PterygiumPhase 1NCT00344201
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery
A Phase 1 study testing Tisseel fibrin adhesive in people with Pterygium and Ocular Surface Cicatrizing Diseases, run by Singapore National Eye Centre at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium, Ocular Surface Cicatrizing Diseases
- What is being tested?
- Tisseel fibrin adhesive
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2004to Jan 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- significant pterygium clinically requiring excision
- willingness to participate in research project and to attend research clinic
Who cannot join
- age < 18 years
- other concurrent corneal pathology
- poor acuity due to other ocular pathology
- poor general health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction
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.
Read the 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.
- Conditions
- Pterygium, Ocular Surface Cicatrizing Diseases
- Being tested
- Tisseel fibrin adhesive
- Keywords
- Pterygium, Fibrin adhesive, Conjunctival graft, Ocular surface reconstruction
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisseel fibrin adhesiveDevice
Intraoperative application to scleral bed and graft
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft dislocation
Measured: 3 months
Pterygium recurrence
Measured: 6 months
Secondary outcomes (3)
Graft dimensions
Measured: 6 months
Patient comfort on visual analogue scale
Measured: 1 month
Visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startNov 2004
- Primary completionJan 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- National University of Singapore
- Investigators
- Donald TH Tan, FRCOphth, Principal investigator, Singapore Eye Research InstituteYong M Por, FRCS, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344201
- Sponsor's protocol ID
- R389/47/2004
- Status last verified
- May 2010
- First submitted
- 23 Jun 2006
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9338666Koranyi 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.
PubMed 15205236Cohen 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.
PubMed 8363455Biedner B, Rosenthal G. Conjunctival closure in strabismus surgery: Vicryl versus fibrin glue. Ophthalmic Surg Lasers. 1996 Nov;27(11):967.
PubMed 8938809Schlag G , Redl H. Fibrin Sealant in Operative Medicine. Vol 2.Ophthalmology, neurosurgery. Berlin, Heidelberg: Springer Verlag, 1986.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of Ocular Surface Reconstruction
- ClinicalTrials.gov ID
- NCT00344201
- Acronym / sponsor ID
- R389/47/2004
- Conditions
- Pterygium, Ocular Surface Cicatrizing Diseases
- Keywords
- Pterygium, Fibrin adhesive, Conjunctival graft, Ocular surface reconstruction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- National University of Singapore
- Study start
- Nov 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- significant pterygium clinically requiring excision
- willingness to participate in research project and to attend research clinic
Key exclusion criteria (4 listed)
- age < 18 years
- other concurrent corneal pathology
- poor acuity due to other ocular pathology
- poor general health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tisseel fibrin adhesiveIntraoperative application to scleral bed and graft | Device | – |
Primary outcome
Graft dislocation
Time frame: 3 months
Pterygium recurrence
Time frame: 6 months
3 secondary outcomes
Graft dimensions
Time frame: 6 months
Patient comfort on visual analogue scale
Time frame: 1 month
Visual acuity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Background: PubMed 9338666Tan 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.
- Background: PubMed 15205236Koranyi 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.
- Background: PubMed 8363455Cohen 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.
- Background: PubMed 8938809Biedner B, Rosenthal G. Conjunctival closure in strabismus surgery: Vicryl versus fibrin glue. Ophthalmic Surg Lasers. 1996 Nov;27(11):967.
- BackgroundSchlag G , Redl H. Fibrin Sealant in Operative Medicine. Vol 2.Ophthalmology, neurosurgery. Berlin, Heidelberg: Springer Verlag, 1986.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald TH Tan, FRCOphth principal investigator
Singapore Eye Research Institute
Yong M Por, FRCS principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tisseel fibrin adhesive in people with Pterygium and Ocular Surface Cicatrizing Diseases, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft dislocation (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.