System and method for subjective float assessment

Abstract

An automated system for assessing the subjective severity of a patient-perceived float in an eye of a patient includes a display screen, a patient-operated feedback device, and a float assessment system (FAS). The FAS is configured to present a visual target on the display screen at a primary gaze point and possibly at a plurality of secondary gaze points arranged radially around the primary gaze point. The FAS also receives a feedback signal from the patient operated feedback device in response to the patient activating the patient operated feedback device. The feedback signal is indicative of the position and possible size of the float in the patient's field of view perceived by the patient. In addition, the FAS uses the feedback signal to calculate a numerical float severity score that quantifies the subjective severity of the float (s).

Description

Cross-references to related applications on systems and methods for subjective floating object assessment

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 614,830, filed December 26, 2023, which is incorporated herein by reference in its entirety for all purposes. Background Technology

[0002] This disclosure relates to hardware-based and associated software technologies for assessing the severity of floaters in the vitreous humor of a patient's eye.

[0003] The human eye is filled with a viscous gel containing collagen, called the vitreous body, vitreous fluid, or simply the vitreous. In a healthy eye, the vitreous body is transparent, a feature that allows light entering the eye through the pupil to travel unobstructed through the vitreous body to the retina. However, factors such as a patient's age, level of myopia, and history of injury can cause the vitreous body to liquefy and the collagen fibers to clump together over time. Within the vitreous cavity of the eye, clumps of collagen fibers can project shadows onto the retina. These shadows may appear as irregularly shaped lines, spiderwebs, or spots, and can appear anywhere in the patient's field of vision.

[0004] While floaters are often small or transparent enough to be ignored by patients, depending on their size, number, and location within the vitreous cavity, they can adversely obstruct a patient's vision to some extent. To appropriately address the severity and potentially treat symptomatic floaters, ophthalmic surgeons can illuminate the vitreous cavity and observe the vitreous in real time using a set of magnifying optics. However, floaters are dynamic phase objects that typically absorb only 1-2% of incident light. Due to the significant variability in floater composition and floater tolerance within a given patient population, determining floater severity in an accurate and reproducible manner can be challenging. Summary of the Invention

[0005] This paper discloses a system for assessing the severity of floaters in a patient's eye and an associated clinic-based approach. This disclosure enables a simplified, technician-monitored, self-guided psychophysical floater assessment performed within a clinic based on standardized parameters. Among other collateral benefits, this solution allows for accurate and repeatable assessment of floater severity to inform potential treatment decisions, such as laser vitrectomy or vitrectomy. In particular, the system and method described herein can be used prior to interactive, real-time visualization to help identify floaters that may be medically significant or symptomatic, i.e., potential candidates for surgical treatment.

[0006] In particular, a representative embodiment of a system for subjectively assessing the severity of floaters perceived by a patient in their eye, wherein the system captures the patient's response to floaters perceived anywhere in the patient's field of vision. The system may include a display screen, a patient-operated feedback device, and an electronic floater assessment system (FAS) communicating with the display screen and the feedback device. The FAS is configured to perform psychophysical floater assessment by presenting a visual target on the display screen (e.g., in various embodiments, an observation station or virtual reality (VR) glasses). Target presentation occurs at a primary fixation point, which is typically a neutral "directly forward" fixation as understood in the art.

[0007] In one or more alternative embodiments, a plurality of secondary fixations may be eccentrically arranged around the primary fixation point at different distances or locations, such that these secondary fixations are located outside the fovea, for example, above, below, to the left, to the right, or diagonally relative to the visual axis extending between the patient's pupil and the primary fixation point.

[0008] In the embodiments envisioned herein, the FAS responds to patient activation of a feedback device, receiving feedback signals from which the feedback signals indicate the position of(multiple) floaters relative to a visual target as perceived by the patient. The FAS then uses the feedback signals to calculate a numerical floater severity score. Subsequently, the surgeon can assign practical medical meaning to(multiple) floaters based on the patient's subjective input and other objective and / or subjective criteria described below.

[0009] In one or more embodiments, the FAS is configured to present a visual target at the primary fixation point on the display screen, thereafter the patient maintains focus on the primary fixation point while recording instances of floaters within their visual field. In other alternative embodiments, the visual target may be presented sequentially above, to each side, and below the primary fixation point according to a predetermined evaluation sequence, wherein the visual target may return to the position of the primary fixation point during evaluation at each secondary fixation point. This approach is based on the Busacca rise phenomenon detected via a slit-lamp test performed by a physician and can be used to collect information about vitreous movement relative to eye movement, for example, to determine whether floaters consistently obstruct the patient's central vision.

[0010] In embodiments that implement optional secondary fixations, the FAS can also be configured to maintain the visual target at the primary fixation point and at each different secondary fixation point for a calibrated dwell time, for example, several seconds or longer at each point.

[0011] In a possible implementation, different secondary fixation points can be separated from each other by about 5° to about 10°.

[0012] The FAS can also be configured to diagnose one or more floaters perceived by the patient that are potentially "medically significant" (i.e., sufficient to obstruct the patient's normal vision), thus necessitating further evaluation and possible surgical treatment. Standardization is key to performing the disclosed assessment. The true / actual medical significance of a given floater or group of floaters is ultimately determined by the surgeon by correlating data from the FAS and psychophysical data as described herein with vitreous examination / visualization and vitreous imaging performed via optical coherence tomography (OCT) and / or scanning laser funduscopy (SLO). This obstruction can be assessed using density measures as described herein. This action can occur based on or using a floater severity score, which will allow for accurate and reproducible assessment of what would otherwise be a subjective or patient-centered determination.

[0013] In one possible approach, the FAS can be configured to use a feedback signal to calculate a float severity score by assigning different weights to specific locations where the patient perceives the float while maintaining focus on the primary gaze point. These different weights can include the highest weight for the primary gaze point (i.e., the float perceived in the patient's central vision). Floats perceived away from the primary gaze point exist in the patient's eccentric or extrafocal locations / visual fields and can be assigned a lower severity score, as disclosed herein.

[0014] The visual target may include a grayscale visual target arranged on a white background. In other embodiments, the visual target may include a white target arranged on a black or grayscale background, wherein the background may change during the evaluation.

[0015] In some instances, FAS is configured to dynamically transfer the visual target between the primary gaze point and different secondary gaze points using smooth following, i.e., such that the visual target remains at the primary gaze point or any different secondary gaze point for, for example, no more than about 1 second.

[0016] FAS can be configured to perform assessments based on a specific set of visual characteristics of the visual target (e.g., a predetermined contrast level of the visual target) to take into account a specific eye type (normal eye vs. eye with cataracts). A technician interface device can be used to select and record visual characteristics appropriate for the patient.

[0017] The above-described features and advantages, as well as other possible features and advantages, of this disclosure will become apparent from the following detailed description of the best mode for implementing this disclosure, taken in conjunction with the accompanying drawings. Attached Figure Description

[0018] Figure 1 is an illustration of an automated floatation assessment system (FAS) for assessing the severity of floaters in a patient’s eye, according to this disclosure.

[0019] Figure 2 depicts an eye with a swarm of floating debris, the severity of which can be subjectively assessed using the system shown in Figure 1.

[0020] Figure 3 is an illustration of a representative visual target according to one aspect of this disclosure.

[0021] Figure 4 is a flowchart illustrating a method for subjectively assessing floaters in a patient's eye using the representative system of Figure 1.

[0022] Figure 5 is an illustration of a representative visual target according to another aspect of this disclosure.

[0023] The accompanying drawings are not necessarily drawn to scale and may present slightly simplified representations of various features of this disclosure, including, for example, specific dimensions, orientations, positions, and shapes. Details associated with such features will be determined in part by the specific intended application and usage environment. Detailed Implementation

[0024] This disclosure is readily embodied in many different forms. Representative examples of this disclosure are shown in the accompanying drawings and are described in detail herein as non-limiting examples of the disclosed principles. Therefore, elements and limitations described in the abstract, background, summary, and detailed description sections but not expressly set forth in the claims should not be incorporated into the claims, individually or collectively, by implication, reasoning, or otherwise.

[0025] Referring to the accompanying drawings, in which the same reference numerals denote the same features throughout several views, Figure 1 depicts an interactive system 10 for subjectively assessing the severity of floaters within a patient's eye 12. As shown in Figure 2, factors such as age, genetics, high myopia, or injury can cause discrete aggregates or amorphous clumps of collagen fibers within the vitreous cavity 16 of the eye 12. These clumps float within the normally transparent vitreous body 18 and thus move with limited mobility within the vitreous cavity 16 depending on their type and location.

[0026] As incident light (LL) passes through the pupil 20, any collagen fibers of floaters 14 positioned in the path of the light (LL) may cast shadows on the retina 22, which is located on the posterior wall of the vitreous cavity 16. Therefore, when these collagen fibers move within the vitreous body 18, for example in response to eye movement, eye position, or gravitational settling, the patient may perceive the shadows as visual disturbances or “floaters.” For clarity and simplicity, these specific collagen fibers that cast shadows on the retina 22 and are perceived by the patient are hereinafter referred to as floaters 14.

[0027] The severity of floaters is largely patient-specific and highly subjective. That is, different patients may have different perceptions or tolerances of floaters 14 of a given size and / or location. Therefore, the system 10 of Figure 1, as envisioned herein, enables a subjective in-clinic assessment of the severity of floaters 14 known through real-time input from the patient rather than relying solely on objective measurements. Among other potential benefits, this solution also allows surgeons to determine, on a patient-by-patient basis, whether floaters 14 within the eye 12 are medically significant relative to an objective threshold, and therefore whether further investigation and possible surgical interventions (e.g., laser vitreolysis or vitrectomy) may be necessary.

[0028] Referring again to Figure 1, system 10 is operable for assessing the severity of floaters 14 in the eye 12 of patient 28, with the patient 28's hand shown for simplicity. System 10 includes one or more displays 11, a patient-operated feedback device 25, and an electronic floater assessment system (FAS) 26 communicating with the displays 11 and feedback device 25. While the display 11 is shown as a representative display panel for simplicity, it can be configured as an observation station 11A (e.g., similar to a driver's license vision tester, autorefractor, fundus camera, or optical coherence tomography (OCT) package), a set of virtual reality (VR) glasses 11B, digital eyepieces, goggles, or another device capable of presenting a visual target 30 to patient 28 during in-clinic floater assessment. In this process, FAS 26 receives an electronic feedback signal from the feedback device 25 in response to patient activation (arrow CC). FB ).

[0029] Briefly referring to Figure 5, in the envisioned use scenario, the patient 28 of Figure 1 observes a visual target 30A directly at the primary fixation point P1, which is also marked "C" to indicate its position in the patient's central vision. In other embodiments, the visual target 30 of Figure 1 may be displayed in different areas on the display screen 11, where the option is indicated by the viewing angle (α) in Figure 1. Fixation and possible eye movements may be made verbally and / or visually, for example, in response to a voice prompt from a technician (e.g., "Find the visual target without moving your eyes") or movement of the visual target 30 controlled by the FAS. When the patient 28 perceives a floating object 14 while viewing the visual target 30, the patient 28 activates the feedback device 25 and indicates the relative position (and, where possible, the size) of the floating object(s) relative to the primary fixation point P1.

[0030] As shown, when the feedback device 25 of FIG1 is configured as a handheld multi-axis joystick 29 with one or more buttons 290, the patient 28 can press and hold the buttons 290 while moving the joystick 29. In some configurations, the joystick may be attached to a base (not shown). Movement of the joystick 29 causes a patient-visible cursor 17 to move on the display screen 11, as indicated by the various dashed arrows in FIG5. Although the cursor 17 can be displayed in a range of possible shapes, in one or more embodiments, a circular cursor 17 as shown may be used. Again, as perceived by the patient 28 of FIG1 while maintaining focus on the command primary gaze point P1 of FIG5, when the cursor 17 overlaps with a portion of the float(s) 14, the patient 28 can double-click or otherwise activate the buttons 290 to record the corresponding position of the float(s) 14. If more than one float(s) 14 is perceived, the patient 28 can repeat the sequence by manipulating the cursor 17 at various locations on the display screen 11 and recording all perceived float(s) 14 until the corresponding position of such float(s) 14 is recorded.

[0031] In some implementations, in addition to the location of the floater 14, the patient 28 may also communicate the size of the floater, for example, by pressing and holding button 290 after a single click, double-clicking, or providing other suitable control input, and adjusting the diameter of the circular cursor 17 (as indicated by the double-headed arrow AA) and / or tracking the approximate circumference of the floater 14. Alternatively, the patient 28 may tap the touchscreen (not shown) after positioning the cursor 17, causing the FAS 26 to count the floaters 14, and hold the touch while indicating the size of the floater 14 to adjust the size of the cursor 17. In other implementations, other devices, such as knobs or dials, may be used, provided the hardware is configured to allow the patient 28 to report the location and possible size of each perceived or symptomatic floater 14.

[0032] Using an appropriate completion signal, such as a long press of button 290 or pressing another button (not shown) on feedback device 25, FAS 26 learns that all symptomatic floaters 14 have been identified by patient 28 and recorded in the memory 54 of FAS 26. A suitable configuration of feedback device 25 should not require patient 28 to take their gaze off visual target 30, but may include a device that patient 28 can operate by touch / feel, such as a tablet or other touchscreen. Feedback signal (arrow CC) FB The FAS 26 indicates the patient's perception of (multiple) floating objects 14 in their visual field and any possible subjective obstruction of the visual target 30 based on the floating objects (i.e., obstruction as determined by the patient during the in-clinic severity assessment). The FAS 26 then uses feedback signals (arrow CC) FB Calculate the severity score of floating objects, as described in Figure 4 below with particular reference.

[0033] Referring again to Figure 1, for clarity and simplicity only, FAS 26 is schematically depicted as a single computing node. Embodiments of FAS 26 may include one or more networked computing devices, each having one or more processors (P) 52 and a sufficient amount of the aforementioned memory (M) 54, including a non-transitory (e.g., tangible) computer-readable storage medium on which a set of computer-readable instructions is recorded or stored. Such instructions embody method 50M, an exemplary embodiment of which is shown in Figure 4 and described below, wherein the instructions can be read and executed by the processor(s) 52 to perform method 50M.

[0034] As part of this method 50M, FAS 26 transmits display control signals (arrow CC) to (multiple) displays 11. 11 This allows control over the appearance, position, movement, and other possible characteristics or parameters of the visual target 30 presented thereon. In some embodiments, the technician interface device (INT) 31 can communicate with the FAS 26 via wired or wireless communication, wherein the technician selects a mode or parameter that causes input signals to be transmitted to the FAS 26 (arrow CC). 31 As described below. Memory 54 can take many forms, including but not limited to non-volatile media and volatile media. Instructions embodying method 50M can be stored in memory 54 and selectively executed by processor(s) 52 to perform the various functions described below.

[0035] As those skilled in the art will understand, non-volatile computer-readable storage media may include optical discs and / or magnetic disks or other persistent storage, while volatile media may include dynamic random access memory (DRAM), static RAM, etc., any or all of which may constitute part of memory 54. Input / output (I / O) circuitry may be used to facilitate connection and communication with various peripheral devices used during surgical or visualization procedures. Other hardware not depicted in Figure 1 but commonly used in the art may be included as part of FAS 26, including but not limited to local oscillators or high-speed clocks, signal buffers, filters, amplifiers, etc.

[0036] DICOM / EMR: The use of FAS 26 and the corresponding method 50M in a medical office environment as envisioned herein involves ordering tests from an electronic medical record (EMR) 13 or an electronic health record (EHR). For this purpose, instead of locally storing image data and test results, secure network communication with the Digital Medical Imaging and Communications (DICOM) protocol stack 130 of the EMR 13 is performed. As understood in the art, the DICOM protocol stack 130 is used in medical office environments for magnetic resonance imaging (MRI), computed tomography (CT), digital X-ray, positron emission tomography (PET) scans, ultrasound, etc. Using the DICOM protocol stack 130, collected imaging data, biometrics, fields of view, test orders, test results, etc., are securely sent and received via bidirectional communication with one or more cloud servers (e.g., using a local area network (LAN) connection or another suitable set of communication nodes). This also facilitates the input of patient data, such as name and medical record number, from dropdown lists. The floatation assessment test performed according to the method described herein is ordered by a clinician (typically via a clerk / secretary / technician) using the DICOM component of the EMR 13. Subsequently, the assessment results / data are automatically loaded into the patient's EMR 13 via the aforementioned secure network connection through the DIACOM protocol stack 130.

[0037] Referring now to Figure 3 and as described above, the floatability assessment system (FAS) 26 schematically shown in Figure 1 is configured to present a visual target 30 on the display screen 11. This action occurs at the primary gaze point P1, which is controlled via the display control signal (arrow CC) of Figure 1. 11 The assessment is accomplished through communication. The assessment can occur only at the primary fixation point P1, as described above with reference to Figure 5, or the patient 28 in Figure 1 can be prompted to view visual targets 30 at different secondary fixations P2, P3, P4, P5, etc., each of which is radially arranged around the primary fixation point P1 on the display screen 24. As described above, the use of secondary fixations P2, P3, P4, P5 statistically collects additional information about the movement of the vitreous body 18 relative to the movement of the eye 12.

[0038] The visual target 30, as envisioned herein, can be a simple point of light on a suitable background, or it can be a grayscale visual target or a black visual target 30 arranged on a white background 300 as shown in the figure. Multiple visual targets 30 can be fixed at relatively low intensity (relative to the background 300) so as not to interfere with the visualization of floating objects. In possible implementations, the background 300 can also be changed in two or more discrete steps to obtain a density score. In other embodiments, a white target can be used, in which case the background 300 can be black or grayscale. Envisioned methods include changing the background 300 from white to, for example, sky blue, or to a white chromaticity close to the appearance of white paper, a computer screen, or a white ceiling / wall. Initial changes can be performed during prototyping and subsequently performed via discrete steps when calculating a numerical floating object severity score as described herein to determine floating object density. Specific black / grayscale and white combinations can be calibrated a priori and subsequently used for standardized assessments of a given patient population (e.g., patients without cataracts and patients with cataracts).

[0039] In the representative visual target 30 of Figure 3, the primary fixation point P1 forms the baseline “directly forward” focus, which may be located approximately at the center (C) of the display screen 11 (and the patient’s central vision). Optional secondary fixations P2, P3, P4, and P5 are eccentrically positioned relative to the primary fixation point P1, for example, in the left (L), upper / upper (U), right (R), and lower / lower (D) directions. According to a predetermined evaluation sequence, the FAS 26 of Figure 1 can present the visual target 30 on the display screen 11 at the primary fixation point P1 and possibly at different fixations P1–P5.

[0040] In a representative predetermined assessment sequence, visual target 30 is thus formed on display screen 11 of FIG. 1 as a software-controlled target that visually prompts the patient to focus in one or more directions relative to the primary fixation point P1. When testing fixation at different eye positions and the possible effects on movement of the vitreous body 18, the patient 28 may be prompted to look up at secondary fixation point P3, return to primary fixation point P1, look left at secondary fixation point P2, return to primary fixation point P1, look right at secondary fixation point P4, return to primary fixation point P1, look down at secondary fixation points P1P5, and return to primary fixation point P1 again. In one or more embodiments, a technician may use the interface device 31 of FIG. 1 to select the actual assessment sequence and, possibly, the dwell time (or no dwell time) at each fixation point P1-P5. However, in possible implementations, all parameters of a given assessment are standardized for a specific category of eye 12 as described above (e.g., an eye with cataracts or an eye without cataracts), so that the technician only needs to select the correct sequence for the specific patient.

[0041] Therefore, FAS 26 is configured to (i) hold the visual target 30 at a specific focal point P1-P5 for the duration of the assessment, as shown in Figure 5, or (ii) dynamically transfer the visual target 30 between the primary / foveal fixation point P1 and different secondary / extrafoveal fixation points P2-P5 to determine the movement of the vitreous body 18, such that the visual target 30 remains at any fixation point P1-P5 for, for example, no more than 1 second. As understood in the art, when the patient 28 blinks, the eye 12 of the patient 28 in Figure 1 will roll upward, a response known as Bell's phenomenon. The eye 12 then refocuses upon completion of the blink. Therefore, the sequence of eye movement 12 is potentially beneficial for assessing the resulting movement of the vitreous body 18 and its effect on the position of possible floaters 14 in the resulting patient visual field. The technician may choose to repeat the sequence(s), performing the assessment at least three times to obtain sufficient data for a statically meaningful assessment. Both (i) and (ii) can be performed during the full assessment to provide additional details about the true state of the floating object-based obstruction under different gazes or combinations thereof.

[0042] In one or more embodiments, FAS 26 can hold the visual target 30 at the primary fixation point P1 during floatation assessment (Figure 5). Alternatively, when using different secondary fixation points P2-P5 (Figure 3), these points can be separated from each other by about 5° to about 10°, or by another suitable angular value. In some embodiments, one or more additional secondary fixation points P(n) can be used between the four nominal secondary fixation points P2-P5 (e.g., between fixation points P2 and P3, P3 and P4, P4 and P5, and / or P2 and P5). Similarly, FAS 26 can be configured to hold the visual target 30 at one or more of the different fixation points P1-P5 for a calibrated dwell time (e.g., more than about 1 second (1s) or about 1-5 s in possible embodiments) to allow the dynamic floatation object 14 to reach a stable state.

[0043] Surgeons, clinicians, or technicians can use the optional interface device 31 of Figure 1, for example as described above, to select an appropriate assessment for the normal eye 12 relative to the eye with cataracts, and thereby select one or more characteristics of the visual target 30 as shown in Figure 3. That is, although a separate cataract scheme violates the standardization of the assessment, it is still possible to increase the use of brightness and / or contrast for cataracts if performed in a standardized manner. FAS 26 can respond to an input signal from the interface device 31 (arrow CC). 31Visual target 30 is configured prior to evaluation. Once evaluation is selected, FAS 26 can be configured to hold visual target 30 at the primary fixation point P1, or dynamically transfer visual target 30 between the primary fixation point P1 and different secondary fixations P2-P5 using smooth following, as described above, such that visual target 30 remains at the primary fixation point P1 or any different secondary fixations P2-P5 for no more than about 1 second. Similarly, possible stepwise or continuous contrast adjustments (or normalization) can be commanded by a technician via interface device 31, or such contrast adjustments can be pre-programmed into the memory 54 of FAS 26 to achieve optimal sensitivity taking into account the patient's eye health, visual ability, or photosensitivity.

[0044] Referring now to Figure 4, for clarity, this paper uses discrete code segments, algorithm sequences, or logic blocks to describe method 50M. The corresponding instructions of each block in the constituent blocks of method 50M are executed by the processor(s) 52 of the floatation assessment system (FAS) 26 shown in Figure 1, ultimately causing the described action to be performed. Method 50M is performed on one eye at a time, as envisioned herein, for example, by using an eye patch, a mechanical shutter, or otherwise obstructing the vision of the patient's non-test eye. Method 50M can be performed in response to a test order entered by a surgeon or clinician via the patient's electronic medical record.

[0045] An exemplary implementation of method 50M begins at box B51. Here, a technician can set target parameters for subsequent subjective float assessments. For example, the technician can select from a set of options presented via interface device 31 either the target parameters or a calibrated assessment sequence of the primary fixation point P1 and one or more possible secondary fixations (e.g., P2-P5). Selecting these options causes the generation of display control signals (arrow CC). 31 The target parameters used herein may include, if any, the physical appearance and motion characteristics of the visual target 30 of Figure 3, as standardized as described herein. Among other possible target parameters, the technician may select a profile with a specific white-on-black (white-on-grayscale) or black-on-black / grayscale-on-white scheme, contrast level, and predetermined size, shape, and position of each fovea and the optional foveal foveal foveal fixation points P1-P5 of Figure 3.

[0046] Additional target parameters may include the progression sequence or order (if any) that the patient will follow. For example, while this document envisions the best benefit of recording the position of the floaters 14 perceived by the patient while the patient is only fixating on the primary fixation point P1 (as shown in Figure 5), some implementations may also assess visual obstruction while prompting the patient 28 to look between the various secondary fixations P1-P5. Target parameters may also include a specific contrast level of the visual target 30 and its background. However, in possible implementations, parameters may be predetermined for a given patient population (e.g., the cataract / non-cataract patient population as described above), where the technician simply selects a relevant assessment sequence for the patient being assessed for the severity of their floaters.

[0047] For adjustments, technicians can manually select predetermined / standardized target parameters using interface device 31. Example configurations may include a touchscreen device displaying options, a panel with buttons, or other suitable mechanisms that allow technicians to physically select the desired target parameters. In one or more embodiments, interface device 31 may be voice-activated, enabling technicians to verbally state the desired target parameters, with FAS 26 of Figure 1 setting the target parameters in response to the spoken phrase. In yet another embodiment, one or more sequences and associated target parameters may be programmed into the memory 54 of FAS 26, allowing technicians to adjust the target parameters simply by manually or verbally selecting pre-programmed options. Audio and on-screen text are also useful for standardization, efficiency (technician time), and for reducing the level of training / skill required to perform assessments in a repeatable and consistent manner across a wide range of patients 28. Once the target parameters have been initially set or subsequently adjusted, method 50M proceeds to box B52.

[0048] At box B52, method 50M includes displaying the visual target 30 at the initial fixation point (n). Although any of the various fixation points P1-P5 in FIG3 can be used as the initial fixation point (n) according to a predetermined or standardized subjective float assessment, the initial fixation point (n) is typically the primary fixation point / foveal fixation point P1 of FIG3, i.e., the fixation point when the patient is looking straight ahead. In one or more embodiments, the primary fixation point P1 may be the only fixation point used in the assessment, and in other embodiments, it is possible to optionally shift between the primary focus P1 and various eccentric secondary focuses P2-P5. Method 50M then proceeds to box B54.

[0049] At box B54, after being verbally instructed to do so by the technician, the patient fixates on the initial fixation point (n) and observes the appearance of the visual target 30 and its surrounding area in the patient's field of vision. Possible auditory instructions to the patient could be to "look straight ahead at the target, and if you are..." Anywhere"Upon seeing the floating object, press the button and move the cursor to the floating object," where cursor 17 and button 290 are shown in Figures 5 and 1, respectively. As the floating object 14 moves into and out of the incident light (LL) of Figure 2, for example, the patient may perceive the floating object 14 as darker, larger, or otherwise more prominent relative to the main focal point P1 at various locations in their field of vision. When one or more floating objects 14 are perceived anywhere in their field of vision, the patient may activate the feedback device 25 of Figure 1, for example, by pressing button 290 in a non-limiting button embodiment of the feedback device 25, to initially indicate the presence of the floating object 14. When this occurs, the processor 52 of the FAS 26 registers the floating object-based visual event, for example, by recording bit codes indicating the presence of the floating object(s) 14.

[0050] Initially pressing button 290 triggers a counter in FAS 26, allowing patient 28 sufficient time to record information describing the position of floaters(s)14 relative to the primary fixation point P1 within their field of vision. For example, using the multi-axis joystick 29 of Figure 1, patient 28 can manipulate cursor 17 (Figure 5) on display 11 until cursor 17 overlaps with the symptomatic floaters(s). Patient 28 then activates button 290, which initiates another timed window allowing patient 28 to move cursor 17 to the corresponding position of another floater(s). A predetermined termination signal (such as pressing and holding button 290 for several seconds or a "double-click" action familiar in computer mouse operation) can be used to signal that FAS 26 has recorded or registered the positions of all floaters(s)14 in the patient's field of vision in memory 54. After completing box B54, method 50M proceeds to box B56.

[0051] Box B56 includes, in an alternative embodiment where testing is desired at other fovea points P2-P5, determining via FAS 26 whether the fovea point (n) corresponding to the current counter value is equal to the predetermined final fovea point (N) in the aforementioned progression sequence. As an example, the representative fovea points P1-P5 of Figure 3 may have their secondary fovea point P5 set as the final fovea point (N). In this particular example where N = P5, box B58 may need to determine whether all component fovea points in the progression sequence have been performed. One of the parameters input at box B51 may include performing more than one evaluation sequence, for example, iterating two, three, or four times, and therefore, box B56 may also include determining whether the required number of iterations has been completed. When the evaluation at the final fovea point (N) has not yet been performed, or if the evaluation has been performed (regardless of whether the number of occurrences is as many as specified at box B51), method 50M proceeds to box B58. When the evaluation has already been performed at the final fovea point, i.e., when n = N, alternatively, method 50M proceeds to box B60.

[0052] At box B58, FAS 26 of Figure 1 increments a counter having a register value corresponding to the current gaze point. Therefore, box B58 effectively includes progressing to the next gaze point (n + 1) in the programmed or selected progression sequence. To implement box B56, FAS 26 can increment the register value of an integer counter, which is one of its various hardware components. Thereafter, method 50M returns to box B51.

[0053] At box B60, method 50M includes calculating a numerical severity score that indicates the severity of the floaters as perceived by the patient. As described above, throughout the process, FAS 26 receives feedback signals from the feedback device 25 in response to patient activation (arrow CC). FB As an example, despite the presence of the float 14 in Figure 2, the patient's vision may not be significantly obstructed (from the patient's perspective) when viewing the visual target 30 at the primary fixation point P1 in Figure 3. For example, the patient might move the aforementioned cursor to an area around the primary fixation point P1 without recording subjective visual obstruction at P1. However, when the patient is prompted to view the visual target 30 at other locations (e.g., secondary fixations P2 and / or P4), the same float 14 may become symptomatic. If this occurs, the patient activates the feedback device 25 to generate a feedback signal (arrow CC). FB These feedback signals will then be recorded in the memory 54 of the FAS 26. Therefore, the results recorded during the floatation assessment correspond to specific eye positions of the eye 12 and the fixation points P1-P5 indicated when the floatation object (multiple) 14 is perceived (i.e., during the recording of feedback signals (arrow CC)). FB The specific gaze points P1-P5 that are being observed at the time of observation, and the position of the floating object 14 relative to the gaze points.

[0054] When calculating the numerical severity score, the FAS 26 in Figure 1 can assign different weights to each fixation point. In this way, standardized assessments programmed into the FAS 26 can associate higher or lower relative importance with a specific fixation point where the patient perceives floaters 14. For example, for the five representative fixations P1-P5 in Figure 3, the numerical floater severity score (FS) can be calculated using, for example, the following formula: Each of the weights W1, W2, W3, W4, and W5 can be pre-assigned or calibrated. The weights can be the same or different, with 1 or 0 associated with fixations P1-P5 based on whether the patient recorded visual obstruction at that particular fixation point. In some implementations, the primary fixation point P1 can have the highest weight relative to the foveal fixations, i.e., W1 >> W2, W3, W4, and W5. For example, if patient 28 records the presence of a floater 14 directly on the primary fixation point P1 itself (an example of this is depicted in Figure 5), this event is given a higher weight compared to the case where the same patient 28 records a floater 14 at a distance from the primary fixation point P1 (also shown in Figure 5). Therefore, in embodiments where only the primary fixation point P1 is used for floater assessment, the aforementioned secondary points P2-P5 are eccentric regions surrounding the primary fixation point P1.

[0055] In another implementation that prompts movement between each fixation point P1-P5, standardized testing can assess the severity of the float at the primary fixation point P1 at various stages of the evaluation. For example, the above formula can be expressed as: Among them, different weights W 1A W 1B ... W 1E Associated with each successive assessment at the primary fixation point P1.

[0056] For example, consistent with the above example sequence in which the patient is visually and / or verbally prompted to focus on the primary (foveal) fixation point P1, then the secondary (extrafoveal) fixation point P2, then back to fixation point P1, and then proceeding to fixation point P3, the initial portion of the complete assessment sequence involves two fixations on the visual target 30 at the primary fixation point P1, denoted in this case as P1A and P1B for clarity. Fixation point P1A can be associated with a weight W. 1A The correlation is such that subsequent gazes at point P1B have their own correlation weight W. 1B And so on. In this way, surgeons can assess the effect of a specific movement or combination of movements on the resulting steady-state gaze / direct forward gaze.

[0057] In one or more embodiments, the patient-operated feedback device 25 may record more than just simple / discrete visual obstruction recordings. For example, instead of implementing a simple button 290 as shown in FIG. 1, the feedback device 25 may record different values ​​based on the number and / or density of floaters 14 perceived by the patient in their observation. Thus, in addition to quantity, the feedback device 25 may also be used, for example, to signal the density of the perceived floaters 14 using analog inputs (such as dials or knobs as described elsewhere herein). In such an implementation, the FAS 26 may calculate a numerical severity score as a composite score based on the density, number, and location of floaters 14 as reported by the patient 28. Then, after determining the numerical floater severity score (FS), method 50M proceeds to block B62.

[0058] Box B62 requires the use of the numerical severity score (FS) determined at box B60 to complete the assessment of the severity of the floaters. Box B60 may include: generating a digital output file based on the numerical floater severity score via FAS 26 of Figure 1, which characterizes the floater obstruction as symptomatic or potentially medically significant, where the true medical significance is ultimately determined by the surgeon / clinician. The surgeon can review this automatically generated severity determination and verify that the result is consistent with the severity determined by the surgeon in professional judgment following objective verification. Possible controls associated with box B62 include outputting a digital report in which FAS 26 characterizes the floater 14 as potentially medically significant or symptomatic based on a subjective assessment performed via method 50M. In response to such a report, the surgeon can perform additional visualization techniques and localization of the symptomatic floater 14, whereby the surgeon may treat the floater 14 via vitrectomy or laser vitreolysis as described above, or using other invasive or non-invasive treatment options.

[0059] This document describes embodiments of the disclosure. However, the disclosed embodiments are merely examples, and various alternative forms may be taken for other embodiments. The drawings are not necessarily drawn to scale. Some features may be enlarged or minimized to show details of specific components. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but only as a representative basis for teaching those skilled in the art to employ the disclosure in various ways.

[0060] In the following description, certain terms may be used for illustrative purposes only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to directions referenced in the accompanying drawings. Terms such as “front,” “rear,” “before,” “after,” “left,” “right,” “rear,” and “side” describe the orientation and / or position of a part or element within a consistent but arbitrary frame of reference, which will become clear by referring to the text describing the part or element under discussion and the associated drawings. Furthermore, terms such as “first,” “second,” and “third” may be used to describe individual parts. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0061] The detailed descriptions and accompanying drawings are supportive and descriptive of this disclosure, but the scope of this disclosure is defined only by the claims. While some best modes and other embodiments for implementing the claimed disclosure have been described in detail, various alternative designs and embodiments exist to practice the disclosure as defined in the appended claims.

Claims

1. An automated system for assessing the subjective severity of patient-perceived floaters in a patient's eye, the system comprising: Display screen; Feedback devices for patient input; The system includes a floatation assessment system (FAS) that communicates with the display screen and a patient-operated feedback device, wherein the FAS is configured to: present a visual target on the display screen at a primary fixation point; receive a feedback signal from the patient-operated feedback device in response to the patient activating the patient-operated feedback device, the feedback signal indicating the position of a floatation object perceived by the patient relative to the visual target; and calculate a numerical floatation severity score using the feedback signal, wherein the numerical floatation severity score quantifies the subjective severity of the perceived floatation object.

2. The automation system as described in claim 1, wherein, The FAS is configured to present the visual target on the display screen only at the primary gaze point.

3. The automation system as described in claim 1, wherein, The patient operation feedback device includes a multi-axis joystick, wherein the FAS is configured to display on the display screen and move a cursor in response to movement of the multi-axis joystick to indicate the position of the perceived floating object relative to the visual target.

4. The automation system of claim 1, further comprising: The FAS generates a digital output file based on the numerical floatation severity score, which characterizes the floatations perceived by the patient as potentially medically significant.

5. The automation system as described in claim 1, wherein, The FAS is configured to sequentially present the visual target at a plurality of secondary fixations located off-center relative to the primary fixation point according to a predetermined evaluation sequence, during which the visual target is presented sequentially above, to each side and below the primary fixation point.

6. The automation system as described in claim 5, wherein, The FAS is configured to use the feedback signal to calculate the numerical float severity score by assigning different weights to the primary gaze point and the one or more secondary gaze points.

7. The automation system as described in claim 6, wherein, Assigning the different weights to the primary gaze point and the one or more secondary gaze points includes assigning the highest weight to the primary gaze point.

8. The automation system as described in claim 5, wherein, The FAS is configured to dynamically transfer the visual target between the primary fixation point and the secondary fixation point, such that the visual target remains at either the primary fixation point or the secondary fixation point for no more than about 1 second.

9. The automation system as described in claim 1, wherein, The visual targets include grayscale targets arranged on a white background.

10. The automation system of claim 1, further comprising: An interface device, wherein the FAS is configured to select a visual characteristic or parameter of the visual target in response to an input signal from the interface device.

11. The automation system of claim 10, wherein, The characteristics or parameters of the visual target include the contrast level of the visual target.

12. A method for assessing the subjective severity of patient-perceived floaters in a patient's eye, the method comprising: The visual target is displayed on the screen at the main gaze point via the processor of the FAS (Floating Object Assessment System). The processor receives a feedback signal from the patient-operated feedback device in response to the patient activating the patient-operated feedback device, the feedback signal indicating a patient-perceived floating object in the patient's field of vision; The processor uses the feedback signal to calculate a numerical floatation severity score, which quantifies the subjective severity of the floatation perceived by the patient.

13. The method of claim 12, wherein, Presenting the visual target sequentially at the primary gaze point on the display screen includes periodically adjusting the position of the primary gaze point on the display screen.

14. The method of claim 12, wherein, Receiving feedback signals from the patient-operated feedback device includes receiving the feedback signals from joystick and button devices.

15. The method of claim 12, further comprising: The FAS generates a digital output file based on the numerical floatation severity score, the digital output file representing the floatation perceived by the patient.

16. The method of claim 12, wherein, Calculating the numerical floating object severity score using the feedback signal includes assigning different weights to floating objects perceived at the primary gaze point compared to floating objects perceived at a location outside the fovea in the field of vision.

17. The method of claim 12, wherein, Presenting the visual target on the display screen includes presenting a grayscale target on a white background.

18. The method of claim 12, further comprising: The input signal is received from the interface device via the FAS; And adjust the contrast level of the visual target in response to the input signal from the interface device.

19. A computer-readable storage medium having instructions recorded thereon for assessing the subjective severity of floaters perceived by a patient in the patient's eye, wherein, The processor of the Floating Object Assessment System (FAS) executes the instructions to cause the processor to: display a grayscale visual target on a white background at the main gaze point via a display screen; In response to the patient activating a patient operation feedback device, a feedback signal is received from the patient operation feedback device, the feedback signal indicating a floating object perceived by the patient in the patient's field of vision; The processor uses the feedback signal to calculate a numerical floatation severity score, which quantifies the subjective severity of the floatation perceived by the patient. And generate a digital output file based on the numerical floatation severity score, the digital output file characterizing the floatation perceived by the patient as potentially medically significant.

20. The computer-readable storage medium of claim 19, wherein, The processor of the FAS executes the instructions to assign different weights to the patient-perceived floaters perceived at the primary fixation point compared to floaters perceived at a location outside the fovea in the visual field.

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