A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Primary Purpose
Pterygium
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conjunctival autograft with fibrin glue
sutured conjunctival autograft
sutureless and glue-free conjunctival autograft
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- Patients complaining of primary Progressive nasal pterygium.
- Patients with pterygium threatening the visual axis.
Exclusion Criteria:
- Double head pterygium.
- Pseudopterygium
- Recurrent pterygium
- Patients with history of any bleeding abnormalities
- Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
conjunctival autograft with fibrin glue
sutured conjunctival autograft
sutureless and glue-free conjunctival autograft
Arm Description
Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
Sutured conjunctival autograft done for patients of group 2 after pterygium excision
Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
Outcomes
Primary Outcome Measures
Recurrence Rate
The main postoperative primary outcomes measure the recurrence rate
Secondary Outcome Measures
Graft stability
postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
Postoperative inflammation
postoperative inflammation rated from grade 0 to 4 using a 5 point scale
Postoperative discomfort
postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
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.
Complications
Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03301974
Brief Title
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Official Title
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conjunctival autograft with fibrin glue
Arm Type
Experimental
Arm Description
Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
Arm Title
sutured conjunctival autograft
Arm Type
Experimental
Arm Description
Sutured conjunctival autograft done for patients of group 2 after pterygium excision
Arm Title
sutureless and glue-free conjunctival autograft
Arm Type
Experimental
Arm Description
Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
Intervention Type
Procedure
Intervention Name(s)
conjunctival autograft with fibrin glue
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
sutured conjunctival autograft
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
sutureless and glue-free conjunctival autograft
Intervention Description
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)
Primary Outcome Measure Information:
Title
Recurrence Rate
Description
The main postoperative primary outcomes measure the recurrence rate
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Graft stability
Description
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
Title
Postoperative inflammation
Description
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
Title
Postoperative discomfort
Description
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
Title
Overall patient satisfaction
Description
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
Title
Complications
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients complaining of primary Progressive nasal pterygium.
Patients with pterygium threatening the visual axis.
Exclusion Criteria:
Double head pterygium.
Pseudopterygium
Recurrent pterygium
Patients with history of any bleeding abnormalities
Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
12. IPD Sharing Statement
Learn more about this trial
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
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