To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

February 12, 2008 updated by: Chulalongkorn University

Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.

Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.

  • Preserve healthy superior conjunctiva for future glaucoma filtering surgery
  • Can use in big or 2-headed pterygium
  • Not contract as conjunctival graft esp. in case of fibrin glue
  • Potential easier to use with fibrin glue
  • Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 3

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

  • Thailand
      • Bangkok, Thailand, 10330
        • Department of Ophthalmology, King Chulalongkorn Memorial 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary pterygium

Exclusion Criteria:

  • Pregnant women
  • Recurrent pterygium
  • Pseudopterygium
  • Uncontrolled systemic disease.
  • Known allergy to any of the study agents or preservatives used in the formulations.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1Fibrin glue
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®)
Procedure: Amniotic membrane transplantation using fibrin glue
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
Other Names:
  • Quixil®
  • Nylon 10-0
Active Comparator: 2 Suture
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0
Procedure: Amniotic membrane transplantation using fibrin glue
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
Other Names:
  • Quixil®
  • Nylon 10-0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and discomfort during and after surgery using visual analog scale
Time Frame: during surgery and after surgery up to 30 days
during surgery and after surgery up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical time
Time Frame: start and to the end of surgery
start and to the end of surgery
Healing of epithelial defect on cornea and AMT
Time Frame: until 30 days
until 30 days
Postoperative inflammation
Time Frame: up to 30 days
up to 30 days
Complications e.g. Recurrent, graft loss/dehiscent, re-operation
Time Frame: until last follow up
until last follow up

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Investigators

  • Study Chair: Ngamjit Kasetsuwan, MD, Ophthalmology department, Faculty of medicine, Chulalongkorn university

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

April 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 401/49

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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