Active, Not Recruiting

NCT Number: NCT06657716

Heidelberg Engineering ANTERION Software Comparison Study

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Eyes With Normal Anterior Segment Eyes With Abnormal Anterior Segment

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fischer Eye Laser Center

Wilmar, Minnesota, 56201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Normal Anterior Segment

Age 22 years or older
Able and willing to undergo the test procedures, sign informed consent, and follow instructions
Able to fixate
Eye(s) with normal anterior segment

Exclusion criteria

Normal Anterior Segment

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

Inclusion criteria

Abnormal Anterior Segment

Age 22 years or older
Able and willing to undergo the test procedures, sign informed consent, and follow instructions
Able to fixate
Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion criteria

Abnormal Anterior Segment

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

Treatment and study plan

ANTERION investigational

Device

Device: ANTERION investigational

Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)

Primary outcomes

Central Cornea Thickness

Time frame: Through study completion, an average of 1 day

Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Thinnest Point Thickness

Time frame: Through study completion, an average of 1 day

Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
Lens Thickness

Time frame: Through study completion, an average of 1 day

Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
Anterior Chamber Depth

Time frame: Through study completion, an average of 1 day

Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Axial Length

Time frame: Through study completion, an average of 1 day

Reproducibility and repeatability of Axial Length of ANTERION and the reference device

Secondary outcomes

Adverse Events Rate

Time frame: Through study completion, an average of 1 day

Adverse events found during the clinical study

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Official study title

The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 24, 2024
Registry last updated: Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.