Comparison Between Topical Mitomycin C and Cyclosporine

Pterygium Clinical Trial

Official title:

Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627947
• Other study ID #: OMNEYA HEGAZY
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 30, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pterygium

Intervention

Drug:
• Mitomycin c
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia University	Shibin Al Kawm

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from baseline to 3 months after primary pterygium surgery.