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Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shaheed Beheshti Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371280
First received: September 1, 2006
Last updated: May 10, 2010
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371280

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

No publications provided

ClinicalTrials.gov 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 Shaheed Beheshti Medical University:
hydroxyapatite
peg
prosthetic motility
orbital implant

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

ClinicalTrials.gov processed this record on May 19, 2013