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OpenTrials
Completed

NCT Number: NCT06216067

Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–87 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chesapeake Eye Care and Laser Center, LLC

Annapolis, Maryland, 21401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CALLISTO eye

Device

Cataract toric lens placement tool

Wavetec AnalyzOR

Device

Cataract toric lens placement tool

Primary outcomes

  1. Diopters of Residual Cylinder

    Time frame: 1 Month postoperatively from implantation of intraocular lens

    Diopters of Residual Cylinder at Month 1 with an upper boundary and lower boundary of +0.50 D and - 0.50 D

Secondary outcomes

  1. Accuracy of Residual Astigmatism (Predictive Error)

    Time frame: Month 1

    Residual Astigmatism of +/- 0.25 D or less, +/- 0.75 D or less, +/- 1.00 or less

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

    Time frame: Month 1

    MRSE within 0.25, 0.50, 0.75, 1.00 of target

  3. Uncorrected Distance Visual Acuities Achieved - Snellen

    Time frame: Month 1

    Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better

  4. Procedure and Operating Room Time

    Time frame: Procedure time (up to 2 minutes)

    Suction on (start of LenSx), treatment time of LenSx in seconds, Suction off (end of LenSx)

  5. Operating Room Time

    Time frame: Operating Room Time (up to 30 minutes)

    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

Sponsors and collaborators

Lead sponsor

Chesapeake Eyecare and Laser Center, LLC

Other

Collaborators

  • Carl Zeiss Meditec, Inc.

Registry information

Official study title

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

Acronym: CORTCO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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