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OpenTrials
Completed

NCT Number: NCT05627947

Comparison Between Topical Mitomycin C and Cyclosporine

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mitomycin C

Drug

Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery

Other names: Cyclosporine

Primary outcomes

  1. Post Operative recurrence of pterygium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2022
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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