Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Shahid Beheshti Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371280
First received: September 1, 2006
Last updated: May 10, 2010
Last verified: June 2008

September 1, 2006
May 10, 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
Not Provided
Complete list of historical versions of study NCT00371280 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00371280
8422
Yes
Not Provided
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti Medical University
June 2008

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