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Orbital fracture registry aims to improve eye injury care

NCT ID NCT03887988

Knowledge-focused Sponsor: AO Innovation Translation Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow about 300 adults with orbital blow-out fractures to see how different treatments affect double vision and eye position over 6 months. Patients may receive surgery or non-surgical care as part of routine practice. The goal is to collect real-world data to better understand recovery and guide future treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could provide better data on which treatments work best for orbital fractures, helping guide future care.
What could go wrong
This is an observational registry, not a treatment trial, so it won't directly test a new therapy. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bone fracture Diplopia Orbital Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blow out fracture of orbit Orbital fractures

Contacts and locations

Locations

  • 12 de Octubre University Hospital

    Madrid, Madrid, Spain

  • Clinic for Maxillofacial Surgery, University of Belgrade

    Belgrade, Serbia

  • Emergency Clinical County Hospital of Constanta

    Constanța, Romania

  • Eramus MC

    Rotterdam, Netherlands

  • Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

    Moscow, Russia

  • Hamad Medical Corporation

    Doha, Qatar

  • Hospital Vall d' Hebron

    Barcelona, Catalonia, Spain

  • King Edward VIII Hospital

    Durban, South Africa

  • Klinikum der LMU München

    Munich, 80337, Germany

  • Mayo Hospital

    Lahore, Pakistan

  • Medical Center Hamburg Eppendorf

    Hamburg, Germany

  • UC Davis

    Sacramento, California, 95817, United States

  • Universitaetsspital Basel

    Basel, Switzerland

  • Uppsala University Hospital

    Uppsala, Sweden

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