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Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371280
First Posted: September 4, 2006
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
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
Anophthalmos Orbital Implants Procedure: orbital implant Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371280


Locations
Iran, Islamic Republic of
Babak Babsharif, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00371280     History of Changes
Other Study ID Numbers: 8422
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: May 12, 2010
Last Verified: June 2008

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

Additional relevant MeSH terms:
Anophthalmos
Eye Abnormalities
Eye Diseases
Congenital Abnormalities