Clinical trial

Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery

Name
OMNEYA HEGAZY
Description
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.
Trial arms
Trial start
2021-01-01
Estimated PCD
2022-06-15
Trial end
2022-06-30
Status
Completed
Phase
Early phase I
Treatment
Mitomycin c
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
Arms:
Cyclosporine Group, artificial eye drops Group, mitomycine-C Group
Other names:
Cyclosporine
Size
57
Primary endpoint
Post Operative recurrence of pterygium
from baseline to 3 months after primary pterygium surgery.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}
Updated at
2023-10-17

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Indication
Pterygium