Clinical Trial: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: National University Hospital, Singapore
Current Primary Outcome:
- visual acuity
- Enophthalmos
- Diplopia
- Cosmetic appearance
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National University Hospital, Singapore
Dates:
Date Received: October 5, 2005
Date Started: July 2004
Date Completion:
Last Updated: May 12, 2008
Last Verified: May 2008
