The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heidelberg Engineering GmbH
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Precision and Agreement 2
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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
- •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:
- •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)
Outcomes
Primary Outcomes
Precision and Agreement 2
Time Frame: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 4
Time Frame: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 5
Time Frame: 1 day
Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device
Precision and Agreement 1
Time Frame: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 6
Time Frame: 1 day
Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device
Precision and Agreement 3
Time Frame: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 7
Time Frame: 1 day
Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm\^3) of ANTERION and the reference device
Secondary Outcomes
- Adverse Events Rate(1 day)