Pterygium
Conditions
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.
Interventions
DRUGMitomycin c
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
Sponsors
Egymedicalpedia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed