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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
September 1, 2006
September 4, 2006
May 12, 2010
November 2005
October 2006   (Final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00371280 on ClinicalTrials.gov Archive Site
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Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants
Not Provided
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anophthalmos
  • Orbital Implants
Procedure: orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants
  • Active Comparator: 1
    Pegged unpegged hydroxyapatite orbital implantation
    Intervention: Procedure: orbital implant
  • Active Comparator: 2
    Unpegged hydroxyapatite orbital implantation
    Intervention: Procedure: orbital implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
November 2006
October 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • orbital hydroxyapatite implants

Exclusion Criteria:

  • history of systemic disease
  • history of radio therapy
  • secondary hydroxapatite implant
  • complications lead to re-surgery
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00371280
8422
Yes
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Shahid Beheshti University of Medical Sciences
Not Provided
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti University of Medical Sciences
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP