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

N/AUnknownNCT03301974
Assiut University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

60

Conditions

Pterygium

Interventions

conjunctival autograft with fibrin gluePROCEDURE

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).

sutured conjunctival autograftPROCEDURE

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).

sutureless and glue-free conjunctival autograftPROCEDURE

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)

Eligibility

Sex: ALL
Medical Language ↔ Plain English
Inclusion Criteria: 1. Patients complaining of primary Progressive nasal pterygium. 2. Patients with pterygium threatening the visual axis. 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.

Outcomes

Primary Outcomes

Recurrence Rate

The main postoperative primary outcomes measure the recurrence rate

Time frame: 6 months postoperatively

Secondary Outcomes

Graft stability

postoperative Graft stability rated from grade 0 to 4 using a 5 point scale

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

Data from ClinicalTrials.gov

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