Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

July 29, 2009 updated by: Hospital de Olhos Sadalla Amin Ghanem
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SC
      • Joinville, SC, Brazil, 89201-010
        • Sadalla Amin Ghanem Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary pterygium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Fibrin glue
Procedure: Conjunctival autograft using fibrin glue
Conjunctival autograft using fibrin glue in pterygium surgery
Other Names:
  • Pterygium surgery using fibrin glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of pterygium after its excision with the conjunctival autograft technique.
Time Frame: One, three and five months after surgery.
One, three and five months after surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
One day, one week and one month after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Olhos Sadalla Amin Ghanem

Investigators

  • Principal Investigator: Renan F Oliveira
  • Study Director: Ramon C Ghanem, M.D., Sadalla Amin Ghanem Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (ESTIMATE)

July 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2009

Last Update Submitted That Met QC Criteria

July 29, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cola106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pterygium

Clinical Trials on Conjunctival autograft using fibrin glue

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe