Efficacy of Autologous Fibrin Glue in Pterygium

February 25, 2022 updated by: Hospital de Clinicas de Porto Alegre

Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials

Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.

OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.

This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

64

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

    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Santa Casa de Misericórdia

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • nasal primary pterygium

Exclusion Criteria:

  • relapsed pterygium
  • patients with a history of previous eye surgery
  • patients with glaucoma using hypotensive eye drops
  • eye surface diseases
  • eye allergy
  • diabetic patients,

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous fibrin glue
Conjunctival graft fixation with autologous fibrin glue
Active Comparator: Sutures
Graft fixation using 10.0 mononylon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pterygium Recurrence
Time Frame: 6 months
Recurrence in 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autograft Retraction
Time Frame: Postoperative day 1, 7, 21 and 30
Graft detachment or retraction
Postoperative day 1, 7, 21 and 30
Postoperative Pain
Time Frame: Postoperative day 1, 7, 21 and 30
Presence Pain measured by a five-point scale, in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities
Postoperative day 1, 7, 21 and 30
Graft Edema
Time Frame: Postoperative day 1, 7, 21 and 30
Graft edema (1-4).
Postoperative day 1, 7, 21 and 30

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Diane Marinho, Hospital de Clínicas de Porto Alegre

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 (Actual)

June 12, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20170467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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