A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Study Overview
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Brief Summary
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Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

Detailed Description
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Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital & El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

Official Title
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A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: conjunctival autograft with fibrin glue
* Procedure: sutured conjunctival autograft
* Procedure: sutureless and glue-free conjunctival autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients complaining of primary Progressive nasal pterygium. Patients with pterygium threatening the visual axis. Exclusion Criteria: Double head pterygium. Pseudopterygium Recurrent pterygium Patients with history of any bleeding abnormalities Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conjunctival autograft with fibrin glue<br>Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision | Procedure: conjunctival autograft with fibrin glue<br>* Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).<br>|
| Experimental: sutured conjunctival autograft<br>Sutured conjunctival autograft done for patients of group 2 after pterygium excision | Procedure: sutured conjunctival autograft<br>* Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).<br>|
| Experimental: sutureless and glue-free conjunctival autograft<br>Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision | Procedure: sutureless and glue-free conjunctival autograft<br>* Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate | The main postoperative primary outcomes measure the recurrence rate | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft stability | postoperative Graft stability rated from grade 0 to 4 using a 5 point scale | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | 
| Postoperative inflammation | postoperative inflammation rated from grade 0 to 4 using a 5 point scale | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | 
| Postoperative discomfort | postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS) | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | 
| Overall patient satisfaction | Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction. | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | 
| Complications | Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis. | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively |