Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Post Operative recurrence of pterygium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
mitomycine-C Group
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.
干预措施: Mitomycin c (Drug)
Cyclosporine Group
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.
干预措施: Mitomycin c (Drug)
artificial eye drops Group
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.
干预措施: Mitomycin c (Drug)
结局指标
主要结局
Post Operative recurrence of pterygium
时间窗: 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.
次要结局
未报告次要终点