Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery

May 11, 2010 updated by: Singapore National Eye Centre

Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction

Tisseel fibrin adhesive has been used extensively in many forms of surgery. Its use in eye surgery has been relatively recent. A few studies recently showed it was effective in securing conjunctival grafts in pterygium surgery, and in securing wounds after glaucoma and squint surgery.

We sought to confirm its effectiveness in pterygium surgery, as well as prove its effectiveness in securing other material to the ocular surface such as amniotic membrane. Our hypothesis is that fibrin adhesive is effective in securing various types of material to the ocular surface for a sufficient length of time to allow adequate healing before it is absorbed and degraded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AIMS OF STUDY:

This project seeks to evaluate the efficacy of fibrin glue (Tisseel) as an alternative to conventional sutures in ocular surface reconstruction, including pterygium excision with conjunctival autografting and other forms of conjunctival and amniotic membrane surgery.

It aims to evaluate the safety and efficacy of fibrin glue in pterygium and other forms of ocular surface conjunctival and amniotic membrane surgery, as an alternative to conventional suturing. We will perform conjunctival autografting in 30 patients with primary or recurrent pterygium, and in addition, up to 20 patients undergoing either conjunctival or amniotic membrane ocular surface reconstruction for a variety of diverse ocular surface disorders including persistent epithelial defects, Stevens Johnson syndrome, chemical and thermal burns and other fornix shortening/symblepharon conditions. Efficacy endpoints will be the ability of fibrin glue to form stable adherence of the conjunctival/AM graft postoperatively, and in cases of pterygium, the percentage of pterygium recurrence at 6 months following surgery, and subjective indications of postoperative comfort/discomfort. Safety data will include the close monitoring of any potential side-effects including graft loss, infection, pain/discomfort, excessive ocular surface inflammation, epithelial breakdown, and any complications resulting in visual loss. Patients will not be charged for the fibrin glue.

If successful, the use of fibrin glue will be a useful adjunct in ocular surface reconstruction, reducing time of surgery and suture-related complications and discomfort. The cost-benefit ratio will need to be examined, but full-paying patients who can afford it may be offered fibrin glue in pterygium surgery as a surgical option.

Study Plan

This will be a non-randomized prospective series of surgical cases of pterygium surgery or ocular surface reconstruction in which the viability and efficacy of fibrin glue in replacing or augmenting sutures will be evaluated.

Patient Numbers and Selection

  1. Pterygium cases: Patients will be referred by SNEC doctors to the Corneal Clinic for study counseling and enrolment. Up to 30 cases of either primary or recurrent pterygium requiring pterygium excision with conjunctival autografting will be counseled for study inclusion. The potential benefits and risks of using fibrin glue as opposed to conventional sutures will be explained with full informed consent. All surgery will be performed by the PI.
  2. Other ocular surface reconstructions: Up to 20 cases of ocular surface reconstruction from the SNEC Corneal Clinic requiring suturing of conjunctival grafts or AM will be counseled for study inclusion. Significant variations in diagnosis and indications exist for ocular surface transplantation and are too numerous to elucidate, but cases will generally include ocular surface and fornix reconstructions following symblepharon and cicatrizing disorders, chemical and thermal burns, etc. The potential benefits and risks of using fibrin glue as opposed to conventional sutures will be explained with full informed consent. All surgery will be performed by the PI.

All patients will be followed up at 1 day post-operatively, 1 week, 1 month, 3 months and 6 months. Regular slit-lamp anterior segment photography and detailed recording of the status of the grafts will be performed.

Procedures and Data Collection

The patients will be fully informed of the aim and procedures of the study.

The following data will be captured:

  1. Visual acuity on standard Snellen chart
  2. Pterygium Grading (T1-3)
  3. Documentation of pterygium location, primary or recurrent status
  4. Slit-lamp photography, pre- and post-surgery
  5. subjective assessment of postoperative discomfort
  6. Practical benefits anticipated from successfully completed project (1/2 page)

If successful, the use of fibrin glue will be a useful adjunct in ocular surface reconstruction, significantly reducing surgical time, and obviating suture-related complications and discomfort. The cost-benefit ratio will need to be examined, but full-paying patients who can afford it may be offered fibrin glue in pterygium surgery as a surgical option. Up to 3 consecutive cases can be performed with one Tisseel unit.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

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

  • Singapore
      • Singapore, Singapore, 168751
        • Singapore National Eye Centre

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. significant pterygium clinically requiring excision
  2. willingness to participate in research project and to attend research clinic

Exclusion Criteria:

  1. age < 18 years
  2. other concurrent corneal pathology
  3. poor acuity due to other ocular pathology
  4. poor general health

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft dislocation
Time Frame: 3 months
3 months
Pterygium recurrence
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months
Graft dimensions
Time Frame: 6 months
6 months
Patient comfort on visual analogue scale
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Singapore National Eye Centre

Collaborators

National University, Singapore

Investigators

  • Principal Investigator: Donald TH Tan, FRCOphth, Singapore Eye Research Institute
  • Principal Investigator: Yong M Por, FRCS, Singapore National Eye Centre

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

November 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 23, 2006

First Posted (Estimate)

June 26, 2006

Study Record Updates

Last Update Posted (Estimate)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 11, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R389/47/2004

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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