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

Not Applicable

Completed

• Conditions: Cataract; Corneal Ulcers; Pterygium; Retinal Detachment
• Interventions: Procedure: Fibrin Glue assisted external eye surgery; Device: Fibrin glue

• Registration Number: NCT02138019
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-07-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Study First Posted: 2014-05-14
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibrin glue	Fibrin Glue assisted external eye surgery	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.
Fibrin glue	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.

Primary Outcome Measures

Name	Time	Method
pterygium recurrence	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.

Secondary Outcome Measures

Name	Time	Method
Caruncular Morphology in Nasal Pterygia	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.

Trial Locations

Locations (1)

National Taiwan University Hospital, department of Ophthalmology; 🇨🇳 Taipei,, Taiwan