The Application of Fibrin Glue (Tissucol Duo Quick) in External Eye Surgeries

May 13, 2014 updated by: National Taiwan University Hospital
The fibrin sealants are prepared from fibrinogen, thrombin, and sometimes factor XIII that have been purified from human plasma. Tissucol Duo Quick (Baxter, Vienna, Austria) is a kind of fibrin sealants with popular use. It is a 2-component tissue adhesive that resembles natural fibrin formation. This glue has 2 components: fibrinogen (mixed with factor XIII and aprotinin) and thrombin-CaCl2 solution. When equal amounts of the 2 components are mixed, the monomers aggregate by cross-linking, resulting in a fibrin clot. It forms a elastic, whitish substance and provides strong adhesion to the tissue. Therefore, it is a good agent to seal small wounds or to replace the use of suture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Biologic adhesives have been used in medicine for many years. It has been applied to numerous surgical fields. As for the ophthalmic field, The use of organic glues has provided good results for the repair of leaking blebs and perforated corneal ulcers, conjunctival closure in strabismus surgery, surgery for retinal detachment, cataract surgery, trabeculectomy, and mucous membrane grafting to repair lesions of the conjunctival fornix. The fibrin sealants are prepared from fibrinogen, thrombin, and sometimes factor XIII that have been purified from human plasma. Tissucol Duo Quick (Baxter, Vienna, Austria)is a kind of fibrin sealants with popular use. It is a 2-component tissue adhesive that resembles natural fibrin formation. This glue has 2 components: fibrinogen (mixed with factor XIII and aprotinin) and thrombin-Calcium Chloride solution. When equal amounts of the 2 components are mixed, the monomers aggregate by cross-linking, resulting in a fibrin clot. It forms a elastic, whitish substance and provides strong adhesion to the tissue. Therefore, it is a good agent to seal small wounds or to replace the use of suture.

Pterygium is a triangular-shaped growth of abnormal conjunctival tissue that extends horizontally from the bulbar conjunctiva, across the limbus, and onto the cornea. Surgical removal is still the treatment of choice. Over the years, various treatment strategies such as simple excision with or without adjunctive measures (eg, postoperative [beta]-irradiation, intraoperative, and/or postoperative mitomycin C) and various techniques of conjunctival grafting have been tried to decrease recurrence after surgery. Conjunctival autograft and amniotic membrane transplantation are commonly used methods. However, they are time-consuming techniques because the graft must be fixed, usually by sutures. Tissue adhesives provide alternative ways for attaching conjunctival grafts and may shorten operating time, diminish postoperative discomfort, and remove suture-related complications. Using tissue adhesive instead of sutures results in shorter operation time. It has been reported by several studies. Furthermore, it seems also contributed to lower recurrence rate. National Taiwan University Hospital (NTUH), as one of the largest tertiary medical centers in Taiwan, is now in charge of a big part of difficult cases of ocular surface, including the refractory pterygium. With the previous experiences reported, the investigators are competent for this meaningful program to evaluate the effect and benefit of fibrin adhesives in external eye disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei,, Taiwan
        • National Taiwan University Hospital, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • It has been applied to numerous surgical fields.
  • As for the ophthalmic field, The use of organic glues has provided good results for the repair of leaking blebs and perforated corneal ulcers, conjunctival closure in strabismus surgery, surgery for retinal detachment, cataract surgery,trabeculectomy,and mucous membrane grafting to repair lesions of the conjunctival fornix.

Exclusion Criteria:

  • age: under 12 years and above 85 years
  • cognitive impairment
  • rejection from patients
  • over size corneal ulcer (over 3mm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fibrin glue
In ophthalmic field, the use of organic glues has provided good results for the repair of leaking blebs and perforated corneal ulcers, conjunctival closure in strabismus surgery, surgery for retinal detachment, cataract surgery, trabeculectomy, and mucous membrane grafting to repair lesions of the conjunctival fornix. In this study, the investigators try to evaluate the effect of Fibrin Glue assisted external eye surgery.
Procedure: Fibrin Glue assisted external eye surgery
Device: Fibrin glue

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pterygium recurrence
Time Frame: 12 months
The grading system of postoperative recurrence of pterygium is as the follows: grade 1 with normal appearance of the operated site; grade 2 with the presence of fine episcleral vessels extending to the limbus, but no fibrous tissue; grade 3 with fibrovascular tissue in the excised area, reaching to the limbus but not invading the cornea; grade 4 with a true corneal recurrence, with fibrovascular tissue invading the cornea and across the limbus.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caruncular Morphology in Nasal Pterygia
Time Frame: 12 months
A grading scale of 1 to 4 for the caruncle morphological characteristics was designed. Grade 1 with a normal appearance; grade 2 with synechia of conjunctival wound edge to the amniotic membrane covered area without change of caruncle location; grade 3 with thickened conjunctival wound edge without change of caruncular morphology; grade 4 with synechia of conjunctival wound edge to the amniotic membrane covered area with anterior advancement of caruncle location less than 3mm; grade 5 with synechia of conjunctival wound edge to the amniotic membrane covered area with anterior advancement of caruncle location more than 3mm.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wei-Li Chen, MD,PhD, NTUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200910010M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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