Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery

Study Overview
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Brief Summary
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Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.

Detailed Description
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Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt. Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).

Official Title
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Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Sutureless and glue free limbal conjunctival autograft
* Procedure: Sutured limbal conjunctival autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis. Exclusion Criteria: All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 74 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sutured limbal conjunctival autograft<br>Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision | Procedure: Sutured limbal conjunctival autograft<br>* Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).<br>* Other names: Sutured LCAG;|
| Experimental: Suturless and glue free Limbal conjuctival autograft<br>Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision | Procedure: Sutureless and glue free limbal conjunctival autograft<br>* Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1)<br>* Other names: Sutureless and glue free LCAG;|

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 which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative signs and symptoms | The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis. | Third postoperative day,then weekly for one month | 
| Overall patient satisfaction | Overall satisfaction with the procedure 3 weeks post-operatively was 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 two groups were compared for overall satisfaction. | Third post-operative week | 
| Complications | Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.