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

History of Changes

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

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

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:

Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4.

Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405.

Marticorena J, Rodríguez-Ares MT, Touriño R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6.

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 May 23, 2013

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