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

Primary Purpose

Corneal Ulcers, Cataract, Pterygium

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fibrin Glue assisted external eye surgery
Fibrin glue
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Ulcers focused on measuring corneal ulcers, conjunctival closure in strabismus surgery, surgery for retinal detachment, cataract surgery, mucous membrane grafting

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Taiwan University Hospital, department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibrin glue

Arm Description

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.

Outcomes

Primary Outcome Measures

pterygium recurrence
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.

Secondary Outcome Measures

Caruncular Morphology in Nasal Pterygia
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.

Full Information

First Posted
July 1, 2011
Last Updated
May 13, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02138019
Brief Title
The Application of Fibrin Glue (Tissucol Duo Quick) in External Eye Surgeries
Official Title
The Application of Fibrin Glue (Tissucol Duo Quick) in External Eye Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcers, Cataract, Pterygium, Retinal Detachment
Keywords
corneal ulcers, conjunctival closure in strabismus surgery, surgery for retinal detachment, cataract surgery, mucous membrane grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin glue
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fibrin Glue assisted external eye surgery
Intervention Type
Device
Intervention Name(s)
Fibrin glue
Primary Outcome Measure Information:
Title
pterygium recurrence
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Caruncular Morphology in Nasal Pterygia
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Chen, MD,PhD
Organizational Affiliation
NTUH
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital, department of Ophthalmology
City
Taipei,
Country
Taiwan

12. IPD Sharing Statement

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

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