To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Amniotic membrane transplantation using fibrin glue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1Fibrin glue<br>After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) | Procedure: Amniotic membrane transplantation using fibrin glue<br>* 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.<br>* Other names: Nylon 10-0;|
| Active Comparator: 2 Suture<br>After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0 | Procedure: Amniotic membrane transplantation using fibrin glue<br>* 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.<br>* Other names: Nylon 10-0;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort during and after surgery using visual analog scale |  | during surgery and after surgery up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time |  | start and to the end of surgery | 
| Healing of epithelial defect on cornea and AMT |  | until 30 days | 
| Postoperative inflammation |  | up to 30 days | 
| Complications e.g. Recurrent, graft loss/dehiscent, re-operation |  | until last follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture