Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR (CORTCO)

Chesapeake Eyecare and Laser Center, LLC

Status: Completed

Conditions: Cataract

Treatments: Device: CALLISTO eye; Device: Wavetec AnalyzOR

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06216067

MCS12112021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 55 to 87 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

36 participants in 2 patient groups

Group 1 (Operating Room #1) CALLISTO eye

Description:

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.

Treatment:

Device: CALLISTO eye

Group 2 (Operating Room #2) Wavetec AnalyzOR

Description:

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.

Treatment:

Device: Wavetec AnalyzOR