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

NCT ID: NCT02009072

Last Updated: 2014-01-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-11-30

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).

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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Sutured limbal conjunctival autograft

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

Group Type EXPERIMENTAL

Sutured limbal conjunctival autograft

Intervention Type PROCEDURE

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).

Suturless and glue free Limbal conjuctival autograft

Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision

Group Type EXPERIMENTAL

Sutureless and glue free limbal conjunctival autograft

Intervention Type PROCEDURE

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)

Interventions

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Sutureless and glue free limbal conjunctival autograft

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)

Intervention Type PROCEDURE

Sutured limbal conjunctival autograft

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).

Intervention Type PROCEDURE

Other Intervention Names

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Sutureless and glue free LCAG Sutured LCAG

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.
Minimum Eligible Age

24 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role collaborator

Shaaban Elwan

OTHER

Sponsor Role lead

Responsible Party

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Shaaban Elwan

Assisstent professor of ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shaaban A Elwan, Assist Prof Ophth

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt

Locations

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Shaaban A Elwan

Al Minyā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Pterygium Surgery

Identifier Type: -

Identifier Source: org_study_id

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