The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Heidelberg Engineering GmbH59 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Narrow Angle Open Angle

Interventions

ANTERIONDEVICE

3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

State University of New York College of Optometry

New York, New York, United States

Outcomes

Primary Outcomes

Repeatability and Reproducibility 1

Reproducibility and repeatability of Spur to Spur distance parameter \[mm\] of ANTERION and the reference device

Time frame: 1 day

Repeatability and Reproducibility 2

Reproducibility and repeatability of Angle to Angle distance parameter \[mm\] of ANTERION and the reference device

Time frame: 1 day

Repeatability and Reproducibility 3

Reproducibility and repeatability of Lens Vault parameter \[µm\] of ANTERION and the reference device

Time frame: 1 day

Repeatability and Reproducibility 4

Reproducibility and repeatability of Anterior Segment Angles parameter \[°\] of ANTERION and the reference device

Time frame: 1 day

Repeatability and Reproducibility 5

Reproducibility and repeatability of TISA parameters \[mm2\] of ANTERION and the reference device

Time frame: 1 day

Repeatability and Reproducibility 6

Reproducibility and repeatability of AOD parameters \[µm\] of ANTERION and the reference device

Time frame: 1 day

Agreement 1

Agreement of Spur to Spur distance parameter \[mm\] between the ANTERION and the reference device

Time frame: 1 day

Agreement 2

Agreement of Angle to Angle distance parameter \[mm\] between the ANTERION and the reference device

Time frame: 1 day

Data from ClinicalTrials.gov

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The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes