The Application of Fibrin Glue in Ocular Surface Diseases

Phase 1

Withdrawn

• Conditions: Pterygium; Corneal Ulcer
• Interventions: Drug: tissue fibrin glue application (Tisseel)

• Registration Number: NCT00155402
• Lead Sponsor: National Taiwan University Hospital

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 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.

Study Timeline

• Status Verified: 2005-03
• Study Start: 2005-04
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2008-03
• Last Update Submitted: 2008-05-28
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Children younger than 3 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	tissue fibrin glue application (Tisseel)	Use of fibrin glue after corneal surgery or transplantation

Primary Outcome Measures

Name	Time	Method
cure of the diseases	1week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcome Measures

Name	Time	Method
integrity of the ocular surface	1week, 2 weeks, 3 weeks, 4 weeks
visual acuity	1week, 2 weeks, 3 weeks, 4 weeks

Trial Locations

Locations (1)

Wei-Li Chen; 🇨🇳 Taiwan, Taiwan