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

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:

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: CALLISTO eye; Device: Wavetec AnalyzOR

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Chesapeake Eye Care and Laser Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients undergoing unilateral or bilateral cataract extraction

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: CALLISTO eye; Cataract toric lens placement tool
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.	Device: Wavetec AnalyzOR; Cataract toric lens placement tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Chesapeake Eyecare and Laser Center, LLC
• Collaborators: Carl Zeiss Meditec, Inc.
• Investigators: Principal Investigator: Maria C. Scott, Chesapeake Eyecare and Laser Center, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cataract; cataract surgery; toric; residual astigmatism
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MCS12112021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes