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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 anterior segment parameters with the ANTERION
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye with normal Anterior Segment | 3 repeat measurements on each of the 3 investigational and reference devices |
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| Eye with cataract | 3 repeat measurements on each of the 3 investigational and reference devices |
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| Eye with corneal abnormality | 3 repeat measurements on each of the 3 investigational and reference devices |
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| Eye with status post-keratorefractive surgery | 3 repeat measurements on each of the 3 investigational and reference devices |
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| Eye without a crystalline lens | 3 repeat measurements on each of the 3 investigational and reference devices |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANTERION | Device | 3 repeat measurements performed with two of the ANTERION acquisition types and 3 repeat measurements performed with 2 acquisition types of the references devices |
| Measure | Description | Time Frame |
|---|---|---|
| Precision and Agreement 1 | Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device | 1 day |
| Precision and Agreement 2 | Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device | 1 day |
| Precision and Agreement 3 | Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device | 1 day |
| Precision and Agreement 4 | Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device | 1 day |
| Precision and Agreement 5 | Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device | 1 day |
| Precision and Agreement 6 | Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device | 1 day |
| Precision and Agreement 7 | Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm^3) of ANTERION and the reference device |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Rate | Adverse events found during the clinical study | 1 day |
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Inclusion Criteria:
Age 22 years or older
Able and willing to undergo the test procedures, sign informed consent, and follow instructions
Able to fixate
With the following eye pathology status for the individual eye population:
Exclusion Criteria:
Subjects which were enrolled in the B-2018-1 clinical study
Active infection or inflammation in the study eye
Insufficient tear film or corneal reflex
Physical inability to be properly positioned at the study devices or eye exam equipment
Rigid contact lens wear 2 weeks prior to imaging
Soft lenses worn within one hour prior to imaging
With the following eye pathology status for the individual eye population:
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Eyes with normal anterior segment and crystalline lens; eyes with cataract of grade 1.5 or higher; eyes with abnormal corneal shape; eyes with status post-keratorefractive surgery and eyes without a crystalline lens
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Dul | State University of New York College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York College of Optometry | New York | New York | 10036 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 1 day |