Back to resultsTo Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Amniotic membrane transplantation using fibrin glue
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture
Eligibility Criteria
Inclusion Criteria:
- primary pterygium
Exclusion Criteria:
- Pregnant women
- Recurrent pterygium
- Pseudopterygium
- Uncontrolled systemic disease.
- Known allergy to any of the study agents or preservatives used in the formulations.
Sites / Locations
- Department of Ophthalmology, King Chulalongkorn Memorial hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1Fibrin glue
2 Suture
Arm Description
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®)
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0
Outcomes
Primary Outcome Measures
Pain and discomfort during and after surgery using visual analog scale
Secondary Outcome Measures
Surgical time
Healing of epithelial defect on cornea and AMT
Postoperative inflammation
Complications e.g. Recurrent, graft loss/dehiscent, re-operation
Full Information
NCT ID
NCT00457223
First Posted
April 4, 2007
Last Updated
February 12, 2008
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT00457223
Brief Title
To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Official Title
Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1Fibrin glue
Arm Type
Experimental
Arm Description
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®)
Arm Title
2 Suture
Arm Type
Active Comparator
Arm Description
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0
Intervention Type
Procedure
Intervention Name(s)
Amniotic membrane transplantation using fibrin glue
Other Intervention Name(s)
Quixil®, Nylon 10-0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain and discomfort during and after surgery using visual analog scale
Time Frame
during surgery and after surgery up to 30 days
Secondary Outcome Measure Information:
Title
Surgical time
Time Frame
start and to the end of surgery
Title
Healing of epithelial defect on cornea and AMT
Time Frame
until 30 days
Title
Postoperative inflammation
Time Frame
up to 30 days
Title
Complications e.g. Recurrent, graft loss/dehiscent, re-operation
Time Frame
until last follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary pterygium
Exclusion Criteria:
Pregnant women
Recurrent pterygium
Pseudopterygium
Uncontrolled systemic disease.
Known allergy to any of the study agents or preservatives used in the formulations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngamjit Kasetsuwan, MD
Organizational Affiliation
Ophthalmology Department, Faculty of Medicine, Chulalongkorn University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ophthalmology, King Chulalongkorn Memorial hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
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