NCT02910362已完成不适用
Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
Intuor Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Eyes With Stable IOP
研究概览
简要总结
This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.
What is known:
- Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment.
- Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations.
- Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •• Age 18 or greater
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- •Subjects able to give informed consent
- •Nuclear Sclerotic cataract graded 2+ or 3+
- •Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
- •Preoperative corneal astigmatism of 2.5 D or less
- •Ages between 55 and 80
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
排除标准
- •• Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- •Intraoperative complications
- •Subjects with only one functional eye
- •Those with one eye having poor or eccentric fixation
- •Mild or severe cataracts, predominantly posterior subcapsular cataracts
- •High corneal astigmatism (i.e. those eyes displaying an oval contact image)
- •Those with corneal scarring or who have had corneal surgery including corneal laser surgery
- •Microphthalmos
- •Buphthalmos
- •Severe Dry eyes
- •Blepharospasm
- •Nystagmus
- •Keratoconus
- •Any other corneal or conjunctival pathology or infection.
- •Central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma or prior ocular surgery
- •Fuchs Dystrophy
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention, including LRI's
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens
研究组 & 干预措施
Alcon phacoemulsification equipment
Experimental
cataract surgery performed with the Alcon phacoemulsification equipment
干预措施: Alcon phacoemulsification equipment (Device)
AMO phacoemulsification equipment
Active Comparator
cataract surgery with the AMO phacoemulsification equipment
干预措施: AMO phacoemulsification equipment (Device)
结局指标
主要结局
Number of Eyes With Stable IOP
时间窗: intraoperative
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
次要结局
未报告次要终点
研究者
研究点 (2)
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