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

Study Overview

• Status: Completed
• Conditions: Normal Cornea; Corneal Abnormality
• Intervention / Treatment: Device: ANTERION

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 56201
      • Fischer Laser Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Normal and Abnormal Cornea populations

Description

Inclusion Criteria:

1. Subjects ≥ 22 years of age
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate

4. 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

  1. Active infection in either eye
  2. Insufficient corneal reflex, in the study eye
  3. Physical inability to be properly positioned at the study devices or eye exam equipment

• Exclusion Criteria Normal Cornea Group

  4. Abnormal cornea shape or corneal surgery in the study eye

  5. Contact lens wear within 3 months prior to imaging in the study eye

  6. Dry eye disease in the study eye

• Exclusion Criteria Abnormal Cornea Group

  4. For Keratoconus (a):

  • Contact lenses worn within one hour prior to imaging

    5. For Contact Lens Wearer (b):

  • Keratoconus
  • Post-Keratorefractive surgery

  • Contact lenses worn within one hour prior to imaging

    6. For Post-Keratorefractive Surgery (c):

  • Keratoconus

  • Contact lens wear within 3 months prior to imaging in the study eye

    7. For Dry Eye Disease (d):

  • Keratoconus
  • Post-Keratorefractive surgery
  • Contact lens wear within 3 months prior to imaging in the study eye

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Cornea; 3 repeat measurements on each of the 3 investigational and 3 reference devices	Device: ANTERION; 3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices.
Corneal Abnormality; 3 repeat measurements on each of the 3 investigational and 3 reference devices	Device: ANTERION; 3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Epithelial Thickness 0-2mm ring	Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (0-2mm ring) of ANTERION and the reference device	Through study completion, an average of 1 day
Corneal Epithelial Thickness 2-5mm ring	Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device	Through study completion, an average of 1 day
Corneal Epithelial Thickness 5-7mm ring	Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device	Through study completion, an average of 1 day
Minimum Thickness from 7mm zone	Reproducibility and repeatability of minimum thickness (7mm zone) of ANTERION and the reference device	Through study completion, an average of 1 day
Maximum Thickness from 7mm zone	Reproducibility and repeatability of maximum thickness (7mm zone) of ANTERION and the reference device	Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Rate	Adverse events found during the clinical study	Through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Jeffrey Fischer, MD, Fischerr Laser Eye Center, MN, USA

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: B-2020-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No