Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyes with Open Angle | 3 repeat measurements on each of the 3 investigational and reference devices |
| |
| Eyes with Narrow Angle | 3 repeat measurements on each of the 3 investigational and reference devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANTERION | Device | 3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability and Reproducibility 1 | Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device | 1 day |
| Repeatability and Reproducibility 2 | Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device | 1 day |
| Repeatability and Reproducibility 3 | Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device | 1 day |
| Repeatability and Reproducibility 4 | Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device | 1 day |
| Repeatability and Reproducibility 5 | Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device | 1 day |
| Repeatability and Reproducibility 6 | Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device | 1 day |
| Agreement 1 | Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device | 1 day |
| Agreement 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Rate | Adverse events found during the clinical study | 1 day |
Not provided
Inclusion Criteria:
A. Eye with Open Angle (defined by Spaeth gonioscopy grading)
B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)
Exclusion Criteria:
Not provided
Not provided
Not provided
Eyes with narrow angle and eyes with open angle
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device |
| 1 day |
| Agreement 3 | Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device | 1 day |
| Agreement 4 | Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device | 1 day |
| Agreement 5 | Agreement of TISA parameters [mm2] between the ANTERION and the reference device | 1 day |
| Agreement 6 | Agreement of AOD parameters [µm] between the ANTERION and the reference device | 1 day |