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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This study has been withdrawn prior to enrollment.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:
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
History of Changes

September 8, 2005
May 28, 2008
April 2005
Not Provided
cure of the diseases [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • cure of the diseases
  • visual acuity
  • side effects
Complete list of historical versions of study NCT00155402 on ClinicalTrials.gov Archive Site
  • 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 ]
integrity of the ocular surface
Not Provided
Not Provided
 
The Application of Fibrin Glue in Ocular Surface Diseases
Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pterygium
  • Corneal Ulcer
Drug: tissue fibrin glue application (Tisseel)
Apply several droplets within several seconds to several minutes
Experimental: 1
Use of fibrin glue after corneal surgery or transplantation
Intervention: Drug: tissue fibrin glue application (Tisseel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
March 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Children younger than 3 years old
Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00155402
940208
No
Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
National Taiwan University Hospital
Not Provided
Principal Investigator: Fung-Rong Hu, MD National Taiwan University Hospital
National Taiwan University Hospital
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP