The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Completed

• Conditions: Narrow Angle; Open Angle
• Interventions: Device: ANTERION

• Registration Number: NCT04083742
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eyes with Open Angle	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices
Eyes with Narrow Angle	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events Rate	1 day	Adverse events found during the clinical study

Trial Locations

Locations (1)

State University of New York College of Optometry; 🇺🇸 New York, New York, United States