Digital Marking Systems
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
digital marking system
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract focused on measuring Astigmatism, Digital Marking Systems
Eligibility Criteria
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
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Verion and Callisto
Arm Description
Alignment axis will be analysed with both, the Verion and the Callisto, digital marking system in the same eye of the same patient
Outcomes
Primary Outcome Measures
Alignment axis
Difference in aligment axis will be assessed with the Verion and the Callisto digital marking system
Secondary Outcome Measures
Loss of Tracking
Loss of Tracking will be analysed during the different steps of surgery
Luminance
Luminance necessary for registration will be analysed using a luxmetre
Full Information
NCT ID
NCT05220683
First Posted
January 21, 2022
Last Updated
January 21, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT05220683
Brief Title
Digital Marking Systems
Official Title
Comparing Two Digital Marking Systems
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Astigmatism, Digital Marking Systems
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verion and Callisto
Arm Type
Experimental
Arm Description
Alignment axis will be analysed with both, the Verion and the Callisto, digital marking system in the same eye of the same patient
Intervention Type
Device
Intervention Name(s)
digital marking system
Intervention Description
Verion or Callisto, digital marking system
Primary Outcome Measure Information:
Title
Alignment axis
Description
Difference in aligment axis will be assessed with the Verion and the Callisto digital marking system
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Loss of Tracking
Description
Loss of Tracking will be analysed during the different steps of surgery
Time Frame
24 months
Title
Luminance
Description
Luminance necessary for registration will be analysed using a luxmetre
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Zeilinger, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Zeilinger, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
No
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Digital Marking Systems
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