Personalized Patient Interface for an Ophthalmic Device

Abstract

The medical ophthalmic system uses a patient-specific face mask to establish a predetermined alignment between the ophthalmic system and the patient's eye. The patient-specific face mask optionally provides a light-tight enclosure for the eye. The face mask is coupled directly to an ophthalmic device or housing / enclosure of the ophthalmic system. The face mask is 3D printed based on a 3D model of the patient's face.

Description

Technical Field

[0001] The present invention generally relates to an ophthalmic system. More particularly, the present invention relates to a system, device, and / or method for aligning an ophthalmic device with a patient's eye. In particular, the present invention is directed to an ophthalmic system that supports self-administered ophthalmic procedures (such as self-administered ophthalmic examinations, self-administered ophthalmic drug treatments, self-administered ophthalmic diagnoses, self-administered ophthalmic tests, self-administered ophthalmic imaging, self-administered ophthalmic treatments, etc.).

Background Art

[0002] An ophthalmic system / device needs to be aligned with a patient's eye and may particularly require alignment with the patient's pupil. Various ophthalmic systems have various levels of alignment requirements, but all ophthalmic systems require some level of alignment, and some ophthalmic systems have very high alignment requirements for proper operation. Some ophthalmic systems impose sub-millimeter accuracy alignment requirements in three spatial dimensions on the pupil of a patient's eye. Generally, the higher the alignment requirements, the more complex and intricate the system procedures for achieving precise alignment become. In such cases, the alignment task has conventionally been performed by an eye technician or by an automatic positioning system.

[0003] System-patient alignment can be difficult to achieve, particularly when it is desirable for the system to support self-administered ophthalmic procedures (for home use, portable use, and / or personal use, etc.). Such systems cannot rely on an operator to provide system-patient alignment. Furthermore, such systems often have low-cost requirements that can severely limit the use of an automatic alignment subsystem because they are typically complex, expensive, and prone to reliability issues.

[0004] Various types of ophthalmic systems / devices are known and are often used for diagnostic and / or therapeutic (e.g., treatment) purposes. Examples of ophthalmic therapeutic systems / devices may include ophthalmic therapeutic systems such as ophthalmic drug delivery systems (manual, automated, or semi-automatic systems) or systems used in ophthalmic therapeutic procedures (e.g., ophthalmic laser surgery). Examples of ophthalmic diagnostic systems / devices may include perimeters, automated refractometers, corneal thickness meters, ophthalmic ultrasound devices, slit lamps, tonometers, surgical instruments / tools, and various ophthalmic imaging systems. Ophthalmic devices typically require alignment of the device with respect to the patient's eye, and some devices have more critical alignment requirements than others. Presented herein are general alignment systems / methods suitable for ophthalmic systems, but which can also provide high levels of ocular alignment for more critical applications in a reproducible and consistent manner.

[0005] The present invention is not limited to any particular type of ophthalmic system (diagnosis and / or therapy), but for the sake of brevity, this description relates to an ophthalmic imaging system as an exemplary system using the present invention, with the understanding that the present invention may be applied to other types of ophthalmic systems such as perimeters.

[0006] One example of an ophthalmic imaging system is a fundus imaging device, typically used to image the fundus (or retina) of the eye. The fundus is the inner surface of the eye opposite the ocular lens (i.e., the crystalline lens) and may include the retina, optic disc, macula, fovea, and posterior pole. Two categories of fundus imaging devices used to image the fundus are illuminated imaging devices and scanning imaging devices. Scanning imaging devices can be further divided into confocal scanning fundus imaging devices and linear scanning imaging devices. Another example of an ophthalmic imaging device is an optical coherence tomography (OCT) system, which allows for real-time cross-sectional (e.g., depth) imaging of tissue (e.g., imaging of the anterior or posterior part of the eye). An OCT system measures the scattering profile of the OCT beam as it strikes a sample (e.g., the fundus) and can construct one-dimensional (1D) depth information, two-dimensional (2D) cross-sectional and en-face images, and three-dimensional (3D) stereoscopic images at a single point. Multiple OCT images can be acquired at the same location and processed to extract motion information (such as fluid flow, e.g., blood flow). An OCT system that extracts blood flow information may be called an OCT angiography (OCTA) system.

[0007] Regardless of the type of ophthalmic system, correct alignment of the human eye with the ophthalmic diagnostic system can be critical to performance. For example, correctly aligning the pupil of the eye with the exit pupil (or opening) of an ophthalmic imaging system is critical for imaging the human retina with a fundus camera or OCT system. In fundus imaging devices, this is complicated by the need to divide the aperture of the imaging system into an illumination pupil through which light enters the eye and an acquisition pupil through which light exiting the eye is collected for imaging (e.g., to collect image data). Typical ophthalmic imaging systems are usually operated by technicians using various feedback mechanisms and alignment aids to position the ophthalmic imaging system, which is typically mounted on an adjustable mechanical stage, against a patient whose head is held in a fixed position by a rigid chin rest. Automated control systems using various feedback mechanisms for alignment have been demonstrated, but such automated systems tend to increase system complexity and cost and require periodic maintenance for optimal performance.

[0008] Smaller, lower-cost, portable or handheld ophthalmic imaging systems have been proposed. However, such systems still require trained technicians and the use of eye cups, stabilization rods, etc., to achieve reproducible positioning of the imaging system on the patient's eye. Further complicating their use, low-cost portable systems tend to have a reduced set of alignment aids for the technician, and therefore require a higher level of skill to achieve good image data.

[0009] A significant portion of the cost of ophthalmic imaging system devices goes towards achieving device-patient alignment, both from the perspective of the mechanical placement of the imaging device relative to the eye and from the perspective of alignment aids that help the operator and / or automated system know how to move the device to achieve the best alignment.

[0010] Another alignment technique that can be used as part of self-managed ophthalmic procedures may be called "self-alignment." In this technique, the patient moves themselves and / or the imaging device to achieve alignment with themselves and the imaging device. Generally, to facilitate self-alignment, it is desirable that the imaging system has alignment aids to provide the patient with feedback to enable correct alignment correction with minimal effort and training, and to obtain good measurement results with high reproducibility. Such a system requires collaborative work from the patient (e.g., voluntary cooperation), including, but not limited to, physical movement and mental processing of feedback. Situations in which this technique is desirable are those of personal care and / or home care.

[0011] Home care and / or residential care are poised to become an increasingly important market as the need for home solutions grows (especially as the cost of various components of ophthalmic diagnostic systems (e.g., digital cameras and computing equipment) decreases). Home care presents specific cases where it is unlikely that auxiliary operators (e.g., technicians) will be available to assist in acquiring image data. In these cases, the patient and the ophthalmic diagnostic system need to work together to acquire good data without a significant increase in cost or a decrease in ease of use.

[0012] To assist with alignment, ophthalmic imaging systems typically provide several forms of visual stimulation to the eye of the person whose retina is being imaged. Good alignment may require: 1) the pupil of the eye is precisely positioned in three dimensions relative to the system's illumination pupil (aperture) and acquisition pupil (aperture); 2) the eye is gazing in the correct angular direction; and 3) the retina is in focus. Generally, imaging systems provide alignment aids (e.g., feedback mechanisms) only for the system's illumination pupil, but do not provide alignment information related to the system's acquisition pupil.

[0013] To assist technicians in achieving proper alignment, the imaging system may provide a secondary illumination / imaging system to provide a preview of the patient's retina prior to activating image data acquisition. The secondary illumination system may be low-intensity white and red light to which the human eye has relatively low sensitivity, or infrared light to which the human eye has very low sensitivity. When the device is properly aligned, this light may cover an area of ​​the retina slightly wider than the field of view of the imaging system. As the subject approaches the system's aperture from a distance, the subject may visualize the camera's illuminated pupil as an illuminated virtual object a few millimeters in diameter that appears to float in the air a few centimeters beyond the imaging system's objective lens. As the subject looks into the fundus camera and moves their eye toward overlapping the illuminated virtual object, approaching proper alignment, it becomes impossible to focus on the virtual object, and the subject begins to see the shadow of their own pupil illuminated by the virtual object near their eye. This can appear to the subject as an annular illumination field that increases in size as the subject approaches the correct axial position and shifts laterally depending on the lateral alignment. When the subject successfully positions their eyes so that the illumination reaches its maximum field size and maximum luminosity, it can be assumed that the pupil of the eye is aligned with the illumination pupil of the imaging system, and most of the light passes through unrestricted.

[0014] A fixation target is commonly used to orient a subject's gaze direction in a specific direction. Frequently, the fixation target is presented to the same eye being imaged via the optical elements of an ophthalmic imaging system. The fixation target may be moved relative to the field of view of the ophthalmic imaging system to guide the subject so that different parts of the retina are within the system's field of view. Multiple images acquired at different gazing positions may be combined (montaged) to form a mosaic image spanning a larger field of view than might be possible with a single exposure. Such fixation targets are typically presented to be in focus for the subject and have at least some features with a small angular range to allow the subject to orient their gaze direction with high precision. Some fixation targets may include a larger lateral spread, particularly for individuals with low central visual acuity who may not be able to perceive small targets in the center of their field of view. The subject may have access to a focus knob to control the position of the lens inside the system so that the fixation focus is optimized. Optionally, the fixation target may be back-projected through the collecting pupil. In this case, looking at the fixation target is sufficient to verify that at least a portion of the focusing pupil is unobstructed.

[0015] As is clear from the above, achieving proper alignment of a patient's eye to the ophthalmic system is a complex but critical task. In summary, the ophthalmic system typically needs to be aligned to the patient's pupil with three-dimensional sub-millimeter precision. This task has traditionally been performed by trained ophthalmic technicians and / or can be easily done using automated positioning systems. Both of these methods introduce complexity and cost constraints, and therefore neither is suitable for self-managed ophthalmic procedures such as home use (home care). Patients at home cannot rely on operators (e.g., visiting technicians) to adjust the equipment, and automated systems are complex, expensive, prone to reliability issues, and cannot be expected to be dealt with by patients. Previous self-alignment methods remain complex, unreliable, difficult for the elderly, and tend to be unattainable. [Overview of the project] [Problems that the invention aims to solve]

[0016] The objective of this invention is to reduce the complexity of aligning a patient's eye with an ophthalmic system. Another object of the present invention is to provide an ophthalmic patient-device alignment system suitable for self-administered procedures, self-alignment, and / or home care use.

[0017] A further objective of the present invention is to provide an ophthalmic system that offers highly accurate alignment that can be reproduced with minimal technician training. Another objective of the present invention is to reduce the cost of ophthalmic patient alignment systems, particularly for home use.

[0018] Another object of the present invention is to facilitate the self-management of ophthalmic procedures, including imaging procedures, therapeutic procedures, drug therapy procedures, and diagnostic-related procedures. [Means for solving the problem]

[0019] The above objective is satisfied in a system / device / method that uses a patient-specific face mask to establish a predetermined (known) alignment between the ophthalmic system and the patient's eye. The face mask may be coupled to the ophthalmic device (housing / enclosure) of the ophthalmic system or directly to the base of the ophthalmic system. The face mask may be 3D printed based on a 3D model of the patient's face.

[0020] Essentially, all mechanical alignment adjustments of a typical ophthalmic system (including self-alignment adjustments, alignment adjustments operable by a system operator, and automated system adjustments) can be eliminated. This is achieved by positioning the patient's face in a reproducible location using a personalized facial interface consisting of or including a full or partial face mask. The face mask may include a molded forehead, nasal bridge, brow ridge, temples, cheeks, chin, chin tip, or any combination thereof.

[0021] 3D scanning applications (or software tools) may be used to acquire a 3D model of a patient's face, and the 3D model may then be used to 3D print a customized face mask or a part thereof. The 3D model may be acquired using a 3D imaging device such as a multi-camera imaging system or depth-sensing camera, either of which may be integrated into a portable computing device (such as a smartphone or tablet computer). It should be understood that the 3D model may be acquired using any other known 3D scanning / imaging techniques, either alone or in combination. 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.

[0022] Other objects and achievements of the present invention will become apparent and understandable by referring to the following description and claims, which are to be interpreted in conjunction with the accompanying drawings, along with a more thorough understanding of the present invention.

[0023] To facilitate understanding of the present invention, several publications are cited or referenced herein. All publications cited or referenced herein are incorporated herein in their entirety by reference.

[0024] The embodiments disclosed herein are illustrative and the scope of this disclosure is not limited thereto. Any feature of any embodiment described in one claim category, for example, a system, can also be claimed in another claim category, for example, a method. Dependencies or backreferences in the supplementary claims are selected for formal reasons only. However, any subject matter derived from careful backreferences to the earlier claims can also be claimed, thereby disclosing any combination of claims and their features, regardless of the dependencies selected in the supplementary claims.

[0025] In the attached drawings, similar reference numerals / letters refer to similar components.

Brief Description of the Drawings

[0026] [Figure 1] Shows the housing 11 of an ophthalmic system as may be found in a clinical environment. [Figure 2A] Shows a first method of providing a patient personalized face interface according to the present invention. [Figure 2B] Shows a second method of providing a patient personalized face interface according to the present invention. [Figure 2C] Shows a second method of providing a patient personalized face interface according to the present invention. [Figure 2D] Shows the use of the contact array 40 of FIG. 2B within the frame 48, which is configured with an aperture 60 corresponding to the patient's eye region(s) such that the contact array 40 can be used as a face mask in a manner similar to the face mask 63 of FIG. 2A. [Figure 3] Shows a patient personalized face mask incorporated (e.g., retrofitted) within the patient interface of the system 11 of FIG. 1. [Figure 4a-4b] Shows a profile view of the housing of FIG. 3 incorporating the full face mask and partial face mask of FIG. 2, respectively. [Figure 5] Shows an alternative (smaller profile) housing suitable for home, assisted living, or other non - clinical environments where a trained system operator / technician may not be readily available. [Figures 6a-6c] FIG. 6a shows a first configuration of a (home / portable) ophthalmic system incorporating a face mask and a housing, FIG. 6b shows a second configuration of the ophthalmic system of FIG. 6a in which a light blocking extension is incorporated into the face mask or the housing, and FIG. 6c shows a third configuration of the ophthalmic system of FIG. 6a in which the light blocking extension of FIG. 6b is rigid and provides sufficient structural support to couple the face mask to the ophthalmic housing. [Figures 7a-7b] Shows a method of aligning a monocular system with either of a patient's two eyes by moving the measuring instrument and / or moving the patient. [Figures 8a-8c]An alternative embodiment of the ophthalmic system according to the present invention is shown, in which the face mask is positioned at one or more different off-vertical inclination angles relative to the ophthalmic device housing 73. [Figures 9a-9b] Two alternative configurations are provided, in which the ophthalmic system according to the present invention has a portable configuration, and the face mask is directly coupled to the housing without using a table base. [Figures 10a-10b] This shows an ophthalmic device housing directly attached to a face mask. [Figures 11a-11e] This provides various examples of partial face masks according to the present invention. [Figure 12] This diagram shows an exemplary visual field testing device (perimeter) used to examine a patient's visual field. [Figure 13] This figure shows an example of a slit-scan ophthalmic system for imaging the fundus of the eye. [Figure 14] This invention illustrates a general-purpose frequency-domain optical coherence tomography system used to collect 3D image data of the eye, which is suitable for use with this invention. [Figure 15] This figure shows an example of an en face vascular image. [Figure 16] An exemplary (stationary / portable / handheld) computer system (or computing device or computer) suitable for use in the present invention is illustrated. [Modes for carrying out the invention]

[0027] Ophthalmic systems (e.g., ophthalmic diagnostic systems, ophthalmic therapy systems (e.g., ophthalmic lasers such as yttrium aluminum garnet lasers and YAG lasers), and ophthalmic drug therapy (i.e., drug dispensing) systems) typically have a certain level of patient-instrument alignment requirements to ensure proper operation. Systems with higher alignment requirements are usually limited to clinical settings where a system operator (e.g., a technician) can assist in the system alignment process. Ophthalmic systems supporting self-administered ophthalmic procedures (home "self-acquisition" and / or "self-testing") ophthalmic devices typically rely on the patient self-aligning their eyes to the ophthalmic system. Small or portable ophthalmic systems, such as the ZEISS Matrix® Desktop Perimeter (frequency doubling technology (FDT) visual field measurement device), can be designed with a large exit pupil (eyebox) to accommodate a much wider range of pupil positions, thereby easing their ocular alignment requirements. However, such techniques for easing alignment requirements are not typically possible in high-precision ophthalmic systems such as ophthalmic surgical systems and ophthalmic imaging systems. Ophthalmic imaging systems, such as fundus imaging devices, optical coherence tomography (OCT) systems, and OCT angiography (OCTA) systems, tend to have high eye-system alignment requirements. This has hindered their use in self-managed applications (e.g., home applications), and has typically limited their use to clinical settings requiring high levels of system operator training or automation. The present invention aims to facilitate the operation of ophthalmic systems, including high-precision ophthalmic systems, by providing a mechanism / system for more easily achieving appropriate patient-system alignment.

[0028] For illustrative purposes and to demonstrate the effectiveness of the present invention, several embodiments of the present invention are presented herein as being implemented within ophthalmic imaging devices; however, it should be understood that the present invention can be incorporated into other types of ophthalmic systems, including therapeutic and drug therapy systems. A detailed description of several exemplary ophthalmic systems suitable for use according to the present invention is provided below; however, the applications of the present invention are not limited to these specific examples and may be applied to any ophthalmic system requiring ophthalmic alignment. Examples of ophthalmic systems that may incorporate the present invention include tonometers, ophthalmic drug dispensers / applicators (e.g., eye droppers), biometric systems, refractometers, visual field testers, wavefront sensors, slit lamps, ophthalmic laser processing systems, surgical devices, fundus imaging systems, OCT systems, and OCT angiography systems.

[0029] For illustrative purposes, Figure 1 shows a housing 11 for an ophthalmic system that may be found in a clinical setting. The housing 11 may house one or more types of ophthalmic systems, such as a fundus imaging device, OCT, or OCTA. The housing 11 may be placed on a surface 13 (e.g., an adjustable table) and may be coupled with a patient interface 15 that functions to position a patient 21 relative to the ophthalmic system 11. Typically, a conventional patient interface 15 may include a headrest 17 and / or chin rest 19 for supporting the patient 21 (or subject, e.g., the patient's eyes). Various parts of the instrument 11 and / or patient interface 15 may be moved relative to each other to facilitate ocular alignment of the instrument 11 while the subject is being imaged (e.g., by using hardware controls such as a joystick 23 and knobs 25, 27). A display (e.g., an electronic screen, not shown) may also be mounted on the table 13. An ophthalmic lens 29 may function as an aperture for the instrument for image acquisition, etc. Therefore, the joystick 23, knobs 25 / 27, and display may be used to adjust the position of the patient interface 15 and instrument 11 to adjust patient alignment to achieve the optimal horizontal, vertical, and axial position of the patient's eye / pupil relative to the system (e.g., the ophthalmic lens 29 and / or the internal optical elements of the system).

[0030] The present invention aims to facilitate the patient-system alignment process by eliminating the need for all (or most) alignment adjustments (or processes), whether self-alignment adjustments, operator-assisted alignment adjustments, or system-automated alignment adjustments. This is achieved by a mechanism / method for reliably and reproducibly positioning the patient's face in a known and predetermined position relative to the ophthalmic system. One approach is to use a patient-personalized facial interface (e.g., a full face mask or a partial face mask) having a molded forehead, nasal bone frame, cheek rests, and / or chin rest (or any combination thereof) that is custom-made (or custom-fitted) to the patient's facial features. As described below, this combination may preferably include a nasal bone frame that can be configured to hold the patient's nose in a predictable position (e.g., angle and position in 3D space) relative to the opening of the ophthalmic system.

[0031] Figure 2A shows a method for providing a patient-personalized face mask according to the present invention. The method may begin by acquiring a 3D model 31 of a patient 21. The 3D model 31 may be a "wireframe" or a polygon mesh, such as a quad mesh (4 edge / vertex combination) or a triangular mesh (3 edge / vertex combination). There are several methods for generating the 3D model 31, two of which are shown in Figure 2A as indicated by arrows 33 and 35. The first method is to use a 3D imaging device 37, such as a depth-sensing camera, which can be moved around the head of patient 21 to scan over the entire face and / or head of the patient (as indicated by arrows 39a and 39b). The depth-sensing camera 37 may be embodied in a portable device such as a smartphone or in other portable computing devices such as a tablet computer or custom computing / electronic device. The portable device may run a 3D scanning software application (app) and / or transmit the captured 3D data to a remote computer device (e.g., over the Internet or an intranet connection) for processing and / or generation of the 3D model 31. Optionally, the 3D model 31 may be fully or partially generated within the 3D imaging device 37.

[0032] Alternatively, the 3D imaging device can be implemented by a multi-camera imaging system 41. In this case, 3D data can be acquired by capturing multiple superimposed images of the patient 21 from various angles (e.g., simultaneously) using multiple cameras 38 preferably straddling the patient's face and / or head. While a single row of cameras 38 is shown, it should be understood that multiple rows / columns of cameras may be used (e.g., to straddle the upper and lower parts of the head). Again, the captured 3D data can be processed locally or remotely to generate a 3D model 31. The remote site processing the 3D model 31 may be accessible on a computer network such as a local area network (LAN) or the internet and may be provided as a website service (e.g., accessible via a web browser).

[0033] 3D imaging devices can embody other 3D scanning / imaging techniques, either alone or in combination. For example, a 3D imaging device can embody (or be based on) laser triangulation 3D scanning techniques, which can project a laser beam onto a face / head and measure the deformation of the laser beam. Another example is structured light 3D scanning techniques, which can measure the deformation of a light pattern on the face / head to 3D scan the shape of the face / head surface. Additional 3D imaging techniques include photogrammetry (e.g., "3D scanning from photography"), which can construct a 3D model of the face / head from multiple 2D image captures (e.g., captured digital images or photographs), usually by using computer vision algorithms and computational geometry algorithms. Yet another example is time-of-flight (e.g., "laser pulse") 3D scanning techniques 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 (3D model of face / head) can be determined from the time of laser progression between emission and reception. Alternatively, 3D models can also be constructed using various mechanical techniques, such as contact-based 3D scanning techniques. For example, contact-based 3D scanning techniques can be used to generate a 3D model by measuring / sampling several points on the face / head surface using the deformation (i.e., displacement) of a contact surface (e.g., a probe or multiple probes).

[0034] Regardless of how the 3D model is acquired, a patient-personalized (e.g., patient-specific) face mask 43 can be generated 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 face mask 43 or a portion thereof. Arrow 45 identifies an exemplary perspective view of the entire patient-personalized face mask 43, and arrow 47 identifies a side view of the entire face mask 43. In summary, the method may include generating a patient-specific 3D model 31, such as by 3D scanning the patient's face / head, and generating a physical mask 43 by using the patient-specific 3D model 31 as a guide. Not only are the contours, structures (e.g., skeleton), sizes, and positions (e.g., the position of the eye in the orbit relative to the nasal bone) of various parts of the patient's face / head known from the patient-specific 3D model 31, but it is also known which parts of the human face are generally rigid and which parts (e.g., cheeks) tend to be malleable or compressible, so that a face mask 43 can be generated that positions the patient's eyes in a desired alignment position relative to an ophthalmic device (e.g., an ophthalmic diagnostic device, an ophthalmic therapy device, an ophthalmic treatment device, or an ophthalmic drug dispensing device) when attached to the ophthalmic device.

[0035] Next, the 3D face mask 43 thus generated can be used as, or be part of, or incorporated into an existing patient interface for an ophthalmic device. Since the contours of the patient's face / head are known (e.g., determined from the patient's individual 3D face model), and the physical properties of the ophthalmic system / device (e.g., the position and orientation of the system's aperture, the system's optical path, imaging characteristics, etc.) are also known, the face mask 43 can be designed to hold the patient's head in a specific position and orientation for an ophthalmic device designed to provide optimal alignment to the ophthalmic device. That is, the exterior of the face mask (e.g., the outside of the mask facing the ophthalmic device) can be personalized for a particular patient and / or a particular ophthalmic device. For example, the exterior of the face mask can incorporate a custom connector for coupling to a particular ophthalmic device. The position of the connector (e.g., connector pins) and / or the shape of the face mask may be configured such that the patient's pupil is always positioned to coincide with the plane center of the ophthalmic device (e.g., zero in the XY plane), by considering, for example, 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, orbit, bridge of the nose, cheek structure, etc. Furthermore, the thickness and / or shape of the face mask may be configured relative to the ophthalmic device so that the face mask does not interfere with the working distance of the ophthalmic device (e.g., its adjustment). The face mask may also be designed to take patient comfort into consideration. For example, the face mask may provide sufficient clearance between the patient and the ophthalmic device to facilitate comfortable breathing and to avoid producing restrictive sensations (e.g., avoiding claustrophobic perception). Where necessary, the face mask may be constructed so that, when coupled to the ophthalmic device, the face mask shields the patient's eyes from ambient light. This may allow for natural dilation of the pupils. Furthermore, since the mechanical reference between the face mask and the ophthalmic device is fixed, the face mask can be made to fit snugly to the face, creating a light-shielding housing. This may be beneficial in several ophthalmic applications, such as imaging / scanning ophthalmic applications.Therefore, the interior of the face mask (e.g., the inside of the mask facing the patient) may be personalized (or associated) with a specific patient among several patients, and the exterior of the face mask may be customized (or associated) with a specific device among several (e.g., several types) of ophthalmic devices.

[0036] Figures 2B and 2C illustrate another method for generating a 3D model of a face (such as the 3D model 31 in Figure 2A), and Figure 2D builds upon the methods in Figures 2B and 2C to generate a custom face mask (such as the face mask 43 in Figure 2A). As described above, the 3D model may be defined using a mechanical contact-based scanning system, such a mechanical system may also provide the physical patient-personalized face mask itself, or function (fully or partially) as the physical patient-personalized face mask itself. Figure 2B shows an example of a contact-based 3D scanning system that may be used to define the 3D model 31 in Figure 2A. This contact-based 3D scanning system may include a contactor array 40 of individual movable probes (e.g., pins or pistons) 42, the contact surfaces (e.g., the tip 44a of the piston rod 44b) of which may be optionally covered by a film (not shown). When patient 46a pushes their face / head into the contactor array 40, different parts of the contactor array 40 will be deformed / displaced in different ways, as 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 come into contact with the tip 44a (or the membrane surface above the tip 44a), pushing forward the corresponding piston rod 44b, displacing the corresponding piston rod 44b by an amount determined by the face contour (e.g., optionally moving it into the cylinder barrel 44c). The resulting height (and / or the amount of its deformation / displacement) of each probe / piston 42 is detected / measured to encode the shape of the patient's face, thereby allowing for the generation of a face scan (which may be represented as a pin / piston / probe height (displacement / deformation) map). Figure 2C shows the use of the contactor array 40 in frame 48. After patient 46b pushes his face into the contactor array 40 as indicated by the curved arrow 50, the individual probe / piston / pin deformation / displacement positions 52 are read and stored to maintain a record of the 3D scan. Optionally, the displaced positions 52 may be locked in place within the frame 48.

[0037] This mechanical 3D scanning system can be adapted to function as a face mask (or part of a face mask) by being configured to have an open area (or translucent area) for light from an ophthalmic system to pass through and reach the patient's eye. Thus, this mechanical system can not only generate a 3D model of the face / head but also function as a patient-personalized (e.g., patient-specific) face mask. Figure 2D shows an exemplary use of a contactor array 40 in a frame 48 which may be integrated into or attachable to, or otherwise coupled to, the housing 11 of the ophthalmic system (see Figure 1), as described in more detail below. In this example, the contactor array 40 includes an aperture 60 for light to pass between the patient's eye 46b and the ophthalmic system. By locking the probe / piston / pin deformation 52 in place, the face mask of the patient's face / head is defined within the frame 48. That is, the probe position may be locked (and memorized) to ensure that "when the patient next brings their face to the face mask, the patient's head will be in the same position as the first time."

[0038] As described above, the probes / pistons / pins may be covered with a film or other soft piece(s) or surface(s)(s) to produce a surface similar to the 3D printed face mask 43 in Figure 2A. It should be understood that the contactor array 40 may be configured to capture / scan the contours of selected portions of the patient's face (e.g., to generate a partial face mask) and / or to store only the probe / piston / pin displacement / deformation information of selected portions of the patient's face. In this way, if probe displacement position data(s) (all of them, or selected portions of the piston corresponding to the mask shape) are stored, this data may be retrieved when the patient returns to the device. The probes / pistons / pins can then be returned (manually or automatically) to their previously detected positions and then locked in place. For example, the system may automatically actuate the selected cylinder barrels 44c in Figure 2B to move the individual piston rods 44b to their individually stored displacement positions (according to the corresponding probe height map as needed). This regenerates an accurate imprint of the patient's face / head in a usable state. It should be understood that this system stores mask information (e.g., probe height maps) for multiple patients in electronic memory and can retrieve custom mask information for each patient to reconfigure the mask (e.g., contactor array 48) to suit the specific patient who will be using the system. Therefore, this embodiment allows multiple patients to be imaged on the same device. For each different patient, the system retrieves the piston height map (e.g., from memory storage such as a local or remote database accessible via a computer network (e.g., the Internet)) and configures the device accordingly. This enables repeated measurements of larger groups in a central laboratory or station (e.g., in a nursing home or a walk-up laboratory in a clinic).Optionally, once the precise shape of the patient's face / head (or a target area of ​​the face / head such as the temples, the entire or partial nose (e.g., the bridge of the nose), and the cheekbones) has been scanned, the system may rotate and / or translate, or otherwise reposition, the face mask to ensure that "the patient will be properly aligned with the system the next time the patient touches the face mask."

[0039] For illustrative purposes, Figure 3 provides a perspective view of the housing 11 of Figure 1 and a full face mask 43 or a partial face mask 43' (indicated by arrow 49) that is incorporated (e.g., retrofitted) into the patient interface 15 of the system 11. Unless otherwise stated or understood from the context, it should be understood that all descriptions / embodiments / features of the face mask 43 and partial face mask 43' apply to the face mask defined by the probe array 40. The face mask replaces the need to align the system 11 in the X,Y,Z spatial directions (e.g., three-dimensional (3D) space). If the full face mask 43 is to be incorporated into the patient interface 15, the headrest 17 and / or chin rest 19 may be removed and replaced by the full face mask 43. When a partial face mask 43' is incorporated into the patient interface 15, the headrest 17 may be removed and replaced by the partial face mask 43', while the adjustable chin rest (cup) 19 may be optionally retained to provide not only chin rest functionality but also height adjustment. Alternatively, the patient interface 15 may be replaced by a new patient interface based on the full face mask 43 and / or partial face mask 43' (e.g., customized for the full face mask 43 and / or partial face mask 43'). While the partial face mask 43' is shown to include patient-specific forehead / cheek portions, it should be understood that different partial face mask configurations are possible. Several other partial face mask configurations are described below.

[0040] Figures 4a and 4b show profile diagrams of the housing 11 of Figure 3 incorporating the full face mask 43 and partial face mask 43' of Figure 2A, respectively. In Figure 4a, the full face mask 43 is incorporated into the patient interface 15, replacing the headrest 17 and chin rest 19 of Figure 3. In Figure 4b, the partial face mask 43' is incorporated into the patient interface 15, replacing the headrest 17, although the patient interface 15 can still provide general height adjustment using the chin rest cup 19. This would be an example of the full face mask 43 or partial face mask 43' used in a clinical setting. In this example, the full face mask 43 and partial face mask 43' are personalized to the patient's face and used to establish a known alignment between the ophthalmic system 11 and the patient's eyes 21. In other words, face masks 43 and 43' each have a pre-configured shape based on the known contours of the patient's face (determined from a pre-acquired 3D facial model of the patient and configured to hold the patient's face in a predetermined position (establishing known and desired alignments)). Using this method, the only task the patient 21 needs to perform is to place their face inside either face mask 43 or 43' to achieve alignment with little to no assistance from an operator or automated feedback system. Face masks 43 and 43' eliminate the need for X, Y, Z spatial adjustments to achieve proper patient-system alignment. Face masks 43 and 43' each have a pre-configured shape based on the known contours of the patient's face and configured to hold the patient's face in a predetermined position to establish desired and predetermined alignments. Because the face masks are personalized to the contours of the patient's face, the patient's own level of comfort becomes an indicator of proper alignment. In other words, the patient can identify that "when the number of pressure points generated by the face mask is minimized, the eyes are correctly aligned to the desired position." That is, when the patient's head is correctly positioned within the face mask 43 or 43', pressure points on the forehead, nasal bone, temples, cheeks, and / or chin are eliminated or minimized, creating a comfortable setting for the patient.The experimental results demonstrated a reproducible alignment accuracy of 0.1 mm in all three spatial dimensions (which would have previously required the assistance of many operators to achieve). Therefore, by using a patient-specific mask 43 or 43', the ophthalmic system is pre-aligned for each individual patient without any alignment adjustments before the patient approaches the ophthalmic system.

[0041] Optionally, the face masks 43, 43' may be removable and replaceable according to patient identification. For example, a library (e.g., collection or storage) of patient-specific personalized face masks may be constructed, and a first face mask corresponding to a first patient may be removed from the patient interface 15 and replaced with a second face mask corresponding to a second patient in preparation for examining the eyes of the second patient. In this way, the ease and speed of sequential examination of various patients may be improved.

[0042] Figure 5 shows an alternative, smaller-profile housing 51 suitable for self-administered ophthalmic treatment applications in home, caregiving, or other non-clinical settings where trained system operators / technicians may not be readily available. Such devices may be used to treat and / or monitor chronic or short-term diseases in a home care setting. In this example, the full face mask 43 and / or partial face mask 43' may be directly coupled to the housing 51 or form an integral part of the housing 51, as indicated by the individual arrows 53, 54. Alternatively, either the patient-specific face mask 43 or 43' may be incorporated into a patient interface (e.g., frame or support) 55, which may be part of the ophthalmic system including the housing 51 (as indicated by arrow 57).

[0043] Figure 6a shows a first configuration of an ophthalmic system 59 (e.g., home / portable) incorporating a face mask 43 and a housing 51. In this example, a patient interface 55 is fixed to the base 57 of the ophthalmic system 59 and holds a patient-specific face mask 43 in place to align the patient (not shown) with the housing 51. Similarly, the housing 51 may be held in a known predetermined position by an arm 61 coupled to the base 57. Optionally, the arm 61 may be coupled to a rail and / or ratchet system 62 for translational movement (e.g., left to right, forward and backward, up and down, and / or curved movement) and / or a swivel hub 63 for rotational movement of the housing 51. In this way, the system may provide position adjustment of the housing 51 for better patient comfort. Alternatively, the system may be pre-configured to modular positions deemed appropriate for a particular patient. The system may also provide position adjustment between predetermined positions (optionally lockable positions). For example, such a position may be set to provide alternatingly aligned fields of view for the patient's eyes (e.g., pupil and / or retina).

[0044] Figure 6b shows a second configuration of the ophthalmic system 51 of Figure 6a, where the light-shielding extension 64 is incorporated into the face mask 43 or the housing 51. In this way, when the face mask 43 is coupled to the ophthalmic housing / device 51, the face mask 43 functions to block ambient light (for example, it acts / functions as a light-shielding section).

[0045] Figure 6c shows a third configuration of the ophthalmic system 51 in Figure 6a, where the light-shielding extension 64 is rigid and provides sufficient structural support to directly connect the face mask to the ophthalmic housing / device 51. In this way, the patient interface 55 in Figure 6a can be eliminated. Optionally, a support rod 66 may provide additional structure as needed. The support rod may further provide an additional coupling for connecting to the face mask 43 and / or function as a rotating rod for lifting the face mask 43 and / or the light-shielding extension 64 above the housing 51.

[0046] The ophthalmic system may be binocular (for example, having two apertures for examining, imaging, diagnosing, treating, or drug-treating one eye individually or both eyes simultaneously) or monocular (for example, having one aperture for examining, imaging, diagnosing, treating, or drug-treating one eye at a time). In the case of a monocular system, the housing 51 (or its interior, which can define the optical path) may be moved from one position to another to align with one eye or the other (for example, sliding from left to right, and vice versa). In a binocular system, the housing 51 may 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, using a mirror switching system to selectively direct the field of view of either eye to the single optical path, or using a mechanism to physically move the single optical path within the housing 51 (for example, translationally and / or axially) so that it can selectively align with one or the other of the patient's two eyes).

[0047] Figures 7a and 7b illustrate two methods for aligning the monocular system to one of the patient's two eyes. In Figure 7a, the face mask 43 is stationary, and the housing 51 can be moved between at least two (predetermined) positions (each position aligning the housing 51 to one of the patient's individual eyes). In this example, the housing 51 can be swiveled around the swivel hub 63 from a first position 65a to a second position 65b (as indicated by arrow 67). When in position 65a, the housing 51 is aligned to the patient's right eye (as indicated by symbolic target crosshairs 69a). Similarly, when the housing 51 is in position 65b (as indicated by the dotted contour), the housing 51 is aligned to the patient's right eye, which is symbolically identified by target crosshairs 69b. Alternatively, the housing 51 can be moved laterally between positions 65a and 65b (e.g., using a rail system 62).

[0048] Figure 7b shows a second method for aligning the monocular system to one of the patient's two eyes. For simplicity of explanation, Figure 7b shows a front view of the face mask 43 as part of the patient interface 55, but omits the figure of the housing 51. It should be understood that the housing 51 is stationary and will be positioned in front of the face mask 43 in a manner similar to that of Figure 6a. In this embodiment, the face mask 43 can be moved between at least two (predetermined) positions while the housing 51 is stationary in front of the face mask 43. For example, the face mask 43 may be moved according to arrow 73a (e.g., by sliding along the rail of the patient interface 55) to a first position 71a that aligns the patient's left pupil 69a to the opening of the housing 51, and may be moved according to arrow 73b to a second position 71b that aligns the patient's right pupil 69b to the same opening of the housing 51.

[0049] Figures 8a, 8b, and 8c illustrate alternative embodiments of the ophthalmic system according to the present invention, where the face mask 43 may be positioned at one or more different oblique vertical inclination angles relative to the ophthalmic device housing 73. Embodiments of Figures 8a and 8b include a light-shielding section 72 similar to that in Figure 6c. In Figure 8a, the light-shielding section 72 (which may be part of the face mask 43) directly couples and supports the face mask 43 to the ophthalmic device housing 73. In Figure 8b, an optional support rod 74 may be provided to assist in coupling the face mask 43 to the ophthalmic device housing 73. Figures 8a–8c provide three different examples 75a, 75b, and 75c of the face mask 43 showing three different inclination angles α1, α2, and α3, respectively. As can be understood, each angle will require a different level of inclination by the patient to position the patient's face within the face mask 43. The patient may find a more comfortable tilt angle than other tilt angles, and the ophthalmic system may be configured to present the face mask 43 to a given patient or group of patients at a comfortable angle. The angle may be fixed or adjustable.

[0050] Figure 9 provides two configurations 77a and 77b of alternative embodiments, in which the ophthalmic system according to the present invention has a portable configuration, and the face mask 43 is directly coupled to the housing 51 without using a table base. This configuration may be beneficial when the ophthalmic device is lightweight and can be grasped with one or both hands. Optionally, one or more handles 79 (embodiment 77a) or one or more handles 81 (embodiment 77b) may be provided to facilitate grasping and positioning by the patient. In this way, the ophthalmic device can be used in an inclined or recumbent position without placing an excessive burden on a bedridden patient. That is, the ophthalmic device can be determined to be in a proper alignment state when it is comfortably pressed against the patient's face in a stationary position.

[0051] Optionally, the face mask 43 may include all or most of the patient interface. For example, Figures 10a and 10b show ophthalmic device housings that are directly coupled to the face mask 43. This structure is preferred when the ophthalmic device housing is small, such as when housing a tonometer 81 (shown in Figure 10a) and / or an eye medication dispenser (shown in Figure 10b) (shown in Figure 10b).

[0052] A tonometer measures intraocular pressure (IOP), which may be of particular interest to patients with glaucoma. Glaucoma is a cupping (detachment) of the optic nerve. This usually results in steadily progressing damage to the optic nerve, leading to a uniform and steady decline in the patient's field of vision. Without treatment, this can result in vision loss. The exact cause of glaucoma or damage to the optic nerve is not fully understood, but increased IOP has been identified as a likely indicator.

[0053] Therefore, home administration of medications and monitoring of intraocular pressure (IOP) are essential parts of glaucoma care. Both require fine motor skills over many years and continuous patient adherence, as people typically enter old age while living with the disease. However, it can be difficult for patients to adhere strictly to monitoring and medication administration plans without support. Self-managed medications (especially eye drop administration) have been shown to result in poor patient adherence and unsuccessful eye drop management outcomes. The global increase in chronic diseases (along with their associated burden on healthcare systems) is likely to increase the demand for patient self-management. One reason for poor adherence may be the difficulty associated with using such ophthalmic devices.

[0054] Figure 10a shows a tonometer 81 based on the rebound measurement principle, where a probe (e.g., a rod) 85 repeatedly moves in and out of the eyeball and rebounds to measure intraocular pressure (e.g., the tip of the rod 85a can be repeatedly pressed against the eyeball and bounced back). This device enables IOP monitoring outside the clinic and provides ophthalmologists with more information. Figure 10b shows a drug applicator base based on a droplet delivery system using a drug vial 83. Other drug delivery systems (e.g., for topical drugs) may include a probe that applies ophthalmic drugs by contacting the eye in a similar manner to the probe 85 of the tonometer 81, or a piezoelectric drug delivery system that ejects droplets of drug into the eye.

[0055] In any case, such ophthalmic devices are typically portable, and it can be difficult for elderly people or those with unstable hands to self-administer medical procedures that require bringing a portable ophthalmic device very close to or in contact with a person's eye. By typically attaching a portable ophthalmic device to a patient-specific face mask 43, the face mask 43 maintains the ophthalmic device at a predetermined and safe distance from the patient's eye, so that the patient can confidently bring the ophthalmic device (e.g., tonometer 81 or medication vial 83) to their eye.

[0056] This configuration also simplifies the use of the system in a lateral position, which may be preferable when applying ophthalmic drugs using a squeeze-type dropper, a manually activated (e.g., piezoelectric or piezo-printed) drug dispenser, or an automated electrical / electronic drug dispenser that automatically dispenses the drug when it senses that the eyeball is available (which may be determined, for example, using a camera).

[0057] Optionally, the coupling mechanism (e.g., connector arm) 87 for connecting / coupling the face mask 43 to a housing (e.g., a tonometer 81 or a drug vial 83) may have modular or flexible ends 87a for accepting various types of housings (e.g., a tonometer 81 or a drug vial 83) and thus various types of ophthalmic devices. In this way, the patient may be presented with a single face mask 43 to which any one of several ophthalmic devices (such as a tonometer 81 or an ophthalmic drug dispenser 83) can be selectively (interchangeably) attached.

[0058] While some of the embodiments described above demonstrate the use of a full-face patient-specific face mask 43, all embodiments may be carried out with a full face mask or a partial face mask. Figures 11a to 11e provide various examples of partial face masks. In all of these configurations, a portion of the face mask used may be configured to align with one or more bone regions of the patient's face (optionally to bone regions only). Figure 11a shows a two-piece partial face mask 91 including an upper portion 91a and a lower portion 91b. The upper portion 91a may span a first region R1 configured to align with the patient's forehead (and optionally, the patient's temple region) and a second region R2 configured to align with the patient's nasal bone. The lower portion 91b may span the patient's chin (and mandible).

[0059] Figure 11b shows an alternative one-piece partial face mask 93 spanning the forehead region R1 and the nasal bone region R2 in a similar manner to Figure 11a. When the partial face mask is coupled to a patient interface (for example, as shown in Figures 3-6), the portion of the patient's face not covered by the face mask can be fitted to the patient interface. For example, the patient interface may provide an adjustable chin rest, as shown in Figure 3, which can be fitted to the patient along with the patient's face embedded within the face mask.

[0060] Figure 11c shows yet another one-piece partial face mask 95 that expands the coverage of the partial face mask 93 to include at least a portion of the patient's cheek region R3. A third one-piece configuration that limits mask coverage to the nasal region R2 (optionally at least one portion of the nasal bridge and nasal cartridge) and the supraorbital ridge (e.g., brow ridge) R4 is shown in Figure 11d.

[0061] Optionally, all partial face mask configurations include at least the patient's nasal bone area. Referring to Figure 11e, a portion 99 of the face mask configured for the patient's nasal area R2 is effective in ensuring that the patient's face (and therefore the patient's eyes) are in a predetermined position (and angle) for proper alignment. The portion 99 preferably does not constrict the patient's nose, but proper alignment is improved by the patient comfortably inserting their nose into the portion 99. Having a face mask that covers other areas in addition to the patient's nose helps to provide the patient with additional points of contact as reference points.

[0062] When this face mask is incorporated into an ophthalmic system, such as a fundus imaging device or OCT-based system, which relies on a selective view of the patient's retina, critical alignment specifications may be required. In such cases, it may be beneficial to provide additional refinement techniques for alignment. This refinement technique may be provided simply by the patient changing their gaze direction, without any additional mechanical adjustment of the patient's position. In this situation, gaze adjustment may be provided by the inclusion of a fixation target within the ophthalmic system. The fixation target (e.g., fixation light or fixation light pattern) provides the patient with something to gaze at, thereby directing the patient's gaze in the desired direction. A more detailed description of the fixation target is given below.

[0063] Various hardware and architectures suitable for the present invention are described below. Visual field testing system The improvements described herein can be used in combination with any type of visual field tester / system (e.g., a perimeter). One such system is a “bowl” visual field tester VF0, as shown in Figure 12. The subject (e.g., patient) VF1 is shown observing a hemispherical projection screen (or other type of display) VF2, which is generally bowl-shaped, hence the name of the tester VF0. Typically, the subject is instructed to gaze at a point in the center of the hemispherical screen VF3. The subject places their head on a patient support, which may include a chin rest VF12 and / or a forehead rest VF14. For example, the subject places their head on the chin rest VF12 and their forehead on the forehead rest VF14. Optionally, the chin rest VF12 and forehead rest VF14 can be moved together or independently of each other to correctly fix / position the patient’s eye, for example, relative to a trial lens holder VF9 that may hold a lens through which the subject can view the screen VF2. For example, the chin rest and headrest can move independently vertically to accommodate different patient head sizes, and can move together horizontally and / or vertically to properly position the head. However, this is not limiting, and those skilled in the art can envision other arrangements / movements.

[0064] A projector or other image-forming 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. The subject VF1 indicates that they have seen the stimulus VF6 by activating user input VF7 (e.g., by pressing an input button). This subject response can be recorded by processor VF5. Based on the subject's response, processor VF5 may function to evaluate the field of vision of the eye and determine, for example, the size, position, and / or intensity of the test stimulus VF6 that can no longer be seen by subject VF1, thereby determining the (visible) threshold of the test stimulus VF6. A camera VF8 can be used to capture the patient's line of sight (e.g., gaze direction) throughout the examination. The gaze direction can be used to confirm patient alignment and / or the patient's adherence to the proper examination procedure. In this example, camera VF8 is positioned on the Z-axis relative to the patient's eye (e.g., relative to the trial lens holder VF9) and behind the bowl (screen VF2) to capture live images (one or more) or video of the patient's eye. In other embodiments, this camera may be positioned away from this Z-axis. Images from the gaze camera VF8 can optionally be displayed on a second display VF10 to the clinician (which may be interchangeably called a technician herein) to assist in patient alignment or verification of the examination. Camera VF8 can record and store one or more images of the eye during each stimulus presentation. This allows for the collection of tens to hundreds of images in a single visual field test, depending on the examination conditions. Alternatively, camera VF8 can also record and store full-length video during the examination, providing timestamps indicating when each stimulus was presented. Furthermore, images can also be collected between stimulus presentations to provide details of the subject's overall attention throughout the VF examination.

[0065] To correct refractive errors of the eye, the trial lens holder VF9 may be placed in front of the patient's eye. Optionally, the lens holder VF9 can carry or hold a liquid trial lens that can be used to provide variable refractive correction to the patient VF1 (see, for example, U.S. Patent No. 8,668,338, which is incorporated herein in its entirety by reference). However, it should be noted that the present invention is not limited to the use of liquid trial lenses for refractive correction, and other conventional / standard trial lenses known in the art may also be used.

[0066] In some embodiments, one or more light sources (not shown) that generate reflections from the surface of the eye, such as the cornea, can be placed in front of the subject's VF1 eye. In one modification, the light source may be a light-emitting diode (LED).

[0067] Figure 12 shows a projected field of view tester VF0, but the present invention as described herein can be used with other types of devices (field of view testers) that include devices that generate images via liquid crystal displays (LDCs) or other electronic displays (see, for example, U.S. Patent No. 8,132916, incorporated herein by reference). Other types of field of view testers include, for example, flat-screen testers, miniature testers, and binocular field of view testers. Examples of these types of testers can be found in U.S. Patent No. 8,371696, U.S. Patent No. 5,912723, U.S. Patent No. 8,931905, and U.S. Industrial Design Registration No. D472637, which are all incorporated herein by reference, respectively.

[0068] The visual field tester VF0 may incorporate an instrument control system (e.g., running an algorithm that may be software, code, and / or routine) that uses hardware signals and an electric positioning system to automatically position the patient's eye to the desired position (e.g., the center of the refractive correction lens in the lens holder VF9). For example, stepping motors may move the chin rest VF12 and forehead rest VF14 under software control. Rocker switches may be provided to allow the technician to adjust the patient's head position by operating the chin rest and forehead stepping motors. Manually movable refractive lenses may also be positioned as close to the patient's eye as possible on the lens holder VF9 without adversely affecting patient comfort. Optionally, the instrument control algorithm may pause the visual field test if such movement interferes with the performance of the test while the chin rest / or forehead motor movement is in progress.

[0069] Fundus imaging system Two categories of imaging systems used to image the fundus are floodlight imaging systems (or floodlight imaging devices) and scanning illumination imaging systems (or scanning imaging devices). Floodlight imaging devices simultaneously illuminate the entire field of view (FOV) of the object under examination, for example, by using a flash lamp, and capture a full-frame image of the object under examination (e.g., the fundus) using a full-frame camera (e.g., a camera with a two-dimensional (2D) optical sensor array large enough to capture the desired FOV as a whole). For example, a floodlight fundus imaging device illuminates the fundus of the eye and captures a full-frame image of the fundus in a single image acquisition sequence of the camera. Scanning imaging devices provide a scanning beam that scans across an object, such as an eye, and the scanning beam is imaged at different scanning positions when the scanning beam is scanned across the object and reconstructed to create a composite image of the desired FOV, for example, creating a series of image segments that can be synthesized. The scanning beam can be a point, a line, or a two-dimensional region such as a slit or a broad line.

[0070] Figure 13 illustrates an example of a slit-scanning ophthalmic system SLO-1 for imaging the fundus F, which is the inner surface of the eye E opposite to 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 a so-called "scan-descan" configuration, in which the scanning line beam SB traverses the optical components of the eye E (including the cornea Crn, iris Irs, pupil Ppl, and crystalline lens) so as to scan across the entire fundus F. In the case of a light-projecting fundus imaging device, a scanner is not required, and light is projected onto the entire desired field of view (FOV) at once. Other scanning configurations are known in the art, and a particular scanning configuration is not important to the present invention. As shown, the imaging system includes one or more light sources LtSrc, preferably a multicolor LED system or laser system with suitably tuned etendue. An optional slit Slt (adjustable or stationary) may be positioned in front of the light sources LtSrc and used to adjust the width of the scanning line beam SB. Additionally, the slit Slt may remain stationary during imaging or may be adjusted to different widths to allow for different confocal levels and different applications during scanning, either for specific scans or for reflection suppression. An optional objective lens ObjL may be placed in front of the slit Slt. The objective lens ObjL may be any of the leading lenses, including but not limited to refractive, diffracting, reflective, or hybrid lenses / systems. Light from the slit Slt passes through the pupil-splitting mirror 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 of the system. An optional optical system DL may be included to manipulate the optical distance between the images of the two components. The pupil-splitting mirror SM may pass the illumination beam from the light source LtSrc to the scanner LnScn and reflect the detection beam from the scanner LnScn (e.g., reflected light returning from eye E) towards the camera Cmr. The task of the pupil-splitting mirror SM is to separate the illumination beam and the detection beam and to assist in suppressing system reflections.The scanner LnScn can be a rotating Garbo 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 splitting is performed before or after the scanner LnScn, the scan can be divided into two steps, with one scanner in the illumination path and separate scanners in the detection path. Specific pupil splitting configurations are described in detail in U.S. Patent No. 9,456,746, which is incorporated herein by reference in its entirety.

[0071] From the scanner LnScn, the illumination beam passes through one or more optical systems, in this case a scanning lens SL and an ophthalmic or eyepiece lens OL, which allow the pupil of eye E to be imaged into the system's image pupil. Generally, the scanning lens SL receives the scanning illumination beam from the scanner LnScn at one of several scanning angles (angle of incidence) and generates a scanning line beam SB with a substantially planar focal plane (e.g., a collimated optical path). The ophthalmic lens OL focuses the scanning line beam SB onto the fundus F (or retina) of eye E, so that the fundus can be imaged. In this way, the scanning line beam SB creates a transverse scanning line that moves across the fundus F. One possible configuration of these optical systems is a Keplerian telescope in which the distance between the two lenses is selected to produce an intermediate fundus image (4-f configuration) with a substantially telecentric distance. 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 hybrid, as is known to those skilled in the art. The focal lengths of the ophthalmic lens OL, scanning lens SL, pupil division mirror SM, and scanner LnScn may vary depending on the desired field of view (FOV). Therefore, arrangements can be envisioned where multiple components can be switched in and out of the beam path, for example, by using optical system flips, motorized wheels, or detachable optical elements, depending on the field of view. Since changes in the field of view result in different beam sizes on the pupil, the pupil division can also be changed in accordance with the change in 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° to 120° or more, can also be achieved. Wide field of view FOVs may be desirable in combination with broadline fundus imaging devices (BLFI) and other imaging modalities such as optical coherence tomography (OCT). The upper limit of the field of view may be determined by the accessible working distance combined with physiological conditions around the human eye. Because a typical human retina has a field of view (FOV) of 140° horizontally and 80°–100° vertically, it is sometimes desirable to have an asymmetrical field of view with respect to the highest possible FVO on the system.

[0072] The scanning beam SB passes through the pupil Ppl of eye E and is directed to the retina or fundus, i.e., the surface F. The scanner LnScn1 adjusts the position of the light on the retina or fundus F so that a range of lateral positions of eye E is illuminated. The reflected or scattered light (or synchrotron light in the case of fluorescence imaging) is directed along a similar path to the illumination and defines a focused beam CB on the detection path to the camera Cmr.

[0073] In the “scan-descan” configuration of the exemplary slit-scanning ophthalmic system SLO-1 of the present invention, the light returning from the eye E is “descanned” by the scanner LnScn on its way to the pupil-splitting mirror SM. That is, the scanner LnScn scans the illumination beam SB from the pupil-splitting mirror SM to define a scanning illumination beam SB that crosses the eye E, but since the scanner LnScn also receives the light returning from the eye E at the same scanning position, it has the effect of descanning the light returning (e.g., canceling the scanning operation) to define a non-scanning (e.g., steady or stationary) focused beam from the scanner LnScn to the pupil-splitting mirror SM, which then folds the focused beam toward the camera Cmr. At the pupil-splitting mirror SM, the reflected light (or emitted light in the case of fluorescence imaging) is separated from the illumination light on the detection path, which is led to the camera Cmr, which may be a digital camera having a light sensor to capture an image. The imaging (e.g., objective lens) lens ImgL may be positioned in the detection path so that the fundus is imaged by the camera Cmr. As in the case of the objective lens ObjL, the imaging lens ImgL can be any type of lens known in the art (e.g., refractive, diffracting, reflective, or hybrid lens). Additional operational details, in particular methods for reducing artifacts in the image, are described in International Publication No. 2016 / 124644, the entire contents of which are incorporated herein by reference. The camera Cmr captures the received image and, for example, creates an image file, which can be further processed by one or more (electronic) processors or computing devices (e.g., the computer system shown in Figure 16). Thus, the focused beam (returning from all scanning positions of the scan line beam SB) is collected by the camera Cmr, and the full-frame image Img can be constructed from the synthesis of the individually captured focused beams, by montage, etc. However, other scanning configurations are also conceivable, including one in which the illumination beam is scanned across the eye E and the focused beam is scanned across the camera's photosensor array.International Publication No. 2012 / 059236 and U.S. Patent Application Publication No. 2015 / 0131050, incorporated herein by reference, describe several embodiments of slit-scanning ophthalmoscopy, including various designs such as designs in which the reflected light is swept across the camera's optical sensor array and designs in which the reflected light is not swept across the camera's optical sensor array.

[0074] 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, and both the processor and the display may be part of the image system itself, or they may be part of a separate, dedicated processing and / or display unit, such as a computer system, where data is transmitted from the camera Cmr to the computer system via a cable or computer network, including a wireless network. The display and processor may be an integrated unit. The display may be a conventional electronic display / screen or a touchscreen and may include a user interface for displaying information to and receiving information from the equipment operator or user. The user may 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.

[0075] It is sometimes desirable for the patient's gaze to remain fixed during imaging. One way to achieve gaze fixation is to provide a fixation target that the patient can be instructed to gaze at. The fixation target can be inside or outside the device, depending on which area of ​​the eye is being imaged. One embodiment of an internal fixation target is shown in Figure 13. In addition to the primary light source LtSrc used for imaging, an optional second light source FxLtSrc, such as one or more LEDs, can be positioned using a lens FxL, a scanning element FxScn, and a reflector / mirror FxM so that a light pattern is imaged onto the retina. The fixation scanner FxScn can move the position of the light pattern, and the reflector FxM guides the light pattern from the fixation scanner FxScn to the fundus F of the eye E. Preferably, the fixation scanner FxScn is positioned in the pupil plane of the system so that the light pattern on the retina / fundus can be moved according to the desired fixation position.

