Devices, systems, and methods for performing electroretinography

Abstract

A wearable device for administering electroretinography to a wearer can have a housing defining first and second compartments. Each of the first and second compartments can include a stimulus light source, a focused light source, an active electrode configured to engage the wearer's skin, and a reference electrode spaced from the active electrode and configured to engage the wearer's skin. A processor can be communicatively coupled to the stimulus light source, active electrode, and reference electrode in each of the first and second compartments of the housing. A memory can be in communication with the processor. The device can implement a method including flashing the stimulus light source in the first compartment and storing a signal from the active electrode in the first compartment. The housing can further include a ground electrode.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 912,920, filed October 9, 2019, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to systems, devices, and methods for testing for retinal diseases. [Background technology]

[0003] Diabetic retinopathy (DR) is a leading cause of blindness in working-age adults. Fundus photography is the traditional method for diagnosing DR. However, by the time DR is evident on fundus photography, irreversible damage and vision loss have already occurred. Electroretinography (ERG) is a powerful tool for recording retinal function and is used in ophthalmology clinics to diagnose or monitor retinal diseases. By detecting defects in the rod-driven pathway, ERG can be used to screen for DR at an early stage before sight-threatening damage is present. The usefulness of ERG as a screening device for diagnosing retinal diseases is hindered by the following reasons: (a) the need for prolonged dark adaptation of the patient's eyes in a dark room, which is necessary to detect different retinal cell types; (b) the size / footprint of the ERG system; and (c) the expertise required to interpret the results. These characteristics limit the use of ERG in primary care settings.

[0004] ERG is traditionally performed using a desktop system with a Ganzfeld dome, within which the patient places their face and receives a uniform flash stimulus to both eyes. A typical clinical ERG follows standards published by the International Society for Clinical Electrophysiology of Vision (ISCEV), which recommends pupil dilation followed by 20 minutes of dark adaptation and 10 minutes of light adaptation to isolate cone photoreceptor responses before presenting a test flash to effectively probe rod-based retinal responses. The ERG flash response can be recorded using a contact lens or fiber electrodes placed under the eye, either touching the cornea or skin electrodes. The recorded response requires expert analysis to generate diagnostically relevant information. Recent advances in ERG include handheld ERG systems, which are more portable and potentially usable outside of the clinic. One of the latest testing devices is the RETeval, developed by LKC Technology, Inc. The RETeval is a handheld, portable ERG system used to assess retinal function. It includes a pupil tracker, eliminating the need for dilation drops to enlarge the pupil diameter. RETeval has been used in clinical and preclinical ophthalmology studies. For example, RETeval has been shown to accurately screen for diabetic retinopathy using noninvasive skin electrodes and a portable, handheld ERG system with sensitivity similar to or better than current DR methods using fundus examination, and to detect drug toxicity with reliability similar to desktop ERG models.

[0005] However, the RETeval device has limitations. RETeval is limited to examining one eye at a time, doubling the valuable clinic time required to assess retinal function in both eyes. When using standard ERG devices or RETeval, a dark adaptation step must be performed in a darkened room to allow the patient to dark-adapt before the test. Because few clinics have a designated room with a revolving dark door for the dark adaptation period, the clinician or technician performing the test must also perform tasks requiring high dexterity in the dark, such as placing electrodes in the eye.

[0006] ERGs acquired by RETeval require expert analysis and interpretation of the results to derive meaningful diagnostic information from the recordings, which requires highly trained professionals who can spare valuable time for analysis in busy clinics. Summary of the Invention

[0007] Described herein is a wearable device for administering electroretinography to a wearer of the device. The wearable device can include a housing having a first side and a second side spaced apart relative to a horizontal axis. The housing can define first and second compartments positioned along the horizontal axis, each configured to be positioned over a respective eye of the wearer. Each of the first and second compartments can include a stimulus light source, a focused light source positioned where the respective eye of the wearer will focus during administration of the electroretinography, an active electrode configured to engage the wearer's skin, and a reference electrode spaced from the active electrode and configured to engage the wearer's skin. At least one processor can be communicatively coupled to the stimulus light source, active electrode, and reference electrode in each of the first and second compartments of the housing. The memory can be in communication with the processor, the memory including instructions that, when executed by the processor, implement a method including flashing a stimulation light source in the first section and storing a signal from an active electrode in the first section. The housing can further include a ground electrode.

[0008] The memory may include instructions that, when executed by the processor, perform the step of detecting at least one characteristic of the signal.

[0009] The memory may include instructions that, when executed by the processor, perform the step of determining a time delay between a flash of the stimulating light source and a time of at least one characteristic of the signal.

[0010] The stimulation light sources in the first and second compartments may be configured to uniformly illuminate the entire field of view of each eye of the wearer.

[0011] The stimulus light sources of the first and second compartments may be configured to provide a dim flash having a single flash intensity.

[0012] The stimulating light sources of the first and second compartments may be configured to provide multiple flashes of varying intensity.

[0013] The wearable device may further include a head strap having a first end attached to a first side of the housing and a second end attached to a second side of the housing.

[0014] The housing may include a flexible rim configured to conform to the wearer's face.

[0015] The housing can be configured to block substantially all ambient light from reaching the wearer's eyes.

[0016] The active and reference electrodes of the first and second compartments, as well as the ground electrode, may be embedded within the rim.

[0017] The active electrodes of the first section may be positioned to engage the wearer's skin beneath each of the wearer's eyes.

[0018] The ground electrode may be positioned to engage at least one of the wearer's forehead skin or eyebrow skin.

[0019] The reference electrode in the first compartment can be further away from a plane perpendicular to the lateral axis and bisecting the housing between the first and second sides than the active electrode in the first compartment.

[0020] The wearable device may further comprise an output device, the output device being one of a cable, a wireless transmitter, and an I / O port.

[0021] The housing may define a slot between the first and second sections that is configured to conform to the shape of the wearer's nose.

[0022] The spacing between the focused light sources in the first and second sections may be fixed.

[0023] The spacing between the focused light sources in the first and second sections may be selectively adjustable.

[0024] Each of the first and second compartments may include a peripheral inner wall extending circumferentially around a respective eye of the wearer, and a distal wall extending between distal surfaces of the peripheral inner walls to enclose a space viewed by the wearer's eye, with the stimulating light source and the focusing light source being fixed to the distal wall.

[0025] A method of using the wearable device may include positioning the wearable device over a wearer's eye, executing instructions in the memory that cause the wearable device to perform an electroretinogram test, and receiving an output from the wearable device.

[0026] Executing the instructions in the memory to cause the wearable device to perform an electroretinogram test may include performing an electroretinogram test on each eye of the wearer simultaneously.

[0027] The method may further include analyzing the output from the wearable device to determine whether the patient has diabetic retinopathy.

[0028] The instructions may be executed after an acclimation period of at least 5 minutes.

[0029] These and other aspects of the present invention will become more apparent in the following detailed description, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 1 is a front perspective view of a wearable device according to an embodiment disclosed herein. [Figure 2] FIG. 2 is a rear view of the wearable device of FIG. 1. [Figure 3]FIG. 2 is a schematic diagram of the wearable device of FIG. 1. [Figure 4] A computing device for receiving and / or processing data from a wearable device. [Figure 5] 2 is a graph showing raw data collected by the wearable device of FIG. 1. [Figure 6] 6 is a graph showing the data of FIG. 5 after it has been filtered. [Figure 7] 7 is the graph of FIG. 6 with waveform characteristics shown. [Figure 8] 1 is a plot showing data for healthy and unhealthy retinas. [Figure 9] FIG. 1 is a rear view of a wearable device according to an embodiment disclosed herein, with the location of the wearer's eyes indicated schematically. DETAILED DESCRIPTION OF THE INVENTION

[0031] The present invention may be more readily understood by reference to the following detailed description, examples, figures, and claims, as well as the accompanying text. However, before the present devices, systems, and / or methods are disclosed and described, it is to be understood that, unless otherwise specified, the present invention is not limited to the particular devices, systems, and / or methods disclosed, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0032] The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein while still obtaining the beneficial results of the invention. It will also be apparent that some of the desired advantages of the invention can be obtained by selecting some of the features of the invention without utilizing other features. Accordingly, those skilled in the art will recognize that many modifications and adaptations to the present invention are possible and may even be desirable in certain circumstances and are a part of the present invention. Accordingly, the following description is offered as an illustration of the principles of the invention, and not as a limitation.

[0033] As used throughout, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to "an electrode" can include two or more such electrodes unless the context dictates otherwise.

[0034] Ranges can be expressed herein as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations by use of the antecedent "about," it is understood that the particular value forms another embodiment. It will be further understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint. Optionally, in some embodiments, when values are approximated by use of the antecedents "approximately," "about," "generally," or "substantially," it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (more or less) of the particularly stated value or characteristic can be included within the scope of those embodiments.

[0035] As used herein, the term "optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and the description is meant to include both the occurrence and non-occurrence of the event or circumstance.

[0036] As used herein, the term "communicatively coupled" refers to a state in which two components can communicate with each other using any conventional wired or wireless communication protocol, including, but not limited to, a direct / cable connection, a Wi-Fi® connection, a Bluetooth® connection, a radio frequency (RF) communication protocol, etc.

[0037] As used herein, the word "or" means any one member of a particular list and also includes any combination of members of that list, unless the context clearly indicates otherwise.

[0038] Systems and methods for diagnosing retinal diseases, such as diabetic retinopathy (DR), are described herein with reference to Figures 1-4 and 9. According to one embodiment, a wearable, non-invasive diagnostic system can detect DR using ERG. The system can include a compact device that is wearable as a pair of goggles (or other suitable eye covering). The device can include at least one electrode (optionally, multiple electrodes). The electrodes can be disposed within the rims of the goggles and are configured to receive and record electrical signals indicative of the eye's electrical function via contact with the skin surrounding the eye.

[0039] The system can fully cover both eyes, allowing dark adaptation to occur in a controlled manner under various settings (e.g., bright or partially lit rooms), allowing technicians to operate and perform tests even when the room remains illuminated. Thus, in contrast to conventional ERG systems, it is contemplated that the systems, devices, and methods disclosed herein can be used without the need for a dark room. According to some embodiments, the system can screen for DR using a predetermined dim flash (e.g., a single duration or interval flash) to probe the rod-driven pathways affected by DR, eliminating the need for the lengthy, multi-step flash protocols employed by conventional ERG systems. In these embodiments, it is contemplated that the flash delivery of the disclosed system can consist of a single interval or duration stimulus. In further embodiments, the system can automatically process and analyze recordings to provide diagnostic information. The disclosed system can correct current shortcomings of clinical ERG that prevent its use as a standard, routine screening device for DR in primary care or ophthalmology clinics.

[0040] An electroretinogram system according to embodiments disclosed herein may include a wearable device 10 including a housing 12 having a first side 14 (shown in FIG. 2 as the left side of the device from the wearer's perspective) and a second side 16 (shown in FIG. 2 as the right side of the device from the wearer's perspective). The first side 14 and the second side 16 may be spaced apart relative to a horizontal axis 18. The housing 12 may define a first compartment 20 on the first side 14 and a second compartment 22 on the second side 16. The first and second compartments may be sized and spaced apart to be positioned over the wearer's respective eyes. For example, according to some embodiments, the distance between the centers of the first and second compartments may be approximately the average interpupillary distance (PD) between the eyes of an adult. In these embodiments, it is contemplated that the distance between the centers of the first and second compartments may be in the range of about 58 mm to about 68 mm. Each compartment can include a peripheral inner wall 24 that extends circumferentially around the wearer's respective eye (when in the operative / use position) and projects distally outward (away from the eye). A distal wall 26 can extend between distal ends (e.g., distal edges or surfaces) of the peripheral inner wall 24 such that the wearer's respective eye faces the distal wall 26 when the device is in the operative / use position. The inner peripheral wall 24 and the distal wall 26 can cooperate to enclose a space viewed by the wearer's eye. Although described above as forming distinct sections of the compartment, it is contemplated that the peripheral inner wall 24 and the distal wall 26 can cooperate to define a rounded compartment profile that does not include a defined separation between the two walls.

[0041] Each compartment may include a stimulus light source 30 and a focus light source 32. In some optional embodiments, the focus light source 32 may emit red light. In further optional embodiments, the stimulus light source 30 may emit white light (e.g., a light transmission consisting of white light). Optionally, the stimulus light source 30 and the focus light source 32 may be fixed to the distal wall 26 of each compartment 20, 22. Optionally, the housing may define a respective slot within each compartment into which the respective stimulus light source 30 and / or focus light source 32 may be embedded. The housing 12 may cooperate with each stimulus light source 30 to create a ganzfeld dome over each of the wearer's eyes. That is, the stimulus light source 30 may be configured to uniformly or substantially uniformly illuminate the entire field of view of each of the wearer's eyes. This may be achieved with a housing having sufficient depth and each compartment, or compartments containing or covered with a reflective ganzfeld paint (e.g., a matte paint) within a plastic that diffuses the light evenly. Optionally, the stimulus light source 30 may include a filter configured to produce a diffuse light source as disclosed herein. In an exemplary embodiment, the color of the stimulus light source 30 is not controlled. The focused light source 32 may optionally be centered in each of the compartments so that when the stimulus light source 30 generates a flash, the flash can bounce off the walls of each compartment and be evenly distributed across the retina of each eye of the wearer. In some embodiments, the spacing between the focused light sources 32 of the first and second compartments 20, 22 may be fixed. In other embodiments, the spacing between the focused light sources 32 of the first and second compartments 20, 22 may be adjustable. For example, it is contemplated that each compartment may include a respective track or series of mounting locations that allow adjustment of the position of each focused light source 32. Optionally, the spacing between the first and second compartments may itself be adjustable. For example, the device may include a nose bridge (as is known in other types of goggles) that allows selective adjustment of the spacing between the two compartments. In this example, it is contemplated that the compartments may be formed as separate components joined together by the nose bridge.

[0042] The housing may include a rim 40 that may extend around the periphery of each compartment. Optionally, the rim 40 may comprise a flexible polymer (e.g., silicone or rubber) that may be configured to elastically conform to the wearer's face, thereby blocking most, substantially all, or all ambient light from entering the wearer's field of vision. In this manner, the device may be used in a lit or partially lit room, thereby allowing the medical professional to see during setup and examination while allowing the wearer's eyes to dark adapt. The rim 40 may comprise a material that can be disinfected with an alcohol prep pad. The rim 40 may be removable for hygiene or replacement. A band 42 (optionally an elastic band) may be attached at a first end to a first side of the housing and at a second end to a second side of the housing. The band 42 may extend around the wearer's head to secure the device 10 to the wearer. The band 42 may optionally be adjustable via known means (e.g., buckles, slip locks, and other adjustment elements) to provide a comfortable fit and to apply the housing 12 to the wearer's face with pressure that conforms the rim 40 to the wearer's face while adequately blocking ambient light. The band 42 may be attached to the housing via a snap closure to allow the band to be removed for cleaning or replacement. The housing may define a slot 46 between the first and second sections 20, 22, the slot 46 configured to conform to, substantially conform to, or be complementary to the shape of the wearer's nose.

[0043] The active electrode 50 and the reference electrode 52 may be disposed within a rim in each of the first and second compartments 20 and 22. Optionally, the active electrode and the reference electrode 52 may be disposed within the rim to engage the skin directly under the wearer's eye. The active electrode 50 may be spaced apart from the respective reference electrode 52. The reference electrode 52 may be spaced further from the eye than the respective active electrode 50. Optionally, the active electrode 50 may be spaced inward of the respective reference electrode 52 relative to the horizontal axis 18 (i.e., closer to the compartment for the contralateral eye). That is, the reference electrode 52 in each compartment may be further away from the plane 36 that is perpendicular to the horizontal axis 18 and bisects the housing between the first and second sides than the active electrode 50 in the respective compartment. The ground electrode 54 may be disposed within the rim 40 of the housing 12. Optionally, the ground electrode 54 may be positioned within the rim 40 to engage the skin of the wearer's eyebrow or forehead. Optionally, it is contemplated that the ground electrode 54 may be positioned approximately centrally along the horizontal axis 18 such that the ground electrode 54 intersects the reference plane 36. Thus, as shown in FIG. 2, it is contemplated that the ground electrode 54 may be disposed on the upper part of the rim 40 (above the wearer's eye), while the active and reference electrodes 50, 52 for each compartment are disposed on the lower part of the rim (below the wearer's eye).

[0044] In exemplary embodiments, the rim can define respective receptacles that receive at least a portion of a corresponding active, reference, or ground electrode, with each receptacle defining an opening that allows direct contact between the electrode and the wearer's skin. Additionally or alternatively, the rim can define at least one receptacle that receives multiple active, reference, or ground electrodes. Optionally, the electrodes can be adhesively secured within each receptacle. Alternatively, the electrodes can be mechanically held within each receptacle (e.g., at least partially by a portion of the rim extending over the electrode). In still further embodiments, it is contemplated that the rim and housing of wearable device 10 can cooperate to define a structure that accommodates any circuit components electrically connected to the various electrodes provided within the rim.

[0045] Also, referring to FIG. 9 , as shown with respect to eye location 90, the active electrodes 50 can be positioned within the rim to minimize their distance from the wearer's respective eyes. The active electrodes 50 can have a horizontal, elongated profile to help maximize the skin-electrode contact surface area. In an exemplary embodiment, the active electrodes 50 can be longer (measured relative to the horizontal axis 18) than the corresponding reference electrodes. The reference electrodes 52 can be located below the eyes and spaced closer to the respective sides of the goggles than the respective active electrodes. The ground electrode 54 can be located above the goggle-skin interface and configured to contact the center of the lower forehead. The electrodes can be flat, thin metal sheets, such as foil. The electrodes can optionally be flexible. The edges of the electrodes can be covered by the rim to prevent sharp edges from being exposed to the wearer. The electrodes can protrude from the rim toward the wearer by about 0.1 mm to about 1 mm (optionally about 0.5 mm) to facilitate contact with the wearer's skin. Optionally, in exemplary embodiments, it is contemplated that the overall configuration and arrangement of the active and reference electrodes 50, 52 may be symmetrical or generally symmetrical with respect to a plane that bisects the goggles between the first and second sections.

[0046] The device 10 may include a processor 60 (or multiple processors) communicatively coupled to the stimulus light source 30, active electrode 50, reference electrode 52, and ground electrode 54 for each of the first and second segments, and optionally, the focused light source 32 for each segment. A memory 62 may be in communication with the processor 60. The memory 62 may include instructions for conducting an ERG test on at least one eye. For example, the instructions may cause a stimulus light in the first segment to flash and then cause the device 10 to store one or more signals received from the active electrode in the first segment. The memory 62 may optionally provide instructions for simultaneously conducting an ERG test on the contralateral eye. For example, the instructions may cause a stimulus light in the second segment to flash and then cause the device to store one or more signals received from the active electrode in the second segment. As will be appreciated, conducting the test simultaneously (on both eyes) should not be limited to simultaneous flashing of stimulus lights, although simultaneous flashing may be used in some embodiments. However, in further embodiments, simultaneous testing can simply refer to device 10 conducting a series of ERG tests on a first eye of the wearer using a first compartment while conducting a series of ERG tests on a second eye of the wearer using a second compartment during the same period.

[0047] The device 10 can be configured to perform an ERG test, including a dim flash test. In some embodiments, the flash duration can be less than 0.5 milliseconds. In some embodiments, the ERG test can include only one single intensity flash. In this manner, the device 10 can be configured for one type of screening. In further embodiments, the test can include multiple flash intensities. In these embodiments, it is contemplated that multiple flash intensities can be delivered in a desired sequence or pattern. In an exemplary embodiment, the flash test can consist of a single sequence or pattern of flashes.

[0048] The device 10 can communicate with a remote computing device 1001, such as a desktop computer, tablet, or smartphone. For example, the device 10 can communicate through an output device 64, such as a cable, an I / O port, or a wireless transmitter. The device 10 and the remote computing device 1001 can communicate via any protocol, including, but not limited to, RS-232, Wi-Fi, RF, and Bluetooth.

[0049] Data from the ERG test can be further processed, for example, to determine whether the wearer has diabetic retinopathy. In some embodiments, the remote computing device 1001 can perform the data processing. Optionally, in further embodiments, the processor 60 can be configured to perform at least some (or, optionally, all) of the data processing. For example, the processor can extract abstract waveform features that can be used to diagnose early retinal dysfunction associated with diabetic retinopathy. With reference to FIGS. 5-8 , an algorithm can extract the negative time of the a-wave from the raw data. The raw data can include the potential (in microvolts) measured by the electrodes as a function of time. The negative time can indicate the period from the onset of a flash stimulus to a waveform feature (such as the a-wave, b-wave, or pulsatility). Such waveform features can optionally be local maxima and minima in the raw data (or raw data filtered by a low-pass filter) and can be extracted via software that finds such maxima and minima. For example, the software can find the first derivative of the raw data (or filtered raw data), or a curve through the raw data (or filtered raw data), and determine potential waveform features where the first derivative changes from positive to negative. Peaks of potential waveform features can be compared to a threshold to determine whether the potential waveform features are waveform features or noise based on their respective amplitudes and widths. In a further aspect, a search algorithm can search for maximum or minimum data values to find such maxima and minima.

[0050] Optionally, signal smoothing and / or bandpass filters can be used to reduce noise in the raw data or enhance features from the raw data for data processing. For example, as shown in Figure 6, the data can be passed through one or more digital bandpass filters to isolate and output rhythmic potential (OP) waveforms.

[0051] Referring to FIG. 7, the negative time and OP waveform can be input to the second layer of the algorithm. Additional waveform features, such as OPs, can be identified based on a function of the a-wave negative time and one or more waveform characteristics (e.g., the height, prominence, and width of the waveform feature). The a-wave negative time can be used as a basis for initiating the search for OPs. For example, the search algorithm can begin the search for OPs after the a-wave negative time, since waveform features cannot precede the a-wave negative time. As disclosed above, the first derivative of the data (raw or filtered) can be searched to find local minima and maxima in the data. The maxima and minima can be compared to absolute and relative amplitude and width thresholds to extract waveform features (e.g., OPs) from noise-induced maxima and minima.

[0052] The time delay from the stimulus flash to the waveform feature can indicate whether the retina is healthy or unhealthy. For example, FIG. 8 illustrates the delay of ERG rhythmic wavelet waveforms in a diabetic patient and a non-diabetic patient, but without signs of retinopathy in the fundus. The patients whose data is shown in FIG. 8 were of the same age and had no signs of ocular disease. Optionally, the time delay associated with a particular waveform feature can be automatically compared to a reference value (corresponding to recorded time delays associated with both healthy and unhealthy patients) to determine whether the patient's retina is healthy or diseased (e.g., DR), and the device can output a binary (e.g., positive / negative) diagnosis. In these optional aspects, it is contemplated that the reference value can be stored in memory (optionally as a database) and retrieved by a processor to perform the comparison. In further embodiments, the data can be output to a monitor (e.g., on a remote computing device) for review by a medical professional. For example, the time delay of the waveform feature can be provided to the professional, who can then provide a diagnosis. It is contemplated that in some embodiments, the device may provide a non-conclusive diagnosis if comparison with historical data does not produce a clear indication of the patient's retinal health. According to a further aspect, data collected by device 10 may optionally be used to test for drug toxicity, using data capture and analysis methods similar to those described herein.

[0053] To use the device 10, a medical professional or wearer can position the device over the wearer's eye. The band 42 can be adjusted until the device is comfortable while blocking substantially all ambient light from reaching the wearer's eye. The wearer can wait an acclimation period for the wearer's eye to adjust to the darkness. The acclimation period can be at least 5 minutes, at least 10 minutes, at least 20 minutes, or more. The medical professional can then cause the device 10 to execute instructions in the memory 62 to begin the test. In further embodiments, the acclimation period can be part of the instructions, including a delay period to allow for acclimation, and the device does not begin the test until the acclimation period has passed. Optionally, the device can perform an electroretinogram test on both eyes simultaneously. Alternatively, the device can perform an electroretinogram test on each eye sequentially without removing the device from the wearer's eye. The device 10, the remote computing device 1001, or the medical professional can then analyze the data collected by the test. For example, the device can output a positive or negative diagnosis on a display (e.g., an embedded display on the device or a remote display, such as one in communication with a remote computing device 1001). In further embodiments, the computing device 1001 can receive data from the device 10 and process the data as disclosed herein. In still further embodiments, a professional can analyze the data. The device can further output an error signal if a recording could not be made or if the data is unusable due to excessive noise, for example, often caused by electrodes not making proper contact with the wearer.

[0054] The disclosed system and method offer various advantages over traditional electroretinography. The device 10 can evaluate both eyes simultaneously, eliminating the need for repeated testing on the contralateral eye and reducing testing time. Furthermore, patients can dark-adapt simply by wearing the device, eliminating the need for a darkened clinic room and, as a result, clinicians or technicians do not need to work in the dark. This may allow testing to be performed outside of an ophthalmology clinic in a variety of settings, whether in primary care offices or hospitals not equipped with traditional ERG systems, specialty clinics and physicians, or remote, underserved areas lacking transportation. The device 10 can automatically process and analyze ERG recordings within the device and report information relevant to the diagnosis without the need for expert analysis. Unlike existing devices, the disclosed device 10 can provide a stimulating light flash that does not substantially change pupil size, thereby avoiding the need to provide an in-device camera or otherwise monitor pupil size.

[0055] Computing Devices 4 illustrates a system 1000 including an exemplary configuration of a computing device 1001 for use with device 10. Processor 60 and memory 62 can have a structure consistent with that of computing device 1001. Furthermore, in some embodiments, all of the aspects disclosed herein with respect to separate computing device 1001 can be integrated within device 10 such that device 10 can perform all of the functions from setting initial test parameters, to initiating the test, controlling the test, processing data, and providing diagnostic output. In further embodiments, separate computing device 1001 can interface with device 10 to control some or all of the ERG testing and analysis disclosed herein. In still further aspects, it is contemplated that computing device 1001 can communicate with and cooperate with a remote computing device 1014 to control or perform one or more portions of the ERG analysis disclosed herein.

[0056] Computing device 1001 may include one or more processors 1003, a system memory 1012, and a bus 1013 that couples various components of computing device 1001, including the one or more processors 1003, to the system memory 1012. With multiple processors 1003, computing device 1001 may utilize parallel computing.

[0057] The bus 1013 may comprise one or more of several possible types of bus structures such as a memory bus, a memory controller, a peripheral bus, an accelerated graphics port, and a processor or local bus using any of a variety of bus architectures.

[0058] The computing device 1001 may operate on and / or comprise a variety of computer-readable media (e.g., non-transitory). Computer-readable media may be any available media that is accessible by the computing device 1001 and includes non-transitory, volatile, and / or non-volatile media, removable and non-removable media. The system memory 1012 has computer-readable media in the form of volatile memory, such as random access memory (RAM), and / or non-volatile memory, such as read-only memory (ROM). The system memory 1012 may store data, such as electrode data 1007 (i.e., data from signals received by the electrodes), and / or program modules, such as electrode data processing software 1006, accessible to and / or operated by the operating system 1005 and one or more processors 1003.

[0059] Computing device 1001 may also include other removable / non-removable, volatile / non-volatile computer storage media. The mass storage device 1004 may provide non-volatile storage of computer code, computer-readable instructions, data structures, program modules, and other data for computing device 1001. The mass storage device 1004 may be a hard disk, a removable magnetic disk, a removable optical disk, a magnetic cassette or other magnetic storage device, a flash memory card, a CD-ROM, a digital versatile disk (DVD) or other optical storage, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), etc.

[0060] Any number of program modules may be stored on the mass storage device 1004. An operating system 1005 and electrode data processing software 1006 may be stored on the mass storage device 1004. One or more of the operating system 1005 and electrode data processing software 1006 (or some combination thereof) may include program modules and electrode data processing software 1006. Electrode data 1007 may also be stored on the mass storage device 1004. The electrode data 1007 may be stored in any of one or more databases known in the art. The databases may be centralized or distributed across multiple locations within the network 1015.

[0061] A user (e.g., a medical professional) may enter commands and information into the computing device 1001 using input devices (not shown). Such input devices include, but are not limited to, keyboards, pointing devices (e.g., computer mice, remote controls), microphones, joysticks, scanners, tactile input devices such as gloves and other body coverings, motion sensors, etc. These and other input devices may be connected to the one or more processors 1003 using a human-machine interface 1002 coupled to a bus 1013, but may also be connected by other interface and bus structures such as a parallel port, a game port, an IEEE 1394 port (also known as a Firewire port), a serial port, a network adapter 1008, and / or a universal serial bus (USB).

[0062] A display device 1011 may also be connected to the bus 1013 using an interface such as a display adapter 1009. It is contemplated that the computing device 1001 may have more than one display adapter 1009, and that the computing device 1001 may have more than one display device 1011. The display device 1011 may be a monitor, an LCD (liquid crystal display), a light-emitting diode (LED) display, a television, a smart lens, smart glasses, and / or a projector. In addition to the display device 1011, other output peripheral devices may include components such as speakers (not shown) and a printer (not shown), which may be connected to the computing device 1001 using the input / output interface 1010. Any step and / or result of a method may be output (or caused to be output) in any form to an output device. Such output may be any form of visual representation, including, but not limited to, text, graphics, animation, audio, tactile, etc. The display 1011 and the computing device 1001 may be part of a single device or may be separate devices.

[0063] The computing device 1001 may operate within a networked environment using logical connections to one or more remote computing devices 1014a,b,c. The remote computing devices 1014a,b,c may be personal computers, computing stations (e.g., workstations), portable computers (e.g., laptops, mobile phones, tablet devices), smart devices (e.g., smartphones, smart watches, activity trackers, smart apparel, smart accessories), security and / or surveillance devices, servers, routers, network computers, peer devices, edge devices, or other common network nodes. The logical connections between the computing device 1001 and the remote computing devices 1014a,b,c may be made using a network 1015, such as a local area network (LAN) and / or a general wide area network (WAN). Such network connections may be through a network adapter 1008. The network adapter 1008 may be implemented in both wired and wireless environments. Such network environments are conventional and commonplace in homes, offices, enterprise-wide computer networks, intranets, and the Internet. It is contemplated that the remote computing devices 1014a, b, c may optionally have some or all of the components disclosed as part of the computing device 1001.

[0064] Although application programs and other executable program components, such as the operating system 1005, are illustrated herein as separate blocks, it is recognized that such programs and components may reside at various times in different storage components of the computing device 1001 and be executed by one or more processors 1003 of the computing device 1001. An implementation of the electrode data processing software 1006 may be stored on or transmitted across some form of computer-readable media. Any of the disclosed methods may be performed by processor-executable instructions embodied on a computer-readable medium.

[0065] Exemplary Embodiments In view of the described devices, systems, and methods and variations thereof, certain more particularly described aspects of the invention are set forth herein below. However, these specifically recited aspects should not be construed as having any limiting effect on any different claims that incorporate different or more general teachings set forth herein, or that the "particular" aspects are limited in any way other than the inherent meaning of the language literally used therein.

