PterygiumPhase 2/3NCT00457223
To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
A Phase 2/3 study testing Amniotic membrane transplantation using fibrin glue in people with Pterygium, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Amniotic membrane transplantation using fibrin glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2007to Aug 2007
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary pterygium
Who cannot join
- Pregnant women
- Recurrent pterygium
- Pseudopterygium
- Uncontrolled systemic disease.
- Known allergy to any of the study agents or preservatives used in the formulations.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Ophthalmology, King Chulalongkorn Memorial hospital
Bangkok, 10330
About this study
Official title: Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.
Read the detailed description
There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.
Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.
- Preserve healthy superior conjunctiva for future glaucoma filtering surgery
- Can use in big or 2-headed pterygium
- Not contract as conjunctival graft esp. in case of fibrin glue
- Potential easier to use with fibrin glue
- Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.
- Conditions
- Pterygium
- Being tested
- Amniotic membrane transplantation using fibrin glue
- Keywords
- pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane transplantation using fibrin glueProcedure or surgery
Also called Quixil®, Nylon 10-0
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
| Study group | Role | What they receive |
|---|---|---|
| 1Fibrin glue | Experimental | After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) Receives: Procedure: Amniotic membrane transplantation using fibrin glue |
| 2 Suture | Active comparator | After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0 Receives: Procedure: Amniotic membrane transplantation using fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and discomfort during and after surgery using visual analog scale
Measured: during surgery and after surgery up to 30 days
Secondary outcomes (4)
Surgical time
Measured: start and to the end of surgery
Healing of epithelial defect on cornea and AMT
Measured: until 30 days
Postoperative inflammation
Measured: up to 30 days
Complications e.g. Recurrent, graft loss/dehiscent, re-operation
Measured: until last follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Ngamjit Kasetsuwan, MD, Study chair, Ophthalmology Department, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457223
- Sponsor's protocol ID
- 401/49
- Status last verified
- Feb 2008
- First submitted
- 4 Apr 2007
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
- ClinicalTrials.gov ID
- NCT00457223
- Acronym / sponsor ID
- 401/49
- Conditions
- Pterygium
- Keywords
- pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 6 Apr 2007 (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.
The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.
Detailed description
There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.
Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.
- Preserve healthy superior conjunctiva for future glaucoma filtering surgery
- Can use in big or 2-headed pterygium
- Not contract as conjunctival graft esp. in case of fibrin glue
- Potential easier to use with fibrin glue
- Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Fibrin glue | Experimental | Procedure: Amniotic membrane transplantation using fibrin glueAfter pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) |
| 2 Suture | Active comparator | Procedure: Amniotic membrane transplantation using fibrin glueAfter pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary pterygium
Key exclusion criteria (5 listed)
- Pregnant women
- Recurrent pterygium
- Pseudopterygium
- Uncontrolled systemic disease.
- Known allergy to any of the study agents or preservatives used in the formulations.
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 |
|---|---|---|
| Amniotic membrane transplantation using fibrin glueAlso: Quixil®, Nylon 10-0After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group. | Procedure or surgery | 1Fibrin glue, 2 Suture |
Primary outcome
Pain and discomfort during and after surgery using visual analog scale
Time frame: during surgery and after surgery up to 30 days
4 secondary outcomes
Surgical time
Time frame: start and to the end of surgery
Healing of epithelial defect on cornea and AMT
Time frame: until 30 days
Postoperative inflammation
Time frame: up to 30 days
Complications e.g. Recurrent, graft loss/dehiscent, re-operation
Time frame: until last follow up
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 13 Feb 2008.
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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.
Ngamjit Kasetsuwan, MD study chair
Ophthalmology Department, Faculty of Medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amniotic membrane transplantation using fibrin glue in people with Pterygium, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 5 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 13 Feb 2008. 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 Thailand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain and discomfort during and after surgery using visual analog scale (time frame: during surgery and after surgery up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2008.