The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Heidelberg Engineering GmbH
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Corneal Epithelial Thickness 0-2mm ring
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Exclusion Criteria General
- •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
- •Exclusion Criteria Normal Cornea Group
- •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
- •Exclusion Criteria Abnormal Cornea Group
- •For Keratoconus (a):
Outcomes
Primary Outcomes
Corneal Epithelial Thickness 0-2mm ring
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Through study completion, an average of 1 day
Reproducibility and repeatability of maximum thickness (7mm zone) of ANTERION and the reference device
Secondary Outcomes
- Adverse Events Rate(Through study completion, an average of 1 day)