The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

March 14, 2025 updated by: Heidelberg Engineering GmbH
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Willmar, Minnesota, United States, 56201
        • Fischer Eye Laser Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Eyes with normal and eyes with abnormal anterior segment population

Description

Inclusion Criteria Normal Anterior Segment

  1. Age 22 years or older
  2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
  3. Able to fixate
  4. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

  1. Active infection or inflammation in the study eye
  2. Insufficient tear film or corneal reflex
  3. Physical inability to be properly positioned at the study devices or eye exam equipment
  4. Rigid contact lens wear 2 weeks prior to imaging
  5. Soft lenses worn within one hour prior to imaging
  6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

  1. Age 22 years or older
  2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
  3. Able to fixate
  4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

  1. Active infection or inflammation in the study eye
  2. Insufficient tear film or corneal reflex
  3. Physical inability to be properly positioned at the study devices or eye exam equipment
  4. Rigid contact lens wear 2 weeks prior to imaging
  5. Soft lenses worn within one hour prior to imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eyes with normal anterior segment
Device: ANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
Eyes with abnormal anterior segment
Device: ANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Cornea Thickness
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Through study completion, an average of 1 day
Thinnest Point Thickness
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
Through study completion, an average of 1 day
Lens Thickness
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
Through study completion, an average of 1 day
Anterior Chamber Depth
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Through study completion, an average of 1 day
Axial Length
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Axial Length of ANTERION and the reference device
Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Rate
Time Frame: Through study completion, an average of 1 day
Adverse events found during the clinical study
Through study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg Engineering GmbH

Investigators

  • Principal Investigator: Jeffrey Fischer, MD, Fischer Laser Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2024

Primary Completion (Actual)

November 5, 2024

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • B-2023-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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