Digital Marking Systems

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Recruiting
CT.gov ID
NCT05220683
Collaborator
(none)
15
1
1
36
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: digital marking system
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparing Two Digital Marking Systems
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Verion and Callisto

Alignment axis will be analysed with both, the Verion and the Callisto, digital marking system in the same eye of the same patient

Device: digital marking system
Verion or Callisto, digital marking system

Outcome Measures

Primary Outcome Measures

  1. Alignment axis [24 months]

    Difference in aligment axis will be assessed with the Verion and the Callisto digital marking system

Secondary Outcome Measures

  1. Loss of Tracking [24 months]

    Loss of Tracking will be analysed during the different steps of surgery

  2. Luminance [24 months]

    Luminance necessary for registration will be analysed using a luxmetre

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna Austria 1140

Sponsors and Collaborators

  • Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, MD, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT05220683
Other Study ID Numbers:
  • VE
First Posted:
Feb 2, 2022
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2022