A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Pterygium Clinical Trial

Official title:

A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03301974
• Other study ID #: 17200138
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 24, 2019
• Est. completion date: January 2020

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

Description:

Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital & El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients complaining of primary Progressive nasal pterygium.

2. Patients with pterygium threatening the visual axis.

Exclusion Criteria:

1. Double head pterygium.

2. Pseudopterygium

3. Recurrent pterygium

4. Patients with history of any bleeding abnormalities

5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• conjunctival autograft with fibrin glue
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).
• sutured conjunctival autograft
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).
• sutureless and glue-free conjunctival autograft
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rate	The main postoperative primary outcomes measure the recurrence rate	6 months postoperatively
Secondary	Graft stability	postoperative Graft stability rated from grade 0 to 4 using a 5 point scale	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Secondary	Postoperative inflammation	postoperative inflammation rated from grade 0 to 4 using a 5 point scale	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Secondary	Postoperative discomfort	postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Secondary	Overall patient satisfaction	Overall satisfaction with the procedure 4 weeks post-operatively will 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 three groups will compared for overall satisfaction.	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Secondary	Complications	Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.	1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively