NCT05220683

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 21, 2022

Last Update Submit

January 21, 2022

Conditions

Cataract

Keywords

AstigmatismDigital Marking Systems

Outcome Measures

Primary Outcomes (1)

  • Alignment axis

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

    24 months

Secondary Outcomes (2)

  • Loss of Tracking

    24 months

  • Luminance

    24 months

Study Arms (1)

Verion and Callisto

EXPERIMENTAL

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

Interventions

digital marking systemDEVICE

Verion or Callisto, digital marking system

Verion and Callisto

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Vienna, 1140, Austria

RECRUITING

Related Publications (1)

  • Zeilinger J, Schlatter A, Ruiss M, Bayer N, Kronschlager M, Findl O. Comparison of two digital alignment systems for toric intraocular lens implantation. BMJ Open Ophthalmol. 2024 Sep 16;9(1):e001875. doi: 10.1136/bmjophth-2024-001875.

    PMID: 39284678DERIVED

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Oliver Findl, MD

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Zeilinger, MD

CONTACT

+43 (1) 91021office@viros.at

Oliver Findl, MD

CONTACT

+43 (1) 91021office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 2, 2022

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)