Pterygium
Conditions
Brief 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.
Detailed 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).
Interventions
PROCEDUREconjunctival 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).
PROCEDUREsutured 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).
PROCEDUREsutureless 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)
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 6 months postoperatively | The main postoperative primary outcomes measure the recurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft stability | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | postoperative Graft stability rated from grade 0 to 4 using a 5 point scale |
| Postoperative inflammation | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | postoperative inflammation rated from grade 0 to 4 using a 5 point scale |
| Postoperative discomfort | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS) |
| Overall patient satisfaction | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | 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. |
| Complications | 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively | Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis. |
Outcome results
None listed