Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR

NCT06216067 | Completed FDA Device

• 1 other identifier: MCS12112021
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

cataract; toric; cataract surgery; residual astigmatism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Accuracy of Residual Astigmatism (Predictive Error)

  Month 1

• Refractive predictability of the IOL (absolute difference between MRSE and target MRSE)

  Month 1

• Uncorrected Distance Visual Acuities Achieved - Snellen

  Month 1

• Procedure and Operating Room Time

  Procedure time (up to 2 minutes)

• Operating Room Time

  Operating Room Time (up to 30 minutes)

Study Arms (2)

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

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

Interventions

CALLISTO eye DEVICE

Cataract toric lens placement tool

Group 1 (Operating Room #1) CALLISTO eye

Wavetec AnalyzOR DEVICE

Cataract toric lens placement tool

Group 2 (Operating Room #2) Wavetec AnalyzOR

Eligibility Criteria

• Age: 55 Years - 87 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing unilateral or bilateral cataract extraction

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chesapeake Eyecare and Laser Center, LLC: lead
• Carl Zeiss Meditec, Inc.: collaborator

Study Sites (1)

Chesapeake Eye Care and Laser Center, LLC

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Maria C. Scott

  Chesapeake Eyecare and Laser Center, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maria C. Scott, MD

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 22, 2024
• Study Start: December 14, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)