Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344201
Status:
COMPLETED
Last Update Posted:
2010-05-12
First Post:
2006-06-23
Brief Title:
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 shorteningsymblepharon conditions Efficacy endpoints will be the ability of fibrin glue to form stable adherence of the conjunctivalAM graft postoperatively and in cases of pterygium the percentage of pterygium recurrence at 6 months following surgery and subjective indications of postoperative comfortdiscomfort Safety data will include the close monitoring of any potential side-effects including graft loss infection paindiscomfort 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 12 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
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 shorteningsymblepharon conditions Efficacy endpoints will be the ability of fibrin glue to form stable adherence of the conjunctivalAM graft postoperatively and in cases of pterygium the percentage of pterygium recurrence at 6 months following surgery and subjective indications of postoperative comfortdiscomfort Safety data will include the close monitoring of any potential side-effects including graft loss infection paindiscomfort 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 12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None