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

Not Applicable

Completed

• Conditions: Pterygium
• Interventions: Procedure: Sutured limbal conjunctival autograft; Procedure: Sutureless and glue free limbal conjunctival autograft

• Registration Number: NCT02009072
• Lead Sponsor: Shaaban Elwan

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2010-10
• Study Completion: 2012-11
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-07
• Study First Posted: 2013-12-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-05
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sutured limbal conjunctival autograft	Sutured limbal conjunctival autograft	Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision
Suturless and glue free Limbal conjuctival autograft	Sutureless and glue free limbal conjunctival autograft	Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision

Primary Outcome Measures

Name	Time	Method
Recurrence Rate	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative signs and symptoms	Third postoperative day,then weekly for one month	The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis.
Overall patient satisfaction	Third post-operative week	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.
Complications	24 months	Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.

Trial Locations

Locations (1)

Shaaban A Elwan; 🇪🇬 Al Minya, Egypt