The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

Heidelberg Engineering

Status: Completed

Conditions: Narrow Angle; Open Angle

Treatments: Device: ANTERION

Study type: Observational

Funder types: Industry

Identifiers

NCT04083742

B-2018-3

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

59 participants in 2 patient groups

Eyes with Open Angle

Description:

3 repeat measurements on each of the 3 investigational and reference devices

Treatment:

Device: ANTERION

Eyes with Narrow Angle

Description:

3 repeat measurements on each of the 3 investigational and reference devices

Treatment:

Device: ANTERION