[0066] Aspect 1: A wearable device for administering electroretinography to a wearer of the device, the wearable device comprising: a housing having a first side and a second side spaced apart relative to a horizontal axis, the housing defining first and second compartments positioned along the horizontal axis, each of the first and second compartments configured to be positioned over a respective eye of the wearer; a stimulus light source; a focused light source positioned at a location where the respective eye of the wearer will be focused during administration of the electroretinography; and an active electrode configured to engage the skin of the wearer. a housing including a ground electrode, a reference electrode spaced from the active electrode and configured to engage the skin of a wearer; at least one processor communicatively coupled to the stimulation light source, the active electrode, and the reference electrode in each of first and second sections of the housing; and a memory in communication with the processor, the memory including instructions that, when executed by the processor, implement a method including flashing the stimulation light source in the first section and storing a signal from the active electrode in the first section;

[0067] Aspect 2: The wearable device of aspect 1, wherein the memory includes instructions that, when executed by the processor, perform the step of detecting at least one characteristic of the signal.

[0068] Aspect 3: The wearable device of claim 2, wherein the memory includes instructions that, when executed by the processor, perform the step of determining a time delay between a flash of the stimulus light source and at least one characteristic of the signal.

[0069] Aspect 4: A wearable device described in any one of the preceding aspects, wherein the stimulation light sources of the first and second compartments are configured to uniformly illuminate the entire visual field of each eye of the wearer.

[0070] Aspect 5: A wearable device described in any one of the preceding aspects, wherein the stimulation light sources of the first and second sections are configured to provide a dim flash having a single flash intensity.

[0071] Aspect 6: A wearable device described in any one of the preceding aspects, wherein the stimulation light sources of the first and second sections are configured to provide multiple flashes of varying intensity.

[0072] Aspect 7: A wearable device described in any one of the preceding aspects, wherein the wearable device further includes a head strap having a first end attached to a first side of the housing and a second end attached to a second side of the housing.

[0073] Aspect 8: A wearable device according to any one of the preceding aspects, wherein the housing comprises a flexible rim configured to conform to the wearer's face.

[0074] Aspect 9: A wearable device as described in aspect 8, wherein the housing is configured to block substantially all ambient light from reaching the wearer's eyes.

[0075] Embodiment 10: A wearable device described in embodiment 8 or embodiment 9, wherein the active and reference electrodes of the first and second compartments, and the ground electrode, are embedded within the limb.

[0076] Aspect 11: A wearable device described in any one of the preceding aspects, wherein the active electrodes of the first section are positioned to engage the wearer's skin under each of the wearer's eyes.

[0077] Aspect 12: A wearable device described in any one of the preceding aspects, wherein the ground electrode is positioned to engage at least one of the wearer's forehead skin or eyebrow skin.

[0078] Aspect 13: A wearable device described in any one of the preceding aspects, wherein the reference electrode in the first compartment is further away from a plane perpendicular to the horizontal axis and bisecting the housing between the first and second sides than the active electrode in the first compartment.

[0079] Aspect 14: The wearable device of any one of the preceding aspects, further comprising an output device, the output device being one of a cable, a wireless transmitter, and an I / O port.

[0080] Aspect 15: A wearable device described in any one of the preceding aspects, wherein the housing defines a slot between the first and second compartments that is configured to conform to the shape of the wearer's nose.

[0081] Embodiment 16: A wearable device described in any one of the preceding embodiments, wherein the spacing between the focused light sources of the first and second sections is fixed.

[0082] Embodiment 17: A wearable device described in any one of the preceding embodiments, wherein the spacing between the focused light sources of the first and second sections is selectively adjustable.

[0083] Aspect 18: A wearable device described in any one of the preceding aspects, wherein each of the first and second compartments comprises a peripheral inner wall extending circumferentially around a respective eye of the wearer, and a distal wall extending between distal surfaces of the peripheral inner walls and enclosing a space viewed by the wearer's eye, and wherein the stimulating light source and the focusing light source are fixed to the distal wall.

[0084] Aspect 19: A method of using a wearable device described in any of aspects 1 to 18, comprising: positioning the wearable device over a wearer's eye; executing instructions in a memory that cause the wearable device to perform an electroretinogram test; and receiving output from the wearable device.

[0085] Aspect 20: The method of aspect 19, wherein executing instructions in the memory that cause the wearable device to perform an electroretinogram test includes performing an electroretinogram test simultaneously on each eye of the wearer.

[0086] Aspect 21: The method of aspect 19, further comprising analyzing output from the wearable device to determine whether the patient has diabetic retinopathy.

[0087] Embodiment 22: The method of any one of embodiments 19 to 21, wherein the instructions are executed after an acclimation period of at least 5 minutes.

[0088] Aspect 23: A wearable device for administering an electroretinography test to a wearer of the device, the wearable device comprising: a housing having a first side and a second side spaced apart relative to a horizontal axis, the housing defining first and second compartments positioned along the horizontal axis, each of the first and second compartments configured to be positioned over a respective eye of the wearer; the housing comprising: a stimulus light source; a focused light source positioned at a location where each eye of the wearer will be focused during administration of the electroretinography test; an active electrode configured to engage the wearer's skin; and a reference electrode spaced from the active electrode and configured to engage the wearer's skin, the housing configured to block substantially all ambient light from the wearer's eyes.

