Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery
Primary Purpose
Pterygium, Ocular Surface Cicatrizing Diseases
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Tisseel fibrin adhesive
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Fibrin adhesive, Conjunctival graft, Ocular surface reconstruction
Eligibility Criteria
Inclusion Criteria: significant pterygium clinically requiring excision willingness to participate in research project and to attend research clinic Exclusion Criteria: age < 18 years other concurrent corneal pathology poor acuity due to other ocular pathology poor general health
Sites / Locations
- Singapore National Eye Centre
Outcomes
Primary Outcome Measures
Graft dislocation
Pterygium recurrence
Secondary Outcome Measures
Graft dimensions
Patient comfort on visual analogue scale
Visual acuity
Full Information
NCT ID
NCT00344201
First Posted
June 23, 2006
Last Updated
May 11, 2010
Sponsor
Singapore National Eye Centre
Collaborators
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00344201
Brief Title
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery
Official Title
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Singapore National Eye Centre
Collaborators
National University of Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
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.
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:
Visual acuity on standard Snellen chart
Pterygium Grading (T1-3)
Documentation of pterygium location, primary or recurrent status
Slit-lamp photography, pre- and post-surgery
subjective assessment of postoperative discomfort
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Ocular Surface Cicatrizing Diseases
Keywords
Pterygium, Fibrin adhesive, Conjunctival graft, Ocular surface reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Tisseel fibrin adhesive
Intervention Description
Intraoperative application to scleral bed and graft
Primary Outcome Measure Information:
Title
Graft dislocation
Time Frame
3 months
Title
Pterygium recurrence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Graft dimensions
Time Frame
6 months
Title
Patient comfort on visual analogue scale
Time Frame
1 month
Title
Visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
significant pterygium clinically requiring excision
willingness to participate in research project and to attend research clinic
Exclusion Criteria:
age < 18 years
other concurrent corneal pathology
poor acuity due to other ocular pathology
poor general health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald TH Tan, FRCOphth
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong M Por, FRCS
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
9338666
Citation
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. doi: 10.1001/archopht.1997.01100160405001. Erratum In: Arch Ophthalmol 1998 Apr;116(4):552.
Results Reference
background
PubMed Identifier
15205236
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. doi: 10.1136/bjo.2003.032854.
Results Reference
background
PubMed Identifier
8363455
Citation
Cohen RA, McDonald MB. Fixation of conjunctival autografts with an organic tissue adhesive. Arch Ophthalmol. 1993 Sep;111(9):1167-8. doi: 10.1001/archopht.1993.01090090017006. No abstract available.
Results Reference
background
PubMed Identifier
8938809
Citation
Biedner B, Rosenthal G. Conjunctival closure in strabismus surgery: Vicryl versus fibrin glue. Ophthalmic Surg Lasers. 1996 Nov;27(11):967.
Results Reference
background
Citation
Schlag G , Redl H. Fibrin Sealant in Operative Medicine. Vol 2.Ophthalmology, neurosurgery. Berlin, Heidelberg: Springer Verlag, 1986.
Results Reference
background
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Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery
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