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The Application of Fibrin Glue in Ocular Surface Diseases

NCT ID: NCT00155402

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Pterygium Corneal Ulcer

Keywords

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fibrin glue corneal perforation pterygium conjunctiva corneal ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Use of fibrin glue after corneal surgery or transplantation

Group Type EXPERIMENTAL

tissue fibrin glue application (Tisseel)

Intervention Type DRUG

Apply several droplets within several seconds to several minutes

Interventions

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tissue fibrin glue application (Tisseel)

Apply several droplets within several seconds to several minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ocular surface diseases, which are expected to be treated by tissue fibrin glues

Exclusion Criteria

* Pregnancy
* Children younger than 3 years old
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University, Department of Ophthalmology

Principal Investigators

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Fung-Rong Hu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Wei-Li Chen

Dawan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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940208

Identifier Type: -

Identifier Source: org_study_id