The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

NCT06397976 | Terminated FDA Device

• 1 other identifier: B-2023-2
• Study Type: observational
• Target: 37
• 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

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: Probability Sample

Study Population

Eyes with normal and eyes with abnormal anterior segment population

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

Willmar, 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: April 30, 2024
• First Posted: May 3, 2024
• Study Start: April 17, 2024
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-11

Locations

US (1)