Clinical trial NCT05051813: The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
Official title: The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Cornea
Corneal Abnormality
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 151
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal and Abnormal Cornea populations

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


Eligibility criteria: 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

Primary outcomes:
measure: Corneal Epithelial Thickness 0-2mm ring
timeFrame: Through study completion, an average of 1 day
measure: Corneal Epithelial Thickness 2-5mm ring
timeFrame: Through study completion, an average of 1 day
measure: Corneal Epithelial Thickness 5-7mm ring
timeFrame: Through study completion, an average of 1 day
measure: Minimum Thickness from 7mm zone
timeFrame: Through study completion, an average of 1 day
measure: Maximum Thickness from 7mm zone
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Adverse Events Rate
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fischer Laser Eye Center
state: Minnesota
Study officials:
affiliation: Fischerr Laser Eye Center, MN, USA
name: Jeffrey Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References: