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

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ClinicalTrials.gov Identifier: NCT03298841
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Melissa Toyos, Toyos Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment
Cataract Device: Zeiss

Detailed Description:

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


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Zeiss Lumera Microscope With Callisto Software
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract


Intervention Details:
  • Device: Zeiss

    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 Outcome Measures :
  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: 6 months ]
    operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope


Secondary Outcome Measures :
  1. accuracy of toric outcomes [ Time Frame: 6 months ]
    will analyze accuracy of predicted versus observed astigmatism correction with toric lenses implanted during cataract surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 patients with visually significant cataracts
Criteria

Inclusion Criteria:

  • Visually significant cataract

Exclusion Criteria:

  • Not visually significant cataract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298841


Locations
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United States, Tennessee
Toyos Clinic
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Toyos Clinic
  Study Documents (Full-Text)

Documents provided by Melissa Toyos, Toyos Clinic:
Study Protocol  [PDF] September 20, 2017


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Responsible Party: Melissa Toyos, Principal Investigator, Toyos Clinic
ClinicalTrials.gov Identifier: NCT03298841     History of Changes
Other Study ID Numbers: ZEISS-2017-003
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases