The Application of Fibrin Glue in Ocular Surface Diseases

Pterygium Clinical Trial

Official title:

Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00155402
• Other study ID #: 940208
• Status: Withdrawn
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: May 28, 2008
• Start date: April 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 30
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Ulcer
• Pterygium

Intervention

Drug:
• tissue fibrin glue application (Tisseel)
Apply several droplets within several seconds to several minutes

Locations

Country	Name	City	State
Taiwan	Wei-Li Chen	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure of the diseases		1week, 2 weeks, 3 weeks, 4 weeks	No
Secondary	integrity of the ocular surface		1week, 2 weeks, 3 weeks, 4 weeks	No
Secondary	visual acuity		1week, 2 weeks, 3 weeks, 4 weeks	No