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The Application of Fibrin Glue in Ocular Surface Diseases

This study has been withdrawn prior to enrollment.
(Short of supply of fibrin glue)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00155402
First Posted: September 12, 2005
Last Update Posted: May 29, 2008
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.
Information provided by:
National Taiwan University Hospital
  Purpose
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.

Condition Intervention Phase
Pterygium Corneal Ulcer Drug: tissue fibrin glue application (Tisseel) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • cure of the diseases [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ]

Secondary Outcome Measures:
  • integrity of the ocular surface [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ]
  • visual acuity [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ]

Estimated Enrollment: 30
Study Start Date: April 2005
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1
Use of fibrin glue after corneal surgery or transplantation
Drug: tissue fibrin glue application (Tisseel)
Apply several droplets within several seconds to several minutes

Detailed Description:

This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:

  1. ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
  2. infectious or noninfectious corneal ulcer with perforation less than 3 mm
  3. conjunctival transplantation/suture
  4. corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.

Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ocular surface diseases, which are expected to be treated by tissue fibrin glues

Exclusion Criteria:

  • Pregnancy
  • Children younger than 3 years old
  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): NCT00155402


Locations
Taiwan
Wei-Li Chen
Taiwan, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fung-Rong Hu, MD National Taiwan University Hospital
  More Information

Responsible Party: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00155402     History of Changes
Other Study ID Numbers: 940208
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: May 29, 2008
Last Verified: March 2005

Keywords provided by National Taiwan University Hospital:
fibrin glue
corneal perforation
pterygium
conjunctiva
corneal ulcer

Additional relevant MeSH terms:
Ulcer
Pterygium
Corneal Ulcer
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Eye Infections
Infection
Keratitis
Corneal Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants