The Application of Fibrin Glue in Ocular Surface Diseases

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00155402
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium; Corneal Ulcer	Drug: tissue fibrin glue application (Tisseel)	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2005
• Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. cure of the diseases [1week, 2 weeks, 3 weeks, 4 weeks]

Secondary Outcome Measures

1. integrity of the ocular surface [1week, 2 weeks, 3 weeks, 4 weeks]

2. visual acuity [1week, 2 weeks, 3 weeks, 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Wei-Li Chen	Taiwan		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Fung-Rong Hu, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00155402
• Other Study ID Numbers: 940208
• First Posted: Sep 12, 2005
• Last Update Posted: May 29, 2008
• Last Verified: Mar 1, 2005

• Keywords provided by , ,: fibrin glue; corneal perforation; pterygium; conjunctiva; corneal ulcer
• Additional relevant MeSH terms: Corneal Ulcer; Pterygium; Ulcer; Fibrin Tissue Adhesive

Study Results

No Results Posted as of May 29, 2008