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Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949728
First Posted: July 30, 2009
Last Update Posted: July 30, 2009
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:
Hospital de Olhos Sadalla Amin Ghanem
  Purpose
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium

Condition Intervention
Pterygium Primary Procedure: Conjunctival autograft using fibrin glue

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Further study details as provided by Hospital de Olhos Sadalla Amin Ghanem:

Primary Outcome Measures:
  • Recurrence of pterygium after its excision with the conjunctival autograft technique. [ Time Frame: One, three and five months after surgery. ]

Secondary Outcome Measures:
  • Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure. [ Time Frame: One day, one week and one month after surgery. ]

Enrollment: 151
Study Start Date: October 2006
Study Completion Date: July 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fibrin glue Procedure: Conjunctival autograft using fibrin glue
Conjunctival autograft using fibrin glue in pterygium surgery
Other Name: Pterygium surgery using fibrin glue

  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:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of primary pterygium
  • Symptomatic pterygium
  • Limbal invasion

Exclusion Criteria:

  • Secondary pterygium
  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): NCT00949728


Locations
Brazil
Sadalla Amin Ghanem Eye Hospital
Joinville, SC, Brazil, 89201-010
Sponsors and Collaborators
Hospital de Olhos Sadalla Amin Ghanem
Investigators
Principal Investigator: Renan F Oliveira
Study Director: Ramon C Ghanem, M.D. Sadalla Amin Ghanem Eye Hospital
  More Information

Publications:
Responsible Party: Ramon Coral Ghanem, Sadalla Amin Ghanem Eye Hospital
ClinicalTrials.gov Identifier: NCT00949728     History of Changes
Other Study ID Numbers: cola106
First Submitted: July 17, 2009
First Posted: July 30, 2009
Last Update Posted: July 30, 2009
Last Verified: July 2009

Keywords provided by Hospital de Olhos Sadalla Amin Ghanem:
Pterygium
Autologous Transplantation
Conjunctiva
Fibrin Tissue Adhesive
Recurrence

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants