Patent Application Titled “System And Methods For Use In Vision Assessment To Determine Refractive Errors And Neurodegenerative Disorders By Ocular Biomarking Features” Published Online (USPTO 20210330185): Patent Application

2021 NOV 15 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Borowczyk, Klaudia (Warsaw, PL); Krukowski, Piotr (Warsaw, PL); Maciaszek, Dorota (Warsaw, PL); Maciejewski, Marcin (Warsaw, PL); Piszczek, Marek (Warsaw, PL); Pomianek, Mateusz (Warsaw, PL), filed on April 23, 2021, was made available online on October 28, 2021.

No assignee for this patent application has been made.

Reporters obtained the following quote from the background information supplied by the inventors: “Many people suffer from neurodegenerative diseases such as Alzheimer and Parkinson. In addition to the unquestioned pain of lost health and lives of individuals, this group of disorders carries a huge economic cost that is ultimately borne by entire societies. Early detection of neurodegenerative disorders can save $230 B a year in the US only in direct treatment and long-term care costs. Today there is no affordable, non-invasive, objective screening solution that can be provided to everyone over the age of 40. Known prodromal (neurodegenerative diseases) NDD screening method characteristics (currently) include: expensive screening (mostly based on MRI/PET findings); inaccessibility (provided by specialized care units); symptoms occur individual (there is no single, visible syndrome suiting all the cases); unharmonized criteria (most of the markers are nonspecific, science is on early stage of knowledge development); and Low social awareness (symptoms may be interpreted as normal aging). Which lead to the following: 1) Detecting prodromal PD (Parkinson’s disease) is relatively uncommon, with prevalence estimates ranging from 0.5-4%; 2) One of the greatest current challenges is to identify markers for prodromal disease stages, which would allow novel disease-modifying therapies to be started earlier; 3) Global data indicate that PD will become a pandemic: prevalence more than doubled between 1990 and 2015, and PD now affects 6.2 million individuals; 4) Projected PD prevalence (US) will be more than 1.6 million with projected total economic burden surpassing $79 billion by 2037, and the economic burden of PD was previously underestimated; 5) The cost of AD (Alzheimer’s disease) now rivals that of cancer and heart disease, but the growing epidemic of AD means that these costs will race ahead of the costs of other diseases in the coming years; thus, by 2050, it is predicted that 16 million Americans will have AD, resulting in $1 trillion per year in expenses to Medicare and Medicaid alone; and 6) Given our aging population, AD represents a looming public health crisis. The development of novel medical devices for AD treatment or detection requires the combined expertise and resources of many different research projects.

“According to various studies, approximately 54 percent of U.S. adults said they visit or consult an optometrist/ophthalmologist (eye care doctors) at least once a year, which creates perfect conditions to supplement with additional set of screening tests focused on NDDs.

“However, refractive errors exam are burdened with following issues: 1) Assessment requires 20 ft examination space, expensive equipment, and it is not reimbursed; 2) Inconsistent prescription results are the norm in eyecare as it relies on different OD/MD each time combined with patient declarative subjective judgment; 3) High cost of qualified personnel (average optometrist salary may exceed ˜110.000 USD/year); and 4) Possible human error caused by lack of unified procedures, lack of objective data or lack of proper education.

“Up to 5% of minors in a worldwide population who have problems with lazy eye or crossed eyes. Untreated, or not properly treated those conditions are likely to further adversely affect minor’s binocular vision disorders, stereo-deficiency, learning abilities, motoric skills and willingness to socialize, which may lead to low self-esteem, disabilities and depression in such a minor’s adult life. At least some known vision treatment therapies require the patient to attend vision therapy sessions at a clinic or therapists office, which may be difficult for patients to attend and receive consistent and frequent treatments. Also, traditional vision therapy tools are obsolete, with hard to follow treatment procedures. According to some studies, a prevalence of approximately 10% accommodation and convergence related disorders has been observed in schoolchildren, and that visual discomfort is also common among teenagers who carry these conditions (such as headaches and loss of concentration). Moreover, stereo deficiency may limit career options for patients with binocular vision disorders.

