Systems and methods for ophthalmic examination

Abstract

An eye examination system is presented, comprising a semi-autonomous system for performing eye examination sessions and a control system. The semi-autonomous system includes an illumination device, which includes an optical projector capable of automatically projecting a series of illumination spots of a specific shape onto multiple locations in the eye region during the examination session, and an imaging device capable of acquiring images of the illuminated eye and generating image data associated with the multiple locations. The control system defines operational data for the semi-autonomous system, which defines the operational parameters of the examination session, in response to input data, which includes preset data indicating the examination task. The control system can operate the imaging device in synchronization with each optical projector, thereby minimizing image degradation factors in the image data and minimizing the illumination exposure time of the eye during the examination session.

Description

Technical Field

[0001] The present disclosure relates to eye examination techniques, and is particularly useful in slit lamp type eye examinations.

Background Art

[0002] For about 90% of the diseases that cause severe visual impairment, timely diagnosis and treatment can lead to successful treatment, preventing further deterioration or improving the condition. The increase in the world population, the increase in the elderly population with eye diseases due to the extension of the average life span, and the spread of various eye diseases in the general population are all contributing to the rapid increase in the demand for ophthalmic medical services.

[0003] The population is distributed throughout the world, including rural and surrounding areas. However, ophthalmologists tend to concentrate in urban and metropolitan areas. Furthermore, the limited availability of medical services mainly affects many people around the world due to the shortage of ophthalmologists, geopolitical situations, financial constraints, and various other factors.

[0004] Under the above circumstances, the demand for teleophthalmology and tele-ophthalmoscopy solutions to address these problems is increasing. That demand has been further amplified by the occurrence of pandemics such as COVID-19. As will be described later, conventionally, mainly due to technical constraints, there is no appropriate solution for remotely controlled slit lamp examinations.

[0005] Imaging of tissues using a projection system is well known in the art. Examples of imaging and light projection systems include magnifying microscopes used for detailed examinations. This type of imaging and projection system generates an image or field of view that provides detailed information about the examination object and the specific layers that make it up.

[0006] One such system is the "slit lamp" device used in eye examinations. This device has been used as a primary examination tool by ophthalmologists for nearly a century. In this device, a slit of light is projected onto the area of ​​the eye being examined. The projected slit has a sharp edge and bends along any structure it encounters in its path. The slit of light partially penetrates translucent or transparent layers / tissues (such as the tear film, conjunctiva, cornea, aqueous humor, lens, vitreous humor, and inner layers of the retina). It is also partially reflected (and partially absorbed) by opaque layers / tissues (appendages, sclera, iris, and pigment epithelium of the retina).

[0007] The reflection and refraction of the slit are observed by the ophthalmologist through a binocular microscope. The sharp edges curving over various structures help the ophthalmologist evaluate the three-dimensional structure of the area being examined. The binocular microscope further contributes to the ophthalmologist's three-dimensional interpretation by providing a stereo view of the area being examined.

[0008] Light slits are also useful for measuring the size, depth, boundaries, and proportions of structures and findings.

[0009] Furthermore, the light slit helps ophthalmologists focus on the examination structure being illuminated by the slit, against darker background tissue.

[0010] As a result of all these properties of the slit, the ophthalmologist's brain can interpret, analyze, and distinguish between normal and pathological findings in the area of ​​the eye being examined.

[0011] During the examination, the ophthalmologist moves the slit across the entire eye by physically manipulating specific optical components of the illumination source, focusing the slit and microscope on various parts of the eye. This allows the ophthalmologist to assess the overall condition of the eye being examined.

[0012] Ophthalmologists can select various slit attributes, such as width, length, color, intensity, and irradiation angle. This provides ophthalmologists with additional clinical information, enabling them to make appropriate diagnoses of findings.

[0013] According to conventional technology, a highly skilled ophthalmologist (an ophthalmologist or optometrist) must operate the slit-lamp device to aim and focus the light slit and binocular microscope, examine the area of ​​interest, and evaluate pathological and normal findings of various organs of the patient's eye. Therefore, the ophthalmologist must engage with the patient throughout the entire examination and document their own findings of the situation without visual reference data (as there are no images to refer to). For posterior segment examinations performed through the pupil, the ophthalmologist must hold an additional type of lens between the microscope and the eye being examined, aiming it along with the microscope and illumination, requiring even higher skill. Conventional slit-lamp devices are suitable tools in face-to-face examination environments. [Overview of the project]

[0014] In this field, there is a need for an improved system for slit-lamp eye examinations of patients that can be easily operated remotely and on-site with only a short period of training, even by non-experts, and that can solve the problem of patient cooperation by providing short, non-glare light exposure.

[0015] The conventional approach described above has the drawback of requiring the ophthalmologist, the patient being examined, and the slit-lamp device to be in the same location for all eye examinations, and also lacks visual recording and follow-up capabilities. In fact, conventional slit-lamp examination technology was not designed for remote use and therefore cannot be used in remote examination environments. Ophthalmologists typically need to observe the eye, memorize their findings, document them, record them in memory, and submit a final report. Furthermore, the conventional approach does not address patient convenience issues, such as reducing "consultation time."

[0016] However, during the examination, cooperation between the ophthalmologist and the patient is necessary due to the nature of the strong illumination, the patient's sensitivity to it, and the discomfort caused by the illumination to the eye, which can last up to 2-3 minutes (and longer in the case of lesions). The difficulty in obtaining proper cooperation between the ophthalmologist and the patient is one of the major drawbacks of current slit lamp examination techniques.

[0017] The "digital slit lamp" technology is a development based on the use of conventional slit lamps, equipped with a digital camera, enabling documentation, visual follow-up, and patient education. Video / image acquisition is performed by ophthalmologists, and the acquired information can be used to obtain additional opinions or for consultations between ophthalmologists, thereby enabling a certain degree of ophthalmic telemedicine (remote examination). However, in most conventional settings requiring remote examination or consultation, the local operator is not a doctor and does not have sufficient qualifications to acquire high-quality examinations (video / images) with a camera.

[0018] In many cases, local operators are not qualified to aim and focus lighting and cameras on various parts of the eye. Furthermore, local operators have not received medical training to photograph specific structures or layers of the eye. Most importantly, local operators are not qualified to medically interpret the observed normal or pathological findings, and therefore cannot continue the examination according to those findings or select appropriate parameters for the examination, as a trained ophthalmologist would. This makes it extremely difficult for a remote ophthalmologist to make an accurate diagnosis based on the received video / images.

[0019] Furthermore, in this technology field, "manual remote-controlled slit lamps" are also known, which include, for example, "digital slit lamps" equipped with motors on various motion axes and a web-connected motion controller, capable of receiving commands from a remote ophthalmologist and sending a live stream video back to the ophthalmologist. Micromanagement of this "manual remote-controlled slit lamp" allows remote ophthalmologists to perform examinations synchronously from different geographical locations. In addition to motion control, the remote ophthalmologist can observe the eye being examined on a screen while manipulating the examination procedure and its various parameters (such as illumination intensity and color).

[0020] However, this type of synchronized real-time examination, in which a remote ophthalmologist directly controls the system's operation, has significant limitations. These limitations hinder proper medical examination and diagnosis. Such limitations include the following:

[0021] (i) Eye movement delays present a limitation specific to synchronous telemedicine. Such delays include delays in bidirectional communication, high-quality image and video streaming, and motor operation. These delays, combined with various eye movements such as saccades and blinks, prevent the remote ophthalmologist from aiming and focusing the light slit and microscope on a desired part of the eye. Even if the remote ophthalmologist instructs the eye to move or focus on a specific desired position, the eye may have already moved by the time the instruction is carried out, and the desired part of the eye is no longer present. Therefore, the remote ophthalmologist cannot aim on a desired part of the eye as they would in a conventional slit-lamp examination.

[0022] (ii) Image distortion - In conventional slit-lamp examinations, at every moment of the examination, the ophthalmologist can only see sharp, high-quality fragments of the image, while other parts are blurry, distorted, out of focus, or in some cases completely invisible. Therefore, the ophthalmologist repeatedly aims and focuses on different parts of the eye, gathering all the information observed to reconstruct a complete three-dimensional model of the eye being examined in their mind.

[0023] The aforementioned limitations still exist even with known "manual remote-controlled slit lamp" technology. Specifically, the time required for examinations using a "manual remote-controlled slit lamp" can often be much longer than that of face-to-face examinations (average 2-3 minutes). This is because (i) delays and communication lags, and (ii) it is much more difficult for the physician to focus the system on the desired area of ​​the eye. These difficulties result in a much longer examination time (far exceeding 2-3 minutes). Furthermore, the examination time can lead to a decrease in the clinical quality of the examination, potentially causing medical legal issues. Specifically, the much longer examination time due to delays causes fatigue for both the physician (by trying to focus and track the eye) and the patient (due to the illumination intensity and examination time), which leads to a decrease in the clinical quality of the examination. As a result, when observing a series of images on the screen, the ophthalmologist cannot mentally correct for all the distortions, and low-quality images remain low-quality images.

[0024] This disclosure provides novel ophthalmic examination technologies, including semi-autonomous systems, that offer faster and more convenient eye examinations for on-site or remote ophthalmologists. As described below, the ophthalmic examination technologies of this disclosure provide advanced systems with medical quality, functionality, and operating modes for ophthalmologists that are equivalent to (or better than) those known in the art for on-site or remote "slit-lamp based" eye examinations.

[0025] Furthermore, this disclosure provides techniques for imaging, preserving, processing, image analysis, and displaying various tissue layers of the anterior and posterior segments of the eye and its accessory organs. According to some aspects of this disclosure, it is intended for use in ophthalmic medical devices by ophthalmologists, including telemedicine.

[0026] From an ophthalmologist's perspective, the examination technology utilizing the principles of this disclosure allows for a focus on the clinical aspects of the examination, rather than on the "micromanagement" of the examination device, especially in remote settings.

[0027] Furthermore, from the perspective of an ophthalmologist, when performing an examination using the eye examination system of the present disclosure, despite the different underlying technical concepts, the data, viewing, examination, and experience are similar to general medical practice. As a result, the learning curve for an ophthalmologist to use the eye examination system of the present disclosure is shortened.

[0028] The visual documentation of medical findings enables highly reliable and convenient follow-up. Furthermore, the unique approach of the present disclosure enables asynchronous dynamic slit scanning controlled by an ophthalmologist, thereby allowing past examinations to be re-run.

[0029] For example, to perform a standard examination, the system needs to aim at 22.5 degrees with a slit projection of about 300 micrometers in width, during which the imaging part of the system is fully oriented forward. Assume that about 100 images need to be taken to cover the eye. Asynchronous dynamic slit scanning means that when the imaging process is initiated, the system automatically aims itself at the correct position (angle and focus) in front of the eye, and all about 100 images are automatically taken without any interference from the operator or the doctor. What is important in this example is that there is no motor operation and the system remains stationary while about 100 images are being automatically acquired.

[0030] The images of the results obtained by the system of the present disclosure can be used for patient education and information sharing with patients. It can also be used for general education such as staff and professional student education.

[0031] The images obtained by the system of the present disclosure can be used for obtaining (clinical) second opinions, sharing images, sharing on clinical notes and markings on the images, collaborative work on suspicious findings, or asynchronous examinations. Furthermore, a remote doctor providing a second opinion can also control the system and set the operation parameters synchronously.

[0032] Solutions using still images (as opposed to video-based solutions), as described in this disclosure, can reduce the required bandwidth and achieve higher image quality and resolution. Furthermore, the technology of this disclosure provides improved resilience to poor network connectivity in terms of both throughput and latency.

[0033] The physician can view this series of images as a video stream and stop at a specific image while maintaining its full resolution without image compression. Furthermore, the physician can tag findings, use digital zoom, and examine images frame by frame.

[0034] In some embodiments, saving image acquisition parameters allows for re-acquisition of images in the same scene, location, and characteristics as previous examinations, enabling comparison of the same findings acquired in two different examinations, displaying them side-by-side (or transparently overlaid), and simultaneously scrolling / viewing the same slit in both images.

[0035] From the patient's perspective, eye examinations using the technology of this disclosure can be performed more simply and comfortably. At least one reason for this is that the technology of this disclosure can significantly reduce the time required for examination sessions in which patients must minimize eye movement while receiving strong light exposure to their eyes.

[0036] The combination of all the features described above in the ophthalmic examination technology of this disclosure enables highly reliable and efficient remote slit-lamp examinations, contributing to vision preservation and improved ophthalmic medical services, and saving time for physicians, local operators, and patients alike.

[0037] According to a broad aspect of this disclosure, a system for eye examination is provided, and this system is A lighting device comprising at least one optical projector, each of which is configured and controllable to automatically project a series of pre-defined shaped illumination spots onto multiple positions extending spaced apart from each other across the eye region during an eye examination session. At least one imaging device, each configured and operable to acquire an image of the eye including multiple locations illuminated by an irradiation spot during an examination session, and to generate image data associated with the multiple locations, wherein the image data indicates anomalies with respect to each of the multiple locations within the eye region, The system comprises a manager utility and a controller, wherein the manager utility is configured and operable to define operational data for a semi-autonomous system controlled by the controller in response to input data including preset data indicating an examination task, the operational data defining operational parameters for an eye examination session, and the controller is configured to operate each of at least one imaging device in synchronization with each of at least one optical projector to minimize image degradation factors in the image data and minimize the eye's illumination exposure time during the examination session.

[0038] The input preset data includes (i) pre-stored data indicating examination tasks (associated with corresponding operational data of the semi-autonomous system) aimed at identifying specific lesions and / or imaging specific areas of the ocular region, and / or (ii) inputs dynamically provided by a physician at a remote physician-related station.

[0039] The preset data may include a list / sequence of patterns used in eye examinations and / or various image acquisition parameters (illumination intensity, illumination type, illumination spectrum, focus conditions, etc.), each of which is associated with the examination of a specific lesion type and / or a specific part (organ) of the eye region.

[0040] Preset data can be designed / configured for each clinical examination (to detect / analyze lesions) and may include predefined or dynamically updated data for one or more of the following: illumination angle, imaging angle, illumination intensity, slit shape, etc. In some embodiments, the preset includes parameters for the desired focal position, specifying the exact spot in the eye that the system should focus on.

[0041] Preset data may include data specifically for lesion detection and / or data for use in specific focal mechanisms.

[0042] It should be noted that the term "semi-autonomous system" should be interpreted broadly to include fully autonomous systems as well. This is because the technology described in this disclosure relating to the performance of eye examinations can actually be performed by fully autonomous devices. For example, the system contains pre-stored information about the examination to be performed on a particular patient. The patient can operate the system by entering their ID and pressing an activation button to start the examination. As will be described later, the system first performs a safety check to confirm that the patient is in the appropriate designated position, etc.

[0043] In some embodiments, the eye examination system of the present disclosure is configured and operable to perform a general examination using a so-called “asynchronous mode,” which is a mode in which one or more predefined examinations are performed fully automatically according to their respective examination-related presets, thereby enabling the automatic execution of a sequence of two or more examinations spanning different areas of the eye and providing data that provides a broad overview of the condition of one or both eyes. Such a procedure can be initiated even by staff without clinical training.

[0044] In some embodiments, the system is configured and operable to define operational data based on selecting an examination configuration from input data using synchronous or asynchronous modes. For example, the system makes a selection from a list of examinations (pre-stored data) intended to correspond to a specific area of ​​the eye (ocular region) or a suspected lesion. This provides a predefined set / number of examinations optimized for the selected eye area and / or lesion. This can be done with or without the ophthalmologist observing in real time. In another example, the selection is made using synchronous mode, and accordingly, the examination is performed while the ophthalmologist observes the eye in real time (usually at a remote station), allowing the physician to preview the expected image acquisition. This allows the physician to select and provide various examination parameters (as input data, which are part of a preset).

[0045] In some embodiments, the system is configured and capable of implementing and operating in a so-called "hybrid mode," which combines the synchronous and asynchronous modes described above.

[0046] Furthermore, the term "synchronous mode," as one possible mode of system operation, should not be confused with the "synchronous" operation of the optical projector and imaging device. The latter is maintained in all operating modes of the system, enabling synchronized image acquisition.

[0047] In other words, in some embodiments, the input data includes preset data containing a list of records associated with at least one specific lesion type, function, and examination of a particular area of ​​the eye region, where the records include multiple data records relating to various types of behavioral data used in the examination session. Furthermore, the input data may include data received from the physician's remote station, indicating physician preview data of image acquisition expected to be obtained during the examination session, based on the physician's review of initial image data provided by the control system, where the physician preview data may include data indicating one or more examination parameters. Alternatively or additionally, the input data may include preset data containing data indicating two or more examination tasks spanning different areas of the eye. The control system is configured to operate the semi-autonomous system in fully automatic mode, enabling the automatic execution of a sequence of two or more examination tasks, thereby providing data that provides a broad overview of the eye's condition.

[0048] The semi-autonomous system of this disclosure is preferably configured to avoid any movement of any physical elements of the system after an activation signal is generated to start an inspection session (for example, in response to a button press). In other words, the position of the system elements remains stationary during the inspection session.

[0049] The technology described herein performs eye examinations by electronically scanning the eye region and projecting images onto it. This allows different or changing patterns to be projected onto the eye region during an examination session (while maintaining the system's "physical stationary state").

[0050] The system may include N (N≧1) optical projectors and M (M≧1) imaging devices, where N and M may be the same or different.

[0051] For example, a pair of optical projectors associated with (operating synchronously with) one or two imaging devices can be used to perform binocular examinations simultaneously or for monocular stereo imaging. Alternatively or additionally, different optical projectors configured to operate with different operating parameters (e.g., focal conditions, intensity, spectrum, etc.) can be used to perform simultaneous or sequential examinations of different parts of the eye, such as the anterior segment (cornea and / or lens and / or iris) and the posterior segment (retina).

[0052] In some embodiments, at least one optical projector and at least one imaging device are configured to have an extended depth of field, so that the illumination spot projected automatically to multiple positions is focused at each of the multiple positions, and the image data shows a focused image at each of the multiple positions.

[0053] In some embodiments, at least one optical projector and at least one imaging device are configured to have an extended depth of field that is independently controlled by a controller.

[0054] More specifically, an extended depth of field can be selected to simultaneously bring multiple anterior segments and appendages into focus.

[0055] In some embodiments, the semi-autonomous system includes a focusing mechanism configured and operable to first focus at least one of an optical projector and an imaging device on a relatively high-contrast area of ​​the eye (such as the iris), and then move the focus forward or backward toward the area to be examined (e.g., the cornea) based on a known distance between the relatively high-contrast area and the area to be examined.

[0056] For example, to focus on the cornea, which is transparent in a healthy person, the system uses autofocus on the iris (high-contrast area), and then moves a few millimeters backward to position the focal point closer to the cornea.

[0057] In some embodiments, the system analyzes the 3D structure of parts of the eye related to the examination area (for example, by using a slit as a structured light element) and sets a focal position in a desired area.

[0058] In some embodiments, the semi-autonomous system includes an autofocus mechanism that is automatically operated by a controller according to the operating parameters of the eye examination session. At least one of the optical projector and imaging device may include the autofocus mechanism.

[0059] In some embodiments, the lighting system is configured to enable electronic iris and / or electronic zoom functions.

[0060] Preferably, the pre-set shape of the irradiation spot is a slit shape.

[0061] At least one optical projector is configured and controllable to automatically project a series of slit-shaped illumination spots in a single-slit continuous manner, wherein the image data includes corresponding continuous image data pieces, each image data piece including a single-slit image.

[0062] At least one optical projector is configured and controllable to automatically and simultaneously project at least a first array of spaced-apart slit-shaped illumination spots in at least a first multi-slit configuration, wherein the image data includes at least one first image, each of which is an image of a spaced-apart position in at least the first array.

[0063] The optical projector is capable of sequentially projecting a first array of slit-shaped illumination spots using a first multi-slit method and a second array of slit-shaped illumination spots using a second multi-slit method onto the respective positions of the first and second arrays, where the positions of the first and second arrays are arranged in an interlaced manner, and the image data includes first and second images of the respective positions of the first and second arrays. The first and second positions may partially overlap.

[0064] In some embodiments, at least one optical projector is configured and operable to automatically change the spherical angle of the projection of an illumination spot onto the eye, and the image data includes image data fragments of each position associated with data indicating the spherical angle of the projection.

[0065] In some embodiments, the system further includes an imaging unit configured and operable to acquire a wide-field image of the eye, thereby enabling alignment of a foreground image formed by the image data onto a background image formed by the wide-field image of the eye.

[0066] In some embodiments, the system further includes an alignment assembly for aligning the user's face during an inspection session. For example, the control system further includes a start utility configured and operable to start the semi-autonomous system to perform an inspection session in response to a control signal indicating a safety condition that the user's face is in a specified position, and / or the system further includes a sensing system configured and operable to monitor the position of the user's face and generate corresponding sensing data, which is analyzed to determine the position of the user's face relative to a specified position and enable the selective generation of a control signal.

[0067] The sensing system is configured and operable to transmit sensing data to a safety controller at a remote control station, where the sensing data is analyzed, and control signals are selectively generated and transmitted to the controller. For example, the system includes a safety controller configured and operable to generate a control signal to the controller when it analyzes the sensing data in response to the sensing data and identifies a specified location of the user's face.

[0068] In some embodiments, the lighting device includes a flash illuminator.

[0069] In some embodiments, a semi-autonomous system includes an eye aiming device that is automatically operated by a controller according to the operating parameters of an eye examination session.

[0070] In some embodiments, the semi-autonomous system includes an eye-tracking mechanism that is automatically operated by a controller during the examination session.

[0071] A semi-autonomous system may include one or more motion mechanisms for achieving controllable movement of one or more elements of the system, and a safety controller configured and operable to control one or more motion mechanisms.

[0072] At least one imaging device is configured and capable of acquiring 3D images.

[0073] At least one imaging device may include a color sensor or a monochrome sensor.

[0074] At least one imaging device may include a monocular sensor and / or a multispectral sensor.

[0075] The control system may further include an image processor utility configured and operable to analyze image data and generate data indicating anomalies at each location.

[0076] The control system is preferably configured and operable to transmit data indicating image data to a remote control station for further processing to identify and analyze eye abnormalities.

[0077] The control system may further include an image processor utility configured and operable to extract a single-slit image from each of the continuous image data fragments at each position, cut out the extracted single-slit images, and paste the cut-out extracted single-slit images onto a background image which is a wide-field image of the eye. For example, the control system may further include an image processor utility configured and operable to divide at least a first multi-slit image into a set of corresponding single-slit images.

[0078] The image processor utility is further configured and operable to overlay each of the single-slit images extracted from at least the first multi-slit image onto a background image which is a wide-field image of the eye.

[0079] The image processor utility is configured and operable to generate data showing the dynamic motion of a single-slit image over the eye, and it is possible to artificially pause the data presented for a particular slit view.

[0080] The image processor is configured and capable of using image data to generate a 3D reconstruction of the acquired data in the acquired image.

[0081] In embodiments where the lighting device includes at least a pair of optical projectors, and each pair of optical projectors is associated with one or two imaging devices to perform stereo imaging of the eye and provide stereo image data of the eye region, the image processor is configured and operable to utilize the stereo image data to generate a 3D reconstructed image from two multi-slit images, identify at least one 3D single-slit image in the 3D reconstructed image, project at least one 3D single-slit image onto a 2D image to obtain a 2D projected image containing at least one single-slit image, extract at least one single-slit image from the 2D projected image, cut out the extracted single-slit image, and paste the cut-out extracted single-slit image onto a background image which is a wide-field image of the eye.

[0082] In some embodiments, an image processing utility is configured and operable to analyze image data by applying algorithmic techniques including one or more of artificial intelligence, image enhancement, image recognition, image sharpening, image restoration, and encoding.

[0083] The image processing utility can be integrated with at least one of an optical projector and an imaging device.

[0084] In some embodiments, a control system (e.g., a manager utility) is configured to communicate data with an image processor at a remote control station. This data communication may include data transfers using encrypted, secure communication. The control system (e.g., a manager utility) is configured and operable to generate a compressed representation of image data and transmit the compressed representation to the image processor at the remote control station.

[0085] The control system is configured and operable to independently control and operate one or more automatic changes among operating parameters, which include the dimensions of the illumination spot, illumination wavelength, illumination intensity, illumination angle, imaging angle, focal offset of the illumination device and / or imaging device, eye guidance, and background illumination.

[0086] According to another broader aspect of the present disclosure, a control system is provided for managing and controlling an eye examination performed by a semi-autonomous examination system, the semi-autonomous examination system comprising at least one optical projector capable of operating to automatically project a series of pre-defined shaped illumination spots onto a plurality of positions extending spaced apart from one another across the eye region during an eye examination session, and at least one imaging device capable of acquiring images of the plurality of positions during an examination session and generating image data associated with the plurality of positions, wherein the control system is configured as a computerized system having data input / output utilities, memory and image processor utilities, A manager utility configured and operable to define operational data for a semi-autonomous system in response to input data including preset data indicating an examination task, wherein the operational data defines operational parameters for an eye examination session. The system includes a controller configured to use motion data to synchronize at least one imaging device with an optical projector, thereby minimizing image degradation factors in image data and minimizing the time the eyes are exposed to light during an examination session.

[0087] The control system can be configured as an electronic unit installed in a semi-autonomous inspection system.

[0088] The control system is configured and operational to communicate with a remote control station, and the manager utility updates at least one of the preset data and operational data in response to instructions from the remote control station.

[0089] The Disclosure, in yet another aspect, provides a server control system which is a computerized system (including input / output utilities, memory, processor, etc.) that can be connected to a subscriber eye examination system of the type that performs semi-autonomous eye examination procedures via a communication network. Such a server control system is configured and operable to produce output data which includes, as output data, (i) data indicating suspicious areas and findings in the eye region under examination to enable the detection of abnormalities and / or lesions, (ii) data indicating abnormalities and / or lesions in one or more areas of the eye region under examination, and / or (iii) the quality level of the received image data provided by the subscriber system, and / or (iv) data indicating recommended preset data (e.g., system operating parameters, e.g., patterns to be used) for an examination session performed by a particular subscriber system (with respect to a particular area of ​​the eye and / or a particular abnormality to be detected and / or a particular patient). [Brief explanation of the drawing]

[0090] Hereinafter, embodiments will be described with reference to the accompanying drawings, as merely non-limiting examples, in order to better understand the subject matter disclosed herein and to illustrate how it may actually be carried out. [Figure 1] Figure 1 illustrates the basic principles of the eye examination technology described herein. [Figure 2] Figure 2 shows the eye examination system of this disclosure in block diagram form. [Figure 3] Figure 3 shows an example of an eye examination system relating to the principle of this disclosure. [Figure 4] Figures 4A to 4C show examples of single-slit images obtained using the eye examination system of this disclosure. [Figure 5]Figure 5A shows an example of a common technique for single-slit images with pathological findings marked. Figures 5B and 5C illustrate single-slit images obtained with the technique of this disclosure that enable the extraction of lesion-related data. [Figure 6] Figure 6 shows a multi-slit image of a multi-slit pattern projection onto an actual human eye. [Figure 7] Figure 7 shows an example of separating a set of multi-slit images into single slits, pasting them onto a background image, and the resulting single-slit image. [Figure 8] Figures 8A and 8B illustrate the technique of the present disclosure, in which first and second sets of multi-slit shaped illumination spots are projected onto first and second sets of positions on the eye, respectively, and then the multi-slit image is reconstructed into a set of single-slit images, in which the first and second positions are arranged in an interlaced manner. [Figure 9] Figure 9 shows a stereo single-slit view of the eye being examined, as displayed to a remote ophthalmologist. Each image is generated by overlaying the same slit, captured from different angles, onto a background image. The two images are interpreted by the ophthalmologist as a stereo single-slit image, similar to examinations using conventional binocular slit-lamp devices. [Figure 10] Figures 10A and 10B illustrate the asynchronous (store-and-forward) and synchronous (real-time) examination flows enabled by the eye examination system of this disclosure, respectively. [Modes for carrying out the invention]

[0091] Figure 1 schematically illustrates the concept of the eye examination technology of this disclosure, which provides highly reliable remote examinations with examination quality independent of the operator's (non-physician) skills. The eye examination technology of this disclosure enhances the detailed visual information displayed to the ophthalmologist.

[0092] The technology of this disclosure utilizes a real-time, automated or semi-automated ophthalmological examination system 100 configured and operable in accordance with this disclosure, which enables an ophthalmologist at a remote station 102 to operate multiple system sites and provide short-term or long-term medical follow-up for a particular patient.

[0093] The examination system 100 and the physician-related station 102 can also communicate data with the cloud computing (server) system 105 (via any known and appropriate type of communication network and protocol). As described later, the physician-related station 102 is used for browsing and remote parameter setting, while high-load computation / data processing can be performed on the cloud computing server 105. The server 105 can be used for examination management, examination metadata and visual documentation, and high-level processing. Such a server 105 can also function as an intermediate layer between the components of system 100 and the physician-related system 102. Cloud computing can also be implemented on an actual cloud server, a remote PC, or on the local PC of system 100 or system 102.

[0094] The automated image acquisition performed by System 100 can be initiated by pressing a button on the System 100's local controller or a remote control station, such as the physician's station 102, thus eliminating the need for micromanagement (i.e., direct and continuous micromanagement control of specific motors and system components is not required; micromanagement regarding slit movement and image acquisition is performed automatically by System 100).

[0095] The system of this disclosure significantly reduces discomfort during the examination for the patient because the patient's eye is exposed to strong slit lamp illumination for a short time (e.g., less than 1 second), resulting in improved patient cooperation and further shortening of the eye examination time. The short exposure time also solves a major limitation of conventional slit lamp devices, which is the inability to aim at the desired area of ​​the eye during the eye examination session due to the patient's (voluntary and involuntary) eye movements. Attempts have been made to realize a "manual remote-controlled slit lamp" by connecting a motor to control the movement of various slit lamps with a digital camera to capture video or images of the eye being examined, but these have been limited in success due to delays in communication and motor operation.

[0096] The short exposure time achieved by the system of this disclosure is made possible by a novel optical setup for the semi-autonomous system of the eye examination system of this disclosure. As described later, such an optical setup includes at least one illumination device configured and operable to automatically project a series of illumination spots of a preset shape, e.g., a slit shape, onto the eye while electronically moving the position of a slit on the eye. The movement (scanning) of the slit position is performed electronically, i.e., there is no need to move the light source component with a motor, thus inevitably avoiding motor operation delays / artifacts. The system of this disclosure also includes at least one imaging device, e.g., one or more cameras, which can remain stationary during the examination session, i.e., while acquiring a series of slit images. Note that in some embodiments, motor operation may be used, provided that micromanagement is performed automatically.

[0097] The projection of the illumination spot and the acquisition of each image in the sequence are performed synchronously, enabling continuous viewing of the examination area while avoiding discontinuous slit coverage caused by blinking, occlusion, pupil constriction, etc., and can be performed quickly enough to eliminate image blurring caused by motion artifacts (e.g., by avoiding eye movements as much as possible). It should be noted that the technology of this disclosure makes it possible to perform the acquisition of images necessary for the examination session before the eye moves to a different position and discontinuities occur (including blinking).

[0098] Therefore, all the data necessary for examining the desired area of ​​the eye can be obtained within a short period of time, making it possible to implement image freezing technology.

[0099] Specifically, the technology disclosed herein allows an operator / remote physician to preview the eye scene in real time and focus the system on the required area. At the moment the capture button is pressed, the previewed state is frozen, and a series of images are captured as still images (i.e., frozen image technology).

[0100] As described later, the system of this disclosure allows physicians to change imaging parameters such as illumination angle, shooting angle, slit size (width, height, shape, orientation), and slit intensity. However, when the physician presses the capture button, all micromanagement related to acquisition is performed automatically by the system. This system enables independent control of viewing parameters such as zoom (optical and / or digital) and observation angle.

[0101] Figure 2 shows a block diagram of the eye examination system 100 of the present disclosure. The system 100 includes, in particular, a semi-autonomous system 110 and a control system 150. The system 100 is also configured to communicate with at least one remote system of a remote control station 160 (using any known suitable communication technology), the remote control station can serve in particular as a tool for an ophthalmologist to remotely operate the semi-autonomous system 110.

[0102] Furthermore, as shown in the figure, system 100 and / or remote control station 160 are also capable of data communication with server system 105 (using any known appropriate communication technology).

[0103] System 100 may further include a technician's screen 176, a sensing system 170, and a safety controller 172. The technician's screen 176, as well as the remote control system 160, can be used to control the system and its parameters.

[0104] The remote control system 160 may include a data processor unit 158, which may be located on an external server (remote control system).

[0105] The semi-autonomous system 110 is configured and operable to perform multiple eye examination sessions on a patient and provide corresponding image data. The semi-autonomous system 110 includes at least one illumination device 130 and at least one imaging device 120. In some embodiments, the semi-autonomous system 110 may include an eye aiming device 144, an overall motion control unit 146, and an alignment assembly 174.

[0106] The illumination device 130 includes at least one optical projector 132, each configured and controllable to automatically project a series of pre-shaped illumination spots at multiple locations spaced apart across the eye region during an eye examination session. The optical projector 132 includes a scanning unit 134 (e.g., a scanning mirror) associated with the illumination source 136 and may further include various optical systems 138. In some embodiments, the projector 132 may include an operation controller 140.

[0107] In some embodiments, the projector 132 may include a scanning mirror mechanism (DMD), an LCD, an electronic DOE, or a combination thereof, thereby enabling projection to various positions within its field of view without moving the lighting device 130.

[0108] As shown in the figure, the system 110 preferably further includes an additional lighting unit 142, which may or may not be part of the lighting device 130. The additional lighting unit 142 provides backlight and / or background lighting.

[0109] The optical projector 132 is configured and controllable to automatically project a series of pre-defined shaped illumination spots at multiple positions that extend at intervals across the eye region during an eye examination session. These pre-defined shaped illumination spots can be focused at multiple positions within the field of view of the optical projector 132. In some embodiments, the projector 132 can be configured to project radial patterns, concentric patterns, and multiple patterns (such as multi-slit patterns).

[0110] In some embodiments, a series of illumination spots can be projected at time intervals, thereby enabling specific examinations, such as pupillary response to illumination, strabismus testing, tear film breakdown time, and dynamic movement of contact lenses.

[0111] In some embodiments, the optical projector 132 is configured and operable to automatically change the spherical angle of the projection of a series of illumination spots onto the eye. The operation control unit 140 of the optical projector 132 can automatically or manually change the projection angle to any feasible angle relative to the field of view. For this reason, the image data provided by the semi-autonomous system 110 includes image data fragments associated with data indicating the orientation of the spherical angle of the projection.

[0112] In some embodiments, the illumination device 130 and the imaging device 120 may include optical systems that support a depth of field that can focus on an area including the entire anterior segment of the eye (approximately 13 mm). To achieve this depth of field, the illumination device and the imaging device may each have their own optical systems. However, in some embodiments, they may share the same optical path / axis partially or entirely.

[0113] The imaging device 120 of the semi-autonomous system 110 includes an imaging sensor 122, typically one or more cameras, which is associated with or includes a built-in optical system 124.

[0114] The imaging device 120 is configured and operable to acquire focused images of multiple locations illuminated by the illumination spot during an examination session and to generate image data that includes at least multiple image data fragments associated with each of the multiple locations. The image data indicates abnormalities at locations within the ocular region and allows for further image processing and / or manual extraction of abnormality-related information by the physician. For example, deformation of the slit may indicate a lesion or disorder in the structure of the eye. For the physician to examine the edge of the slit, the edge needs to be as sharp as possible at points where both the illumination system and the observation system are focused.

[0115] The same imaging device 120 or another imaging unit 128 is preferably further configured to work with an illumination device 130 or an additional illumination unit 142 to achieve a wide-field imaging mode.

[0116] At least one imaging device 120 is capable of operating in synchronization with at least one optical projector 132 during an examination session (using SW and / or HW synchronization) to properly acquire images of a series of projected illumination spots.

[0117] Typically, system 110 includes N (N≧1) optical projectors and M (M≧1) imaging devices, but note that the numbers N and M may be the same or different.

[0118] Image data can be processed by a control system 150 that is integrated with or connectable to the semi-autonomous system 110. The results of data analysis obtained by the control system, or the raw image data provided by the imaging device 120, or both, are appropriately stored and appropriately transmitted / transferred to the remote control system and / or server of the physician-related station 160.

[0119] A local operator or physician can perform an asynchronous (store-and-forward) examination of a patient's eye by scrolling through a report of generated images and findings from the examination session after executing a fully autonomous, pre-configured set of examinations. This examination scenario does not require simultaneous interaction with the patient / examination device. Medical information, including images and data acquired by system 110, is stored and then transferred to a physician / specialist to review and interpret the data. Alternatively, the physician can also perform a synchronous (real-time) examination, in which case they control the examination parameters of the semi-autonomous system 110 and / or view the findings in real time. In this scenario, the examination is dynamically guided by the physician. For example, the physician selects the angle of the subsystem of the imaging device 120, the projection angle of the optical projector 132, the slit / projection type, width, and intensity level in real time, and the semi-autonomous system 110 then autonomously executes the selected illumination and imaging parameters. Thus, the technology of this disclosure provides an optimal approach for combining synchronous (real-time) and asynchronous (store-and-forward) examination flows. The control system 150 is configured as a computerized system having, in particular, a data input / output utility (not shown), memory 153, and a processor 152. According to the art of this disclosure, the control system includes a manager utility 155 and a controller 151. The latter includes, or is associated with, an actuator utility 154 for starting / triggering the operation of illumination and imaging devices, as described later. The control system also appropriately includes a communication utility 156 for data communication with a remote physician-related station 160 and, optionally, with system 110. The control system 150 is also associated with (includes or connected to) a sensing system 170 and a safety controller 172, as described later.

[0120] The manager utility 155 is configured and operable to identify data indicating examination tasks related to specific eye examinations prescribed for a particular patient and to define operational data for the semi-autonomous system 110. To this end, the manager utility can, in response to input data including patient-related data, select examination task data from data pre-stored in memory in association with each operational data, or, in response to input data similarly including examination task data, select operational data pre-stored in memory. The operational data is used by the controller 151 to control the corresponding operations of the system 110. The operational data defines the operational parameters of the eye examination session.

[0121] As will be described in more detail below, the ophthalmic examination system 100 can function autonomously and perform a series of examinations entirely on its own. A predefined set of examinations is stored, for example, in the memory 153 of the control system 150. Each predefined examination, accompanied by its respective pre-stored operational data, is referred to herein as a “preset” and is specific to each clinical examination (e.g., targeted at detecting / analyzing a particular lesion or part of the eye). Presets can be obtained / updated from a physician at station 160 (reference numeral 102 in Figure 1) and / or directly from server 105. The manager utility 155 is responsible for selecting pre-stored operational data according to a specific examination task. For example, a predefined preset may include, but is not limited to, predefined values ​​such as illumination angle, imaging angle, slit shape, and intensity required for a particular examination of a corneal lesion.

[0122] Presets are predefined on the server and can be configured by system administrators and physicians as a set of actions for future, recurring examinations.

[0123] The technology disclosed herein optimizes the management and execution of examination procedures (image acquisition and image data evaluation modes). It should be noted that in the world of telemedicine, there are two main operating modes: synchronous (real-time) and asynchronous (store-and-forward).

[0124] During a synchronous (real-time) examination procedure, the physician controls the device's examination parameters and views the findings in real time. The examination is dynamically guided by the physician. Suitable examples include the da Vinci surgical robot and devices for remote eyeglass fitting (subjective refraction).

[0125] During asynchronous examination (store-and-forward) procedures, patient medical information is collected and documented for later interpretation by healthcare providers. This mode clearly allows for both geographical and temporal separation between physicians and patients. Medical information, including images and data, is stored and then sent to specialists who can later review and interpret it without requiring simultaneous interaction.

[0126] The eye examination system 100 of this disclosure can function autonomously or at least semi-autonomously to perform a series of examinations entirely on its own. The system can track the subject's eyes, adjust accordingly, guide the subject's eyes to the optimal orientation, perform autofocus tailored to the specific examination required, and autonomously and rapidly acquire all necessary images.

[0127] For example, the cornea of ​​a healthy human is transparent, making it difficult to focus. Therefore, this system can operate as follows: The system focuses the projection of the slit onto a high-contrast element within the field of view (e.g., the iris), and then adjusts the focal position to achieve optimal focus at the average distance from the iris at the examination position and point. For example, the system can use the distance from the iris entered as data for a specific patient. Note that for myopic patients, the average distance from the iris estimated from the general population cannot be used. In some embodiments, the system can also analyze the curvature of the area being examined using slit projection (or multi-slit projection) to detect the optimal focal position, and adjust the focal position using knowledge of the curvature of the area being examined.

[0128] Furthermore, the control system 150 can evaluate the quality of the acquired images and proceed to the next examination, continuing this process until the entire series of tests is complete. Image quality can be defined into three classes: good, acceptable, and poor, and images judged to be of poor quality require re-acquisition. For this reason, in the case of asynchronous examinations, the on-site operator can simply press a button to start a series of tests, which are then sent for analysis by a physician. Alternatively, the physician can set the examination parameters and monitor the subject's eyes while managing them synchronously in real time. Alternatively, the system can be configured to acquire multiple sets of the same preset and transfer the best set, or transfer a new set created using the best images taken from all acquired sets, providing the same continuous coverage as a single set.

[0129] It should be noted that image quality can be controlled using image processing heuristics, contrast level estimation, hue / saturation measurement known in the art, or using a dedicated deep neural network for image quality estimation (e.g., a CNN designed for classification of several quality classes). Furthermore, in some embodiments, the system ensures that all slit images in the set are captured, and that they provide complete coverage of the inspection area using image processing methods, DNN models, etc., known in the art.

[0130] The technologies disclosed herein provide a range of selectable levels of control and automation, depending on the required use case, through fully or at least semi-autonomous inspection capabilities. These include:

[0131] General Examination (Asynchronous) - This involves the fully autonomous execution of multiple predefined tests, each with a different preset. This can be initiated even by staff without clinical training. These tests are performed across various areas of the eye, allowing the ophthalmologist to understand the overall condition of the eye and identify any potential lesions.

[0132] Selection of Examination Configuration (Synchronous / Asynchronous) - A selection is made from a list of examinations intended to address a specific area of ​​the eye or suspected lesion. Depending on the selection, several predefined sets of examinations optimized for the selected area of ​​the eye or lesion will be performed. This can be done with or without real-time observation by an ophthalmologist.

[0133] Selection of Examination Parameters (Synchronized) - In this mode, the examination is performed while the ophthalmologist observes the eye in real time. This allows the doctor to get a "preview" of the expected acquisition results. The doctor can select various examination parameters such as illumination and imaging angle, slit parameters (width, height, color, shape), zoom, aperture, and intensity. They can also control the position of the slit beam. Once the preview is satisfactory, a series of images of the entire region of interest are acquired.

[0134] Fully manual control (synchronous) – this is a "micro-management mode" and is very similar to other remotely controlled slit lamp solutions. This involves complete manual control of the inspection device, including various mechanical degrees of freedom and positioning of the slit relative to the eye being inspected. This process is primarily useful in face-to-face inspection scenarios.

[0135] One or more optional routes include one in which a local operator manually aims the system in front of them, then operates the system to perform autofocus (AF) (or manually adjust the focus), adjusts the angle and slit characteristics, and only then uses automated image acquisition.

[0136] The system can operate in a so-called "hybrid inspection mode," which combines synchronous and asynchronous modes with one or more of the optional routes described above.

[0137] In simple terms, the operation works as follows: When a new patient arrives at the examination site, the local operator initiates a default series of general examinations, which are automatically acquired by system 110. The acquired series of examination results are sent to the ophthalmologist at station 160. The ophthalmologist reviews the series of examination results, dynamically adjusting the slit position for each examination. If the doctor discovers or suspects a finding and wishes to further examine the suspected area / lesion, they can acquire a related series of examination results, such as a series of corneal examination results, while observing the eye in real time. In extreme cases, if the related series of examination results do not provide a satisfactory answer, the doctor can request examinations with a specific set of parameters. A manual mode can also be used for face-to-face examinations.

[0138] It should be noted that the system 110 of this disclosure is configured to support the physician's observation mode. The system is designed to provide a continuous sensation and be intuitive to the physician, similar to conventional slit-lamp examinations. Therefore, the transition between the acquisition process and the observation of the acquisition results is intuitive and smooth. Switching between observing examination results with different parameters is also intuitive. For example, when switching to another examination with a wider slit, the initial position of the slit is maintained at the position from the previous examination, so the physician's sensation is similar to widening the slit during a conventional examination.

[0139] Furthermore, the acquired results can be observed through several user-friendly modes, including video mode, slit position change mode, and frame-by-frame transition mode. Video mode provides automatic and continuous transitions between multiple slit frames, with the slit position in each frame slightly different from the previous frame, covering the region of interest (in some cases, the entire anterior segment) as a whole. The physician can get the impression of a video, as if the slit is moving over the eye. The physician can adjust the "video speed" at any time as needed. In slit position change mode, the physician can perform a controlled slit scan of the eye using a slider. This slider can also be used to "aim" the slit at a desired area of ​​the eye being examined. In frame-by-frame transition mode, the frame containing the desired slit position can be selected from the gallery. This mode is useful when a finding is found and the physician wants to observe it at a slightly different slit position.

[0140] The above modes can be switched between, enabling efficient video observation while also ensuring examination quality by allowing physicians to linger on specific areas for consideration, tag findings, and zoom in on desired areas with digital zoom at any time. The system also provides more advanced viewing modes for reviewing data, comparing with past examinations, and referencing second opinions.

[0141] The above and other details of the technology of this disclosure are described in further detail below.

[0142] Illumination and imaging devices can generally have any known suitable configuration. The illumination source 136 can consist of any or a combination thereof of halogen / xenon, LED, laser, or any light / energy source known in the art. The illumination source 136 can use narrowband or broadband light. The illumination color can be monochromatic or a combination of monochromatic and broadband colors. The color can be outside the visible spectrum, i.e., infrared or a combination of several wavelengths. The illumination source 136 can include a bandpass filter or a cutoff optical filter. In some embodiments, the illumination source can include a DMD, LCD, electrical DOE, and other subsystems that can produce spot characteristics as projections.

[0143] The optical system 138 may include one or more lenses to obtain the required region of interest (ROI) of the eye under examination, and / or one or more apertures to obtain the required depth of field (DOF). The aperture size may be fixed, or it may be variable by manual or software control. Changes in aperture size may be triggered by another system component or performed manually. The aperture size may also be set manually according to a predefined preset or at the request of the physician. The optical system 138 may further include a polarizer and / or filters.

[0144] The scan unit (illumination projection means) 134 can be configured using one or more of the following techniques: programmable LCD or DLP projection, micro-LED projection, use of electrodiffractive optical elements (DOEs), hardware-predefined patterns, and switching between multiple such patterns.

[0145] Generally, the lighting device 130 may include a motor, rails, encoder, limit sensors, and any other optional components for radial and linear motion, and their control may be performed by the motion controller 140. Its mechanism may include any combination of the six possible degrees of freedom, and any number of degrees of freedom may be motor-driven. Furthermore, the optical projector 132 may include a focusing mechanism, and in particular, may include autofocus support.

[0146] In embodiments where a laser is used as the illumination source, the optical projector 132 may be equipped with a defocus function to define a specific depth of field. In such embodiments, the optical projector 132 may also include a distance sensor.

[0147] Furthermore, in some embodiments, the relative angle between cameras (stereo angle) can be changed manually or automatically.

[0148] The semi-autonomous system 110 of this disclosure solves the major problem of distorted images encountered during conventional slit-lamp examinations. In a typical conventional slit-lamp examination, at any given moment of the examination, the ophthalmologist can only see sharp, high-quality fragments of images, while other parts are blurry, distorted, out of focus, or not visible at all. The ophthalmologist repeatedly aims and focuses on different parts of the eye, gathering all the observed information to reconstruct a complete three-dimensional model of the eye being examined in their mind. Due to the very limited DOF of illumination and microscopes known in the prior art, the ophthalmologist must scan various layers of the eye at different distances from the microscope and light source to avoid missing pathological findings. These constraints still exist in existing prior art, such as "manual remote-controlled slit-lamp" systems. However, when observing a set of images on a screen, the physician cannot mentally correct for all of their distortions, and poor images remain poor images.

[0149] The semi-autonomous system 110 of this disclosure solves the above-mentioned problems by providing an optical system with an extended depth of field (DOF) for the sensor of the imaging device 120 and the illumination device 130, in addition to autofocus support (as described later). This provides all layers of the object of observation of the eye as a clear and sharp slit view on the same image. The DOF of the optical projector 132 is wide enough to simultaneously capture multiple parts and appendages of the anterior segment of the eye in focus. As described later, the acquisition time is short, so in many cases it is possible to acquire all the necessary images before the eyeball moves significantly.

[0150] Standard image system planners well known in the art can be used for the autofocus operation of both the illumination and imaging devices. For example, during the automatic operation of the semi-autonomous system 110 of this disclosure, a standard focus measurement function (FMF) can be used to measure the relative focus quality, and a standard probabilistic search can be applied to detect the overall maximum sharpness of the image. Furthermore, autofocus adjustment of the illumination can be performed by using the imaging device and inspecting the projection at the desired point using a standard FMF method to adjust the focus of the illumination.

[0151] As mentioned above, the illumination device 130 may include an additional illumination unit 142 (or the illumination device 130 may operate in an additional illumination mode) and can work in cooperation with the imaging device 120 (e.g., an additional imaging unit 128) to acquire a wide-field image of the eye. This makes it possible to align a foreground image formed by image data fragments associated with a series of illumination spots onto a background image formed by a wide-field image of the eye, as will be described later.

[0152] The additional lighting 142 may include direct or indirect lighting sources and may be controllable in terms of lighting intensity and / or color. This control may be performed by software, triggered by another system component, or manually.

[0153] In some preferred embodiments of the present disclosure, the optical projector 132 is configured and controllable to automatically project a series of slit-like shapes onto a plurality of predefined positions that are spaced apart and extend across the eye region during an examination session. In other embodiments, each projected illumination spot may have a preset pattern suitable for diagnosing different parts and appendages of the eye.

[0154] Furthermore, in some embodiments, each irradiation spot may have a preset pattern suitable for diagnosing most of the areas of the eye and its adnexa (which can reduce examination time).

[0155] The projected pattern may be a single pattern projection, a series of projection patterns of the same type, or shifted patterns forming the same type. Integrating a series of shifted patterns to adjacent positions can provide coverage of the entire region of interest. A single pattern may have vertical lines / slits, similar to the shapes / patterns used in conventional slit lamps. The orientation of these lines can also be changed to horizontal, diagonal, etc.

[0156] The optical projector 132 can be configured to project slits having a common shape, such as concentric circles, radial patterns, or any other common shape. The projected pattern / slits can have varying widths and heights for each slit, the number of slits / patterns is arbitrary, and the spacing between slits can be a constant, variable interval. The spacing between slits in the projected pattern can also be variable. Slits in different patterns can be partially or completely overlapped.

[0157] In some embodiments, as will be described in more detail below, the projection of a series of illumination spots includes the projection of a multi-slit shape / pattern, i.e., an array of spaced-apart slit-shaped illumination spots. Typically, two or more such multi-slit patterns are projected sequentially onto the eye area. The optical projector 132 is configured and controllable to automatically project a series of multi-slit patterns onto the eye area during an examination session, such that the illumination spots are focused at multiple positions that extend spaced apart from each other across the eye area.

[0158] Given the constraints on the focusing slit width and the spacing between slits, as well as the requirement to scan the entire ocular region during the examination session while minimizing session time, the multi-slit projection mode is preferably implemented in an interlaced manner. The first and second sets of irradiation spots are projected sequentially (in a temporally separated order) onto the first and second sets / arrays at spaced-out positions, respectively. Here, the first and second positions are arranged in an interlaced manner. The first and second positions may be arranged to partially overlap.

[0159] Interlaced mode is preferred for retinal imaging. For anterior segment imaging, the so-called "semi-interlaced" mode can be used, in which the entire anterior segment is covered by a series of non-overlapping slit / multi-slit projections (partial overlap between slits / multi-slits can also be used to provide a semi-continuous slit scan).

[0160] The camera used by the imaging device 120 may be monochrome, color, multicolor, IR, or any other wavelength or combination of multiple wavelengths (including simultaneous operation). Instead of moving to various shooting positions, multiple cameras positioned at different locations may be used. In some embodiments, each camera may have a different optical system. Furthermore, in some embodiments, one or more cameras are integrated to extend the depth of field or to enable simultaneous acquisition of the anterior and posterior segments. Similarly, in some embodiments, multiple projectors positioned at different locations may be used, each having a different optical system.

[0161] In some embodiments, stereo imaging with two cameras can be used to obtain focused images of multiple locations illuminated by the irradiation spot during an examination session. Alternatively, any pair of cameras can be used to obtain stereo images of the ocular region to provide the ophthalmologist with three-dimensional visualization (similar to conventional binocular slit-lamp examinations).

[0162] In some embodiments, multiple cameras can be used to obtain higher resolution and / or more data and / or more accurate measurements.

[0163] In some embodiments, a multi-lens imaging device can be used to obtain the 3D shape of the illuminated spot.

[0164] In general, the technology of this disclosure can utilize any known 3D imaging technology and is not limited to stereo vision or multivision.

[0165] Each camera of the imaging device 120 may have an extended DOF in the range of 10 to 14 mm and / or an autofocus setting function.

[0166] Furthermore, the DOF of the optical projector 132 and the DOF of the imaging device 120 are independent and can be controlled individually (for example, by the controller 151 of the control system 150). However, it should also be noted that the DOF makes it possible to arrange the projection and imaging concentrically, thereby achieving an extended DOF of the system without restricting the movement of the DOF of the illumination and imaging devices together.

[0167] More specifically, when using lateral projection (i.e., projecting at an angle to the central axis of the eye), a high depth of field allows illumination (and corresponding imaging) to be in focus at all illuminated (acquired) positions.

[0168] The extended depth of field allows for capturing all / almost all of the anterior segment within the same field of view, making it possible to project and capture the entire set of slits in autonomous acquisition sessions without the use of motors or moving parts.

[0169] In some embodiments, a trigger mechanism can be used between the illumination source 136 and the camera 122 to ensure simultaneous illumination and acquisition for multiple imaging devices, transitions between consecutive patterns in a series of patterns, and a reduction in the time required for the image acquisition process.

[0170] More specifically, transitions between consecutive patterns in a series of patterns are performed as follows: First, a pattern is projected, a trigger is sent to the imaging device (camera) to acquire each image, and once image acquisition is complete, the projector is triggered to project the second (next) image, and when the next pattern is projected, the camera is triggered again, and so on, until all predefined patterns of a particular preset are properly projected and captured. The images are stored (for example, the system saves the images locally, e.g., in the camera's memory) until the preset patterns are projected and captured, i.e., until the required number of image acquisitions for the inspection session have been performed, and then transferred for further processing or viewing (for example, sent to the backend).

[0171] In some embodiments, the eye / pupil tracking mechanism may be implemented by using the imaging device described above, which utilizes an imaging sensor involved in eye examination, such as camera 122, or by using an additional sensor for this purpose, or by implementing other eye tracking methods (e.g., a method using a second dedicated camera, or a method using a combination of IR illumination and another camera (a camera with a VIS cut filter, whereas the examination system uses an IR cut filter)). Eye / pupil tracking can be operated automatically by a control system 150 (e.g., controller 151) during an examination session.

[0172] In some embodiments, eye tracking may include iris tracking. Eye tracking, iris tracking, or pupil tracking can be performed using any suitable technique known in the art, for example, using techniques known in the fields of image processing and deep learning, such as utilizing RT segmentation mechanisms or known suitable RT eye tracking methods. Advantageously, such techniques enable positioning of the system in front of the eye, automatic centering of the system, and further, image stabilization and slit projection stabilization. Any of these advantageous features improve image quality and / or image set quality and / or the overall clinical quality of the examination.

[0173] The optical system 124 of the imaging device 120 may include one or more of lenses, diaphragms, polarizers, filters, and other optical elements. Specifically, lenses may be used to image the desired region of interest (ROI) of the eye under examination, and diaphragms may be used to obtain the desired depth of field (DOF). The desired DOF may be wide enough (10-14 mm) to bring all parts and appendages of the anterior segment of the eye into focus at once. The DOF depends on the specifications of the lens used, in addition to the diaphragm size. The diaphragm may be of a fixed size or a variable size (changed manually or electronically (controlled by appropriate software)). The optical system 124 may have an optical magnification function. This function may be controlled manually or electronically (using pre-programmed software, for example, in response to activation by a trigger signal from another component).

[0174] The optical system 124 may further include internal moving parts or other mechanisms that enable focusing on various depths / structures / layers of the eye being examined. In particular, the optical design can be configured to image both the anterior and posterior segments of the eye (retina, vitreous humor, choroid, and optic disc).

[0175] The motion controller 126 of the imaging device 120 may include some or all of the motors, rails, encoders, limit sensors, and any other components for radial and linear motion and its control. It is possible to control any combination of any of the six possible “degrees of freedom” of motion. In particular, the distance between the camera and the eye, and / or the angle between the optical axis of the camera and the surface of the eye are adjustable, and the mechanical and electronic elements that control these distances / angles may be motor-driven and / or computer-controlled. The motion controller 126 may further include functions such as automatic zoom and autofocus (e.g., including a distance sensor). Generally, autofocus is a programmable mechanism that can be performed using dedicated hardware, or a combination of hardware and software.

[0176] As described above, the imaging device 120 of the semi-autonomous system 110 may include a wide-field imaging unit 128 configured to acquire a wide-field image of the eye, as illustrated in relation to additional illumination 142. In some embodiments, a dedicated wide-field imaging unit 128 is not required, and a wide-field image of the eye's background may be acquired by one of the cameras of the sensor 122. Similarly, a dedicated illumination unit 142 may not be used, and the same illumination source 136 can be used when the projection device is inactive. A zoom lens (electronic) can be used for this purpose (wide-range imaging).

[0177] As described above, in some embodiments, the semi-autonomous system 110 includes an eye-targeting device 144 (commonly referred to as a “fixation target”). In some embodiments, the fixation target can be positioned within the imaging axis using a beam splitter / combiner.

[0178] The fixation target is set and synchronized with the current preset and examination requests. This can be done automatically, for example, by having the user track it using voice prompts.

[0179] A fixation target is used to align the eye under examination and / or the other eye to a desired direction or position (i.e., it can replace some of the motor's movement). The fixation target / eye aiming device 144 may be used to stabilize the image of the eye by reducing the frequency and / or amplitude of eye movements and to return it to the desired position after such movements. The eye aiming device 144 can be implemented by a display or by an LED or laser marker or any other aiming solution, and (e.g., in the case of aiming by LED) it can also be motor-driven. Furthermore, the eye aiming device 144 is automatically controlled and operated by a controller 151, thereby illuminating the LED / pixel / target on the screen according to the direction required by the examination task being performed.

[0180] Note that while the illumination and imaging assemblies / components are configured to move independently, in some cases, or depending on the examination, it may be necessary to move them together. Also note that in embodiments where separate movements of various components belonging to either the illumination device 130 or the imaging device 120 are used, a larger part of the system, for example, all components of the illumination device 130 and the imaging device 120, can be moved together (with arbitrary linear or angular degrees of freedom) to position the semi-autonomous system in front of the eyes of the subject being examined (and to switch between the left and right eyes) at a desired position and angle. This "large-scale" movement of the entire system can be controlled by the overall motion controller 146. Such movements are typically performed only once before the start of an examination session and do not affect the high-speed image acquisition itself during the examination session.

[0181] As described above, the control system 150 includes a manager utility 155, a controller 151, a processor 152, memory 153, a communication utility 156, and, in some embodiments, a startup utility 154. The manager utility 155 responds to input data obtained from a local operator's control unit (e.g., a technician's screen 176) or a remote control station 160 (e.g., a PC / laptop 162) to select one or more preset sets (predefined examinations) that are optimized for the selected eye area or lesion indicated in the input data and include corresponding motion data. This motion data defines all the parameters necessary to acquire all the images required for each of the one or more presets (predefined examinations).

[0182] The controller 151 is configured to operate the semi-autonomous system 110 according to operational data provided by the manager 155. This includes, but is not limited to, the operation of the optical projector 132 in a preset mode (for a specific examination session), i.e., operation of single-slit and / or multi-slit projection, projection angle, slit dimensions, etc., and the operation of the imaging device 120 in synchronization with the optical projector 132. The operational data defines, on the one hand, optimal examination parameters for a specific examination task so that the physician can acquire and analyze the most necessary information in the optimal format, and on the other hand, defines optimal examination conditions so that the examination session time is desirablely short (for example, shorter than the period of large saccadic movements of the eye), thereby minimizing image degradation factors in image data and minimizing the time the eye is exposed to light during the examination session.

[0183] The controller 151 is configured as a computing device, which may be a microcontroller, desktop computer, laptop, small or minicomputer, single-board computer, or DSP.

[0184] The controller 151 is configured and operable to manage the operation (commands) of all peripheral devices, including the illumination device 130, the imaging device 120, and the alignment mechanism (including the eye-sight device 144 and the overall motion control unit 146). The controller 151 manages the projection of illumination patterns and the acquisition of images or a series of images via control signals or commands, and manages the motion control of all degrees of freedom by transmitting motion control signals (move commands) to move each element (movable part) to a desired position while monitoring the actual position reported by a driver card that directly controls the motors. The controller 151 is responsible for performing higher-level tasks such as automatic aiming, autofocus, automatic acquisition, testing the effectiveness of a series of images, grading, quality evaluation and approval or rejection, managing the acquisition of inspection sets, and, in some cases, executing image processing procedures.

[0185] In particular, as part of the automated operation of the semi-autonomous system of this disclosure, the controller 151 is responsible for performing repeated imaging of the eye with various lighting, imaging conditions, and other system parameters, initiated by a remote ophthalmologist or on-site operator based on a pre-configured examination protocol for each lesion / disease stage / or part of the eye.

[0186] As previously mentioned, the controller 151 is responsible for communicating with the server / processor unit 158 ​​via the communication utility 156, via an internet connection, or via other interfaces with other components or devices of the system 100. The controller 151 drives one or more of the moving parts, motors, controllers, drivers, slides, and gears. The controller 151 can support the automatic or semi-automatic movement of the camera subsystem of the optical projector 132 and imaging device 120 toward the direction of the eye. The controller 151 can also monitor the position of all motors in all degrees of freedom, as well as their homing, switches, photocouplers, optical sensors (e.g., optical sensors that react as microswitches), and any other hardware limitations.

[0187] The processor 152 may be responsible for executing some or all of the image processing algorithms necessary for the operation of the semi-autonomous system 110, as well as any other necessary algorithms and software. In particular, the processor 152 may include an image processor utility 157 that is configured and operable to analyze image data generated by the imaging device 130 and generate data indicating the number of anomalies at multiple illumination locations within the eye.

[0188] The server / processor unit 158 ​​of the remote station 160 can be configured to perform one or more of the following tasks: image processing (including image reconstruction), matching examinations between ophthalmologists and patients, managing patient medical data / files (including history and past examinations), and other medical and general tasks performed by modern systems.

[0189] More specifically, image processing tasks that are typically performed offline and typically run in the cloud (generally performed by the control system 150, or distributed among processors 152 and 158) include: (i) The task of reconstructing an image by cutting out slits from a "multi-slit" image and pasting the cut-out slits onto a background image, thereby generating multiple single-slit images, (ii) The task of identifying different parts of the eye, such as the sclera, adnexa, pupil, and iris (this is performed by cloud computing (to perform autonomous centering in front of the patient's eye) or by the physical unit 110), (iii) The task of identifying and removing specular reflections, (iv) The task of ordering slits of different sets (single slit sets) or constructing an ordered series of frames or video from reconstructed images, (v) The task of generating a three-dimensional partial or complete model of the eye for imaging purposes (this may be an AI-based modeling technique), including, but not limited to, the task of generating a three-dimensional partial or complete model of the eye for imaging purposes.

[0190] As described above and as will be discussed later, the technology of this disclosure provides optimal data (image data) that enables the use of AI-based data processing, particularly suggestive AI modeling techniques. This not only enables data analysis but can also be used to optimize inspection procedures.

[0191] When using multi-slit imaging, it should be noted that the construction of an ordered series of frames in video is achieved. When ordering slits from different single-slit sets, this could be a set of wide slits, a set of medium slits, or a set of narrow slits. The system is configured and operable so that the physician can transition from wide slits to narrow slits at the same location (e.g., by rolling a mouse roller back and forth). For this purpose, the slits need to be in a specific order. For example, when using wide slits, a set of two medium slits and five narrow slits is used at the same location, and this requires data indicating the position of each slit within the set. The technique of this disclosure can also image projected wide and narrow slits and render medium-sized slits.

[0192] Regarding the generation of partial or complete 3D models of the eye, it should be noted that the 3D model of the eye can retain information such as geometric information (through 3D calibration), which can be used as an aid when extracting a single slit from a multi-slit image. The 3D model makes it possible to convert pixels to an inch / mm scale.

[0193] In some embodiments, the server / processor unit 158 ​​may be responsible for storing one or more of the entire medical files, such as images (and metadata of their acquisition parameters), medical data, visual records, follow-up, and test data for sending a second opinion.

[0194] In some other embodiments, the processor unit 158 ​​may be responsible for managing the pairing flow between the examination unit and the physician unit and / or the examination flow, monitoring system usage, and enforcing encryption and data security protocols.

[0195] The technician screen 176 can function as a control unit for a field operator and may include, as control accessories and functions (not shown in Figure 2), one or more of the following: control accessories, e.g., a keyboard and / or joystick and / or mouse and / or touchscreen; control accessories for a field technician to operate the examination device; control accessories to assist a remote ophthalmologist in performing the examination; and a user interface that provides options for starting a pre-configured set of examinations or a manually selected set of examinations. The technician screen / operator control unit 176 may be a simple screen and / or other display, may be a touchscreen and / or adjustable, and the screen may be rotatable for convenience. The display allows the field operator to review the acquired images and determine whether reshoots are necessary.

[0196] As described above, in some embodiments, the system 100 includes a positioning assembly 174, a sensing system 170, and a safety controller 172.

[0197] The alignment assembly 174 is used to align the user's face during an inspection session and may include a chin rest mechanism or face cradle to fix the user's face in a specified position during the inspection session. The alignment assembly 174 may include a support platform that holds a face cradle which defines a face support surface for supporting the user's face in a specified position during the inspection session so that the user's eyes are directed toward the eye-aiming target 144. The face cradle may or may not include a chin rest element.

[0198] The sensing system 170 is configured and operable to monitor the position of the user's face relative to the face cradle and to generate corresponding sensing data that is analyzed to selectively generate control signals to enable or disable the operation of system 110 (i.e., inspection procedures). The sensing system 170 may include one or more sensors on the face cradle to monitor the degree of contact between the user's face and the face support surface. Such one or more sensors on the face cradle may include at least one of at least one pressure sensor, proximity sensor, or at least one IR sensor. Generally, one or more pressure sensors can be used to monitor contact between the user's face and the face support surface, and alternatively or additionally, an imaging device can be used.

[0199] The safety controller 172 is configured and operable to respond to sensing data, analyze that sensing data, and generate a control signal to the controller 151 when it determines that the user's face meets safety conditions. The control system's activation utility 154 is configured and operable to activate the semi-autonomous system to run an inspection session in response to a control signal indicating the safety condition that the user's face is in a specified position. If the analysis of the sensing data indicates that the alignment between the semi-autonomous system and the user's face does not meet the pre-set requirements and may fall under pre-set risk conditions, the safety controller 172 notifies the controller 151, and the controller sends appropriate commands to various system components via the activation utility 154, for example, to stop the movement of a specific device.

[0200] The remote control station 160 may include, in particular, a processor unit 158, a PC / laptop 162, a display 164, control peripherals 166, 3D visualization peripherals 168, and a safety controller 178. The PC / laptop 162 may be part of the system 100 or a third-party PC / laptop (generally any device with communication capabilities and a display, such as a laptop / PC / tablet / smartphone, can be used). Generally, the PC / laptop 162 functions as an ophthalmologist's tool for remotely controlling the semi-autonomous system 110, but it can also be used to operate the system 110 locally. Additional functions that the PC / Laptop 162 can perform include allowing ophthalmologists to view original or reconstructed images by scrolling through single-slit and / or multi-slit images (or other relevant data when used as an imaging device), serving as a tool for ophthalmologists to review other clinical data of patients, performing diagnoses (e.g., using it to mark findings, write clinical and non-clinical comments, scan history, etc.), making decisions about the next steps, and serving as a tool for ophthalmologists to "direct" the acquisition of additional images of the patient's eye with selected parameters.

[0201] The display 164 may be a conventional 2D display, or a standard 3D display screen implemented by, for example, a VR headset or other three-dimensional solution (3D visualization peripheral device 168 in Figure 1), such as a hologram or binocular image projection technology.

[0202] In some embodiments, the sensing system 170 is configured and operable to transmit sensing data to a safety controller 178 of the remote control station 160, where the sensing data is analyzed, and control signals are selectively generated and transmitted to the controller 151.

[0203] Additional parts of System 100 not shown in Figure 2 include one or more additional optical elements such as chin rests and forehead rests, armrests, interchangeable optical subunits for various examinations of different eye segments and diseases, and folding mirrors and prisms. External add-ons include, but are not limited to, goniolens, external mirrors, and contact lenses.

[0204] Furthermore, the system 100 may include means for manually or by software control to change the parameters of the optical system, such as changing the distances between various lenses in the optical system, or replacing, adding, or removing some or all of the lenses.

[0205] System 100 can be used as a standalone system or as a subsystem of another system.

[0206] As illustrated with reference to Figures 1 and 2, system 100 is capable of data communication with cloud computing system 105, which performs high-load data processing tasks. Cloud computing can be performed on an actual cloud service, a remote PC, or even on the local PC of system 100.

[0207] The technology of this disclosure can operate / utilize AI-based processing of image data to identify suspicious areas / locations and findings and to detect abnormalities / lesions of the eye. In fact, since the system of this disclosure utilizes an autonomous or semi-autonomous eye examination system configured as described above, the image data collected by such a system includes high-quality images of various eye regions from various patients collected by the same system (same operating conditions), and furthermore, such image data is little to no effect of errors caused by differences in operators. This results in data optimized for machine learning processing, particularly suggestive AI-based processing. In particular, suggestive AI-based technology can also be used to automatically optimize operating data in response to updated findings.

[0208] Typically, AI-based functionality can be installed in a remote control system (system 105 in Figures 1 and 2). This remote control system is a server system (a computerized system including input / output utilities, memory, processor, etc.) that can connect to subscriber eye examination systems of a type that perform semi-autonomous eye examination procedures via a communication network. Each subscriber system has a unique ID appropriately assigned to such a system during the enrollment process. The subscriber system sends image data acquired by the system to the server, associated with preset data and / or examination task data used to acquire each image data, and possibly other relevant patient-related data. Patient-related data may include the patient's IP address, and the server can access other patient-related data, such as historical data of the patient's past eye examination results (on the server or at a physician-related station, depending on the situation). The server system is configured and operable to perform model-based processing (AI-based processing) of the input data received from each subscriber system and generate output data. Such output data may include data indicating suspicious areas and findings in the eye region under examination to enable the detection of abnormalities and / or lesions, and / or data indicating abnormalities and / or lesions detected in one or more areas of the eye region under examination, and / or data indicating the quality level of image data provided by the subscriber system, and / or data indicating recommended preset data for an examination session performed by a particular subscriber system for eye examinations.

[0209] Such recommended preset data may include optimized operating parameters of the system, such as patterns to be used, which are optimized for specific areas of the eye and / or specific abnormalities to be detected and / or specific patients. For example, AI-based processing may identify insufficient image quality and generate recommended data (e.g., optimized preset data) indicating optimized operating data to improve image quality. System 100 (its manager utility) can respond to such optimized / updated preset data and automatically start running additional examination sessions using the optimized operating data. Additionally or alternatively, AI-based processing on server 105 may generate optimized preset data for specific examination sessions for a particular patient based on an analysis of historical data regarding past eye examinations of that particular patient, and send the respective data to the examination system 100.

[0210] In some embodiments, the AI ​​subsystem can specifically perform one or more of the following functions: detecting low-quality images and notifying the user of the problem (via the user interface of system 100 and, optionally, the physician's system); reacquiring low-quality images (since acquisition and projection parameters are retained within the system); detecting suspicious areas / sites, findings, or lesions and marking them for the user; autonomously providing or performing additional acquisition sets using existing or AI-generated presets suitable for further investigation; and drawing conclusions on findings as necessary. Optionally, the user or operator may retain the ability to manually override the AI's judgment.

[0211] Figure 3 illustrates an eye examination system 200 of the present disclosure, including a semi-autonomous system 250 (showing a non-limiting example of system 110 described above) and a control system / computer 212 (which may constitute control system 150 or control system 160). In this non-limiting example, the semi-autonomous system 250 includes two digital cameras 204A, 204B for stereo imaging of multiple positions of the eye 220 illuminated by an optical projector 202 during an examination session. By using a pair of cameras, a three-dimensional visualization can be provided to the ophthalmologist (similar to conventional binocular slit-lamp examinations). However, it should be noted that the technology of the present invention utilizes autonomous or semi-autonomous examination systems that can be configured for monovision or stereovision, and the principles of the technology of the present disclosure are not limited to the use of 3D imaging.

[0212] Furthermore, in this non-limiting example, a beam splitter / combiner mechanism is used to achieve 3D imaging. However, the aspects of the technology of this disclosure are not limited to this configuration. For example, two direct imaging axes (without using a beam splitter) can be used, for example, in conjunction with microlensing technology.

[0213] The optical projector 202 includes an illumination source, illumination projection means (e.g., a scanning mirror), and various optical systems.

[0214] Illumination IL is incident on / combined to the eye 220 at a preset angle using a mirror / prism 206. The reflected light RL from the eye 220 is collected (typically perpendicular to the patient's face). The reflected light RL is split into two propagation paths by a beam splitter 208 and led to two digital cameras 204A and 204B. The digital cameras include respective lens modules 210A and 210B, which may include multiple lenses and an autofocus mechanism for obtaining focused images with extended DOF.

[0215] The optical axis of the eye 220 can have various orientations with respect to the optical axis of, for example, the digital camera 204B. The optical axis of the digital camera is defined by the eye aiming device 144 in Figure 2, which is not shown in Figure 3.

[0216] The operation of system 200 is managed and controlled by control system 212. This control system is configured and operable as described above with respect to control system 150 of system 110, and is responsible for transmitting trigger signals TR to the optical projector 202 and the two digital cameras 204A and 204B. This ensures that the projection of the illumination spot and the acquisition of a corresponding series of images are performed synchronously, preferably at a speed fast enough to eliminate image blurring caused by eye movements such as saccadic eye movements, blinking, and eye movements (e.g., due to eye fatigue in the patient). As described in detail with reference to Figure 2, control system 212 controls the operation of the optical projector 202 and digital cameras 204A and 204B, and is configured and operable to select pre-stored operation data for semi-autonomous system 250 using data indicating the examination task. The operation data defines the operation parameters of the eye examination session.

[0217] Figures 4A–4C show examples of single-slit images obtained using the eye examination system of this disclosure. Figure 4A shows illumination with white light, Figure 4B shows illumination with a high-intensity blue channel, and Figure 4C shows that different illumination intensities are required to examine different parts / regions of the eye. In the images of Figures 4A and 4B (using such different illuminations), both sides (anterior and posterior) of the lens can be observed. Figure 4C shows that although the illumination intensity is sufficient to adequately observe the slits on the cornea and iris, there is saturation above and below the iris (on the sclera), and the illumination intensity should be lower if the sclera is also to be examined.

[0218] It can be seen that a clear image of the slit is obtained simultaneously with respect to reflections from the cornea, iris, and posterior capsule of the lens. This supports the fact that a depth of field (DOF) of approximately 12 mm can be obtained with the ophthalmological examination system of this disclosure.

[0219] Figure 5A shows an example of a single-slit image with lesion findings marked. In a healthy eye, the projection onto the iris is expected to be relatively uniform. However, as seen in this example, the slit projected onto the iris exhibits distortion in shape, width, and color. As mentioned earlier, slit distortion may be associated with a lesion or disorder in the structure of the eye.

[0220] Figures 5B and 5C show examples of single-slit images that enable the extraction of lesion-related data. In the example in Figure 5B, corneal scarring is seen in a post-traumatic eye. The width of the slit projected onto the cornea indicates a change in thickness, and (at the location indicated by the arrow) the inner layer (Descemet's membrane) is torn. Figure 5C shows another location in the same eye, where the arrow points to an area where the corneal thickness is changing.

[0221] Figure 6 shows an example of multi-slit projection onto a real eye. The slit images can be seen on the cornea, iris, and lens behind the pupil.

[0222] In embodiments where a multi-slit pattern is projected onto the eye, image reconstruction is utilized. This technique utilizes so-called "image slicing," which is related to image reconstruction in which a portion of an acquired image is extracted and pasted onto another image.

[0223] Figure 7 shows an example of such image reconstruction, where multiple multi-slit images are acquired and the relative positions of the slits in the temporally adjacent projected multi-slit patterns are shifted by a predetermined amount. A wide-field image of the eye is also acquired during the examination session. During the image processing step, the slits are extracted from each multi-slit image, and each extracted slit is superimposed onto a wide-field image that serves as the background image. This generates multiple reconstructed single-slit images from a smaller set of acquired images illuminated by the multi-slit projection and the "background" image (ROI illumination). The single-slit / multiple single-slit superimposed on the background image of the eye can simulate a single-slit scan (or simultaneous scan with multiple slits), similar to the scans performed by ophthalmologists in conventional systems.

[0224] In the simplest embodiment, any anomalies within the region of interest can be sufficiently identified simply by displaying a series of acquired multi-slit patterns, i.e., the initially acquired image, and scrolling through such a series of images to cover the entire region of interest.

[0225] In some embodiments, the system acquires a set of multi-slits and a set of single-slits, and when a slit is pointed to in the multi-slit image, a single slit (from the other acquired sequences) is presented to the viewer. Pattern matching techniques, eye segmentation and mapping, or the multi-slit to single-slit processing described later can be used to detect the correct position of the slit.

[0226] To separate the slits of a multi-slit image (for use as single slits), the techniques of the present disclosure may use image processing techniques known in the art, such as image binarization, foreground / background separation, or semantic segmentation (using DNNs), or a combination thereof. Following foreground / background separation and slit segmentation, the slits are cut out from the multi-slit image and pasted onto a “background image,” and then the slits are arranged / aligned as a series of single slits according to the order of their respective positions.

[0227] In posterior segment and anterior slit projection and imaging, the inventors have found that the quality of the reconstructed single-slit image is improved when the optical projector is operable to sequentially project first and second sets of multi-slit shaped illumination spots onto the positions of the first and second sets, respectively, and the first and second positions are arranged in an interlaced manner. This interlaced manner for arranging the first and second positions is referred to herein as the "even / odd method" and is used for multi-slit imaging of the retina or imaging of the entire anterior region (without tilt angle) based on multi-slit projection.

[0228] Figures 8A and 8B illustrate how to capture two multi-slit pattern projections, "even" and "odd." Here, the "odd" projection includes inverted illumination of the "even" projection; for example, areas that were bright in the "even" set are dark in the "odd" set, and areas that were dark in the "even" set are bright in the "odd" set. The white dashed lines drawn on the two "even" and "odd" interlaced multi-slit images help to understand the principle of interlacing.

[0229] An additional third "background" image is acquired in a similar manner. Interlaced multi-slit projection can include non-overlapping slits, and the two projections ("even" and "odd") can either overlap or not overlap. That is, continuous coverage can be created by summing the alternating projections as needed, or gaps can be intentionally left. The slits in the "even" and "odd" pattern can cover the entire field of view, and when the two projections are illuminated simultaneously, it is equivalent to illuminating the entire field of view with full illumination. The projection angle, slit width, and slit spacing can be correlated to create a multi-slit row. Typically, interlaced (i.e., "even" and "odd") images are subtracted from each other to obtain better contrast.

[0230] Methods used for slit separation during image processing include one or more adaptive image binarization methods, such as foreground binarization using the Otsu method and foreground cropping. Furthermore, known semantic segmentation methods, such as deep neural networks (DNNs), can also be used. Labeling is performed using standard image processing methods, such as the known Watershed method and Enhanced Watershed image processing methods. A Depth-First Search (DFS) algorithm can be applied to collect slits in their projection order.

[0231] During reconstruction, a single slit or multiple isolated slits can be superimposed onto a wide-field background image of the eye.

[0232] In embodiments requiring slit-scan emulation as described above, the generated image is reconstructed by pasting each of the slits in the "even" and "odd" multi-slit images onto a background image. This method provides complete coverage of the ROI and, if selected during the examination session, enables single-slit scan emulation by displaying an image with the slit at the current scan position. In this method, due to the even-odd nature, only three images (even, odd, and background) may be used to cover the entire region of interest. This allows for a very short acquisition process, shorter than saccadic motion, resulting in highly accurate imaging when photographing the posterior segment.

[0233] This reconstruction method can also be used when images are acquired simultaneously by two cameras, enabling stereo vision slit scans, similar to conventional slit-lamp methods. Such stereo vision slit scans allow for video-like slit scans of the eye region being examined, similar to scans obtained through conventional slit-lamp devices. The scan can be stopped / repeated / played back from end to start, thereby changing the scan direction and modifying the playback speed, similar to a recorded video.

[0234] Figure 9 shows a stereo single-slit view of the eye being examined, displayed to an ophthalmologist at a remote location. Each slit is acquired from its respective angle (as if the doctor were viewing it through the eyepiece of a slit lamp). The two images are interpreted by the ophthalmologist as a stereo single-slit image, similar to that obtained with a conventional binocular slit lamp device.

[0235] In some embodiments, a physician can view the multi-slits acquired simultaneously (from the right and left cameras) and observe them in a stereo view.

[0236] In some embodiments, the method of obtaining multiple reconstructed single-slit images from a set of fewer multi-slit images can also be applied to non-frontal slits of any part of the eye, including the anterior segment, where the slits are observed in multiple layers, surfaces, and depths of the translucent layer. In these embodiments, multiple slit pattern projections are acquired with constant and / or variable slit spacing. The patterns may not overlap between slits of different patterns, or they may partially overlap (for example, during a later examination procedure, during the slit scanning phase, to allow the physician to obtain a smoother, more continuous scan). In some embodiments, the slits may cover the entire field of view or a portion of a region of interest (ROI) for the current examination. The collection of all slits from all projected patterns, acquired rapidly while a series of multi-slit images remain in the same / similar positions, will cover the entire ROI, resulting in virtually every location of the ROI being covered by the slits. Reconstruction may include pasting single / multiple separated slits onto a background image, as described above.

[0237] In previous applications of slit-scan emulation, the generated image is reconstructed by pasting each slit of each multi-slit image onto a background image, thereby providing complete ROI coverage. If single-slit scan emulation is requested, for example by a physician, the reconstructed image is displayed with the slit at the current scan position.

[0238] It should be noted that the pattern of projected illumination spots (e.g., having a slit shape) must ensure sufficient spacing between consecutive spots / slits on the captured image of the eye. The spacing between spots / slits can be set according to other system parameters of the acquired examination, namely, slit width, projection angle, and specific ophthalmic conditions. In anterior segment examinations, each slit projection onto the cornea should not overlap with the subsequent slit projection onto the iris.

[0239] This non-overlap condition also applies to the cornea / iris with projection onto the lens, and to the cornea or iris with continuous slits (it may apply in the case of illumination from a large angle). For example, when acquiring an image of the eye using illumination guided / propagated along an axis at an angle of approximately 60 degrees from the right of the optical axis of the eye, a situation arises where the projection onto the right cornea appears to the left of the iris reflection.

[0240] In some embodiments, single-slit images can be used as part of an acquisition sequence to address the separation of slit images that are difficult to separate or machine-read. This can occur in cases of saturation, overexposure, iris boundaries, etc. Multi-slit images can be used without projecting specific slits that were separately captured in single-slit images. A multi-slit image can be decomposed into separate single-slit images, which can then be added to a single-slit image for problematic areas to form a single continuous series. In this case, a sequence of multi-slit images and a sequence of single-slit images are acquired (in the same FOV), and the single-slit images are used to separate the single slits from the multi-slit image. In some embodiments, combinations of multi-slit and single-slit sets can be used during the same acquisition or in a continuous acquisition.

[0241] In these embodiments, more images may be required than in a standard multi-slit projection sequence, and the image analysis is similar to the "even / odd" method described above.

[0242] In the example above, the physician is viewing the image in 3D. This disclosure also provides an alternative approach using 3D reconstruction, namely, a method for creating a solid mesh of the eye using slits, for example, as structured light, and then holding and displaying the slits as textures on this solid. This allows for the use of a three-dimensional single-slit image rendering method for the anterior or posterior segment of the eye. This method allows for the reconstruction of the three-dimensional structure of the eye examination area acquired by multi-slit sequence pattern projection, followed by the rendering of the necessary slits and background. The slits can be generated sequentially, thereby enabling the emulation of a dynamic scan of the object / eye.

[0243] Such 3D reconstructions can be used in one or more of the following ways: (1) to assist in multi-slit slit separation, particularly slit projection onto the cornea, because the 3D position of the cornea is on a higher surface (closer to the camera) than the iris or lens. (2) 3D reconstruction provides 3D information of the slits. (3) 3D reconstruction provides actual physical measurements of the findings (through pixel-to-inch / mm conversion as part of the calibration) because a calibration process is always performed during 3D reconstruction. (4) 3D reconstruction provides an emulation view of the eye without requiring virtual reality (VR) or a 3D screen.

[0244] This disclosure provides a method for measuring elements of an eye, such as distance (two-dimensional and three-dimensional), using the structure of the eye extracted from image data provided by at least one camera. The three-dimensional structure can be analyzed using methods known in the art. For example, the three-dimensional structure of the eye can be obtained from structured light projection, even when only a single camera is used, by slit projection. Structural analysis can utilize three-dimensional stereo vision when the imaging device includes at least two cameras and / or when three-dimensional structured light is combined with stereo vision for higher accuracy.

[0245] Furthermore, by using 3D reconstruction of the acquired image data, [pixels / mm] measurements can be obtained as part of the 3D calibration process, which can then be used during the analysis of the eye structure extracted from the acquired image data.

[0246] The techniques of this disclosure are made possible by a single acquisition of a series of multi-slit patterns, or by using other structured light or any other method. Three-dimensional image / eye reconstruction of image data obtained from any possible slit scan with any inspection parameters can be performed at a later date. In some embodiments, slit separation is performed by using the three-dimensional shape of the acquired slits.

[0247] In some other embodiments, the slit point cloud is constructed using methods known in the art, such as structured light (when using a single camera) or stereo vision (when using multiple cameras) or a combination thereof. Analysis and rendering of the slit are performed using depth maps derived from the point cloud using methods known in the art. The depth of parts of the eye, such as the sclera, iris, cornea, or retina, is determined by the depth maps obtained from the point cloud. Note that the projection direction relative to the eye determines the order in which the slits are projected.

[0248] Generating multiple reconstructed single-slit images from a small number of acquired images and a "background" image using multi-slit projection can be achieved by utilizing semantic segmentation techniques using DNN (Deep Neural Network) technologies known in the art, such as SegNet and UNet. These methods are considered ways to analyze image data and generate a final three-dimensional map.

[0249] Generally, image quality can be evaluated by convolutional neural network (CNN) classification or other methods known in the art.

[0250] Figure 10A is a flowchart illustrating an asynchronous examination procedure 800 using the ophthalmological examination system of this disclosure, including high-speed projection of a multi-slit pattern (and acquisition of each image). Note that the procedure illustrated in this figure can also be used with single-slit set acquisition or a combination of those methods described above.

[0251] This procedure begins with the local operator assisting the patient in preparing for the examination, for example, by having them place their head on the chin rest (step 810). Then, the local technician begins the examination program (step 812).

[0252] As described above, one or more presets (predefined examinations) are selectable via a user interface, such as a technician screen 176 communicating with a manager utility 155. Generally, a set of predefined examinations to be performed by default (hereinafter referred to as “presets”) is stored in memory 153 or dynamically retrieved from a server in the control system 150 and initiated by a field operator. Examples of presets selected / instructed by a physician include, but are not limited to, corneal, fluorescein, contact lens fitting, anterior chamber, iris and posterior chamber, retroillumination, crystalline lens / IOL (intraocular lens), adnexa, eye movements, and pupillary response to light.

[0253] The saved presets may be specific to each clinical examination (for example, aimed at detecting / analyzing a particular lesion). Each preset may include, but is not limited to, pre-set values ​​such as illumination angle, imaging angle, slit shape, and intensity. Furthermore, the semi-autonomous system 110 of this disclosure can focus on the optimal point of the eye as required by a particular examination. For this purpose, the system utilizes a novel focusing mechanism based on an understanding of the anatomical structure of both eyes, the requirements of the clinical examination, and the adjustment of the system. For example, if the examination targets the cornea (a transparent object), the preset may instruct the system to first focus on the iris or blood vessels on the cornea (which provide high contrast), and then move the system's focus posteriorly from the iris focus toward the required focus on the cornea (e.g., about 6 mm posterior), which can be easily estimated based on the average size of the human eye.

[0254] In some embodiments, the preset may include specific illumination patterns and colors that help detect contact lenses and markings on them.

[0255] Specifically, preset parameters include, but are not limited to, one or more of the following: target eye (left / right / both), initial hardware position (for all or some degrees of freedom) (may also include chin rest height), fixation target (eye aim / line of sight target) (may change frame by frame during acquisition), background illumination (may be a multispectral parameter or may change frame by frame during acquisition), region of interest, optical / digital zoom, aperture control for camera and light source lenses, autofocus target (including final offset correction), lens selection (if multiple interchangeable lenses are available), lens parameters (if zoom and / or focus can be controlled internally), number of acquisitions (sets with the same preset), image quality threshold (minimum required grade), spot shape / binary map of each pattern including the contours of each projected pattern, and hardware limit parameters related to safety.

[0256] When a series of slits / multi-slits are used, the preset parameters include one or more of the following: slit parameters (exposure time, width, height, offset (of the leftmost slit in the pattern)), number of slits in the pattern / single-multi-slit selection, spacing (spacing between consecutive slits in the case of multi-slits), rotation angle, tilt, acquisition (projector) illumination (which may also vary per frame / pattern during acquisition if it is a multispectral parameter (additional illumination)), illumination duty cycle (%) for slit segments of each part of the eye (e.g., cornea = 100%, sclera = 45% (to mitigate scleral saturation issues; see example in Figure 4C)), per-frame adjustable camera parameters (including one or more exposure times), gamma, gain (each (color) channel and master gain), and black level.

[0257] It should be noted that the manager utility 155 of the semi-autonomous system 110 of this disclosure enables the system to function autonomously, for example, during an asynchronous examination 800. The local operator simply presses a button to start a series of tests (presets), and the results are sent for analysis by a physician.

[0258] The examination plan guides the technician to orient the eye being examined in the desired direction (step 814) and set the illumination parameters for the aiming phase (step 816). Automatic aiming and centering of the camera and eye illumination (manual aiming assistance is also possible) is performed in step 818. The correct positions of the imaging / capturing unit and illumination unit are defined by the examination plan. Autofocus of the camera and illumination on the desired area of ​​the eye is performed in step 820. These steps (818 and 820) can be performed manually, automatically, or a combination of both. Positioning and other operations (described later) are performed using IR / "soft" or ambient illumination, taking patient comfort into consideration. Automatic actions before image acquisition, such as steps 818 and 820, can be performed iteratively. That is, if automatic aiming and autofocus are unsuccessful (step 822), steps 818 and 820 can be repeated. The control software can independently control the DOF of both illumination and image acquisition and set parameters as needed.

[0259] Therefore, the automatic operation of the semi-autonomous system before image acquisition includes one or more of the following: automatic aiming of the line of sight direction of the eye under examination / the other eye, automatic centering of the eye under examination, initial autofocus, automatic illumination, and final autofocus. If the acquisition of a series of images is successful (confirmed in step 824 by the on-site operator, remote OD estimation, or using an image quality method, e.g., CNN or image processing method), in step 826, the acquired (one or more) images are saved (e.g., in memory 153) and sent to the server (step 828), and multiple single-slit images are generated / reconstructed (but not limited to) (step 830).

[0260] Steps 814–828 are performed for each required examination, as shown in the predefined set of examinations acquired by the on-site technician in step 812. The acquired / generated / reconstructed single-slit images are saved (locally or remotely, for example, to a cloud server, which may be implemented in the actual cloud or on a local or remote computer as described above) and sent to the ophthalmologist's PC for evaluation (step 832). The ophthalmologist performs an asynchronous "slit scan" of the patient's eye by scrolling through the generated single-slit images (step 834) and reports the findings of the examination session (step 836). The ophthalmologist may choose to display the results as multi-slit images (in the case of a multi-slit image acquisition mode shown as any step 830) or single-slit images (algorithmically separated). Display to the ophthalmologist may include two-dimensional and / or three-dimensional displays, such as virtual reality, deep reality viewers, three-dimensional screens, three-dimensional modeling of the image (textured three-dimensional mesh), or reconstructions from images acquired from different angles.

[0261] Figure 10B is a flowchart illustrating a synchronous examination procedure 850 using the ophthalmological examination system of the present disclosure, including high-speed projection of a multi-slit pattern (and acquisition of each image). This procedure 850 is similar to procedure 800 in Figure 10A, but differs in that the ophthalmologist can decide in real time whether to repeat the examination with the same or different examination parameters.

[0262] For example, an ophthalmologist may determine if additional examinations are necessary (step 852). In that case, as some non-limiting operations, (i) the ophthalmologist may select the necessary set of examinations with preset or manually selected parameters (854); (ii) the ophthalmologist may use the remote control capabilities of the semi-autonomous system of the Disclosure to center and aim the illumination, camera, and the eye being examined (856); and further, the ophthalmologist may control the slit position and other parameters in real time to obtain a sense of the examination being acquired (858). Non-limiting examples of controlled examination parameters include slit width, slit height, RGB (wavelength), illumination intensity, illumination angle, shooting angle, focus offset, eye guidance, and background illumination.

[0263] The eye examination system of this disclosure may further include various human-machine interface (HMI) functions not shown in the figures, such as a touchscreen, joystick or keyboard of virtual reality hardware for controlling various system components, visual instructions (e.g., for aiming at the eye being examined or the other eye), and voice instructions (for initiating the examination, documenting procedures / findings by the physician, and for automatic instructions from the system to the patient). Furthermore, the eye examination of this disclosure may further include means for remote / local definition of the area to be examined, and means for remote / local requests for zooming and focusing on the required area.

[0264] The flowchart described above illustrates a specific example of the technology described herein, but is not limited to it.

[0265] In addition, in some embodiments, appropriate AI-based data analysis can be used to identify suspicious areas or findings, recognize and warn of lesions, mark suspicious areas, colorize physician findings, automatically measure (radius, change, etc.) of physician-marked lesions, automatically center and aim based on findings, and / or capture images with specifications related to those findings.

[0266] The examination procedure can utilize different illumination intensities for different regions / locations of the eye being imaged. For example, within the same slit or projection, a lower illumination intensity can be used to image the scleral region, while a higher illumination intensity can be used to image the corneal region. In another example, the illumination can be appropriately adjusted. For instance, the illumination can be adjusted based on the color of the iris or modified according to the characteristics of the examination area (e.g., a nevus that may be darker than the surrounding area). Furthermore, illumination adjustment can be performed automatically and autonomously as part of the process.

Claims

1. It is a system for eye examinations. A semi-autonomous system configured and operable to perform an eye examination session, Equipped with a control system, The aforementioned semi-autonomous system A lighting device comprising at least one optical projector, each of which is configured and controllable to automatically project a series of pre-defined shaped illumination spots onto a plurality of positions spaced apart from each other across the eye region during an eye examination session. The present invention comprises at least one imaging device, each configured and operable to acquire an image of the eye including the plurality of locations illuminated by the irradiation spot during the examination session, and to generate image data associated with the plurality of locations, wherein the image data indicates an anomaly relating to each of the plurality of locations within the eye region. The control system comprises a manager utility and a controller, wherein the manager utility is configured and operable to define operational data for the semi-autonomous system controlled by the controller in response to input data including preset data indicating an inspection task, the operational data defining operational parameters for an eye inspection session, and the controller is configured to operate each of the at least one imaging devices in synchronization with each of the at least one optical projectors, thereby minimizing image degradation factors in the image data and minimizing the eye's illumination exposure time during the inspection session.

2. In the system described in claim 1, The system is characterized in that the input preset data includes at least one of pre-stored data indicating the examination task and input dynamically provided by a physician at a remote physician-related station, which includes data indicating the examination task.

3. In the system described in claim 1, The system is characterized in that the input preset data includes a list of records associated with at least one of a specific lesion type and an examination of a specific area of ​​the eye region, and the records include a plurality of data records relating to various types of motion data used in the examination session.

4. In the system described in claim 1, The system is characterized in that the input data includes data received from the physician's remote station while the physician is reviewing image data provided by the control system, thereby enabling the physician to preview the expected image acquisition during the examination session and provide various examination parameters.

5. In the system described in claim 1, The system is characterized in that the preset data includes data indicating two or more examination tasks spanning different regions of the eye, and the control system is configured to operate the semi-autonomous system in fully automatic mode, enabling the automatic execution of a series of two or more examination tasks, thereby providing data that provides a broad overview of the eye's condition.

6. In the system described in claim 1, The system is characterized in that the input preset data includes identification data for multiple patients associated with predetermined operation data.

7. In the system described in claim 1, The aforementioned input data, Input preset data comprising a list of records associated with at least one of a specific lesion type, a function of a specific part of the eye region, and an examination, wherein the records comprise multiple data records relating to various types of motion data used in an examination session, Input data received from a physician's remote station, which indicates physician preview data of expected image acquisition during an examination session, based on a physician's review of initial image data provided by the control system, wherein the physician preview data includes data indicating one or more examination parameters. Preset data including data representing two or more examination tasks spanning different regions of the eye, wherein the control system is configured to operate the semi-autonomous system in fully automatic mode, enabling the automatic execution of a series of two or more examination tasks, thereby providing data representing a broad overview of the eye's condition. A system characterized by including at least one of the following.

8. In the system described in claim 1, The control system is configured and operable to generate an activation signal for the semi-autonomous system in order to initiate an inspection session, and is characterized in that, after the activation signal is generated, no physical elements of the semi-autonomous system are operated.

9. In the system described in claim 1, The system is characterized in that the semi-autonomous system performs an electronic scan of the eye region while maintaining a physically stationary state of the semi-autonomous system during the examination session, and is configured and operable to illuminate the eye region during the examination session with irradiation spots that form different patterns or changing patterns.

10. In the system described in claim 1, The system is characterized in that the illumination device includes N (N≧1) optical projectors, and the imaging device includes M (M≧1), and the numbers N and M are the same or different.

11. In the system according to claim 10, The illumination device comprises at least a pair of optical projectors, each of which is associated with one or two imaging devices to perform at least one of (i) simultaneous examination of both eyes of a patient, or (ii) stereo imaging of the eyes.

12. In the system according to claim 10, The lighting device is characterized by including two or more optical projectors configured to operate with different operating parameters in order to simultaneously or sequentially perform examinations of different parts of the eye region.

13. In the system described in claim 1, A system characterized in that the at least one optical projector and the at least one imaging device are configured to have an extended depth of field, thereby automatically projecting illumination spots to multiple positions and focusing them at each of the multiple positions, and the image data showing a focused image at each of the multiple positions.

14. In the system described in claim 1, A system characterized in that the at least one optical projector and the at least one imaging device are configured to have an extended depth of field that is independently controlled by the controller.

15. In the system described in claim 14, The system is characterized in that the extended depth of field is selected to simultaneously bring multiple anterior eye segments and appendages into focus.

16. In the system described in claim 1, The semi-autonomous system is characterized by including a focusing mechanism configured and operable to first focus at least one of the optical projector and the imaging device on a relatively high-contrast area of ​​the eye, and then move the focus forward or backward toward a region of the eye to be examined based on a known distance between the relatively high-contrast area and the area to be examined.

17. In the system described in claim 1, The system is characterized in that the semi-autonomous system includes an autofocus mechanism that is automatically operated by the controller according to the operating parameters of the eye examination session.

18. In the system described in claim 17, A system characterized in that at least one of the optical projector and the imaging device includes the autofocus mechanism.

19. In the system described in claim 1, A system characterized in that the predetermined shape of the irradiation spot is a slit shape.

20. In the system described in claim 19, The system is characterized in that at least one optical projector is configured to automatically project a series of slit-shaped illumination spots in a single-slit continuous manner and is controllable to operate, and the image data includes corresponding continuous image data pieces, each image data piece including a single-slit image.

21. In the system described in claim 19, The system is characterized in that the at least one optical projector is configured and controllable to automatically and simultaneously project at least a first array of spaced-apart slit-shaped illumination spots in at least a first multi-slit method, and the image data includes at least one first image, each of which is an image of a spaced-apart position in at least the first array.

22. In the system described in claim 21, The optical projector is operable to sequentially project a first array of slit-shaped illumination spots using a first multi-slit method and a second array of slit-shaped illumination spots using a second multi-slit method onto the positions of the first and second arrays, respectively, the positions of the first and second arrays are arranged in an interlaced manner, and the image data includes first and second images of the positions of the first and second arrays, respectively.

23. In the system according to claim 22, A system characterized in that the first and second positions partially overlap.

24. In the system described in claim 1, The system is characterized in that at least one optical projector is configured and operable to automatically change the spherical angle of the projection of an illumination spot onto the eye, and the image data includes image data fragments of each position associated with data indicating the spherical angle of the projection.

25. In the system described in claim 1, The system further includes an imaging unit configured and operable to acquire a wide-field image of the eye, thereby enabling alignment of a foreground image formed by the image data onto a background image formed by the wide-field image of the eye.

26. In the system described in claim 1, A system further comprising an alignment assembly for aligning the user's face during an inspection session.

27. In the system described in claim 26, The system further comprises a startup utility configured and operable to start the semi-autonomous system to perform an inspection session in response to a control signal indicating a safety condition that the user's face is in a specified position.

28. In the system described in claim 26, The system further includes a sensing system configured and operable to monitor the position of a user's face and generate corresponding sensing data, wherein the sensing data is analyzed to determine the position of the user's face relative to a specified position and enable the selective generation of the control signal.

29. In the system according to claim 28, The system is characterized in that the sensing system is configured and operable to transmit sensing data to a safety controller of a remote control station, the sensing data is analyzed at the remote control station, and a control signal is selectively generated and transmitted to the controller.

30. In the system according to claim 28, A system characterized by including a safety controller configured and capable of generating and operating a control signal for the controller when it analyzes the sensing data in response to the sensing data and identifies a predetermined position of the user's face.

31. In the system described in claim 1, The system is characterized in that the lighting device includes a flash illuminator.

32. In the system described in claim 1, The system is characterized in that the semi-autonomous system includes an eye aiming device that is automatically operated by the controller according to the operating parameters of an eye examination session.

33. In the system described in claim 1, The system is characterized in that the semi-autonomous system includes an eye-tracking mechanism that is automatically operated by the controller during the examination session.

34. In the system described in claim 1, The semi-autonomous system is characterized by including one or more motion mechanisms for realizing controllable movement of one or more elements of the system, and a safety controller configured and operable to control the one or more motion mechanisms.

35. In the system described in claim 1, A system characterized in that the at least one imaging device is configured and operable to acquire a 3D image.

36. In the system described in claim 1, A system characterized in that the at least one imaging device includes a color sensor or a monochrome sensor.

37. In the system described in claim 1, A system characterized in that the at least one imaging device includes a monocular sensor and / or a multispectral sensor.

38. In the system described in claim 1, The system further comprises an image processor utility configured and capable of analyzing image data and generating data indicating anomalies at each location.

39. In the system described in claim 1, A system characterized in that the control system is configured and operable to transmit data indicating image data to a remote control station in order to perform further processing for identifying and analyzing eye abnormalities.

40. In the system described in claim 20, The system further includes an image processor utility configured and operable to extract a single-slit image from each of the continuous image data pieces at each position, cut out the extracted single-slit image, and paste the cut-out extracted single-slit image onto a background image which is a wide-field image of the eye.

41. In the system described in claim 21, The system further comprises an image processor utility configured and operable to divide at least a first multi-slit image into a corresponding set of single-slit images.

42. In the system described in claim 41, The system is characterized in that the image processor utility is further configured and operable to paste each of the single-slit images extracted from at least the first multi-slit image onto a background image which is a wide-field image of the eye.

43. In the system described in claim 41, The system is characterized in that the image processor utility is configured and operable to generate data showing the dynamic movement of a single slit image over the eye, and that it is possible to artificially pause the data presented for a particular slit view.

44. In the system described in claim 38, The system is characterized in that the image processor is configured and capable of generating a 3D reconstruction of the acquired data in the acquired image using the image data.

45. In the system described in claim 21, The semi-autonomous system is configured and operable to perform stereo imaging of the eye and provide stereo image data of the eye region, and the image processor is configured and operable to generate a 3D reconstructed image from two multi-slit images using the stereo image data, identify at least one 3D single-slit image in the 3D reconstructed image, project the at least one 3D single-slit image onto a 2D image to obtain a 2D projected image containing the at least one single-slit image, extract the at least one single-slit image from the 2D projected image, cut out the extracted single-slit image, and paste the cut-out extracted single-slit image onto a background image which is a wide-field image of the eye.

46. In the system described in claim 45, The system is characterized in that the illumination device includes at least a pair of optical projectors, each pair of optical projectors being associated with one or two imaging devices for performing stereo imaging of an eye.

47. In the system described in claim 38, The system is characterized in that the image processing utility is configured and operable to analyze image data by applying algorithmic techniques including one or more of the following: artificial intelligence, image enhancement, image recognition, image sharpening, image restoration, and encoding.

48. In the system described in claim 38, A system characterized in that the image processing utility is integrated with at least one of the optical projector and the imaging device.

49. In the system described in claim 1, The system is characterized in that the manager utility is configured to communicate data with the image processor of the remote control station.

50. In the system described in claim 49, The system is characterized in that the aforementioned data communication includes data transfer using encrypted secure communication.

51. In the system described in claim 49, The system is characterized in that the manager utility is configured and operable to generate a compressed representation of the image data and transmit the compressed representation to the image processor of the remote control station.

52. In the system described in claim 1, The control system is configured and operable to independently control and operate one or more automatic changes among operating parameters consisting of the dimensions of the illumination spot, illumination wavelength, illumination intensity, illumination angle, imaging angle, focal offset of the illumination device and / or imaging device, eye guidance, and background illumination.

53. In the system described in claim 1, The system is characterized in that the control system is configured to respond to input data from updated preset data from a suggestive AI-based processor and to optimize the operation data for the semi-autonomous system using the updated preset data.

54. A control system for managing and controlling eye examinations performed by a semi-autonomous examination system, The semi-autonomous examination system comprises at least one optical projector capable of operating to automatically project a series of pre-defined shaped illumination spots onto a plurality of positions extending spaced apart from each other across the eye region during an eye examination session, and at least one imaging device capable of acquiring images of the plurality of positions during the examination session and generating image data associated with the plurality of positions, wherein the control system is configured as a computerized system having data input / output utilities, memory and image processor utilities, and the control system A manager utility configured and operable to define operational data for the semi-autonomous system in response to input data including preset data indicating an examination task, wherein the operational data defines operational parameters for an eye examination session; A control system comprising a controller configured to use the aforementioned operation data to operate at least one imaging device in synchronization with the optical projector, thereby minimizing image degradation factors in the image data and minimizing the time the eyes are exposed to illumination during an examination session.

55. In the control system according to claim 54, A control system characterized by being configured as an electronic unit installed in the aforementioned semi-autonomous inspection system.

56. In the control system according to claim 54, A control system configured and operable to communicate with a remote control station, wherein the manager utility updates at least one of preset data and operational data in response to instructions from the remote control station.

57. A control system including a computerized system that can be connected to a subscriber eye examination system of the type that performs semi-autonomous eye examination procedures via a communication network, The control system is configured and operable to receive input image data from each of the subscriber eye examination systems, apply model-based processing to the received input image data, and generate output data that includes at least one of the following: (i) data indicating suspicious areas and findings in the eye region to be examined to enable the detection of abnormalities and / or lesions; (ii) data indicating abnormalities and / or lesions in one or more areas of the eye region examined by each subscriber eye examination system; (iii) data indicating the quality level of the received image data provided by each subscriber eye examination system; and (iv) data indicating recommended preset data defining operational data for the examination session performed by each subscriber eye examination system.

Images