The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

Last updated: March 14, 2025
Sponsor: Heidelberg Engineering GmbH
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

ANTERION investigational

Clinical Study ID

NCT06397976
B-2023-2
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 37
Treatment Group(s): 1
Primary Treatment: ANTERION investigational
Phase:
Study Start date:
April 17, 2024
Estimated Completion Date:
November 05, 2024

Connect with a study center

  • Fischer Eye Laser Center

    Willmar, Minnesota 56201
    United States

    Site Not Available

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