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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344201
First Posted: June 26, 2006
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National University, Singapore
Information provided by:
Singapore National Eye Centre
  Purpose

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.


Condition Intervention Phase
Pterygium Ocular Surface Cicatrizing Diseases Device: Tisseel fibrin adhesive Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Graft dislocation [ Time Frame: 3 months ]
  • Pterygium recurrence [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Graft dimensions [ Time Frame: 6 months ]
  • Patient comfort on visual analogue scale [ Time Frame: 1 month ]
  • Visual acuity [ Time Frame: 6 months ]

Enrollment: 32
Study Start Date: November 2004
Study Completion Date: January 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tisseel fibrin adhesive
    Intraoperative application to scleral bed and graft
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344201


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
National University, Singapore
Investigators
Principal Investigator: Donald TH Tan, FRCOphth Singapore Eye Research Institute
Principal Investigator: Yong M Por, FRCS Singapore National Eye Centre
  More Information

Publications:
Responsible Party: Yong Ming Por, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00344201     History of Changes
Other Study ID Numbers: R389/47/2004
First Submitted: June 23, 2006
First Posted: June 26, 2006
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Singapore National Eye Centre:
Pterygium
Fibrin adhesive
Conjunctival graft
Ocular surface reconstruction

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants