The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

Completed

• Conditions: Normal Cornea; Corneal Abnormality

• Registration Number: NCT05051813
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-07
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-18
• Study First Posted: 2021-09-21
• Primary Completion: 2024-02-28
• Study Completion: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events Rate	Through study completion, an average of 1 day	Adverse events found during the clinical study

Trial Locations

Locations (1)

Fischer Laser Eye Center; 🇺🇸 Minneapolis, Minnesota, United States