Agreement and Precision Study of UNITY® DX and a Comparator Biometer

Agreement and Precision Study of UNITY® DX and a Comparator Biometer

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 the biometric measurements will be evaluated.

This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.

Inclusion Criteria:

• Able to understand and sign an Institution Review Board approved Informed Consent form.
• Willing and able to attend all scheduled study visits as required by the protocol.
• Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.

Exclusion Criteria:

• Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
• Any ocular disease and/or condition that, in the investigator's clinical judgment, 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.
• Rigid or contact lens wear during the previous two weeks prior to Screening.