EP3334327A1 - Dispositif et procédé de détection quantitative de troubles du champ visuel - Google Patents

Dispositif et procédé de détection quantitative de troubles du champ visuel

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Publication number
EP3334327A1
EP3334327A1 EP16753878.4A EP16753878A EP3334327A1 EP 3334327 A1 EP3334327 A1 EP 3334327A1 EP 16753878 A EP16753878 A EP 16753878A EP 3334327 A1 EP3334327 A1 EP 3334327A1
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EP
European Patent Office
Prior art keywords
grid
deviation
vertical
horizontal
index
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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EP16753878.4A
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German (de)
English (en)
Inventor
Ronald V. Krüger
Daniela Claessens
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Individual
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Individual
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Publication date
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Publication of EP3334327A1 publication Critical patent/EP3334327A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/02—Subjective types, i.e. testing apparatus requiring the active assistance of the patient
    • A61B3/028—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for testing visual acuity; for determination of refraction, e.g. phoropters
    • A61B3/032—Devices for presenting test symbols or characters, e.g. test chart projectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/02—Subjective types, i.e. testing apparatus requiring the active assistance of the patient
    • A61B3/024—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for determining the visual field, e.g. perimeter types
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F17/00—Digital computing or data processing equipment or methods, specially adapted for specific functions
    • G06F17/10—Complex mathematical operations
    • G06F17/11—Complex mathematical operations for solving equations, e.g. nonlinear equations, general mathematical optimization problems
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F3/00—Input arrangements for transferring data to be processed into a form capable of being handled by the computer; Output arrangements for transferring data from processing unit to output unit, e.g. interface arrangements
    • G06F3/01—Input arrangements or combined input and output arrangements for interaction between user and computer
    • G06F3/011—Arrangements for interaction with the human body, e.g. for user immersion in virtual reality
    • G06F3/013—Eye tracking input arrangements

Definitions

  • the present invention relates to a device for the quantitative detection and / or monitoring of visual field disorders of a subject's eye according to the preamble of claim 1 and to a method for the quantitative detection of visual field disorders of a subject's eye according to the preamble of claim 15.
  • the present invention relates to the quantitative detection, measurement and display of disorders of the visual field of a human eye, in particular distortions (metamorphopsia [1]) and visual field defects (scotoma).
  • Different diseases of the eye can lead to accumulation of fluid in the middle of the retina (macular edema) or to the formation of a pellicle on the retina (epiretinal gliosis) or to a hole in the retina center (macular (layer) hole) or to lift off Retinal layers (eg retinal pigment epithelial detachment).
  • a pellicle on the retina epiretinal gliosis
  • a hole in the retina center acular (layer) hole
  • Retinal layers eg retinal pigment epithelial detachment
  • Eye disorders leading to macular edema leading to severe visual impairment or blindness include age-related macular degeneration (AMD), diabetic macular edema, edema after retinal vein thrombosis, myopathy of macular degeneration, macular edema after cataract surgery, and inflammatory diseases (uveitis , Retinitis centralis serosa).
  • AMD age-related macular degeneration
  • diabetic macular edema edema after retinal vein thrombosis
  • myopathy of macular degeneration macular edema after cataract surgery
  • inflammatory diseases uveitis , Retinitis centralis serosa
  • an AMD may indicate that the patient suddenly sees straight lines crooked or letters blur when reading.
  • AMD is an eye disease that causes loss of vision in the area of the sharpest vision, the so-called macula lutea (also called “yellow eye") Everyday activities such as reading, watching TV, working on the screen, driving a car, recognizing colors or recognizing faces become less and less possible as the disease progresses, leaving only the external field of vision - and thus the orientation of the patient.
  • the risk of contracting AMD increases with age, so it has been recommended that people over the age of 50 should have their ophthalmologist check up annually to detect any early-onset AMD.
  • the AMD distinguishes between a ' dry ' and a ' wet ' form. With about 85 percent far more common is the dry AMD. In this form, it comes over years to the loss of light-sensitive cells of the retina of the eye and thus to a slow vision deterioration with mostly long-term readability.
  • Retinal examination examination of the retina by means of a magnifying glass after administration of pupil-dilating drops
  • Fluorescence angiography fluorescence or indocyanine green angiography after fluorescein or indocyanine green bolus injection .i.v. and by means of
  • OCT Optical coherence tomography
  • macular edema e.g. In the case of the chronic disease "wet AMD", there are repeated surgical procedures performed under sterile conditions in the operating room Monthly intraocular injections of vascular epithelial growth factor VEGF antagonists are performed by an ophthalmologist with an average of 8 injections per year.
  • the AMD is responsible for about 30 percent of all new blindness worldwide, in Germany for 50% of all new blindness [3]
  • Fast-moving wet AMD is the leading cause of blindness beyond the age of 60 in industrialized countries [5] (Bertram B: Blindness and visual impairment in Germany: causes and frequency. The ophthalmologist, 39th year, December 2005) Often the disease is not noticed until the second eye is already affected. Since one in four of the over-65s and one in three of the over-75s are affected by various stages of AMD, early detection and, as far as possible, prevention are particularly important. This is where the present invention starts.
  • Performing diagnosis and treatment of macular edema requires the search of a specialized center or clinic and the use of economic resources.
  • optical coherence tomography should be performed monthly in the first half of the year both before an injection therapy and after a completed therapy cycle.
  • many statutory health insurance companies do not reimburse the OCT examination. This examination is charged to the patient privately, the cost per examination is about 100 euros, the purchase price for a Spectral Domain OCT, which meets the requirements of the recommendations of the ophthalmological societies, is approximately 100,000 euros.
  • blindness and the four eye diseases mentioned lead to a significant deterioration of well-being. According to the said study, the economy will lose 123 million working days annually. It is estimated that blindness and the eye diseases mentioned in the countries surveyed cause economic costs of about eight to 24 billion euros per year.
  • Metamorphopsia are the most prominent symptom of macular edema, e.g. in macular degeneration, scotomas are a leading symptom of diseases such as wet or dry AMD and glaucoma.
  • the Amsler grid can only make qualitative predictions about perceived distortions and visual field defects and no documentation or follow-up is possible, it still plays a fast screening method for the rough detection of central visual field defects, for example age-related macular degeneration or others exudative or degenerative processes in the retina center a significant role. It does not allow for substantial and detailed assessments of the visual field, for example, with regard to the amount of quantitative distortion.
  • the test itself consists of a 40 cm x 40 cm square grid with a center point to be fixed during monocular testing.
  • the other eye is completely covered with the flat hand or an eye patch, which must be done for neurological reasons, since the brain can compensate for small distortions of the visual impression of an eye through the "correct" visual impression of the partner's eye and the subject generally in binocular vision no Distortions will be discovered.
  • the test distance for the Amsler grid is about 40-50 cm. With appropriate findings, the test person will notice waves or distortions of the grid lines, possibly also apparent “holes” in the grid or “dark spots” in the grid pattern can. Such perceptions should - if experienced in the self-test - always lead to an immediate ophthalmological control.
  • WO 2014/022850 A1 discloses methods for testing for metamorphopsia by means of portable devices, wherein a patient enters in a displayed grid whether he perceives a distortion. If so, the remainder of the remaining area is calculated by the program and split into further segments. Then we repeat the procedure with each generated new segment. If the segment appears distorted, it remains in the area to be tested, if it does not leave the further test. The steps are repeated until the affected field of view area is limited and can be displayed as an area.
  • Document GB 2 457 735 A relates to a method and a system for measuring visual field disturbances by deforming an (Amsler) grid pattern on the screen of a personal computer, whereby the points of intersection of the grid used can be moved by the patient in a disturbed visual field perception, for example by means of a computer mouse in that the grid is returned to its original state.
  • the teaching of GB 2 457 735 A requires that the examinee can see the crossing points.
  • Distortion can only be approximated according to GB 2 457 735 A. Distortions which lie only between 2 adjacent nodes can not be represented.
  • the method disclosed in GB 2 457 735 A does not involve fixation control. This can lead to the multiple marking of distortions and thus to a false recording of the distortions when the fixation is changed (a new fixation causes the "same" distortion to be redrawn elsewhere.)
  • US 8,708,495 B2 discloses a method and apparatus for correcting vision disorders such as occur in patients with macular degeneration.
  • a quantitative diagnostic method used to correct the visual field distortions of a patient suffering from age-related macular degeneration.
  • a computer-assisted Amsler grid is generated, which is perceived distorted by the patient.
  • the patient then has the opportunity to move individual intersection points of the grid so that it again perceives the original undistorted Amsler grid.
  • the software of the computer system calculates, from the adjustments made by the patient, two-dimensional displacement vectors for the individual crossing points and stores the determined vector set in the memory of the computer.
  • These displacement vectors represent a quantitative according to US 8,708,495 B2 Diagnosis of the macular degeneration geometry of the examined patient, however, in practice only represents an approximation of the pathophysiological state of AMD.
  • US 5,589,897 also describes a method and apparatus for detecting visual field distortions by means of an Amsler grid, wherein the horizontal (or vertical) lines are not shown to the patient at the same time, but it is started with the line through the fixation point and then in Distance from 2-5 ° further lines shown.
  • This offering of single lines enhances the brain's "fill in” phenomenon, which may prevent the distortion seen when offering a line-filled field (such as the AMD) when looking at individual lines.
  • No. 5,892,570 discloses a metamorphopsia detection on a computer, on the screen of which a deformable Amsler grid is displayed and in which the test person can "neutralize” distortions which he perceives by inputting by means of a mouse. the nodes of a grid used) on the distorted perceived line until the line appears straight again.
  • the method described is the creation of a geometrically opposite pattern which, mathematically speaking, represents a function which is an ideal image
  • metamorphopsia can be visualized - more accurately approximated - a quantification of the obtained data is not addressed.
  • no indices are measured or calculated in US 5,892,570 pictorial storage of distortion and visual field failure.
  • the study according to US Pat. No. 5,892,570 does not represent an actual measurement of metamorphopsia, but rather an estimation of the pathophysiological conditions, which can be clearly removed from reality.
  • Ciaessens and Krüger 2015 do not reveal any hints on how to straighten a distorted grid and / or calculate the indices or weight the localization of visual field disturbance. Also, neither at the ARVO conference nor anywhere else was a source code provided for the software, whereby the disclosure according to Ciaessens and Krüger 2015 for the expert without knowledge of the present application is not reproducible.
  • the present invention relates to a device for the quantitative detection and / or monitoring of visual field disorders of a subject's eye with:
  • each individual section of the square grid is changed by at least one input signal to a curve which is suitable, the curved by the disturbed field of view of a subject perceived non-linear grid back into the to transform the original square grid, the boundaries of each individual field of the square grid being defined by bounding functions, which in an initial state, respectively Routes are displayed so that the individual fields are present geometrically as squares and are displayed as such by the display device, but are perceived as partially curved by subjects with disturbed visual field; and the curved perceived boundary lines are changed by a series of input signals, the boundary curves defined by the boundary functions such that the original linear grid network is perceived, the transformation-related geometric deviations of
  • the invention further relates to a method for the quantitative detection of disorders of the visual field of an eye of a subject, wherein a square grid of a parallel group equidistant horizontal and a parallel crowd equidistant vertical straight line at a defined distance from each other (indicated in ° degree depending on the viewing distance) and a substantially centrally located fixation point is displayed on a display device; each individual segment of the quadratic grid being changeable by at least one input signal to a curve suitable for transforming the nonlinear grid network, which has been curvedly perceived by the disturbed visual field of a subject, back into the original square grid; the boundary lines of each individual field of the square grid are defined by limiting functions which are respectively displayed as distances in an initial state, so that the individual fields are present geometrically as squares and as such are displayed by the display device, but by Subjects with disturbed visual field are perceived as partially curved; and the curved perceived boundary lines through a series of input signals that are altered by boundary functions defined bounding curves such that the original linear grid network
  • the "open path" may consist of 10 cubic Bezier curves per horizontal and as many cubic Bezier curves per horizontal open polygon.
  • the curve distances should be selected so that they are 1 ° apart from the examined eye, for example.
  • the Bezier curve consists of a starting point, two vertices and an endpoint in the plane. All four points are shifted orthogonal to the initial orientation of the line, depending on the position of the input signal.
  • the index is calculated as the sum of the amounts of the deviations of each point orthogonal to the "zero point" (undistorted).
  • Open polygon with, for example, n 10 straight lines: The n straight lines are positioned so that they give 10 vertical and 10 horizontal lines (open polygons) of the grid (see Fig. 5). These vertical open polygons lie in each case e.g. 1 ° apart. The same applies analogously to the horizontal open polygons.
  • the start and end points of the lines are orthogonally shifted to their starting position depending on the corresponding input signal, so that they continue to form an open polygon (see Fig. 5, points H (3, 39, 2) are not shifted, the points H (3,3o, 2) to H (3,39, i) are shifted). This happens until the visual impression of the subject is undistorted.
  • the sine function consists of a start and an end point (section of the sine line).
  • the sine lines to the left and right of the nearest sine wave to the input signal are removed, and the starting point of the selected sine curve is set to the starting point of the sine line to the left.
  • the end point of the selected sine curve is set analogously to the end point of the sine line on the right.
  • An advantageous embodiment of the device according to the invention is such, wherein the device is designed as a PC, a notebook, a tablet computer or a smartphone.
  • the subject can easily the correct angle to the display device and the optimum reading distance are maintained, so that misinterpretation or misalignment of the grid lines due to incorrect positioning, improper viewing angle or incorrect distance can be largely avoided by the choice of the device.
  • the terminals used in particular, PC, notebook, tablet computer or smartphone are network-capable and according to the prior art in 2015 with the usual interfaces to the Internet, such as Bluetooth, LAN, WLAN , High speed telephone network, eg LTE, are equipped, but are also specially adapted to the present invention data transmission paths with z.
  • At least one camera is provided on the device.
  • it can be determined automatically via an appropriate integrated software, which eye should be examined.
  • the optimal positioning of the device and / or test person can be detected by the software and appropriate suggestions for the correction of its position and / or the positioning of the device can be made to the subject.
  • a further aspect is that in telemetric transmission of the data, eg to the treating ophthalmology practice or ophthalmic clinic, the identity of the subject can be determined automatically by facial recognition and assigned to the examined subject by the patient data management software on the receiver side.
  • at least one ultrasonic or infrared distance sensor is provided on the device. This can ensure the optimal removal of the subject from the screen, so that the distance of the lines in ° degree can be displayed correctly, or - when changing the distance - can be tracked correctly.
  • covering means are provided for the eye not to be examined. This can be, for example, an external eye patch.
  • spacer and / or positioning devices with opaque diaphragms which can be attached to the display device for this purpose.
  • a further preferred embodiment of the present invention is one in which retina and / or iris scans are provided for the identification of the subject and for the unambiguous assignment of the examined eye to the subject.
  • retina and / or iris scans are provided for the identification of the subject and for the unambiguous assignment of the examined eye to the subject.
  • a particularly advantageous device of the present invention is when the device is designed in the manner of a pair of glasses, in particular a pair of diving goggles, wherein display devices are provided instead of the lenses.
  • this device is done by an input device corresponding to the prior art 2015, which can be moved on the plane to simulate a pen input or the drawing with a finger (mouse, electronic pen, etc.).
  • the correct positioning similar to a video glasses or a head-up display, when creating or placing the device already set.
  • the eye to be examined can be determined automatically and an integrated camera can then be done via facial recognition and / or iris and / or retina scan, the assignment of the measured field of view data to the examined subjects and, for example via a cryptographic algorithm (with a key exchange corresponding to the prior art 2015) to the treating ophthalmologist via Bluetooth, LAN, WLAN, high-speed telephone network, eg LTE, etc. are transmitted.
  • a particular advantage of the device according to the invention results when the determination of the transformation-related geometric deviations is independent of the limiting function. This ensures that the measured distortion corresponds to the visual impression of the subject.
  • a distortion index and / or a visual field failure index (scotoma index) from the determined horizontal and vertical deviations.
  • a visual field failure index (scotoma index)
  • Such an index allows the treating ophthalmologist to quantitatively detect, on the one hand, the severity of disorders of the visual field of one eye or both of a subject's eyes and / or on the other hand initiate therapy, for example in wet AMD with periodic intraocular injection of anti-VEGF monitor and quantify the progress of therapy.
  • the patient also has the possibility to check his visual impression of visual field defects and distortions in the interval between ophthalmological examinations and - if a worsening is indicated by an increase in an index - to have an ophthalmological examination carried out earlier than originally planned.
  • the distortion index and the visual field loss index as a function of the distance to weight the fixation point, with disturbances closer to the fixation point being weighted more heavily. Furthermore, the amplitudes of the distortions are disproportionately weighted and the size of the distortion range is weighted less than proportionally. As a result, a statement about the visual ability-based quality of life of a subject is possible.
  • Eccentricity V ((xF b / 2) 2 + (yF b / 2) 2 )
  • Fb the field width (width of the grating)
  • x is a horizontal coordinate
  • y is a vertical coordinate of a considered point in the grating field ;
  • the present invention is in the field of detection and / or monitoring of visual disturbances.
  • the device of the present invention uses the notion of a negative image: a square grid image perceived distorted by a subject or patient may be "aligned” by moving the mouse or touching or actuating another input device through one or more input signals
  • the degree of distortion and the coordinates of the distorted lines and / or field-of-view defects are converted into indices for quantitative detection of the field of view distortions Distorted lines are stored in the memory device of the device according to the invention in an array of approximate curves ,
  • a telemetric transmission of the measured field and / or the calculated measurements and / or indices as a measure of the distortion and / or as a measure of the present visual field loss from the subject to ophthalmology practice e.g. transmitted via end-to-end encrypted e-mail communication (eg via RSA and / or AES encryption).
  • the device according to the invention provides fixation by means of a camera, automatically identifies the examined eye and, by means of an ultrasound sensor, ensures the correct line spacing in degrees.
  • the patient the device itself - without ophthalmological support - to carry out a
  • the device according to the invention and the method according to the invention can alternatively also be used as a mobile test by an optometrist center, general practitioner or company doctor for prophylaxis ,
  • the software of the device according to the invention is based on the Amsler grid [10] [Marc Amsler: The Investigation of the Qualitative Vision with the Square Network. Instruction on the use of the test charts. Theodore Hamblin LTD, London 1958]
  • the Amsler grid consists of a box on which a grid of horizontal and vertical lines is arranged as a square grid.
  • the examinee must - after covering one eye - observe the grid with the uncovered eye and describe to the ophthalmologist, where he sees distortions.
  • the ophthalmologist receives only a qualitative statement about any visual field distortions and / or - failures. Since no quantitative data are obtained in this conventional test, the detection and monitoring of visual field disturbances with the classical Amsler grid are only of a qualitative nature and therefore only of limited scope.
  • the invention underlying the present application and in particular the software implementable method according to the invention uses the concept in the manner of a "negative image" of disorders of the visual field of a human eye.
  • a distorted by the patient image of the test grid can be distorted by moving an input device such as a mouse or a finger or pen on a device according to the invention, which is designed as a PC, touchpad or smartphone or as a special device back to the original square grid by modifying the aligned grid lines are aligned.
  • the test person or patient changes the curved perceived lines with the input device until they appear linear again.
  • a healthy eye would therefore, as it were, see a distorted "negative image" of the Amsler lattice It is then possible to quantitatively detect the degree, localization and dimension of the perceived metamorphopsia or scotoma and to transform distortions and / or a scotoma into indices on the basis of the "negative image" with which the present disturbances of the visual field can be detected and already initiated treatments can be monitored.
  • the method according to the invention correlates excellently with the conventional methods for measuring scotoma on the one hand and metamorphopsia on the other hand. Comparing the data on visual field defects of a conventional computer perimetry with those determined by means of the device according to the invention, one finds a match of the localization of the scotoma (see Fig. 3) in both methods.
  • the present invention is used not only in the diagnosis of retinal diseases but also in the monitoring of already initiated therapies of retinal diseases.
  • the AURA [13], COMPASS [14] and WAVE [15] studies have shown that patients in clinical trials have underutilized diagnostic procedures and that too few injections have been given in the treatment of chronic retinal diseases. The latter was due to logistical issues, suboptimal compliance and lack of adherence, or simply because patients did not notice or notice the worsening of visual symptoms. According to the studies mentioned, late diagnoses and therapy frequencies that were too low resulted in poorer therapeutic results compared to optimized diagnostic and therapeutic conditions than would be possible with the possibilities of modern ophthalmology [15], [13-14].
  • the present invention may assist the ophthalmologist in the diagnosis and evaluation of OCT images, as the OCEAN study [1 8] or its subgroup in the ORCA module and the CATT study [19] has shown that about 30 % of OCT images are wrongly diagnosed by the treating ophthalmologist.
  • the device according to the invention as well as the method according to the invention enable high-frequency screening and monitoring by the subject or patient himself. This is because the device is easy to use, affordable and by using already existing mobile or stationary terminals for most Persons is available.
  • the present invention it is possible for the first time to identify pathophysiological disorders of the eye which are associated with visual field distortions and / or visual field defects, on the one hand with an initial suspicion or known risk, e.g. through familial dispositions, underlying disease (diabetes, myopia, HIV infection, pseudoxanthoma elasticum) or nicotine abuse, early detection and treatment and on the other hand, the therapeutic measures over time closely - with as few doctor visits - monitor.
  • an initial suspicion or known risk e.g. through familial dispositions, underlying disease (diabetes, myopia, HIV infection, pseudoxanthoma elasticum) or nicotine abuse
  • the device according to the invention has therefore been developed in particular in order to provide a set of instruments that can be used as a mobile or home monitoring device by the patient himself to control his disease course, but also as a high-precision diagnostic tool for the experienced ophthalmologist for daily practice.
  • the device according to the invention and the method according to the invention it is possible for the first time by simple means not only to qualitatively recognize metamorphopsia and scotoma, but also to do so quantify their severity, pinpoint their location and sizing.
  • a visual field test can be performed by means of the device according to the invention due to their ease of use of the patient at home.
  • Apparatus and methods according to the present invention are capable of controlling patient compliance with therapy intervals, e.g. Intravitreal injections in wet AMD, or to point out the need for increased frequency of therapeutic measures early.
  • therapy intervals e.g. Intravitreal injections in wet AMD
  • a particular economic aspect of the present invention is based on the fact that even in remote areas without easy access to a targeted ophthalmological care the device according to the invention plays a role as a public health tool. In particular, it can help early diagnosis and control of macular disease in such areas.
  • the present invention can help to achieve optimal therapeutic results by increasing the number of patients who use them for guided self-diagnosis and monitoring avoidable visual impairment and blindness and increase the quality of life of those affected.
  • the present invention can also make an important economic contribution, at least in the early detection and therapy monitoring of AMD.
  • visual distortions can be quantified.
  • the results can be stored in an encrypted (AES-256) data array and shared by both the patient and the treating ophthalmologist.
  • the monitoring is performed using a mobile device, wherein it is preferable to perform the measurement with a handheld device, such as a tablet computer or a smartphone.
  • a further embodiment relates to monitoring with a stationary device, which is provided for example in an ophthalmology practice with connection to the patient data management system and other diagnostic devices.
  • the invention provides a method for evaluating and / or treating a patient, wherein the patient suffers from visual field disorders.
  • Eye disorders that lead to distortions include those that lead to macular edema. These include, but are not limited to, choroidal neovascularization, age-related macular degeneration (wet and dry forms), macular edema in retinal venous occlusion (RVO), including minor vein occlusions (VAV) and central vein occlusions (CW), choroidal neovascularization secondary to pathological myopia (PM), a diabetic Macular edema (DME), a uveitis or in Pseudoxanthoma elasticum, in retinal Pigmentblattabhebitch in eg retinitis centralis serosa.
  • diseases of other areas of the retina epiretinal gliosis, macular (layer) hole
  • other structures of the eye such as the cornea, such as corneal scars or keratoconus, can lead to metamorphopsia.
  • the present invention can be used to monitor the patient's response to treatment by the patient himself and, if necessary, by the optometrist and / or ophthalmologist, if necessary also telemetrically, to provide the patient with an indication of if and when the next treatment is required.
  • the treating ophthalmologist can tailor the patient's treatment regimen and therapy to the individual patient to provide the maximum therapeutic benefit to the patient with minimal risk.
  • the term "remote monitoring” or “remote monitoring” is understood to mean that the patient himself decides which data he would like to share, for example, with the ophthalmologist of his choice Depending on the result of the evaluation of the data by the specialist, which evaluates the visual field data of the patient, then further therapeutic and / or diagnostic measures can be recommended as needed based on the longer-term trend of the examination results For example, an AMD patient may be advised to discontinue or continue treatment, taking into account his remaining examination results carry out diagnostic measures and, if necessary, dose recommendations for the administration of pharmaceuticals are given.
  • the present invention is ideally suited to be used on mobile devices.
  • the device according to the invention is operated via a display, cursor control and an interface.
  • the device may further include a camera.
  • the device can on the one hand cause an individual identification of the patient and on the other hand automatically recognize which eye is being examined and whether the eye fixes the center of the test field (eye tracking), which allows a tracking of the entire grid.
  • the device may also include an ultrasonic distance sensor that provides the subject with the correct distance from the screen to automatically display the correct line spacing in degrees on the screen.
  • the display of the device according to the invention is designed as a touchscreen, so that the patient can enter directly on this. This is likely to appeal to elderly patients in particular, as they do not need to use a keyboard or a mouse, which often leads to anxiety and rejection in elderly patients.
  • the display device complies with one or more of the following standards: (A) ANSI Z80.21 -30 1992 (R2004) for the background luminance (ie falling within the range of 80 to 320 cd / m 2 ), (b) a contrast ratio of 300: 1, 600: 1 or more, and is in accordance with ISO 8596, and (c) ISO 8596: 1994 (E) (ie has a color temperature of 2500K to 7000K).
  • the device comprises a camera facing the patient while the test is being performed.
  • the device may initialize a face recognition software such that the device in combination with the camera confirms the identity of the patient as well as the termination of the patient Tests (iris detection, retinal scan) can determine. It also allows the camera to determine if the right eye is being tested (ie, the patient has closed or covered the other eye).
  • the camera may also identify, for example, the typical formation of nasal and temporal retinal vessels to identify the patient, and the device may evaluate this data for identification.
  • the camera also allows to monitor the constant, predetermined distance from the eyes of the patient, which is required for the examination, and to issue corresponding warnings when it exceeds or falls below it.
  • warnings, information, advice for example, via appropriate corrective lenses, distance to the device, etc.
  • the device according to the invention can also measure the distance between the eyes of the patient and the device and adapt the test accordingly.
  • the size of the grid used in the test can be automatically adjusted to ensure that the angle between two initial parallel lines remains x ° degrees (e.g., 1 ° degrees).
  • a distance measuring device can be realized for example by contactless sensors, in particular by the use of ultrasonic or infrared sensors or by means of a distance defined by the hardware, such as by means of a mechanical spacer.
  • the patient may wear an eye patch over the eye that is not tested.
  • the device may further comprise a microphone, a speaker and speech recognition, text-to-speech software. In this way, the device can be operated by voice commands given by the patient and voice instructions, information and warnings obtained from the device.
  • this (negative) image accurately reflects its distortions: amplitude, eccentricity and area are measured and calculated in the case of distortions due to individual values. In the case of visual field defects, the values area and eccentricity are measured and calculated.
  • the eccentricity flows, since they logarithmically in the calculation of Horizontal Aug. Vertical deviation enters disproportionately (in terms of its physiological significance) disproportionately (the more central, the higher weighted) in the calculation of the eccentricity index and the total index.
  • This reflects the fact that distortions located centrally in the field of vision affect the quality of life significantly more than peripheral ones. If a central distortion in a text is perceived, is always distorted just the syllable that is to be read or the place of an image (eg the eyes of a fellow human being) to be considered. Since in the center of the retina (fovea) is the highest density of nerve cells (cones) that allow sharp vision and seeing colors, a distortion in this area particularly compromised: sharp vision is difficult, objects appear distorted.
  • the lines are always given according to the invention at a distance of x degrees, with a range between 0.5 ° and 2 ° being preferred, in particular 0 , 5 °; 1 ° or 2 ° and is not displayed in a specified distance in mm on the screen.
  • the line spacing in degrees always results from the distance of the eye to be examined from the screen, which can be done, for example, by a conventional ultrasonic measurement.
  • the size of the detectable field of view results primarily from the screen size and secondarily from the distance eye - screen.
  • visual field defects can be marked and measured.
  • the visual field loss is recorded as a total index.
  • the overall index reflects the size of the visual field loss and its location: central failure leads to a higher index than a peripheral failure of the same area.
  • the present invention allows - unlike the cited prior art - the representation of the negative image of the distortion true to the image and is thus considerably more accurate than conventional methods.
  • the representation using the method according to the invention not only allows an approximation to the visual impression, but an exact representation of the negative image of the visual impression by curves can be drawn and not only crossing points are moved in a grid.
  • fixation control z. B. by eye-tracking, ensures that distortions are not marked or drawn repeatedly by the patient in the wrong place in the field of view and / or thus.
  • Distortions can also be imaged with the method according to the invention if they relate to a distance that is smaller than the distance between two adjacent lines. This is especially important in the case of central distortions (or visual field defects), which are very noticeable to those affected even at a small size.
  • the interpolation between two (e.g., vertical) lines is possible by the distortion of the orthogonal (e.g., horizontal) lines.
  • FIG. 1 shows a detail (left upper quadrant) of a distorted Amsler grating; represented by cubic Bezier curves.
  • Fig. 2a / b show a visual field distortion representation by means of the invention, central and right of the fixation point, as well as in the right lower quadrant a representation of the retina with visible edema in the retina center obtained by means of optical coherence tomography; and
  • Fig. 3a / b shows a visual field defect representation by means of the invention, in the vicinity of the fixation point as well as in the lower left quadrant faded in the same visual field loss, represented by means of conventional computer perimetry;
  • FIG. 5 shows a section (left upper quadrant) of a distorted Amsler grating, representation by means of straight lines;
  • Fig. 6 is an illustration of quadrant anopsia obtained in accordance with the present invention (e.g., in the course of the visual pathway in neurological disease);
  • Fig. 7 shows a representation of a hemisphere vision (hemianopsia), obtained according to the present invention, e.g. after stroke.
  • the average decrease of the central retinal thickness measured by OCT was 77.54 ⁇ (median 55 ⁇ ; SD 49.99; Cl 1 1 1.74; 43.33), the average decrease of the Metamorphopsia Index was 6.0 (median 4.76, SD 3.5, Cl 7.9, 4.1).
  • the mean best corrected visual acuity was 0.38 logMAR (SD 0.28) before and 0.25 logMAR (SD 0.21) after injection therapy (CI 0.21, 0.03).
  • the display of the grating is constructed by an appropriate number (5 to 20) cubic Bezier curves per horizontal or vertical line at a distance of 1 ° (relative to the distance of the eye to be examined).
  • These lines form the basis of the grid.
  • each field of the grid is bounded by 4 cubic Bezier curves.
  • Each horizontal and each vertical line can consist of eg 10 cubic Bezier curves.
  • the points H (13,3) and H (14,3) described in Fig. 1 are defined as vertices of the cubic Bezier curve.
  • the patient first fixes the fixation point (see Fig. 1, bottom right) in the middle of the lattice with an eye.
  • the device automatically recognizes the patient and the eye to be examined via iris or retina scan or detecting the characters on the cover of the eye not to be examined and detects whether the patient fixes the center.
  • the patient is prompted to select only one type of line (horizontal or vertical lines) for display.
  • the next step for the user is to straighten out those lines which he perceives distorted, fixing the fixation point with the aid of an input device. This can be done by means of a mouse wheel, a mouse click, a finger, a pen or by means of a touchpad.
  • a second step the patient is asked to select those other lines that are perpendicular to the one already processed.
  • the user moves with these lines as well as with the other line type. He straightens those lines, which he perceives distorted in exactly those places, where he perceives distortions, also under fixation of the fixation point (and under cover of the unexamined eye).
  • the "straightening" of the curved lines perceived by the patient results in a negative or complementary image of his real field of vision, with disturbances on the one hand by delineated zones in the scotoma and on the other hand in metamorphopsia by visible distortions in the grid used Visual field loss can then be quantified, stored, and tracked for any period of time using the cubic Bezier functions by calculating a scotoma index and a metamorphopsia index, to monitor the success of a therapy that has already begun, and to take early therapeutic measures can, if a worsening of the pathophysiological state occurs.
  • the mentioned indexes are formed as follows (only M g and Sg are an index, while the other values are used for the calculation):
  • Fb field width (width of the grid)
  • Wi distortion amplitude
  • n number of displayed fields, resp. Number of vertical or horizontal lines
  • the distortion values W1 disortion amplitude
  • W2 distortion eccentricity and W3 disortion surface
  • ⁇ 3 ⁇ x- component of the eccentricity of the center of gravity of the ellipse
  • Measured is the a) the extent (area) of the visual field disturbance and b) the eccentricity of the center of gravity of the ellipse: in this case, the larger the area (SA) the higher the measured value and the more central the visual field disturbance is (SE)).
  • the normal retinal thickness is between 250 and 300 ⁇ . In the presence of macular edema, the retinal thickness increases.