“The present invention is aimed at one or more of the problems identified above.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors’ summary information for this patent application: “In one aspect of the present invention, a diagnostic device for use in performing refractive errors assessment and neurodegenerative disorders screening is provided. The diagnostic device includes a display configure to render dynamically adjusted, dichoptic visual stimuli to a user, a varifocal optics system orientated between the display and the user’s eyes, an ocular reflex analyzer emitting light signals towards the user’s eye s and obtaining light signal reflected from selected part of the eye to measure eye accommodation during an on-going visual stimulation, and an eye tracking system configured to track movement of the user’s eyes.

“In another aspect of the present invention, a method of operating a diagnostic device for performing a neurodegenerative disease screening exam is provided. The diagnostic device includes a display configure to render dynamically adjusted, dichoptic or binocular visual stimuli to a user, a varifocal optics system orientated between the display and the user’s eyes, an eye tracking system configured to track movement of the user’s eyes, and a processor. The method includes the processor executing the algorithm steps of: adjusting the varifocal optics system to an initial refractive correction, displaying visual stimuli on the display based on desired test procedure, collecting eye movement data using eye tracking system, and determining neurodegenerative disease by comparing collected eye movement data with baseline eye movement data associated with desired test scenario.

“In yet another aspect of the present invention, a method of operating a diagnostic device for performing a refractive errors assessment is provided. The diagnostic device including a display configure to render dynamically adjusted, dichoptic visual stimuli to a user, a varifocal optics system orientated between the display and the user’s eyes, an ocular reflex analyzer emitting light signals towards the user’s eye s and obtaining light signal reflected from selected part of the eye to measure eye accommodation during an on-going visual stimulation, an eye tracking system configured to track movement of the user’s eyes, and a processor. The method including the processor executing the algorithm steps of: displaying visual stimuli on the display based on desired refractive errors assessment test procedure, collecting eye movement data using eye tracking system, collecting ocular accommodation data using the ocular reflex analyzer, and determining best refractive correction and ocular behavior based on collected eye movement data and ocular behavior data.

“Corresponding reference characters indicate corresponding components throughout the several views of the drawings.”

The claims supplied by the inventors are:

“1. A diagnostic device for use in performing refractive errors assessment and neurodegenerative disorders screening, comprising: a display configure to render dynamically adjusted, binocular or dichoptic visual stimuli to a user; a varifocal optics system orientated between the display and the user’s eyes; an ocular reflex analyzer emitting light signals towards the user’s eye s and obtaining light signal reflected from selected part of the eye to measure eye accommodation during an on-going visual stimulation; and an eye tracking system configured to track movement of the user’s eyes.

“2. The diagnostic device of claim 1, further comprising a processor programmed to performing a neurodegenerative disease screening exam by executing an algorithm including the steps of: adjusting the varifocal optics system to provide an initial refractive error correction; displaying visual stimuli on the display based on desired test procedure; collecting eye movement data using eye tracking system; and determining neurodegenerative disease by comparing collected eye movement data with baseline eye movement data associated with desired test scenario.

“3. The diagnostic device of claim 2, wherein the processor is programmed to perform a refractive errors assessment by executing an algorithm including the steps of: displaying visual stimuli on the display based on desired refractive errors assessment test procedure; collecting eye movement data using eye tracking system; collecting ocular accommodation data using the ocular reflex analyzer; and determining ocular behavior and best refractive correction based on collected eye movement data and ocular behavior data.

“4. The diagnostic device of claim 1, wherein the varifocal optics system includes a pair of metalenses, each metalens being associated with a corresponding eye of the user.

“5. The diagnostic device of claim 1, wherein the varifocal optics system includes a first set of metalenses associated with a first eye of the user and a second set of metalenses associated with a second eye of the user, each set of metalenses including at least one tunable metalens.

“6. The diagnostic device of claim 1, wherein the varifocal optics system includes a pair of tunable liquid-membrane lenses, each tunable liquid-membrane lens being associated with a corresponding eye of the user.

“7. The diagnostic device of claim 1, wherein the ocular reflex analyzer includes a projection assembly including a near-infrared (NIR) marker projecting module configured to produce an image marker on both a retina and a cornea of the eye.

“8. The diagnostic device of claim 7, wherein the ocular reflex analyzer includes an acquisition assembly is configured to perform detection of the image marker produced by the projection assembly.

