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

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009072
• Other study ID #: Pterygium Surgery
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: January 5, 2014
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

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)
• 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).

Locations

Country	Name	City	State
Egypt	Shaaban A Elwan	Al Minya

Sponsors (2)

Lead Sponsor	Collaborator
Shaaban Elwan	Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Calculation of operative time for each patient procedure	Intraoperative	Yes
Other	Gain in uncorrected visual acuity (UCVA)	Gain in uncorrected visual acuity (UCVA) for each patient from the base line measurement	First post-operative month	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes