The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Rescue Medication
研究概览
简要总结
The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
详细描述
Objective/ Unmet Medical Need:
To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.
Design:
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.
STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.
- •Inclusion Criteria:
- •Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes
- •Unremarkable ocular health but inclusive of early AMD
排除标准
- •H/o ocular surgery including corneal refractive surgery
- •Compromised zonular integrity or stability
- •Uncontrolled diabetes and diabetic retinopathy
- •Small pupils
- •H/o systemic inflammatory disease/uveitis
- •H/o chronic pain medications (including narcotics) and benzodiazepine usage
- •Abnormal liver or renal function
研究组 & 干预措施
Centurion with Active Sentry at a traditionally high IOP setting
Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.
干预措施: High IOP Setting (Device)
Unity VCS/CS with Intelligent Fluidics at a low IOP setting
Unity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.
干预措施: Low IOP Setting (Device)
结局指标
主要结局
Rescue Medication
时间窗: During cataract surgery
Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain
Rescue Medication
时间窗: During cataract surgery
Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain
次要结局
- VAS Pain Score(During Phaco, I/A, and Visco Removal)
- Surgeon Intraoperative Experience(During cataract surgery)
- Cost Analysis(During cataract surgery)
- Breakthrough pain and discomfort High Axial Length(During cataract surgery)
- 1 day Post Op Patient Survey(1 day post op cataract surgery, each eye)
- Anesthesiologist Review Blood Pressure(During cataract surgery)
- Anesthesiologist Review Pulse Rate(During cataract surgery)
研究者
Matthew Rauen
Principal Investigator
Wolfe Eye Clinic