The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

Heidelberg Engineering

Status: Terminated

Conditions: Eyes with Abnormal Anterior Segment; Eyes with Normal Anterior Segment

Treatments: Device: ANTERION investigational

Study type: Observational

Funder types: Industry

Identifiers

NCT06397976

B-2023-2

Details and patient eligibility

About

This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)

Enrollment: 37 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Normal Anterior Segment

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. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

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. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging

Trial design

37 participants in 2 patient groups

Eyes with normal anterior segment

Treatment:

Device: ANTERION investigational

Eyes with abnormal anterior segment

Treatment:

Device: ANTERION investigational