Orbital Fractures Registry (NCT03887988) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Orbital Fractures Registry
United States, Germany, Netherlands300 participantsStarted 2019-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.