NCT04426240已完成4 期
A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Corneal florescence staining score
研究概览
简要总结
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21+ adult men and women
- •Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract
- •Corneal fluorescein staining score (Oxford) is II or less
- •Preoperative MMP-9 positive
- •Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery.
- •Those who have voluntarily written consent to participate in this clinical trial
- •Exclusion Criteria
- •Those who have used systemic or topical cyclosporine within 4 weeks
- •Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes
- •Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial.
- •Abnormal eyelid function
- •An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status
- •Patients with active eye infections
- •Patients with conflicts with this clinical trial
- •Pregnant and lactating mothers
- •Patients who are determined to be inappropriate by other investigators
排除标准
- 未提供
研究组 & 干预措施
Cyclosporine
Active Comparator
Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery
干预措施: Cyclosporine microemulsion (Drug)
结局指标
主要结局
Corneal florescence staining score
时间窗: 1 month
Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points.
次要结局
- Schirmer test(1 montn)
- tear break-up time(1 month)
研究者
tae-young chung
Professor
Samsung Medical Center
研究点 (1)
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