CataractCORTCONCT06216067
Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR
An observational study of Cataract, run by Chesapeake Eyecare and Laser Center, LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism. Read more about this study
- Who is it for?
- Ages 55 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- CALLISTO eye and Wavetec AnalyzOR
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 21 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 87 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing unilateral or bilateral cataract extraction
Who may be able to join
- Unilateral or bilateral cataract extraction with single piece hydrophobic acrylic posterior capsular intraocular lens correcting astigmatism.
- Clear intraocular media other than cataract.
- Willing and able to complete all required postoperative visits.
- Able to comprehend and sign a statement of informed consent in English.
Who cannot join
- Ocular disease or pathology that, in the opinion of the Investigator, will affect the post-operative visual acuity and manifest refraction.
- Prior intraocular or corneal refractive surgery, corneal transplant, or retinal detachment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chesapeake Eye Care and Laser Center, LLC
Annapolis, Maryland, 21401
About this study
Official title: Comparison of Operating Room Toric Placement Tools, CALLISTO Eye vs. Wavetec AnalyzOR (CORTCO)
The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism.
The main question it aims to answer is:
Read more
Show the refractive predictability comparing the use of Operating Room cataract toric lens placement tools against the standard manual technique.
Participants will be implanted with the TECNIS Toric II IOL Lens Model ZCU; the second eye, if applicable, is to be implanted within 45 days of the first-eye surgery.
Researchers will compare two Operating Room cataract lens placement tools: the Zeiss CALLISTO vs. the Wavetec AnalyzOR to determine refractive predictability.
Read the detailed description
To evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism (maximum allowable up to 3.0D) comparing the ZEISS CALLISTO eye and the Wavetec AnalyzOR at the one-month post-operative visit. Both surgery rooms will be using Veracity, IOL Master and Zeiss Opmi Lumera i Operating Room Microscopes. Operating Room #1 will be utilizing the ZEISS CALLISTO eye for axis alignment, along with Veracity and IOL Master for lens selection, and Operating Room #2 will be utilizing the Wavetec AnalyzOR for lens selection and axis alignment. Procedure times for the ZEISS CALLISTO eye and the Wavetec AnalyzOR will be obtained by using a start/stop watch, including phakic power calculation and toric positioning. In addition, the suction on (start of LenSx), treatment time of LenSx in seconds, suction off (end of LenSx), start time of primary incision, the beginning of Phaco, end of phaco, CDE (Combined Diffused Energy) total and the end time of procedure will all be documented. All times will be analyzed and compared between Operating Room #1 and Operating Room #2.
- Conditions
- Cataract
- Being tested
- CALLISTO eye, Wavetec AnalyzOR
- Keywords
- cataract, toric, cataract surgery, residual astigmatism
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALLISTO eyeDevice
Cataract toric lens placement tool
Wavetec AnalyzORDevice
Cataract toric lens placement tool
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Operating Room #1) CALLISTO eye | Group 1 (Operating Room #1) will have preoperative measurements with the IOL Master 700 and lens selection will be based on Veracity. The subjects in group 1 will have LenSx surgery and placement of the lens will be based on the CALLISTO eye. Receives: Device: CALLISTO eye | |
| Group 2 (Operating Room #2) Wavetec AnalyzOR | Group 2 (Operating Room #2) will also have preoperative measurements with the IOL Master700, but lens selection will be based on the Wavetec AnalyzOR. The subjects in group 2 will have LenSx surgery and placement of the lens will be based on the Wavetec AnalyzOR. Receives: Device: Wavetec AnalyzOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diopters of Residual Cylinder
Diopters of Residual Cylinder at Month 1 with an upper boundary and lower boundary of +0.50 D and - 0.50 D
Measured: 1 Month postoperatively from implantation of intraocular lens
Secondary outcomes (5)
Accuracy of Residual Astigmatism (Predictive Error)
Residual Astigmatism of +/- 0.25 D or less, +/- 0.75 D or less, +/- 1.00 or less
Measured: Month 1
Refractive predictability of the IOL (absolute difference between MRSE and target MRSE)
MRSE within 0.25, 0.50, 0.75, 1.00 of target
Measured: Month 1
Uncorrected Distance Visual Acuities Achieved - Snellen
Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better
Measured: Month 1
Procedure and Operating Room Time
Suction on (start of LenSx), treatment time of LenSx in seconds, Suction off (end of LenSx)
Measured: Procedure time (up to 2 minutes)
Operating Room Time
Start and end time of matching reference image to microscope image, start time-primary incision, beginning of Phaco, end of Phaco, CDE (Combined Diffused Energy) Total, Start and end time of phakic power calculation, start and end time of toric positioning, end time of procedure
Measured: Operating Room Time (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start14 Dec 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chesapeake Eyecare and Laser Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Principal investigator, Maria C. Scott, Chesapeake Eyecare and Laser Center, LLC
- Investigators
- Maria C. Scott, Principal investigator, Chesapeake Eyecare and Laser Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216067
- Sponsor's protocol ID
- MCS12112021
- Acronym
- CORTCO
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operating Room Toric Placement Tools, CALLISTO Eye vs. Wavetec AnalyzOR (CORTCO)
- ClinicalTrials.gov ID
- NCT06216067
- Acronym / sponsor ID
- CORTCO / MCS12112021
- Conditions
- Cataract
- Keywords
- cataract, toric, cataract surgery, residual astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chesapeake Eyecare and Laser Center, LLCUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism.
The main question it aims to answer is:
Show the refractive predictability comparing the use of Operating Room cataract toric lens placement tools against the standard manual technique.
Participants will be implanted with the TECNIS Toric II IOL Lens Model ZCU; the second eye, if applicable, is to be implanted within 45 days of the first-eye surgery.
Researchers will compare two Operating Room cataract lens placement tools: the Zeiss CALLISTO vs. the Wavetec AnalyzOR to determine refractive predictability.
Detailed description
To evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism (maximum allowable up to 3.0D) comparing the ZEISS CALLISTO eye and the Wavetec AnalyzOR at the one-month post-operative visit. Both surgery rooms will be using Veracity, IOL Master and Zeiss Opmi Lumera i Operating Room Microscopes. Operating Room #1 will be utilizing the ZEISS CALLISTO eye for axis alignment, along with Veracity and IOL Master for lens selection, and Operating Room #2 will be utilizing the Wavetec AnalyzOR for lens selection and axis alignment. Procedure times for the ZEISS CALLISTO eye and the Wavetec AnalyzOR will be obtained by using a start/stop watch, including phakic power calculation and toric positioning. In addition, the suction on (start of LenSx), treatment time of LenSx in seconds, suction off (end of LenSx), start time of primary incision, the beginning of Phaco, end of phaco, CDE (Combined Diffused Energy) total and the end time of procedure will all be documented. All times will be analyzed and compared between Operating Room #1 and Operating Room #2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Operating Room #1) CALLISTO eye | – | Device: CALLISTO eyeGroup 1 (Operating Room #1) will have preoperative measurements with the IOL Master 700 and lens selection will be based on Veracity. The subjects in group 1 will have LenSx surgery and placement of the lens will be based on the CALLISTO eye. |
| Group 2 (Operating Room #2) Wavetec AnalyzOR | – | Device: Wavetec AnalyzORGroup 2 (Operating Room #2) will also have preoperative measurements with the IOL Master700, but lens selection will be based on the Wavetec AnalyzOR. The subjects in group 2 will have LenSx surgery and placement of the lens will be based on the Wavetec AnalyzOR. |
Who may qualify
- Ages
- 55 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing unilateral or bilateral cataract extraction
Key inclusion criteria (4 listed)
- Unilateral or bilateral cataract extraction with single piece hydrophobic acrylic posterior capsular intraocular lens correcting astigmatism.
- Clear intraocular media other than cataract.
- Willing and able to complete all required postoperative visits.
- Able to comprehend and sign a statement of informed consent in English.
Key exclusion criteria (2 listed)
- Ocular disease or pathology that, in the opinion of the Investigator, will affect the post-operative visual acuity and manifest refraction.
- Prior intraocular or corneal refractive surgery, corneal transplant, or retinal detachment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALLISTO eyeCataract toric lens placement tool | Device | Group 1 (Operating Room #1) CALLISTO eye |
| Wavetec AnalyzORCataract toric lens placement tool | Device | Group 2 (Operating Room #2) Wavetec AnalyzOR |
Primary outcome
Diopters of Residual Cylinder
Time frame: 1 Month postoperatively from implantation of intraocular lens
Diopters of Residual Cylinder at Month 1 with an upper boundary and lower boundary of +0.50 D and - 0.50 D
5 secondary outcomes
Accuracy of Residual Astigmatism (Predictive Error)
Time frame: Month 1
Refractive predictability of the IOL (absolute difference between MRSE and target MRSE)
Time frame: Month 1
Uncorrected Distance Visual Acuities Achieved - Snellen
Time frame: Month 1
Procedure and Operating Room Time
Time frame: Procedure time (up to 2 minutes)
Operating Room Time
Time frame: Operating Room Time (up to 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria C. Scott principal investigator
Chesapeake Eyecare and Laser Center, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Chesapeake Eyecare and Laser Center, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diopters of Residual Cylinder (time frame: 1 Month postoperatively from implantation of intraocular lens). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.