“9. The diagnostic device of claim 1, wherein the ocular reflex analyzer includes: a light emitter configured to emit light to obtain retinal reflex of the user’s eye; a sensor configured to receive reflected light from the user’s eye and record the retinal reflex of the user’s eye; a NIR sensor configured to receive reflected light from the user’s eye and record the cornea reflex of the user’s eye; a hot mirror configured to reflect the light emitted from the light emitter towards the user’s eye and reflect the reflected light from the user’s eye towards the sensor; and a varifocal optics for image synthesis of the measurement marker from retina and cornea reflex of the user’s eye.

“10. The diagnostic device of claim 9, wherein the ocular reflex analyzer further includes a beam splitter orientated to reflect the light emitted from the light emitter towards the hot mirror and pass the reflected light from the hot mirror towards the sensor.

“11. The diagnostic device of claim 1, wherein the eye tracking system includes a micro-electro-mechanical systems (MEMS) sensor assembly for tracking a position of the user’s eyes.

“12. The diagnostic device of claim 11, wherein the MEMS sensor assembly includes: a laser diode for emitting a beam of light; a light detector configured to detect reflected light from the user’s eye; and an oscillating micro-mirror configured to reflect the light emitted from the laser diode towards the user’s eye and reflect radiation from the user’s eye towards the light detector.

“13. The diagnostic device of claim 12, wherein the MEMS sensor assembly further includes a beam splitter orientated to reflect the beam of light from the laser diode towards the oscillating micro-mirror and pass the reflect radiation received from the oscillating micro-mirror towards the light detector.

“14. The diagnostic device of claim 11, wherein the eye tracking system further includes a 2D profile sensor for providing temporal features of eye movements based on retina position.

“15. A method of operating a diagnostic device for performing a neurodegenerative disease screening exam, the diagnostic device including a display configure to render dynamically adjusted, binocular or dichoptic visual stimuli to a user, a varifocal optics system orientated between the display and the user’s eyes, an eye tracking system configured to track movement of the user’s eyes, and a processor, the meth-od including the processor executing the algorithm steps of: adjusting the varifocal optics system to an initial refractive correction; displaying visual stimuli on the display based on desired test procedure; collecting eye movement data using eye tracking system; and determining neurodegenerative disease by comparing collected eye movement data with baseline eye movement data associated with desired test scenario.

“16. The method of claim 15, wherein the processor executes the algorithm step of: adjusting the visual stimuli based on collected eye movement data; collecting subsequent eye movement data in response to adjusted visual stimuli; and determining indication of neurodegenerative disease by comparing collected eye movement data with baseline eye movement data associated with desired test scenario.

“17. The method of claim 15, wherein the eye tracking system includes a MEMS sensor assembly for eye movements spatial parameters determination and a 2D profile sensor for eye movements spatial parameters determination.

“18. A method of operating a diagnostic device for performing a refractive errors assessment, the diagnostic device including a display configure to render dynamically adjusted, binocular or dichoptic visual stimuli to a user, a varifocal optics system orientated between the display and the user’s eyes, an ocular reflex analyzer emitting light signals towards the user’s eye s and obtaining light signal reflected from selected part of the eye to measure eye accommodation during an on-going visual stimulation, an eye tracking system configured to track movement of the user’s eyes, and a processor, the method including the processor executing the algorithm steps of: displaying visual stimuli on the display based on desired refractive errors assessment test procedure; collecting eye movement data using eye tracking system; collecting ocular accommodation data using the ocular reflex analyzer; and determining best refractive correction and ocular behavior based on collected eye movement data and ocular behavior data.

“19. The method of claim 18, wherein the processor executes the algorithm step of: adjusting optical conditions and/or visual stimuli; collecting subsequent eye movement data and ocular accommodation data in response to adjusted optical conditions and/or visual stimuli; and determining ocular behavior based on the subsequent eye movement data and ocular accommodation data.

“20. The method of claim 18, wherein the eye tracking system includes a MEMS sensor assembly for eye movements spatial parameters determination and a 2D profile sensor for eye movements spatial parameters determination.”

For more information, see this patent application: Borowczyk, Klaudia; Krukowski, Piotr; Maciaszek, Dorota; Maciejewski, Marcin; Piszczek, Marek; Pomianek, Mateusz. System And Methods For Use In Vision Assessment To Determine Refractive Errors And Neurodegenerative Disorders By Ocular Biomarking Features. Filed April 23, 2021 and posted October 28, 2021. Patent URL: https://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220210330185%22.PGNR.&OS=DN/20210330185&RS=DN/20210330185

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