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NCT Number: NCT02009072

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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

24 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaaban A Elwan

Al Minyā, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sutureless and glue free limbal conjunctival autograft

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)

Other names: Sutureless and glue free LCAG

Sutured limbal conjunctival autograft

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).

Other names: Sutured LCAG

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Operative time

    Time frame: Intraoperative

    Calculation of operative time for each patient procedure

  2. Gain in uncorrected visual acuity (UCVA)

    Time frame: First post-operative month

    Gain in uncorrected visual acuity (UCVA) for each patient from the base line measurement

Sponsors and collaborators

Lead sponsor

Shaaban Elwan

Other

Collaborators

  • Minia University

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Dec 11, 2013
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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