Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Anophthalmos Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00371280
• Other study ID #: 8422
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 1, 2006
• Last updated: May 10, 2010
• Start date: November 2005
• Est. completion date: November 2006

Study information

• Verified date: June 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anophthalmos
• Orbital Implants

Intervention

Procedure:
• orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants

Locations

Country	Name	City	State
Iran, Islamic Republic of	Babak Babsharif, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing movement in up gaze: 0.58 mm
Primary	Changing movement in down gaze: 0.83 mm
Primary	Changing movement in medial gaze: 0.75 mm
Primary	Changing movement in lateral gaze: 1.2 mm