A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- Aqueous PGE2 Inhibition
研究概览
简要总结
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 18 years of age or older
- •Scheduled for cataract surgery by phacoemulsification
- •Subjects must be willing to comply with all study requirements and be willing to give informed consent
排除标准
- •Any subject that has a history of uveitis or active iritis
- •Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
- •No ocular use of prostaglandins within 2 weeks of surgery
- •Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
- •Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Active ocular infection
研究组 & 干预措施
Xibrom
Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
干预措施: Bromfenac (Drug)
Nevanac
Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
干预措施: nepafenac (Drug)
Acuvail
Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
Aqueous PGE2 Inhibition
时间窗: Day 4 of treatment
A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.
次要结局
未报告次要终点
研究者
Frank A. Bucci, Jr., M.D.
Medical Director
Bucci Laser Vision Institute