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Digital Marking Systems

Comparing Two Digital Marking Systems

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05220683
Enrollment
15
Registered
2022-02-02
Start date
2021-07-01
Completion date
2024-07-01
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Astigmatism, Digital Marking Systems

Brief summary

Comparison of the alignment axis of the Alcon Verion and the Zeiss Callisto alignment systems intraoperatively

Detailed description

In most patients undergoing cataract surgery, emmetropia can be achieved by implantation of a monofocal intraocular lens (IOL). However, several studies have shown that approximately 20% to 30% of patients who undergo cataract surgery have a preexisting corneal astigmatism of 1.25 diopters (D) while the prevalence of corneal astigmatism \>2.00 D is 8% and over \>3.00 D 2.6%. This astigmatism, if not corrected during surgery, leads to postoperative spectacle dependence. In patients without contraindications and a desire to achieve postoperative freedom from spectacles for distance vision, correction of astigmatism can be achieved at the time of surgery by using toric IOLs. A number of factors relating to corneal astigmatism are critical to lens selection and positioning.The most important factors are the preoperative corneal measurements and the correct alignment of the toric lens itself. Each degree of deviation results in a 3% reduction in astigmatism correction. The introduction of digital marking systems is intended to minimize the disadvantages of manual marking, such as tilting of the head during marking, incorrect and smudged marking. In addition to several different manual marking methods, there is also a range of digital markers which have been proven to be equal or even better than manual marking. These include among others the Callisto Eye with Z-Align and the Alcon VERION Digital Marker. The principle of these digital marking systems is based on a preoperative photo which is recorded in the course of biometry where the keratometry values are obtained. In the further course, the steep axis is determined on the basis of this image and the target axis is projected on to the eye intraoperatively. Beside the ideal implantation axis for the T-IOL, the size of the capsulorhexis and position, as well as incision placement can be displayed. In the course of this study, we will investigate the alignment axis of the two most used digital guidance systems from Alcon and Zeiss. A head to head comparison has already been carried out by Hura et al. in 2017. 15 eyes of 15 patients will be included into this study. There will only be one preoperative study visit, on the day of surgery, where reference pictures with a slitlamp camera and the biometers will be taken.

Interventions

DEVICEdigital marking system

Verion or Callisto, digital marking system

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
No

Inclusion criteria

* age-related cataract and scheduled for cataract surgery * age 21 or older * written informed consent prior to surgery

Exclusion criteria

* dense cataract or corneal pathology that would significantly influence the measurements * previous ocular surgery, ocular inflammation, or ocular trauma * nystagmus or pathologies that might affect patient's fixation * pregnancy * corneal astigmatism \> 1.5 dpt. or need for a toric IOL

Design outcomes

Primary

MeasureTime frameDescription
Alignment axis24 monthsDifference in aligment axis will be assessed with the Verion and the Callisto digital marking system

Secondary

MeasureTime frameDescription
Luminance24 monthsLuminance necessary for registration will be analysed using a luxmetre
Loss of Tracking24 monthsLoss of Tracking will be analysed during the different steps of surgery

Countries

Austria

Contacts

Primary ContactJohannes Zeilinger, MD
office@viros.at+43 (1) 91021
Backup ContactOliver Findl, MD
office@viros.at+43 (1) 91021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026