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

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00344201
First received: June 23, 2006
Last updated: May 11, 2010
Last verified: May 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Pterygium recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft dimensions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient comfort on visual analogue scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 23, 2006
Last Updated: May 11, 2010
Health Authority: Singapore: Health Sciences Authority

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014