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OpenTrials
Completed

NCT Number: NCT03298841

Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toyos Clinic

Nashville, Tennessee, 37203, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Visually significant cataract

Exclusion criteria

  • Not visually significant cataract

Treatment and study plan

Zeiss

Device

This study proposal will highlight the advanced technology features of the Zeiss Lumera surgical operating microscope which include but are not limited to:

Stereo Coaxial Illumination for improved visualization High resolution video screen/co-observation tool to help OR staff anticipate next steps Integrated toric alignment tool Surgical microscope touch screen Cordless foot control for faster turnover between cases

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Number of Serious Adverse Events During Intra-operative and Post-operative Period

    Time frame: 6 weeks

    events that are life or vision threatening, that require hospitalization or permanent disability of any type

Sponsors and collaborators

Lead sponsor

Toyos Clinic

Other

Registry information

Official study title

Zeiss Lumera Microscope With Callisto Software

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2017
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.