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| Name | Class |
|---|---|
| Carl Zeiss Meditec, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALLISTO eye | Device | Cataract toric lens placement tool |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 Month postoperatively from implantation of intraocular lens |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Residual Astigmatism (Predictive Error) | Residual Astigmatism of +/- 0.25 D or less, +/- 0.75 D or less, +/- 1.00 or less | Month 1 |
| Refractive predictability of the IOL (absolute difference between MRSE and target MRSE) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing unilateral or bilateral cataract extraction
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| Name | Affiliation | Role |
|---|---|---|
| Maria C. Scott | Chesapeake Eyecare and Laser Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Eye Care and Laser Center, LLC | Annapolis | Maryland | 21401 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Wavetec AnalyzOR |
| Device |
Cataract toric lens placement tool |
|
MRSE within 0.25, 0.50, 0.75, 1.00 of target
| Month 1 |
| Uncorrected Distance Visual Acuities Achieved - Snellen | Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better | Month 1 |
| Procedure and Operating Room Time | Suction on (start of LenSx), treatment time of LenSx in seconds, Suction off (end of LenSx) | 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 | Operating Room Time (up to 30 minutes) |