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Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.
Age
20 - 70 years
Sex
ALL
Healthy Volunteers
Yes
National University Hospital
Singapore, Singapore
Start Date
July 1, 2004
Completion Date
July 1, 2007
Last Updated
May 13, 2008
80
ESTIMATED participants
Osteosheet(r)
DEVICE
Lead Sponsor
National University Hospital, Singapore
Collaborators
NCT06369129
NCT06850857
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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