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临床试验/NCT03298841
NCT03298841已完成不适用

Zeiss Lumera Microscope With Callisto Software

Toyos Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Toyos Clinic
入组人数
50
试验地点
1
主要终点
Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope

研究概览

简要总结

Study design will be a mix of retrospective (older Zeiss microscope previously in use at our surgery center) and prospective data collection with the Lumera and Callisto software.

The Lumera and Callisto software system will be used for all cataract surgeries including toric analyses and lens placement.

详细描述

Needs Assessment

Research on this topic is needed as over 3 million cataract surgeries are performed in the United States each year. The number of surgeries performed is growing as baby boomers age. Reimbursements continue to decline, necessitating ever improving operating and surgical efficiencies in the operating room setting for physicians and small business owners to remain financially viable. New governmental regulations dictate that physician payments will be related to patient satisfaction and outcomes which may be better provided by newer and better surgical technologies.

The Lumera operating microscope and Callisto software system provide several features that may enhance operating room flow including HD video screen and co-observant microscopes that can be independently adjusted to help operating room staff anticipate the needs of the surgeon. Enhanced retroillumination would be expected to translate into fewer complications and more confidence during surgery which could lead to less operating time, phaco energy used and improved visual outcomes. The toric alignment assistance device may lead to more accurate toric placement and improved visual outcomes after surgery.

Target audience would include all cataract surgeons both high and lower volume.

There is currently a dearth of published literature on this technology and its benefits in routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Visually significant cataract

排除标准

  • Not visually significant cataract

结局指标

主要结局

Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope

时间窗: during surgery assessed up to one hour

operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center

次要结局

  • Number of Serious Adverse Events During Intra-operative and Post-operative Period(6 weeks)

研究者

发起方
Toyos Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Toyos

Principal Investigator

Toyos Clinic

研究点 (1)

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