Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope
Zeiss Lumera Microscope With Callisto Software
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 2, 2017
CompletedResults Posted
Study results publicly available
April 22, 2021
CompletedApril 22, 2021
April 1, 2021
7 months
September 22, 2017
January 11, 2018
April 21, 2021
Conditions
Outcome Measures
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
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
during surgery assessed up to one hour
Secondary Outcomes (1)
Number of Serious Adverse Events During Intra-operative and Post-operative Period
6 weeks
Interventions
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
Eligibility Criteria
100 patients with visually significant cataracts
You may qualify if:
- Visually significant cataract
You may not qualify if:
- Not visually significant cataract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Toyos Cliniclead
Study Sites (1)
Toyos Clinic
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melissa Toyos
- Organization
- Toyos Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Toyos, md
Toyos Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 22, 2017
First Posted
October 2, 2017
Study Start
March 1, 2017
Primary Completion
September 20, 2017
Study Completion
September 20, 2017
Last Updated
April 22, 2021
Results First Posted
April 22, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share