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Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

This study is ongoing, but not recruiting participants.
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: September 1, 2006
Last updated: May 10, 2010
Last verified: June 2008
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.

Condition Intervention Phase
Orbital Implants
Procedure: orbital implant
Phase 2
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: November 2005
Estimated Study Completion Date: November 2006
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pegged unpegged hydroxyapatite orbital implantation
Procedure: orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants
Active Comparator: 2
Unpegged hydroxyapatite orbital implantation
Procedure: orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • orbital hydroxyapatite implants

Exclusion Criteria:

  • history of systemic disease
  • history of radio therapy
  • secondary hydroxapatite implant
  • complications lead to re-surgery
  Contacts and Locations
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Please refer to this study by its identifier: NCT00371280

Iran, Islamic Republic of
Babak Babsharif, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information Identifier: NCT00371280     History of Changes
Other Study ID Numbers: 8422 
Study First Received: September 1, 2006
Last Updated: May 10, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti University of Medical Sciences:
prosthetic motility
orbital implant

Additional relevant MeSH terms:
Eye Abnormalities
Eye Diseases
Congenital Abnormalities processed this record on January 18, 2017