The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

NCT05051813 | Completed FDA Device

• 1 other identifier: B-2020-1
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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

Conditions

Normal Cornea; Corneal Abnormality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Adverse Events Rate

  Through study completion, an average of 1 day

Study Arms (2)

Normal Cornea

3 repeat measurements on each of the 3 investigational and 3 reference devices

Device: ANTERION

Corneal Abnormality

3 repeat measurements on each of the 3 investigational and 3 reference devices

Device: ANTERION

Interventions

ANTERION DEVICE

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

Corneal Abnormality; Normal Cornea

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normal and Abnormal Cornea populations

You may qualify if:

• 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

You may not qualify if:

• 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
• \. 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
• \. 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Fischer Laser Eye Center

Minneapolis, Minnesota, 56201, United States

Location

Study Officials

• Jeffrey Fischer, MD

  Fischerr Laser Eye Center, MN, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 21, 2021
• Study Start: September 7, 2021
• Primary Completion: February 28, 2024
• Study Completion: December 16, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (1)