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Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

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ClinicalTrials.gov Identifier: NCT00371280
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 4, 2006
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Anophthalmos Orbital Implants Procedure: orbital implant Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2005
Estimated Primary Completion Date : October 2006
Estimated Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Durapatite

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Changing movement in up gaze: 0.58 mm
  2. Changing movement in down gaze: 0.83 mm
  3. Changing movement in medial gaze: 0.75 mm
  4. Changing movement in lateral gaze: 1.2 mm


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

ClinicalTrials.gov Identifier: NCT00371280     History of Changes
Other Study ID Numbers: 8422
First Posted: September 4, 2006    Key Record Dates
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