Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants
This trial is active, not recruiting.
|Conditions||anophthalmos, orbital implants|
|Phase||phase 2/phase 3|
|Sponsor||Shahid Beheshti Medical University|
|Start date||November 2005|
|End date||October 2006|
|Trial size||50 participants|
|Trial identifier||NCT00371280, 8422|
Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Changing movement in up gaze: 0.58 mm
Changing movement in down gaze: 0.83 mm
Changing movement in medial gaze: 0.75 mm
Changing movement in lateral gaze: 1.2 mm
Male or female participants of any age.
Inclusion Criteria: - orbital hydroxyapatite implants Exclusion Criteria: - history of systemic disease - history of radio therapy - secondary hydroxapatite implant - complications lead to re-surgery
|Principal investigator||Babak Babsharif, MD|
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