Heidelberg Engineering ANTERION Software Comparison Study

NCT06657716 | Active Not Recruiting FDA Device

• 1 other identifier: B-2024-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Eyes With Normal Anterior Segment; Eyes With Abnormal Anterior Segment

Outcome Measures

Primary Outcomes (5)

• Central Cornea Thickness

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

  Through study completion, an average of 1 day

• Thinnest Point Thickness

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

  Through study completion, an average of 1 day

• Lens Thickness

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

  Through study completion, an average of 1 day

• Anterior Chamber Depth

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

  Through study completion, an average of 1 day

• Axial Length

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

  Through study completion, an average of 1 day

Secondary Outcomes (1)

• Adverse Events Rate

  Through study completion, an average of 1 day

Study Arms (2)

Eyes with normal anterior segment

Device: ANTERION investigational

Eyes with abnormal anterior segment

Device: ANTERION investigational

Interventions

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)

Eyes with abnormal anterior segment; Eyes with normal anterior segment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Normal Anterior Segment * Abnormal Anterior Segment

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Fischer Eye Laser Center

Wilmar, Minnesota, 56201, United States

Location

Study Officials

• Jeffrey Fischer, MD

  Fischer Laser Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 2, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)