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

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.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Sutured limbal conjunctival autograft; Procedure: Sutureless and glue free limbal conjunctival autograft

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Minya, Egypt
    • Shaaban A Elwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sutured limbal conjunctival autograft; Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision	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).; Other Names: Sutured LCAG
Experimental: Suturless and glue free Limbal conjuctival autograft; Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision	Procedure: 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); Other Names: Sutureless and glue free LCAG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Rate	The main postoperative primary outcomes measure the recurrence rate which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative signs and symptoms	The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis.	Third postoperative day,then weekly for one month
Overall patient satisfaction	Overall satisfaction with the procedure 3 weeks post-operatively was 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 two groups were compared for overall satisfaction.	Third post-operative week
Complications	Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Calculation of operative time for each patient procedure	Intraoperative
Gain in uncorrected visual acuity (UCVA)	Gain in uncorrected visual acuity (UCVA) for each patient from the base line measurement	First post-operative month

Collaborators and Investigators

• Sponsor: Shaaban Elwan
• Collaborators: Minia University
• Investigators: Principal Investigator: Shaaban A Elwan, Assist Prof Ophth, Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 7, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): January 7, 2014
• Last Update Submitted That Met QC Criteria: January 5, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Pterygium surgery; Sutureless glue free conjunctival autograft; Amniotic membrane graft.
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• Other Study ID Numbers: pterygium surgery