An interventional study of conjunctival autograft with fibrin glue and sutured conjunctival autograft in Pterygium, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
Procedure: conjunctival autograft with fibrin glue
Sutured conjunctival autograft done for patients of group 2 after pterygium excision
Procedure: sutured conjunctival autograft
Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
Procedure: sutureless and glue-free conjunctival autograft
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).
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).
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)
Recurrence Rate
The main postoperative primary outcomes measure the recurrence rate
Time frame: 6 months postoperatively
Graft stability
postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative inflammation
postoperative inflammation rated from grade 0 to 4 using a 5 point scale
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative discomfort
postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
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.
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Complications
Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
No study locations are listed for this record.
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Assiut University