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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Cornea | 3 repeat measurements on each of the 3 investigational and 3 reference devices |
| |
| Corneal Abnormality | 3 repeat measurements on each of the 3 investigational and 3 reference devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANTERION | Device | 3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Rate | Adverse events found during the clinical study | Through study completion, an average of 1 day |
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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
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
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Normal and Abnormal Cornea populations
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Fischer, MD | Fischerr Laser Eye Center, MN, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fischer Laser Eye Center | Minneapolis | Minnesota | 56201 | United States |
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