Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Vitreous NSAIDs and PGE2 levels
研究概览
简要总结
The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.
All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.
Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.
PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.
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, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •epiretinal membrane or full thickness macular hole scheduled for vitrectomy
排除标准
- •vitreous hemorrhage
- •concurrent retinovascular disease
- •previous ocular inflammation
- •previous ocular surgery
- •history of ocular trauma
- •previuos intravitreal injections
- •concomitant intake of topical or systemic NSAIDs or corticosteroid therapy
研究组 & 干预措施
Placebo
Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
干预措施: Placebo (Other)
Dicloftil
Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
干预措施: Dicloftil (Drug)
Nevanac
Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
干预措施: Nevanac (Drug)
Indom
Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
干预措施: Indom (Drug)
Yellox
Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery
干预措施: Yellox (Drug)
结局指标
主要结局
Vitreous NSAIDs and PGE2 levels
时间窗: 3 days after topical NSAID administration
次要结局
未报告次要终点
研究者
Marco Rocco Pastore
Principal Investigator
University of Trieste