NCT00155402

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 29, 2008

Status Verified

March 1, 2005

First QC Date

September 8, 2005

Last Update Submit

May 28, 2008

Conditions

PterygiumCorneal Ulcer

Keywords

fibrin gluecorneal perforationpterygiumconjunctivacorneal ulcer

Outcome Measures

Primary Outcomes (1)

  • cure of the diseases

    1week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcomes (2)

  • integrity of the ocular surface

    1week, 2 weeks, 3 weeks, 4 weeks

  • visual acuity

    1week, 2 weeks, 3 weeks, 4 weeks

Study Arms (1)

1

EXPERIMENTAL

Use of fibrin glue after corneal surgery or transplantation

Drug: tissue fibrin glue application (Tisseel)

Interventions

tissue fibrin glue application (Tisseel)DRUG

Apply several droplets within several seconds to several minutes

1

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Children younger than 3 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei-Li Chen

Dawan, 100, Taiwan

Location

MeSH Terms

Conditions

PterygiumCorneal UlcerCorneal Perforation

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesEye InfectionsInfectionsKeratitisCorneal DiseasesCorneal InjuriesEye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Fung-Rong Hu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2005

Study Completion

March 1, 2008

Last Updated

May 29, 2008

Record last verified: 2005-03

Locations

TW(1)