Fibrin Glue vs. Suture in Pterygium Surgery

Study Overview
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Brief Summary
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The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.

Detailed Description
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Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%. Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient. Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.

Official Title
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Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft

Conditions
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Conjunctival Autograft

Intervention / Treatment
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* Procedure: Fibrin Glue, Quixil
* Procedure: Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary pterygium healthy subject ability to attend follow-up visits Exclusion Criteria: recurrent pterygium underwent previous surgery / intervention to treat pterygium ocular surface disease 0 minor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Fibrin Glue, surgery<br>Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal | Procedure: Fibrin Glue, Quixil<br>* quixil 0.1 ml<br>|
| Active Comparator: Control<br>Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal | Procedure: Suture<br>* vicryl 10/0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium recurrence | Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | suturing a conjunctival graft takes 15-10 minutes while gluing only 5 minutes, we believe that by lowering OR time, total costs of surgery are less | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pterygium, conjunctival graft, recurrence, primary pterygium