RU2846045C1 - System for study of subjective refraction - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine and can be used for self-examination of subjective refraction for measurement of refractive disorders in eyes. Disclosed is a method which is realized by a system comprising a device, wherein method includes steps of: displaying at least one image to the test subject, wherein said at least one image has at least one one-dimensional feature having an appearance for the test subject based on the physical characteristics of the eye of the test subject, wherein said at least one one-dimensional feature comprises at least two parallel lines; receiving input information from the test subject with respect to the appearance of said at least one image at least two distances between said eye and said at least one image, wherein said input information includes the test subject binary perception of said at least one image at said at least two distances, wherein the binary perception includes an indication of whether the subject sees said at least two parallel lines or not; and transmitting said input information from the test subject and said at least two distances.

EFFECT: group of inventions provides the objective examination of subjective refraction.

17 cl, 29 dwg

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Patent Application Ser. No. 63/044,910, filed June 26, 2020, entitled "SUBJECTIVE REFRACTION EXAM SYSTEM," the entire disclosure of which is hereby incorporated by reference.

Field of technology

[0002] The present disclosure relates generally to systems and methods for providing self-administered medical advice, and in particular relates to systems for self-administered subjective refraction testing for measuring refractive errors in the eyes.

State of the art

[0003] A refraction, also called a vision test or eye exam, is typically ordered by an ophthalmologist to determine whether a patient needs (or needs to change) prescription lenses such as glasses and contact lenses. The doctor often presents images, symbols, or words to the patient, who provides comments on the sharpness or blurriness of their vision, and this information is used to determine a prescription for the patient. In some cases, doctors may have equipment configured to scan or otherwise measure the characteristics of the patient's lens and other structures of the eye to obtain a prescription. However, this means that prescriptions are difficult to obtain without the doctor's expertise and experience or without access to specialized equipment. For this and other reasons, there is an ongoing need for improvements in refractive testing systems for measuring refractive errors in the eye.

Disclosure of the essence of the invention

[0004] One aspect of the present disclosure relates to a method comprising the steps of displaying at least one image to a subject, wherein said at least one image has an appearance to the subject based on physical characteristics of the subject's eye, receiving input information from the subject regarding the appearance of said at least one image, and transmitting said input information from the subject.

[0005] In some embodiments, displaying at least one image to a subject and receiving input from the subject includes: displaying a set of shapes to the subject and receiving input indicating a sphere of the eye; displaying a set of radial segments and rings to the subject and receiving input indicating a cylinder measurement value of the eye; displaying an image for controlling accommodation to the subject and receiving input confirming the sphere of the eye; displaying an image for testing visual acuity and receiving input about the best corrected visual acuity (BCVA) of the eye and providing instructions for relaxing the eye.

[0006] In some embodiments, displaying at least one image includes displaying said at least one image in a first size and displaying said at least one image in a second size. The at least one image may be simultaneously or sequentially displayed in the first and second sizes.

[0007] Displaying at least one image may include displaying said at least one image at a first distance measured along an optical path between the subject and the at least one image, and displaying said at least one image at a second distance measured along the optical path between the subject and the at least one image.

[0008] In some embodiments, the input information is subjective input information based on physical characteristics of the eye of the subject. The input information from the subject may include an indication of the brightness value of a portion of the at least one image. In some embodiments, the method further includes providing instructions to the subject to change the optical path length between the subject and the at least one image. The input information from the subject may include an indication of the sharpness of a portion of the at least one image.

[0009] Another aspect of the present disclosure pertains to a product comprising one or more tangible computer-readable non-transitory storage media comprising computer-executable instructions configured to, when executed by at least one computer processor, cause said at least one computer processor to cause a computing device to perform the following steps: display at least one image to a subject, wherein said at least one image has an appearance to the subject based on physical characteristics of the subject's eye; receive input from the subject regarding the appearance of said at least one image; and transmit the input from the subject.

[0010] Another aspect of the present disclosure relates to a device for subjectively testing an optical parameter of the eye of a subject, wherein the device comprises: a processor; a display; an input device; a network device, and a memory device including executable instructions. The instructions may be configured to, when executed by the processor: display at least one image to the subject via the display, wherein said at least one image has an appearance to the subject based on physical characteristics of the eye of the subject; receive input information from the subject via the input device regarding the appearance of said at least one image; and transmit the input information from the subject via the network device.

[0011] The above disclosure is not intended to describe each embodiment or every mode of implementation of the present invention. The drawings and detailed description in the "Design" section that follows more particularly exemplify one or more preferred embodiments.

Brief description of the drawings

[0012] The accompanying drawings and figures illustrate a number of exemplary embodiments and are a part of the description. Together with the present description, these drawings illustrate and explain various principles of this disclosure. A further understanding of the nature and advantages of the present invention can be realized by reference to the following drawings. In the accompanying drawings, similar components or features may have the same reference designation.

[0013] Fig. 1 shows a schematic illustration of a system 100 for obtaining a subjective refraction of a subject.

[0014] Fig. 2 shows a flow chart of the user process for subjective refraction of a subject.

[0015] Fig. 3 shows a flow chart of an interactive process for setting up a testing environment for an online refraction test.

[0016] Fig. 4 shows a flow chart of the refraction testing process.

[0017] Fig. 5 shows the target for screening.

[0018] Fig. 6 shows a target for determining the location of an approximate sphere.

[0019] Fig. 7 shows an exemplary group of steps for testing forms.

[0020] Fig. 8 shows a target for testing radial sections and rings.

[0021] Figs. 9A-9B show an exemplary group of steps for testing radial sections and rings.

[0022] Fig. 10 shows the purpose of the achromatic monograting.

[0023] Figs. 11A-11G show an exemplary set of testing steps for an achromatic monograting.

[0024] Fig. 12 shows the target for cylinder confirmation.

[0025] Fig. 13 shows an exemplary group of steps for testing to confirm a cylinder.

[0026] Fig. 14 shows an exemplary group of steps for testing for axis refinement.

[0027] Fig. 15A-15B show an exemplary group of steps for testing for accommodation control.

[0028] Fig. 16 shows an exemplary group of steps for testing visual acuity.

[0029] Fig. 17 shows an exemplary group of steps for testing the cylinder size.

[0030] Fig. 18A-18B show an exemplary group of steps for testing a cylinder size.

[0031] Fig. 19 shows a block diagram of the software system.

[0032] Fig. 20 shows a functional diagram of a subjective optical parameter testing system.

[0033] While the embodiments described herein are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. However, the exemplary embodiments described herein are not intended to be limited to the specific forms disclosed. On the contrary, the present disclosure covers all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Implementation of the invention

[0034] Embodiments of the present disclosure relate to a subjective refraction testing process that includes a combination of multiple stages or portions of a testing process. Each of the stages may include displaying at least one specially designed image to a user (i.e., a subject), wherein this image or set of images may be referred to as a "target." The target may have a different appearance to the subject according to the physical characteristics of his eyes (e.g., their refraction, color matching, etc.), their distance from the target, the size of the target, the graphic design of the target (i.e., contrast, brightness, etc.) and similar factors. At each stage, the testing process may be used to determine one or more optical parameters of the subject based on measurements and/or calculations of the distance along the optical path from the target to the subject, based on a change in the size of the target and/or based on what the subject actually sees based on his input information (e.g., verbal responses or other data entered into a computing device). Taken together, these parameters can be used to determine the details of the subject's refractive error, including, for example, its spherical, cylindrical, and axial measurement values. In some embodiments, the testing process can include instructing the subject via visual and auditory information to guide the user through the test. In some configurations, the test is performed for each eye separately, while covering the opposite eye, so that the subject performs the test twice.

[0035] The testing process may be self-administered, meaning that the subject may be the user who controls and implements the testing process. Thus, in some embodiments, the subject may be alone or without assistance from other people during the testing process. The results of the testing process may, in some cases, be provided to a third party (e.g., an ophthalmologist) for interpretation of the results and appropriate clinical action. Information collected using the testing process (e.g., the subject's spherical, cylindrical, and axial measurement values) may be used to formulate a diagnosis of the subject's needs. For example, the subject's refractive error measurement values may be used to formulate a prescription for glasses and/or contact lenses for the subject.

[0036] The testing process can be used with subjects of various ages, including, for example, adult males and females between the ages of 18 and 39, and with subjects with various spectacle and/or contact lens prescriptions, including, for example, sphere powers between 1.00D and -5.00D, cylinder powers up to -2.50D, and combined (sphere + cylinder) powers up to -6.00D.

[0037] In some embodiments, the measurement values captured during the testing process are not displayed to the user or test subject. They may instead be presented to a third party, such as a licensed health care provider, for access and interpretation. Thus, in some cases, the third party may be able to access the output of the testing process to take appropriate action (e.g., clinical action or confirmation). The third party may access the measurement values of the testing process and related information through the testing device used to obtain the measurement values and related information, or the information may be transmitted to the third party (e.g., via a network) for access.

[0038] Various types of output data can be generated using the above processes and systems, including, for example, information on the correspondence of the output information (including the spherical power, the cylinder power, and the cylinder axis for both eyes) for each eye by performing two separate testing processes, or information on the correspondence of the binocular BCVA between the testing process and the SOC assessments performed sequentially. In addition, information on the correspondence of the output information (including the spherical power, the cylinder power, and the cylinder axis for both eyes) for each eye between the testing process and the SOC assessments performed sequentially can be generated.

[0039] In an exemplary embodiment, the compliance information for each measurement value in each eye may indicate whether 80% is within certain optical parameters, such as, for example, sphere power: ±0.50D, cylinder power: ±0.50D, and cylinder axis: ±20 degrees. In some embodiments, the axis parameter may not be compared when the cylinder power is between -0.25D and 0.00D.

[0040] The present description provides examples and does not limit the scope, applicability or configuration set forth in the claims. Thus, it will be understood that changes can be made in the function and arrangement of the discussed elements without departing from the spirit and scope of the present disclosure, and various embodiments can omit, substitute or add other procedures or components as needed. For example, the described methods can be performed in an order different from the order described, and various steps can be added, omitted or combined. Also, features described with respect to some embodiments can be combined in other embodiments.

[0041] Fig. 1 is a schematic illustration of a system 100 for obtaining a subjective refraction of a subject in accordance with the examples described herein. It should be understood that this and other arrangements and elements (e.g., machines, interfaces, functions, orders and groupings of functions, etc.) may be used in addition to or instead of those shown, and some elements may be omitted altogether. Additionally, many of the elements described may be implemented as separate or distributed components or in conjunction with other components, and in any suitable combination and location. The various functions described herein as being performed by one or more components may be performed by firmware, hardware, and/or software. For example, and as described herein, the various functions may be performed by a processor executing instructions stored in a memory.

[0042] Among other components not shown, the system 100 of FIG. 1 includes at least one data store 104, at least one computing device 106, at least one imaging device 108, and at least one display device 110. The computing device 106 may include a processor 116 and a memory 118. The memory 118 includes (e.g., may be encoded with) executable instructions 120 for performing a subjective refraction testing process. The memory 118 may comprise a non-transitory computer-readable medium having the instructions 120 stored therein or encoded thereon. The imaging device 108 may capture an image (e.g., a photograph) or a sequence of images (e.g., photographs or video images). It should be understood that the system 100 shown in FIG. 1 is an example of one suitable architecture for implementing certain aspects of the present disclosure. Additional, fewer and/or different components may be used in other examples. It should be noted that embodiments of the present disclosure are equally applicable to other types of devices, such as mobile computing devices and devices that accept gestures, touch and/or voice input. Any and all such variations, and any combination thereof, are considered to be within the scope of embodiments of the present disclosure. Additionally, although illustrated as separate components of the computing device 106, any number of components may be used to perform the functionality described herein. Although illustrated as being part of the computing device 106, the components may be distributed across any number of devices. For example, the processor 116 may be provided by one device, server or server cluster, while the memory 118 may be provided by another device, server or server cluster.

[0043] As shown in Fig. 1, the computing device 106, the imaging device 108, and the display device 110 may be electronically connected to each other via a network 102, which may include, without limitation, one or more direct (e.g., wired) connections, local area networks (LANs), and/or wide area networks (WANs). Such network environments are common in offices, corporate computer networks, laboratories, homes, intranets, and the Internet. Accordingly, the network 102 is not further described herein. It should be understood that any number of computing devices, sensors, and/or meters may be used in the system 100 within the scope of embodiments of the present disclosure. Each embodiment may comprise one device or a plurality of devices interacting in a distributed environment. For example, the computing device 106 may be provided by a plurality of server devices that collectively provide the functionality of the computing device 106 as described herein. Additionally, other components not shown may also be included in the network environment. In some embodiments, individual components may electronically communicate directly with one another.

[0044] The computing device 106, the imaging device 108, and the display device 110 may access (e.g., via the network 102) at least one data store or repository, such as the data store 104, which may include any data related to prescription data, refractive measurement values of the eye, refractive data, user data, size data, historical data, and comparative data, as well as any metadata associated therewith. The data store 104 may further include any data related to methods or executable instructions for obtaining a refraction using a subjective refraction testing process, images for presentation to a test subject, instructions for a test subject or an ophthalmological practitioner, product properties, control signals, and indicator signals. In embodiments of the present disclosure, the data store 104 may be accessible for searching its data and the methods or executable instructions described herein.

[0045] Such information stored in the data store 104 may be accessible to any component of the system 100. The content and scope of such information are not intended to limit the scope of aspects of the present technology in any way. Additionally, the data store 104 may be a single, independent component (as shown) or a plurality of storage devices, such as a database cluster, portions of which may be in associative communication with the computing device 106, the imaging device 108, the display device 110, another external computing device (not shown), and/or any combination thereof. Additionally, the data store 104 may include a plurality of unrelated data repositories or sources within the scope of embodiments of the present technology. The data store 104 may be local to the computing device 106, the imaging device 108, or the display device 110. The data warehouse 104 can be updated at any time, including information on the conversion of water activity to water content for various products, isotherms, measurement values, historical weight, water activity or water content data, etc.

[0046] Examples of the imaging device 108 described herein may generally implement the collection of image information. In some embodiments, the imaging device 108 may be part of the computing device 106, such as being located in a housing of the computing device 106. In some embodiments, the computing device is a mobile computing device, such as a smartphone device or a tablet computer, configured with a camera as the imaging device 108. In some embodiments, the imaging device 108 comprises a plurality of imaging devices adapted to collect image data. A single imaging device 108 may be used to obtain an image of a user, the user's eyes, a displayed image (e.g., on the display device 110), or other objects, or a plurality of imaging devices may be used to obtain different images. In some embodiments, the imaging device 108 may be used to obtain user control signals, commands, or other user signals. For example, the subject may provide input to the computing device 106 using the imaging device 108 (e.g., by looking in a certain direction, focusing on a particular target image, speaking into the imaging device 108, etc.).

[0047] Display device 110 may be used to display images to a subject or another user of system 100. In some embodiments, display device 110 may comprise an electronic display (e.g., a liquid crystal display (LCD), an e-ink display, an image projector, or a similar device). In some cases, display device 110 may comprise non-electronic display devices such as posters, prints, books, and similar devices, and the display device is not electronically connected to network 102. Display device 110 may be used to present a plurality of images to a subject, such as images for assessing refractive error in spherical, cylindrical, and axial dimensions. The subject may view images on display device 110 and provide input to computing device 106 regarding his perception (e.g., sharpness or blurriness) of the images. Based on feedback from the subject, display device may be configured to present different images to the subject in order to assess different aspects of his vision.

[0048] Examples herein may include computing devices, such as computing device 106 in Fig. 1. Computing device 106 may, in some examples, be combined with one or more sensors (e.g., imaging device 108, microphones, keyboards, and other input devices) described herein. Computing device 106 may be further centralized, such as not combined with one or more sensors described herein. In some examples, computing device 106 may be implemented using one or more computers, servers, smartphones, smart devices, or tablets. Computing device 106 may provide the testing processes described herein. Computing device 106 may include computer-readable media encoded with executable instructions (e.g., 120), and a processor 116 that can execute the instructions to provide power system stabilization and vibration damping control. As described herein, the computing device 106 includes a processor 116 and a memory 118. The memory 118 may include executable instructions for weighing and tracking a change in moisture content or detecting a loss of a result. In some embodiments, the computing device 106 may be physically connected to the imaging device 108 and/or the display device 110 (e.g., the components may be combined and/or may be connected using a wired interface such as a bus, an interconnect, a board, etc.). In other embodiments, the computing device 106 may not be physically connected to the imaging device 108 and/or the display device 110, but be co-located with the imaging device and/or the display device. In yet other embodiments, the computing device 106 may neither be physically connected to the imaging device 108 and/or the display device 110, nor be co-located with the imaging device 108 and/or the display device 110. Data provided by the imaging device 108 or the display device 110 may be stored in a location accessible to other components in the system in some examples.

[0049] While the imaging device 108 and the display device 110 are shown in Fig. 1, any number may be used. In some embodiments, a single tool may be used to perform the functions of these devices. Additionally, the systems described herein may include a plurality of sensors or output devices distributed throughout the system.

[0050] Computing devices, such as computing device 106 described herein, may include one or more processors, such as processor 116. Any type and/or number of processors may be present, including one or more of the following: central processing unit(s) (CPU), graphics processing units (GPU), other computer processors, mobile processors, digital signal processors (DSP), microprocessors, computer chips, and/or processors configured to execute machine language instructions and process data, such as executable instructions 120. Computing device 106 may also contain other computer components (not shown) to enable and communicate computing device 106, such as, for example, an input/output controller, a display or other output device, input devices, network interfaces, etc. with each other.

[0051] Computing devices, such as the computing device 106 described herein, may further include memory 118. Any type or kind of memory may be present (e.g., read-only memory (ROM), random access memory (RAM), solid-state drive (SSD), and secure digital card (SD card). While a single unit is depicted as memory 118, any number of memory devices may be present. Memory 118 may be in communication (e.g., electronically coupled) with processor 116.

[0052] Memory 118 may store executable instructions for execution by processor 116, such as executable instructions 120 for determining subjective refraction of the eyes of the subject. Processor 116, communicatively connected to imaging device 108 and display device 110, and by executing executable instructions 120 for determining subjective refraction, may track input information of the subject and changes based on collected data from imaging device 108, among other input devices.

[0053] Some embodiments relate to software in the form of a medical device (SaMD) and a mobile medical application (MMA) for self-administered subjective refraction testing that measures refractive error for each of the user's eyes. Embodiments of the system may be referred to as "GoEyes" herein. The testing is a combination of several stages, each of which contains a specially designed image called a "target". The target may appear visually different to the user according to his refraction, distance from the target, and size of the target. At each stage, a special optical parameter is measured and calculated by analyzing the distance from the target, the change in target size, and what the user actually sees, based on the user's verbal responses. Together, these parameters will provide users with full details of their refractive error in terms of spherical, cylindrical, and axial measurement values. Instructions, both visual and auditory, will be provided to guide the user through the testing. The test is performed for each eye separately while covering the opposite eye, so the user will need to perform the test twice.

[0054] The target user has myopia or myopia with astigmatism. The supported range of the testing application (GoEyes) may be defined as follows: sphere power from -1 diopter (D) to -5D, cylinder power up to -2.5D, and total power (sphere + cylinder) up to -6D. The testing application may be adapted to identify users who are outside the tested range and stop testing them.

[0055] Clinical principles

[0056] The systems of the present disclosure may employ the following clinical principles: The maximum distance of best acuity (MDBA) is the greatest distance from the eye at which the user can still focus an image on their retina. The MDBA (in meters) correlates with the best corrective lens power (BCLP) (in diopters), such that Therefore, accurate measurement of the distance between the smartphone and the user's eye is the basis for calculating MDBA and BCLP.

[0057] The size of the target on the retina of the eye is identified in LogMAR units, which represent features in angular resolution that are correlated with visual acuity tables. There is a minimum angular size that a user with normal visual acuity can see at the focal point and be able to resolve details in the image, such as sharp edges, different colors or shades, etc. The farther the user is from his MDBA (or, in other words, "the greater the blur"), the greater the angular size will be required for him to be able to resolve details in the image. Using projected images, or "targets", that contain specific details that are perceived differently when blurred compared to when clear, the user can identify a clear point in the distance when the image goes from blurred to clear (and vice versa). This point indicates the MDBA.

[0058] Accommodation is the adjustment of the optical system of the eye to keep an object in focus on the retina of the eye when its distance from the eye changes. By using MDBA (i.e., finding the most distant focal point), a decrease in accommodation can be achieved.

[0059] Based on the MDBA, the target size on the retina, and the accommodation attenuation, the system may use four fundamental tests/steps to obtain spherical, cylindrical, and axial measurement values for the test eye using the front camera of the smartphone and the depth sensor (e.g., IPHONE® X and above or ANDROID® 6.0 and above) to measure the distance of the test eye from the smartphone screen.

[0060] The system may implement steps including: first, displaying a dedicated target (e.g., an image) for a particular aberration. Next, weakening the accommodation. Third, determining the location of the near point and measuring the MDBA distance. Next, inferring the refractive error from .

[0061] In addition to the above, in some embodiments, the user (subject) may be required to meet the following criteria:

[0062] (1) Have a previous prescription for glasses and/or contact lenses in the supported range, i.e., a sphere power in the range of about -1.00D to about -5.00D, a cylinder power of up to about -2.50D, and a combined power (sphere + cylinder) of up to about -6.00D;

[0063] (2) Have single vision only (no multifocal, bifocal, or progressive lenses);

[0064] (3) Not having a prismatic dimension in its previous prescription;

[0065] (4) Have no history of amblyopia, diabetes, hypertension, glaucoma, cataracts, retinal detachment, strabismus, head injury, neurological problems, etc.;

[0066] (5) Have no recent discomfort or symptoms of acute eye pain, flashes and/or floaters in the eyes; and

[0067] (6) Can hear, understand, and respond verbally to auditory instructions.

[0068] Embodiments of the systems of the present disclosure may be loaded and accessed without first contacting the ECP. Over-the-counter (OTC) use may be supported through appropriate labeling and human factors testing to ensure that mitigations in identified use-related risks are sufficient. In addition, the results of testing the system may be hidden from, inaccessible to, or otherwise not disclosed to the test subject until the output has been reviewed and verified by the ECP.

[0069] The proposed clinical sequence of operations, as an example, is as follows:

[0070] (1) User - The user may download an application of computer-executable instructions to their smartphone or other computing device adapted for testing (e.g., a computing device having an input device (e.g., a camera, a depth sensor, and a microphone) and an output device (e.g., a display device and a speaker). The user then launches the application. The user completes a questionnaire regarding their medical history and the need for a prescription for glasses and/or contact lenses. The purpose of the questionnaire is to identify whether the user is in a specified user population and to provide access to refraction testing. The user will follow the audio instructions provided by the application and perform refraction testing for both eyes. The user will receive a message indicating that the test is complete and the results are reviewed by an eye care provider (ECP). The device may communicate/transmit testing data to the ECP.

[0071] (2) ECP - The ECP will receive a message indicating that the test in question is pending review and its system can accept data collected from the user device. The ECP will access a secure online environment that will provide test details: the user's responses to the questionnaire, test parameters, and results for spherical, cylindrical, and axial measurement values. The ECP will review the test details and determine whether to approve or reject the test details.

[0072] (3) User - If the testing details were approved, the user will receive their prescription along with a recommendation to test their corrected visual acuity upon receipt of their glasses and/or contact lenses by taking an online visual acuity test. If the testing details were rejected, the user will receive a message directing them to an in-person examination by the ECP.

[0073] An exemplary user flow is described in Fig. 2, which may be initiated after the user has downloaded the application to his mobile device. The following paragraphs detail each action illustrated in Fig. 2. The steps, actions, and tests described in connection with Fig. 2 may be applied, bypassed, or skipped, and it should be understood that portions of the process shown in Fig. 2 are optional.

[0074] Questionnaire - When a user first opens the application, the user may be prompted to complete a questionnaire before continuing. The questionnaire may obtain the user's medical history and address various inclusion/exclusion requirements before performing refractive testing. The user's inclusion requirements may be defined as including: (1) Being between 18 and 39 years of age; (2) Having normal color vision; (3) Being prescribed or using single vision corrective eyeglasses in the supported range; and (4) Being able to use, understand, and respond to voice instructions from the mobile device.

[0075] Examples of user exclusion requirements may be defined as including the following: (1) Has been prescribed or is using reading glasses, multifocals, bifocals, or progressive lenses; (2) Has a prismatic correction in his or her prescription; (3) Has a history of amblyopia, diabetes, hypertension, glaucoma, cataracts, retinal detachment, strabismus, head injury, neurological problems, etc.; or (4) Has recent discomfort or symptoms of sharp eye pain, flashes of light, and/or floaters in the eyes.

[0076] Check if the device is supported - Once the user has been identified as part of the specified user population, the application may check the mobile device model and will accept devices that have the required hardware and software configurations (e.g., IPHONE X and above with iOS 13.0 and above and ANDROID models according to the whitelist with OS ANDROID 6.0 MARSHMALLOW and above). Automatic alerts may notify the user if the mobile device is not supported or if certain sensors (e.g., the gyro sensor) are not responding.

[0077] The application may use at least two methods for distance measurements. First, a distance or depth sensor (e.g., a TRUEDEPTH® sensor or an infrared dot projector), which does not require calibration but is not available in all mobile devices, or second, an RGB camera method (e.g., if dedicated depth sensors are not available).

[0078] Onboarding - If the mobile device is supported, the user may be directed through an onboarding step. The onboarding may include the following steps: (1) Presenting an "About" page that introduces users to the application, (2) Presenting a user agreement with the application's privacy notice and terms and conditions, and (3) Requesting access to desired phone features (e.g., camera, microphone, and speech recognition). The onboarding may also include providing guidance to users about the requirements of the testing environment.

[0079] Training - Next, users may be guided through a training step. The training (shown schematically in Fig. 3) may be an interactive sequence of operations where the user will set up the testing environment conditions for online refractive testing. The steps in the training may include operations to: (1) Guide the user on how to place the device; (2) Ensure that the device is placed in a stable state; (3) Ensure that the device is placed in a portrait position; (4) Ensure that the device is placed at the correct angle; (5) Ensure that the user's face is detected; (6) Guide the user to remove his glasses and cover his left eye; and (7) Ensure that the user understands how to use the audio communication.

[0080] Refraction Testing (Left and Right Eyes) - Refraction testing 400 may be performed for each eye separately, starting, for example, with the user's right eye, as shown in Fig. 4, then switching to the left eye.

[0081] Shapes - The shape step (i.e., 402 shape testing) may include steps to screen out users with severe myopia, emmetropia, and hyperopia who should be excluded from testing (i.e., < -5D and > -1D); and finding the approximate sphere of the eye being measured.

[0082] Targets in shape testing may be configured and designed to emphasize spatial isotropic features while the target is within a distance corresponding to the refractive error of the sphere equivalent. When the target is beyond the sphere distance, the target may disappear (i.e., the blurred target features are perceived as blending into the background). Shapes may "appear" to the subject directly when the user reaches the distance where the image initially strikes the retina, thereby obtaining an MDBA for the sphere equivalent power.

[0083] The screening target may include one large shape (e.g., a duck) and two small shapes (e.g., small ducks, as shown in Fig. 5), and the target for determining the location of the approximate sphere consists of a combination of the first shape and a set of other shapes (Fig. 6). The number of the first shape and the additional shapes (and their order) may be shown randomly.

[0084] An example of shape testing is shown in Fig. 7 for a user whose right eye has a -3D sphere, a -0.5D cylinder, and an axis of 135 degrees. Shape testing may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[0085] Spokes and Rings (SNR) - Spokes and Rings (SNR) testing 404 may include: (1) Identifying whether the user has astigmatism, (2) Measuring the axis of a cylinder if astigmatism exists, and (3) Measuring the optical power of a sphere by obtaining MDBA features at a specified meridian.

[0086] If an asymmetric optical aberration such as astigmatism exists, the perceived SNR image (e.g., the target shown in Fig. 8) may appear deformed to the subject according to the astigmatic aberration. When the phone is placed near the distance of the sphere, spatial features aligned with the astigmatism axis "fall" onto the retina of the eye and are thus perceived as dark and sharp lines, while perpendicular features are focused as being in front of the retina of the eye and are thus perceived as gray and blurred.

[0087] Once an axis has been identified where some lines are darker than others (astigmatic), or in the absence of astigmatism (spherical) where all lines are perceived symmetrically, the user can provide feedback by ranking the perceived sharpness and darkness of lines at further distances on a numerical scale. The identification of the farthest distance of perceived sharpness beyond which lines appear blurred is used to determine the MDBA of the sphere.

[0088] An exemplary SNR target is shown in Fig. 8. The "radial segments" may be labeled with different colors to help users identify which lines appear darkest or "blackest" and how sharp these lines are on a numerical scale, as indicated in Figs. 9A-9B.

[0089] An example of SNR testing is shown in Fig. 9A-9B for a user whose right eye has a -3D sphere, -0.5D cylinder, and 135 degree axis. SNR testing may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[0090] Achromatic Monograting - Testing 406 of an achromatic monograting may specify a spherical power measurement value and, for astigmatism, obtain a cylinder power measurement value. An exemplary achromatic monograting target is shown in Fig. 10. The target is designed to blend two parallel mid-bright lines into a dark rectangular background strip when a slight blur is introduced and, therefore, has a binary perception by the subject (i.e., he only sees or does not see the target). The target has one-dimensional features (i.e., lines) and can be rotated to the meridian being tested; thus, the responses are related to the power of the specific rotated meridian being tested (e.g., the meridian identified in conjunction with the SNR testing). This enables the system to obtain the subject's MDBA by requiring the user to back away (i.e., move away from the displayed image) until the mid-bright lines are no longer visible, and to provide feedback at such distances. Displaying the target at multiple frequencies (i.e., display refresh rates) is used to identify the optical transfer function and obtain the spherical and near forces, respectively.

[0091] An example of testing an achromatic monograting is shown in Figs. 11A-11G for a user whose right eye has a -3D sphere, a -0.5D cylinder, and a 135 degree axis. Testing an achromatic monograting may vary depending on the user's responses to cues provided by the testing system, such as repeating steps, changing the images shown, waiting for the subject, etc.

[0092] Cylinder Verification (CYL) - Testing 410 for cylinder verification (CYL) can refine the axial measurement and obtain a near power measurement value using the MDBA approach by processing the estimated sharpness vector for the cylinder meridian. An example target for CYL verification is shown in FIG. 12. Observation of the effect of the astigmatism angle for the presented features is optimal when viewed at a sphere distance. After the sphere power is obtained (e.g., using the achromatic monograting target of FIG. 10, and as described above), the axial measurement is repeated at the sphere distance (as opposed to the approximate sphere equivalent distance). In addition, in order to increase the resolution of the axial measurement, the system can use a super-resolution procedure on a low resolution target. In other words, a target with a particular fundamental angular feature, such as the angle created by two adjacent radial segments, can be rotated by half of this fundamental angle. Then, two (or more) measurement values can be averaged.

[0093] Obtaining MDBA for features presented on the cylinder meridian corresponds to the near force. Positioning the phone near the approximate near force (obtained in the previous steps) and conducting a survey about the user's perceived sharpness for features that coincide with the cylinder axis provides a quantitative measure of the MDBA function near the near force.

[0094] An example of testing for CYL confirmation is shown in Fig. 13 for a user whose right eye has a -3D sphere, -0.5D cylinder, and a 135 degree axis. Testing for CYL confirmation may vary depending on the user's responses to cues provided by the application, such as repeating steps, changing the images shown, waiting for the subject, etc.

[0095] Axis Refinement - Axis refinement testing may refine the axial measurement value by receiving feedback on the darkest lines while the target itself is rotated at smaller angles than the angles between two adjacent radial segments. An example target used for axis refinement testing may be the same as the target used for SNR testing (i.e., FIG. 8).

[0096] An example of an axis refinement test is shown in Fig. 14 for a user whose right eye has a -3D sphere, a 1.5D cylinder, and a 5 degree axis. The axis refinement test may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[0097] Accommodation control - Accommodation control testing 412 may confirm the optical power of the sphere in an accommodation attenuation procedure. Provided that both eyes of the user are open, the eyes are allowed to achieve a minimal accommodative state. The target used for accommodation control testing may be the same as the target used for testing the achromatic monograting (e.g., Fig. 10). The system may require rapid responses (e.g., within about 2-3 seconds) to the target after the eye being tested is closed again. In such a short period of time, unwanted accommodation has not yet contributed, and therefore the eye is tested in a substantially or completely accommodation-free state.

[0098] An example of testing for accommodation control is shown in Fig. 15A-15B for a user whose right eye has a -3D sphere, -0.5D cylinder, and a 135 degree axis. Testing for accommodation control may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[0099] Visual Acuity (VA) - Visual acuity (VA) testing 414 may confirm that the best corrected visual acuity (BCVA) for a given refractive error is 20/25 or better. The target used for VA testing is the same as the target used for testing the achromatic monograting (e.g., Fig. 10). The target shown may be two bright lines separated by 6 arc minutes. The Early Treatment Diabetic Retinopathy Study (ETDRS) 20/20 symbol size is 5 arc minutes with each band 1 arc minute. Low contrast lines with a high contrast background span the resolution interval. Visual acuity at different meridians without cylindrical lenses is obtained by aligning a one-dimensional target with the meridian being tested.

[00100] An example of VA testing is shown in Fig. 16 for a user whose right eye has a -3D sphere, -0.5D cylinder, and 135 degree axis. VA testing may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[00101] Cylinder Magnitude (CYL) - Cylinder Magnitude (CYL) testing 416 can confirm the cylinder power while mitigating any temporal changes in the accommodative state. Additionally, CYL magnitude testing is obtained by measuring the sphere power. An exemplary target used for CYL magnitude testing is shown in FIG. 17, which includes a pair of dark bands oriented at different angles relative to each other, and each dark band has a corresponding pair of light parallel lines passing through them. A dashed line divides the dark bands into left and right sides of the target image, and two indicators (e.g., symbols) indicate different sides of the dashed line. When the primary cylinder power measurement metrics are obtained from the sphere power and the near power taken at two different times, a change in the accommodative state between them can affect the calculated cylinder power. To mitigate this, the user can position themselves at the distance of their sphere power at which the threshold of the required resolution is reached for each principal meridian (i.e., the sphere meridian). The system can then guide the user to identify the LogMAR delta and the distance at which the user moves from a position where they can identify both meridians to a position of approximately +0.25D where both meridians can no longer be identified. The system can then confirm the cylinder power from the delta between the meridian targets.

[00102] An example of testing the CYL value is shown in Fig. 18A-18B for a user whose right eye has a -3D sphere, -0.5D cylinder, and a 135 degree axis. Testing the CYL value may vary depending on the user's responses to cues provided by the application, such as by repeating steps, changing the images shown, waiting for the subject, etc.

[00103] Blurred Background - The 418 blurred background test determines the final MDBA while relaxing the accommodation. The system may set the user's distance to approximately +0.75D blur from the final sphere and may confirm that the user cannot achieve better resolution than 0.55 LogMAR using an achromatic monograting target (e.g., Fig. 10). The system may employ accommodation relaxation techniques that push the user to a more distant location from the display screen while maintaining the same best corrected visual acuity. This is derived from the methodology used in optometry to relax accommodation by placing +1.00D lenses above the subject's received prescription and confirming that visual acuity has deteriorated as expected with the +1.00D lens. While any extra accommodation will produce poorer vision with this myopic shift, the user should probably reduce accommodation. Likewise, the system can push the user further away from the received sphere or near power, creating the same +1.00D in vergence eye movements.

[00104] "Give Your Eyes a Rest" - Throughout the process flow of Fig. 4 and between tests/steps in the process flow, the application guides the user to rest their eyes by looking as far away as possible (e.g., to the horizon, out the window, etc.).

[00105] Second eye sequence - At the end of the first eye sequence (e.g., the right eye was tested), the system may instruct the user to close the other eye (e.g., the left eye) and provide input (e.g., a click) to continue. The second eye testing sequence (e.g., beginning at block 420) may skip training blocks and may include short versions of the audio instructions provided earlier during the first eye sequence.

[00106] Results - After both eyes have been evaluated using the refraction test, the user may be presented with a 422 message stating that the testing is complete and that the results have been electronically sent to the ECP. The ECP may use these results and the questionnaire data as part of its comprehensive diagnostic process. The user may not be able to view their results in the application until the ECP verifies the results and writes a prescription for glasses and/or contact lenses.

[00107] Device Development Overview

[00108] Fig. 19 illustrates an exemplary block diagram of a software system. The system consists of a mobile device application, cloud servers, and a SPA (single page application) web client. The system may be designed to support various operating systems and devices, such as, for example, IOS and ANDROID-based mobile devices (on the white list of supported devices).

[00109] Each of the following components can run separately in a different environment: IOS/ANDROID application, PHP server running on a server (e.g. AWS server), CMS (administration client) running in a browser (e.g. CHROME® browser (downloaded from the server)).

[00110] The system can be designed using a classic client-server architecture. Clients present data to the user and accept user input, and the server receives requests from the client, prepares the data, and sends it back to the client. The system uses a thin-client architecture wherever possible. The core logic of the system occurs only on the server. Only the required real-time logic is computed on the client.

[00111] The system client can be divided into an SDK (software development kit) responsible for all the testing application screens and logic, and an application serving the container that runs the SDK.

[00112] The testing application and the associated system may include various software modules.

[00113] Client Mobile GlassesOnSDK - This module can be configured as a wrapper for all client code of the testing application. All logic, sensor inputs, and network connectivity to the server are performed in this high-level module. This module can also wrap other client code of the product. The API of this module can be used to integrate the functionality of the testing application into third-party applications.

[00114] Client Mobile GoEyes Application - This module can be configured as a container running only the Client Mobile GlassesOnSDK and can provide the ability to test, deploy, and distribute SDK functionality within the application.

[00115] Client Session Manager Module - This module may be configured to be responsible for all client-side logic in the testing application exploration. The logic for some portion of the testing application exploration process must be evaluated in real time. This logic may be written to/included in this module. The module definition and parameters may be taken from the Server Session Manager Module Flows and Pages submodules. The module may accept or receive parameters from the server (data from the Sensor Input Modules and the decision result from the Client State Machine Logic Module) and decide what to present to the consumer in the client application. This module may be used as a bridge for network connectivity between the client and the server.

[00116] Client State Machine Logic Module - This module may be a submodule of the Client Session Manager Module. This module may be specifically designed to contain client-side logic for deciding what to present to the user regarding sensor input and the current state of the workflow. This client logic may be real-time logic, so it cannot use the Server Session Manager Module.

[00117] Client Sensor Input Modules (Services) - This module can be configured as a wrapper for all sensor service submodules on the client. Each service receives raw data from a sensor and runs relevant computations on the data and provides the results to the Client Session Manager Module. Some services run neural networks on the data received from sensors, for example using the CORE ML (IOS)/TENSORFLOWLITE (ANDROID) framework.

[00118] Server Session Manager - GoEyes Server Logic Module - This module can be responsible for all the logic in a testing application study. The logic can be divided into workflows. Each workflow is a definition of a state machine for the pages viewed by the consumer. A workflow can define the order of the pages. Each page submodule is a definition of what the consumer is viewing and all the internal logic of that particular page (i.e. screen). This module can supply the client with all the information needed to decide what page should be presented to the client next and all the parameters for how to display the page and its internal behavior.

[00119] Server Request Processing Module - This module is a general module that covers server functionality that supports the main logic module - GoEyes Server Logic Module. This module provides networking, security, logging, and server routing.

[00120] Server Data Access Module - This module is a general module responsible for storing the data read from the database. This module stores the necessary schema information and saves all the sessions of the testing application when used by the GoEyes Server Logic Module.

[00121] Administration CMS SPA Module - This module is the main console for system administration. The module is a single-page application built on a language such as JAVASCRIPT®. This module can provide the ability to view all data from testing application sessions.

[00122] Fig. 20 shows a functional diagram of a system 2000 for testing a subjective optical parameter. The system 2000 may include a plurality of functional modules that interact to perform the methods described herein. For example, the system 2000 may be broadly configured to request, receive, analyze, and process subjective vision indicators from a test subject to determine optical parameters of the test subject's eye.

[00123] For this, the system 2000 may include a display and image control module 2002. The display and image control module 2002 may be configured to display at least one image to the test subject. The displayed image(s) may include any of the images mentioned above for various testing procedures and steps, including, for example, any of the steps, tests and procedures shown and described in connection with Fig. 4, and the related steps, tests and procedures described in connection with Fig. 5-18B. The display and image control module 2002 may therefore select images to display to the subject based on the optical parameter currently being tested (e.g., an image to test for accommodation control, radial segments and rings, etc.), display the selected image to the subject (e.g., via an electronic display similar to the display device 110), and may display instructions to the subject (e.g., instructions to change his position relative to the image/display, instructions to close the eye, and other instructions described above). As a result, the display and image control module 2002 may guide the subject through the testing (or a set of tests (e.g., sequentially)) to determine the optical parameter of the subject's eye.

[00124] In some embodiments, the input information management module 2004 may be included to receive and accept input information from the test subject. The input information may be "subjective" input information, meaning that the input information is based on the test subject's perception of a portion of the test (e.g., the test subject's provided indication of visual clarity or his ability to see or read certain shapes or objects in images provided and displayed to the test subject), as opposed to objective input information, such as the test subject's eye measurement value using an external instrument. The input information management module 2004 may control and receive signals from an input device, such as, for example, an input device connected to the computing device 106. In some embodiments, the input device may comprise a microphone, keyboard, mouse, or other computer interface configured to convert user input data into computer-readable signals. In some embodiments, the input device may include a camera, and the input information organization module 2004 may perform shape detection, text detection, or other computer vision methods to detect user input (e.g., a thumbs up gesture or an "okay" hand sign from a test subject).

[00125] The display and image control module 2002 and the input information organization module 2004 may work together to provide and receive input information from the test subject during the testing procedure. For example, the display and image control module 2002 may display a set of shapes to the test subject, while the input information organization module 2004 receives input information characterizing the sphere of the test subject's eye. Similarly, the display and image control module 2002 may display a set of radial segments and rings, an image for accommodation control, or an image for visual acuity testing, and the input information organization module 2004 may receive input information indicating a measurement value of the cylinder of the eye, input information confirming the sphere of the eye, or the best corrected visual acuity (BCVA) of the eye, respectively.

[00126] In some embodiments, the display and image control module 2002 may output images, such as shapes, having different appearance characteristics, such as images that are smaller or larger (e.g., as described in connection with Figs. 5-6 and elsewhere herein), rotated, etc. Accordingly, the displayed images and the received input data may change as the test sequence is conducted over time to detect subjective aspects of the test subject's vision.

[00127] The system 2000 may also include a communication module 2006 configured to generate a signal providing information about the collected input information from the subject. For example, the communication module 2006 may be configured to interact with an external device (e.g., the data storage 104 or the servers or administrators disclosed in connection with Fig. 19). The communication module 2006 may therefore be used to transmit information about the subject, the tests performed, the determined optical parameters of the eye, and the related information disclosed herein.

[00128] Various inventions have been described herein with reference to certain specific embodiments and examples. However, it will be recognized by those skilled in the art that many variations are possible without departing from the scope and spirit of the inventions disclosed herein, and that the inventions set forth in the claims below are intended to cover all variations and modifications of the disclosed inventions without departing from the spirit of the inventions. The terms "including:" and "having," when used in the specification and claims, shall have the same meaning as the term "comprising/including."

Claims (36)

1. A method for assessing refractive errors in the eyes, including the following stages: displaying at least one image to the subject, wherein said at least one image has at least one one-dimensional feature having an appearance to the subject based on physical characteristics of the subject's eye, wherein said at least one one-dimensional feature comprises at least two parallel lines; receiving input information from a test subject regarding the appearance of said at least one image at at least two distances between said eye and said at least one image, wherein said input information includes a binary perception by the test subject of said at least one image at said at least two distances, wherein the binary perception includes an indication of whether the test subject sees said at least two parallel lines or not; and transmit the specified input information from the subject and the specified at least two distances. 2. The method according to paragraph 1, according to which the display of at least one image to the subject and the receipt of input information from the subject include the steps of: display a set of shapes to the subject and receive input information characterizing the eye's sphere; display a set of radial segments and rings to the subject and receive input information indicating the value of the eye cylinder measurement; display an image to control accommodation to the subject and receive input information confirming the eye's sphere; display an image for visual acuity testing and receive input information indicating the best corrected visual acuity of the eye and provide instructions for relaxing the eye. 3. The method according to claim 1, according to which displaying at least one image includes displaying said at least one image in a first size and displaying said at least one image in a second size. 4. The method according to claim 3, according to which said at least one image is simultaneously displayed in the first and second sizes. 5. The method according to claim 3, wherein said at least one image is sequentially displayed in the first and second sizes. 6. The method according to claim 1, wherein the input information is subjective input information based on the physical characteristics of the eye of the subject. 7. The method according to claim 1, according to which the input information from the subject includes an indication of the brightness value of a part of said at least one image. 8. The method of claim 1, further comprising providing instructions to the subject to change the optical path length between the subject and the at least one image. 9. The method according to claim 1, according to which the input information from the subject includes an indication of the sharpness of a part of said at least one image. 10. A system for measuring refractive errors in the eye, comprising one or more tangible computer-readable non-transitory storage media containing computer-executable instructions configured to, when executed by at least one computer processor, enable said at least one computer processor to cause the computing device to perform the following steps: display at least one image to a test subject, wherein said at least one image has at least one one-dimensional feature having an appearance to the test subject based on physical characteristics of the test subject's eye, wherein said at least one one-dimensional feature comprises at least two parallel lines; receive input information from a test subject regarding the appearance of said at least one image at at least two distances between said eye and said at least one image, wherein said input information includes a binary perception by the test subject of said at least one image at said at least two distances, wherein the binary perception includes an indication of whether the test subject sees said at least two parallel lines or not; and transmit input information from the subject and at least two specified distances. 11. The system of claim 10, wherein displaying at least one image includes displaying said at least one image in a first size and displaying said at least one image in a second size. 12. The system of claim 10, wherein the instructions are further configured to provide the at least one computer processor with the ability to cause the computing device to provide instructions to the test subject to change the length of the optical path between the test subject and the at least one image. 13. The system of claim 10, wherein the appearance of at least one image includes the brightness or sharpness of a portion of said at least one image. 14. A device for subjectively testing an optical parameter of the eye of a subject, the device comprising: processor; display; input device; network device; and a storage device that includes executable instructions configured to, when executed by a processor: display at least one image to a test subject via a display, wherein said at least one image has at least one one-dimensional feature having an appearance to the test subject based on physical characteristics of the test subject's eye, wherein said at least one one-dimensional feature comprises at least two parallel lines; receive input information from a test subject via an input device regarding the appearance of said at least one image at at least two distances between said eye and said at least one image, wherein said input information includes a binary perception by the test subject of said at least one image at said at least two distances, wherein the binary perception includes an indication of whether the test subject sees said at least two parallel lines or not; and transmit input information from the subject and at least two specified distances via a network device. 15. The device of claim 14, wherein displaying at least one image includes displaying said at least one image in a first size and displaying said at least one image in a second size. 16. The device of claim 14, wherein the instructions are further configured to enable the processor to provide instructions to the subject to change the length of the optical path between the subject and the at least one image. 17. The device of claim 14, wherein the appearance of said at least one image includes the brightness or sharpness of a portion of said at least one image.