Orbital Fractures Clinical Trial
— OFxOfficial title:
International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Medical Center Hamburg Eppendorf | Hamburg | |
Germany | Klinikum der LMU München | Munich | |
Netherlands | Eramus MC | Rotterdam | |
Pakistan | Mayo Hospital | Lahore | |
Qatar | Hamad Medical Corporation | Doha | |
Romania | Emergency Clinical County Hospital of Constanta | Constanta | |
Russian Federation | Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation | Moscow | |
Serbia | Clinic for Maxillofacial Surgery, University of Belgrade | Belgrade | |
South Africa | King Edward VIII Hospital | Durban | |
Spain | Hospital Vall d' Hebron | Barcelona | Catalonia |
Spain | 12 de Octubre University Hospital | Madrid | |
Sweden | Uppsala University Hospital | Uppsala | |
Switzerland | Universitaetsspital Basel | Basel | |
United States | UC Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Publishing Documentation |
United States, Germany, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diplopia | 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) |
24 weeks post-treatment | |
Secondary | Globe position | 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 | 6, 12, 24 weeks post-treatment | |
Secondary | Visual acuity | Measured using a visual test chart in healthy and injured sides with and without vision aids. | 6, 12, 24 weeks post-treatment | |
Secondary | Extra-ocular mobility | Follow-my finger test | 6, 12, 24 weeks post-treatment | |
Secondary | Patient-reported outcomes | AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry | pre-treatment, 6, 12, 24 weeks post-treatment |
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