International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 26
- Primary Endpoint
- Diplopia
Study Overview
Brief Summary
Approximately 300 patients presenting orbital blow-out fracture will be enrolled prospectively in this registry. All patients, surgically and nonsurgically treated as per standard (routine) of care will be followed-up (FU) within the registry for a period of 6 months.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older at the time of the injury
- •Patients with a dislocated fracture of the inferior and/or medial orbital wall, either
- •Diagnosed at the study site via CT or CBCT within 2 weeks of the date of the injury, OR
- •Who will undergo secondary reconstruction
Exclusion Criteria
- •Bilateral orbital fracture
- •Concomitant displaced fracture(s) of the orbital roof or any other area of the orbit
- •Concomitant ruptured globe
- •Displaced fracture of the malar bone
- •Displaced midface fracture
- •Displaced nasoorbitoethmoidal (NOE) fracture or complex zygoma fractures
- •Presence at the time of enrollment of any disease with influence on eye motility (eg, strabismus, myasthenia gravis, Graves' ophthalmopathy)
- •Previous radiotherapy in the orbital region
- •Participation in any other medical device or medicinal product study within the previous month(s) that could influence the results of the present study
Outcomes
Primary Outcomes
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 1. mild (diplopia appears more than 30 degrees from the primary position) 2. moderate (diplopia appears between 10 and 30 degrees from the primary position) 3. severe (diplopia appears within 10 degrees from the primary position)
Secondary Outcomes
- Extra-ocular mobility(6, 12, 24 weeks post-treatment)
- Patient-reported outcomes(pre-treatment, 6, 12, 24 weeks post-treatment)
- Globe position(6, 12, 24 weeks post-treatment)
- Visual acuity(6, 12, 24 weeks post-treatment)