A comparative study of efficacy and saftey of topical nonsteriodal anti-inflammatory eye drops in immediate post cataract surgery at a tertiary care hospital.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare by The Sun Working Group Grading Scheme .
研究概览
简要总结
This study is a randomized, double blind, parallel group trail comparing the safety and efficacy of topical Flurbiprofen 0.03% eye drops thrice daily and topical Nepafenac 0.1%, eye drops thrice daily for one week in 80 patients with uncomplicated cataract undergoing phacoemulsification/small incision cataract surgery fulfilling the inclusion/exclusion criteria that will be conducted in one center in India. The primary outcome measures will be Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare after by Sun Working Group Grading Scheme for one week. The secondary outcomes will be Conjunctival redness by conjunctival hyperemia score and lid edema by Lid edema scoring after one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to give written informed consent.
- •2.Patients undergoing uncomplicated cataract surgery.
排除标准
- •1.Surgeries other than phacoemulsification/small incisional cataract surgery.
- •2.Known sensitivity to any of the ingredients in the study medications.
- •3.Patients with preexisting ocular pathology, inflammation, tumor and glaucoma.
- •4.History of previous intraocular surgery, uveitis and iritis or intraocular inflammation in the study eye.
- •5.Use of steroids and Non steroidal inflammatory drugs by systemic route within the 14 days of surgery.
结局指标
主要结局
1.Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare by The Sun Working Group Grading Scheme .
时间窗: one week
次要结局
- Conjunctival redness by conjunctival hyperemia score and lid edema by Lid edema scoring(one week)