- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301974
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
January 8, 2019 updated by: Mohamed Fathy Ahmed Oraby, Assiut University
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: conjunctival autograft with fibrin glue
Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
|
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
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence Rate
Time Frame: 6 months postoperatively
|
The main postoperative primary outcomes measure the recurrence rate
|
6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft stability
Time Frame: 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
|
1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
|
Postoperative inflammation
Time Frame: 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
|
1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
|
Postoperative discomfort
Time Frame: 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)
|
1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
|
Overall patient satisfaction
Time Frame: 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.
|
1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
|
Complications
Time Frame: 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.
|
1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 24, 2019
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
January 1, 2020
Study Registration Dates
First Submitted
September 27, 2017
First Submitted That Met QC Criteria
September 29, 2017
First Posted (ACTUAL)
October 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17200138
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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