Eyes With Abnormal Anterior Segment, Eyes With Normal Anterior Segment
Conditions
Brief summary
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
Interventions
DEVICEANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
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
Normal Anterior Segment 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. Eye(s) with normal anterior segment
Exclusion criteria
Normal Anterior Segment 1. Active infection or inflammation in the study eye 2. Insufficient tear film or corneal reflex 3. Physical inability to be properly positioned at the study devices or eye exam equipment 4. Rigid contact lens wear 2 weeks prior to imaging 5. Soft lenses worn within one hour prior to imaging 6. Cataract grade ≥1.5 Inclusion Criteria Abnormal Anterior Segment 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. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Cornea Thickness | Through study completion, an average of 1 day | Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device |
| Thinnest Point Thickness | Through study completion, an average of 1 day | Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device |
| Lens Thickness | Through study completion, an average of 1 day | Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device |
| Anterior Chamber Depth | Through study completion, an average of 1 day | Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device |
| Axial Length | Through study completion, an average of 1 day | Reproducibility and repeatability of Axial Length of ANTERION and the reference device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Rate | Through study completion, an average of 1 day | Adverse events found during the clinical study |
Countries
United States
Outcome results
None listed