The objective of this study is to validate the performance of the OcuSense TearLab™ osmolarity test when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects and contrived tear samples.
To validate the performance and usability of the TearLab osmometer, specifically human factor usability, when used in the hands of intended users, i.e. ophthalmology and optometry clinics. This testing is required to insure that the Osmolarity System meets the Product Requirements and for completion of the Technical File, Design History File and FDA 510(k) Submission.
Study Type
OBSERVATIONAL
Enrollment
233
Gordon Binder Weiss Vision Institute
San Diego, California, United States
Kentucky Lion Eye Center, University of Louisville
Louisville, Kentucky, United States
The Ohio State University College of Optometry
Columbus, Ohio, United States
Tear Osmolarity in Human Measured by TearLab System
Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.
Time frame: Single visit, at time of tear osmolarity testing.
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