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The TFI’s non-contact, quantifies measurement of the tear film inner layers and within minutes enables improved diagnosis of the Dry Eye (DE) disease. This challenge translates to an incredible resolution of 1 nanometer (1/1,000 micrometer) where the entire film is only 5 micrometers thick and even thinner for Dry Eye patients. As a reference, spectral domain OCT, the gold standard as diagnostic for the back of the eye, has a practical resolution of about 2-5 micrometers - the same order of magnitude of the whole tear film. 

The AdOM hyperspectral technology implemented within the Tear Film Imager stands on 3 pillars: Spectral Imaging which provides an accurate measurement (nanometer resolution) of the tear film inner layers over time, full field imaging which provides a quantification of the tissue 3D structure, and, algorithms to resolve the anatomy. The TFI platform is based on a proprietary light band shaping of a halogen lamp source within a meticulously designed optical system. Furthermore, we obtain an image of the tear film provided by the camera, using our full field acquisition unit and then analyze it using 3 algorithmic stages – signal processing, image processing and modeling.

Analyzing the tear film structure is an extremely tough challenge: each inner layer is extremely thin and the subject's eyeball is constantly moving. The TFI tomography capabilities enable 3D imaging as a function of time between blinks to evaluate the behavior of each of the tear film inner layers. Such capabilities can deduce the evaporation rate and uniformity of each layer which is then able to support the physician's decision as to the appropriate care.

The TFI is presenting remarkable results from the 3D-WLT study in Meir Medical Center in Israel, where both healthy and DES subjects were tested. The study’s interim results show that the TFI can detect DE with 87% sensitivity and 88% specificity. These promising data were reviewed by leading individuals specializing in the DE medical field from around the world with overwhelming reactions. Moreover, peer reviews of these results approved publications in leading ophthalmology conferences.  

Our second study, the TFI-EEC, examined DE and normal subjects in the Inflamax Low Humidity (LH)-Environmental Exposure Chamber (EEC) facility in Canada. This study found extremely high reproducibility of up to 90% of the TFI layer thickness quantified estimations for both the lipid and the Muco-aqueous layers of the tear film, that can enable improve DE management.  

The demonstrated AdOM hyperspectral technology in measuring tear film inner layers will be incorporated to the TFI market version during 2018 to withstand the demanding medical standards as required by the FDA and CE. This sound basis will enable us to obtain the CE mark in a straightforward manner and thereafter to seek clearance from the FDA. After obtaining regulatory approval AdOM plans to introduce the TFI technology to the ophthalmology market during 2019 and transform the DE medical management.

The TFI and the information provided about it have not been evaluated by the United States Food and Drug Administration and is not approved to diagnose, treat, cure or prevent disease or any condition. The αTFI has yet to receive any regulatory approvals.