CompletedNot Applicable

Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

United States, Germany, Singapore185 participantsStarted 2010-06

Plain-language summary

Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients ≥ 18 years
✓. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor
✓. Scheduled for reconstruction surgery with one of the following implants:
✓. At least partial sight in both eyes before the accident
✓. Willingness and ability to participate in the study follow-up according to the protocol
✓. Ability to understand and read local language at elementary level
✓. Signed informed consent

Exclusion criteria

✕. Bilateral orbital fracture
✕. Fractures of the orbital roof
✕. Comminuted zygoma fracture
✕. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
✕. Previous dislocated orbital fractures on either side
✕. Vision or diplopia not assessable
✕. Injury of the globe
✕. Neurological diseases with influence on eye motility or sight

What they're measuring

shape and volume assessing software

Timeframe: up to 3 days after surgery

Trial details

NCT IDNCT01121159

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Orbital Floor Fracture trials