JP6128814B2 - Visual function evaluation program and visual function evaluation apparatus - Google Patents

Description

  The present invention relates to a visual function evaluation program and a visual function evaluation apparatus for inspecting or training a visual function for a patient using a test target.

  When retinal photoreceptor cells, which are one type of cells constituting the retina, degenerate or die due to retinal pigment degeneration, age-related macular organization, etc., visual acuity may be reduced, leading to blindness. Therefore, a visual regeneration assisting device that outputs stimulation signals from a plurality of electrodes implanted in the body and electrically stimulates cells constituting the retina to promote visual regeneration has been studied. For example, there is a visual regeneration assisting device that directly arranges an electrode array on or under the retina, electrically stimulates cells constituting the retina and promotes visual regeneration (see, for example, Patent Document 1). In addition, there is a visual regeneration assisting device in which an electrode array is placed between the sclera and the venous membrane, and the cells constituting the retina are electrically stimulated to promote visual regeneration (see, for example, Patent Document 2).

US Pat. No. 5,944,747 JP 2004-57628 A

There is a need for the development of a device and method for examining the visual function of a patient before and after implantation of such a visual regeneration assisting device and for training the visual function so that the patient can correctly identify an object.

  In view of the above-described problems of the prior art, it is an object of the present invention to provide a visual function evaluation program and a visual function evaluation apparatus capable of examining or training a patient's visual function.

  In order to solve the above problems, the present invention is characterized by having the following configuration.

(1) A visual function evaluation program for examining or training a patient's visual function, the first display control step of displaying an examination target to be presented to the patient at a predetermined display coordinate on the first display screen; An acquisition step of acquiring a signal of a press coordinate specified by contact from a touch panel installed covering the first display screen, and causing the sound output means to output a sound based on a positional relationship between the display coordinate and the press coordinate. A visual function evaluation program that causes a computer to execute a sound control step.
(2) The computer further executes a calculation step for obtaining a positional relationship between the display coordinates and the pressed coordinates, and the sound control step controls a sound output from the sound output unit based on a calculation result in the calculation step. (1) Visual function evaluation program.
(3) The visual function evaluation program according to (2) , wherein the sound control step causes the sound output means to output a sound indicating a direction of the pressed coordinate with respect to the display coordinate obtained in the calculation step.
(4) The sound control step outputs different sounds from the sound output means depending on whether the display coordinates of the inspection target and the pressed coordinates coincide with each other within a required range or not. The visual function evaluation program according to any one of (1) to (3).
(5) A visual function evaluation device for examining or training a patient's visual function, the first display control means for displaying a test target to be presented to the patient at predetermined display coordinates on the first display screen; An acquisition unit that acquires a signal of a pressed coordinate specified by contact from a touch panel installed to cover the first display screen, and a sound output unit that outputs a sound based on a positional relationship between the display coordinate and the pressed coordinate And a visual function evaluation device.

  ADVANTAGE OF THE INVENTION According to this invention, the visual function evaluation program and visual function evaluation apparatus which can test | inspect or train a patient's visual function can be provided.

  Embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an explanatory diagram of a visual function evaluation apparatus 100 according to the present disclosure. The visual function evaluation apparatus 100 includes a test target display device 60 to be presented to a patient, a target selection device 70 for designating a test target to be displayed on the display device 60, and a sound generation device 80. The display device 60 and the sound generation device 80 are placed on the patient side, and the selection device 70 is placed on the examiner side.

  The display device 60 displays a test target to be presented to a patient's eye (retina) before or after implantation of the visual reproduction assisting device 1 described later. The display device 60 includes a display 61 that displays an inspection target and a touch panel 62 installed on the display 61. As the display 61, a well-known self-fluorescent type such as a liquid crystal display, an EL display plate, a CRT, or a liquid crystal display plate provided with a backlight is used. As the touch panel 62, a well-known analog type or digital type such as a resistive film type, an optical type, a capacitance type, an ultrasonic surface acoustic wave type, a distortion type, or the like is used. The touch panel 62 is adjusted in advance and pasted to the display 61 so that the coordinates (pressing coordinates) of the touch panel 62 and the coordinates (display coordinates) of the display 61 coincide.

  The selection device 70 includes a display 71, an input unit 72, a control unit 50, a storage unit 73, and a time measurement device (timer) 74. For example, the selection device 70 is configured by a known personal computer or the like. A well-known input means such as a keyboard and a mouse is used for the input unit 72 for setting various conditions relating to the inspection.

  The control unit 50 controls operations of the selection device 70, the display device 60, and the sound generation device 30. The control unit 50 displays a desired examination target on the display 61 of the display device 60 based on an input signal from the input unit 72 of the selection unit 70. Also, the positional relationship (matching or mismatching) between the signal of the pressed coordinate output by sensing touch (pressing) with a finger or the like on the touch panel 62 and the display coordinate of the inspection target on the display 61 is obtained by calculation. The sound is output from the speaker 80 based on the calculation result.

In the storage unit 73, various inspection targets displayed on the displays 61 and 71, an inspection procedure program, sound information output from the speaker 80, and a visual function for executing the processing shown in FIGS. An evaluation program and the like are stored.
As various inspection targets, static targets and dynamic targets having various shapes are stored. A specific example of the inspection target will be described later. In addition, a test mode and a training mode are stored as a program for the inspection procedure. In the test mode, the visual function is inspected for the patients before and after implantation of the visual reproduction assisting apparatus 1 and the low vision patient. In the training mode, visual function training is performed on a patient after implantation of a visual regeneration assisting device or a low vision patient in order to correctly identify an object. In addition, the visual function said by this embodiment means the function which specifies an object by the visual reaction which a patient's retina produced.

As the “sound” output from the speaker 80, a sound indicating that the display coordinates of the test target on the display 61 and the pressed coordinates of the touch panel 62 match within the required range, and the display coordinates and the pressed coordinates are within the required range. Sounds indicating that they do not match are stored. Further, when the display coordinates and the press coordinates do not match, a sound for indicating the direction in which the press coordinates are deviated from the display coordinates is stored. For example, sounds such as “left”, “right”, “upper”, and “lower” are stored. Further, a voice indicating in detail the direction of deviation such as “upper right” and “lower left” may be stored according to the degree of difficulty of inspection. It is assumed that the “sound” shown in the present embodiment includes various types that are vibrated at a frequency that can be perceived by humans. For example, musical sounds used for music, human voices, and the like can be output from the speaker 80 as “sounds”.
The timer 74 measures the time from when the test target is displayed on the display 61 until the pressing coordinates are output by the patient touching the touch panel 62. The time measured by the timer 74 is stored in the storage unit 73.

With the visual function evaluation device 100 having the above-described configuration, visual function training and visual function training are performed for the patient to correctly identify an object. FIG. 2 shows a flowchart of the operation procedure of the visual function evaluation apparatus 100.
First, the examiner positions the patient at a predetermined distance from the display device 60 (for example, 40 cm), and selects an examination mode by operating the input unit 72 in step S1. The inspection mode includes a test mode and a training mode. Here, it is assumed that the test mode is selected. Based on the signal from the input unit 72, the control unit 50 displays a plurality of examination targets corresponding to the examination mode on the display 71 so as to be selectable (not shown).

In step S2, when an examination target to be presented to the patient is selected by the operation of the input unit 72 on the display 71, the control unit 50 calls information on the designated examination target from the memory 73, and the patient side Are displayed on the display 61.
3A and 3B show examples of inspection targets. The inspection target 91 is composed of a background 91d that is always lit with a low luminance (black) and rectangular regions 91a to 91c whose display is switched between the same black as the background or a luminance that is brighter than the background (white). . 3A and 3B, the regions 91a are arranged side by side in the horizontal direction so that the region 91a is on the left side of the display 61, the region 91b is the center of the display 61, and the region 91c is on the right side of the display 61. In addition to this, each of the regions 91 a to 91 c may be arranged vertically or obliquely with respect to the display 61. It is sufficient that at least one area is prepared. Here, it is assumed that each of the regions 91a to 91c has a short side of 10 degrees and a long side of about 40 degrees. In addition to this, the size of each of the regions 91a to 91c may be variable according to the difficulty level of the inspection, and may have a size that can be specified by contact with a patient's finger.

In step S3, the control unit 50 determines the display states of the areas 91a to 91c according to the inspection program. For example, as shown in FIGS. 3A and 3B, the area 91a is displayed in white, and the other areas 91b and 91c are displayed in black. In FIG. 3, the white area is indicated by diagonal lines.
When the test target is displayed on the display 61, the control unit 50 causes the speaker 80 to output a sound (voice) that prompts the patient to select an index. Alternatively, the examiner may directly instruct the patient to select the target without outputting sound from the speaker 50. Further, the control unit 50 starts counting the elapsed time by the timer 74 at the same time as outputting sound from the speaker 80 (or by the operation of the input unit 72 by the examiner).

  In step S <b> 4, the patient receives sound (or an examiner's instruction) from the speaker 50, confirms the display position of the test target on the display 61, and presses the corresponding position on the touch panel 62. The signal of the press coordinates output by pressing the touch panel 62 is sent to the selection means 70 side. In step S <b> 5, the control unit 50 compares the pressed coordinates with the display coordinates, and whether the patient has correctly specified the examination target (whether the pressed coordinates and the display coordinates match within the required range) or has not been correctly specified. (Whether the pressed coordinates and the display coordinates do not match within the required range). Further, the control unit 50 stores the elapsed time from the start of the inspection by the timer 74 in the storage unit 73 and also stores the correct / incorrect information on the touch position in the storage unit 73.

  Here, the process of step S5 will be described in detail with reference to the flowchart of FIG. First, when the signal of the press coordinates output from the touch panel 62 in step S4 described above is input to the control unit 50, in step S21, the control unit 50 is within the frame of the region 91a where the press coordinates are displayed in white. Whether or not the pressed coordinate and the display coordinate match is determined depending on whether it is included (including a part of the frame) or not.

  When it is determined that the patient has correctly identified the target and the pressed coordinates correspond to the display coordinates in the frame of the area 91a, the process proceeds to step S22, and the control unit 50 outputs the correct sound from the speaker 80. Let On the other hand, if it is determined that the patient has not correctly specified the display position of the optotype and the pressing coordinates are out of the frame of the region 91a, the process proceeds to step S23, and the control unit 50 determines the pressing coordinates and the display coordinates. The difference is obtained, and the direction in which the touch position (pressed coordinate) is deviated from the target display position (area 91a) is obtained. In addition, the control unit 50 obtains a shift amount (distance d) from the display position (display coordinates) of the target to the touch position (pressed coordinates). Note that the shift amount (distance d) and direction are obtained, for example, based on the coordinates 01 (x1, y1) of the center of the area 91a and the coordinates O2 (x2, y2) of the center of the touch position.

  Next, in step S24, a sound corresponding to the direction in which the pressed coordinate is deviated from the display coordinate is output. For example, as shown in FIG. 3A, when the patient presses (designates) the right position p with respect to the target display position (area 91a), the speaker 80 sounds “right”. Is output. In addition to this, sounds such as “left”, “right”, “up”, and “down” are output in accordance with the direction of displacement of the position p designated by the patient with respect to the visual target.

  At this time, the control unit 50 may change the volume of the sound to be output according to the degree (amplitude) of the shift amount with respect to the inspection target presentation position obtained in step S23. In this case, the threshold value (distance) for determining the shift amount (distance d) between the display coordinate and the pressed coordinate is stored in the storage unit 73 in advance. The control unit 50 adjusts the number of times the sound is output from the speaker 80, the magnitude (gain), and the like by comparing the threshold value (distance) and the shift amount (distance d). That is, when it is determined that the distance between the display coordinates and the pressed coordinates is greater than the threshold, the control unit 50 outputs a sound indicating the direction “right” a plurality of times in succession (at a required time interval). The threshold value may be prepared in a plurality of stages. When there are a plurality of threshold values, the number of times the sound is output is determined by comparing each threshold value with the shift amount. Alternatively, the volume of sound output from the speaker 80 may be adjusted according to the shift amount (distance) of the position p (pressed coordinate) with respect to the inspection target. Note that the volume of the sound can be adjusted stepwise or linearly in a predetermined step. In this way, by adjusting the output of the sound according to the amount of deviation (distance d) from the examination target, the degree of deviation of the position p (pressed coordinate) with respect to the examination target can be easily shown to the patient. .

  In addition to the number of sound outputs and the volume, the degree of deviation can be indicated by changing the tone of the sound. For example, a high frequency sound may be output when the position p with respect to the inspection target is large, and a low frequency sound may be output when the position p with respect to the inspection target is small. Further, the sound output state may be adjusted by a combination of the number of sound outputs, the volume, and the tone, and at least one of the parameters may be adjusted.

  When the sound output is completed in step S24, it is determined in step S6 whether or not the inspection is finished. If it is determined in step S6 that the inspection is continued, the process returns to step S3, and the control unit 50 switches the display state of the inspection target 91 (each region 91a to 91c). For example, as shown in FIG. 3B, the area 91a is switched from white to black, and the area 91c is switched from black to white. At this time, a sound (a sound different from the sounds output in Step 22 and Step 24) may be output from the speaker 80 to indicate to the patient that the examination target has been switched.

  By repeating steps S3 to S6 as described above, the visual inspection of the patient is repeatedly performed using the same type of inspection target. The display state of the inspection target is randomly switched by the control unit 50 based on a program stored in the storage unit 73, and can be manually switched based on an input signal of the input unit 72.

  In step S6, when the control unit 50 determines that a series of inspection programs has been completed, the inspection ends. In addition to this, when an inspection end signal is input from the input unit 72 based on the judgment of the examiner, the inspection may be manually ended.

  While a series of inspection programs as described above is being executed, every time a coordinate signal is output from the touch panel 62 in step S4, the storage unit 73 stores the correctness / incorrectness of the inspection result (the patient correctly indicates the index). And whether or not it has been specified) and information on the elapsed time from when the test target is presented until the pressing coordinates are input are stored. And the change of a patient's visual function etc. can be evaluated from the test result memorize | stored in the memory | storage part 73. FIG. For example, it is possible to evaluate the effectiveness of implanting the visual regeneration assisting device from the comparison of the visual function test results before and after the visual regeneration assisting device is implanted. Further, in the training for correctly identifying the patient, which will be described later, the result of the visual function training can be evaluated from the combination of the correctness of the test result and the elapsed time. Moreover, the tendency of the visual function obtained from the information in the storage unit 73 can be used for planning such as training for each patient.

  In step S3, when the control unit 50 switches the display state of the display 61, the number of trials for repeating the inspection may be set in advance. The number of trials can be set by an input signal from the selection means 70.

Further, during the examination, information on the patient-side display 61 may be displayed on the examiner-side display 71. For example, the control unit 50 displays the parameters of the inspection target on the display 61 as text. Alternatively, the control unit 50 displays a reduced image of the display screen (inspection target 91) displayed on the display 61 on the display 71. Information on the display screen of the display 61 is acquired by capturing an image.
In this case, information on the touch position of the patient with respect to the examination target may be displayed on the reduced image. For example, the control unit 50 displays information on the pressed coordinates of the touch panel 61 as a mark at a corresponding position on the reduced image. When the information on the display 61 on the patient side is reflected on the display 71 on the examiner side, the examiner can easily check the examination status of the patient via the display 71. In addition, by reflecting the information of the patient's test results, it becomes possible to quickly and accurately follow up the test.

  Various types of inspection targets are displayed on the display 61. For example, as shown in FIG. 5, an inspection target 92 in which a plurality of square regions 92a are prepared on the background 92b may be displayed. As a result of examining the visual function using the inspection target 91 of FIG. 3, when it is confirmed that the patient's visual function is relatively excellent, the process returns to step S2 and is relatively difficult. The examination target 92 of FIG. 5 may be selected to examine the patient's visual function.

  The visual function can be inspected using a dynamic inspection target. As shown in the inspection target 93 of FIG. 6, a white bar-shaped region 93a is formed on the black background 93b. The controller 50 performs image processing so as to move the region 93a in the arrow A direction or the B direction at a predetermined speed. The patient confirms the moving area 93a on the display 61, and designates the position p on the touch panel 62 as described above. Then, the position p designated by the touch is slid in accordance with the movement direction of the region 93a. At this time, it is inspected whether the patient can follow the movement of the inspection target. In this case, when the patient correctly specifies the test target based on the above-described steps S21 to S24, the correct sound is once output from the speaker 80 in step 22. When it is determined that the position p has deviated from the region 93a when the patient follows the inspection target, the control unit 50 outputs a sound indicating the direction of the position p with respect to the region 93a from the speaker 80 in step S24. Let The moving speed of the dynamic test target is assumed to be viewing angle / second. Alternatively, it is assumed that the maximum value of the moving speed at which the screen moves from end to end in the horizontal or vertical direction is 1 second, and the minimum value is about 0.5 degrees / second.

  When the visual inspection function by the dynamic inspection target shown in FIG. 6 is good, as shown in FIG. 7, a dynamic inspection target 94 composed of a plurality of circular regions 94a is displayed on the background 94b. You may let them. In this case, the control unit 50 randomly moves each region 94a in the vertical and horizontal directions (arrow CDEF direction). Also in this case, as in FIG. 4, for example, in a state where the patient has selected the specific region 94 a, the position p designated by touching is made to follow as the region 94 a moves.

When a dynamic target is displayed on the display 61, the moving speed of the test target can be set by the selection means 70. For example, the moving speed of the examination target may be adjusted according to the result of the examination or training of the patient's visual function.
Further, the inspection target may be displayed with the white color and the black color inverted depending on the purpose of the inspection. In addition to the above, visual function inspection and visual function can be trained using targets such as E targets and fringe targets.

  Although the example of the test mode has been described above, in the training mode, training is performed for the patient to correctly identify an object. In this case, when the training mode is selected in step S1, if the examination target is not correctly specified in step S21, the control unit 50 passes through steps S23 to S24 and S6 and returns to step S3. Maintains the display state of the inspection target (does not switch). That is, in the example of the inspection target 91 of FIG. 3, the area 91a is continuously displayed in white and the other areas are continuously displayed in black. And it is made to repeat the process of step S3-S6 until it determines with the patient having specified the optotype correctly in step S21. At this time, the number of trials for inspection may be determined by the input unit 72.

  In the test mode and the training mode, when the position p designated by the patient on the touch panel 62 is shifted with respect to the test target 91, the patient has specified so that the patient can correctly specify the test target 91. A sound for guiding the position p to the display position of the inspection target 91 may be output. For example, when the position p designated by the patient with respect to the examination target 91 is shifted in the “right” direction, a sound “left” is output from the speaker 80. Also in this case, the control unit 50 adjusts the sound output from the speaker 80 according to the shift amount of the position p with respect to the inspection target 91. As described above, a sound indicating a direction opposite to the direction of the shift of the position p with respect to the test target 91 may be output so that the patient can follow the test target 91 correctly.

  Here, the visual reproduction assisting device will be described. FIG. 8 is an external view of the visual reproduction assisting device. FIG. 9 is a schematic view of an intracorporeal device. The visual reproduction assisting apparatus 1 is broadly classified into an extracorporeal apparatus 10 that captures the outside world (subject) and an in-vivo apparatus 20 that stimulates visual reproduction by applying electrical stimulation to cells constituting the retina. The extracorporeal device 10 includes glasses 11 worn by a patient, an imaging device 12 attached to the glasses, an image processing unit 13 that generates electrical stimulation pulse data based on a subject image captured by the imaging device 12, and a visual reproduction assisting device. 1 a power supply source (power source) 14 for supplying power to the whole, a modulation means 16 for generating an electromagnetic wave by modulating the power of the power supply 14 based on the electrical stimulation pulse data, and an electromagnetic wave generated by the modulation means 16 Is composed of a transmission means (primary coil) 15 and the like. A magnet (not shown) is attached to the center of the transmission means 15, and the position is fixed to the reception means 21 on the intracorporeal device 20 side, which will be described later, by magnetic force.

  The intracorporeal device 20 has a receiving unit 20a and a stimulating unit 20b connected by a cable 30. The receiving unit 20 a includes a receiving unit 21, a control unit 22, and a counter electrode 26. The receiving unit 21 receives an electromagnetic wave transmitted from the extracorporeal device 10. The controller 22 demodulates the electromagnetic wave received by the receiving means 21 to obtain electrical stimulation pulse data and power. The electric power extracted by the control unit 22 is used not only for driving the in-vivo device 20 but also for the stimulation current output from the electrode 27. The electrical stimulation pulse data includes an electrode designation signal for outputting a stimulation current from the electrode 27. The counter electrode 26 is placed at a position facing the electrode 27 across the retina.

  The stimulation unit 20 b includes a substrate 25, a demultiplexer 40, and an electrode 27. The substrate 25 is formed with a predetermined thickness using a resin having flexibility to bend along the shape of the eyeball. A plurality of electrodes 27 are formed on the front end side (open side) of the substrate 27. The electrode 27 is made of a biocompatible metal such as platinum. A demultiplexer 40 is mounted on the base end side of the substrate 27 (connection side of the cable 30). The demultiplexer 40 distributes the stimulation current to each electrode 27.

  The in-vivo device 20 having the above configuration is installed at a predetermined position in the patient's body. FIG. 10 shows an example in which the stimulation unit 40 is installed on the patient's eye E. With the electrode 27 formed on the substrate 25 in contact with the choroid E2, a part of the substrate 25 is placed between the sclera E3 and the choroid E2. Further, the range of the substrate 25 where the demultiplexer 40 is mounted is placed outside the sclera E3. The substrate 25 is set by first incising a part of the sclera E3 to form a sclera pocket, inserting the electrode 27 portion of the substrate 25 into the sclera pocket (outside of the choroid E2), and stitching or the like. This is performed by a procedure for fixing the substrate 25. The indifferent electrode 26 is placed at a position in the eye facing the electrode 27 across the retina. In FIG. 10, the intracorporeal device 20 (stimulation unit 40) is installed on the sclera E3 side, and the cells constituting the retina E1 are electrically stimulated from the sclera side (choroid side). In addition to this, the electrode 27 should just be installed in the position which can stimulate the cell which comprises the retina of a patient's eye. For example, the intracorporeal device 20 may be installed in the eye of the patient's eye (on the retina or below the retina), and the substrate 25 on which the electrode is formed may be installed below the retina (between the retina and choroid) or on the retina.

  For the patients before and after implantation of the visual reproduction assisting apparatus 1 as described above, the visual function evaluation apparatus including the visual function evaluation program as described above is preferably used for visual function inspection and visual function training. Will be able to.

It is explanatory drawing of a visual function evaluation apparatus. It is a flowchart of the operation | movement procedure of a visual function evaluation apparatus. It is an example of a visual function test | inspection target. It is a flowchart for determining whether a patient can specify a target correctly. It is an example of a visual function test | inspection target. It is an example of a visual function test | inspection target. It is an example of a visual function test | inspection target. It is an external view of a visual reproduction auxiliary device. 1 is a schematic view of an intracorporeal device. It is explanatory drawing of the state which implanted the intracorporeal apparatus in the eyeball.

DESCRIPTION OF SYMBOLS 1 Visual reproduction | regeneration assistance apparatus 10 Extracorporeal apparatus 20 In-vivo apparatus 27 Electrode 50 Control part 60 Display apparatus 61 Display 62 Touch panel 70 Selection apparatus 71 Display 72 Input part 73 Memory | storage part 74 Time measuring apparatus 80 Sound generator 100 Visual function evaluation apparatus

Claims (5)

A visual function evaluation program for examining or training a patient's visual function,
A first display control step for displaying an examination target to be presented to the patient at predetermined display coordinates on the first display screen;
An acquisition step of acquiring a signal of a press coordinate specified by contact from a touch panel installed covering the first display screen;
A sound control step for causing the sound output means to output a sound based on the positional relationship between the display coordinates and the pressed coordinates;
A visual function evaluation program characterized by causing a computer to execute the above. Causing the computer to further perform a calculation step for obtaining a positional relationship between the display coordinates and the pressed coordinates;
The visual function evaluation program according to claim 1, wherein the sound control step controls a sound output from the sound output unit based on a calculation result in the calculation step.   The visual function evaluation program according to claim 2, wherein the sound control step causes the sound output means to output a sound indicating a direction of the pressed coordinates with respect to the display coordinates obtained in the calculation step. The sound control step, as when the pressing coordinates and the display coordinates of the test chart is consistent with the required range, according to claim 1 to 3, which in the case does not match to output different sounds from said sound output means One of the visual function evaluation programs. A visual function evaluation apparatus for examining or training a visual function of a patient,
First display control means for displaying an examination target to be presented to the patient at predetermined display coordinates on the first display screen;
An acquisition means for acquiring a signal of a press coordinate specified by contact from a touch panel installed covering the first display screen;
Sound control means for outputting sound to the sound output means based on the positional relationship between the display coordinates and the pressed coordinates;
A visual function evaluation apparatus comprising:

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