[0076] Slit-scan ophthalmoscopy systems can operate in different imaging modes depending on the light source and wavelength-selective filtering elements used. True-color reflectivity imaging (similar to imaging observed by clinicians when examining the eye using a handheld or slit-lamp ophthalmoscope) can be achieved by imaging the eye using a series of colored LEDs (red, blue, and green). Each color image can be constructed stepwise with each LED turned on at each scanning position, or each color image can be captured separately and completely. The three color images can be combined to display a true-color image, or 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 retina. Additionally, light of specific frequencies (e.g., individual colored LEDs or lasers) can be used to excite different phosphors (e.g., autofluorescence) within the eye, and the resulting fluorescence can be detected by filtering out the excitation wavelength.

[0077] Fundus imaging systems can also provide infrared reflectance images by using an infrared laser (or other infrared light source). The infrared (IR) mode has the advantage that the eye is not sensitive to IR wavelengths. This infrared (IR) mode can allow the user to continuously capture images without interfering with the eye, for example, to assist the user during instrument alignment. Additionally, IR wavelengths have high penetration through tissue and can improve the visualization of choroidal structures. Furthermore, fluorescein angiography (FA) and indocyanine green (ICG) angiography can be achieved by acquiring images after a fluorescent dye has been injected into the patient'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 patient's bloodstream. It should be noted that fluorescent dyes can cause life-threatening allergic reactions in some individuals, so caution is necessary. High-contrast grayscale images are captured using specific light frequencies selected to excite the dye. As pigments flow through the eye, various parts of the eye glow brightly (for example, they fluoresce), making it possible to visualize how the pigments, and consequently the blood flow, are progressing within the eye.

[0078] Optical coherence tomography system In addition to fundus photography, fundus autofluorescence (FAF), and fundus angiography (FA), ophthalmic images may be produced by other imaging modalities, such as optical coherence tomography (OCT), optical coherence tomography (OCTA), and / or ophthalmic ultrasound. The present invention, or at least a part of it, may be applied to these other ophthalmic imaging modalities with some modifications, as is understood in the industry. More specifically, the present invention may also be applied to ophthalmic images produced by OCT / OCTA systems that produce OCT and / or OCTA images. For example, the present invention may also be applied to en face OCT / OCTA images. Examples of fundus images are provided in U.S. Patent No. 8,967806 and No. 8,998411, examples of OCT systems are provided in U.S. Patent No. 6,741359 and No. 9,706915, and examples of OCTA imaging systems may be found in U.S. Patent No. 9,700206 and No. 9,759544, all of which are incorporated herein by reference in their entirety. For the sake of clarity, exemplary examples of OCT / OCTA systems are provided herein.

[0079] Figure 14 illustrates a general frequency-domain optical coherence tomography (FD-OCT) system for acquiring 3D image data of the eye suitable for use with 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 with short time coherence lengths or swept laser light sources. The beam of light from the light source LtSrc1 is typically guided by an optical fiber Fbr1 to illuminate a sample, e.g., an eye E, a typical sample being human intraocular tissue. The light source LrSrc1 can be either a broadband light source with short time coherence lengths in the case of spectral-domain OCT (SD-OCT) or a wavelength-tunable laser source in the case of swept light source OCT (SS-OCT). The light is typically scanned by a scanner Scrnr1 between the output of the optical fiber Fbr1 and the sample E, thereby scanning the beam of light (dashed line Bm) laterally (in x and y) over the image acquisition area of ​​the sample. In full-field OCT, a scanner is not required, and light is directed across the entire desired field of view (FOV) at once. Light scattered from the sample is focused onto the same optical fiber Fbr1 typically used to guide the illumination light. A reference light derived from the same light source LtSrc1 travels along a different path, in this case including an optical fiber Fbr2 and a back reflector RR1 with an adjustable optical delay. As those skilled in the art will know, a transmissive reference path can also be used, and the adjustable delay can be placed within the sample or the reference arm of the interferometer. The focused sample light is typically coupled with the reference light at a fiber coupler Cplr1 to form an optical interference within the OCT photodetector Dtctr1 (e.g., a photodetector array, digital camera, etc.). Although it is shown that one fiber port reaches the detector Dtctr1, as those skilled in the art will know, various designs of interferometers can be used for balancing or unbalancing the interference signal. The output from detector Dtctr1 is supplied to processor Cmp1 (e.g., a computing device), which converts the observed interference into sample depth information. The depth information is stored in memory associated with processor Cmp1 and / or may be displayed on a display (e.g., a computer / electronic display / screen) Scin1.Processing and storage functions may be located within the OCT device, or the functions may be performed on an external processing unit (e.g., the computer system shown in Figure 16) to which the collected data is transferred. This unit may be dedicated solely to data processing, or it may perform other general tasks not specific to the OCT device. Processor Cmp1 may include, for example, a field-programmable gate array (FPGA), digital signal processor (DSP), application-specific integrated circuit (ASIC), graphics processing unit (GPU), system-on-a-chip (SoC), central processing unit (CPU), general-purpose graphics processing unit (GPGPU), or a combination thereof, which perform some or all of the data processing steps before or in parallel with supplying them to the host processor.

[0080] The sample arm and reference arm within the interferometer can consist of a bulk optical system, a fiber optical system, or a hybrid bulk optical system, and can have different architectures, such as Michelson, Mach-Zehnder, or common path system designs, as is known to those skilled in the art. The term "light beam," as used herein, should be interpreted as any carefully directed optical path. Instead of mechanically scanning a beam, the light field can illuminate a one- or two-dimensional area of ​​the retina to generate OCT data (e.g., U.S. Patent No. 9332902, D. Hillmann et al., "Holoscopy-holographic optical coherence tomography," Optics Letters, Vol. 36(13), p. 2290, 2011; Y. Nakamura et al., "High-Speed ​​three-dimensional human retinal imaging by line field spectral domain optical coherence tomography," Optics Express). (See Applied Optics, Vol. 44(36), p. 7722 (2005)), Blazkiewicz et al., "Signal-to-noise ratio study of full-field Fourier-domain optical coherence tomography," Express, Vol. 15(12), p. 7103, 2007. In time-domain systems, the reference arm must have an adjustable optical delay to produce interference. Balance detection systems are typically used in TD-OCT and SS-OCT systems, and spectrometers are used in detection ports for SD-OCT systems. The inventions 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 to multiple types of ophthalmic diagnostic systems and / or ophthalmic diagnostic systems including, but not limited to, fundus imaging systems, visual field testing devices, and scanning laser polarimeters.

[0081] In Fourier-domain optical coherence tomography (FD-OCT), each measurement is a real-value spectrally controlled interference figure (Sj(k)). The real-value spectral data typically undergoes several post-processing steps, including background removal and dispersion correction. The Fourier transform of the processed interference figure yields the complex OCT signal output Aj(z) = |Aj|eiφ. From the absolute value of this complex OCT signal, |Aj|, ​​the scattering intensity at different path lengths, and therefore the scattering profile with respect to depth (z-direction) within the sample, is revealed. Similarly, the phase φj can also be extracted from the complex OCT signal. The scattering profile with respect to depth is called the axial scan (A-scan). A collection of A-scans measured at adjacent locations within the sample generates a cross-sectional image (tomographic image or B-scan) of the sample. A collection of B-scans collected at different lateral locations on the sample constitutes a data volume or cube. For a given data volume, the fast axis refers to the scanning direction along a single B-scan, and the slow axis refers to the axis along which multiple B-scans are collected. The term "cluster scan" may refer to a unit or block of data generated by repeated acquisitions at the same (or substantially the same) location (or region) for the purpose of analyzing motion contrast that may be used to identify blood flow. A cluster scan can consist of multiple A-scans or B-scans collected at relatively short time intervals at approximately the same location on a sample. Because the scans in a cluster scan are of the same region, static structures remain relatively unchanged between scans in the cluster scan, whereas motion contrast between scans that meet certain criteria may be identified as blood flow. Various methods for generating B-scans are known in the art, and these include, but are not limited to, those along the horizontal or x-direction, along the vertical or y-direction, along the x and y diagonals, or in circular or spiral patterns. A B-scan may be in the xz dimension, but may also be a cross-sectional image including the z dimension.

[0082] In OCT angiography or functional OCT, the analysis algorithm may be applied to OCT data collected at different times (e.g., cluster scans) at the same or nearly the same sample location on the sample to analyze motion or flow (see, for example, U.S. Patent Publication Nos. 2005 / 0171438, 2012 / 0307014, 2010 / 0027857, 2012 / 0277579, and U.S. Patent No. 6549801, all of which are incorporated herein by reference). The OCT system may use any one of many OCT angiography processing algorithms (e.g., motion contrast algorithms) to identify blood flow. For example, a motion contrast algorithm can be applied to intensity information derived from image data (intensity-based algorithm), phase information from image data (phase-based algorithm), or complex image data (complex-based algorithm). An en-face image is a 2D projection of 3D OCT data (e.g., by averaging the intensity of each individual A-scan, thereby defining each A-scan as a pixel in the 2D projection). Similarly, an en-face vascular image is an image that displays motion contrast signals, in which the data dimension corresponding to depth (e.g., the z-direction along the A-scan) is typically represented as a single representative value (e.g., a pixel in the 2D projection image) by adding or accumulating all or isolated portions of the data (see, for example, U.S. Patent No. 7301644, which is incorporated herein by reference in its entirety). An OCT system that provides angiography capabilities may be called an OCT angiography (OCTA) system.

[0083] Figure 15 shows an example of an en face vascular structure image. After processing the data and highlighting the motion contrast using one of the motion contrast methods known in the industry, a pixel range corresponding to a certain tissue depth from the surface of the retinal internal limiting membrane (ILM) is added to the en face of the vascular structure. A face image (e.g., a front view) may be generated.

[0084] Computing devices / systems Figure 16 illustrates an exemplary computer system (or computing device or computer device). In some embodiments, one or more computer systems may provide the functions 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), or a single-board computer system (SBC) (e.g., a computer-on-a-module (COM) or system-on-a-module (SOM)), a desktop computer system, a laptop or notebook computer system, a computer system mesh, a mobile phone, a portable information terminal (PDA), a server, a tablet computer system, an augmented / virtual reality device, or two or more combinations thereof. Where appropriate, the computer system may reside in a cloud, which may include one or more cloud components in one or more networks.

[0085] In some embodiments, the computer system may include a processor Cpnt1, memory Cpnt2, storage Cpnt3, an input / output (I / O) interface Cpnt4, a communication interface Cpnt5, and a bus Cpnt6. The computer system may optionally also include a display Cpnt7, such as a computer monitor or screen.

[0086] Processor Cpnt1 includes hardware for executing instructions, such as components of a computer program. For example, processor Cpnt1 may be a central processing unit (CPU) or a general-purpose computing-on-graphics processing unit (GPGPU). Processor Cpnt1 may read (or fetch) instructions from internal registers, internal caches, memory Cpnt2, or storage Cpnt3, decode and execute these 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 speed up the reading of these instructions by processor Cpnt1. Processor Cpnt1 may include any appropriate number of internal registers and may include one or more arithmetic logic units (ALUs). Processor Cpnt1 may be a multicore processor or may include one or more processors Cpnt1. While this disclosure describes and illustrates a specific processor, this disclosure assumes any appropriate processor.

[0087] Memory Cpnt2 may include main memory that stores instructions for processor Cpnt1 to execute processes or hold intermediate data during processing. For example, a computer system may load instructions or data (e.g., a data table) into memory Cpnt2 from storage Cpnt3 or from another source (e.g., another computer system). Processor Cpnt1 may load instructions and data from memory Cpnt2 into one or more internal registers or internal caches. To execute an instruction, processor Cpnt1 may read and decode the instruction from an internal register or internal cache. During or after the execution of an instruction, processor Cpnt1 may write one or more results (which may be intermediate or final results) to an internal register, internal cache, memory Cpnt2, or storage Cpnt3. Bus Cpnt6 may include one or more memory buses (each of which may include an address bus and a data bus) that connect processor Cpnt1 to memory Cpnt2 and / or storage Cpnt3. Optionally, one or more memory management units (MMUs) facilitate data transmission between the processor Cpnt1 and memory Cpnt2. Memory Cpnt2 (which may be high-speed volatile memory) may include random-access memory (RAM), such as dynamic RAM (DRAM) or static RAM (SRAM). Storage Cpnt3 may include long-term or high-capacity memory storage for data or instructions. Storage Cpnt3 may be built into or external to the computer system and may include one or more of the following: disk drives (e.g., hard disk drives (HDD) or solid-state drives (SSD)), flash memory, ROM, EPROM, optical disks, magneto-optical disks, magnetic tapes, Universal Serial Bus (USB)-accessible drives, or other types of non-volatile memory.

[0088] The I / O interface Cpnt4 may be software, hardware, or a combination of both, and may include one or more interfaces (e.g., serial or parallel communication ports) for communicating with I / O devices, which may enable 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, table, touchscreen, trackball, video camera, other suitable I / O devices, or two or more combinations thereof.

[0089] Communication interface Cpnt5 may provide a network interface for communicating with other systems or networks. Communication interface Cpnt5 may include a Bluetooth® interface or other types of packet-based communication. For example, communication interface Cpnt5 may include a network interface controller (NIC) and / or a wireless NIC or wireless adapter for communication with a wireless network. Communication interface Cpnt5 may provide communication with Wi-Fi networks, ad-hoc networks, personal area networks (PANs), wireless PANs (e.g., Bluetooth WPAN), local area networks (LANs), wide area networks (WANs), metropolitan area networks (MANs), mobile phone networks (e.g., Global System for Mobile Communications (GSM®) networks), the Internet, or a combination of two or more of these.

[0090] Bus Cpnt6 may provide communication links between the aforementioned components of the computing system. For example, bus Cpnt6 may include an Accelerated Graphics Port (AGP) or other graphics bus, an Enhanced Industry Standard Architecture (EISA) bus, a Frontside Bus (FSB), a HyperTransport (HT) interconnect, an Industry Standard Architecture (ISA) bus, an InfiniBand bus, a Low-Pin-Count (LPC) bus, a memory bus, a Microchannel Architecture (MCA) bus, a Peripheral Component Interconnect (PCI) bus, a PCI-Express (PCIe) bus, a Serial Advanced Technology Attachment (SATA) bus, a Video Electronics Standards Association Local (VLB) bus, or any other suitable bus, or a combination of two or more of these.

[0091] While this disclosure describes and illustrates a particular computer system having a particular number of particular components in a particular arrangement, this disclosure also assumes any particular computer system having any particular number of particular components in any particular arrangement.

[0092] In this specification, computer-readable non-temporary storage media may include one or more semiconductor-based or other integrated circuits (ICs) (e.g., field-programmable gate arrays (FPGAs) or application-specific ICs (ASICs)), hard disk drives (HDDs), hybrid hard drives (HHDs), optical disks, optical disk drives (ODDs), magneto-optical disks, magneto-optical drives, floppy diskettes, floppy disk drives (FDDs), magnetic tapes, solid-state drives (SSDs), RAM drives, secure digital cards or drives, or any other suitable computer-readable non-temporary storage media, or any two or more of these in any suitable combination. Computer-readable non-temporary storage media may be volatile, non-volatile, or a combination of volatile and non-volatile, as appropriate.

[0093] Although the present invention has been described in conjunction with several specific embodiments, many other alternatives, improvements, and variations will be apparent to those skilled in the art by referring to the above description. Therefore, the invention described herein is intended to encompass all such alternatives, improvements, applications, and variations that may fall within the spirit and scope of the accompanying claims.

Claims

1. 1. An ophthalmic system comprising: An ophthalmic system comprising a patient interface including a face mask that establishes a predetermined alignment between the ophthalmic system and the patient's eyes.

2. The system of claim 1 , wherein the ophthalmic system is one of an ophthalmic diagnostic system, an ophthalmic treatment system, or an ophthalmic medication dispensing system.

3. 3. The system of claim 1, wherein the face mask is personalized to the patient's face.

4. 4. The system of claim 1, wherein the face mask has a pre-configured shape based on known contours of the patient's face and is configured to hold the patient's face in a predetermined position that establishes the predetermined alignment.

5. 5. The system of claim 4, wherein the patient's face is in the predetermined position when the number of pressure points caused by the face mask is minimized.

6. 6. The system of claim 1, wherein the face mask is 3D printed.

7. 7. The system of claim 1, wherein the face mask is 3D printed based on a pre-acquired 3D model of the patient's face.

8. The system of claim 7 , wherein the 3D model is acquired using a 3D imaging device.

9. The system of claim 8 , wherein the 3D imaging device includes one or more of a depth-sensing camera and a multi-camera imaging system.

10. The system according to claim 8 , wherein the 3D imaging device is integrated into a smartphone.

11. 11. The system of claim 8, wherein the 3D imaging device 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.

12. 12. The system of any one of claims 1 to 11, wherein the face mask is removable and replaceable according to patient identification.

13. The system of claim 7 , wherein the 3D model is acquired using a mechanical scanning system including one or more contact probes.

14. 6. The system of claim 1, wherein the face mask is embodied in a mechanical scanning system including a plurality of contact probes, the displacement of the contact probes defining the contours of the face mask.

15. 15. The system of claim 14, wherein the contact probe is displaced in response to a patient pressing their face into the mechanical scanning system, and the displaced position of the contact probe is lockable in the displaced position.

16. 16. The system of claim 15, wherein the displaced positions of the contact probes define a probe height map stored in electronic memory, and a selected probe is movable to a target position defined by the corresponding already-stored probe height map of the selected probe.

17. 17. The system of claim 16, wherein the electronic memory stores a plurality of probe height maps for a plurality of different patients, and the face mask of the mechanical scanning system is configurable for any selected patient from among the plurality of different patients by moving a selected probe to a corresponding target position of the selected probe according to the stored probe height map of the selected patient.

18. The system includes an ophthalmic device and a connector that couples the face mask to the ophthalmic device; 18. The system of claim 1, wherein the connector is adapted to receive a plurality of different types of ophthalmic devices.

19. 20. The system of claim 18, wherein the plurality of different types of ophthalmic devices comprises one or more of a tonometer, a therapeutic drug dispenser, a fundus imaging system, an optical coherence tomography system, an optical coherence tomography angiography system, a biometric system, a refractor, a visual field tester, a surgical device, an ophthalmic laser, and a wavefront sensor.

20. The system includes an ophthalmic device and a connector that couples the face mask to the ophthalmic device; the face mask is one of a plurality of personalized face masks, each personalized for a different patient; 20. The system of any one of claims 1-19, wherein the connector is adapted to selectively receive any of the plurality of personalized face masks.

21. 21. The system of claim 1, wherein the face mask is one of a full face mask or a partial face mask that covers one or more of the patient's forehead, cheekbones, bridge of the nose, and chin.

22. 21. The system of claim 1, wherein the face mask is a partial face mask configured to align only one or more bones of the patient's face, including the nasal bone.

23. 23. The system of any one of claims 1 to 22, wherein the face mask is a partial face mask integrated into the patient interface, and a portion of the patient's face not covered by the face mask is fitted to the patient interface.

24. The system of claim 1 , wherein the ophthalmic system is portable.

25. The system of claim 1 , wherein the ophthalmic system includes a fixation target.

26. 26. The system of any one of claims 1 to 25, wherein the ophthalmic system includes one or more of a fundus imaging system, an optical coherence tomography system, an optical coherence tomography angiography system, a biometric system, a refractor, a visual field tester, a wavefront sensor, a tonometer, a surgical device, an ophthalmic laser, and a therapeutic drug dispenser.

27. 27. The system of claim 1, wherein the face mask forms a light-tight enclosure where the patient's face shields the eyes from ambient light.

28. 28. The system of any one of claims 1 to 27, wherein the face mask allows natural dilation of the eyes by blocking ambient light from the eyes.

29. The system includes an ophthalmic device; the internal configuration of the face mask is patient-specific; 29. The system of any one of claims 1 to 17 and 21 to 28, wherein the external configuration of the face mask is specific to the ophthalmic device.

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