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Active, not recruitingNCT03887988OFxUpdated May 26, 2026

Orbital Fractures Registry

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Orbital Fractures
  • Blow Out Fracture of Orbit

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Keywords

  • Fracture fixation
  • Orbital implant
  • Midface fracture
  • Diplopia
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In context

Orbital Fractures

29 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.

Browse Orbital Fractures studies →

Lead sponsor

AO Innovation Translation Center is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Orbital Fracture

    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

Interventions

  • ProcedurePrimary "early" reconstruction

    Primary surgical reconstruction of the fracture within 3 weeks after injury

    Also known as: Operative, Surgical

  • OtherNonsurgical

    Nonsurgical treatment of fracture

    Also known as: Conservative

  • ProcedurePrimary "delayed" reconstruction

    Primary surgical reconstruction of the fracture more than 3 weeks after injury

    Also known as: Operative, Surgical

  • ProcedureSecondary reconstruction

    Second surgical reconstruction of the fracture after a primary reconstruction.

    Also known as: Secondary surgery

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Extra-ocular mobility

    Follow-my finger test

    Time frame: 6, 12, 24 weeks post-treatment

  4. 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

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Study locations

14 sites
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References and documents

Publications

  • Strabbing EM; OFx Registry Study Group; Wolvius EB. Surgical versus non-surgical management of orbital fractures: study protocol for evidence generation of a prospective multicentre observational cohort registry. BMJ Open. 2025 Jul 30;15(7):e100508. doi: 10.1136/bmjopen-2025-100508. PubMed 40738644 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03887988
Lead sponsor
AO Innovation Translation Center
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Nov 1, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 26, 2026

Study contacts

Eppo B. Wolvius, Prof.
principal investigator · Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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