The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05051813

Enrollment

151

Registered

2021-09-21

Start date

2021-09-07

Completion date

2024-12-16

Last updated

2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Abnormality, Normal Cornea

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

Interventions

DEVICEANTERION

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026