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

NCT ID: NCT03301974

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-24

Study Completion Date

2020-01-31

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).

Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conjunctival autograft with fibrin glue

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

Group Type EXPERIMENTAL

conjunctival autograft with fibrin glue

Intervention Type PROCEDURE

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 autograft

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

Group Type EXPERIMENTAL

sutured conjunctival autograft

Intervention Type PROCEDURE

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 autograft

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

Group Type EXPERIMENTAL

sutureless and glue-free conjunctival autograft

Intervention Type PROCEDURE

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)

Interventions

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conjunctival autograft with fibrin glue

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).

Intervention Type PROCEDURE

sutured conjunctival autograft

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).

Intervention Type PROCEDURE

sutureless and glue-free conjunctival autograft

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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fathy Ahmed Oraby

Specialist of ophthalmology, El-Mabarah hospital for Health insurance, Assuit, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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17200138

Identifier Type: -

Identifier Source: org_study_id

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