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

Assiut University

Status: Unknown

Conditions: Pterygium

Treatments: Procedure: conjunctival autograft with fibrin glue; Procedure: sutureless and glue-free conjunctival autograft; Procedure: sutured conjunctival autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT03301974

17200138

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

conjunctival autograft with fibrin glue

Experimental group

Description:

Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision

Treatment:

Procedure: conjunctival autograft with fibrin glue

sutured conjunctival autograft

Experimental group

Description:

Sutured conjunctival autograft done for patients of group 2 after pterygium excision

Treatment:

Procedure: sutured conjunctival autograft

sutureless and glue-free conjunctival autograft

Experimental group

Description:

Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision

Treatment:

Procedure: sutureless and glue-free conjunctival autograft