NCT06216067

Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR

Comparison of Operating Room Toric Placement Tools, CALLISTO Eye vs. Wavetec AnalyzOR (CORTCO)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Chesapeake Eyecare and Laser Center, LLC · Academic / Other
• Sex: All
• Age: 55 Years – 87 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	CALLISTO eye	Cataract toric lens placement tool
DEVICE	Wavetec AnalyzOR	Cataract toric lens placement tool

Timeline

• Start date: 2021-12-14
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study