The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of corneal and epithelial thickness maps will be evaluated.
The study population will consist of male and female adult subjects with normal corneas (approximately 30 subjects), keratoconus (approximately 20 subjects), prior corneal laser vision correction (approximately 20 subjects), current and habitual contact lens wear (approximately 20 subjects), and dry eye (approximately 20 subjects). In this single visit study, measurements will be taken by 3 different operators using their own set of devices (configuration), UNITY DX and ANTERION. Each subject's participation is expected to last approximately 3 hours with a planned duration of exposure generally not longer than 10 minutes per device. Only one eye (designated as the study eye) will be enrolled per subject.
Study Type
OBSERVATIONAL
Enrollment
110
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
The Eye Institute of Utah
Salt Lake City, Utah, United States
Mean corneal thickness
Corneal thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Time frame: Day 1
Mean epithelial thickness
Epithelial thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Time frame: Day 1
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