The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Narrow Angle Clinical Trial

Official title:

The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083742
• Other study ID #: B-2018-3
• Status: Completed
• Start date: August 22, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 31, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Narrow Angle

Intervention

Device:
• ANTERION
3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices

Locations

Country	Name	City	State
United States	State University of New York College of Optometry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeatability and Reproducibility 1	Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device	1 day
Primary	Repeatability and Reproducibility 2	Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device	1 day
Primary	Repeatability and Reproducibility 3	Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device	1 day
Primary	Repeatability and Reproducibility 4	Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device	1 day
Primary	Repeatability and Reproducibility 5	Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device	1 day
Primary	Repeatability and Reproducibility 6	Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device	1 day
Primary	Agreement 1	Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device	1 day
Primary	Agreement 2	Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device	1 day
Primary	Agreement 3	Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device	1 day
Primary	Agreement 4	Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device	1 day
Primary	Agreement 5	Agreement of TISA parameters [mm2] between the ANTERION and the reference device	1 day
Primary	Agreement 6	Agreement of AOD parameters [µm] between the ANTERION and the reference device	1 day
Secondary	Adverse Events Rate	Adverse events found during the clinical study	1 day