Optical coherence tomography analysis equipment, method and system

Abstract

According to one aspect of the present invention, there is provided an optical coherence tomography apparatus, method and system, the optical coherence tomography apparatus comprising: an eyepiece for accommodating at least one eye of a user; the light source is used for outputting light, and the light penetrates through the eyepiece to enter eyes of a user; 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 with the detector. The electronics may be configured to perform a risk assessment analysis based on optical coherence tomography measurements obtained with the interferometer. An output device may be electrically coupled with the electronic device and may be configured to output a risk assessment result to a user through the output device. The optical coherence tomography apparatus may be self-manipulated, and the eyepiece may be a monocular system or a binocular system.

Description

[0001] This application is a divisional application of Chinese Patent Application CN 202110028197.X, filed on March 17, 2009, entitled "Optical Coherence Tomography Analysis Device, Method, and System".

[0002] Cross - reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 61 / 040,084, filed on March 27, 2008, entitled "OPTICAL COHERENCE TOMOGRAPHY DEVICE, METHOD, AND SYSTEM" (DOHENY.001PR), and claims priority to U.S. Patent Application No. 12 / 111,894, filed on April 29, 2008, entitled "OPTICAL COHERENCE TOMOGRAPHY DEVICE, METHOD, AND SYSTEM" (DOHENY.001A). The foregoing applications are hereby incorporated by reference in their entirety, including, for example, the optical coherence tomography analysis device, method, and system disclosed herein, but not limited thereto. Technical field

[0004] Embodiments of the present invention relate to the field of optical coherence tomography analysis, and more particularly to devices, systems, and methods for performing precise measurements on eye tissue using such optical coherence tomography analysis data to detect eye diseases. Background art

[0005] Optical coherence tomography (OCT) is widely used in industrial, medical, and other fields. OCT generally refers to a non - invasive optical tomography imaging technique that uses interferometry to provide micron - scale longitudinal and lateral resolution with millimeter penetration (penetrating approximately 2 - 3 mm into tissue). For example, in medical applications, doctors typically desire a non - invasive in - vivo imaging technique for obtaining images of the lower surface, cross - section, and / or three - dimensional images of transparent and / or opaque materials with a resolution comparable to that of a low - power microscope. Therefore, it is expected that 20 million OCT scans will be performed on patients each year in the coming years. Most of these are likely to occur in the ophthalmology field. In current optical coherence tomography systems, doctors or other medical professionals operate the OCT scans in a doctor's clinic or a medical institution. Summary of the invention

[0006] Various embodiments of the present invention relate to the use of optical coherence tomography, which generally refers to a non-invasive optical tomography imaging technique using an interferometer and can be used for detecting and analyzing, for example, eye tissues and / or disease characteristics, including: cystoid macular degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, etc., but not limited thereto. For example, according to one aspect of the present invention, an optical coherence tomography device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters the user's eye; an interferometer configured to generate optical interference using the 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 being configured to output a risk assessment to the user through the output device. Generally, the optical coherence tomography devices, apparatuses, systems, and methods disclosed herein can be self-operating, and the eyepiece can be a single-eyepiece system or a binocular system.

[0007] According to another aspect of the present invention, an optical coherence tomography device includes: a first eyepiece and a second eyepiece for receiving a pair of eyes of a user; a light source for outputting light that passes through the first eyepiece and the second eyepiece and enters the user's eye; an interferometer configured to generate optical interference using the 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 the optical coherence tomography measurement results obtained using the interferometer.

[0008] In another aspect of the present invention, an optical coherence tomography device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and enters the user's eye; an interferometer configured to generate optical interference using the 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 the optical coherence tomography measurement results 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 through the output device.

[0009] According to another aspect of the present invention, an optical coherence tomography device for providing self-managed disease screening includes: an eyepiece for receiving at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and enters 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, wherein the user is capable of manifesting 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 present invention, an optical coherence tomography device includes: an eyepiece for receiving 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 and enters 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 measurement results 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 device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters 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 optical coherence tomography measurement results; 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 (OCT) device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters 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 optical coherence tomography measurement results obtained using the interferometer; a memory including a list of healthcare providers; and a device electrically coupled to the electronic device to provide the output to the user, wherein the electronic device is further 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 (OCT) device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters 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 optical coherence tomography measurement results obtained using the interferometer; and an output device electrically coupled to the electronic device and configured to provide the output to the user, wherein the electronic device is configured to provide a recommended deadline for consulting a healthcare provider based on a risk level of a patient having a specific type of disease determined using the optical coherence tomography measurement results.

[0014] According to another aspect of the present invention, an optical coherence tomography (OCT) device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting a light beam that passes through the eyepiece and enters 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 associate optical coherence tomography measurement results with spatial positions using the positions of the display target on the array of display elements.

[0015] According to another aspect of the present invention, an optical coherence tomography (OCT) device includes: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters 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 including statistical information correlating OCT measurement results with the 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 OCT measurement results of the object's eye using the interferometer with the statistical information to provide an assessment of the risk that the object has the at least one disease.

[0016] According to another aspect of the present invention, an optical coherence tomography (OCT) device includes: an eyepiece for receiving the user's eye; a light source for outputting light that passes through the eyepiece and enters 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 the OCT measurement results 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 adjust the optical element using a signal from the detector to focus the light.

[0017] For purposes of generalization, specific aspects, advantages, and novel features of the present invention are described herein. It should be understood that not all of these aspects, advantages, and features need to be employed and / or implemented in any particular embodiment of the present invention. Thus, for example, those skilled in the art will recognize that the present invention may be embodied or implemented in a manner that achieves one advantage or a group of advantages taught herein without necessarily achieving other advantages taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0020] Figure 2 is a schematic diagram of an embodiment of an interferometer arranged to perform measurements on an eye.

[0021] Figure 3ASchematic diagram of an embodiment of an OCT system including a body configured to facilitate interference with the human eye, the body communicating with the various systems described herein.

[0022] Figure 3B Schematically illustrates Figure 3A Perspective view of an embodiment of the body shown.

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

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

[0025] Figures 6A to 6C Schematic diagram showing scanning of retinal tissue using optical coherence tomography to generate A-scans and B-scans.

[0026] Figures 7A to 7F Schematic diagram of an embodiment for adjusting and / or calibrating the interpupillary distance.

[0027] Figure 8 Block diagram schematically illustrating an embodiment of a computer system of the optical coherence tomography system described herein.

[0028] Figure 9 Flowchart of an embodiment showing performing precise measurements on retinal tissue to detect specific disease characteristics.

[0029] Figures 10A to 10D Schematic diagram showing possible embodiments of positioning the body of an optical coherence tomography device relative to a user.

[0030] Figures 11A to 11B Schematic diagram showing possible embodiments of an output report generated by an optical coherence tomography device.

[0031] Figure 12 Block diagram schematically illustrating another embodiment of a computer system for the optical coherence tomography system described herein.

[0032] Figure 13 Block diagram schematically illustrating components in an embodiment of a computer system of the optical coherence tomography system described herein.

[0033] Figure 14A Diagram schematically illustrating an embodiment for determining a risk assessment.

[0034] Figure 14BSchematic of a graph of the risk of retinal disease relative to retinal thickness used to determine a risk assessment in another embodiment.

[0035] Figure 15 Schematic of RPE detection, RPE polynomial fit curvature, and the difference therebetween.

[0036] Figure 16 Schematic of dividing 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, in which, in all the drawings, like reference numerals refer to like elements. The specialized terms used in the specification presented here are simply utilized in connection with the detailed description of certain specific embodiments of the present invention and are not intended to be construed in a limiting or restrictive manner. In addition, embodiments of the present invention may include several novel features, none of which alone is responsible for its desired attributes or is essential for practicing the present invention disclosed here. The embodiments used here enable users to more easily perform OCT screening, thereby enabling earlier detection and / or treatment of various diseases, ailments, or conditions, such as macular lesions, glaucoma, and the like.

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

[0039] Generally, OCT employs an interferometer. Light from a light source (e.g., a broadband light source) is split (e.g., by a beam splitter) and passes through a sample arm (usually including a sample) and a reference arm (usually including a mirror). The light from the sample arm is partially reflected by the sample. The light is also reflected by the mirror in the reference arm. (The light from the test arm and the reference arm is recombined, for example, by a beam splitter.) When the distance the light travels in the sample arm is within the coherence length of the distance the light travels in the reference arm, light interference will occur, which affects the intensity of the recombined light. The intensity of the recombined reflected light changes according to the sample properties. Therefore, the change in the intensity of the measured reflectance ratio indicates the physical characteristics 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 reflection ratios observed as the reference arm distance changes indicate 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 reflection ratios 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 over a dispersive element such as a grating, and a detector array can be used to separate and detect different wavelengths. Fourier analysis can transform the frequency-based reflection ratio characteristics into distance-based reflection ratio characteristics, thereby indicating sample characteristics at different sample depths. In certain embodiments, OCT can show additional information or data other than non-mydriatic color fundus imaging.

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

[0042] In an ophthalmic example, an A-scan typically can include data from the cornea to the retina, and a B-scan includes cross-sectional data from the medial edge to the lateral 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 humans and other mammals whether or not under the treatment of a physician, but are not limited thereto.

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

[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 the presence of one or more disorders, diseases, ailments, etc. The term "diagnosis" generally refers to determining the nature and symptoms of a disorder, ailment, or serious condition by examination and / or testing.

[0046] The present disclosure provides various methods, systems, and devices for generating and utilizing optical coherence tomography image data to perform precise measurements on retinal tissue to detect disease characteristics and generate a risk assessment and / or diagnosis based on data obtained through optical coherence tomography techniques. In some embodiments, these methods, systems, and devices can employ a statistical analysis of the detected disease characteristics obtained through optical coherence tomography techniques. These methods, systems, and devices can be used for screening for diseases.

[0047] Refer to Figure 1 , which schematically shows a block diagram depicting an embodiment of an optical coherence tomography system. In one embodiment, computer system 104 is electrically coupled to output device 102, communication medium 108, and user card reader system 112. Communication medium 108 can enable computer system 104 to communicate with other remote systems 110. Computer system 104 can be electrically coupled to body 106, and user 114 places body 106 in a position close to the user's eye or on the user's eye. In the illustrated example, body 106 is a binocular system (e.g., having two eyepieces or optical paths for two eyes, providing one view to one eye and another view to the other eye, or the like), and the binocular system is configured to scan both eyes without having to reposition the eyepieces relative to the patient's head, thereby reducing the time for scanning the patient. In some embodiments, a scanner (e.g., a galvanometer) is used to scan both eyes simultaneously, and the scanner interleaves the measurements of the two eyes. Other embodiments are possible, for example, a binocular system or two-eyepiece system having two optical paths that separately reach the two eyes can be configured to scan in a serial manner, which means scanning one eye first and then the second eye. 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, body 106 can include a single-eyepiece system, or an eyepiece system or optical path for one eye, for performing eye scanning.

[0048] Refer to Figure 1, user 114 can hold the handle 118 and position the body 106 appropriately (e.g., upward, downward, or laterally). The body 106 is at least partially supported by and connected to the zero-gravity arm 116, so the system 100 does not require a chin rest. In some embodiments, due to jaw movement, this configuration may introduce positioning errors. 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 10 mm to 30 mm, or 5 mm to 25 mm, or 5 mm to 10 mm. The proximity of the lens system to the user's eye increases the compactness of the system, reduces the position variation when the patient positions his eyes against the body (e.g., the orbital rim), and increases the viewing angle of the OCT device when imaging through an unamplified pupil. Accordingly, the body 106 may also include an eye shield 120 (e.g., a disposable eye shield), 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 114's eye socket. The eye shield 120 has a central opening (e.g., an aperture) to allow light from the light source in the instrument to pass through and reach the eye. The eye shield 120 can be made of paper, cardboard, plastic, silicone, metal, rubber, or a combination thereof. The eye shield 120 can be a flexible or semi-rigid structure that is tubular, conical, or cup-shaped with an opening at either end. Other materials, shapes, and designs are possible. In some embodiments, the eye shield 120 is made of rubber that fits around the eyepiece portion of the body 106. After the eye scan is completed, the eye shield 120 can be detached from the body 106, and a new eye shield 120 can be attached for a new user to ensure hygiene and / or prevent the spread of disease. The eye shield 120 can be transparent, translucent, or opaque, but an opaque eye shield 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, a detector, and / or an alignment system. 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 signal processing components (e.g., electronics) for performing, for example, Fourier transforms. Other types of optical coherence tomography systems may also be employed.

[0050] Figure 2FIG. shows a diagram of an exemplary optical coherence tomography system. Light 150 is output from a light source 155. The light source 155 may include a broadband light source, such as a superluminescent light emitting 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, a collimating lens is utilized to collimate the light 150 from the light source 155. The light is split 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 travels along a sample arm and directly towards a sample, such as the eye 165 of a user 114. Another portion of the light 150 travels along a reference arm and directly towards a reference mirror 170. The light reflected by the sample and the reference mirror 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)). The two-dimensional array may be included in a full-field OCT instrument, which can collect information more quickly compared to using a one-dimensional photodetector array. In time-domain OCT, the length of the reference arm (which can be determined in part by the position of the reference mirror 170) may vary over time.

[0051] Whether interference occurs between the light reflected by the sample and the light reflected by the reference mirror 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 light that has traveled a similar optical path (e.g., light with a difference less than the coherence length). The coherence length is determined by the bandwidth of the light source. A broadband light source corresponds to a smaller coherence length.

[0052] In time-domain OCT, when the relative lengths of the reference arm and the sample arm vary over time, the intensity of the output light can be analyzed as a function of time. The detected optical signal is generated by light rays scattered from the sample, and the light rays scattered from the sample interfere constructively with the light rays reflected by the reference mirror. 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. Thus, 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, this narrow depth range can move within the thickness of the sample while monitoring the intensity of the reflected light to obtain information related to the sample. The sample of scattered 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 micrometers) 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 the light reflected by the reference mirror. A spectrum of the reflected signal can be obtained. For example, the light can be input into a spectrometer or a spectrograph, which includes, for example, a grating and a detector array for detecting the 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 positions within the sample. Thus, data from multiple sample depths can be collected simultaneously without scanning the reference arm (or the 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 the light emitted from the light source varies with time. Thus, the difference in the light intensity as a function of time is related to different light frequencies. When using a spectrally time-varying light source, the detector can detect the light intensity as a function of time to obtain the spectrum of the interference signal. A Fourier transform of the spectrum as described above can be employed. Various other techniques are also possible.

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

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

[0058] The light from the light source 240 is split at a beam splitter 245. In some embodiments, the beam splitter 245 is replaced by a high-frequency switch that uses, for example, a galvanometer and that directs approximately 100% of the light to a mirror 250a during approximately 1 / 2 cycle and then approximately 100% of the light to a mirror 250b during the remaining cycle. The light source 240 can include a broadband light source, such as a superluminescent light-emitting diode. The light split at the beam splitter 245 is split again at a beam splitter 285a or 285b to form a reference arm and a sample arm. The first portion of the light split at the beam splitter 285a or 285b is reflected by a reference mirror 273a or 273b, a reference mirror 270a or 270b, and a reference mirror 265a or 265b. The second portion of the light split at the beam splitter 285a or 285b is reflected by a mirror 250a or 250b, a mirror 255a or 255b, and a mirror 260a or 260b. The mirrors 255a or 255b and the mirrors 250a and 250b are connected to a Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, the length of the sample arm is adjusted. Thus, the adjustment stage 290a or 290b can adjust the difference between the optical path from the light source 240 to a portion of the sample and the optical path from the light source 240 and the reference mirror 270a or 270b and / or the reference mirror 273a or 273b. This difference can be small, for example, less than the coherence length, facilitating 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., the reference mirror 270a or 270b and the reference mirror 273a or 273b) is also movable, or the position of one or more reference mirrors (e.g., the reference mirror 270a or 270b and the reference mirror 273a or 273b) is movable in place 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 mirror 260a or 260b is combined with the light from the display 215a or 215b at the beam splitter 230a or 230b. The displays 215a and 215b may include one or more light sources, such as a light-emitting display like a matrix LED array. Other types of displays may also be used. The display may display targets with variable shapes and configurations, including bars and / or one or more points. 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 displays 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 beams from the displays 215a and 215b, and thus the display can be used to determine the position of the eye and align the eye with the eyepiece.

[0060] As will be described in further detail below, for example, the user 114 may use the images from the display to adjust the interpupillary distance. In various embodiments, for example, the 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 controllers 235 may be used to adjust the distance between the display targets 215a and 215b and / or between the eyepieces 203. The adjustment controller 235 may be provided on the side or other location of the body 106. In a particular embodiment, the adjustment controller 204 may include a handle on the body 106 as Figure 3B shown. In this embodiment, the rotation of the adjustment controller 204 may increase or decrease the interpupillary distance.

[0061] The combined light (the light reflected by the mirror 260a or 260b and the light from the display 215a or 215b) may be focused by an adjustable powered optics (e.g., a lens) 210 and possibly in combination with an optical element 205. The adjustable optics 210 may include a zoom lens or a lens system that may have, for example, an adjustable focal length and / or magnification. The adjustable optics 210 may be part of an autofocus system or may be manually adjusted. The adjustable optics 210 may provide optical correction when such correction is needed (e.g., the user removes their glasses during testing). The position of the powered optics 210 may be based on a signal from the device, which will be described in detail below. Then, the focused light passes through an eyepiece window or lens 205 located at the proximal end of the eyepiece 203 and is directed towards the eye of the user 114. In the case where the lens 205 is included, the lens 205 may focus the light onto the eye.

[0062] Light focused onto the eye can be scattered by tissues or features within the eye. A portion of the scattered light can be reflected back into the eyepiece. Thus, lens 205 can receive light 207 reflected by the user's eye, which propagates through active optics 210 and is reflected by beam splitter 230a or 230b towards beam splitter 220a or 220b, which reflects the light towards 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 includes mirrors 273a or 273b and 270a or 270b). (Correspondingly, the sample arm includes the optical path between beam splitter 285a or 285b and beam splitter 295a or 295b, which includes mirrors 250a or 250b and 255a or 255b and the sample or the eye). The light is then reflected by mirror 255a or 255b and directed towards switch 275. In some embodiments, 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 data acquisition device 202. The switch can include a low-frequency switch such that all data collected from one eye can be acquired before collecting data from the other eye. Alternatively, the switch can 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 repositioned. Other techniques can also be used.

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

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

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

[0067] In some embodiments, computer system 104 analyzes data received by data acquisition device 202 to determine whether one or more adjustment stages 290a and / or 290b and / or active optics 210 should be adjusted. In one example, A-scans are analyzed to determine the location of the retina (e.g., a rough location), from which 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, an A-scan can be obtained by translating Z adjustment stage 290a or 290b. Similarly, the A-scan includes values of reflected signals obtained for different positions of the Z adjustment stage. The retina reflects more light than other parts of the eye, and thus, the position of adjustment stage 290a or 290b at which the retina can be imaged effectively can be determined by evaluating which depth provides an enhancement in the reflection intensity. In some embodiments, the Z adjustment stage can be translated and the intensity values can be monitored. An extended peak in intensity for a plurality of Z adjustment stage positions can correspond to the retina. Multiple different methods and values can be monitored to determine the location 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 a peak cumulative intensity. In a particular embodiment, the intensity values within an A-scan can be compared to other values and / or thresholds within the A-scan. The intensity values corresponding to the preferred location can be greater than a predetermined or relative threshold, and / or different from the remaining intensity values (e.g., larger than the latter by a specified number of standard deviations). Various methods can be employed.

[0068] After determining the positions of adjustment stages 290a and 290b, subsequent image analysis can be performed to account for vibrations or movements of the user's head, eye, or retina relative to light source 240. A feedback system such as a closed-loop feedback system can be employed to provide as stable a signal as possible in the presence of such motion. The optical coherence tomography signal can be monitored and its feedback provided to, for example, one or more translation stages to compensate for such vibrations or movements. In some embodiments, the subsequent image analysis can be based on the initial image and / or detected 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. Thus, adjustment stage 290a or 290b can be moved based on this analysis. Other methods can be used.

[0069] In some instances, optical coherence tomography signals are used to adjust the active optical device 210 to provide enhanced or improved focusing, for example, when a patient requires refractive correction. For example, many users / patients can perform the test with or without glasses. The active optical device 210 can be adjusted based on the reflected signal to determine what kind of correction to apply to enhance or improve the signal quality. Thus, 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 position among 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, the image quality. The position of the active optical device 210 can be selected based on these image quality measurement results.

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

[0071] In one embodiment, a noise value is estimated as a certain reflected light value such that approximately 75% of the measured reflected light is below the value and approximately 25% of the measured reflected light is above the value. A saturation value is estimated as a certain reflected light value such that for approximately 99% of the measured reflected light is below the value and approximately 1% of the measured reflected light is above the value. An intermediate value is defined as the average of the noise value and the saturation value. An intensity ratio is defined as the difference between the saturation value and a low value divided by the low value, then multiplied by 100. A tissue signal ratio is defined as the ratio of the number of reflected light values between the intermediate value and the saturation value to the number of reflected light values between the noise value and the saturation value. A quality value is defined as the product of the intensity ratio and the tissue signal ratio. For example, additional details are described in Stein DM, Ishikawa H, Hariprasad R, Wollstein G. Noecker RJ, Fujimoto JG, Schuman JS. A new quality assessment parameter for optical coherence tomography. Br. J. Ophthalmol. 2006; 90; 186-190. 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 tunable active optical device 210. For example, for each scan or group of scans, the active optical device can be continuously moved towards the eye in defined increments. Alternatively, the multiple positions can depend on previously determined image quality measurements. For example, if a first movement of the active optical device 210 towards the eye improves the image quality measurement, but a subsequent second movement towards the eye degrades the image quality measurement, then a third movement can be away from the eye. Thus, an optical magnification setting can be obtained to improve and / or maintain an improved signal. In some embodiments, the optical magnification setting can correspond to an optical correction and improve the focusing of the beam in the eye (e.g., in the retina).

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

[0074] Figure 4 FIG. 400 shows a block diagram of a spectrometer 400 that can be used as a data acquisition device 202 of a frequency-domain OCT system. The light 405 input to the spectrometer 400 is focused by a condenser lens 410. Then, the focused light exits through a slit 415 and is 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 concentrate the spectral distribution onto an image plane. It should be noted that other separating components such as a prism can be used to separate the light. Then, the separated light is directed towards a detector array by a focusing lens 430 to measure the spectral components of each frequency from each ray.

[0075] Various OCT designs can be adopted. For example, the frequency can vary with time. The reference and sample arms can overlap. In some embodiments, the reference arm is different from the sample arm, while in other embodiments, the reference arm and the sample arm can be shared. For example, see 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). The OCT arrangement should not be limited to those described here. Other variations are also possible.

[0076] In some embodiments, as Figure 5 shown, the body 106 includes only a single display target 215. The light from the display target 215 is separated at an X - prism 505. It should be noted that other optical devices that separate the source light into multiple rays can also be used. The separated light is reflected at a mirror 510a or 51b and directed towards the user 114.

[0077] The user can be guided to fixate on the display target 215 while one or more galvanometers 280 move the 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 an area of tissue. For example, in Figure 6A , the display target 215 can move horizontally (e.g., along a direction from the inside to the outside) to guide the patient to see from the left to the right or from the right to the left. At the same time, the vertical scanner (e.g., a galvanometer) allows the vertical position of the sample scan (e.g., from high to low) to vary with time. Figures 6A to 6CAn eye is shown, and the eye is guided to move along the 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 generate a C-scan. In some embodiments, continuous and / or regularly formed pattern 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 such that the user 114 keeps their eyes fixated 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 a vertical and a horizontal scanner simultaneously, the user 114 can move their eyes in the horizontal direction, thus eliminating the need for a horizontal scanner.

[0078] Figure 6B An example of an A-scan is shown. The A-scan includes signal intensity (indicated by brightness) as a function of depth for one horizontal and vertical position. Thus, an A-scan includes a plurality of intensity values corresponding to different anterior and posterior positions. A plurality of A-scans make up a B-scan. Figure 6C A B-scan is shown, where 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] Referring to Figure 7A , in which an enlarged view of an embodiment of the body 106 is schematically shown. The body 106 is configured with a handle 118 for adjusting the eyepieces to suit the user's pupil distance. In the schematic embodiment, the body 106 includes a left eyepiece 712 and a right eyepiece 714, each of which is connected to the other by a pupil distance adjustment device 718. The pupil distance adjustment device 718 is coupled to the handle 118, and the handle 118 is configured to allow the user to adjust the distance between the left eyepiece 712 and the right eyepiece 714 through the handle 118 to match or adequately suit the pupil distance between the user's eyes.

[0080] Referring to Figure 7A, the user can rotate, spin, or twist the handle 118 to adjust the distance between the left eyepiece 712 and the right eyepiece 714, so as to match or adequately 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 back and forth 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 user-activated motor. 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 the appropriate positions to match the pupil distance between the user's eyes. In these instances, the systems described herein can include an eye tracking device. In other embodiments, the foregoing combinations are utilized to adjust the distance between the left eyepiece 712 and the right eyepiece 714 to match or adequately adapt to the user's pupil distance.

[0081] The user 114 can adjust the pupil distance based on the user's observation of one or more fixation targets on one or more displays 215. For example, the displays 215 and the fixation targets can be configured such that when the pupil distance is appropriate for the user 114, the user can observe two aligned images that can form a single complete image. As Figure 7A shown, the user 114 can adjust (e.g., rotate) the adjustment controller 204 based on the fixation target image to change the pupil distance. Figures 7B to 7F Schematically illustrates an embodiment of a fixation target seen through an observer under multiple conditions. However, other fixation targets are also possible, including a fixation target in a square pattern, but not limited thereto. Figure 7B Shows a U-shaped fixation target 715a on the display 215a for the left eye. Figure 7C Shows an inverted U-shaped fixation target 715b on the display 215b for the right eye.

[0082] When the pupil distance is appropriately adjusted, the bottom and top images 715a and 715b are aligned, as Figure 7D shown, forming a complete H-shaped fixation target 715. When the pupil distance is too narrow, the fixation target 715a that appears on the display 215a for the left eye shifts to the right, and the fixation target 715b that appears on the display 215b for the right eye shifts to the left, and the user sees Figure 7EThe image shown. Conversely, when the interpupillary distance is too wide, the fixation target 715a that appears on the display 215a for the left eye is shifted to the left, and the fixation target that appears on the display 215b for the right eye is shifted to the right, and the user sees Figure 7F The image shown. Therefore, the interpupillary distance can be adjusted based on these images.

[0083] Specifically, in Figure 7D , the aligned image 715 is in the shape of an "H". Therefore, when the interpupillary distance is appropriately adjusted, the fixation targets overlap on the left and right displays to form an "H". Other aligned images 715 can be provided.

[0084] Referring to Figure 8 , an embodiment of the computer system 104 is illustrated. In the illustrated embodiment, the computer system 104 may include a scan control and analysis module 824 configured to control the scan operation performed by the subject 106. The computer system 104 may also include a fixation marker control system 822 configured to display a fixation marker that can be seen by the user from the subject 106. In a particular embodiment, the fixation marker is displayed as an "X", a dot, a square, etc. The fixation marker may be configured to move in a horizontal, vertical, diagonal, circular, or a combination thereof manner. When the eyes reposition themselves, the fixation marker 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 focusing lens in the subject 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] Referring to Figure 8, in the illustrative embodiment, 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 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. Computer system 104 may also include an image / scan database configured to store images and / or scans generated for a plurality of users by subject 106 and to 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 assist in generating a risk assessment and / or diagnosis of a user's eye disease.

[0086] In Figure 8 the illustrative embodiment shown, 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, residential address, office address, unique identifier, age, affiliated physician, telephone number, email address, social security number, race, gender, eating habits and related information, lifestyle and / or exercise history information, use of corrective lenses, family medical history, medical and / or ophthalmic history, prior treatments, or other similar user information. Computer system 104 may also include a physician referral database for storing and accessing physician information such as physician name, physician training and / or specialty / expertise, physician office address, physician telephone number and / or email address, physician schedule, physician rating or quality, physician office hours, or other physician information.

[0087] Referring to Figure 8, the computer system 104 may also include a user interface module 805 (which may include, but is not limited to, the general 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 a particular embodiment, the user interface module 805 is configured to indicate and / or guide the user in using and / or positioning the body 106 of the optical coherence tomography system 100. The computer system 104 may also include a reporting / output module 806, configured to generate, output, display, and / or print a report (e.g., Figure 10A and Figure 10B ), the report including a 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] Refer to Figure 8, the computer system 104 may also include an authentication module 816 that interfaces with the user card reading system 112, into which a user may insert a user identification card. In a particular embodiment, the authentication module 816 is configured to authenticate the user by reading data from the identification card and compare that information with data stored in the user / patient database 802, and / or store that information in the user / patient database 802. In a particular embodiment, the authentication module 816 is configured to read or obtain the user's insurance information from the user's identification card via the user card reading system 112. The authentication module 816 may be configured to compare the user's insurance information with data stored in the 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 messages and / or charge sheets to the user's insurance company and / or the equipment 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 to, for example, perform the test being conducted or receive the output from the machine. In other embodiments, the billing module 810 is configured to communicate with the user interface module 805 to request payment from the user for all or some (e.g., self-pay) of the costs associated with performing the scan. In a particular 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 draw on the credit stored on the user identification card. Alternatively, the billing system 810 is configured to receive payment from the user by receiving paper currency, coins, vouchers, etc. via a communication and / or control interface device. 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 protocol / channel to obtain credit card information, billing address, or to charge the user's mobile network service account (e.g., cellular carrier network).

[0089] Referring to 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 directly print (on the surface of the card) or store (in the chip or magnetic stripe) the scan results, risk assessments, and / or reports 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 particular embodiment, the system (e.g., the scan analysis module 824) performs the calculation of the risk assessment. In a particular embodiment, the calculated risk assessment is transmitted to a central server system (e.g., the remote system 110) located at another location, and the remote system provides the results to physicians, users, patients, etc. via a web page. The central server system (e.g., the remote system 110) allows users, patients, or doctors to enter their card codes to view the results stored in the central database.

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

[0091] Referring to Figure 8 , the remote system 110 can be configured to remotely perform (based on immediate, delayed, and / or batch processing) 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 the 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 via the computer system 104. The remote system 110 can also be configured to transmit the risk assessments, diagnoses, and / or reports to the user's (or doctor's) mobile phone, computer, email account, fax, etc. via a network or communication medium.

[0092] Referring to Figure 9, which schematically illustrates a method for using an optical coherence tomography analysis system 100 to control an OCT scan of a user's eye and obtain a risk assessment or diagnosis of various diseases and ailments. The process begins at block 901, where the user approaches the optical coherence tomography analysis system 100 and activates the system by, for example, pressing a certain button or entering an activation code or an anonymous identification number. In other embodiments, the user interface module 805 instructs the user at block 901 to first insert an identification card or an anonymous coding protection card into the user card reading system 112 to activate the system. The system can also be activated at block 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 actuation devices for detecting the presence of the user, but not limited to these. Alternatively, when the billing module 810 detects that the user has inserted banknotes, coins, vouchers, etc. into an interface device configured to receive such payments, the optical coherence tomography analysis system 100 can be activated. Alternatively, the billing module 810 can also be configured to: activate the optical coherence tomography analysis 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 charges the user's mobile network service account (e.g., a cellular carrier network).

[0093] Referring to Figure 9 Block 902 of, the user interface module 805 is configured to guide the user to attach a disposable eye mask to the body 106, and then bring the body 106 with the disposable eye mask close to the user's eye and / or support the disposable eye mask close to the user's eye socket. 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 sufficiently accommodate Figures 6A to 6C the pupil distance of the user as described. After the user has properly calibrated and / or adjusted the body 106 and the pupil distance, the user inputs to the user interface module 805 or instructs the user interface module 805 to start the scan. 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 start the scan.

[0094] Referring to Figure 9, the Z-module 818 automatically adjusts the z-offset in the body 106 at block 906 in order 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 that position. Those skilled in the art will recognize that there are multiple ways to perform such adjustments. For example, the Z-module 818 can include a motor such as a piezoelectric motor to longitudinally translate a reference mirror such that the optical path length from the beam splitter to the retina is approximately equal (within one coherence length) to the optical path length within the reference arm. This movement can cause light from the reference arm to interfere with light reflected from the desired portion of the sample (e.g., the retina). At block 908, the illustrative method uses a focal length adjustment module 820 to perform a focal length adjustment. Those skilled in the art will recognize that there are different techniques to perform such autofocus calibration. Block 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 in conjunction with or is combined with the fixation marker control system 722 and can test both eyes simultaneously or one eye at a time. For example, the fixation marker initially appears small and then gradually increases in size until the user indicates via the user interface module 705 that the fixation marker is visible. Based on the size at which the user can clearly see the fixation marker, the fixation marker control system 722 can estimate or determine or evaluate the visual acuity of the user's eye (e.g., 20 / 20, 20 / 40, etc.).

[0095] Referring Figure 9 to block 912 in, the user interface module 805 instructs the user to track the movement of a fixation marker visible to the user from the body 106. In one embodiment, the fixation marker controller 822 is configured to display a horizontally moving fixation marker. In some embodiments, the horizontal movement of the fixation marker allows the scan control and analysis module 824 to vertically scan the eye as the eye moves horizontally, and thus a two-dimensional, stereoscopic, or raster scan of the problematic eye tissue can be obtained. Alternatively, the scan control and analysis module 824 and / or the fixation marker controller can cause the fixation marker or the beam to jump or move back and forth to obtain measurements at different lateral positions on the eye.

[0096] During the scanning of the eye, the scan control and analysis module 824 can be configured to detect whether the position of the subject 106 at box 913 has shifted relative to the user. In one embodiment, the scan 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 values that the module 824 expects to receive during the scan. For example, when the scan control and analysis module 824 scans the retina, the module 824 expects to detect a change in the signal (e.g., based on the position of the fixation target and / or the state of the scanner) as the scan approaches the optic nerve. Alternatively, the expected value or the expected change in value can also be determined or generated using a nomogram. If the system does not detect the 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 tracking properly. Other features such as the fovea of the retina can be used to determine whether the expected signal is observed. If improper tracking occurs frequently enough (e.g., based on a threshold determination), the system 100 can request the user to re-fixate (using the fixation marker controller 822) for another scan. If the foregoing shift detection process does not occur in real time or substantially in 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 shift has occurred during the scan. If it is detected that a shift has indeed occurred, the user can be instructed (using the user interface module 805, via visual, audible, or verbal indication) to sit forward again to perform another scan. If the system detects 2 or 3 or more shifts, the system can be configured to advise 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 applicable to the patient. For example, if the patient has eccentric fixation, the confidence value will be lower than that of a patient with good fixation.

[0098] In a real-time embodiment, the system can be configured to perform a fast cross-correlation between adjacent A-scans or B-scans to ensure that the eye moves slightly. In some embodiments, the foregoing is beneficial to the ANSI laser safety standard to prevent the user from staring at the same position on the user's retina where the laser energy bombards. Accordingly, in some embodiments, if the system fails to detect eye movement (e.g., the cross-correlation exceeds a specific threshold), the system is equipped with a laser timeout feature. In some embodiments, to accelerate 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 fixation problem is detected, the scan control and analysis module 824 completes the scan of the user's eye, 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 A-scan group, some or all of the B-scans, or some or all of the C-scan data may be analyzed.

[0100] As used herein, the term "nomogram" generally refers to a prediction tool, algorithm, and / or dataset. A nomogram can generally provide a prediction for a user based on a comparison of the user's characteristics to the nomogram. A 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 characteristics. Accordingly, in some cases, the nomogram can provide a personalized prediction related to the risk grouping of a patient population sharing similar disease characteristics. In some embodiments, the nomogram can be used to provide a risk estimate or assessment on a scale of 0 - 100%. Alternatively, the nomogram as used herein can provide an expected value, e.g., at a certain location in the eye, the expected eye thickness value is 100 microns.

[0101] Generally, nomograms have been developed and validated in a large number of patients and are highly generalizable. Thus, 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 disease. In addition, the nomograms as used herein can assist physicians in clinical diagnosis and provide consistent, standardized, reliable predictions.

[0102] In Figure 9 the schematic method shown at block 917, as Figure 10A and Figure 10BAs shown, an eye health assessment or an eye health level report for a user is generated by accessing a disease risk assessment / diagnosis database 808. At block 918, a physician recommendation database 804 is accessed to generate a recommendation as to when the user should visit a 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 a patient. The physician recommendation list can be randomly generated or selected based on a referral fee paid by the physician, an 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 block 919, the report is displayed to the user by using a report / output module 806 and an output device 102. In a particular embodiment, the report data is stored in a user / patient database 802 for future analysis or for comparative analysis with future scans.

[0103] In some embodiments, the body 106 is not supported by the user 114. For example, as Figure 10A shown, the body 106 can be supported by a freestanding structure. The user 114 can look into the eyepiece. The user 114 can sit on a seat device that can include a height-adjustable mechanism. The body 106 can be supported by a height-adjustable support.

[0104] In some embodiments as Figures 10B to 10C shown, a strap 1005 is connected to the body 106. As Figure 10B shown, the strap can serve to support all or part of the body 106. In some embodiments, the strap 905 can be excluded. 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 of the optical elements are contained within the body 106 directly or indirectly supported by the user 114. For example, Figure 10B the body 106 in Figure 10C can include an optical coherence tomography system, an alignment system, and a data acquisition device. The data acquisition device can wirelessly send data to a network or computer system, or can use a cable to transmit control signals. Figure 10C Similar to Figure 1 and 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 some embodiments as Figure 10DIn some of the illustrated embodiments, a user wears an object 1010 connected to an eyepiece. The wearable object 1010 can 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 spectacle frame such as glasses worn by the user. The wearable object 1010 can fully or partially support the body 106 and / or can help to align the body 106 with one or both eyes of the user 114.

[0106] Referring Figure 11A and Figure 11B , two exemplary embodiments of an eye health grade and an eye health assessment report are illustrated. Referring Figure 11A , the eye health grade report can unrestrictedly include numerical and / or alphabetical grades for each eye of the user for various eye health categories, including macular health, optic nerve health, eye clarity, etc., but not limited thereto. The eye health grade report can also include at least one recommendation to see a doctor or consult a doctor within a specific time period, and can provide at least one possible doctor for contact. The data for generating the recommendation information and the list of recommended doctors is stored in the doctor recommendation database 804. Referring Figure 11B , the eye health assessment report can include a graphical representation for each eye of the user for various eye health categories. The report can be presented to the user via an electronic display, printed on paper, printed on a card inserted by the user into a machine, electronically stored on the user identification card, sent to the user via email, or a combination thereof.

[0107] Referring Figure 12 , another embodiment of a computer system 104 is illustrated, which is connected to a remote system 110 and a billing / insurance claim and payment system 1201. The billing module 810 can be configured to communicate with the billing / insurance claim and payment system 1201 via a communication medium 108 to request or process an insurance claim for performing a scan of the user's eyes. Based on the communication with the billing / insurance claim 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 out-of-pocket amount to be charged to the consumer. In a particular 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 a doctor. The computer system 104 or the remote system 110 can be configured to send a reminder to the user via email, text message, ordinary mail, automated phone message, etc.

[0108] Computer system

[0109] In some embodiments, the above systems, computer clients, and / or servers takeFigure 13 in the form of the illustrated computing system 1300 Figure 13 is a block diagram of an embodiment of a computing system (which may be a stationary system or a mobile device) that communicates via one or more networks 1310 with one or more computing systems 1310 and / or one or more data sources 1315. The computing system 1300 can be used to implement one or more of the systems and methods described herein. Additionally, in one embodiment, the computing system 1300 can be configured to process image files. Although Figure 13 illustrates an embodiment of the computing system 1300, it should be understood that the functions provided in the components and modules of the computing system 1300 can be combined into fewer components and modules, or further divided 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 can be executed on the computing system 1300 by a central processing unit 1304, which will be further discussed below.

[0112] Computing system components

[0113] In one embodiment, the processes, systems, and methods illustrated above can be embodied, in part or in whole, as software running on a computing device. The functions provided in the components and modules of the computing device can include one or more components and / or modules. For example, the computing device can include multiple central processing units (CPUs) and mass storage devices, such as can be implemented as an array of servers.

[0114] In general, the term "module" as used herein refers to logic embodied in hardware or firmware, or a collection of software instructions, and may have entry and exit points written in a programming language (e.g., Java, C, or C++). Software modules may be compiled and linked into an executable program, installed in a dynamic link library, or may be written in an interpreted programming language such as BASIC, Perl, Lua, or Python. It should be understood that software modules may be called by other modules or by themselves, and / or may be called in response to detected events or interrupts. Software instructions may be embedded in firmware such as an EPROM. It will be further understood that hardware modules may include connecting logic units such as logic gates and flip-flops, and / or may include programmable units such as programmable gate arrays or processors. The modules described herein are preferably implemented as software modules, but may be represented in hardware or firmware. In general, the module descriptions herein refer to logical modules that may be combined with other modules or divided into sub-modules, regardless of their 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 a large number of transaction processes, and generating reports from the large database. Computing system 1300 also includes a central processing unit ("CPU") 1304, which may include a conventional microprocessor. Computing system 1300 also includes a memory 1305 such as random access memory ("RAM") for temporarily storing information and read-only memory ("ROM") for permanently storing information; and a mass storage device 1301 such as a hard disk, magnetic disk, or optical media storage device. In general, the modules in computing system 1300 are connected to the computer using a standard bus-based system. In different 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] Example computer system 1300 includes one or more commonly available input / output (I / O) devices and interfaces 1303, such as a keyboard, mouse, touchpad, and printer. In one embodiment, the I / O devices and interfaces 1303 include one or more display devices such as a monitor to allow data to be presented to a user via a visual display. More specifically, the display device provides, for example, the presentation of a GUI, application software data, and multimedia presentations. In Figure 13In an embodiment, the I / O device and interface 1303 also provide a communication interface 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 device / operating system

[0118] The computing system 1300 may run on various computing devices, such as servers, Windows servers, Structured Query Language servers, Unix servers, personal computers, computer mainframes, laptops, mobile phones, personal digital assistants, public telephone booths, audio players, and so on. 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 systems. In a Macintosh system, the operating system may be any available operating system, such as Mac OS X. In other embodiments, the computing system 1300 may be controlled by a proprietary operating system. Traditional operating systems control and schedule computer programs for execution, perform memory management, provide file systems, networking, and I / O services, and provide user interfaces such as graphical user interfaces (“GUIs”).

[0119] Network

[0120] In Figure 13 an embodiment, the computing system 1300 is coupled to a network 1310 via a communication link 1315, such as a wired, wireless, or a combination of wired and wireless, for example, using a modem system for 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. In Figure 13 an example embodiment, the network 1310 communicates with one or more computing systems 1317 and / or one or more data sources 1319.

[0121] Access to the remote computing system 1317 and / or data source 1319 by the image processing and analysis module 1306 in the computing system 1300 can be through a web-enabled user access point such as a personal computer, mobile phone, laptop, or other device capable of connecting to the network 1310, such as the computing system 1317 or data source 1319. Such a device can have a browser module implemented as modules using 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 addressable displays, such as a cathode ray tube (CRT), liquid crystal display (LCD), plasma display, or other types, and / or a display combination. In addition, the browser module or other output module can be implemented to communicate with the input device 1303 and can also include software with an appropriate interface that enables a user to access data by using stylized screen elements such as menus, windows, dialog boxes, toolbars, and controls (e.g., radio buttons, check boxes, sliders, 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 can include a keyboard, trackball, pen and stylus, mouse, trackpad, voice recognition system, or pre-specified switches or buttons. Output devices can include speakers, displays, printers, or voice synthesizers. In addition, a touch screen can be used as a hybrid input / output device. In another embodiment, the user can interact with the system more directly, for example, through a system terminal connected to a fraction generator, without using the Internet, WAN, or LAN, or a similar network.

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

[0125] In certain embodiments, the computing system 1317 within the entity operating the computer system 1300 can access the image processing and analysis module 1306 as an application or process running on 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 of personal computers, interactive public telephones, personal digital assistants, interactive wireless communication devices, handheld computers, embedded computing devices, and the like.

[0128] Other systems

[0129] In addition to the Figure 13 systems shown, network 1310 may communicate with other data sources or other computing devices. The computing system 1300 may also include one or more internal and / or external data sources. In some embodiments, one or more data warehouses and data sources may be implemented by using relational databases such as DB2, Sybase, Oracle, CodeBase, and SQLServer, and other types of databases such as flat file databases, entity relationship databases, object-oriented databases, and / or record-based databases.

[0130] Referring to Figure 14A , an example method for determining or generating a risk assessment for a disease such as an eye disease, so as to be able to generate a health level and a recommended time to see a doctor, is illustrated. Figure 14A The example shown is for retinal diseases. However, the processes and methods illustrated 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 A-scan data derived from the subject 106. This data may include A-scan data from different A-scans, but is not limited thereto. The scan control and analysis module 824 may also be configured to access the data and algorithms in the disease risk assessment / diagnosis database 808 to calculate a risk assessment of retinal diseases as schematically shown by the function curve in Figure 14A . The report / output module 806 may be configured to normalize the calculated risk assessment value to an eye health letter or numeric grade or score. The report / output module 806 may also be configured to access the data and algorithms in the physician recommendation database 804 to calculate a recommended time to see a doctor based on the calculated risk assessment value.

[0131] Referring to Figure 14B, which illustrates another example method or process for determining or generating a disease risk assessment result by comparing scan data with 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 in the form of a nomogram. In a particular embodiment, the system is configured to generate scan data for a scanned eye portion to determine the retinal thickness at any point, and compare such data with a histogram and / or nomogram (e.g., showing the expected thickness or the probability of disease for a given thickness at the location) to obtain a risk assessment. The system may also be configured to generate an average thickness for the entire scanned retina and compare this data with 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 for 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 at which the points occur is represented by rectangular columns or the position of the points; the height of the columns and / or points along the Y-axis is proportional to, or represents, the observed frequency within that range or interval. The "histogram" involved herein may include, for example, measurement data obtained by scanning a user's eye, or may include data obtained from a large population. The histogram in the former case can be analyzed to determine the mean, minimum, or maximum values, 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 can be used to determine the frequency at which the measured values are observed in the survey sample.

[0133] In an example of deriving an average thickness value 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, the maximum thickness value may be required to detect abnormal thickening in the retina. In some embodiments, the maximum thickness value may be caused by partitioning errors. Accordingly, a more reliable way to determine the maximum value may also use the value corresponding to the maximum thickness of 95% (or any value between 75% and 99%). The foregoing can 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 has a macular hole, there is only a small area with zero thickness, and it may not be sufficient to significantly reduce the average thickness, but this is certainly an abnormal condition that can be detected.

[0134] In other embodiments, the system can be configured to create histograms of measured thickness and / or measured intensity values and / or the slope or derivative of intensity values and / or variables used to identify anomalies. For example, a change or significant change in slope (calculated as the derivative of adjacent intensity values) can indicate low-reflectance or high-reflectance structures, which may not affect the average intensity value but can indicate disease or severity. For example, the system can determine whether the distribution of retinal thickness over the measured retinal portion matches the distribution in the normal population. Deviation from this "normal" histogram can 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 of macular lesions based on a comparison of, for example, abnormal thickening of the retina or fovea, the presence of high-reflectance (bright or high-intensity) or low-reflectance (dark or low-intensity) structures in the outer half of the retina, the presence of low-reflectance (dark) structures in the inner half of the retina, irregularities in the contour of the retinal pigment epithelium deviating from the normal curvature of the eye, or high transmittance of light through the retinal pigment epithelium with normal values stored, for example, in a disease assessment / diagnosis database 708.

[0136] As described above, there are several ways to detect or generate a risk assessment for several diseases or severities. In a particular embodiment, the scan data is compared with data found in the 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 the diseased population to identify similarities or differences with a nomogram and / or histogram. Specific disease characteristics can be indicated by a likeness to a nomogram (such as an image, histogram, or other data from a patient).

[0137] In one embodiment, "normal" data (e.g., a histogram) is created for the retinal thickness in each region of the retina (optic nerve, fovea, temporal retina), and the measured, detected, scanned, or encountered values are compared to this "normal" data (e.g., histogram) to determine the relative risk of retinal or other diseases. The same can be done 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 a risk assessment for glaucoma is performed or generated by analyzing collinear A-scan data to see if the curve thinning indicates the presence of glaucoma. The NFL radiates radially around the optic nerve in a curved manner, like iron filings around a magnet. Measuring and analyzing a sequence of A-scan data following this curved path may help identify the thinning characteristic of glaucoma. The analysis can focus on and / or around the optic nerve, or on and / or around the fovea or elsewhere. In another embodiment, the detection or generation of a 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 nerve head.

[0138] The system can also be configured to detect and / or generate a risk assessment for optical clarity, where the system integrates the A-scan data in the Z direction and compares some or all of the A-scan data to nomogram values (or, e.g., a histogram). Generally, darker A-scans will likely indicate the presence of media opacities (e.g., cataracts) that reduce optical clarity (thus increasing the risk that the subject has an optical clarity problem such as a cataract).

[0139] The system can also be configured to detect a risk assessment for 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 differences between these curves. For example, with respect to Figure 15 , the system can be configured to subtract the 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 to values from normal and / or diseased eyes (e.g., values in a graph or nomogram) to generate a diagnosis or risk assessment. The foregoing methods and processes are similar to tortuosity measurements in that bumpy RPE detections typically have a greater offset relative to the polynomial curve compared to smooth RPE measurements, which are common in young, healthy populations.

[0140] This RPE detection can also be used to detect increased transmission of the RPE that is substantially synonymous with RPE degradation or atrophy. In a particular embodiment, the system can be configured to analyze tissue layers above or below the RPE layer. Imaging segmentation techniques can be used to segment the RPE layer. In a particular embodiment, the system can be configured to sum all intensity values below the RPE detection. When atrophy occurs, there are typically many higher values below the RPE line, which will make the overall value higher and may increase the risk that the patient has a severe macular disease such as geographic atrophy.

[0141] Referring Figure 16 , the system can also be used to detect or generate risk factors for abnormal intensities within the retina. In a particular embodiment, the system can be configured to divide the retina into an inner half 1602 and an outer half 1604 based on a midpoint between the inner limiting membrane (ILM) detection 1606 and the RPE detection line 1608. In some instances, a blur filter (e.g., Gaussian blur, radial blur, etc.) is applied to the retinal tissue to remove speckle noise and / or other noise. For each of the inner and outer retinal regions, a first derivative of the intensity value (with respect to position, e.g., d / dx, d / dy, etc.) can be calculated to determine the slope of the curve to distinguish regions with large changes from dark to light (or from light to dark) in the lateral dimension of the tissue. 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 may be the cause of diabetic retinopathy, or a diabetic complication that damages the retina), or age-related macular degeneration.

[0142] Data from normal patients can be used to edit the histogram of intensity and / or slope (derivative) data to indicate the expected values for the normal population. Data from populations with various diseases can be placed in the histogram of intensity and / or derivative (slope) values to indicate the expected values for the diseased population. In a particular embodiment, the relative risk will be displayed for each entry on the histogram so that the risk can be applied to unknown cases. For example, in some instances, a person with 10% of the outer retinal intensity values equal to zero has an 85% chance of having a retinal problem. Therefore, these users can receive a health grade of 15. In another example, anyone with an inner retinal point less than 10 has a 100% chance of being diseased, so these users will receive a health grade 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 with a database of normal and abnormal values stored in disease risk assessment / diagnosis data 708. Similarly, to detect or perform a risk assessment for uveitis, a histogram of desired intensity values, for example, on the inner surface of the retina (vitreous) may be used. The presence of large bright spots (e.g., high intensity regions) within the vitreous cavity will indicate possible uveitis and will likely indicate a need for referral. The foregoing methods and processes may also be used to determine or generate a risk for an eye disease based on comparing the intensity levels of the image signal with a database of normal and abnormal values stored in disease risk assessment / diagnosis 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 highly reflective features within the vitreous cavity with a database of normal and abnormal highly reflective features stored in disease risk assessment / diagnosis data 708. The foregoing methods and processes may also be used to determine or generate a risk assessment for early eye diseases based on the detection of specific disease features such as cystoid macular degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, retinal pigment epithelial detachment, and / or atrophy of the retinal pigment epithelium, where the detected features are compared with such specific disease features stored in disease risk assessment / diagnosis data 708. In a particular embodiment, the system is configured to perform template matching, where the system detects characteristics from an A-scan (also referred to as an unknown A-scan) generated by scanning a user and compares and / or matches it with a database of patterns known to be associated with disease features such as subretinal fluid.

[0145] Referring to Figure 1 , Figure 8 and Figure 9, the optical coherence tomography analysis system 100 is configured to enable a user to self-manipulate an OCT scan of the user's eye without dilating the eye, obtain a risk assessment or diagnosis of various diseases and ailments without the involvement of a doctor and / or technician to align the user's eye with the system, manipulate 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 analysis 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 analysis system 100. The optical coherence tomography analysis system 100 with a binocular system is faster because it can scan both eyes without repositioning, and enables the optical coherence tomography analysis system 100 to scan the eye with poorer vision of a person because the eye with poorer vision will follow the eye with better vision when the person with better vision tracks a fixation marker. Accordingly, the optical coherence tomography analysis system 100 reduces the cost of performing an OCT scan, thereby enabling more people and / or users to have an OCT scan and preventing millions of people from losing their vision due to eye diseases or ailments that can be prevented through early detection. In one embodiment, the optical coherence tomography analysis system 100 is configured to be small and / or portable so that such an optical coherence tomography analysis 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, the office of a general practitioner or other doctor, so that people can use the optical coherence tomography analysis system 100 without seeing a doctor.

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

[0147] Although the invention has been discussed with respect to specific embodiments, it should be recognized that the invention is not limited thereto. Here, the embodiments are presented as examples and various modifications, variations, and other embodiments can be employed, which still fall within the scope of the invention.

[0148] For purposes of this disclosure, specific aspects, advantages, and novel features of the invention are described herein. It is to be understood that, in accordance with any particular embodiment of the invention, not all of these aspects, advantages, and features need to be employed and / or achieved. Thus, for example, those skilled in the art will recognize that the invention may be embodied or implemented in a manner that achieves one advantage or a group of advantages taught herein, without necessarily achieving other advantages taught or suggested herein.

Claims

1. A method for controlling an optical coherence tomography (OCT) scan, the method comprising: positioning an OCT device on at least one user's eye, wherein the positioning is performed by the user; and activating, by the user, the OCT device to start the OCT scan, wherein the OCT device is configured to scan the at least one user's eye, and wherein the OCT device comprises: at least one eyepiece for allowing light to enter the at least one user's eye and receiving light from the at least one user's eye; a light source for outputting light that passes through the at least one user's eye; an interferometer configured to generate optical interference using light reflected from the eye of an object; and an optical detector arranged to detect the optical interference.

2. The method according to claim 1, further comprising displaying a first target display and a second target display to the object through the eyepiece.

3. The method according to claim 1, further comprising automatically focusing the device.

4. The method according to claim 1, wherein, the OCT device is activated by a button, a keyboard, a switch, a touchpad, a touch sensor, a foot switch, a knob, a rotary handle, or a microphone.

5. The method according to claim 1, wherein, activating the device comprises the user inputting an input.

6. The method according to claim 1, wherein, activating the device comprises the user triggering an actuating device, wherein the actuating device is configured to detect the presence of the user near the OCT device.

7. The method according to claim 1, wherein, activating the device comprises the user interfacing with the user's mobile device using an interface module.

8. An OCT system for providing self-controlled scanning, the system comprising: an eyepiece for receiving at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters the at least one eye of the user; an interferometer configured to generate optical interference using light reflected from the at least one eye of the user; an optical detector arranged to detect the optical interference; and an electronic device coupled to the detector and configured to provide an output based on OCT measurement results obtained using the interferometer; wherein the scan is configured to be activated by the user.

9. The OCT system according to claim 8, further comprising a first target display and a second target display visible to the object through the eyepiece.

10. The OCT system according to claim 8, further comprising an autofocus lens configured to focus the device.

11. The OCT system according to claim 8, wherein the scan is configured to be activated by the user by a button, a keyboard, a switch, a touchpad, a touch sensor, a foot switch, a knob, a rotary handle, or a microphone.

12. The optical coherence tomography analysis system according to claim 8, wherein, the scan is configured to be voice-activated by the user.

13. The optical coherence tomography analysis system according to claim 8, further comprising: an actuating device configured to detect the presence of the user near the optical coherence tomography analysis system, and the scan is at least partially activated based on an indication of the presence of the user near the optical coherence tomography analysis system.

14. The optical coherence tomography analysis system according to claim 8, further comprising: a billing module configured to: receive payment from the user; and activate the scan at least partially based on the payment from the user.

15. The optical coherence tomography analysis system according to claim 8, further comprising: a billing module configured to: interface with the user's mobile phone; and obtain user data at least partially based on the interface with the user's mobile phone.

16. The optical coherence tomography analysis system according to claim 8, further comprising an input device for receiving location information of the optical coherence tomography analysis device, and wherein, a part of the list is selected at least partially based on the location information.

17. The optical coherence tomography analysis system according to claim 8, wherein, the electronic device is configured to automatically perform a diagnosis based on the optical coherence tomography analysis measurement results obtained using the interferometer.

18. The optical coherence tomography analysis system according to claim 17, wherein, the electronic device is configured to automatically perform the diagnosis by transmitting the optical coherence tomography analysis measurement results to a remote system via a network, and the remote system is configured to perform a diagnosis based on the optical coherence tomography analysis measurement results.

19. The optical coherence tomography analysis system according to claim 8, further comprising a memory including statistical information correlating optical coherence tomography analysis measurement results with the risk of at least one disease.

20. The optical coherence tomography analysis system according to claim 19, wherein, the electronic device is configured to access the memory to compare data obtained based on the optical coherence tomography analysis measurement results of the user's eyes using the interferometer with the statistical information to provide an assessment of the risk that the user has the at least one disease.

21. The optical coherence tomography analysis system according to claim 8, further comprising a memory including a table associating disease risk with time information for consulting a healthcare provider.

22. The optical coherence tomography analysis system according to claim 8, wherein, the electronic device is configured to perform an assessment of visual acuity.

23. An optical coherence tomography analysis device, comprising: an eyepiece for accommodating at least one eye of a user; a light source for outputting light that passes through the eyepiece and enters 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 perform an analysis based on optical coherence tomography measurement results obtained using the interferometer to determine the likelihood of having a disease.

24. The optical coherence tomography device according to claim 23, further comprising an output device electrically coupled to the electronic device, the output device being configured to provide an output to the user via the output device based on the likelihood of having the disease.

25. The optical coherence tomography device according to claim 23, further comprising an output device electrically coupled to the electronic device, the output device being configured to provide an output via a network through the output device based on the likelihood of having the disease.

26. The optical coherence tomography device according to claim 23, further comprising an output device electrically coupled to the electronic device, the output device being configured to warn the user.

27. The optical coherence tomography device according to claim 23, wherein, the electronic device is configured to perform the analysis by transmitting the optical coherence tomography measurement results to a remote system via a network, the remote system being configured to perform a risk analysis based on the optical coherence tomography measurement results.

28. The optical coherence tomography device according to claim 23, further comprising a memory storing a plurality of processing instructions for instructing the electronic device to perform the analysis.

29. The optical coherence tomography device according to claim 23, wherein, the electronic device determines the risk of macular lesions based on the detection of special disease characteristics such as cystoid macular degeneration, outer retinal edema, subretinal fluid, subretinal tissue, macular hole, drusen, retinal pigment epithelial detachment, or retinal pigment epithelial atrophy.

30. The optical coherence tomography device according to claim 23, wherein, the electronic device determines the risk of glaucoma based on an abnormal pattern of thinning of the macula and / or peripapillary nerve fiber layer or an enlarged excavation of the optic nerve head.

31. The optical coherence tomography device according to claim 23, wherein, the electronic device determines the risk of early eye diseases based on the luminance level of the image signal.

32. The optical coherence tomography device according to claim 23, wherein, the electronic device determines the risk of uveitis based on abnormally highly reflective features in the vitreous cavity.

33. The optical coherence tomography device according to claim 23, wherein, the electronic device is configured to perform an assessment of visual acuity.

34. The optical coherence tomography device according to claim 23, wherein, the electronic device provides a grade associated with the risk level of a specific disease.

35. The optical coherence tomography device according to claim 23, wherein, the output includes a recommendation to visit a doctor.

36. The optical coherence tomography device according to claim 23, further comprising an input device for receiving location information of the optical coherence tomography device, and wherein, a part of the list is selected at least in part based on the location information.

37. The optical coherence tomography analysis device according to claim 23 further includes a memory including statistical information correlating the optical coherence tomography measurement results with the risk of the disease.

38. The optical coherence tomography analysis device according to claim 37, wherein, the electronic device is configured to access the memory to compare data obtained based on the optical coherence tomography measurement results of the user's eyes using the interferometer with the statistical information.

39. The optical coherence tomography analysis device according to claim 23 further includes a memory including a table correlating disease risk with time information for consulting a healthcare provider.

40. An optical coherence tomography analysis device, comprising: a first eyepiece and a second eyepiece for accommodating the binoculars of an object; a light source configured to output light that passes through the first eyepiece and the second eyepiece and enters the eyes of the object; an interferometer configured to generate optical interference using light reflected from at least one eye of the object; an optical detector arranged to detect the optical interference; and an electronic device coupled to the detector and configured to provide an output based on the optical coherence tomography measurement results obtained using the interferometer; and an adjustment controller configured to adjust the pupil distance between the first eyepiece and the second eyepiece.

41. The optical coherence tomography analysis device according to claim 40 further includes at least one of the following: an autofocus lens configured to focus the optical coherence tomography analysis device, or a Z positioning module included in the electronic device and configured to automatically adjust the Z offset to obtain an optical coherence tomography scan of the eye tissue.

42. A method for an object to manipulate an optical coherence tomography examination using the optical coherence tomography analysis device according to claim 40; the method comprises: positioning the first eyepiece and the second eyepiece on the binoculars of the object; activating the optical coherence tomography analysis device to start the optical coherence tomography scan; and allowing the optical coherence tomography analysis device to scan the binoculars of the object by allowing the first eyepiece and the second eyepiece to let light enter the binoculars of the object and receiving light reflected from the binoculars of the object; and providing an output of the optical coherence tomography scan through an output device.

43. An optical coherence tomography analysis device, comprising: at least one eyepiece for accommodating the binoculars of an object; a light source configured to output light that passes through the at least one eyepiece and enters the eyes of the object; an interferometer configured to generate optical interference using light reflected from at least one eye of the object; an optical detector arranged to detect the optical interference; and an electronic device coupled to the detector and configured to provide an output based on the optical coherence tomography measurement results obtained using the interferometer; and wherein the optical coherence tomography (OCT) device is configured to perform a risk assessment based on OCT measurement results obtained using the interferometer, or wherein the OCT device is configured to perform an assessment by transmitting the OCT measurement results obtained using the interferometer to a remote system via a network, the remote system being configured to perform the risk assessment based on the OCT measurement results obtained using the interferometer.

44. The OCT device according to claim 43, further comprising at least one autofocus lens configured to focus the OCT device.

45. The OCT device according to claim 43, further comprising a Z-positioning module included in the electronic device and configured to automatically adjust the Z-offset to obtain an OCT scan of eye tissue.

46. The OCT device according to claim 43, wherein, the electronic device is configured to perform the diagnosis by transmitting the OCT measurement results to a remote system via a network, the remote system being configured to perform a diagnosis based on the OCT measurement results, and wherein the remote system is configured to transmit the diagnosis to the OCT device.

47. The OCT device according to claim 43, further comprising a target display visible to the subject through the at least one eyepiece.

48. The OCT device according to claim 43, wherein, the at least one eyepiece includes a first eyepiece and a second eyepiece.

49. The OCT device according to claim 48, further comprising an adjustment controller configured to adjust the pupil distance between the first eyepiece and the second eyepiece.

50. The OCT device according to claim 48, further comprising at least one beam splitter for coupling light from the light source into the first eyepiece and the second eyepiece.

51. An OCT device, comprising: at least one eyepiece for accommodating the subject's binocular eyes; a light source configured to output light that passes through the at least one eyepiece and enters the subject's eyes; an interferometer configured to generate optical interference using light reflected from at least one of the subject's eyes; an optical detector arranged to detect the optical interference; an electronic device coupled to the detector and configured to provide an output based on OCT measurement results obtained using the interferometer; and at least one of the following: an autofocus lens for focusing the OCT device, or a Z-positioning module included in the electronic device and configured to automatically adjust the Z-offset to obtain an OCT scan of eye tissue, wherein the OCT device is configured to perform a risk assessment based on OCT measurement results obtained using the interferometer; or Among them, the optical coherence tomography analysis device is configured to perform a risk assessment by transmitting the optical coherence tomography measurement results using the interferometer to a remote system via a network, and the remote system is configured to perform the risk assessment based on the optical coherence tomography measurement results using the interferometer.

52. The optical coherence tomography analysis device according to claim 51, wherein, the optical coherence tomography analysis device is configured to output the risk assessment to the subject through an output device.

53. The optical coherence tomography analysis device according to claim 51, wherein, the at least one eyepiece includes a first eyepiece and a second eyepiece.

54. The optical coherence tomography analysis device according to claim 53, further comprising at least one beam splitter for coupling light from the light source into the first eyepiece and the second eyepiece.

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