The Application of Fibrin Glue in Ocular Surface Diseases | NCT00155402

Studies
The Application of Fibrin Glue in Ocular Surface Diseases

NCT00155402

Sponsor

National Taiwan University Hospital

Status

Withdrawn

Last Update Posted

May 29, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Pterygium
Corneal Ulcer

Interventions

tissue fibrin glue application (Tisseel)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Short of supply of fibrin glue

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Mar 2008

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2008

Last Update Posted Date

May 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Use of fibrin glue after corneal surgery or transplantation	Drug: tissue fibrin glue application (Tisseel)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tissue fibrin glue application (Tisseel)	Drug	Apply several droplets within several seconds to several minutes	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cure of the diseases		1week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
integrity of the ocular surface		1week, 2 weeks, 3 weeks, 4 weeks
visual acuity		1week, 2 weeks, 3 weeks, 4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fung-Rong Hu, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wei-Li Chen		Dawan		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D011625	Pterygium
D003320	Corneal Ulcer
D057112	Corneal Perforation

Ancestor Terms

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases
D015817	Eye Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015718	Fibrin Tissue Adhesive

Ancestor Terms

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided