The Application of Fibrin Glue in Ocular Surface Diseases
Primary Purpose
Pterygium, Corneal Ulcer
Status
Withdrawn
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
tissue fibrin glue application (Tisseel)
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring fibrin glue, corneal perforation, pterygium, conjunctiva, corneal ulcer
Eligibility Criteria
Inclusion Criteria: Ocular surface diseases, which are expected to be treated by tissue fibrin glues Exclusion Criteria: Pregnancy Children younger than 3 years old
Sites / Locations
- Wei-Li Chen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Use of fibrin glue after corneal surgery or transplantation
Outcomes
Primary Outcome Measures
cure of the diseases
Secondary Outcome Measures
integrity of the ocular surface
visual acuity
Full Information
NCT ID
NCT00155402
First Posted
September 8, 2005
Last Updated
May 28, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155402
Brief Title
The Application of Fibrin Glue in Ocular Surface Diseases
Official Title
Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Withdrawn
Why Stopped
Short of supply of fibrin glue
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Corneal Ulcer
Keywords
fibrin glue, corneal perforation, pterygium, conjunctiva, corneal ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Use of fibrin glue after corneal surgery or transplantation
Intervention Type
Drug
Intervention Name(s)
tissue fibrin glue application (Tisseel)
Intervention Description
Apply several droplets within several seconds to several minutes
Primary Outcome Measure Information:
Title
cure of the diseases
Time Frame
1week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
integrity of the ocular surface
Time Frame
1week, 2 weeks, 3 weeks, 4 weeks
Title
visual acuity
Time Frame
1week, 2 weeks, 3 weeks, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular surface diseases, which are expected to be treated by tissue fibrin glues
Exclusion Criteria:
Pregnancy
Children younger than 3 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fung-Rong Hu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wei-Li Chen
City
Taiwan
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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The Application of Fibrin Glue in Ocular Surface Diseases
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