Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Medication Rescue
研究概览
简要总结
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
详细描述
Objectives:
To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon
Design:
Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment
Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
- •Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).
排除标准
- •History of ocular surgery including corneal refractive surgery
- •Compromised zonular integrity or stability
- •Uncontrolled diabetes and diabetic retinopathy
- •Small pupils
- •History of systemic inflammatory disease/uveitis
- •History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
- •Abnormal liver or renal function
结局指标
主要结局
Medication Rescue
时间窗: Intraoperative
Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain
次要结局
- Surgeon Experience: Assessment on patient cooperation(Intraoperative)
- Cost- analysis(Intraoperative)
- Physiologic Responses associated with pain/inflammation:(Intraoperative)
- Surgeon Experience: Surgeon intraoperative experience(Intraoperative)
研究者
Matthew Rauen
MD
Wolfe Eye Clinic