A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: conjunctival autograft with fibrin glue Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision |
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).
|
| Experimental: sutured conjunctival autograft Sutured conjunctival autograft done for patients of group 2 after pterygium excision |
Procedure: 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).
|
| Experimental: sutureless and glue-free 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 sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)
|
Outcome Measures
Primary Outcome Measures
- Recurrence Rate [6 months postoperatively]
The main postoperative primary outcomes measure the recurrence rate
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients complaining of primary Progressive nasal pterygium.
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Patients with pterygium threatening the visual axis.
Exclusion Criteria:
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Double head pterygium.
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Pseudopterygium
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Recurrent pterygium
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Patients with history of any bleeding abnormalities
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Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17200138