Clinical Trial: The Application of Fibrin Glue in Ocular Surface Diseases
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
Brief Summary: 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.
Detailed Summary:
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:
- ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
- infectious or noninfectious corneal ulcer with perforation less than 3 mm
- conjunctival transplantation/suture
- 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.
Sponsor: National Taiwan University Hospital
Current Primary Outcome: cure of the diseases [ Time Frame: 1week, 2 weeks, 3 weeks, 4 weeks ]
Original Primary Outcome:
- cure of the diseases
- visual acuity
- side effects
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: integrity of the ocular surface
Information By: National Taiwan University Hospital
Dates:
Date Received: September 8, 2005
Date Started: April 2005
Date Completion: March 2008
Last Updated: May 28, 2008
Last Verified: March 2005
