Pterygium Clinical Trial
Official title:
Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
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 |
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.
Status | Withdrawn |
Enrollment | 30 |
Est. completion date | March 2008 |
Est. primary completion date | |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Wei-Li Chen | Taiwan |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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 |
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