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

NCT02138019 | Completed DMC

• 1 other identifier: 200910010M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Ulcers; Cataract; Pterygium; Retinal Detachment

Keywords

corneal ulcers; conjunctival closure in strabismus surgery; surgery for retinal detachment; cataract surgery; mucous membrane grafting

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Caruncular Morphology in Nasal Pterygia

  12 months

Study Arms (1)

Fibrin glue

EXPERIMENTAL

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

Interventions

Fibrin Glue assisted external eye surgery PROCEDURE

Fibrin glue

Fibrin glue DEVICE

Fibrin glue

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Corneal Ulcer; Cataract; Pterygium; Retinal Detachment

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases; Lens Diseases; Conjunctival Diseases; Retinal Diseases

Study Officials

• Wei-Li Chen, MD,PhD

  NTUH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: May 14, 2014
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

TW (1)