Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Prostaglandin E2 levels in the vitreous (pg/mL)
研究概览
简要总结
The purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy.
A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R & D Systems, Minneapolis, MN).
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •patients with pucker scheduled for vitrectomy
排除标准
- •active inflammation
研究组 & 干预措施
Ketorolac eyedrops
Ketorolac 0.5% eyedrops were administered prior to surgery
干预措施: Ketorolac 0.5% eyedrops (Drug)
Indomethacin eyedrops
Indomethacin 0.5% eyedrops were administered prior to surgery
干预措施: Indomethacin 0.5% eyedrops (Drug)
Nepafenac eyedrops
Nepafenac 0.1% eyedrops were administered prior to surgery
干预措施: Nepafenac 0.1% eyedrops (Drug)
Bromfenac eyedrops
Bromfenac 0.09% eyedrops were administered prior to surgery
干预措施: Bromfenac 0.09% eyedrops (Drug)
结局指标
主要结局
Prostaglandin E2 levels in the vitreous (pg/mL)
时间窗: 7 days after NSAID TID administration, following vitrectomy
次要结局
- NSAIDs concentration (ng/mL) into the vitreous(7 days after NSAID TID administration, following vitrectomy)
- Adverse events(7 days after NSAID TID administration, following vitrectomy)
研究者
Andrea Russo
PhD Candidate
Università degli Studi di Brescia