Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

This study has been completed.
Sponsor:
Information provided by:
Hospital de Olhos Sadalla Amin Ghanem
ClinicalTrials.gov Identifier:
NCT00949728
First received: July 17, 2009
Last updated: July 29, 2009
Last verified: July 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary pterygium
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 17, 2009
Last Updated: July 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014