Personalized patient interface for ophthalmic devices

Abstract

A medical ophthalmic system uses a patient-specific face mask to establish a pre-alignment between the ophthalmic system and the patient's eye. The patient-specific face mask can optionally provide an opaque enclosure for the eye. The face mask can be directly coupled to an ophthalmic device of the ophthalmic system or a housing / enclosure thereof. The face mask can be 3D printed based on a 3D model of the patient's face.

Description

Technical Field

[0001] This invention generally relates to ophthalmic systems. More specifically, it relates to systems, devices, and / or methods for aligning ophthalmic devices with a patient's eyes. In particular, it relates to ophthalmic systems that support self-administered ophthalmic procedures (e.g., self-administered ophthalmic examinations, self-administered ophthalmic medications, self-administered ophthalmic diagnoses, self-administered ophthalmic tests, self-administered ophthalmic imaging, self-administered ophthalmic treatments, etc.). Background Technology

[0002] Ophthalmic systems / devices require alignment relative to the patient's eye, particularly the pupil. While different ophthalmic systems have varying levels of alignment requirements, all require some degree of alignment, and some have very high alignment requirements for proper operation. Some ophthalmic systems demand sub-millimeter accuracy in aligning the pupil to the patient's eye across three spatial dimensions. Generally, the higher the alignment requirement, the more complex / relevant the system process becomes in achieving precise alignment. In such cases, the alignment task is traditionally performed by an ophthalmologist or by an automated positioning system.

[0003] System-to-patient alignment can be challenging, especially when the system is intended to support self-administered ophthalmic procedures, such as for home, portable, and / or personal use. Such systems cannot rely on the operator to provide system-to-patient alignment. Furthermore, the typically low-cost requirements of these systems severely limit the use of automated alignment subsystems, which tend to be complex, expensive, and prone to reliability issues.

[0004] Various types of ophthalmic systems / devices are known, and they are commonly used for diagnostic and / or therapeutic (e.g., diagnostic-treatment) purposes. Examples of ophthalmic therapeutic systems / devices can be ophthalmic drug delivery systems (manual, automatic, or semi-automatic systems) or ophthalmic diagnostic-treatment systems, such as systems used in ophthalmic medical procedures (e.g., ophthalmic laser surgery). Examples of ophthalmic diagnostic systems / devices can include peripheral visual field testing equipment, automated refractometers, pachymeters, ophthalmic ultrasound devices, slit lamps, tonometers, surgical instruments / tools, and various ophthalmic imaging systems. Ophthalmic devices often require alignment between the device and the patient's eye, with some devices having more stringent alignment requirements than others. This paper presents an alignment system / method that is generally suitable for ophthalmic systems but also capable of repeatedly and consistently providing a high level of eye alignment for more critical applications.

[0005] While the present invention is not limited to any particular type of ophthalmic system (diagnosis and / or treatment), for the sake of brevity, this discussion relates to ophthalmic imaging systems as exemplary systems using the present invention. It should be understood that the present invention can be applied to other types of ophthalmic systems, such as visual field testing peripheral devices, etc.

[0006] One example of an ophthalmic imaging system is a fundus imager, which is typically used to image the fundus (or retina) of the eye. The fundus is the inner surface of the eye opposite the lens (or optic disc) and may include the retina, optic disc, macula, fovea, and posterior pole. Two types of fundus imagers used for imaging the fundus are flood illumination imagers and scanning imagers. Scanning imagers can be further classified into confocal scanning fundus imagers and line scanning imagers. Another example of an ophthalmic imaging device is an optical coherence tomography (OCT) system, which allows for in-situ, real-time cross-sectional (e.g., depth) imaging of tissues, such as the front or back of the eye. An OCT system measures the scattering profile of an OCT beam as it impacts a sample (e.g., the fundus) and can construct one-dimensional (1D) depth information, two-dimensional (2D) cross-sectional and frontal images, and three-dimensional (3D) volumetric images at a single point. Multiple OCT images can be taken at the same location and processed to extract motion information, such as fluid (e.g., blood) flow. The OCT system that extracts blood flow information can be called the OCT angiography (OCTA) system.

[0007] Regardless of the type of ophthalmic system, proper alignment of the human eye with the ophthalmic diagnostic system can be critical for performance. For example, proper alignment of the eye's pupil with the exit pupil (or aperture) of an ophthalmic imaging system is crucial for imaging the human retina using a fundus camera or OCT system. In fundus imagers, this is complicated by the need to divide the imaging system's aperture into an illumination pupil through which light enters the eye, and a collection pupil through which light exiting the eye is collected for imaging (e.g., for acquiring image data). Typical ophthalmic imaging systems are usually operated by a physician who uses various feedback mechanisms and alignment aids to position the system relative to the patient, typically mounted on an adjustable mechanical table with the patient's head held in a fixed position by a rigid jaw rest. Automated control systems using various feedback mechanisms for alignment have been demonstrated; however, such automated systems increase system complexity, cost, and tend to require regular maintenance for optimal performance.

[0008] Smaller, lower-cost, portable or handheld ophthalmic imaging systems have been proposed. However, these systems still require trained physicians and often necessitate the use of eye shields, stabilizing rods, etc., to attempt repeatable positioning of the imaging system onto the patient's eye. This leads to a trend towards more complex, lower-cost portable systems with fewer alignment aids for physicians, thus requiring a higher level of skill to obtain good image data.

[0009] The majority of the cost of an ophthalmic imaging system device tends to be related to the mechanical placement of the imaging device relative to the eye and to achieving device-to-patient alignment with alignment aids that help operators and / or automated systems know how to move the device to achieve optimal alignment.

[0010] Another alignment method can be referred to as "self-alignment," which can be used as part of a self-administered ophthalmic procedure. In this method, the patient moves himself and / or the imaging device to achieve alignment between the two. Typically, to facilitate self-alignment, the imaging system is expected to have alignment aids to provide feedback to the patient, thereby enabling correct alignment modifications with minimal effort and training, and achieving good measurements with high repeatability. Such a system requires cooperation from the patient (e.g., willingness to cooperate), including but not limited to physical movement and psychological processing of feedback. This approach is desirable for personal and / or family care.

[0011] With increasing demand for home solutions, particularly as the cost of various components of ophthalmic diagnostic systems (e.g., digital cameras and computing devices) decreases, home care and / or assisted living care is becoming an increasingly important market. Home care presents a unique situation where an assistant operator (e.g., a physician) is unlikely to assist in acquiring image data. In this case, the patient and the ophthalmic diagnostic system must work together to obtain good data without significantly increasing costs or reducing ease of use.

[0012] To aid in alignment, ophthalmic imaging systems typically provide several forms of visual stimulation to the eye of the person being imaged on the retina. Good alignment may require: 1) precise three-dimensional positioning of the eye's pupil relative to the system's illumination pupil (aperture) and collection pupil (aperture); 2) the eye's gaze being in the correct angular direction; and 3) the retina being in focus. Typically, the imaging system only provides alignment aids (e.g., feedback mechanisms) to the system's illumination pupil and does not provide alignment information related to the system's collection pupil.

[0013] To assist physicians in achieving proper alignment, the imaging system can provide auxiliary illumination and an imaging system to offer a preview of the patient's retina before initiating image data acquisition. The auxiliary illumination system can be low-intensity white light, low-intensity red light to which the human eye has relatively low sensitivity, or infrared light to which the eye has very low sensitivity. When the device is properly aligned, this light can cover a retinal area slightly wider than the imaging system's field of view. As the object approaches the system's aperture from a distance, it can be visualized by the camera's illumination pupil as an illuminated virtual object, a few millimeters in diameter, clearly floating a few centimeters outside the imaging system's objective lens. As the object gets closer to proper alignment, looks into the fundus camera, and moves its eye toward overlapping with the illuminated virtual object, it becomes impossible to focus on the virtual object, and the object can begin to see the shadow of its own pupil, as if illuminated by the virtual object near the eye. This may manifest as a circular illumination field for the object, increasing in size as the object approaches the correct axial position and shifting in lateral position depending on lateral alignment. When an object is successfully positioned so that the illumination reaches its maximum field size and maximum brightness, the pupil of the eye can be assumed to be aligned with the illumination pupil of the imaging system, and most of the light passes through unrestricted.

[0014] A fixation target is typically used to orient an object's gaze in a specific direction. Typically, the fixation target is presented to the same eye being imaged by the optics of an ophthalmic imaging system. The fixation target can be moved relative to the field of view of the ophthalmic imaging system to guide the object so that different portions of the retina are within the system's field of view. Multiple images acquired using different fixed positions can be stitched together to form a mosaic image spanning a larger field of view than that can be collected in a single exposure. Such a fixation target is typically presented such that it is in focus for the object and has at least some features with a small angular range that allow the object to orient its gaze with high precision. Some fixation targets may include areas with a larger lateral range, particularly for individuals with low-central vision who may not perceive small targets at the center of their field of view. The object can use a focus knob and control the position of the lenses within the system to optimize the fixation focus. Optionally, the fixation target can be projected back through a collection pupil. In this case, seeing the fixation target is sufficient to verify that at least some portion of the collection pupil is not obstructed.

[0015] As is evident from the above, achieving proper alignment of the patient's eye with the ophthalmic system is a complex but critical task. In short, the ophthalmic system typically needs to be aligned with the patient's pupil in three dimensions with sub-millimeter precision. This task has traditionally been performed by trained ophthalmologists and / or facilitated by the use of automated alignment systems. Both approaches introduce complexity and cost limitations, and neither can easily enable self-implementation of ophthalmic procedures, such as for home use (home care). Patients at home cannot rely on an operator (e.g., a visiting physician) to provide machine alignment, and automated systems are complex, expensive, and prone to reliability issues that cannot be expected to be resolved by the patient. Previous self-alignment methods still tend to be complex, unreliable, and often difficult and unachievable for older adults.

[0016] One object of the present invention is to reduce the complexity of aligning the patient’s eye with the ophthalmic system.

[0017] Another object of the present invention is to provide an ophthalmic patient-to-device alignment system suitable for self-implementation processes, self-alignment, and / or home care.

[0018] Another object of the present invention is to provide an ophthalmic system that provides repeatable, high-precision alignment with minimal physician training.

[0019] Another objective of this invention is to reduce the cost of ophthalmic patient alignment systems, particularly for home use.

[0020] Another object of the present invention is to facilitate the self-implementation of ophthalmic procedures, including imaging, diagnosis, medication and diagnostic-related processes. Summary of the Invention

[0021] The aforementioned objective is achieved in a system / device / method that uses a patient-specific face mask to establish a predetermined (known) alignment between an ophthalmic system and a patient's eye. The face mask can be directly attached to the ophthalmic device (housing / shell) of the ophthalmic system or to the base of the ophthalmic system. The face mask can be 3D printed based on a 3D model of the patient's face.

[0022] Essentially, all mechanical alignment adjustments typical of ophthalmic systems can be eliminated, including self-aligning adjustments, operator-controlled alignment adjustments, and automated system adjustments. This is achieved by placing the patient's face in a repeatable position using a personalized facial interface consisting of or including a full or partial face mask. The face mask may include a molded forehead, bridge of the nose, brow bridge, temples, cheeks, chin, jaw, or any combination thereof.

[0023] 3D scanning applications or software tools can be used to acquire 3D models of a patient's face, which can then be used to 3D print custom masks or parts thereof. 3D models can be acquired using 3D imaging devices, such as multi-camera imaging systems or depth-sensing cameras, either of which can be integrated into handheld computing devices such as smartphones or tablets. It should be understood that 3D models can be acquired, alone or in combination, using any other known 3D scanning / imaging techniques. Examples of suitable 3D scanning / imaging techniques include laser triangulation 3D scanning, structured light 3D scanning, contact-based 3D scanning, time-of-flight 3D scanning, and photogrammetry.

[0024] Other objects and achievements of the invention, as well as a more complete understanding of the invention, will become apparent and readily understood by referring to the following description and claims in conjunction with the accompanying drawings.

[0025] This document may cite or reference several publications to aid in understanding the invention. All publications cited or referenced herein are incorporated herein in their entirety.

[0026] The embodiments disclosed herein are merely examples, and the scope of this disclosure is not limited thereto. Any feature of an embodiment mentioned in one claim class (e.g., a system) may also be claimed in another claim class (e.g., a method). Dependents or references in the appended claims are chosen only for formal reasons. However, any subject matter arising from an intentional reference to any of the preceding claims may also be claimed, such that any combination of the claims and their features is disclosed and can be claimed, regardless of the dependents chosen in the appended claims. Attached Figure Description

[0027] In the accompanying drawings, the same reference numerals / symbols denote the same parts:

[0028] Figure 1 The outer casing 11 of an ophthalmic system is shown, which may be found in a clinical setting, for example.

[0029] Figure 2A The illustration depicts a first method for providing a personalized facial interface to a patient according to the present invention.

[0030] Figure 2B and Figure 2C The illustration shows a second method according to the invention for providing a personalized facial interface for a patient.

[0031] Figure 2D The diagram shows... Figure 2B The contact array 40 is used within the frame 48 and is configured with an opening 60 corresponding to the patient's eye area, so that the contact array 40 can be positioned similarly to... Figure 2AThe mask 63 is used as a mask.

[0032] Figure 3 This illustrates the combination (e.g., modification) to Figure 1 The patient-personalized face mask in the patient interface of System 11.

[0033] Figure 4a and Figure 4b The diagrams show the diagrams respectively. Figure 3 A cross-sectional view of the outer shell, which combines Figures 2A-2D Full face mask and partial face mask.

[0034] Figure 5 The illustration shows a smaller, more streamlined enclosure suitable for home, assisted living, or other non-clinical settings where trained system operators / physicians may not be readily available.

[0035] Figure 6A The illustration shows a first construction of a (home / portable) ophthalmic system that combines a mask and a housing.

[0036] Figure 6B The diagram shows... Figure 6A The second structure of the ophthalmic system, wherein a light shield extension is incorporated into a mask or housing.

[0037] Figure 6C The diagram shows... Figure 6A The third structure of the ophthalmic system, in which, Figure 6B The light shield extension is rigid and provides sufficient structural support to attach the mask to the ophthalmic shell.

[0038] Figure 7a and Figure 7b The illustration shows a method for aligning a monocular system with either of the patient's two eyes by moving the instrument and / or moving the patient.

[0039] Figure 8a , Figure 8b and Figure 8c An alternative embodiment of the ophthalmic system according to the invention is illustrated, wherein the mask can be positioned relative to the ophthalmic device housing 73 at one or more different angles off the vertical.

[0040] Figure 9a and Figure 9b Two alternative implementations are provided, wherein the ophthalmic system according to the invention has a handheld construction and the mask is directly attached to the housing without the use of a stand.

[0041] Figure 10a and Figure 10b The housing of the ophthalmic device is shown, directly attached to the face mask.

[0042] Figures 11a to 11e Various examples of partial face masks according to the present invention are provided.

[0043] Figure 12 The illustration shows an example of a visual field testing instrument (peripheral device) used to test a patient's visual field.

[0044] Figure 13 An example of a slit-scan ophthalmic system used for imaging the fundus is illustrated.

[0045] Figure 14 The illustration shows a general-purpose frequency-domain optical coherence tomography system for collecting 3-D image data of the eye, applicable to the present invention.

[0046] Figure 15 An example of a frontal vascular system image is shown.

[0047] Figure 16 The illustration depicts an exemplary (fixed / portable / handheld) computer system (or computing device or computer) suitable for use with the present invention. Detailed Implementation

[0048] Ophthalmic systems (e.g., ophthalmic diagnostic systems, ophthalmic therapeutic systems (e.g., ophthalmic lasers, such as yttrium aluminum garnet, YAG lasers), and ophthalmic medication or dispensing systems) typically have a certain degree of patient-to-instrument alignment requirement for proper operation. Systems with higher alignment requirements are usually limited to clinical settings where the system operator (e.g., a physician) can assist with the alignment process. Ophthalmic systems that support self-administered ophthalmic procedures (e.g., home-use, "self-access," and / or "self-testing") typically rely on the patient self-aligning their eye with the system. Small or portable ophthalmic systems, such as ZEISS... Desktop peripheral devices (FDT peripherals) can be designed with a larger exit pupil (eye shield) to allow for a much wider range of pupil positions, thus relaxing their eye alignment requirements. However, such techniques for relaxing alignment requirements are generally not feasible in precision ophthalmic systems, such as ophthalmic surgical systems and ophthalmic imaging systems. Ophthalmic imaging systems, such as fundus imagers, optical coherence tomography (OCT) systems, and OCT angiography (OCTA) systems, often have high eye-to-system alignment requirements. This hinders their use in self-implemented applications (e.g., home applications) and typically limits their use to clinical environments requiring a high level of system operator training or automation. This invention attempts to facilitate the operation of ophthalmic systems, including high-precision ophthalmic systems, by providing a mechanism / system that makes it easier to achieve correct patient-system alignment.

[0049] For illustrative purposes and to demonstrate the effectiveness of the invention, some embodiments of the invention are presented herein as being implemented within an ophthalmic imaging apparatus; however, it should be understood that the invention can be incorporated into other types of ophthalmic systems, including diagnostic and treatment systems and medication systems. Detailed descriptions of some exemplary ophthalmic systems applicable to the invention are provided below; however, the application of the invention is not limited to these specific examples and can be applied to any ophthalmic system requiring eye alignment. Examples of ophthalmic systems into which the invention can be integrated include tonometers, ophthalmic drug dispensers / appliers (e.g., eye drops), biostatistical systems, optometers, visual field testers, wavefront sensors, slit lamps, ophthalmic laser diagnostic and treatment systems, surgical devices, fundus imaging systems, OCT systems, and OCT angiography systems.

[0050] For the purpose of explanation, Figure 1 An enclosure 11 for an ophthalmic system is shown, such as those found in a clinical setting. The enclosure 11 can house one or more types of ophthalmic systems, such as fundus imagers, OCT, OCTA, etc. The enclosure 11 can be located on a surface 13 (e.g., an adjustable worktable) and coupled to a patient interface 15 for positioning a patient 21 relative to the ophthalmic system 11. Typically, a conventional patient interface 15 may include a headrest 17 and / or chinrest 19 for supporting the patient 21 (or an object, such as the patient's eye). Various portions of the instrument 11 and / or patient interface 15 can be moved relative to each other to align the instrument 11 with the eye of the object being imaged, for example, by using hardware controls such as a joystick 23 and knobs 25 and 27. A display (e.g., an electronic screen, not shown) may also be mounted on the worktable 13. An ophthalmic lens 29 can be used as an aperture for the instrument, for example, for image acquisition. Therefore, the joystick 23, knobs 25 / 27, and display can be used to adjust the position of the patient interface 15 and the instrument 11 to adjust the patient alignment, thereby achieving the optimal horizontal, vertical, and axial position of the patient's pupil relative to the system (e.g., relative to the ophthalmic lens 29 and / or the system's internal optics).

[0051] This invention seeks to facilitate the alignment process from patient to system and achieves this by eliminating the need for all (or most) alignment adjustments (or processes), whether self-aligning, operator-assisted, or system-automated. This is achieved through a mechanism / method that reliably and repeatedly positions the patient's face in a known, predetermined position relative to the ophthalmic system. One approach is to use a patient-personalized facial interface (e.g., a full or partial mask) with a molded forehead, nasal bone frame, cheek dressing, and / or chin rest (or any combination thereof) tailored to the patient's facial features (or custom-fitted). As described below, this combination may preferably include a nasal bone frame, which can be configured to hold the patient's nose in a predictable position (e.g., angle and position in 3D space) relative to the aperture of the ophthalmic system.

[0052] Figure 2A The illustration depicts a method for providing a personalized face mask to a patient according to the present invention. The method may begin by obtaining a 3D model 31 of a patient 21. The 3D model 31 may be a "wireframe" or a polygonal mesh, for example, a square mesh (4 edge / vertex combinations) or a triangular mesh (3 edge / vertex combinations). Several methods exist for generating the 3D model 31, two of which... Figure 2A The illustration is shown in the diagram, as indicated by arrows 33 and 35. One approach uses a 3D imaging device 37, such as a depth-sensing camera, which can move around the patient 21's head to scan across the patient's face and / or head, as indicated by arrows 39a and 39b. The depth-sensing camera 37 can be contained within a handheld device, such as a smartphone or other portable computing device, such as a tablet or custom computing / electronic device. The handheld device can run a 3D scanning software application (app) and / or can transmit the captured 3D data to a remote computing device (e.g., via the internet or intranet connection) for processing and / or creation of a 3D model 31. Optionally, the 3D model 31 can be generated wholly or partially within the 3D imaging device 37.

[0053] Alternatively, the 3D imaging apparatus can be implemented by a multi-camera imaging system 41. In this case, 3D data can be obtained by capturing multiple overlapping images of the patient 21 from different angles (e.g., simultaneously) using multiple cameras 38, preferably spanning the patient's face and / or head. Although a single-row camera 38 is shown, it should be understood that multi-row / multi-column cameras (e.g., to span the upper and lower parts of the head) can be used. Similarly, the captured 3D data can be processed locally or remotely to create a 3D model 31. The remote site processing the 3D model 31 can be accessed via a computer network such as a local area network (LAN) or the Internet, and can be provided as a website service, for example, accessible via a web browser.

[0054] 3D imaging devices can implement other 3D scanning / imaging techniques individually or in combination. For example, a 3D imaging device can implement laser triangulation 3D scanning, which projects a laser beam onto a face / head and measures the deformation of the laser beam. Another example is structured light 3D scanning, which measures the deformation of a light pattern on a face / head to 3D scan the shape of the face / head surface. Another 3D imaging technique is photogrammetry, such as "3D scanning based on photography," which constructs a 3D model of the face / head based on multiple 2D image captures (e.g., captured digital images or photographs), typically achieved using computer vision and computational geometry algorithms. Yet another example is time-of-flight (e.g., "laser pulse") 3D scanning, which is based on the time-of-flight of a laser beam. For example, a laser beam can be projected onto a face / head and collected on a sensor. 3D geometric information (the 3D model of the face / head) can be determined from the travel time of the laser between its emission and reception. Alternatively, the 3D model can also be constructed using various mechanical methods, such as contact-based 3D scanning techniques. For example, contact-based 3D scanning technology can be used, which can use the deformation or displacement of a contact surface, such as one or more probes, to measure / sample several points on the surface of the face / head, thereby generating a 3D model.

[0055] Regardless of how the 3D model is acquired, a patient-personally-owned (e.g., patient-specific) mask 43 can be created based on a pre-acquired 3D model 31 of the patient's face. For example, a 3D printer can be used to 3D print the mask 43 or parts thereof. Arrow 45 identifies a perspective view of an exemplary patient-personally-owned full mask 43, and arrow 47 identifies a side view of the full mask 43. In summary, this method may include creating a patient-specific 3D model 31, such as by 3D scanning a patient's face / head, and using the patient-specific 3D model 31 as a guide to create a physical mask 43. Because the contours, structures (e.g., skeletal structure), sizes, and positions (e.g., the position of the eyes within their sockets relative to the nasal bones) of the various parts of the patient's face / head are known from the patient-specific 3D model 31, and it is known which parts of the face are typically rigid and which tend to be extensible or compressible (e.g., the cheeks), a mask 43 can be created that, when attached to an ophthalmic device (e.g., an ophthalmic diagnostic device, an ophthalmic treatment device, an ophthalmic diagnostic device, or an ophthalmic drug dispensing device), will position the patient's eyes in a desired alignment relative to the ophthalmic device.

[0056] The resulting 3D mask 43 can then be used as an existing patient interface for an ophthalmic device, or as part of an existing patient interface for an ophthalmic device, or integrated into an existing patient interface for an ophthalmic device. Because the contours of the patient's face / head are known (e.g., determined from a personalized 3D facial model of the patient), and the physical properties of the ophthalmic system / device (e.g., the location and orientation of the system aperture, the system optical path, imaging properties, etc.) are also known, the mask 43 can be designed to hold the patient's head in a specific, predetermined position and orientation relative to the ophthalmic device, designed to provide optimal alignment with the ophthalmic device. That is, the exterior of the mask (e.g., the outer side of the mask facing the ophthalmic device) can be personalized for a specific patient and / or for a specific ophthalmic device. For example, the exterior of the mask can incorporate a custom connector for attachment to a specific ophthalmic device. The position of the connector (e.g., connector pins) and / or the external shape of the mask can be configured such that the patient's pupil is always positioned to coincide with the plane center of the ophthalmic device (e.g., zero point in the XY plane), for example, by taking into account the distance between the patient's pupil and the bridge of the nose and / or the patient's interpupillary distance, and / or the size and contour of the patient's brow ridge, eye socket, bridge of the nose, cheek structures, etc. The thickness and / or shape of the mask can also be configured for the ophthalmic device so that the mask does not interfere with (e.g., adjust) the working distance of the ophthalmic device. The mask can also be designed with patient comfort in mind. For example, the mask can provide sufficient clearance between the patient and the ophthalmic device to promote comfortable breathing and avoid feelings of confinement (e.g., avoid claustrophobia). If desired, the mask can also be configured to protect the patient's eyes from ambient light when attached to the ophthalmic device. This allows for natural pupil dilation. Furthermore, because the mechanical reference between the mask and the ophthalmic device is fixed, the mask can be made to fit snugly against the face to create an opaque shell. This could be beneficial in several ophthalmic applications, such as imaging / scanning ophthalmic applications. Thus, the inside of the mask (e.g., the patient-facing inner side of the mask) can be personalized (or strapped) for a specific one of multiple patients, and the outside of the mask can be customized (or strapped) for a specific one of multiple (e.g., multiple types of) ophthalmic devices.

[0057] Figure 2B and Figure 2C The diagram illustrates the generation of, for example Figure 2A Another method for creating a 3D model of the face of 31, and Figure 2D Based on Figure 2B and Figure 2C On top of the method to create such Figure 2ACustomized face mask 43. As mentioned above, 3D models can be defined using a mechanical, contact-based scanning system, but such a mechanical system can also be provided (in whole or in part) or used as the physical, patient-person-specific face mask itself. Figure 2B An example of a contact-based 3D scanning system is shown, which can be used to define Figure 2A The 3D model 31. The contact-based 3D scanning system of the present invention may include an array 40 of contacts 42 of individual and movable probes (e.g., pins or pistons) 42, the contact surfaces of which (e.g., the tip 44a of the piston rod 44b) may optionally be covered by a membrane (not shown). When a patient 46a presses his / her face / head into the contact array 40, different portions of the contact array 40 will deform / displace differently as the individual pistons (or pins) 42 are pushed back (displaced) according to the contour of the patient's face / head. For example, the patient's face may contact the tip 44a (or the membrane surface above the tip 44a) and push the corresponding piston rod 44b, causing it to displace (e.g., move into an optional cylinder 44c) by an amount determined by the facial contour. The composite height (and / or the amount of deformation / displacement) of each probe / piston 42 can be detected / measured to encode the shape of the patient's face, thereby creating a facial scan, which may be represented as a pin / piston / probe height (displacement / deformation) map. Figure 2C The illustration shows the use of the contact array 40 within frame 48. After the patient 46b has pressed / pushed his / her face into the contact array 40, as indicated by the curved arrow 50, the individual probe / piston / pin deformation / displacement positions 52 can be read and stored to maintain a record of the 3D scan. Optionally, the displacement positions 52 can be locked in place within frame 48.

[0058] This mechanical 3D scanning system can be adapted for use as a mask (or part of a mask), for example, by being configured to have an open area (or a semi-transparent area) to allow light from the ophthalmic system to pass through and reach the patient's eyes. Therefore, this mechanical system can not only create 3D models of the face / head, but also be used as a patient-personalized (e.g., patient-specific) mask. Figure 2D The illustration shows an exemplary use of the contact array 40 within the frame 48, which can be integrated into, attached to, or otherwise coupled to an ophthalmic system (see [link to ophthalmic system]). Figure 1 The outer casing 11 of the contact array 40 is explained more fully below. In this example, the contact array 40 includes an opening 60 for allowing light to pass between the patient 46b's eye and ophthalmic system. A mask for the patient's face / head is contained within the frame 48 by locking the probe / piston / pin deformation 52 in place. That is, the probe position can be locked (and stored) to ensure that the patient's head will be in the same position the next time the patient puts his / her face on the mask.

[0059] As described above, the probe / piston / pin can be covered by a membrane or other flexible material or surface to produce a similar effect. Figure 2A The surface of the 3D-printed face mask 43. It should be understood that the contact array 40 of the present invention can be configured to capture / scan the contours of selected portions of a patient's face (e.g., to create a partial face mask), and / or store only probe / piston / pin displacement / deformation information for selected portions of the patient's face. In this way, if probe displacement position data (probe displacement position data corresponding to all pistons or selected portions of pistons of the face mask shape) is stored, that data can be retrieved when the patient returns to the device. The probe / piston / pin can then be (manually or automatically) moved back to the previously detected position and locked in place. For example, the system can be automatically actuated. Figure 2B The selected cylinder 44c (as required by the corresponding probe height map) moves its corresponding piston rod 44B to its corresponding stored displacement position. This reproduces the precise imprint of the patient's face / head ready for use. It should be understood that the system can store mask information (e.g., probe height maps) for multiple patients in electronic memory, recall customized mask information for each patient, and reconfigure the mask (e.g., contact array 48) to suit the specific patient using the system. Therefore, this embodiment allows imaging of multiple patients on the same device. For each different patient, the system will recall (e.g., access from memory, such as a local or remote database accessible via a computer network (e.g., the Internet)) the piston height map and set the device accordingly. This will allow for repeated measurements of large groups in a central testing room or station, such as an elevatorless testing room in a nursing home or doctor's office. Optionally, once the precise shape of the patient's face / head (or target areas of the face / head, such as the temples, all or part of the nose (e.g., the bridge of the nose), and cheekbones) has been scanned, the system can rotate and / or translate the mask, or otherwise reposition the mask to ensure that the patient is correctly aligned with the system the next time the patient comes into contact with the mask.

[0060] For the purpose of explanation, Figure 3 Provided Figure 1A perspective view of the outer shell 11, and the full mask 43 or partial mask 43' is combined (e.g., modified) into the patient interface 15 of system 11, as indicated by arrow 49. It should be understood that, unless otherwise stated or understood from the context, all discussion / implementation / features of mask 43 and partial mask 43' apply to the mask defined by probe array 40. The mask replaces the need for alignment of system 11 in the X, Y, Z spatial directions (e.g., three-dimensional, 3D, spatial). If the full mask 43 is to be combined into the patient interface 15, the headrest 17 and / or jaw support 19 can be removed and replaced by the full mask 43. In the case where the partial mask 43' is combined into the patient interface 15, the headrest 17 can be removed and replaced by the partial mask 43', but the adjustable jaw support (cup) 19 can optionally be retained and provide height adjustment and jaw support function. Alternatively, patient interface 15 may be replaced by a new patient interface based on (e.g., a customized version of) full mask 43 and / or partial mask 43'. While partial mask 43' is shown as including a patient-specific forehead / cheek portion, it should be understood that different partial mask constructions are possible. Some alternative partial mask constructions are discussed below.

[0061] Figure 4a and Figure 4b The diagrams show the diagrams respectively. Figure 3 A side view of the outer casing 11, which combines Figure 2A A full face mask 43 and a partial face mask 43'. Figure 4a In the middle, the complete mask 43 is integrated into the patient interface 15 and replaced. Figure 3 The headrest 17 and chin rest 19. In Figure 4bIn this embodiment, a partial mask 43' is integrated into the patient interface 15 and replaces the headrest 17, but the patient interface 15 still provides overall height adjustment through the use of the jaw cup 19. This would be an example of a full mask 43 or a partial mask 43' used in a clinical setting. In this example, the full mask 43 and the partial mask 43' are personalized for the patient's face and are used to establish a known alignment between the eyes of the ophthalmic system 11 and the patient 21. That is, masks 43 and 43' each have a pre-configured shape based on the known contours of the patient's face, as determined from a pre-acquired 3D facial model of the patient, and are configured to hold the patient's face in a predetermined position to establish a known and desired alignment. Using this method, the only task that the patient 21 needs to perform is to place his / her face in the mask 43 or 43' to achieve alignment with little or no assistance from an operator or automated feedback system. Masks 43 and 43' eliminate the need for X, Y, Z space adjustments to achieve proper alignment of the patient to the system. Masks 43 and 43' each have a pre-configured shape based on the known contours of the patient's face and are configured to hold the patient's face in a predetermined position to establish the desired pre-alignment. Because the masks are personalized for the patient's facial contours, the patient's own comfort is an indicator of correct alignment. That is, when multiple pressure points generated by the masks are minimized, the patient can discern that the eyes are correctly aligned and in the desired predetermined position. Specifically, when the patient's head is correctly positioned within mask 43 or 43', pressure points on the forehead, nasal bone, temples, cheeks, and / or chin are eliminated or minimized, thus providing a comfortable setting for the patient. Experimental results have achieved a repeatable alignment accuracy of 0.1 mm in all three spatial dimensions, which previously required significant operator assistance. Therefore, by using patient-specific masks 43 or 43', the ophthalmic system becomes pre-aligned with the individual patient before the patient approaches the system without any alignment adjustments.

[0062] Optionally, masks 43 and 43' can be removed and replaced according to the patient's identity. For example, a patient-specific personalized mask library (e.g., collection or storage) can be constructed, and a first mask corresponding to a first patient can be removed from the patient interface 15 and replaced with a second mask corresponding to a second patient in preparation for examining the eyes of a second patient. In this way, the ease and speed of sequential examination of different patients can be improved.

[0063] Figure 5The illustration depicts an alternative, smaller-profile housing 51 suitable for self-administered ophthalmic procedures, such as in home, assisted living, or other non-clinical settings where trained system operators / physicians may not be readily available. Such a device could be used to treat and / or monitor chronic or short-term conditions in a home care setting. In this example, the full-face mask 43 and / or the partial mask 43' may be directly attached to or form an integral part of the housing 51, as indicated by the corresponding arrows 53 and 54. Alternatively, the patient-specific mask 43 or 43' may be integrated into a patient interface (e.g., a frame or support) 55, which may be part of an ophthalmic system including the housing 51, as indicated by arrow 57.

[0064] Figure 6A A first configuration of an ophthalmic system 59 (e.g., home / portable) combining a face mask 43 and a housing 51 is shown. In this example, a patient interface 55 is secured to a base 57 of the ophthalmic system 59, and the patient-specific face mask 43 is held in a predetermined position to align the patient (not shown) with the housing 51. Similarly, the housing 51 can be held in a known predetermined position by an arm 61 coupled to the base 57. Optionally, the arm 61 can be coupled to a track and / or ratchet system 62 for translational movement (e.g., left-right, forward-backward, up-down, and / or bending) and / or coupled to a rotating hub 63 for rotational movement of the housing 51. In this way, the system can provide positional adjustment of the housing 51 for better patient comfort. Alternatively, the system can be preset to a modular position determined to suit a particular patient. The system can also provide positional adjustment between a predetermined position and an optionally lockable position. For example, such a position can be set to provide an alternative aligned view of the patient's eye (e.g., pupil and / or retina).

[0065] Figure 6B The diagram shows... Figure 6A A second configuration of the ophthalmic system 51, wherein a light shield extension 64 is incorporated into the mask 43 or housing 51. In this manner, when the mask 43 is attached to the ophthalmic housing / device 51, the mask 43 functions (e.g., can act as / use as a light shield) and blocks ambient light.

[0066] Figure 6C The diagram shows... Figure 6A The third configuration of the ophthalmic system 51 includes a rigid shield extension 64 that provides sufficient structural support to directly attach the mask to the ophthalmic housing / device 51. In this way, the need for... Figure 6A The patient interface 55. Optionally, if desired, the support rod 66 may provide additional structural support. The support rod may also provide additional connectors for connection to the face mask 43, and / or serve as a rotating rod to raise the face mask 43 and / or the light shield extension 64 above the housing 51.

[0067] This ophthalmic system can be binocular (e.g., having two apertures for examining, imaging, diagnosing, treating, or causating one or both eyes individually or simultaneously) or monocular (e.g., having one aperture for examining, imaging, diagnosing, treating, or causating one eye at a time). In the case of a monocular system, housing 51 (or its interior, which may define an optical path) can be moved from one position to another (e.g., sliding from left to right and vice versa) to align with one or the other eye. In a binocular system, housing 51 can provide two separate optical paths (one for each eye, or one for each aperture), or a single optical path that can be selectively directed to either eye, for example, by using a mirror switching system that selectively directs the field of view of either eye to a single optical path, or by using a mechanism that physically moves (e.g., translationally and / or axially) a single optical path within housing 51 to selectively align with one or the other of the patient's two eyes.

[0068] Figure 7a and Figure 7b The illustration shows two methods for aligning a monocular system with either of the patient's two eyes. Figure 7a In this embodiment, the mask 43 is fixed, and the outer shell 51 is movable between at least two (predetermined) positions, each aligning the outer shell 51 with a corresponding one of the patient's two eyes. In this example, the outer shell 51 can rotate about the rotating hub 63 from a first position 65a to a second position 65b, as indicated by arrow 67. When in position 65a, the outer shell 51 is aligned with the patient's right eye, as indicated by the symbolic target cross 69a. Similarly, when the outer shell 51 is in position 65b, as indicated by the dashed line, the outer shell 51 is aligned with the patient's right eye, symbolically identified by target cross 69b. Alternatively, the outer shell 51 can be moved laterally between positions 65a and 65b, for example, by using the track system 62.

[0069] Figure 7b The illustration depicts a second method for aligning a monocular system with either of the patient's two eyes. For ease of discussion, Figure 7b A front view of the face shield 43, which is part of the patient interface 55, is shown, but the view of the housing 51 is omitted. It should be understood that the housing 51 will be fixed and will be similar to... Figure 6AThe mask 43 is positioned in front of the face shield 43. In this embodiment, the face shield 43 can move between at least two (predetermined) positions while the outer shell 51 remains stationary in front of the face shield 43. For example, the face shield 43 can be moved according to arrow 73a (e.g., sliding along the track of the patient interface 55) to a first position 71a that aligns the patient's left pupil 69a with the aperture of the outer shell 51, and can be moved according to arrow 73b to a second position 71b that aligns the patient's right pupil 69b with the same aperture of the outer shell 51.

[0070] Figure 8a , Figure 8b and Figure 8c An alternative embodiment of the ophthalmic system according to the invention is illustrated, wherein the mask 43 can be positioned relative to the ophthalmic device housing 73 at one or more different angles off the vertical. Figure 8a and Figure 8b The implementation methods include those similar to Figure 6C The sunshade 72. Figure 8a In this context, a light shield 72, which may be part of the mask 43, directly connects and supports the mask 43 to and supports the ophthalmic device housing 73. Figure 8b Optional support rods 74 are provided to help attach the mask 43 to the ophthalmic device housing 73. Figures 8a to 8c Three different examples 75a, 75b, and 75c of the mask 43 are provided, with three distinct tilt angles α1, α2, and α3 shown in the figure. As will be understood, each angle requires the patient to tilt to a different degree to position the patient's face within the mask 43. Patients may find one tilt angle more comfortable than another, and the ophthalmic system can be configured to present the mask 43 at an angle comfortable for a given patient or a group of patients. This angle can be fixed or adjustable.

[0071] Figures 9a-9b Two alternative embodiments, 77a and 77b, are provided, in which the ophthalmic system according to the invention has a handheld configuration, and the mask 43 is directly attached to the housing 51 without the use of a pedestal. This configuration can be advantageous when the ophthalmic device is lightweight and can be gripped by one or two hands. Optionally, a handle 79 (77a in the embodiment) or a handle 81 (77b in the embodiment) can be provided to facilitate patient gripping and positioning. In this way, the ophthalmic device can be used in a tilted or reclining position without unduly burdening a bedridden patient. That is, when the ophthalmic device is comfortably pressed against the patient's face in a resting position, it can be determined that the ophthalmic device is correctly aligned.

[0072] Optionally, the face shield 43 may include all or most of the patient interface. For example, Figure 10a and Figure 10bAn ophthalmic device housing is shown that is directly connected to the face mask 43. In cases where the ophthalmic device housing is small, for example when it is as small as... Figure 10a The diagram shows a tonometer 81 and / or as shown. Figure 10b This configuration may be preferred when the illustrated dispensing device 83 for accommodating eye medication (e.g., eye drops) is shown.

[0073] A tonometer measures the pressure inside the eye (intraocular pressure), which may be of particular interest to patients with glaucoma. Glaucoma is the excavation (removal) of the optic nerve. This usually results in damage to the stability of the optic nerve, leading to a similarly stable reduction in the patient's visual field. Without treatment, this can lead to vision loss. Although the exact causes of glaucoma or optic nerve damage are not fully understood, increased intraocular pressure in the eye is identified as a possible indicator.

[0074] Therefore, home administration of medications and monitoring of intraocular pressure (IOP) are integral parts of glaucoma care. Since patients typically live with the disease into old age, both require years of fine motor skills and sustained patient adherence. However, adhering to strict monitoring and medication regimens without assistance can be difficult for patients. Self-administration of medications, particularly eye drops, has been shown to have poorer patient adherence and unsuccessful drop administration outcomes. The global growth of chronic diseases (and the associated burden on healthcare systems) is likely to increase the demands on patient self-management. One reason for this overlap in adherence may be the difficulties associated with using this ophthalmic device to date.

[0075] Figure 10a A tonometer 81 based on the rebound measurement principle is shown, wherein a probe (e.g., a rod) 85 moves in and out to repeatedly rebound on the eyeball (e.g., the rod tip 85a is repeatedly advanced at the eyeball and allowed to rebound) to measure intraocular pressure. This device allows for IOP monitoring outside of outpatient settings, providing ophthalmologists with more information. Figure 10b A drug applicator based on a drop delivery system using a vial 83 is shown. Other drug delivery systems (e.g., for topical medication) may include a probe that applies ophthalmic medication by contacting the eye in a manner similar to a probe 85 of a tonometer 81, or a piezoelectric drug delivery system that sprays small droplets of medication into the eye.

[0076] In any case, such ophthalmic devices are typically handheld, and they are particularly difficult for the elderly or anyone without a stable hand to perform medical procedures that require bringing the handheld ophthalmic device close to or into contact with their eyes. By attaching a typical handheld ophthalmic device to a patient-specific mask 43, the patient can confidently bring the ophthalmic device (e.g., a tonometer 81 or a medicine bottle 83) to his / her eye, as the mask 43 keeps the ophthalmic device at a predetermined and safe distance from the patient's eyes.

[0077] This configuration also simplifies the use of the system in a reclining position, which may be preferred when applying ophthalmic medications by using a squeeze-actuated dropper, a manually electronically actuated (e.g., piezoelectric or piezo-printed) medication dispenser, or an automated electrical / electronic medication dispenser that automatically dispenses medication when it senses, for example, that the eye can be determined to be available using a camera.

[0078] Optionally, the connection mechanism (e.g., connector arm) 87 for connecting / attaching the mask 43 to a housing (e.g., a tonometer 81 or a vial 83) may have modular or flexible ends 87a to receive different types of housings (e.g., a tonometer 81 or a vial 83), and thus different types of ophthalmic devices. In this way, a single mask 43 can be presented to a patient who can optionally (interchangeably) attach any of a plurality of ophthalmic devices (e.g., a tonometer 81 or an ophthalmic device medication dispenser 83) to that single mask.

[0079] Some of the above embodiments illustrate the use of a full-face, patient-specific mask 43, but all embodiments can be implemented with a full-face mask or a partial mask. Figures 11a to 11e Various examples of localized face masks are provided. In all these configurations, the portion of the mask used can be configured to align with one or more bone segments of the patient's face, and optionally only with that bone segment. Figure 11a The illustration shows a two-piece partial face mask 91 comprising an upper part 91a and a lower part 91b. The upper part 91a spans a first region R1 configured to align with the patient's forehead (and optionally the patient's temple area) and a second region R2 configured to align with the patient's nasal bone. The lower part 91b spans the patient's chin (and mandible).

[0080] Figure 11b It shows a similar Figure 11a An alternative one-piece local mask 93 is used to cross the forehead region R1 and the nasal bone region R2. If the local mask is connected to a patient interface, such as... Figures 3 to 6C As shown, the portion of the patient's face not covered by the mask can be fitted into the patient interface. For example, the patient interface can provide an adjustable chin rest, such as... Figure 3 As shown, the jaw support can be fitted to the patient while the patient's face is in the mask.

[0081] Figure 11c The illustration shows yet another one-piece local mask 95, which extends the coverage of the local mask 93 to at least partially include the patient's cheek area R3. Figure 11dA third one-piece construction is shown, which limits the mask coverage to the nasal region R2 (the bridge of the nose and optionally at least a portion of the nasal tube) and the supraorbital ridge (e.g., the brow ridge) R4.

[0082] Optionally, all partial face masks are constructed to include at least the patient's nasal bone area. (Reference) Figure 11e The configuration of the mask to the patient's nasal region R2, portion 99, effectively ensures that the patient's face (and therefore the patient's eyes) is in a predetermined position (and angle) for proper alignment. While portion 99 preferably does not clamp the patient's nose, proper alignment is improved by allowing the patient to comfortably insert his / her nose into portion 99, and a mask covering areas other than the patient's nose helps provide the patient with additional contact points as reference points.

[0083] In cases where this mask is integrated into ophthalmic systems that rely on the patient's retina for a selected field of view, such as fundus imagers or OCT-based systems, strict alignment specifications may be required. In such situations, providing additional techniques to improve alignment can be beneficial. These techniques can be provided simply by the patient changing their gaze direction without requiring additional mechanical adjustment of the patient's position. In this case, gaze accommodation can be provided by including a fixation target in the ophthalmic system. The fixation target (e.g., a fixed light or light pattern) provides the patient with something to stare at, thereby guiding the patient's gaze in the desired direction. A more detailed description of fixation targets is provided below.

[0084] Descriptions of various hardware and architectures applicable to this invention are provided below.

[0085] Visual field testing system

[0086] The improvements described in this paper can be used in conjunction with any type of visual field tester / system (e.g., peripheral devices). One such system is the "bowl-shaped" visual field tester VF0, such as... Figure 12The diagram illustrates an object (e.g., a patient) observing a bowl-shaped hemispherical projection screen (or other type of display) VF2, with the tester VF0 also referred to as a bowl. Typically, the subject is instructed to gaze at a point at the center of the hemispherical screen VF3. The subject rests his / her head on a patient support, which may include a chin rest VF12 and / or a forehead rest VF14. For example, the subject rests his / her head on the chin rest VF12 and positions his / her forehead against the forehead rest VF14. Optionally, the chin rest VF12 and forehead rest VF14 may move together or independently of each other to properly fix / position the patient's eyes, for example, relative to a test lens holder VF9 through which the subject can view the screen VF2. For example, the chin rest and headrest may move independently in the vertical direction to accommodate different patient head sizes and may move together in the horizontal and / or vertical directions to properly position the head. However, this is not limiting, and other arrangements / movements can be envisioned by those skilled in the art.

[0087] A projector or other imaging device VF4, under the control of processor VF5, displays a series of test stimuli (e.g., test points of any shape) VF6 on screen VF2. Subject VF1 indicates that he / she sees the stimulus VF6 by actuating user input VF7 (e.g., pressing an input button). This subject response can be recorded by processor VF5 and can be used to assess the visual field of the eye based on the subject's response, for example, determining the size, location, and / or intensity of the test stimulus VF6, thus determining the (visibility) threshold of the test stimulus VF6. Camera VF8 can be used to capture the patient's gaze (e.g., gaze direction) throughout the test. The gaze direction can be used for patient alignment and / or determining the patient's adherence to the appropriate test procedure. In this example, camera VF8 is located on the Z-axis relative to the patient's eye (e.g., relative to the test lens holder VF9) and behind the bowl (of screen VF2) to capture a live image or video of the patient's eye. In other embodiments, this camera may be positioned off-axis. Images from the gaze camera VF8 can optionally be displayed on a second display VF10 to a clinician (who may also be interchangeably referred to herein as a physician) to assist patient alignment or test verification. The camera VF8 can record and store one or more images of the eye during each stimulus presentation. This may result in the collection of dozens to hundreds of images in each visual field test, depending on the testing conditions. Alternatively, the camera VF8 can record and store a full-length film during the test, providing timestamps indicating when each stimulus was presented. Additionally, images can be collected between stimulus presentations to provide details about the subject's overall attention throughout the entire duration of the VF test.

[0088] The test lens retainer VF9 can be positioned in front of the patient's eye to correct any refractive error in the eye. Optionally, the lens retainer VF9 can carry or hold a liquid test lens (see, for example, U.S. Patent 8,668,338, the contents of which are incorporated herein by reference in their entirety), which can be used to provide variable refractive correction for the patient's VF1. However, it should be noted that the invention is not limited to using a liquid test lens for refractive correction, and other conventional / standard test lenses known in the art can also be used.

[0089] In some implementations, one or more light sources (not shown) may be located in front of the eye of the object VF1, producing reflections from ocular surfaces such as the cornea. In one variation, the light source may be a light-emitting diode (LED).

[0090] Although Figure 12 A projection-type field of view tester, VF0, is illustrated, but the invention described herein can be used with other types of devices (field of view testers), including those that generate images via liquid crystal displays (LCDs) or other electronic displays (see, for example, U.S. Patent 8,132,916, which is incorporated herein by reference). Other types of field of view testers include, for example, flat-screen testers, miniaturized testers, and binocular field of view testers. Examples of these types of testers can be found in U.S. Patents 8,371,696, 5,912,723, 8,931,905, and U.S. Design Patent D472,637, each of which is incorporated herein by reference in its entirety.

[0091] The visual field tester VF0 can be combined with an instrument control system (e.g., an algorithm, which can be software, code, and / or routines) that uses hardware signals and a motorized positioning system to automatically position the patient's eyes in a desired location, such as the center of the refractive lens at the lens retainer VF9. For example, stepper motors can move the chin rest VF12 and forehead rest VF14 under software control. A rocker switch can be provided to allow the attending physician to adjust the patient's head position by causing the stepper motors on the chin rest and forehead to operate. Manually movable refractive lenses can also be placed in front of the patient's eyes as close to their eyes as possible on the lens retainer VF9 without adversely affecting patient comfort. Optionally, if movement of the chin rest and / or forehead motors would interfere with test execution, the instrument control algorithm can pause peripheral device test execution while such movement is in progress.

[0092] Fundus imaging system

[0093] Two types of imaging systems used for fundus imaging are flood illumination imaging systems (or flood illumination imagers) and scanning illumination imaging systems (or scanning imagers). A flood illumination imager, for example, uses a flash lamp to simultaneously flood illuminate the entire field of interest (FOV) of a sample and captures a full-frame image of the sample (e.g., the fundus) with a full-frame camera (e.g., a camera with a sufficiently large two-dimensional (2D) light sensor array to capture the desired FOV overall). For example, a flood illumination fundus imager would flood illuminate the fundus of the eye and capture a full-frame image of the fundus in a single image capture sequence from the camera. A scanning imager provides a scanning beam that scans across the object (e.g., the eye), and as it scans across the object, the scanning beam images at different scanning locations, producing a series of image fragments that can be reconstructed (e.g., combined) to produce a synthetic image of the desired FOV. The scanning beam can be a point, a line, or a two-dimensional region, such as a slit or a wide line.

[0094] Figure 13An example of a slit-scanning ophthalmic system SLO-1 for imaging the fundus F, which is the inner surface of the eye E opposite the lens (or crystalline lens) CL, and may include the retina, optic disc, macula, fovea, and posterior pole. In this example, the imaging system is in a so-called “scan-to-de-scan” configuration, wherein a scan line beam SB traverses the optical components of the eye E (including the cornea Crn, iris Irs, pupil Ppl, and lens CL) to scan the fundus F. In the case of a floodlight fundus imager, a scanner is not required, and light is immediately applied across the entire desired field of view (FOV). Other scanning configurations are known in the art, and a specific scanning configuration is not critical to the invention. As depicted, the imaging system includes one or more light sources LtSrc, preferably a multicolor LED system or a laser system, wherein the light collection rate has been appropriately adjusted. An optional slit Slt (adjustable or static) is located in front of the light source LtSrc and can be used to adjust the width of the scan line beam SB. Additionally, the slit Slt can remain static during imaging or can be adjusted to different widths to allow for different confocalities and applications, either for a specific scan or to suppress reflections during scanning. An optional objective lens ObjL can be placed in front of the slit Slt. The objective lens ObjL can be any type of existing lens, including but not limited to refractive lenses, diffractive lenses, reflective lenses, or hybrid lenses / systems. Light from the slit Slt passes through the pupil splitter SM and is directed to the scanner LnScn. It is desirable to bring the scanning plane and the pupil plane as close together as possible to reduce vignetting in the system. Optional optics DL can be included to manipulate the optical distance between the images of the two components. The pupil splitter SM allows the illumination beam from the light source LtSrc to pass through to the scanner LnScn and reflects the detection beam from the scanner LnScn (e.g., reflected light returning from the eye E) toward the camera Cmr. The task of the pupil splitter SM is to separate the illumination beam and the detection beam and to help suppress system reflections. The scanner LnScn can be a rotating galvanometer scanner or other types of scanners (e.g., piezoelectric or voice coil, microelectromechanical system (MEMS) scanner, electro-optic deflector, and / or rotating polygon scanner). Depending on whether pupil segmentation is performed before or after the scanner LnScn, the scanning can be divided into two steps, where one scanner is in the illumination path and a separate scanner is in the detection path. A specific pupil segmentation apparatus is described in detail in U.S. Patent 9,456,746, which is incorporated herein by reference in its entirety.

[0095] An illumination beam passes from a scanner LnScn through one or more optics, in this case a scanning lens SL and an ophthalmic lens or eye lens OL, which allows the pupil of the eye E to image onto the system's image pupil. Typically, the scanning lens SL receives the scanning illumination beam from the scanner LnScn at any of a plurality of scanning angles (incident angles) and produces a scanning line beam SB with a substantially planar focal plane (e.g., a collimated optical path). The ophthalmic lens OL can focus the scanning line beam SB onto the fundus F (or retina) of the eye E and image that fundus. In this way, the scanning line beam SB produces a transverse scanning line through the fundus F. One possible configuration of these optics is a Keplerian telescope, in which the distance between two lenses is chosen to produce an approximately telecentric intermediate fundus image (4-f configuration). The ophthalmic lens OL can be a single lens, an achromatic lens, or an arrangement of different lenses. All lenses can be refractive, diffractive, reflective, or a combination thereof, as known to those skilled in the art. Depending on the desired field of view (FOV), the focal lengths of the ophthalmic lens OL, the scanning lens SL, and the size and / or form of the pupillary divider SM and the scanner LnScn can vary, and thus an arrangement can be envisioned in which, depending on the field of view, multiple components can be switched into and out of the beam path, for example, by using optical flipping, motorized wheels, or detachable optical elements. Since changes in the field of view result in different beam sizes on the pupil, pupillary division can also vary along with the FOV. For example, a field of view of 45° to 60° is typical or standard for fundus cameras. Higher fields of view, such as 60°–120° or even larger wide field of view FOVs, may also be feasible. A wide field of view FOV may be desired for combinations of wide-line fundus imaging (BLFI) with another imaging modality such as optical coherence tomography (OCT). The upper limit of the field of view can be determined by the achievable working distance combined with the physiological conditions around the human eye. Because the typical human retina has a 140° horizontal and 80°–100° vertical FOV, an asymmetric field of view with the highest possible FOV for the system may be desired.

[0096] The scanning line beam SB passes through the pupil Ppl of the eye E and is directed towards the retina or fundus surface F. The scanner LnScn1 adjusts the position of the light on the retina or fundus F to illuminate a range of lateral positions on the eye E. The reflected or scattered light (or emitted light in the case of fluorescence imaging) is guided back along a similar path to illumination to define the collection beam CB on the detection path to the camera Cmr.

[0097] In the "scan-de-scan" configuration of the exemplary slit-scan ophthalmic system SLO-1 of the present invention, the light returning from the eye E is "de-scanned" by the scanner LnScn on its path to the pupil splitter SM. That is, the scanner LnScn scans the illumination beam from the pupil splitter SM to define a scanning illumination beam SB passing through the eye E; however, since the scanner LnScn also receives the returning light from the eye E at the same scanning position, the scanner LnScn has the effect of de-scanning the returning light (e.g., canceling the scanning action) to define a non-scanning (e.g., stable or static) collection beam from the scanner LnScn to the pupil splitter SM, which folds the collection beam toward the camera Cmr. At the pupil splitter SM, the reflected light (or emitted light in the case of fluorescence imaging) is separated from the illumination light onto a detection path pointing toward the camera Cmr, which may be a digital camera with a photoelectric sensor for capturing an image. An imaging (e.g., objective) lens ImgL may be located in the detection path to image the fundus onto the camera Cmr. As with the objective lens ObjL, the imaging lens ImgL can be any type of lens known in the art (e.g., a refractive lens, a diffractive lens, a reflective lens, or a hybrid lens). Additional operational details, particularly methods for reducing artifacts in images, are described in PCT Publication WO2016 / 124644, the contents of which are incorporated herein by reference in their entirety. The camera Cmr captures the received images, and for example, creates image files that can be processed by one or more (electronic) processors or computing devices (e.g., ...). Figure 16 The computer system further processes the data. Therefore, the collected beam (returning from all scan positions of the scan line beam SB) is collected by the camera Cmr, and the full-frame image Img can be constructed from the composite of the individually captured collected beams, for example, through montage. However, other scanning configurations are also conceivable, including a scanning configuration in which the illumination beam is scanned on the eye E and the collected beam is scanned on the camera's light sensor array. Several embodiments of the slit scanning ophthalmoscope, including various designs where the returned light sweeps across the camera's light sensor array and where the returned light does not sweep across the camera's light sensor array, are described by reference to PCT Publication WO 2012 / 059236 and U.S. Patent Publication No. 2015 / 0131050, which are incorporated herein by reference.

[0098] In this example, the camera Cmr is connected to a processor (e.g., a processing module) Proc and a display (e.g., a display module, computer screen, electronic screen, etc.) Dspl. Both can be part of the imaging system itself, or they can be part of separate dedicated processing and / or display units, such as a computer system, where data is transmitted from the camera Cmr to the computer system via cable or a computer network including wireless networks. The display and processor can be an integrated unit. The display can be a conventional electronic display / screen or a touchscreen type, and can include a user interface for displaying and receiving information from the instrument operator or user. The user can interact with the display using any type of user input device known in the art, including but not limited to a mouse, knob, button, pointer, and touchscreen.

[0099] It may be desirable for the patient's gaze to remain fixed during imaging. One way to achieve this is to provide a fixation target that the patient can be guided to look at. Depending on which area of ​​the eye is to be imaged, the fixation target can be inside or outside the instrument. Figure 13 An implementation of an internal gaze target is illustrated. In addition to the main light source LtSrc for imaging, a second optional light source FxLtSrc, such as one or more LEDs, can be positioned such that a light pattern is imaged onto the retina using a lens FxL, a scanning element FxScn, and a reflector / mirror FxM. The gaze scanner FxScn can move the position of the light pattern, and the reflector FxM guides the light pattern from the gaze scanner FxScn to the fundus F of the eye E. Preferably, the gaze scanner FxScn is positioned such that it is located at the pupil plane of the system, allowing the light pattern on the retina / fundus to move according to the desired gaze position.

[0100] Slit-lamp ophthalmoscope systems can operate in different imaging modes by selecting filter elements based on the light source and wavelength used. When imaging the eye with a series of colored LEDs (red, blue, and green), true-color reflective imaging (similar to the imaging observed by clinicians when examining the eye using a handheld or slit-lamp ophthalmoscope) is achieved. The image for each color can be progressively built up with each LED turned on at each scanning position, or the entire image for each color can be captured individually. These three color images can be combined to display a true-color image, or they can be displayed individually to highlight different features of the retina. The red channel best highlights the choroid, the green channel highlights the retina, and the blue channel highlights the anterior retinal layer. Additionally, light of specific frequencies (e.g., individual colored LEDs or lasers) can be used to excite different fluorophores in the eye (e.g., autofluorescence), and the resulting fluorescence can be detected by filtering out the excitation wavelength.

[0101] Fundus imaging systems can also provide infrared reflection images, for example, by using an infrared laser (or other infrared light source). The advantage of infrared (IR) mode is that the eye is insensitive to IR wavelengths. This allows the user to capture images continuously without interfering with the eye (e.g., in preview / alignment mode) to assist the user during instrument alignment. Furthermore, IR wavelengths have increased penetration through tissues and can provide improved visualization of choroidal structures. Additionally, fluorescein angiography (FA) and indocyanine green (ICG) angiography imaging can be accomplished by collecting images after a fluorescent dye has been injected into the subject's bloodstream. For example, in FA (and / or ICG), a series of time-lapse images can be captured after a photoreactive dye (e.g., a fluorescent dye) has been injected into the subject's bloodstream. It should be noted that caution must be exercised because fluorescent dyes can cause life-threatening allergic reactions in some individuals. High-contrast grayscale images are captured using a specific light frequency selected to excite the dye. As the dye flows through the eye, it causes different parts of the eye to glow brightly (e.g., fluoresce), making it possible to discern the progress of the dye and, consequently, the blood flow through the eye.

[0102] Optical coherence tomography system

[0103] Besides fundus photography, fundus autofluorescence (FAF), fluorescein angiography (FA), and ophthalmic images can also be created using other imaging modalities, such as optical coherence tomography (OCT), OCT angiography (OCTA), and / or ocular ultrasound. This invention, or at least a portion thereof with minor modifications as understood in the art, can be applied to these other ophthalmic imaging modalities. More specifically, this invention can also be applied to ophthalmic images generated by OCT and / or OCTA images produced by an OCT / OCTA system. For example, this invention can be applied to frontal OCT / OCTA images. Examples of fundus imagers are provided in U.S. Patents 8,967,806 and 8,998,411, examples of OCT systems are provided in U.S. Patents 6,741,359 and 9,706,915, and examples of OCTA imaging systems can be found in U.S. Patents 9,700,206 and 9,759,544, all of which are incorporated herein by reference in their entirety. For completeness, exemplary OCT / OCTA systems are provided herein.

[0104] Figure 14The illustration depicts a general-purpose frequency-domain optical coherence tomography (FD-OCT) system suitable for collecting 3-D image data of the eye, applicable to the present invention. The FD-OCT system OCT_1 includes a light source LtSrc1. Typical light sources include, but are not limited to, broadband light sources or swept-frequency laser sources with short time coherence lengths. The beam from the light source LtSrc1 is typically guided by an optical fiber Fbr1 to illuminate a sample, such as the eye E; a typical sample is tissue within the human eye. In the case of spectral-domain OCT (SD-OCT), the light source LrSrc1 can be a broadband light source with a short time coherence length, or in the case of swept-frequency OCT (SS-OCT), it can be a wavelength-tunable laser source. The light can be scanned, typically using a scanner Scnr1 between the output of the optical fiber Fbr1 and the sample E, such that the beam (dashed line Bm) scans laterally (in x and y) over the sample area to be imaged. In the case of full-field-of-view OCT, no scanner is required, and light is applied immediately over the entire desired field of view (FOV). The light scattered from the sample is typically collected into the same fiber Fbr1 used to guide the illumination. Reference light from the same light source LtSrc1 travels a separate path, in this case involving fiber Fbr2 and a back reflector RR1 with adjustable optical delay. Those skilled in the art will recognize that a transmission reference path can also be used, and the adjustable delay can be placed in either the sample or reference arm of the interferometer. The collected sample light is typically combined with the reference light in fiber connector Cplr1 to form an optical interference in an OCT photodetector Dtctr1 (e.g., a photodetector array, digital camera, etc.). Although a single fiber port leading to detector Dtctr1 is shown, those skilled in the art will recognize that various designs of the interferometer can be used for balanced or unbalanced detection of the interference signal. The output from detector Dtctr1 is provided to a processor Cmp1 (e.g., a computing device) that converts the observed interference into depth information of the sample. This depth information can be stored in memory associated with processor Cmp1 and / or displayed on a display (e.g., a computer / electronic display / screen) Scn1. The processing and storage functions can be located within the OCT instrument, or they can be located in an external processing unit where the collected data is transmitted (e.g., Figure 16 The processor (Cmp1) performs functions on the computer system shown. This unit can be dedicated to data processing or perform other tasks that are fairly general-purpose and not specific to the OCT device. The processor Cmp1 may include, for example, a field-programmable gate array (FPGA), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a graphics processing unit (GPU), a system-on-a-chip (SoC), a central processing unit (CPU), a general-purpose graphics processing unit (GPGPU), or a combination thereof, which performs some or all of the data processing steps before being passed to the host processor or in parallel.

[0105] The sample and reference arms in the interferometer can consist of bulk optics, fiber optics, or hybrid bulk optics systems, and can have different architectures, such as Michelson, Mach-Zehnder, or designs based on common paths, as is known to those skilled in the art. The beams used herein should be interpreted as any carefully guided optical path. Instead of a mechanical scanning beam, an optical field can illuminate a one-dimensional or two-dimensional region of the retina to generate OCT data (see, for example, US Patent 9332902; D. Hillmann et al., “Holographic Analysis – Holographic Optical Coherence Tomography,” Optics Letters, 36(13): 2390 2011; Y. Nakamura et al., “High-Speed ​​Three-Dimensional Human Retinal Imaging via Line-Field Spectral Domain Optical Coherence Tomography,” Optics Express, 15(12): 7103 2007; Blazkiewicz et al., “Signal-to-Noise Ratio Study of Full-Field Fourier Domain Optical Coherence Tomography,” Applied Optics, 44(36): 7722 (2005)). In time-domain systems, the reference arm needs to have a tunable optical delay to generate interference. Balanced detection systems are commonly used in TD-OCT and SS-OCT systems, while spectrometers are used for the detection port of SD-OCT systems. The invention described herein can be applied to any type of OCT system. Various aspects of the present invention can be applied to any type of OCT system or other types of ophthalmic diagnostic systems and / or multiple ophthalmic diagnostic systems, including but not limited to fundus imaging systems, visual field testing devices, and scanning laser polarimeters.

[0106] In Fourier domain optical coherence tomography (FD-OCT), each measurement is a real-valued spectral interferogram (Sj(k)). The real-valued spectral data typically undergoes several post-processing steps, including background subtraction and dispersion correction. The Fourier transform of the processed interferogram produces a complex-valued OCT signal output. The absolute value |Aj| of this complex OCT signal reveals the distribution of scattering intensity at different path lengths, and thus reveals scattering as a function of depth (z-direction) in the sample. Similarly, phase... It can also be extracted from complex-valued OCT signals. The scattering profile as a function of depth is called an axial scan (A-scan). A set of A-scans measured at adjacent locations in a sample produces a cross-sectional image (computed tomography or B-scan) of the sample. The collection of B-scans collected at different lateral locations on the sample constitutes a data volume or cube. For a given amount of data, the term fast axis refers to the scanning direction along a single B-scan, while slow axis refers to the axis along which multiple B-scans are collected. The term "cluster scan" can refer to a single data unit or block of data generated by repeatedly collecting data at the same (or substantially the same) location (or region) for the purpose of analyzing motion contrast, which can be used to identify blood flow. A cluster scan can consist of multiple A-scans or B-scans collected at approximately the same location on the sample at relatively short time intervals. Because the scans in a cluster scan are of the same region, the static structure remains relatively unchanged between scans within the cluster scan, and the motion contrast between scans that meet predetermined criteria can be identified as blood flow. Various methods for generating B-scans are known in the art, including but not limited to: along the horizontal or x-direction, along the vertical or y-direction, along the diagonal of x and y, or in a circular or spiral pattern. B-scans can be in the xz dimension, but can be any cross-sectional image including the z dimension.

[0107] In OCT angiography or functional OCT, analytical algorithms can be applied to OCT data collected at the same or substantially the same sample location on the sample at different times (e.g., cluster scans) to analyze motion or flow (see, for example, U.S. Patent Publications 2005 / 0171438, 2012 / 0307014, 2010 / 0027857, 2012 / 0277579 and U.S. Patent 6,549,801, all of which are incorporated herein by reference in their entirety). OCT systems can use any of a variety of OCT angiography processing algorithms (e.g., motion contrast algorithms) to identify blood flow. For example, motion contrast algorithms can be applied to intensity information derived from image data (intensity-based algorithms), phase information from image data (phase-based algorithms), or complex image data (complex number-based algorithms). A frontal image is a 2D projection of 3D OCT data (e.g., by averaging the intensity of each individual A-scan, such that each A-scan defines pixels in the 2D projection). Similarly, a frontal vascular system image is an image that displays motion contrast signals, where the data dimension corresponding to depth (e.g., along the z-direction of the A-scan) is typically displayed as a single representative value (e.g., a pixel in a 2D projected image) by summing or integrating all or isolated portions of the data (see, for example, U.S. Patent 7,301,644, which is incorporated herein by reference in its entirety). An OCT system providing angiographic imaging capabilities may be referred to as an OCT angiography (OCTA) system.

[0108] Figure 15 An example of a frontal vascular system image is shown. After processing the data using any motion contrast technique known in the art to enhance motion contrast, a range of pixels corresponding to a given tissue depth from the surface of the internal limiting membrane (ILM) in the retina can be summed to generate a frontal (e.g., anterior view) image of the vascular system.

[0109] Computing device / system

[0110] Figure 16 The illustration depicts an example computer system (or computing device or computer apparatus). In some embodiments, one or more computer systems may provide the functionality described or illustrated herein and / or perform one or more steps of one or more methods described or illustrated herein. The computer system may take any suitable physical form. For example, the computer system may be an embedded computer system, a system-on-a-chip (SOC), a single-board computer system (SBC) (e.g., a computer-on-module (COM) or system-on-module (SOM)), a desktop computer system, a laptop or notebook computer system, a computer system grid, a mobile phone, a personal digital assistant (PDA), a server, a tablet computer system, an augmented / virtual reality device, or a combination of two or more of these. Where appropriate, the computer system may reside in a cloud, which may include one or more cloud components within one or more networks.

[0111] In some implementations, the computer system may include a processor Cpnt1, a memory Cpnt2, a storage device Cpnt3, an input / output (I / O) interface Cpnt4, a communication interface Cpnt5, and a bus Cpnt6. The computer system may also optionally include a display Cpnt7, such as a computer monitor or screen.

[0112] Processor Cpnt1 includes hardware for executing instructions, such as those that make up a computer program. For example, processor Cpnt1 may be a central processing unit (CPU) or a general-purpose computing (GPGPU) on a graphics processing unit. Processor Cpnt1 may fetch (or retrieve) instructions from internal registers, internal caches, memory Cpnt2, or storage Cpnt3, decode and execute instructions, and write one or more results to internal registers, internal caches, memory Cpnt2, or storage Cpnt3. In certain embodiments, processor Cpnt1 may include one or more internal caches for data, instructions, or addresses. Processor Cpnt1 may include one or more instruction caches and one or more data caches, for example, to hold data tables. Instructions in the instruction cache may be copies of instructions in memory Cpnt2 or storage Cpnt3, and the instruction cache may accelerate the retrieval of those instructions by processor Cpnt1. Processor Cpnt1 may include any suitable number of internal registers and may include one or more arithmetic logic units (ALUs). Processor Cpnt1 may be a multi-core processor; or may include one or more processors Cpnt1. While this disclosure describes and illustrates a particular processor, this disclosure considers any suitable processor.

[0113] Memory Cpnt2 may include main memory for storing instructions for processor Cpnt1 to execute during processing or for holding intermediate data. For example, a computer system may load instructions or data (e.g., data tables) from memory Cpnt3 or from another source (e.g., another computer system) into memory Cpnt2. Processor Cpnt1 may load instructions and data from memory Cpnt2 into one or more internal registers or internal caches. To execute instructions, processor Cpnt1 may retrieve and decode instructions from internal registers or internal caches. During or after instruction execution, processor Cpnt1 may write one or more results (which may be intermediate or final results) to internal registers, internal caches, memory Cpnt2, or memory Cpnt3. Bus Cpnt6 may include one or more memory buses (each bus may include an address bus and a data bus) and may connect processor Cpnt1 to memory Cpnt2 and / or memory Cpnt3. Optionally, one or more memory management units (MMUs) facilitate data transfer between processor Cpnt1 and memory Cpnt2. Memory Cpnt2 (which may be fast volatile memory) may include random access memory (RAM), such as dynamic RAM (DRAM) or static RAM (SRAM). Memory Cpnt3 may include long-term or high-capacity storage for data or instructions. Memory Cpnt3 may be internal or external to the computer system and includes one or more of the following: disk drives (e.g., hard disk drives, HDDs, or solid-state drives SSDs), flash memory, ROM, EPROM, optical disks, magneto-optical disks, magnetic tape, Universal Serial Bus (USB) accessible drives, or other types of non-volatile memory.

[0114] The I / O interface Cpnt4 can be software, hardware, or a combination of both, and includes one or more interfaces (e.g., serial or parallel communication ports) for communicating with I / O devices, enabling communication with a person (e.g., a user). For example, I / O devices may include a keyboard, keypad, microphone, monitor, mouse, printer, scanner, speaker, still camera, stylus, writing tablet, touchscreen, trackball, camera, another suitable I / O device, or a combination of two or more of these.

[0115] The communication interface Cpnt5 can provide a network interface for communicating with other systems or networks. The communication interface Cpnt5 may include a Bluetooth interface or other types of packet-based communication. For example, the communication interface Cpnt5 may include a network interface controller (NIC) and / or a wireless NIC or a wireless adapter for communicating with a wireless network. The communication interface Cpnt5 can provide communication with Wi-Fi networks, ad hoc networks, personal area networks (PANs), wireless PANs (e.g., Bluetooth WPANs), local area networks (LANs), wide area networks (WANs), metropolitan area networks (MANs), cellular telephone networks (e.g., Global System for Mobile Communications (GSM) networks), the Internet, or a combination of two or more of these.

[0116] The Cpnt6 bus can provide communication links between the aforementioned components of a computing system. For example, the Cpnt6 bus may include an Accelerated Graphics Port (AGP) or other graphics bus, an Enhanced Industry Standard Architecture (EISA) bus, a Front Side Bus (FSB), HyperTransport (HT) interconnect, an Industry Standard Architecture (ISA) bus, an InfiniBand bus, a Low Pin Count (LPC) bus, a memory bus, a Micro Channel Architecture (MCA) bus, a Peripheral Component Interconnect (PCI) bus, a PCI-Express (PCIe) bus, a Serial Advanced Technology Accessory (SATA) bus, a Video Electronics Standards Association Local (VLB) bus, or other suitable buses, or combinations of two or more of these.

[0117] While this disclosure describes and illustrates a particular computer system having a particular number of particular components in a particular arrangement, this disclosure contemplates any suitable computer system having any suitable number of any suitable components in any suitable arrangement.

[0118] In this document, one or more computer-readable non-transitory storage media may include one or more semiconductor-based or other integrated circuits (ICs) (e.g., field-programmable gate arrays (FPGAs) or application-specific integrated circuits (ASICs)), hard disk drives (HDDs), hybrid hard disk drives (HHDs), optical disks, optical disk drives (ODDs), magneto-optical disks, magneto-optical disk drives, floppy disks, floppy disk drives (FDDs), magnetic tape, solid-state drives (SSDs), RAM drives, secure digital cards or drives, any other suitable computer-readable non-transitory storage media, or, where appropriate, any suitable combination of two or more of these. Where appropriate, computer-readable non-transitory storage media may be volatile, non-volatile, or a combination of volatile and non-volatile.

[0119] Although the invention has been described in conjunction with several specific embodiments, many further alternatives, modifications, and variations will be apparent to those skilled in the art from the foregoing description. Therefore, the invention described herein is intended to cover all such alternatives, modifications, applications, and variations that fall within the spirit and scope of the appended claims.

Claims

1. An ophthalmic system comprising: A patient interface includes a mask having a nasal bone frame configured to hold the patient's nose in a predictable position relative to the aperture of the ophthalmic system, wherein the mask is pre-aligned between the aperture of the ophthalmic system and the patient's eyes based on a personalized 3D facial model defining the relative position of the patient's eyes and nose, and based on the position and orientation of the aperture of the ophthalmic system.

2. The ophthalmic system according to claim 1, wherein, The ophthalmology system is one of an ophthalmology diagnostic system, an ophthalmology treatment system, or an ophthalmology drug dispensing system.

3. The ophthalmic system according to claim 1 or 2, wherein, The mask has a pre-configured shape based on the known contours of the bone segments of the patient's face, and is configured to hold the patient's face in a predetermined position to establish the pre-alignment, and the patient's face is in the predetermined position when the number of pressure points generated by the mask is minimized.

4. The ophthalmic system according to claim 1 or 2, wherein, The mask was 3D printed.

5. The ophthalmic system according to claim 1 or 2, wherein, The 3D facial model is acquired using a 3D imaging device that implements one or more of laser triangulation 3D scanning technology, structured light 3D scanning technology, contact-based 3D scanning technology, time-of-flight 3D scanning technology, and photogrammetry, and / or the 3D imaging device includes a depth-sensing camera and one or more of a multi-camera imaging system.

6. The ophthalmic system according to claim 1 or 2, wherein, The 3D facial model is acquired using a mechanical scanning system comprising an array of contact probes that are displaced in response to a patient pressing their face into the mechanical scanning system, and the displaced position of the contact probes defines a probe height map stored in an electronic memory.

7. The ophthalmic system according to claim 1 or 2, wherein, The mask is contained within a mechanical scanning system, which includes multiple contact probes. The face mask includes an array of contact probes covered by a flexible material that defines the surface of the face mask, and the displacement of the contact probes defines the contour of the face mask; and Based on the probe height map stored in electronic memory and the corresponding patient, the contact probe is selected and moved to the target position that defines the shape of the mask.

8. The ophthalmic system according to claim 7, wherein, The electronic memory stores multiple probe height maps of different patients, and the mask of the mechanical scanning system can configure the selected patient by moving the selected contact probe to the target position corresponding to the selected contact probe according to the stored probe height map of any selected patient selected from multiple different patients.

9. The ophthalmic system according to claim 1 or 2, wherein: The ophthalmic system includes an ophthalmic device and a connector for attaching the mask to the ophthalmic device; and The connector is adapted to receive different types of ophthalmic devices, including one or more of a tonometer, a drug dispenser, a fundus imaging system, an optical coherence tomography system, a biostatistics system, an optometer, a visual field tester, and an ophthalmic laser.

10. The ophthalmic system according to claim 1 or 2, wherein, The mask is a partial mask that does not cover the patient's eye sockets.

11. The ophthalmic system according to claim 1 or 2, wherein, The ophthalmic system includes one or more of the following: a fundus imaging system, an optical coherence tomography system, a biostatistics system, an optometer, a visual field tester, a tonometer, an ophthalmic laser, and a drug dispenser.

12. The ophthalmic system according to claim 1 or 2, wherein, The mask includes a light shield forming an opaque outer shell that blocks ambient light relative to the eyes and allows for natural eye expansion by blocking the ambient light relative to the eyes.

13. The ophthalmic system according to claim 1 or 2, wherein, The aperture of the ophthalmic system is divided into: an illumination portion, which defines the area through which light entering the eye passes; The light leaving the eye is collected by the collecting section for imaging; and The eye is aligned with the illumination portion and the collection portion of the aperture.

14. The ophthalmic system according to claim 1 or 2, wherein: The ophthalmic system includes an ophthalmic device and a connector for attaching the mask to the ophthalmic device; and The connector is adapted to receive different types of ophthalmic devices, including one or more of optical coherence tomography angiography systems and wavefront sensors.

15. The ophthalmic system according to claim 1 or 2, wherein, The ophthalmic system includes one or more of an optical coherence tomography angiography system and a wavefront sensor.

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