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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138019
• Other study ID #: 200910010M
• Status: Completed
• Phase: N/A
• First received: July 1, 2011
• Last updated: May 13, 2014
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Corneal Ulcer
• Corneal Ulcers
• Pterygium
• Retinal Detachment

Intervention

Procedure:
• Fibrin Glue assisted external eye surgery

Device:
• Fibrin glue

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, department of Ophthalmology	Taipei,

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	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.	12 months	No