Comparison Between Topical Mitomycin C and Cyclosporine

Phase 1

Completed

• Conditions: Pterygium
• Interventions: Drug: Mitomycin c

• Registration Number: NCT05627947
• Lead Sponsor: Egymedicalpedia

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-30
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-14
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mitomycine-C Group	Mitomycin c	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.
Cyclosporine Group	Mitomycin c	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.
artificial eye drops Group	Mitomycin c	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.

Primary Outcome Measures

Name	Time	Method
Post Operative recurrence of pterygium	from baseline to 3 months after primary pterygium surgery.	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.

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Shibīn Al Kawm, Egypt