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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00155402
Other study ID # 940208
Secondary ID
Status Withdrawn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Status Withdrawn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
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

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


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
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