Purpose The objective of the study was to assess a new technology, the tear film imager (TFI), which can dynamically image the muco-aqueous and lipid layers.
Methods Prospective pilot case series of individuals with and without dry eye (DE). Two sequential images were obtained with the TFI. Measurements were assessed for reproducibility and compared with clinically derived DE metrics. Individuals were grouped into DE categories based on signs of DE.
Results 49 patients participated in the study with a mean age of 58.8 years (SD 15.9) and a female majority (69%). Reproducibility of the muco-aqueous layer thickness (MALT) was excellent (r=0.88). MALT measurements significantly correlated with the Schirmer score (r=0.31). Lipid break up time (LBUT) as measured by the TFI significantly correlated with the clinical measure of tear break up time (TBUT) (r=0.73). MALT and LBUT were significantly thinner and shorter, respectively, in the DE groups (mild–moderate and severe) compared with the control group. When comparing TFI parameters to clinically assessed signs, sensitivity of the device was 87% and specificity was 88%.
Conclusion The TFI is the first machine capable of reproducibly measuring muco-aqueous thickness in human subjects which correlates with Schirmer score. In parallel, it assesses other important aspects of tear film function which correlate with clinician assessed DE metrics.
- dry eye
- tear film
- tear breakup
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Correction notice This paper has been amended since it was published Online First. Author name Avner Belkin was spelt incorrectly and this has now been updated.
Contributors All authors listed made a substantial contribution to the manuscript. All authors assisted in data acquisition, provided significant contribution to data analysis, interpretation, manuscript writing and final review and have approved submission of this version for publication.
Funding The study was supported by Meir Medical Center and the Israeli Innovation Authority. The TFI device was provided by AdOM Advanced Optical Technologies Ltd. Supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Clinical Sciences Research EPID-006-15S (Dr. Galor), NIH Center Core Grant P30EY014801 and Research to Prevent Blindness Unrestricted Grant.
Competing interests FS, NG, YC, RG, YA, SE and AH: equity and consulting to AdOM, Advance Optical Technologies Ltd. AO: consulting to AdOM, Advance Optical Technologies Ltd. AH: consulting to Shire, CIPLA and BioLight Life Sciences Investments Ltd. RG and AH: Equity of Nano Retina Ltd., AH: Equity of Oxymap Ltd.
Patient consent for publication Not required.
Ethics approval Institution Review Board approval was obtained to allow the prospective evaluation of patients 18 years or older.
Provenance and peer review Not commissioned; externally peer reviewed.