The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

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: Completed
• Conditions: Narrow Angle; Open Angle
• Intervention / Treatment: Device: ANTERION

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Repeatability and Reproducibility 1	Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device	1 day
Repeatability and Reproducibility 2	Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device	1 day
Repeatability and Reproducibility 3	Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device	1 day
Repeatability and Reproducibility 4	Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device	1 day
Repeatability and Reproducibility 5	Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device	1 day
Repeatability and Reproducibility 6	Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device	1 day
Agreement 1	Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device	1 day
Agreement 2	Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device	1 day
Agreement 3	Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device	1 day
Agreement 4	Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device	1 day
Agreement 5	Agreement of TISA parameters [mm2] between the ANTERION and the reference device	1 day
Agreement 6	Agreement of AOD parameters [µm] between the ANTERION and the reference device	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Rate	Adverse events found during the clinical study	1 day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Mitchell Dul, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID 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