Narrow Angle, Open Angle
Conditions
Brief summary
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
Interventions
DEVICEANTERION
3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices
Sponsors
Heidelberg Engineering GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 22 years or older 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 following eye status for the corresponding eye population: A. Eye with Open Angle (defined by Spaeth gonioscopy grading) B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)
Exclusion criteria
1. Subjects which were enrolled in the B-2018-1 study 2. Active infection or inflammation in either eye 3. Insufficient tear film or corneal reflex 4. Physical inability to be properly positioned at the study devices or eye exam equipment 5. Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place 6. Soft lenses worn within one hour prior to study device acquisitions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement 6 | 1 day | Agreement of AOD parameters \[µm\] between the ANTERION and the reference device |
| Repeatability and Reproducibility 1 | 1 day | Reproducibility and repeatability of Spur to Spur distance parameter \[mm\] of ANTERION and the reference device |
| Repeatability and Reproducibility 2 | 1 day | Reproducibility and repeatability of Angle to Angle distance parameter \[mm\] of ANTERION and the reference device |
| Repeatability and Reproducibility 3 | 1 day | Reproducibility and repeatability of Lens Vault parameter \[µm\] of ANTERION and the reference device |
| Repeatability and Reproducibility 4 | 1 day | Reproducibility and repeatability of Anterior Segment Angles parameter \[°\] of ANTERION and the reference device |
| Repeatability and Reproducibility 5 | 1 day | Reproducibility and repeatability of TISA parameters \[mm2\] of ANTERION and the reference device |
| Repeatability and Reproducibility 6 | 1 day | Reproducibility and repeatability of AOD parameters \[µm\] of ANTERION and the reference device |
| Agreement 1 | 1 day | Agreement of Spur to Spur distance parameter \[mm\] between the ANTERION and the reference device |
| Agreement 2 | 1 day | Agreement of Angle to Angle distance parameter \[mm\] between the ANTERION and the reference device |
| Agreement 3 | 1 day | Agreement of Lens Vault parameter \[µm\] between the ANTERION and the reference device |
| Agreement 4 | 1 day | Agreement of Anterior Segment Angles parameter \[°\] between the ANTERION and the reference device |
| Agreement 5 | 1 day | Agreement of TISA parameters \[mm2\] between the ANTERION and the reference device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Rate | 1 day | Adverse events found during the clinical study |
Countries
United States
Outcome results
None listed