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.
Study Type
OBSERVATIONAL
Enrollment
36
Cataract toric lens placement tool
Cataract toric lens placement tool
Chesapeake Eye Care and Laser Center, LLC
Annapolis, Maryland, United States
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
Time frame: 1 Month postoperatively from implantation of intraocular lens
Accuracy of Residual Astigmatism (Predictive Error)
Residual Astigmatism of +/- 0.25 D or less, +/- 0.75 D or less, +/- 1.00 or less
Time frame: 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
Time frame: Month 1
Uncorrected Distance Visual Acuities Achieved - Snellen
Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better
Time frame: Month 1
Procedure and Operating Room Time
Suction on (start of LenSx), treatment time of LenSx in seconds, Suction off (end of LenSx)
Time frame: 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
Time frame: Operating Room Time (up to 30 minutes)
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