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

Not Applicable

• Conditions: Pterygium
• Interventions: Procedure: conjunctival autograft with fibrin glue; Procedure: sutureless and glue-free conjunctival autograft; Procedure: sutured conjunctival autograft

• Registration Number: NCT03301974
• Lead Sponsor: Assiut University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Study Start: 2019-02-24
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients complaining of primary Progressive nasal pterygium.
2. Patients with pterygium threatening the visual axis.

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Exclusion Criteria

1. Double head pterygium.
2. Pseudopterygium
3. Recurrent pterygium
4. Patients with history of any bleeding abnormalities
5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conjunctival autograft with fibrin glue	conjunctival autograft with fibrin glue	Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
sutureless and glue-free conjunctival autograft	sutureless and glue-free conjunctival autograft	Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
sutured conjunctival autograft	sutured conjunctival autograft	Sutured conjunctival autograft done for patients of group 2 after pterygium excision

Primary Outcome Measures

Name	Time	Method
Recurrence Rate	6 months postoperatively	The main postoperative primary outcomes measure the recurrence rate

Secondary Outcome Measures

Name	Time	Method
Postoperative discomfort	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively	postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
Graft stability	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively	postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
Postoperative inflammation	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively	postoperative inflammation rated from grade 0 to 4 using a 5 point scale
Complications	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively	Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Overall patient satisfaction	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively	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.