This technology provides an objective and reliable method for diagnosing DED and a device for performing the diagnostic method. Unlike existing technology used to diagnose and evaluate the severity of DED, this technology is simple, non-invasive, rapid and objective which will ultimately lead to better care of patients. Further, this technology does not require consumables.
Measurement reliability of existing microchip technology for DED is influenced by a range of factors, such as ambient temperature and operator error. Further, a number of existing procedures are very invasive but the overall information gained is limited. The cost of existing systems is substantial and employs relatively expensive single-use consumables, therefore limiting use in clinical practice.
Although numerous existing diagnostic tests are routinely used, clinical diagnosis of DED remains complicated by considerable variability in its presentation and the weak association between traditional tests and patient symptoms. Most dry eye clinical diagnostic tests are poorly standardised which confounds diagnostic accuracy in practice. Although an international approach to diagnose DED has been outlined, DED diagnosis is clinically complex due to significant variability in the self-reported diagnostic approaches for DED among clinicians in multiple demographics. Further, there is a lack of universal consensus in relation to the optimal clinical diagnostic protocol for the condition. This technology uses a fundamentally different approach to provide an objectively reliable method of detecting and evaluating DED which overcomes the disadvantages of present methods and devices used in those methods.
The technology features a method for diagnosing DED, assessing the severity of DED and diagnosing clinical sub-types of DED and a device customised for performing the diagnostic methods. Patent protection has been sought for the device and diagnostic method of reliably and accurately evaluating DED. The method uses a novel approach for assessing tear film integrity for clinical diagnosis of DED in a human or animal patient. The device uses acoustically-driven microfluidic extension rheometry (ADMiER) to quantify the viscoelastic properties of human or animal tears, thereby determining thread thinning dynamics of the tear sample. This results in a simple, rapid and objective method of evaluating DED.
DED is a significant public health issue and the direct economic burden of DED in Australia can be conservatively estimated at $1.2 billion per year. As the prevalence of DED increases with age, predictions are that the condition will affect more than 7.5 million Australian by 2020. The effect of severe DED on quality of life is comparable to moderate angina and is not to be underestimated. It is estimated that dry eye medications and devices at the manufacturer level will reach nearly $3.2 billion in 2015 and grow at a compounded annual growth rate (CAGR) of 6.9% over the next five years.
Potential applications for this technology include:
Existing microchip technology for measuring DED is influenced by a range of factors, such as ambient temperature and operator error. Further, most dry eye clinical diagnostic tests are poorly standardised which confounds diagnostic accuracy in practice. This technology is a significant improvement over existing technologies because it provides an objective and accurate evaluation of DED.
Other significant benefits of the technology include: