Back to resultsComparison Between Topical Mitomycin C and Cyclosporine
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Mitomycin c
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary pterygium Pterygium size > or equal 2mm (the horizontal length of the tissue from limbus to cornea will be measured by slit lamp biomicroscopy). Ocular discomfort refractory to medical treatment. Visual loss induced by pterygium. Adult Egyptian population Exclusion Criteria: Patients who had recurrent pterygium or allergy to topical Cyclosporine. Patients who had allergy from Mitomycin C. Pregnant women. Patients with uncontrollable systemic diseases such as hypertension, diabetes, or cardiovascular diseases. Patients with diseases of the eye surface such as conjunctivitis and keratitis. Patients with a history of eye surgery within the previous six months.
Sites / Locations
- Faculty of Medicine, Menoufia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
mitomycine-C Group
Cyclosporine Group
artificial eye drops Group
Arm Description
This is the First Group and consists of !9 Patients and received 0.02% topical mitomycine C , 4 times per day for five days after the surgery.
This is the Second Group and consists of !9 Patients and received topical 0.05% Cyclosporine, 4 times per day for three months after the surgery.
This is the Third Group and consists of !9 Patients and received artificial eye drops, 4 times per day for three months after the surgery.
Outcomes
Primary Outcome Measures
Post Operative recurrence of pterygium
According to the anterior segment slit lamp examination, grade 0 will be defined as no recurrence; grade 1 will be defined as thin episcleral blood vessels, not accompanied by fibrosis, observed around the excised area; grade 2 will be defined as fibrovascular proliferation limited to the sclera in the area will be excised; grade 3 will be defined as fibrovascular proliferation crossing the corneal limbus. Grades 2 and 3 will be defined as recurrence.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627947
Brief Title
Comparison Between Topical Mitomycin C and Cyclosporine
Official Title
Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pterygium is a disease associated with proliferation of the fibrovascular tissues of the conjunctiva into the cornea and is related to factors such as ultraviolet light exposure, chronic stimulation, inflammation, climate, and genetics.
Detailed Description
The first line of treatment for primary pterygium is surgical excision, and despite postoperative adjuvant therapy using mitomycin C, cyclosporine, β-irradiation, argon laser, and bevacizumab, recurrence rates remain high .
Mitomycin C is a metabolic inhibitor extracted from Streptomyces caespitosus that inhibits DNA synthesis .
Cyclosporine is an immunosuppressant that selectively suppresses T-helper cells, controls interleukin synthesis and secretion, and inhibits vascular endothelial growth factor (VEGF)
Bevacizumab is an anti-VEGF antibody that inhibits angiogenesis. Each agent has been studied as an adjuvant therapy to inhibit post-surgery pterygium recurrence.
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
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mitomycine-C Group
Arm Type
Active Comparator
Arm Description
This is the First Group and consists of !9 Patients and received 0.02% topical mitomycine C , 4 times per day for five days after the surgery.
Arm Title
Cyclosporine Group
Arm Type
Active Comparator
Arm Description
This is the Second Group and consists of !9 Patients and received topical 0.05% Cyclosporine, 4 times per day for three months after the surgery.
Arm Title
artificial eye drops Group
Arm Type
Active Comparator
Arm Description
This is the Third Group and consists of !9 Patients and received artificial eye drops, 4 times per day for three months after the surgery.
Intervention Type
Drug
Intervention Name(s)
Mitomycin c
Other Intervention Name(s)
Cyclosporine
Intervention Description
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
Primary Outcome Measure Information:
Title
Post Operative recurrence of pterygium
Description
According to the anterior segment slit lamp examination, grade 0 will be defined as no recurrence; grade 1 will be defined as thin episcleral blood vessels, not accompanied by fibrosis, observed around the excised area; grade 2 will be defined as fibrovascular proliferation limited to the sclera in the area will be excised; grade 3 will be defined as fibrovascular proliferation crossing the corneal limbus. Grades 2 and 3 will be defined as recurrence.
Time Frame
from baseline to 3 months after primary pterygium surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary pterygium
Pterygium size > or equal 2mm (the horizontal length of the tissue from limbus to cornea will be measured by slit lamp biomicroscopy).
Ocular discomfort refractory to medical treatment.
Visual loss induced by pterygium.
Adult Egyptian population
Exclusion Criteria:
Patients who had recurrent pterygium or allergy to topical Cyclosporine.
Patients who had allergy from Mitomycin C.
Pregnant women.
Patients with uncontrollable systemic diseases such as hypertension, diabetes, or cardiovascular diseases.
Patients with diseases of the eye surface such as conjunctivitis and keratitis.
Patients with a history of eye surgery within the previous six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Zaki, Assist.Prof.
Organizational Affiliation
Department of ophthalmology Faculty of Medicine, Menoufia University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Menoufia University
City
Shibīn Al Kawm
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Topical Mitomycin C and Cyclosporine
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