Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR

Cataract Clinical Trial

— CORTCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216067
• Other study ID #: MCS12112021
• Status: Completed
• Start date: December 14, 2021
• Est. completion date: July 21, 2023

Study information

• Verified date: January 2024
• Source: Chesapeake Eyecare and Laser Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• CALLISTO eye
Cataract toric lens placement tool
• Wavetec AnalyzOR
Cataract toric lens placement tool

Locations

Country	Name	City	State
United States	Chesapeake Eye Care and Laser Center, LLC	Annapolis	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Chesapeake Eyecare and Laser Center, LLC	Carl Zeiss Meditec, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Uncorrected Distance Visual Acuities Achieved - Snellen	Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better	Month 1
Secondary	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)
Secondary	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)