Optical coherence tomography device, method and system

Abstract

According to one aspect of the present invention, there is provided an optical coherence tomography apparatus, comprising: an eyepiece for accommodating at least one eye of a user; a light source for outputting light, the light passing through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; and an electronic device coupled to the detector. The electronic device may be configured to perform a risk assessment analysis based on an optical coherence tomography measurement result obtained using the interferometer. An output device may be electrically coupled to the electronic device and may be configured to output a risk assessment result to the user via the output device. The optical coherence tomography apparatus may be self-steering, and the eyepiece may be a single eyepiece system or a dual eyepiece system.

Description

[0001] This application is a divisional application of Chinese patent application CN 201710950092.3 (“Optical coherence tomography equipment, method and system”) filed on March 17, 2009.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 6I / 040,084, filed March 27, 2008, "OPTICAL COHERENCE TOMOGRAPHY DEVICE, METHOD, AND SYSTEM" (DOHENY.001PR), and claims priority to U.S. Pending Application No. 12 / 111,894, filed April 29, 2008, "OPTICAL COHERENCE TOMOGRAPHY DEVICE, METHOD, AND SYSTEM" (DOHENY.001A). The foregoing are hereby incorporated by reference in their entirety, including, for example, but not limited to, the optical coherence tomography devices, methods, and systems disclosed herein. Technical Field

[0004] Embodiments of the present invention relate to the field of optical coherence tomography, and more particularly to devices, systems and methods for utilizing such optical coherence tomography data to perform precise measurements on eye tissues to detect eye diseases. Background Art

[0005] Optical coherence tomography (OCT) is widely used in industry, medicine and other fields. OCT generally refers to a non-invasive optical coherence tomography imaging technology that provides millimeter penetration (approximately 2-3mm into the tissue) with micron-level longitudinal and lateral resolution using interferometry. For example, in medical applications, doctors generally expect a non-invasive in vivo imaging technology to obtain subsurface, cross-sectional and / or three-dimensional images of transparent and / or opaque materials with a resolution equivalent to that of a low-power microscope. Therefore, in the next few years, it is expected that 20 million OCT scans will be performed on patients each year. Most of these are likely to occur in the field of ophthalmology. In current optical coherence tomography systems, doctors or other medical professionals operate OCT scans in the doctor's clinic or in a medical institution. Summary of the invention

[0006] Various embodiments of the present invention relate to utilizing optical coherence tomography, which generally refers to a non-invasive optical tomography imaging technique utilizing an interferometer, and can be used to detect and analyze, for example, ocular tissue and / or disease features, including, but not limited to, cystoid retinal degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, and the like. For example, according to one aspect of the present invention, an optical coherence tomography device includes: an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the optical detector and configured to perform a risk assessment analysis based on the optical coherence tomography measurement results obtained using the interferometer; and an output device electrically coupled to the electronic device, the output device configured to output a risk assessment to the user via the output device. In general, the optical coherence tomography devices, apparatuses, systems and methods disclosed herein may be self-steering, and the eyepiece may be a monocular system or a binocular system.

[0007] According to another aspect of the present invention, an optical coherence tomography apparatus comprises a first eyepiece and a second eyepiece for accommodating a pair of eyes of a user; a light source for outputting light, the light passing through the first eyepiece and the second eyepiece into the eyes of the user; an interferometer configured to generate optical interference using light reflected from the eyes of the user; an optical detector arranged to detect the optical interference; and an electronic device coupled to the optical detector and configured to provide an output to the user based on an optical coherence tomography measurement result obtained using the interferometer.

[0008] In another aspect of the present invention, an optical coherence tomography apparatus includes an eyepiece for accommodating at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and shines into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the optical detector and configured to automatically perform a diagnosis based on an optical coherence tomography measurement result obtained using the interferometer; and an output device electrically coupled to the electronic device, the output device being configured to output a diagnosis result to the user via the output device.

[0009] According to another aspect of the invention, an optical coherence tomography device for providing self-manipulated disease screening includes: an eyepiece for accommodating at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and shines into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; a processor in communication with the detector and configured to identify one or more diseases based on optical coherence tomography measurement results obtained using the interferometer, the user being able to show signs of the one or more diseases; and an output device electrically coupled to the electronic device, the output device being configured to alert the user.

[0010] In another aspect of the invention, an optical coherence tomography apparatus comprises an eyepiece for accommodating at least one eye of a user; at least one target display visible through the eyepiece; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; and an electronic device coupled to the target display and the detector and configured to provide an output to the user based on optical coherence tomography measurements obtained using the interferometer, wherein the electronic device is further configured to generate features on a target display of variable size and receive a user response to test the user's visual acuity.

[0011] According to another aspect of the present invention, an optical coherence tomography apparatus comprises an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the optical detector and configured to provide an output to the user based on an optical coherence tomography measurement result; and a card reader configured to receive a card from the user, the card reader communicating with the electronic device to provide a signal to the electronic device to authorize the electronic device to provide the output to the user.

[0012] According to another aspect of the present invention, an optical coherence tomography apparatus comprises an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the detector and configured to provide an output to the user based on the optical coherence tomography measurement results obtained using the interferometer; a memory including a list of medical service providers; and a device electrically coupled to the electronic device to provide the output to the user, wherein the electronic device is also configured to access the memory to provide at least a portion of the list in the output to the user.

[0013] According to another aspect of the present invention, an optical coherence tomography apparatus includes an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the optical detector and configured to provide an output to the user based on an optical coherence tomography measurement result obtained using the interferometer; and an output device electrically coupled to the electronic device and configured to provide an output to the user, wherein the electronic device is configured to provide a recommended deadline for consulting a medical service provider based on the patient's risk level for suffering from a particular type of disease determined using the optical coherence tomography measurement result.

[0014] According to another aspect of the present invention, an optical coherence tomography apparatus comprises an eyepiece for accommodating at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and shines into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an array of display elements visible to the user through the eyepiece, the array of display elements configured to display a display target at different positions on the array; and an electronic device in communication with the array of display elements and the detector, the electronic device configured to use the position of the display target on the array of display elements to associate an optical coherence tomography measurement result with a spatial position.

[0015] According to another aspect of the present invention, an optical coherence tomography apparatus comprises an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece into the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; a memory comprising statistical information correlating optical coherence tomography measurement results with a risk of at least one disease; and an electronic device coupled to the detector and configured to access the memory to compare data obtained based on the optical coherence tomography measurement results of the subject's eye using the interferometer with the statistical information to provide an assessment of the subject's risk of suffering from the at least one disease.

[0016] According to another aspect of the present invention, an optical coherence tomography apparatus comprises: an eyepiece for accommodating a user's eye; a light source for outputting light, the light passing through the eyepiece into the user's eye; an adjustable optical element configured to change the focus of the light entering the user's eye; an interferometer configured to generate optical interference using light reflected from the user's eye; an optical detector arranged to detect the optical interference; an electronic device coupled to the optical detector and configured to provide an output to the user based on an optical coherence tomography measurement result obtained using the interferometer; and an output device electrically coupled to the electronic device and configured to provide an output to the user, wherein the electronic device is configured to use a signal from the detector to adjust the optical element so that the light is focused.

[0017] For the purpose of summarization, specific aspects, advantages and novel features of the present invention are described herein. It should be understood that, according to any specific embodiment of the present invention, it is not necessary to adopt and / or implement all of these aspects, advantages and features. Therefore, for example, those skilled in the art will recognize that the present invention can be embodied or implemented in a manner that realizes one or a group of advantages taught herein, without having to realize other advantages taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The foregoing and other features, aspects and advantages of the present invention are described in detail below with reference to the accompanying drawings of various embodiments, which are intended to illustrate but not limit the present invention. The accompanying drawings include the following figures, in which:

[0019] Figure 1 is a schematic diagram of one embodiment of an optical coherence tomography system described herein.

[0020] Figure 2 is a schematic diagram of one embodiment of an interferometer arrangement for performing measurements on an eye.

[0021] Figure 3Ais a schematic diagram of one embodiment of an OCT system including a body configured to conveniently interfere with a human eye, the body being in communication with various systems described herein.

[0022] Figure 3B It is a schematic indication Figure 3A A perspective view of an embodiment of the body is shown.

[0023] Figure 4 is a schematic diagram of one embodiment of a spectrometer for analyzing data from an interferometer for OCT.

[0024] Figure 5 is a schematic diagram of the main body of an OCT system including a single display for presenting a display target to a patient.

[0025] FIG. 6A to FIG. 6C is a schematic diagram illustrating scanning of retinal tissue using optical coherence tomography to produce A-scans and B-scans.

[0026] 7A to 7F is a schematic diagram illustrating an embodiment for adjusting and / or calibrating interpupillary distance.

[0027] Figure 8 is a block diagram that schematically illustrates one embodiment of a computer system for an optical coherence tomography system described herein.

[0028] Fig. 9 A flow chart illustrating one embodiment of performing precise measurements on retinal tissue to detect specific disease signatures.

[0029] FIG. 10A to FIG. 10D Possible embodiments of positioning the body of the optical coherence tomography instrument relative to a user are illustrated.

[0030] FIG. 11A to FIG. 11B Possible embodiments of output reports generated by an optical coherence tomography instrument are illustrated.

[0031] Fig.12 is a block diagram that schematically illustrates another embodiment of a computer system for use with the optical coherence tomography system described herein.

[0032] Fig.13 is a block diagram that schematically illustrates components in one embodiment of a computer system for use with the optical coherence tomography system described herein.

[0033] Fig.14A is a diagram schematically illustrating one embodiment for determining a risk assessment.

[0034] Fig. 14Bis an illustration of a graph of risk of retinal disease versus retinal thickness for determining a risk assessment in another embodiment.

[0035] Fig.15 Schematic illustration of RPE detection and RPE polynomial fitting curvature and the difference between them.

[0036] Fig.16 Schematic diagram of the division of retinal tissue into inner and outer retinal tissue regions. DETAILED DESCRIPTION

[0037] Embodiments of the present invention will now be described with reference to the accompanying drawings, wherein like reference numerals refer to like elements throughout the drawings. The technical terms used in the specification presented herein are simply utilized in conjunction with the detailed description of certain specific embodiments of the present invention and are not intended to be understood in a limiting or restrictive manner. In addition, embodiments of the present invention may include several novel features, none of which is solely responsible for its desired properties or is essential to the implementation of the invention disclosed herein. The embodiments used herein enable users to more easily perform OCT screening, thereby enabling earlier detection and / or treatment of various diseases, ailments, or conditions, such as macular degeneration, glaucoma, and the like.

[0038] The terms "optical coherence tomography" and "OCT" generally refer to an interferometric technique used to image a sample, in some cases with micron lateral resolution. Non-invasive optical tomography is used in ophthalmology to provide cross-sectional images of the eye, more specifically the back of the eye, although it can also be used to image other samples or tissues in areas of the user's body.

[0039] Typically, OCT uses an interferometer. Light from a light source (e.g., a broadband light source) is separated (e.g., by a beam splitter) and passes through a sample arm (usually including a sample) and a reference arm (usually including a reflector). The light from the sample arm is partially reflected by the sample. The light is also reflected by the reflector of the reference arm. (The light from the test arm and the reference arm is recombined, for example, by a beam splitter.) When the distance that the light propagates in the sample arm is within the coherence length of the distance that the light propagates in the reference arm, light interference will occur, which will affect the intensity of the recombined light. The intensity of the recombined reflected light changes according to the sample properties. Therefore, changes in the intensity of the measured reflectance indicate the physical properties of the sample being tested.

[0040] In time-domain OCT, the length of the reference arm can be changed (e.g., by moving one or more reference mirrors). The reflectance observed as the reference arm distance changes indicates sample properties at different depths of the sample. (In some embodiments, the length of the sample arm is changed instead of, or in addition to, changing the length of the reference arm.) In frequency-domain OCT, the distance of the reference arm can be fixed and the reflectance can be measured at different frequencies. For example, the frequency of light emitted by a light source can be scanned over a certain frequency range or on a dispersive element such as a grating, and a detector array can be used to separate and detect different wavelengths. Fourier analysis can transform a frequency-based reflectance characteristic into a distance-based reflectance characteristic, thereby indicating sample properties at different sample depths. In certain embodiments, OCT can show additional information or data beyond non-mydriatic color fundus imaging.

[0041] The term "A-scan" describes the light reflectance associated with different sample depths. The term "B-scan" as used herein refers to the use of a cross-sectional view of tissue formed by a collection of multiple A-scans. For ophthalmic cases, light reflected by eye tissue is converted into electrical signals and can be used to provide data about tissue structures in the eye, as well as to display cross-sectional views of the eye. In ophthalmic cases, A-scans and B-scans can be used, for example, to distinguish between normal and abnormal eye tissue or to measure the thickness of tissue layers in the eye.

[0042] In ophthalmology examples, an A-scan may typically include data from the cornea to the retina, and a B-scan includes cross-sectional data from the inner edge to the outer edge of the eye and from the cornea to the retina. A three-dimensional C-scan is formed by combining multiple B-scans.

[0043] As used herein, the terms "user" or "patient" are used interchangeably, and the foregoing terms include, but are not limited to, humans and other mammals with or without being under the care of a physician.

[0044] As used herein, the terms "eye scan," "scanning the eye," or "scanning the eye" are broadly interchangeable terms that generally refer to measurements of any part of the eye or substantially all parts of the eye, including, but not limited to, the cornea, retina, lens, iris, optic nerve, or any other eye-related tissue or nerves.

[0045] Although the terms "risk assessment" and "diagnosis" have different meanings, they are used interchangeably in the specification. The term "risk assessment" generally refers to the probability, number, score, grade, estimate, etc. of the likelihood of having one or more illnesses, diseases, ailments, etc. The term "diagnosis" generally refers to determining the nature and symptoms of an illness, ailment, or condition by examination and / or testing.

[0046] The disclosure herein provides various methods, systems and apparatus for generating and utilizing optical coherence tomography image data to perform precision measurements of retinal tissue to detect disease characteristics and to generate risk assessments and / or diagnoses based on data obtained by optical coherence tomography techniques. In some embodiments, these methods, systems and apparatus may employ statistical analysis of detected disease characteristics obtained by optical coherence tomography techniques. These methods, systems and apparatus may be used to screen for diseases.

[0047] Reference Figure 1 , which illustrates a block diagram depicting one embodiment of an optical coherence tomography system. In one embodiment, a computer system 104 is electrically coupled to an output device 102, a communication medium 108, and a user card reading system 112. The communication medium 108 can enable the computer system 104 to communicate with other remote systems 110. The computer system 104 can be electrically coupled to a body 106, which a user 114 places near or on the user's eyes. In the illustrated example, the body 106 is a binocular system (e.g., having two eyepieces or optical pathways for two eyes, providing one view to one eye and another view to the other eye, or the like) that is configured to scan both eyes without repositioning the eyepieces relative to the patient's head, thereby reducing the time to scan the patient. In some embodiments, both eyes are scanned simultaneously using a scanner (e.g., a galvanometer), and the scanner interleaves measurements of the two eyes. Other embodiments are possible, for example, a binocular system or a two-eyepiece system with two optical paths to each eye, respectively, can be configured to scan in a serial manner, meaning that one eye is scanned first, and then the second eye is scanned. In some embodiments, the serial scanning of the eyes includes scanning a first portion of the first eye, a first portion of the second eye, a second portion of the first eye, and so on. Alternatively, the body 106 can include a monocular system, or one eyepiece system or optical path for an eye, to perform an eye scan.

[0048] Reference Figure 1, the user 114 can hold the handle 118 and place the body 106 in an appropriate position (e.g., upward, downward, or sideways), and the body 106 is at least partially supported by and connected to the zero gravity arm 116, so that the system 100 does not require a chin rest. In some embodiments, this configuration may introduce positioning errors due to the movement of the jaw. When the body 106 is in such a position, the distance between the farthest lens (the lens closest to the user) and the user's eye can be in the range of 10mm to 30mm, or 5mm to 25mm, or 5mm to 10mm. The proximity of the lens system to the user's eye increases the compactness of the system, reduces the position change when the patient places his eye (e.g., the orbital rim) against the body, and increases the viewing angle of the OCT device when imaging through a pupil that is not enlarged. Accordingly, the body 106 can also include an eye mask 120 (e.g., a disposable eye mask), which is configured to contact the user's eye socket to fully block ambient light and / or at least partially support the body 106 at the user's 114 eye socket. Eye mask 120 has a central opening (e.g., aperture) so that light from a light source in the instrument passes through and reaches the eye. Eye mask 120 can be made of paper, card, plastic, silicone, metal, rubber, or a combination thereof. Eye mask 120 can be a tubular, conical, or cup-shaped flexible or semi-rigid structure with an opening at either end. Other materials, shapes, and designs are also possible. In some embodiments, eye mask 120 is made of rubber that fits around the eyepiece portion of main body 106. Eye mask 120 can be detachable from main body 106 after completing eye scanning, and a new eye mask 120 can be attached to a new user to ensure hygiene and / or prevent disease spread. Eye mask 120 can be transparent, translucent, or opaque, but opaque eye mask has the advantage of blocking ambient light for measurements in bright environments.

[0049] The body 106 may include one or more eyepieces, an interferometer, one or more target displays, detectors, and / or alignment systems. The optical coherence tomography system may include a time domain optical coherence tomography system and / or a frequency domain optical coherence tomography system. Thus, in some embodiments, the body 106 includes a spectrometer (e.g., a grating) and a detector array. In some embodiments, the body may include a signal processing component (e.g., an electronic device) for performing, for example, a Fourier transform. Other types of optical coherence tomography systems may also be used.

[0050] Figure 2A diagram of an example optical coherence tomography system is shown. Light 150 is output from a light source 155. The light source 155 may include a broadband light source, such as a superluminescent diode or a white light source. (Alternatively, the light emitted from the light source 155 may vary in frequency as a function of time.) The light 150 may include collimated light. In one embodiment, the light 150 from the light source 155 is collimated using a collimating lens. The light is separated at a beam splitter 160. The beam splitters described herein may include polarization-based beam splitters, time-based beam splitters, and / or 50 / 50 beam splitters or other devices and configurations. A portion of the light propagates along the sample arm and is directed toward the sample, such as the eye 165 of the user 114. Another portion of the light 150 propagates along the reference arm and is directed toward the reference reflector 170. The light reflected by the sample and the reference reflector 170 is combined at the beam splitter 160 and sensed by a one-dimensional photodetector or a two-dimensional detector array, such as a charge coupled device (CCD) or a complementary metal oxide semiconductor (CMOS). A two-dimensional array may be included in a full-field OCT instrument, which may collect information more rapidly than using a one-dimensional photodetector array. In time-domain OCT, the length of the reference arm (which may be determined in part by the position of the reference mirror 170) may vary over time.

[0051] Whether interference occurs between the light reflected from the sample and the light reflected from the reference reflector will depend on the length of the reference arm (compared to the length of the test arm) and the frequency of the light emitted by the light source. High contrast light interference occurs between lights that have traveled similar optical paths (e.g., the difference is less than the interference length). The coherence length is determined by the bandwidth of the light source. Broadband light sources correspond to smaller interference lengths.

[0052] In time-domain OCT, the intensity of the output light can be analyzed as a function of time as the relative lengths of the reference arm and the sample arm vary over time. The detected light signal is generated by light scattered from the sample, which constructively interferes with the light reflected by the reference reflector. However, when the lengths of the sample and reference arms are approximately the same (e.g., within one coherence length in some cases), enhanced interference occurs. Therefore, the light from the reference arm will interfere with the light reflected from a narrow depth range within the sample. As the reference (or sample) arm is translated, the narrow depth range can be moved within the thickness of the sample while monitoring the intensity of the reflected light to obtain information related to the sample. The sample that scatters the light scatters the light back, and the scattered light interferes with the reference arm, thereby generating an interference signal. Using a light source with a shorter coherence length can provide higher resolution (e.g., 0.1-10 microns) because the shorter coherence length results in a small range of depths that can be detected at a single moment in time.

[0053] In various embodiments of frequency domain optical coherence tomography, the reference arm and the sample arm are fixed. Light from a broadband light source including multiple wavelengths is reflected by the sample and interferes with light reflected by the reference reflector. A spectrum of the reflected signal can be obtained. For example, the light can be input to a spectrometer or spectrograph, which includes, for example, a grating and a detector array for detecting light intensity at different frequencies.

[0054] For example, Fourier analysis performed by a processor can convert data corresponding to multiple frequencies into data corresponding to multiple locations within the sample. Therefore, data from multiple sample depths can be collected simultaneously without scanning the reference arm (or sample arm). Additional details related to frequency-domain optical coherence tomography are described in Vakhtin et al. (Vakhtin AB, Kane DJ, Wood WR and Peterson KA. "Common-path interferometer for frequency-domain optical coherence tomography," Applied Optics. 42 (34), 6953-6958 (2003)).

[0055] Other methods of performing optical coherence tomography are also possible. For example, in some embodiments of frequency domain optical coherence tomography, the frequency of light emitted from the light source varies with time. Therefore, the difference in light intensity as a function of time is related to different light frequencies. When a spectrally time-varying light source is used, a detector can detect the light intensity as a function of time to obtain a spectrum of the interference signal. The Fourier transform of the spectrum described above can be used. Various other techniques are also possible.

[0056] Figure 3A One configuration in which the main body 106 includes an optical coherence tomography system and an alignment system is shown. Figure 3A In addition to the system shown, other optical coherence tomography systems and / or alignment systems may be included, or other optical coherence tomography systems and / or alignment systems may be included in place of the system shown. Figure 3A As shown, the body 106 may include two eyepieces 203, each of which is configured to accommodate one eye of the user 114. In other embodiments, the body 106 includes only one eyepiece 203.

[0057] Figure 3AA representative embodiment of an optical coherence tomography system is shown. Light from a light source 240 may propagate along a path modulated, for example, in a vertical or horizontal direction by one or more beam deflectors 280. A galvanometer may be used for this purpose. The galvanometer 280 may control the horizontal and / or vertical position of the light beam from the light source 240, thereby enabling the formation of multiple A-scans (and thus one or more B-scans and / or C-scans).

[0058] Light from light source 240 is split at beam splitter 245. In some embodiments, beam splitter 245 is replaced by a high frequency switch, using, for example, a galvanometer, which directs approximately 100% of the light to reflector 250a for approximately 1 / 2 cycle, and then directs approximately 100% of the light to reflector 250b for the remaining cycle. Light source 240 may include a broadband light source, such as a superluminescent diode. The light split at beam splitter 245 is split again at beam splitter 285a or 285b to form a reference arm and a sample arm. The first portion of the light split at beam splitter 285a or 285b is reflected by reference reflector 273a or 273b, reference reflector 270a or 270b, and reference reflector 265a or 265b. The second part of the light separated at the beam splitter 285a or 285b is reflected by the reflector 250a or 250b, the reflector 255a or 255b, and the reflector 260a or 260b. The reflector 255a or 255b and the reflector 250a and 250b are connected to the Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, the length of the sample arm is adjusted. Therefore, the adjustment stage 290a or 290b can adjust the difference between the optical path from the light source 240 to a part of the sample and the optical path from the light source 240 and the reference reflector 270a or 270b and / or the reference reflector 273a or 273b. The difference can be very small, for example, less than the coherence length, thereby promoting the occurrence of light interference. In some embodiments, in addition to the adjustment stage being movable, the position of one or more reference mirrors (e.g., reference mirror 270a or 270b and reference mirror 273a or 273b) is also movable, or the position of one or more reference mirrors (e.g., reference mirror 270a or 270b and reference mirror 273a or 273b) is movable, instead of the adjustment stage being movable. Thus, the length of the reference arm and / or the sample arm is adjustable. The position of the adjustment stage 290a and / or 290b can be based on a signal from the device, which will be described in detail below.

[0059] The light reflected by the reflector 260a or 260b is combined with the light from the display 215a or 215b at the beam splitter 230a or 230b. The display 215a and 215b may include one or more light sources, such as a light-emitting display such as a matrix LED array. Other types of displays may also be used. The display may display a target with a variable shape and configuration, including bars and / or one or more dots. A portion of the optical path from the light source 240 to the eye may be coaxial with a portion of the path from the display 215a and 215b to the eye. These portions may be extended through the eyepiece. Accordingly, the light beam from the light source 240 is coaxial with the light beam from the display 215a and 215b, so that the display may be used to determine the position of the eye and to align the eye with the eyepiece.

[0060] As will be described in further detail below, for example, user 114 may use images from the display to adjust the interpupillary distance. In various embodiments, for example, proper alignment of the two images presented by the display may indicate that the interpupillary distance has been properly adjusted. Thus, one or more adjustment controls 235 may be used to adjust the distance between display objects 215a and 215b and / or between eyepieces 203. Adjustment controls 235 may be provided on the side or other location of body 106. In certain embodiments, adjustment controls 204 may include, for example, Figure 3B A handle is shown on the body 106. In this embodiment, rotation of the adjustment controller 204 can increase or decrease the interpupillary distance.

[0061] The combined light (the light reflected by the reflector 260a or 260b and from the display 215a or 215b) can be focused by an adjustable powered optics (e.g., a lens) 210 and possibly in conjunction with an optical element 205. The adjustable optics 210 can include a zoom lens or a lens system that can have, for example, an adjustable focal length and / or magnification. The adjustable optics 210 can be part of an autofocus system or can be manually adjusted. The adjustable optics 210 can provide optical correction when such correction is required (e.g., the user removes his glasses during testing). The position of the active optics 210 can be based on a signal from a device, which will be described in detail below. The focused light is then directed toward the eye of the user 114 through an eyepiece window or lens 205 located at the proximal end of the eyepiece 203. Where a lens 205 is included, the lens 205 can focus the light to the eye.

[0062] The light focused to the eye may be scattered by tissue or features in the eye. A portion of the scattered light may be directed back into the eyepiece. Thus, lens 205 may receive light 207 reflected from the user's eye, which propagates through active optical device 210 and is reflected by beam splitter 230a or 230b toward beam splitter 220a or 220b, which reflects the light toward mirror 295a or 295b. At 295a or 295b, the light reflected by the sample interferes with the light in the reference arm (the path between beam splitter 285a or 285b and beam splitter 295a or 295b, which path includes mirror 273a or 273b and 270a or 270b). (Correspondingly, the sample arm includes an optical path between the beam splitter 285a or 285b and the beam splitter 295a or 295b, which includes the mirrors 250a or 250b and 255a or 255b and the sample or eye.) The light is then reflected by the mirror 255a or 255b and directed toward the switch 275. In some embodiments, the switch 275 includes a switchable deflector that switches the optical path to the first or second eye to collect data from the corresponding eye for transmission to the data acquisition device 202. The switch may include a low frequency switch so that all data collected from one eye can be obtained before collecting data from the other eye. Alternatively, the switch may include a high frequency switch that can interleave the data collected from each eye.

[0063] The instrument can have different configurations. For example, a common reference path can be used for each eye. In some embodiments, the reference arm includes one or more movable mirrors to adjust the optical path length difference between the reference arm and the sample arm. In other embodiments, components can be added, removed or relocated. Other techniques can also be used.

[0064] Although not shown, polarizers and polarization beam splitters, for example, may also be used to control the propagation of light through the optical path in the optical system. Other variations are also possible. Other designs may also be used.

[0065] In some embodiments, the A-scan can be formed in the time domain. In these instances, the Z-offset adjustment stage and the corresponding reflector 255a or 255b and the position of the reflector 255a or 255b can change over time. Alternatively, the reference reflectors 270a and 270b and the reference reflectors 273a and 273b or other reflectors in the reference arm or sample arm can also be translated. The combined light associated with the various reflector positions can be analyzed to determine the characteristics of the eye as a function of depth. In other embodiments, the A-scan can be formed in the frequency domain. In these instances, the frequency of the combined light can be analyzed to determine the characteristics of the eye as a function of depth. In addition, one or more galvanometers 280 can control the horizontal and / or vertical position of the A-scan. Therefore, multiple A-scans can be obtained to form a B-scan and / or C-scan.

[0066] The light output from the structure 275 can be input to the data acquisition device 202, which can include, for example, a spectrometer or a light meter. The grating can be in the body 106. The data acquisition device 202 is coupled to the computer system 104, which can present the output based on the scan to the user 114. The output device can include a monitor screen on which the output results are displayed. The output device can include a printer for printing the output results. The output device can be configured to store the data in a portable medium such as an optical disk or a USB drive or a conventional portable data storage device.

[0067] In some embodiments, the computer system 104 analyzes the data received by the data acquisition device 202 to determine whether one or more adjustment stages 290a and / or 290b and / or the active optical device 210 should be adjusted. In one example, the A-scan is analyzed to determine the position (e.g., rough position) of the retina, whereby data related to the retina can be obtained by the instrument. In some embodiments, each A-scan includes a plurality of light intensity values, each of which is associated with a different depth within the sample. In some embodiments, the A-scan can be obtained by translating the Z adjustment stage 290a or 290b. Similarly, the A-scan includes values ​​of the reflected signal obtained for different positions of the Z adjustment stage. The retina reflects more light than other parts of the eye, and therefore, the position of the adjustment stage 290a or 290b that can effectively image the retina can be determined by evaluating which depth provides an enhancement in the reflected intensity. In some embodiments, the Z adjustment stage can be translated and the intensity values ​​can be monitored. The extended peak in intensity for multiple Z adjustment stage positions can correspond to the retina. Multiple different methods and values ​​can be monitored to determine the position of the retina. For example, multiple A-scans can be obtained at different depths, and the cumulative intensity of each scan can be obtained and compared to determine which depth provides the peak cumulative intensity. In certain embodiments, the intensity values ​​within the A-scan can be compared to other values ​​and / or thresholds within the A-scan. The intensity value corresponding to the preferred position can be greater than a predetermined or relative threshold, and / or different from the remaining intensity values, (e.g., greater than the latter by a specified number of standard deviations). Various methods can be used.

[0068] After the positions of the adjustment stages 290a and 290b are determined, subsequent image analysis can be performed to account for vibration or movement of the user's head, eyes, or retina relative to the light source 240. A feedback system, such as a closed-loop feedback system, can be employed to provide a more stable signal as possible in the presence of such movement. The optical coherence tomography signal can be monitored and feedback provided to, for example, one or more conversion stages to compensate for such vibration or movement. In some embodiments, subsequent image analysis can be based on the initial image and / or detect changes in image characteristics. For example, the image analysis can determine that the brightest pixel within an A-scan has moved three pixels from the previous scan. Therefore, the adjustment stage 290a or 290b can be moved based on this analysis. Other methods can be used.

[0069] In some instances, the optical coherence tomography signal is used to adjust the active optical device 210 to provide enhanced or improved focus, for example, when the patient needs refractive correction. For example, many users / patients may wear glasses or not wear glasses for testing. The active optical device 210 can be adjusted based on the reflected signal to determine what correction to apply to enhance the signal quality, or improve it. Therefore, in some embodiments, multiple A-scans are analyzed to determine the position of the active optical device 210. In some instances, multiple A-scans are analyzed to determine the position of the active optical device 210. In some embodiments, this determination occurs after the position of the adjustment stage 290a or 290b has been determined. For each of the multiple positions of the active optical device 210, one or more A-scans, one or more B-scans, or C-scans can be obtained. These scans can be analyzed to evaluate, for example, image quality. The position of the active optical device 210 can be selected based on these image quality measurements.

[0070] The image quality measurements may include noise measurements. The noise measurements may be estimated based on the distribution of different intensity levels of reflected light within the scan. For example, a lower signal may be associated with noise. Conversely, the highest signal may be associated with a saturated signal. The noise measurements may be compared to saturation measurements, similar to signal-to-noise ratio or variations thereof. The lowest reflectivity measured (referred to as a low measurement or low value) may also be considered. In some embodiments, the position of adjustment stage 290a and / or 290b and / or active optical device 210 is determined based on the signal-to-noise ratio measurement, the signal intensity measurement, the noise measurement, the saturation measurement, and the low measurement. Different combinations of these parameters may be used. Values ​​obtained by combining parameters of multiple positions or scans, etc. may also be used. Other parameters and other image quality assessments may also be used.

[0071] In one embodiment, the noise value is estimated as a reflected light value below which approximately 75% of the measured reflected light is below and above which approximately 25% of the measured reflected light is above. The saturation value is estimated as a reflected light value below which approximately 99% of the measured reflected light is below and above which approximately 1% of the measured reflected light is above. The median value is defined as the average of the noise value and the saturation value. The intensity ratio is defined as the difference between the saturation value and the low value divided by the low value, multiplied by 100. The tissue signal ratio is defined as the ratio of the number of reflected light values ​​between the median value and the saturation value to the number of reflected light values ​​between the noise value and the saturation value. The quality value is defined as the product of the intensity ratio and the tissue signal ratio. Additional details are described, for example, in Stein DM, Ishikawa H, Hariprasad R, Wollstein G. Noecker RJ, Fujimoto JG, Schuman JS. A new quality assessment parameter for optical coherencetomography. Br. J. Ophthalmol. 2006; 90; 1 86-190. A variety of other methods can be used to obtain a figure of merit for measuring performance and adjusting the instrument accordingly.

[0072] In some embodiments, multiple positions are tested while adjusting the adjustable active optics 210. For example, the active optics may be continuously moved toward the eye in defined increments for each scan or group of scans. Alternatively, the multiple positions may depend on previously determined image quality measurements. For example, if a first movement of the active optics 210 toward the eye improves the image quality measurements, but a subsequent second movement toward the eye reduces the image quality measurements, a third movement may be away from the eye. Thus, an optical power setting may be obtained to improve and / or maintain an improved signal. In some embodiments, the optical power setting may correspond to an optical correction and improve the focusing of the light beam in the eye (e.g., in the retina).

[0073] As described above, various embodiments employ an arrangement that employs a pair of eyepieces. Accordingly, such adjustments may be applied to each eye, since the user's eyes may be of different sizes and the retina may be located at different depths, and thus a pair of Z adjustment stages may be used in some embodiments. Likewise, the user may have different prescribed optical corrections for different eyes. A variety of arrangements may be employed to meet these needs. For example, measurements and / or adjustments may be performed and completed for one eye and subsequently performed and completed for the other eye. Alternatively, measurements and / or adjustments may be completed simultaneously or staggered. Various other variations are also possible.

[0074] Figure 4 A block diagram of a spectrometer 400 that can be used as the data acquisition device 202 of the frequency domain OCT system is shown. The light 405 input to the spectrometer 400 is collected by a condenser lens 410. The collected light is then emitted through a slit 415 and finally collimated by a collimating lens 420. The collimated light is separated into various spectral components by a grating 425. The grating 425 can have an optical power to focus the spectral distribution onto an image plane. It is noteworthy that other separation components such as prisms can be used to separate the light. The separated light is then directed to a detector array through a focusing lens 430 to measure the spectral components of each frequency from each light ray.

[0075] Various OCT designs may be employed. For example, the frequency may be varied over time. The reference and sample arms may overlap. In some embodiments, the reference arm is distinct from the sample arm, while in other embodiments, the reference arm and sample arm may be shared. See, for example, Vakhtin AB, Kane DJ. Wood WR and Peterson KA. "Common-path interferometer for frequency-domain optical coherence tomography," Applied Optics. 42 (34), 6953-6958 (2003). OCT arrangements should not be limited to those described herein. Other variations are also possible.

[0076] In some embodiments, Figure 5 As shown, the main body 106 includes only a single display target 215. The light from the display target 215 is separated at the X-prism 505. It is worth noting that other optical devices that separate the source light into multiple light rays can also be used. The separated light is reflected at the reflector 510a or 51b and emitted to the user 114.

[0077] The user may be directed to gaze at the display target 215 while one or more galvanometers 280 move light from the light source 240 to image an area of ​​tissue. In some embodiments, the display target 215 moves within the user's field of view while imaging the area of ​​tissue. Fig. 6A In the embodiment, the display target 215 can be moved horizontally (e.g., in a medial to lateral direction) to guide the patient to look from left to right or from right to left. At the same time, the vertical scanner (e.g., galvanometer) allows the vertical position of the sample scan (e.g., from high to low) to be changed over time. FIG. 6A to FIG. 6CAn eye is shown, and the eye is guided to move in a horizontal direction 605. Due to the vertical scanner, the scanning trajectory 610 covers most of the eye 600. Scanning in the horizontal and vertical directions can produce a C-scan. In some embodiments, continuous and / or regularly patterned A-scans are combined to form a full scan, such as a B-scan or a C-scan. In other embodiments, discrete and / or random A-scans are combined to form a full scan. Compared with a comparable system configured to allow the user 114 to keep their eyes fixed on a stationary target, a system configured to guide the user 114 to move their eyes throughout the scan can include fewer scanners. For example, instead of a system that includes both vertical and horizontal scanners, the user 114 can move his eyes in the horizontal direction, thereby eliminating the need for a horizontal scanner.

[0078] Figure 6B An example of an A-scan is shown. An A-scan includes signal intensity (indicated by brightness) as a function of depth for one horizontal and vertical position. Thus, an A-scan includes multiple intensity values ​​corresponding to different front-to-back positions. Multiple A-scans make up a B-scan. Figure 6C A B-scan is shown in which the largest portion of the brightness signal corresponds to retinal tissue and the elevated area beneath the retina corresponds to diseased tissue within the eye.

[0079] Reference Fig. 7A , which illustrates an enlarged view of an embodiment of a body 106 configured with a handle 118 for adjusting the eyepiece to accommodate the interpupillary distance of a user. In the exemplary embodiment, the body 106 includes a left eyepiece 712 and a right eyepiece 714, each of which is connected to the other via an interpupillary distance adjustment device 718. The interpupillary distance adjustment device 718 is coupled to the handle 118, wherein the handle 118 is configured to allow a user to adjust the distance between the left eyepiece 712 and the right eyepiece 714 via the handle 118 to match or substantially accommodate the interpupillary distance between the user's eyes.

[0080] Reference Fig. 7A, the user can rotate, twist, or twist the handle 118 to adjust the distance between the left eyepiece 712 and the right eyepiece 714 to match or fully adapt to the pupil distance between the user's eyes. Alternatively, the handle 118 can be configured to move from one side to the other to allow the user to adjust the distance between the left eyepiece 712 and the right eyepiece 714. In addition, the handle 118 can be configured to move forward and backward to allow the user to adjust the distance between the left eyepiece 712 and the right eyepiece 714. Alternatively, the handle 118 can be configured to move up and down to allow the user to adjust the distance between the left eyepiece 712 and the right eyepiece 714. In another embodiment, the distance between the left eyepiece 712 and the right eyepiece 714 can be adjusted and / or controlled by a motor activated by the user. Alternatively, the motor can be configured to be controlled by the computing system 104 to semi-automatically place the left eyepiece 712 and the right eyepiece 714 in an appropriate position to match the pupil distance between the user's eyes. In these examples, the system described herein may include an eye tracking device. In other embodiments, the aforementioned combination is used to adjust the distance between the left eyepiece 712 and the right eyepiece 714 to match or fully adapt to the user's pupil distance.

[0081] User 114 may adjust the interpupillary distance based on the user's observation of one or more gaze targets on one or more displays 215. For example, displays 215 and gaze targets may be configured so that when the interpupillary distance is appropriate for user 114, the user may observe two aligned images that form a single complete image. Fig. 7A As shown, the user 114 may adjust (eg, rotate) the adjustment controller 204 based on the gaze target image to change the interpupillary distance. FIG. 7B to FIG. 7F One embodiment of a fixation target as viewed through a viewer under multiple conditions is illustrated, however, other fixation targets are possible, including, but not limited to, a fixation target in a square pattern. Figure 7B A U-shaped fixation target 715a is shown on the display 215a for the left eye. Figure 7C An inverted U-shaped fixation target 715b is shown on the display 215b for the right eye.

[0082] When the interpupillary distance is properly adjusted, the bottom and top images 715a and 715b are aligned, as shown in FIG. Fig.7D As shown, a complete H-shaped fixation target 715 is formed. When the interpupillary distance is too narrow, the fixation target 715a appearing on the display 215a for the left eye is shifted to the right, and the fixation target 715b appearing on the display 215b for the right eye is shifted to the left, and the user sees Fig. 7EConversely, when the interpupillary distance is too wide, the fixation target 715a for the left eye that appears on the display 215a is shifted to the left, and the fixation target for the right eye that appears on the display 215b is shifted to the right, and the user sees Figure 7F The images shown in FIG. 1A and FIG. 1B are the images shown in FIG. 1A . Therefore, the interpupillary distance can be adjusted based on these images.

[0083] Specifically, in Fig.7D In FIG. 7 , the aligned image 715 is in the shape of an “H.” Thus, when the interpupillary distance is properly adjusted, the fixation targets overlap on the left and right displays to form an “H.” Other aligned images 715 may be provided.

[0084] Reference Figure 8 , illustrating an embodiment of the computer system 104. In the illustrated embodiment, the computer system 104 may include a scan control and analysis module 824 configured to control the scanning operation performed by the main body 106. The computer system 104 may also include a gaze mark control system 822 configured to display a gaze mark that can be seen by a user from the main body 106. In a specific embodiment, the gaze mark is displayed as an "X", a dot, a square, etc. The gaze mark can be configured to move horizontally, vertically, diagonally, in a circle, or a combination thereof. When the eye repositions itself, the gaze mark can be quickly repositioned to reposition the beam position on the retina. The computer system 104 may also include a focus adjustment module 820 for automatically adjusting the focus lens in the main body 106 as further discussed herein. The computer system 104 may also include a Z positioning module 818 for automatically adjusting the Z offset discussed herein.

[0085] Reference Figure 8In the illustrated embodiment, the computer system 104 includes a disease risk assessment / diagnosis module 808 for storing and accessing information, data, and algorithms for determining, assessing disease risk or likelihood, and / or generating a diagnosis based on data and / or measurements obtained from a scan of a user's eye. In one embodiment, the scan control and analysis module 824 is configured to compare data received from the subject 106 with data stored in the disease risk assessment / diagnosis module 808 to generate a risk assessment and / or diagnosis of a disease in the user's eye, as further described. The computer system 104 may also include an image / scan database configured to store images and / or scans generated by the subject 106 for multiple users and store a unique identifier associated with each image and / or scan. In some embodiments, the scan control and analysis module 824 uses historical images and / or scans of a particular user to compare with current images and / or scans of the same user to detect changes in the user's eye. In a particular embodiment, the scan control and analysis module 824 uses the detected changes to help generate a risk assessment and / or diagnosis of a disease in the user's eye.

[0086] exist Figure 8 In the illustrated exemplary embodiment, the computer system 104 may include a user / patient database 802 for storing and accessing patient information, such as user name, date of birth, mailing address, home address, office address, unique identifier, age, physician affiliation, telephone number, email address, social security number, race, gender, dietary habits and related information, lifestyle and / or exercise history information, use of corrective lenses, family medical history, medical and / or ophthalmic history, previous treatments, or other similar user information. The computer system 104 may also include a physician referral database for storing and accessing physician information, such as physician name, physician training and / or expertise / specialty, physician office address, physician telephone number and / or email address, physician schedule, physician rating or quality, physician office hours, or other physician information.

[0087] Reference Figure 8The computer system 104 may also include a user interface module 805 (which may include, but is not limited to, the general purpose input / output (I / O) devices and interfaces described herein) configured to communicate, instruct, and / or interact with a user via voice commands, a voice recognition interface, a keyboard, a trigger, a joystick, a switch, a button, a visual display, a touch screen display, etc., or a combination thereof. In certain embodiments, the user interface module 805 is configured to instruct and / or guide a user to use and / or position the main body 106 of the optical coherence tomography analysis system 100. The computer system 104 may also include a report / output module 806 configured to generate, output, display, and / or print reports (e.g., Fig. 10A and Fig. 10B ), the report includes the risk assessment and / or diagnosis generated by the disease risk assessment / diagnosis module 808. In other embodiments, the report includes at least one recommended physician to contact related to the risk assessment.

[0088] Reference Figure 8The computer system 104 may also include an authentication module 816 that interfaces with a user card reading system 112, wherein a user may insert a user identification card into the user card reading system 112. In certain embodiments, the authentication module 816 is configured to authenticate the user by reading data from the identification card, and comparing the information with data stored in the user / patient database 802, and / or storing the information in the user / patient database 802. In certain embodiments, the authentication module 816 is configured to read or obtain the user's insurance information from the user's identification card through the user card reading system 112. The authentication module 816 may be configured to compare the user's insurance information with data stored in an insurance acceptance database 828 to determine whether the user's insurance is accepted or whether the user's insurance company will cover the cost of scanning the user's eyes. In other embodiments, the authentication module communicates with the billing module 810 to send a message and / or a bill of charges to the user's insurance company and / or the device manufacturer to request payment for the scan performed on the patient's eyes. The card may activate one or more functions of the machine to allow the user, for example, to perform a test performed or to receive output from the machine. In other embodiments, the billing module 810 is configured to communicate with the user interface module 805 to request payment of all or some (e.g., self-payment) fees for performing scanning from the user. In a specific embodiment, the billing module 810 is configured to communicate with the user card reading system 112 to obtain card information from the user's credit card, debit card, gift card, or to extract the credit stored on the user identification card. Alternatively, the billing system 810 is configured to receive payment from the user by communicating and / or controlling the interface device to receive banknotes, coins, vouchers, etc. Alternatively, the billing module 810 is configured to receive payment from the user by communicating with the user's mobile device via Bluetooth or other communication protocols / channels to obtain credit card information, billing address, or charging the user's mobile network service account (e.g., cellular operator network).

[0089] Reference Figure 8, the insurance company can use the user's card to track which users have used the system. In one embodiment, the system can print the scan results, risk assessments, and / or reports directly (on the surface of the card) or store (in a chip or magnetic stripe) on or in the card that the patient inserts into the system (where the card is returned to the user). The system can be configured to store multiple scan results, risk assessments, and / or reports, and / or erase previous scan results, risk assessments, and / or reports before storing new information on the magnetic stripe. In a specific embodiment, the system (e.g., scan analysis module 824) performs the calculation of the risk assessment. In a specific embodiment, the calculated risk assessment is transmitted to a central server system (e.g., remote system 110) located elsewhere, which provides the results to a physician, user, patient, etc. via a web page. The central server system (e.g., remote system 110) allows the user, patient, or doctor to enter their card code to view the results stored in the central database.

[0090] exist Figure 8 In an example embodiment, the computer system 104 may include a network interface 812 and a firewall 814 for communicating with other remote systems 110 via the communication medium 108. Other remote systems 110 may include, but are not limited to: a system for checking the status / accuracy of the optical coherence tomography system 100; a system for updating the disease risk assessment / diagnosis database 808, the insurance acceptance database 828, the physician recommendation database 804, and / or the scan control and analysis module 824. In a particular embodiment, the computer system 104 may be configured to communicate with the remote systems 110 to implement primary and / or secondary risk assessments based on data from a scan of a user's eye performed using the subject 106.

[0091] Reference Figure 8 , the remote system 110 can be configured to remotely perform (on an immediate, delayed, and / or batch basis) risk assessments and / or diagnoses, and transmit the risk assessments, diagnoses, and / or reports to the computer system 104 via a network or communication medium for output to a user using the output device 102. In a particular embodiment, the output device 102 is configured to display the risk assessments, diagnoses, and / or reports in the form of a web page, which can be printed, emailed, sent, and / or saved by the computer system 104. The remote system 110 can also be configured to transmit the risk assessments, diagnoses, and / or reports to a user's (or doctor's) mobile phone, computer, email account, fax, etc. via a network or communication medium.

[0092] Reference Fig. 9, which illustrates an illustrative method of using the optical coherence tomography system 100 to self-manipulate an OCT scan of a user's eye and obtain a risk assessment or diagnosis of various diseases and ailments. The process begins at box 901, where a user approaches the optical coherence tomography system 100 and activates the system by, for example, pressing a button or entering an activation code or anonymous identification number. In other embodiments, the user interface module 805 instructs the user at box 901 to first insert an identification card or anonymous coded protection card into the user card reading system 112 to activate the system. The system can also be activated at box 901 when the user inserts their user identification card into the user card reading system 112. Other means of activating the system are also possible, including: motion sensors, weight sensors, radio frequency identification (RFID) devices, or other actuators for detecting the presence of a user, but not limited to this. Alternatively, the optical coherence tomography system 100 can be activated when the billing module 810 detects that the user inserts a banknote, coin, voucher, etc. into an interface device configured to receive such payment. Alternatively, the billing module 810 may also be configured to activate the optical coherence tomography system 100 when the billing module 810 communicates with the user's mobile device to obtain the user's credit card information, billing address, etc. or to charge the user's mobile network service account (e.g., a cellular operator network).

[0093] Reference Fig. 9 In block 902, the user interface module 805 is configured to guide the user to attach the disposable eye mask to the main body 106, and then place the main body 106 with the disposable eye mask close to the user's eyes and / or support the disposable eye mask close to the user's eye sockets. The user interface module 805 instructs the user to use the handle 118 to adjust the distance between the left eyepiece 612 and the right eyepiece 614 to match or fully adapt to the user's eye socket. FIG. 6A to FIG. 6C After the user has appropriately calibrated and / or adjusted the subject 106 and the interpupillary distance, the user inputs or instructs the user interface module 805 to begin scanning. The scan control and analysis module 824 sufficiently restricts the movement of the zero gravity arm or locks the position of the zero gravity arm and / or the distance between the left tube 612 and the right tube 614 to begin scanning.

[0094] Reference Fig. 9, the Z module 818 automatically adjusts the z-offset in the body 106 at box 906 to obtain OCT measurements from, for example, retinal tissue. The Z module 818 can identify and / or estimate the position of a portion of the sample (e.g., a portion of the user's 114 eye) and adjust the position of one or more optical components based on the position. Those skilled in the art will recognize that there are many ways to perform such adjustments. For example, the Z module 818 can include a motor such as a piezoelectric motor to longitudinally translate the reference mirror so that the optical path length from the beam splitter to the retina is approximately equal (within one coherence length) to the optical path length in the reference arm. This movement can cause light from the reference arm to interfere with light reflected by the desired portion of the sample (e.g., the retina). At box 908, the schematic method uses the focus adjustment module 820 to perform the focus adjustment. Those skilled in the art will recognize that there are different techniques to perform such automatic focus calibration. Box 910 illustrates an optional test performed by the computer system 104 to determine the visual function and / or acuity of the user's eye. Such visual function and / or acuity tests will be understood by those skilled in the art. In one embodiment, the visual acuity test works or is combined with the fixation mark control system 722 and can test both eyes at the same time or one eye at a time. For example, the fixation mark initially appears small and then gradually increases in size until the user indicates that the fixation mark is visible through the user interface module 705. Based on the size of the fixation mark that the user can clearly see, the fixation mark control system 722 can estimate or determine or assess the visual acuity of the user's eye (e.g., 20 / 20, 20 / 40, etc.).

[0095] Reference Fig. 9 In block 912 of FIG. 1 , the user interface module 805 instructs the user to track the movement of the fixation mark visible to the user from the subject 106. In one embodiment, the fixation mark controller 822 is configured to display a fixation mark that moves horizontally. In some embodiments, the horizontal movement of the fixation mark allows the scanning control and analysis module 824 to scan the eye vertically as the eye moves horizontally, so that a two-dimensional, stereoscopic, or raster scan of problematic eye tissue can be obtained. Alternatively, the scanning control and analysis module 824 and / or the fixation mark controller can cause the fixation mark or beam to jump or move back and forth to obtain measurements at different lateral locations on the eye.

[0096] During the scanning of the eye, the scanning control and analysis module 824 can be configured to detect whether the position of the body 106 has shifted relative to the user at box 913. In one embodiment, the scanning control and analysis module 824 can detect (in real time, substantially in real time, or with a certain delay) whether a shift has occurred based on the value that the module 824 expects to receive during the scanning process. For example, when the scanning control and analysis module 824 scans the retina, the module 824 expects to detect a change in the signal as the scanning process approaches the optic nerve (for example, based on the position of the gaze target and / or the state of the scanner). Alternatively, the expected value or expected value change can also be determined or generated using a nomogram. If the system does not detect an expected signal change consistent with the detection of the optic nerve, and / or does not receive a signal change, the module 824 can be configured to interpret such data when the user is not properly tracking. Other features such as the fovea of ​​the retina can be used to determine whether the expected signal is observed. If inappropriate tracking occurs enough (for example, based on a threshold determination), the system 100 can request the user to re-gaze (using the gaze mark controller 822) for another scan. If the aforementioned deviation detection process does not occur in real time or substantially real time, the system can be configured to complete the scan, perform data analysis, and during the analysis, the system can be configured to detect whether a deviation occurred during the scan. If a deviation is detected to have occurred, the user can be instructed (using the user interface module 805, by visual, audible, or verbal instructions) to sit forward again to perform another scan. If the system detects 2 or 3 or more deviations, the system can be configured to direct the user to seek help from a general ophthalmologist.

[0097] At the end of the scan, the scan control and analysis module 824 can be configured to generate a confidence value indicating the likelihood that the nomogram will be applied to the patient. For example, if the patient has marginal fixation, the confidence value will be lower than for a patient with good fixation.

[0098] In real-time embodiments, the system can be configured to perform a fast cross-correlation between adjacent A-scans or B-scans to ensure that the eye is moving somewhat. In some embodiments, the foregoing is beneficial to ANSI laser safety standards to prevent the user from staring at the same location where the laser energy strikes the user's retina. Accordingly, in some embodiments, if the system does not detect eye movement (e.g., the cross-correlation exceeds a certain threshold), the system is equipped with a laser timeout feature. In some embodiments, to speed up the process and provide real-time analysis in frequency domain OCT, the signal data can be analyzed before performing the FFT. Other techniques can be used to determine that the user has some eye movement.

[0099] If no gaze issues are detected, the scan control and analysis module 824 completes the scan of the user's eyes, stores the image and / or scan data in the image / scan database 826, and analyzes the A-scan data at block 915 to generate / determine a risk assessment and / or diagnosis at block 916 by accessing data and / or algorithms stored in the disease risk assessment / diagnosis database 808. In some embodiments, the analysis may be performed on a set of A-scans, some or all of the B-scans, or some or all of the C-scan data.

[0100] As used herein, the term "nomogram" generally refers to a prediction tool, algorithm and / or data set. A nomogram can generally provide a prediction for a user based on a comparison of the user's characteristics with the nomogram. The nomogram is derived, generated, calculated or computed from a large number (e.g., hundreds, thousands or millions) of users / patients presenting the same condition (normal or diseased). In some embodiments described herein, the nomogram compares disease risks based on physical properties. Accordingly, in some cases, the nomogram can provide personalized predictions related to risk groupings of patient populations sharing similar disease characteristics. In some embodiments, the nomogram can be used to provide risk estimates or risk assessments on a scale of 0-100%. Alternatively, the nomogram used here can provide expected values, such as an expected eye thickness value of 100 microns at a certain location in the eye.

[0101] In general, nomograms have been developed and validated in a large number of patients and are highly generalizable, so nomograms can provide objective, evidence-based, personalized risk estimates or assessments. Accordingly, nomograms can be used as described herein to enable patients to better understand their diseases. In addition, the nomograms used herein can assist physicians in clinical diagnosis and provide consistent, standardized, reliable predictions.

[0102] exist Fig. 9 In the schematic method shown at block 917 of Fig. 10A and Fig. 10BAs shown, an eye health assessment or eye health grade report for the user is generated by accessing the disease risk assessment / diagnosis database 808. At box 918, the physician recommendation database 804 is accessed to generate a suggestion about when the user should visit the physician (e.g., within one to two weeks). The physician recommendation database 804 can also be accessed to generate and edit a list of physicians suitable for treating the patient. The physician recommendation list can be randomly generated or selected based on the recommended fee paid by the physician, the insurance company, or based on the location of the physician relative to the user's location or office / home address, or based on the type of disease detected, or based on the severity of the disease detected, based on the location or proximity of the system relative to the physician's location, or based on a combination thereof. At box 919, the report is displayed to the user using the report / output module 806 and the output device 102. In a specific embodiment, the report data is stored in the user / patient database 802 for future analysis or comparative analysis with future scans.

[0103] In some embodiments, the body 106 is not supported by the user 114. For example, Fig. 10A As shown, the body 106 can be supported by a self-supporting structure. The user 114 can look into the eyepiece. The user 114 can sit on a seating device, which can include a height-adjustable mechanism. The body 106 can be supported by a height-adjustable support.

[0104] In such FIG. 10B to FIG. 10C In some embodiments shown, the ribbon 1005 is connected to the body 106. Fig. 10B As shown, the band can act to fully or partially support the body 106. In some embodiments, the band 905 may not be included. The body 106 can be held by the user. In some embodiments, the body 106 can be supported on an eyeglass frame. In some embodiments, all optical components are contained within the body 106 that is directly or indirectly supported by the user 114. For example, Fig. 10B The main body 106 in the apparatus may include an optical coherence tomography system, an alignment system, and a data acquisition device. The data acquisition device may send data to a network or a computer system wirelessly, or may use a cable to transmit control signals. Fig. 10C and Figure 1 In some embodiments, the body 106 is similar to the body 106 of the user 114 and is supported by a separate support structure (e.g., a zero gravity arm). In some embodiments, a strap, a band, or other fastener helps to align the body 106 with one or both eyes of the user 114.

[0105] In such Fig. 10DIn some embodiments shown, the user wears an object 1010 connected to the eyepiece. The wearable object 1010 may include a head-mounted object, a hat, or an object placed on the user's head. As described above, in some embodiments, the body 106 is supported on a frame of glasses such as glasses worn by the user. The wearable object 1010 may fully or partially support the body 106 and / or may help align the body 106 with one or both eyes of the user 114.

[0106] Reference Fig.11A and Fig. 11B , illustrating two exemplary embodiments of eye health grades and eye health assessment reports. Fig.11A The eye health rating report may include, without limitation, numerical and / or letter ratings for each eye of the user for various eye health categories, including, but not limited to, macular health, optic nerve health, eye clarity, etc. The eye health rating report may also include at least one recommendation to see a physician or consult a physician within a specific time period, and may provide at least one possible physician for contact. Data used to generate the recommendation information and the recommended physician list is stored in the physician recommendation database 804. Fig. 11B The eye health assessment report may include a graphical representation of each eye of the user for each eye health category. The report may be presented to the user via an electronic display, printed on paper, printed on a card that the user inserts into the machine, electronically stored on a user identification card, sent to the user via email, or a combination thereof.

[0107] Reference Fig.12 , which illustrates another embodiment of a computer system 104 connected to a remote system 110 and a billing / insurance declaration and payment system 1201. The billing module 810 can be configured to communicate with the billing / insurance declaration and payment system 1201 via the communication medium 108 to request or process an insurance claim for implementing a scan of the user's eye. Based on the communication with the billing / insurance declaration and payment system 1201, the billing module 810 can also be configured to determine the amount payable or the amount borne by the user's insurance company, and / or calculate or determine the co-payment amount to be charged to the consumer. In a specific embodiment, the user can interact with the user interface module 805 to schedule an appointment with one of the recommended doctors, and / or schedule a reminder to be sent to the user to consult with the physician. The computer system 104 or the remote system 110 can be configured to send reminders to the user via email, text message, regular mail, automatic telephone message, etc.

[0108] Computer Systems

[0109] In some embodiments, the above-mentioned system, computer client and / or server adopts Fig.13 The computing system 1300 shown in FIG. Fig.13 13 is a block diagram of one embodiment of a computing system (which may be a fixed system or a mobile device) that communicates with one or more computing systems 1310 and / or one or more data sources 1315 via one or more networks 1310. Computing system 1300 may be used to implement one or more of the systems and methods described herein. Additionally, in one embodiment, computing system 1300 may be configured to process image files. Although Fig.13 While one embodiment of a computing system 1300 is illustrated, it should be appreciated that the functionality provided in the components and modules of the computing system 1300 may be combined into fewer components and modules, or further separated into additional components and modules.

[0110] Client / Server Module

[0111] In one embodiment, the system 1300 includes an image processing and analysis module 1306 that performs the functions, methods, and / or processes described herein. The image processing and analysis module 1306 may be executed on the computing system 1300 by the central processing unit 1304, which will be discussed further below.

[0112] Computing system components

[0113] In one embodiment, the processes, systems, and methods illustrated above may be partially or entirely implemented using software running on a computing device. The functions provided in the components and modules of the computing device may include one or more components and / or modules. For example, the computing device may include multiple central processing units (CPUs) and mass storage devices, such as server arrays.

[0114] Generally, the word "module" used here refers to logic embodied in hardware or firmware, or a collection of software instructions, which may have entry and exit points written in a programming language (e.g., Java, C, or C++, etc.). Software modules can be compiled and linked into an executable program, installed in a dynamic link library, or can be written using an interpreted programming language such as BASIC, Perl, Lua, or Python. It should be understood that software modules can be called by other modules or themselves, and / or can be called in response to detected events or interrupts. Software instructions can be embedded in firmware such as EPROM. It will be further understood that hardware modules can include connected logic units such as logic gates and triggers, and / or can include programmable units such as programmable gate arrays or processors. The modules described here are preferably implemented as software modules, but can be represented in hardware or firmware. In general, the module description described here refers to a logical module that can be combined with other modules or divided into submodules, regardless of its physical organization or storage state.

[0115] In one embodiment, computing system 1300 also includes a mainframe computer suitable for controlling and / or communicating with a large database, performing high volume transaction processing, and generating reports from a large database. Computing system 1300 also includes a central processing unit ("CPU") 1304, which may include a conventional microprocessor. Computing system 1300 also includes memory 1305 such as random access memory ("RAM") for temporary storage of information and read-only memory ("ROM") for permanent storage of information; and mass storage devices 1301 such as hard disks, magnetic disks, or optical media storage devices. In general, the modules in computing system 1300 are connected to the computer using a standard bus-based system. In various embodiments, for example, the standard bus-based system may be a peripheral component interconnect (PCI), MicroChannel, SCSI, Industry Standard Architecture (ISA), and Extended ISA (EISA) architecture.

[0116] The exemplary computer system 1300 includes one or more commonly available input / output (I / O) devices and interfaces 1303, such as a keyboard, a mouse, a touchpad, and a printer. In one embodiment, the I / O devices and interfaces 1303 include one or more display devices such as monitors to allow data to be presented to a user through a visual display. More specifically, the display device provides, for example, the presentation of a GUI, application software data, and multimedia presentation. Fig.13In the embodiment of the present invention, the I / O devices and interfaces 1303 also provide communication interfaces to various external devices. The computer system 1300 may also include one or more multimedia devices 1302, such as speakers, graphics cards, graphics accelerators, and microphones.

[0117] Computing system equipment / operating system

[0118] The computing system 1300 can be run on a variety of computing devices, such as servers, Windows servers, SQL servers, Unix servers, personal computers, mainframe computers, laptop computers, cell phones, personal digital assistants, public telephone booths, audio players, and the like. The computing system 1300 is typically controlled and coordinated by operating system software, such as z / OS, Windows 95, Windows 98, Windows NT, Windows 2000, Windows XP, Windows Vista, Linux, BSD, SunOS, Solaris, or other compatible operating system systems. In Macintosh systems, the operating system can be any available operating system, such as Mac OS X. In other embodiments, the computing system 1300 can be controlled by a proprietary operating system. Conventional operating systems control and schedule computer programs for execution, perform memory management, provide file system, networking and I / O services, and provide user interfaces such as graphical user interfaces ("GUIs").

[0119] network

[0120] exist Fig.13 In an embodiment of the present invention, the computing system 1300 is coupled to the network 1310, for example, via a wired, wireless, or combination of wired and wireless communication link 1315, such as a modem system using POTS / PSTN (plain old telephone service / public switched telephone network), ISDN, FDDI, LAN, WAN, or the Internet. The network 1310 communicates (e.g., continuously, intermittently, periodically) with various computing devices and / or other electronic devices via wired or wireless communication links. Fig.13 In the example embodiment, network 1310 is in communication with one or more computing systems 1317 and / or one or more data sources 1319 .

[0121] Access to the image processing and analysis module 1306 in the computing system 1300 by the remote computing system 1317 and / or data source 1319 may be through a web-enabled user access point such as a personal computer, cell phone, laptop, or other device capable of connecting to the network 1310 of the computing system 1317 or data source 1319. Such a device may have a browser module implemented as a module that uses text, graphics, audio, video, and other media to present data and enable interaction with the data via the network 1310.

[0122] The browser module or other output module can be implemented as a combination of all point addressable displays such as cathode ray tubes (CRTs), liquid crystal displays (LCDs), plasma displays, or other types and / or display combinations. In addition, the browser module or other output module can be implemented to communicate with input device 1303, and can also include software with appropriate interfaces that enable users to access data by using programmable screen elements such as menus, windows, dialog boxes, toolbars, and controls (e.g., radio buttons, check boxes, sliding scales, etc.). In addition, the browser module or other output module can communicate with a group of input and output devices to receive signals from the user.

[0123] Input devices may include keyboards, rolling balls, pens and styluses, mice, trackballs, speech recognition systems, or pre-specified switches or buttons. Output devices may include loudspeakers, display screens, printers, or speech synthesizers. In addition, touch screens may be used as hybrid input / output devices. In another embodiment, the user may interact with the system more directly, for example, through a system terminal that is connected to a score generator, without having to go through the Internet, a WAN or a LAN, or a similar network.

[0124] In some embodiments, the system 1300 may include a physical or logical connection between a remote microprocessor and a host computer for the express purpose of uploading, downloading, or viewing interactive data and databases online in real time. The remote microprocessor may be operated by an entity operating the computer system 1300, including a client server system or a host server system, and / or may be operated by one or more data sources 1319 and / or one or more computing systems. In some embodiments, terminal emulation software may be used on the microprocessor to participate in the micro-host link.

[0125] In some embodiments, a computing system 1317 within the entity operating the computer system 1300 may access the image processing and analysis module 1306 as an application or process executed by the CPU 1304 .

[0126] User access point

[0127] In one embodiment, the user access point includes a personal computer, a laptop computer, a cellular phone, a GPS system, devices, portable computing devices, servers, computer workstations, local area networks for personal computers, interactive public telephone booths, personal digital assistants, interactive wireless communication devices, handheld computers, embedded computing devices, etc.

[0128] Other Systems

[0129] Except in Fig.13 13. The network 1310 can communicate with other data sources or other computing devices. The computing system 1300 can also include one or more internal and / or external data sources. In some embodiments, one or more data warehouses and data sources can be created using a database such as DB2, Sybase, Oracle, CodeBase, and SQL Server, as well as other types of databases such as flat file databases, entity-relational databases, object-oriented databases, and / or record-based databases.

[0130] Reference Fig.14A , illustrates an example method for determining or generating a risk assessment for a disease, such as an eye disease, thereby enabling the generation of a health rating and a recommended time to see a doctor. Fig.14A The example shown is for retinal diseases, however, the illustrated processes and methods can be used for other diseases or other eye disorders. In this example, the scan control and analysis module 824 is configured to determine the thickness of the retina based on the A-scan data derived from the subject 106. The data may include A-scan data from different A-scans, but is not limited to this. The scan control and analysis module 824 can also be configured to access data and algorithms in the disease risk assessment / diagnosis database 808 to determine the thickness of the retina. Fig.14A The risk assessment of retinal disease is calculated based on the measured retinal thickness as shown in the function curve in FIG. The reporting / output module 806 can be configured to normalize the calculated risk assessment value into an eye health letter or numeric grade or score. The reporting / output module 806 can also be configured to access the data and algorithms in the physician recommendation database 804 to calculate the recommended time to see a doctor based on the calculated risk assessment value.

[0131] Reference Fig. 14B, illustrates another example method or process for determining or generating a disease risk assessment result by comparing scan data to a disease risk assessment / diagnosis database 808 including, for example, minimum and maximum thickness data and algorithms, and such minimum and maximum thickness data and algorithms may be based on or take the form of a nomogram. In a particular embodiment, the system is configured to generate scan data for a scanned portion of the eye to determine the retinal thickness at any point, and compare such data to a histogram and / or nomogram (e.g., showing the expected thickness at the location or the probability of disease at a given thickness) to obtain a risk assessment. The system may also be configured to generate an average thickness for the entire retina scanned, and compare such data to a histogram and / or nomogram to obtain a risk assessment.

[0132] As used herein, a "histogram" generally refers to an algorithm, curve or data, or other representation of the frequency distribution of a particular variable (e.g., retinal thickness). In some cases, the variable is divided into ranges, interval classes, and / or points on a graph (along the X-axis), and the frequency of occurrence of the points is represented by the position of a rectangular column or point; the height of the column and / or point along the Y-axis is proportional to the frequency of observations within the range or interval, or represents the frequency of observations within the range or interval. The "histogram" referred to herein may include, for example, measurement data obtained by scanning the user's eyes, or may include data obtained from a large population. The histogram in the former case may be analyzed to determine the mean, minimum, or maximum value, and to analyze the slope change of the histogram curve, or to detect the shape or curvature of the histogram curve. In the latter case, its histogram may be used to determine the frequency of observed measurements in the survey sample.

[0133] In an example where an average thickness value is derived from scan data, there are some conditions / diseases that can be indicated by thickening of the retina in a local area. Accordingly, such a condition may not significantly affect the average thickness value (e.g., if the thickness of most of the retina is normal). Therefore, a maximum thickness value may be required to detect abnormal thickening in the retina. In some embodiments, this maximum thickness value may be generated due to a division error. Accordingly, a more reliable way to determine the maximum value may also use a value corresponding to the maximum thickness of 95% (or any value between 75% and 99%). The foregoing may also be applied to the minimum retinal thickness or any other value, measurement in the eye, and / or detectable condition. For example, using the minimum retinal thickness, if the user suffers from a macular hole, there is only a small area with zero thickness, and it may not be enough to significantly reduce the average thickness, but it is certainly an abnormality that can be detected.

[0134] In other embodiments, the system can be configured to create a histogram of measured thickness and / or measured intensity values ​​and / or slopes or derivatives of intensity values ​​and / or variables for identifying abnormalities. For example, a change or significant change in the slope (calculated as a derivative of adjacent intensity values) can indicate low or high reflective structures that may not affect the average intensity value but may indicate disease or severe illness. For example, the system can determine whether the distribution of retinal thickness over the measured portion of the retina matches the distribution of a normal population. Deviations from such a "normal" histogram may result in a lower health grade / higher risk assessment.

[0135] In various embodiments, the methods or processes described herein can be used to determine or generate a risk assessment for macular degeneration based on comparing, for example, abnormal thickening of the retina or fovea, the presence of high-reflective (bright or high-intensity) or low-reflective (dark or low-intensity) structures in the outer half of the retina, the presence of low-reflective (dark) structures in the inner half of the retina, irregularities in the retinal pigment epithelial cell contour that deviates from the normal curvature of the eye, or high transmittance of light through the retinal pigment epithelial cells to a database of normal values ​​stored in, for example, a disease assessment / diagnosis database 708.

[0136] As described above, there are several ways to detect or generate risk assessments for several diseases or serious conditions. In certain embodiments, the scan data is compared with data found in a normal population to identify similarities or differences with a nomogram and / or histogram. In other embodiments, the scan data is compared with data found in a diseased population to identify similarities or differences with a nomogram and / or histogram. Specific disease characteristics can be indicated by similarities to a nomogram (e.g., images, histograms, or other data from a patient, etc.).

[0137] In one embodiment, "normal" data (e.g., histograms) are created for retinal thickness in each area of ​​the retina (optic nerve, fovea, retina temporal), and the values ​​measured, detected, scanned, or encountered are compared with these "normal" data (e.g., histograms) to determine the relative risk of retinal disease or other diseases. The same operation can be performed for the thickness of the nerve fiber layer (NFL) to detect glaucoma. In other embodiments, since glaucoma tends to thin the NFL in the curve bundle, the detection or generation of the risk assessment for glaucoma is performed or generated by the following operations: analyzing the collinear A-scan data to see if the thinning of the curve indicates the presence of glaucoma. The NFL is arranged radially from the optic nerve in a curve, like iron filings around a magnet. Measuring and analyzing a sequence of A-scan data that follows this curve path may help identify thinning that is characteristic of glaucoma. The analysis can be centered on and / or around the optic nerve, or centered on and / or around the fovea, or elsewhere. In another embodiment, the detecting or generating of the risk assessment for glaucoma is performed or generated by analyzing the inner surface of the optic nerve to determine the optic cup volume of the optic disc.

[0138] The system can also be configured to detect and / or generate a risk assessment for optical clarity, wherein the system integrates the A-scan data in the Z direction and compares some or all of the A-scan data to a nomogram value (or, e.g., a histogram.) In general, a darker A-scan will likely indicate the presence of media opacities (e.g., cataracts) that reduce optical clarity (therefore, increasing the risk of the subject having optical clarity issues such as cataracts).

[0139] The system can also be configured to detect risk assessment of retinal pigment epithelial (RPE) features that deviate from the normal curvature of the eye (drusen, retinal pigment epithelial detachment). Such RPE features can be detected by fitting the detected RPE layer to a polynomial curve that simulates the desired curvature of the eye and using a computer algorithm to analyze, compare or examine the difference between these curves. For example, with respect to Fig.15 , the system can be configured to deduct a polynomial curve of the desired curvature of the simulated RPE layer 1502 from the detected RPE layer curve 1504, and analyze and / or compare the resulting difference / value 1506 with the value (e.g., the value in a straight line graph or a nomogram) from a normal and / or diseased eye to generate a diagnosis or risk assessment. The similarity of the aforementioned method and process to tortuosity measurement is that a bumpy RPE detection is generally more offset relative to a polynomial curve than a smooth RPE measurement (which is common to young healthy people).

[0140] In certain embodiments, the system can be configured to detect the increase transmission of the RPE by the RPE that is basically synonymous with RPE degeneration or atrophy.In a specific embodiment, the system can be configured to analyze the tissue layer on or below the RPE layer. The RPE layer can be segmented using imaging segmentation techniques. In a specific embodiment, the system can be configured to add up all intensity values ​​under the RPE detection. When atrophy occurs, under the RPE line, usually there will be many higher values, which will make the whole value become higher, and may increase the risk of the patient suffering from the serious macular disease such as map-like atrophy.

[0141] Reference Fig.16 , the system can also be used to detect or generate risk factors for abnormal intensity in the retina. In a specific embodiment, the system can be configured to detect the midpoint between 1606 and the RPE detection line 1608 based on the inner limiting membrane (ILM), and the retina is divided into an inner half 1602 and an outer half 1604. In some instances, fuzzy filtering (e.g., Gaussian blur, radial blur, etc.) is applied to retinal tissue to eliminate speckle noise and / or other noise. For each inner and outer retinal area, the first derivative of the intensity value can be calculated (relative to position, e.g., d / dx, d / dy, etc.) to determine the slope of the curve, to distinguish the area with a larger change from dark to bright (or from bright to dark) on the lateral dimension of the organization. For example, the intensity or derivative values ​​within the retina can be compared to, for example, a normal histogram, where low intensity in the inner retina can be an indication of cystoid macular edema; or, where low intensity in the outer retina can be an indication of cystoid macular edema, subretinal fluid, or diffuse macular edema; or, where high intensity in the outer retina can be an indication of diabetes (which can be the cause of diabetic retinopathy, or a complication of diabetes that damages the retina), or age-related macular degeneration.

[0142] Data from normal patients can be used to compile a histogram of intensity and / or slope (derivative) data to indicate expected values ​​for a normal population. Data from populations with various diseases can be placed in a histogram of intensity and / or derivative (slope) values ​​to indicate expected values ​​for populations with diseases. In certain embodiments, a relative risk will be displayed for each entry on the histogram so that the risk can be applied to unknown situations. For example, in some instances, a person with 10% of outer retinal intensity values ​​equal to zero has an 85% chance of having a retinal problem. Therefore, these users may receive a health rating of 15. In another example, anyone with less than 10 inner retinal points has a 100% chance of being ill, so these users will receive a health rating of 5.

[0143] Alternatively, as discussed herein, the foregoing methods or processes may also be used to determine or generate a risk assessment for glaucoma based on comparing thinning of the macula and / or peripapillary nerve fiber layer or enlarged cupping of the optic nerve head to a database of normal and abnormal values ​​stored in the disease risk assessment / diagnostic data 708. Similarly, to detect or perform a risk assessment for uveitis, a histogram of expected intensity values, for example, on the inner surface of the retina (within the vitreous body) may be used. The presence of large bright spots (e.g., high intensity areas) within the vitreous cavity would indicate possible uveitis and would potentially indicate the need for a recommendation. The foregoing methods and processes may also be used to determine or generate a risk for eye disease based on comparing the intensity level of the image signal to a database of normal and abnormal values ​​stored in the disease risk assessment / diagnostic data 708.

[0144] In other embodiments, the foregoing methods and processes may also be used to determine or generate a risk assessment for uveitis based on comparing the hyperreflective features within the vitreous cavity to the normal and abnormal hyperreflective features stored in the disease risk assessment / diagnosis data 708. The foregoing methods and processes may also be used to determine or generate a risk assessment for early stage eye disease based on the detection of specific disease features such as cystoid retinal degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, retinal pigment epithelial detachment, and / or retinal pigment epithelial atrophy, wherein the detected features are compared to such specific disease features stored in the disease risk assessment / diagnosis data 708. In a particular embodiment, the system is configured to perform template matching, wherein the system detects features from an A-scan generated by scanning a user (referred to as an unknown A-scan) and compares and / or matches them to a database of patterns known to be associated with disease features such as subretinal fluid.

[0145] Reference Figure 1 , Figure 8 and Fig. 9, the optical coherence tomography system 100 is configured to enable a user to self-steer an OCT scan of the user's eye without dilating the eye, obtain a risk assessment or diagnosis for various diseases and ailments without involving a physician and / or technician to align the user's eye with the system, steer the OCT scan and / or interpret data from the scan to generate or determine a risk assessment or diagnosis. In one embodiment, the optical coherence tomography system 100 can perform a screening in less than 2 minutes, in 2-3 minutes, or in 2-5 minutes. In certain embodiments, the use of a binocular system enables the user to self-align the optical coherence tomography system 100. The optical coherence tomography system 100 with a binocular system is faster because it can scan both eyes without repositioning, and enables the optical coherence tomography system 100 to scan a person's less visual eye because the person's less visual eye will follow the better visual eye as the person's better visual eye tracks the fixation marker. Accordingly, the optical coherence tomography system 100 reduces the cost of performing OCT scanning, thereby making OCT scanning more accessible to more people and / or users, and preventing millions of people from losing their sight due to eye diseases or ailments that could be prevented through early detection. In one embodiment, the optical coherence tomography system 100 is configured to be small and / or portable so that such an optical coherence tomography system 100 can be installed or placed in a pharmacy, a retail mall or store, a medical imaging facility, a grocery store, a library, and / or a mobile vehicle, bus or van, a general practitioner's or other physician's office, so that people can use the optical coherence tomography system 100 without having to see a doctor.

[0146] The methods and processes discussed herein may be embodied or fully automated via software code modules executed by one or more general-purpose computers or processors. The code modules may be stored in any type of computer-readable medium or other computer storage device. Alternatively, some or all of the methods may be embodied using dedicated computer hardware.

[0147] Although the present invention has been discussed with respect to specific embodiments, it should be appreciated that the present invention is not limited thereto. Embodiments are described herein as examples, and various modifications, variations, and other embodiments may be employed, which are still within the scope of the present invention.

[0148] For the purpose of this disclosure, specific aspects, advantages and novel features of the present invention are described herein. It should be understood that, according to any specific embodiment of the present invention, it is not necessary to adopt and / or implement all of these aspects, advantages and features. Therefore, for example, those skilled in the art will recognize that the present invention can be embodied or implemented in a manner that realizes one or a group of advantages taught herein, without having to realize other advantages taught or suggested herein.

Claims

1. An optical coherence tomography analysis device, comprising: at least one eyepiece for directing light into both eyes of the subject and receiving light reflected from at least one eye of the subject; a light source for outputting light that shines through the at least one eyepiece into the subject's eye; an interferometer configured to generate optical interference using light reflected from the subject's eye; an optical detector arranged to detect said optical interference; as well as an automatic focusing system including adjustable optics for focusing the optical coherence tomography instrument; as well as a Z positioning module configured to automatically adjust a Z-offset of the at least one eyepiece to obtain an optical coherence tomography scan of ocular tissue, Wherein, the optical coherence tomography device is configured to be activated by the subject to perform the optical coherence tomography scan of eye tissue.

2. The optical coherence tomography apparatus according to claim 1, in, The optical coherence tomography apparatus includes an electronic device coupled to a target display and the optical detector, wherein the electronic device is configured to provide an output to the object based on optical coherence tomography measurements obtained using the interferometer, and The electronic device is further configured to generate features of variable size on the target display and receive subject responses to test the visual acuity of the subject.

3. The optical coherence tomography instrument according to claim 1, wherein: The at least one eyepiece includes a first eyepiece and a second eyepiece.

4. The optical coherence tomography instrument according to claim 1, wherein: The optical coherence tomography scan is configured to be voice activated by the subject.

5. The optical coherence tomography instrument according to claim 1, wherein: The optical coherence tomography scan is configured to be activated by a microphone.

6. The optical coherence tomography instrument according to claim 1, wherein: The optical coherence tomography scan is configured to be activated by a button, a switch, a knob, a rotary handle, a keyboard, or a touch screen display.

7. The optical coherence tomography instrument of claim 1, further comprising an interface module configured to interface with a mobile device of the subject.

8. The optical coherence tomography instrument of claim 1, further comprising at least one beam splitter for coupling light from the light source into the at least one eyepiece.

9. The optical coherence tomography instrument of claim 1, further comprising: An actuator is configured to detect the presence of the object in the vicinity of the optical coherence tomography device, scanning being activated based at least in part on an indication of the presence of the object in the vicinity of the optical coherence tomography device.

10. The optical coherence tomography instrument of claim 1, further comprising: Electronics configured to automatically perform diagnostics based on optical coherence tomography measurements obtained using the interferometer.

11. The optical coherence tomography instrument according to claim 10, wherein: The electronic device is configured to automatically perform a diagnosis by transmitting the optical coherence tomography measurements via a network to a remote system, the remote system being configured to perform the diagnosis based on the optical coherence tomography measurements.

12. The optical coherence tomography instrument of claim 1, further comprising: An electronic device configured to perform an analysis based on optical coherence tomography measurements obtained using the interferometer to determine a likelihood of having a disease.

13. The optical coherence tomography instrument of claim 12, further comprising: An output device is electrically coupled to the electronic device, the output device being configured to provide an output to the subject via the output device based on the likelihood of having a disease.

14. The optical coherence tomography instrument of claim 12, further comprising: An output device is electrically coupled to the electronic device, the output device being configured to alert the subject.

15. The optical coherence tomography instrument according to claim 12, wherein: The electronic device is configured to perform the analysis by transmitting the optical coherence tomography measurements via a network to a remote system, the remote system being configured to perform a risk analysis based on the optical coherence tomography measurements.

16. The optical coherence tomography instrument of claim 12, wherein: The electronic device determines the risk of macular disease based on the detection of characteristic disease features, wherein the characteristic disease features include at least one of the following: cystic retinal degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, retinal pigment epithelial detachment or retinal pigment epithelial atrophy.

17. The optical coherence tomography instrument of claim 12, further comprising: An output device is electrically coupled to the electronic device, the output device being configured to provide an output including a recommendation for accessing a physician.

18. The optical coherence tomography instrument of claim 12, wherein: The electronic device is configured to transmit the possibility of having the disease to a physician via a network.

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