UNITY DX Cornea Study

UNITY DX Cornea Precision and Agreement Study

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.

Key Inclusion Criteria:

• Able to understand and sign an Institutional Review Board approved informed consent form.
• Willing and able to attend all scheduled study visits as required per protocol.
• Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
• Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
• Active ocular infection or inflammation.
• Other protocol-specified exclusion criteria may apply.