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临床试验/NCT02361645
NCT02361645已完成3 期

Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%

Università degli Studi di Brescia0 个研究点目标入组 70 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Ketorolac 0.5% eyedrops were administered prior to surgery

干预措施: Ketorolac 0.5% eyedrops (Drug)

Indomethacin eyedrops

Experimental

Indomethacin 0.5% eyedrops were administered prior to surgery

干预措施: Indomethacin 0.5% eyedrops (Drug)

Nepafenac eyedrops

Experimental

Nepafenac 0.1% eyedrops were administered prior to surgery

干预措施: Nepafenac 0.1% eyedrops (Drug)

Bromfenac eyedrops

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Russo

PhD Candidate

Università degli Studi di Brescia

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NSAIDs and PGE2 Levels in Vitrectomy Patients | 临床试验