An observational study in Cataract, sponsored by Toyos Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Toyos Clinic · Observational
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.
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
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 50 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
100 patients with visually significant cataracts
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Time frame: during surgery assessed up to one hour
Number of Serious Adverse Events During Intra-operative and Post-operative Period
events that are life or vision threatening, that require hospitalization or permanent disability of any type
Time frame: 6 weeks
| Milestone | Zeiss Group | Leica Stativ S3B |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
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
| minutes per surgical procedure | Zeiss Group | Leica Stativ S3B |
|---|---|---|
| Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope | 11.15 ± 2.42 | 14.18 ± 8.67 |
events that are life or vision threatening, that require hospitalization or permanent disability of any type
| Participants | Cataract Surgery Patients |
|---|---|
| Number of Serious Adverse Events During Intra-operative and Post-operative Period | 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zeiss Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Leica Stativ S3B | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
sequential series of patients with uncomplicated cataracts undergoing phacoemulsification at one surgery site
| Age, Categorical(Participants) | Zeiss Group | Leica Stativ S3B | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 23 | 45 |
| >=65 years | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | Zeiss Group | Leica Stativ S3B | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 10 | 9 | 19 |
| Race and Ethnicity Not Collected(Participants) | Zeiss Group | Leica Stativ S3B | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Zeiss Group | Leica Stativ S3B | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Toyos Clinic