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OpenTrials
Completed

NCT Number: NCT05051813

The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess corneal epithelial thickness parameters with the ANTERION

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fischer Laser Eye Center

Minneapolis, Minnesota, 56201, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects ≥ 22 years of age
  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions
  • Able to fixate
  • With at least one of the following eye status for the corresponding eye population:
  • Normal Cornea
  • Abnormal Cornea: eye with at least one of the following

a) Keratoconus b) Contact Lens Wearer c) Status Post-Keratorefractive Surgery (at least 30 days between imaging and Keratorefractive Surgery) d) Dry Eye Disease

Exclusion criteria

  • Exclusion Criteria General
  • Active infection in either eye
  • Insufficient corneal reflex, in the study eye
  • Physical inability to be properly positioned at the study devices or eye exam equipment
  • Exclusion Criteria Normal Cornea Group
  • Abnormal cornea shape or corneal surgery in the study eye
  • Contact lens wear within 3 months prior to imaging in the study eye
  • Dry eye disease in the study eye
  • Exclusion Criteria Abnormal Cornea Group
  • For Keratoconus (a):
  • Contact lenses worn within one hour prior to imaging
  • For Contact Lens Wearer (b):
  • Keratoconus
  • Post-Keratorefractive surgery
  • Contact lenses worn within one hour prior to imaging
  • For Post-Keratorefractive Surgery (c):
  • Keratoconus
  • Contact lens wear within 3 months prior to imaging in the study eye
  • For Dry Eye Disease (d):
  • Keratoconus
  • Post-Keratorefractive surgery
  • Contact lens wear within 3 months prior to imaging in the study eye

Treatment and study plan

ANTERION

Device

3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices.

Primary outcomes

  1. Corneal Epithelial Thickness 0-2mm ring

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

    Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (0-2mm ring) of ANTERION and the reference device

  2. Corneal Epithelial Thickness 2-5mm ring

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

    Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device

  3. Corneal Epithelial Thickness 5-7mm ring

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

    Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device

  4. Minimum Thickness from 7mm zone

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

    Reproducibility and repeatability of minimum thickness (7mm zone) of ANTERION and the reference device

  5. Maximum Thickness from 7mm zone

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

    Reproducibility and repeatability of maximum thickness (7mm zone) of ANTERION and the reference device

Secondary outcomes

  1. 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2021
Registry last updated
Jan 15, 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.

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