Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Phase 2

• Conditions: Anophthalmos; Orbital Implants
• Interventions: Procedure: orbital implant

• Registration Number: NCT00371280
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Primary Completion: 2006-10
• Study Completion: 2006-11
• Status Verified: 2008-06
• Last Update Submitted: 2010-05-10
• Last Update Posted: 2010-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• orbital hydroxyapatite implants

Exclusion Criteria

• history of systemic disease
• history of radio therapy
• secondary hydroxapatite implant
• complications lead to re-surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	orbital implant	Pegged unpegged hydroxyapatite orbital implantation
2	orbital implant	Unpegged hydroxyapatite orbital implantation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Babak Babsharif, MD; 🇮🇷 Tehran, Iran, Islamic Republic of