procedure: Primary "early" reconstruction
Primary surgical reconstruction of the fracture within 3 weeks after injury
Nonsurgical treatment of fracture
Other Name: Conservative
Procedure: Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Procedure: Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Other Name: Secondary surgery
- Diplopia [ Time Frame: 24 weeks post-treatment ]
The degree of diplopia is quantified by measuring the field of single binocular vision, ranging from 0 to 3.
0: no diplopia
- mild (diplopia appears more than 30 degrees from the primary position)
- moderate (diplopia appears between 10 and 30 degrees from the primary position)
- severe (diplopia appears within 10 degrees from the primary position)
- Globe position [ Time Frame: 6, 12, 24 weeks post-treatment ]Exo/enophthalmos (in mm) using Naugle or Hertel exophthalmometer Hyper/hypophthalmos: vertical globe displacement is measured as the pupilar height difference (in mm) from the healthy side to the injured side
- Visual acuity [ Time Frame: 6, 12, 24 weeks post-treatment ]Measured using a visual test chart in healthy and injured sides with and without vision aids.
- Extra-ocular mobility [ Time Frame: 6, 12, 24 weeks post-treatment ]Follow-my finger test
- Patient-reported outcomes [ Time Frame: pre-treatment, 6, 12, 24 weeks post-treatment ]AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887988
|Contact: Victor Diaz, PhD||+41 81 414 25 firstname.lastname@example.org|
|Contact: Brigitte Gallo, PhD||+41 44 200 24 email@example.com|
|United States, California|
|Sacramento, California, United States, 95817|
|Contact: Bradley Strong, MD 916-734-5573 firstname.lastname@example.org|
|Principal Investigator:||Eppo B. Wolvius, Prof.||Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam|