The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

June 18, 2024 updated by: Heidelberg Engineering GmbH
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

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
    • New York
      • New York, New York, United States, 10036
        • State University of New York College of Optometry

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Eyes with narrow angle and eyes with open angle

Description

Inclusion Criteria:

  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. With at least one of following eye status for the corresponding eye population:

A. Eye with Open Angle (defined by Spaeth gonioscopy grading)

B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)

Exclusion Criteria:

  1. Subjects which were enrolled in the B-2018-1 study
  2. Active infection or inflammation in either eye
  3. Insufficient tear film or corneal reflex
  4. Physical inability to be properly positioned at the study devices or eye exam equipment
  5. Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place
  6. Soft lenses worn within one hour prior to study device acquisitions

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Eyes with Open Angle
3 repeat measurements on each of the 3 investigational and reference devices
Device: ANTERION
3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices
Eyes with Narrow Angle
3 repeat measurements on each of the 3 investigational and reference devices
Device: ANTERION
3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Repeatability and Reproducibility 1
Time Frame: 1 day
Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device
1 day
Repeatability and Reproducibility 2
Time Frame: 1 day
Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device
1 day
Repeatability and Reproducibility 3
Time Frame: 1 day
Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device
1 day
Repeatability and Reproducibility 4
Time Frame: 1 day
Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device
1 day
Repeatability and Reproducibility 5
Time Frame: 1 day
Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device
1 day
Repeatability and Reproducibility 6
Time Frame: 1 day
Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device
1 day
Agreement 1
Time Frame: 1 day
Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device
1 day
Agreement 2
Time Frame: 1 day
Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device
1 day
Agreement 3
Time Frame: 1 day
Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device
1 day
Agreement 4
Time Frame: 1 day
Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device
1 day
Agreement 5
Time Frame: 1 day
Agreement of TISA parameters [mm2] between the ANTERION and the reference device
1 day
Agreement 6
Time Frame: 1 day
Agreement of AOD parameters [µm] between the ANTERION and the reference device
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events Rate
Time Frame: 1 day
Adverse events found during the clinical study
1 day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heidelberg Engineering GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mitchell Dul, State University of New York College of Optometry

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-2018-3

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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