The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

Heidelberg Engineering

Status: Completed

Conditions: Normal Cornea; Corneal Abnormality

Treatments: Device: ANTERION

Study type: Observational

Funder types: Industry

Identifiers

NCT05051813

B-2020-1

Details and patient eligibility

About

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

Enrollment: 151 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

151 participants in 2 patient groups

Normal Cornea

Description:

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

Treatment:

Device: ANTERION

Corneal Abnormality

Description:

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

Treatment:

Device: ANTERION