Orbital FracturesOFxNCT03887988
Orbital Fractures Registry
An observational study of Orbital Fractures and Blow Out Fracture of Orbit, run by AO Innovation Translation Center at 14 sites in 12 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures, Blow Out Fracture of Orbit
- What is being tested?
- Primary "early" reconstruction, Nonsurgical and Primary "delayed" reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 14 sitesin 12 countries
- Study dates
- 1 Nov 2019to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
14 sites in 12 countries.
14 sites in 12 countries
Germany2 sites
Medical Center Hamburg Eppendorf
Hamburg
Klinikum der LMU München
Munich, 80337
Spain2 sites
Hospital Vall d' Hebron
Barcelona, Catalonia
12 de Octubre University Hospital
Madrid, Madrid
Russia1 site
Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
Moscow
About this study
Official 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.
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.
- Conditions
- Orbital Fractures, Blow Out Fracture of Orbit
- Being tested
- Primary "early" reconstruction, Nonsurgical, Primary "delayed" reconstruction, Secondary reconstruction
- Keywords
- Fracture fixation, Orbital implant, Midface fracture, Diplopia
- Medical subject headings
- Orbital Fractures, Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary "early" reconstructionProcedure or surgery
Also called Operative, Surgical
Primary surgical reconstruction of the fracture within 3 weeks after injury
NonsurgicalOther
Also called Conservative
Nonsurgical treatment of fracture
Primary "delayed" reconstructionProcedure or surgery
Also called Operative, Surgical
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Secondary reconstructionProcedure or surgery
Also called Secondary surgery
Second surgical reconstruction of the fracture after a primary reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Orbital Fracture | Patients with dislocated fracture of the inferior and/or medial orbital wall Receives: Procedure: Primary "early" reconstruction; Other: Nonsurgical; Procedure: Primary "delayed" reconstruction; Procedure: Secondary reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks post-treatment
Secondary outcomes (4)
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
Measured: 6, 12, 24 weeks post-treatment
Visual acuity
Measured using a visual test chart in healthy and injured sides with and without vision aids.
Measured: 6, 12, 24 weeks post-treatment
Extra-ocular mobility
Follow-my finger test
Measured: 6, 12, 24 weeks post-treatment
Patient-reported outcomes
AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry
Measured: pre-treatment, 6, 12, 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eppo B. Wolvius, Prof., Principal investigator, Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887988
- Sponsor's protocol ID
- OFx Registry_RP_v.1.0
- Acronym
- OFx
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome
- ClinicalTrials.gov ID
- NCT03887988
- Acronym / sponsor ID
- OFx / OFx Registry_RP_v.1.0
- Conditions
- Orbital Fractures, Blow Out Fracture of Orbit
- Keywords
- Fracture fixation, Orbital implant, Midface fracture, Diplopia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orbital Fracture | – | Procedure: Primary "early" reconstruction, Other: Nonsurgical, Procedure: Primary "delayed" reconstruction, Procedure: Secondary reconstructionPatients with dislocated fracture of the inferior and/or medial orbital wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary "early" reconstructionAlso: Operative, SurgicalPrimary surgical reconstruction of the fracture within 3 weeks after injury | Procedure or surgery | Orbital Fracture |
| NonsurgicalAlso: ConservativeNonsurgical treatment of fracture | Other | Orbital Fracture |
| Primary "delayed" reconstructionAlso: Operative, SurgicalPrimary surgical reconstruction of the fracture more than 3 weeks after injury | Procedure or surgery | Orbital Fracture |
| Secondary reconstructionAlso: Secondary surgerySecond surgical reconstruction of the fracture after a primary reconstruction. | Procedure or surgery | Orbital Fracture |
Primary outcome
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)
4 secondary outcomes
Globe position
Time frame: 6, 12, 24 weeks post-treatment
Visual acuity
Time frame: 6, 12, 24 weeks post-treatment
Extra-ocular mobility
Time frame: 6, 12, 24 weeks post-treatment
Patient-reported outcomes
Time frame: pre-treatment, 6, 12, 24 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 40738644Strabbing 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eppo B. Wolvius, Prof. principal investigator
Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam
14 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Fractures and Blow Out Fracture of Orbit, run by AO Innovation Translation Center at 14 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Spain, United States, Netherlands, Pakistan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diplopia (time frame: 24 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.