Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope
- Conditions
- Cataract
- Registration Number
- NCT03298841
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Visually significant cataract
- Not visually significant cataract
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope 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 Outcome Measures
Name Time Method Number of Serious Adverse Events During Intra-operative and Post-operative Period 6 weeks events that are life or vision threatening, that require hospitalization or permanent disability of any type
Trial Locations
- Locations (1)
Toyos Clinic
🇺🇸Nashville, Tennessee, United States