An observational study in Orbital Fractures and Blow Out Fracture of Orbit, sponsored by AO Innovation Translation Center. Active, not recruiting at 14 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by AO Innovation Translation Center · Observational
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.
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.
Patients older than 18 years old with displaced fracture of the inferior and/or medial orbital wall (blow-out fractures) that require treatment (either surgically or non-surgically)
Patients with a dislocated fracture of the inferior and/or medial orbital wall, either
Exclusion Criteria:
Patients with dislocated fracture of the inferior and/or medial orbital wall
Procedure: Primary "early" reconstruction · Other: Nonsurgical · Procedure: Primary "delayed" reconstruction · Procedure: Secondary reconstruction
Primary surgical reconstruction of the fracture within 3 weeks after injury
Also known as: Operative, Surgical
Nonsurgical treatment of fracture
Also known as: Conservative
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Also known as: Operative, Surgical
Second surgical reconstruction of the fracture after a primary reconstruction.
Also known as: Secondary surgery
Diplopia
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)
Time frame: 24 weeks post-treatment
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
Time frame: 6, 12, 24 weeks post-treatment
Visual acuity
Measured using a visual test chart in healthy and injured sides with and without vision aids.
Time frame: 6, 12, 24 weeks post-treatment
Extra-ocular mobility
Follow-my finger test
Time frame: 6, 12, 24 weeks post-treatment
Patient-reported outcomes
AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry
Time frame: pre-treatment, 6, 12, 24 weeks post-treatment
Plan to share: Undecided
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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AO Innovation Translation Center