The Application of Fibrin Glue in Ocular Surface Diseases

This study has been withdrawn prior to enrollment.
(Short of supply of fibrin glue)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155402
First received: September 8, 2005
Last updated: May 28, 2008
Last verified: March 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • integrity of the ocular surface [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • visual acuity [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 8, 2005
Last Updated: May 28, 2008
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Corneal Ulcer
Pterygium
Ulcer
Conjunctival Diseases
Corneal Diseases
Eye Diseases
Eye Infections
Infection
Keratitis
Pathologic Processes
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014