[0089] While several embodiments of the present invention have been disclosed in the foregoing specification, it will be understood that many modifications and other embodiments of the invention to which this invention pertains will come to mind to those skilled in the art having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. It is understood, therefore, that the invention is not limited to the specific embodiments disclosed above, and that many modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims that follow, they are used in a generic and descriptive sense only and not for the purpose of limiting the described invention or the scope of the claims that follow.

Claims

1. A wearable device for administering electroretinography to a wearer of the device, the wearable device comprising: a housing having a first side and a second side spaced apart relative to a horizontal axis, the housing defining first and second compartments positioned along the horizontal axis and having a ground electrode, each of the first and second compartments configured to be positioned over a respective eye of the wearer; A stimulus light source; a focused light source positioned at a location where each of the wearer's eyes will focus during administration of the electroretinogram; and an active electrode configured to engage the wearer's skin; a reference electrode spaced apart from the active electrode and configured to engage the wearer's skin; wherein the first and second compartments are each configured to create a Ganzfeld dome over each eye of the wearer.

2. at least one processor communicatively coupled to the stimulus light source, the active electrode, and the reference electrode in each of the first and second compartments of the housing; a memory in communication with the processor, the memory comprising instructions that, when executed by the at least one processor, cause the wearable device to: flashing the stimulus light source in the first compartment; storing signals from the active electrodes of the first compartment; and causing the at least one processor to detect at least one characteristic of the signal. The wearable device of claim 1 , comprising:

3. 3. The wearable device of claim 2, wherein the memory includes instructions that, when executed by the at least one processor, cause the at least one processor to determine a time delay between the flash of the stimulus light source and at least one feature of the signal.

4. The wearable device of claim 1 , wherein the stimulation light sources of the first and second compartments are configured to uniformly illuminate the entire visual field of each eye of the wearer.

5. The wearable device of claim 1 , wherein the stimulation light sources of the first and second sections are configured to provide a dim flash having a single flash intensity.

6. The wearable device of claim 1 , wherein the stimulation light sources of the first and second sections are configured to provide multiple flashes of varying intensity.

7. 10. The wearable device of claim 1, further comprising a head strap having a first end attached to the first side of the housing and a second end attached to the second side of the housing.

8. The wearable device of claim 1 , wherein the housing comprises a flexible rim configured to conform to the wearer's face.

9. 9. The wearable device of claim 8, wherein the flexible rim is configured to elastically conform to the wearer's face such that the housing blocks substantially all ambient light from reaching the wearer's eyes.

10. The wearable device of claim 8 , wherein the active and reference electrodes of the first and second compartments and the ground electrode are embedded within the flexible limb.

11. The wearable device of claim 1 , wherein the active electrode of the first compartment is positioned to engage the wearer's skin under the respective eye of the wearer.

12. 10. The wearable device of claim 1, wherein the ground electrode is positioned to engage at least one of the wearer's forehead skin or eyebrow skin.

13. 2. The wearable device of claim 1, wherein the reference electrode in the first compartment is further away from a plane perpendicular to the horizontal axis and bisecting the housing between the first side and the second side than the active electrode in the first compartment.

14. The wearable device of claim 1 , further comprising an output device, wherein the output device is a cable, a wireless transmitter, or an I / O port.

15. The wearable device of claim 1 , wherein the housing defines a slot between the first and second compartments configured to conform to a shape of the wearer's nose.

16. The wearable device of claim 1 , wherein the spacing between the focused light sources in the first and second sections is fixed.

17. The wearable device of claim 1 , wherein a spacing between the focused light sources of the first and second sections is selectively adjustable.

18. Each of the first and second compartments comprises: a peripheral inner wall extending circumferentially around each eye of the wearer and projecting distally away from each eye; a distal wall extending between distal ends of the peripheral inner wall and enclosing a space viewed by the eye of the wearer; The wearable device of claim 1 , wherein the stimulating light source and the focused light source are fixed to the distal wall.

19. The wearable device of claim 1 , wherein the wearable device is configured to perform one type of screening that includes flashes of only a single intensity.

20. 10. The wearable device of claim 1, wherein the first and second compartments each comprise ganzfeld paint or plastic that diffuses light evenly and have sufficient depth to create a ganzfeld dome over each eye of the wearer.

21. The wearable device of claim 2 , wherein the at least one processor and the memory are provided in a remote computing device.

22. A method of using the wearable device of claim 2, comprising: Positioning the wearable device over a wearer's eye; Executing instructions in the memory that cause the wearable device to perform an electroretinogram test; and receiving an output from the wearable device.

23. 23. The method of claim 22, wherein executing instructions in the memory that cause the wearable device to perform an electroretinogram test includes performing an electroretinogram test on each eye of the wearer simultaneously.

24. 23. The method of claim 22, wherein the instructions are executed after the wearer has worn the wearable device for an acclimation period of at least five minutes.

25. A wearable device for administering electroretinography to a wearer of the device, the wearable device comprising: a housing having a first side and a second side spaced apart relative to a horizontal axis, the housing defining first and second compartments positioned along the horizontal axis, each of the first and second compartments configured to be positioned over a respective eye of the wearer; A stimulus light source; a focused light source positioned at a location where each of the wearer's eyes will focus during administration of the electroretinogram; and an active electrode configured to engage the wearer's skin; a reference electrode spaced apart from the active electrode and configured to engage the wearer's skin; the housing is configured to block substantially all ambient light from the wearer's eye; wherein the first and second compartments are each configured to create a Ganzfeld dome over each eye of the wearer.

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