Cataract
Conditions
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
Interventions
DEVICEZeiss
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
Sponsors
Toyos Clinic
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Visually significant cataract
Exclusion criteria
* Not visually significant cataract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zeiss Group patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software | 25 |
| Leica Stativ S3B patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Zeiss Group | Leica Stativ S3B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: during surgery assessed up to one hour
Population: patients undergoing uncomplicated phacoemulsification by two surgeons at one surgery site
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zeiss Group | 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 minutes per surgical procedure | Standard Deviation 2.42 |
| 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 | 14.18 minutes per surgical procedure | Standard Deviation 8.67 |
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
Time frame: 6 weeks
Population: patients scheduled for routine cataract surgery with one of two experienced surgeons
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zeiss Group | Number of Serious Adverse Events During Intra-operative and Post-operative Period | 0 Participants |