Overview

This trial is active, not recruiting.

Conditions anophthalmos, orbital implants
Treatment orbital implant
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Pegged unpegged hydroxyapatite orbital implantation
orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants
(Active Comparator)
Unpegged hydroxyapatite orbital implantation
orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants

Primary Outcomes

Measure
Changing movement in up gaze: 0.58 mm
time frame:
Changing movement in down gaze: 0.83 mm
time frame:
Changing movement in medial gaze: 0.75 mm
time frame:
Changing movement in lateral gaze: 1.2 mm
time frame:

Eligibility Criteria

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

Additional Information

Principal investigator Babak Babsharif, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Shahid Beheshti Medical University.