Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery

Pterygium Clinical Trial

Official title:

Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344201
• Other study ID #: R389/47/2004
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2006
• Last updated: May 11, 2010
• Start date: November 2004
• Est. completion date: January 2008

Study information

• Verified date: May 2010
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

Tisseel fibrin adhesive has been used extensively in many forms of surgery. Its use in eye surgery has been relatively recent. A few studies recently showed it was effective in securing conjunctival grafts in pterygium surgery, and in securing wounds after glaucoma and squint surgery.

We sought to confirm its effectiveness in pterygium surgery, as well as prove its effectiveness in securing other material to the ocular surface such as amniotic membrane. Our hypothesis is that fibrin adhesive is effective in securing various types of material to the ocular surface for a sufficient length of time to allow adequate healing before it is absorbed and degraded.

Description:

AIMS OF STUDY:

This project seeks to evaluate the efficacy of fibrin glue (Tisseel) as an alternative to conventional sutures in ocular surface reconstruction, including pterygium excision with conjunctival autografting and other forms of conjunctival and amniotic membrane surgery.

It aims to evaluate the safety and efficacy of fibrin glue in pterygium and other forms of ocular surface conjunctival and amniotic membrane surgery, as an alternative to conventional suturing. We will perform conjunctival autografting in 30 patients with primary or recurrent pterygium, and in addition, up to 20 patients undergoing either conjunctival or amniotic membrane ocular surface reconstruction for a variety of diverse ocular surface disorders including persistent epithelial defects, Stevens Johnson syndrome, chemical and thermal burns and other fornix shortening/symblepharon conditions. Efficacy endpoints will be the ability of fibrin glue to form stable adherence of the conjunctival/AM graft postoperatively, and in cases of pterygium, the percentage of pterygium recurrence at 6 months following surgery, and subjective indications of postoperative comfort/discomfort. Safety data will include the close monitoring of any potential side-effects including graft loss, infection, pain/discomfort, excessive ocular surface inflammation, epithelial breakdown, and any complications resulting in visual loss. Patients will not be charged for the fibrin glue.

If successful, the use of fibrin glue will be a useful adjunct in ocular surface reconstruction, reducing time of surgery and suture-related complications and discomfort. The cost-benefit ratio will need to be examined, but full-paying patients who can afford it may be offered fibrin glue in pterygium surgery as a surgical option.

Study Plan

This will be a non-randomized prospective series of surgical cases of pterygium surgery or ocular surface reconstruction in which the viability and efficacy of fibrin glue in replacing or augmenting sutures will be evaluated.

Patient Numbers and Selection

1. Pterygium cases: Patients will be referred by SNEC doctors to the Corneal Clinic for study counseling and enrolment. Up to 30 cases of either primary or recurrent pterygium requiring pterygium excision with conjunctival autografting will be counseled for study inclusion. The potential benefits and risks of using fibrin glue as opposed to conventional sutures will be explained with full informed consent. All surgery will be performed by the PI.

2. Other ocular surface reconstructions: Up to 20 cases of ocular surface reconstruction from the SNEC Corneal Clinic requiring suturing of conjunctival grafts or AM will be counseled for study inclusion. Significant variations in diagnosis and indications exist for ocular surface transplantation and are too numerous to elucidate, but cases will generally include ocular surface and fornix reconstructions following symblepharon and cicatrizing disorders, chemical and thermal burns, etc. The potential benefits and risks of using fibrin glue as opposed to conventional sutures will be explained with full informed consent. All surgery will be performed by the PI.

All patients will be followed up at 1 day post-operatively, 1 week, 1 month, 3 months and 6 months. Regular slit-lamp anterior segment photography and detailed recording of the status of the grafts will be performed.

Procedures and Data Collection

The patients will be fully informed of the aim and procedures of the study.

The following data will be captured:

1. Visual acuity on standard Snellen chart

2. Pterygium Grading (T1-3)

3. Documentation of pterygium location, primary or recurrent status

4. Slit-lamp photography, pre- and post-surgery

5. subjective assessment of postoperative discomfort

6. Practical benefits anticipated from successfully completed project (1/2 page)

If successful, the use of fibrin glue will be a useful adjunct in ocular surface reconstruction, significantly reducing surgical time, and obviating suture-related complications and discomfort. The cost-benefit ratio will need to be examined, but full-paying patients who can afford it may be offered fibrin glue in pterygium surgery as a surgical option. Up to 3 consecutive cases can be performed with one Tisseel unit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. significant pterygium clinically requiring excision

2. willingness to participate in research project and to attend research clinic

Exclusion Criteria:

1. age < 18 years

2. other concurrent corneal pathology

3. poor acuity due to other ocular pathology

4. poor general health

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ocular Surface Cicatrizing Diseases
• Pterygium

Intervention

Device:
• Tisseel fibrin adhesive
Intraoperative application to scleral bed and graft

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

Biedner B, Rosenthal G. Conjunctival closure in strabismus surgery: Vicryl versus fibrin glue. Ophthalmic Surg Lasers. 1996 Nov;27(11):967. — View Citation

Cohen RA, McDonald MB. Fixation of conjunctival autografts with an organic tissue adhesive. Arch Ophthalmol. 1993 Sep;111(9):1167-8. — View Citation

Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. — View Citation

Schlag G , Redl H. Fibrin Sealant in Operative Medicine. Vol 2.Ophthalmology, neurosurgery. Berlin, Heidelberg: Springer Verlag, 1986.

Tan DT, Chee SP, Dear KB, Lim AS. Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol. 1997 Oct;115(10):1235-40. Erratum in: Arch Ophthalmol 1998 Apr;116(4):552. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft dislocation		3 months	Yes
Primary	Pterygium recurrence		6 months	No
Secondary	Graft dimensions		6 months	No
Secondary	Patient comfort on visual analogue scale		1 month	No
Secondary	Visual acuity		6 months	Yes