Clinical trial NCT06216067: Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR
Official title: Comparison of Operating Room Toric Placement Tools, CALLISTO Eye vs. Wavetec AnalyzOR (CORTCO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract
toric
cataract surgery
residual astigmatism
Lead sponsor: Chesapeake Eyecare and Laser Center, LLC
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec, Inc.
First posted: 2024-01-22
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing unilateral or bilateral cataract extraction

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diopters of Residual Cylinder
timeFrame: 1 Month postoperatively from implantation of intraocular lens
Secondary outcomes:
measure: Accuracy of Residual Astigmatism (Predictive Error)
timeFrame: Month 1
measure: Refractive predictability of the IOL (absolute difference between MRSE and target MRSE)
timeFrame: Month 1
measure: Uncorrected Distance Visual Acuities Achieved - Snellen
timeFrame: Month 1
measure: Procedure and Operating Room Time
timeFrame: Procedure time (up to 2 minutes)
measure: Operating Room Time
timeFrame: Operating Room Time (up to 30 minutes)
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Chesapeake Eye Care and Laser Center, LLC
state: Maryland
Study officials:
affiliation: Chesapeake Eyecare and Laser Center, LLC
name: Maria C. Scott
role: PRINCIPAL_INVESTIGATOR
References: