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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Shaaban Elwan

Current Primary Outcome: Recurrence Rate [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Minia University

Dates:
Date Received: December 2, 2013
Date Started: April 2010
Date Completion:
Last Updated: January 5, 2014
Last Verified: January 2014