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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients with visually significant cataracts
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Toyos, md | Toyos Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyos Clinic | Nashville | Tennessee | 37203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zeiss Group | patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software |
| FG001 | Leica Stativ S3B | patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
sequential series of patients with uncomplicated cataracts undergoing phacoemulsification at one surgery site
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| ID | Title | Description |
|---|---|---|
| BG000 | Zeiss Group | patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software |
| BG001 | Leica Stativ S3B | patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | patients undergoing uncomplicated phacoemulsification by two surgeons at one surgery site | Posted | Mean | Standard Deviation | minutes per surgical procedure | during surgery assessed up to one hour |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zeiss Group | patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Toyos | Toyos Clinic | 6153274015 | mtoyos@toyosclinic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: and Statistical Analysis Plan | Sep 22, 2017 | Oct 16, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2020 | Mar 29, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2017 | Nov 11, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope |
|
|
| Secondary | 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 | patients scheduled for routine cataract surgery with one of two experienced surgeons | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Leica Stativ S3B | patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope | 0 | 25 | 0 | 25 | 0 | 25 |
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