Cataract, Cornea Abnormality, Healthy Eye, IOL, Post-Keratorefractive Surgery
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 parameters with the ANTERION
Interventions
DEVICEANTERION
3 repeat measurements performed with two of the ANTERION acquisition types and 3 repeat measurements performed with 2 acquisition types of the references 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 the following eye pathology status for the individual eye population: * A. Eye with normal anterior segment and crystalline lens * B. Eye with a cataract of grade 1.5 or higher * C. Eye with abnormal corneal shape * D. Eye with status post-keratorefractive surgery * E. Eye without a crystalline lens
Exclusion criteria
1. Subjects which were enrolled in the B-2018-1 clinical study 2. Active infection or inflammation in the study 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 2 weeks prior to imaging 6. Soft lenses worn within one hour prior to imaging 7. With the following eye pathology status for the individual eye population: * A. Eye meets eligibility criteria for eye populations B, C, D or E * B. Eye meets eligibility criteria for eye populations C,D or E * C. Eye meets eligibility criteria for eye populations D or E * E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision and Agreement 7 | 1 day | Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm\^3) of ANTERION and the reference device |
| Precision and Agreement 4 | 1 day | Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device |
| Precision and Agreement 5 | 1 day | Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device |
| Precision and Agreement 1 | 1 day | Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device |
| Precision and Agreement 2 | 1 day | Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device |
| Precision and Agreement 3 | 1 day | Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device |
| Precision and Agreement 6 | 1 day | Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of 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