  • the points are initialized so that Si, i is on the coordinate (0
  • the localization is the distance from the fixation point. This value weights the deviation inversely proportional, since an impairment in the central visual field is perceived as subjectively worse.
  • the summation is performed for each point of the Bezier curves in the horizontal and vertical directions.
  • the sum of the amounts of the deviation is weighted by the logarithm function with the basis> 1.
  • the basis is dependent on the importance for the quality of life in terms of the severity of the distortion, e.g. :
  • the number of shifted points is a measure of the size of the affected area and is included in the overall index multiplicatively or additively also logarithmically to the base B depending on the meaning for the quality of life.
  • This area is represented by an ellipse.
  • the visual field loss index is calculated from the area (A) of the ellipse and the distance (b) of the center of gravity of the ellipse to the fixation point.
  • the distance of the viewer (the eye to be examined) is calculated as follows:
  • Fg b / Xdpi bZW.
  • Fg b / Vdpi
  • n number of fields
  • the device Upon completion of an eye exam, the device will prompt the patient to examine the second eye if necessary.
  • the patient typically has the option to first complete the metamorphopsia test and then perform the scotoma test, or he can perform both tests in combination.
  • the user decides which results are to be stored and preferably sends the results encrypted to his treating physician.
  • the examination may be performed by the patient at medically recommended or self-selected intervals or after notice of symptoms.
  • Adding the field of view module increased the sensitivity of the test: 2 eyes not detected as diseased by the Metamorphopsia module alone could be properly classified as ill by the combination of the Metamorphopsia module and visual field module. These two eyes had a large central visual field loss due to a large extent of dry macular degeneration: for this reason, they were not distorted because they could no longer recognize in the central visual field.
  • One eye * with central serous retinopathy showed no clinical abnormalities: the visual acuity was within the normal range, there were no distortions or visual field defects.
  • Metamorphopsie and scotoma indices which were measured with the device according to the invention in all 13 eyes.
  • the average decrease in central retinal thickness (CRT) as determined by SD-OCT was 77.54 ⁇ ; (Median 55 ⁇ ; SD 49.99; Cl 1 1 1.74; 43.33), the mean decrease in the metamorphopsia index was 6.0 (median 4.76, SD 3.5, CI 7.9, 4.1).
  • the geometric mean of BCVA was 0.38 logMAR (SD 0.28) before and 0.25 logMAR (SD 0.21) after treatment (CI 0.21, 0.03).
  • NEI VFQ 25 increased (QL +) in 1 1 cases and worsened in 2 patients (QL-) (mean change 10.69, median 10, SD 12.96, CI 17.74, 3.65) of one of the two patients with decrease
  • QL- mean change 10.69, median 10, SD 12.96, CI 17.74, 3.65
  • the measured metamorphopsia index results according to the invention correlated excellently with the central retinal thickness measured by means of SD-OCT, the BCVA value, the Amsler test and the Visual Eye questionnaire of the National Eye Institute (NEI-VFQ 25).
  • the visus-related quality of life of patients depends on the localization (central disorders interfere more than peripheral), size and extent of distortion failures in his field of vision.
  • the center of the retina contains the highest density of neurons on the retina.
  • Anatomical changes lead to functionally all the more disturbing distortions and visual field defects the more central and the more pronounced they are. This neurophysiological circumstance leads to the algorithm used to calculate the indices.
  • Figs. 6 and 7 show clinical examples for detecting the severity of visual field disorder by means of the present invention, in which Fig. 6 shows the result of examination of a patient with quadrant anopsia (eg, neurological disease in the course of the visual pathway), and Fig. 7 shows the result An examination of a patient with a half-sided visual field loss (hemianopia), for example after a stroke represents.
  • quadrant anopsia eg, neurological disease in the course of the visual pathway
  • Fig. 7 shows the result An examination of a patient with a half-sided visual field loss (hemianopia), for example after a stroke represents.
  • hemianopia half-sided visual field loss
  • a method for diagnosing disorders of the visual field of an eye of a subject wherein a square grid of a parallel group of equidistant horizontal and a parallelschar equidistant vertical straight line and a substantially centrally located fixing point is displayed on a display device; each individual segment of the quadratic grid is changeable by at least one input signal into a curve suitable for transforming the nonlinear grid network, which has been curvedly perceived by the disturbed visual field of a subject, back into the original square grid; the boundary lines of each individual field of the square grid are defined by limiting functions which are respectively displayed as distances in an initial state so that the individual fields are geometrically represented as squares and displayed as such by the display but by subjects with disturbed visual field as partial be perceived curved; and the curved perceived boundary lines are changed by a series of input signals to define the boundary curves defined by the boundary functions - and not just the intersections of the vertical and horizontal lines of the mesh - such that the original linear mesh is perceived the transformation-related geometric deviations of the curved
  • the clipping functions are selected from the group consisting of: splines, B-splines, nonuniform rational B-splines, cubic splines, Bezier curves, quadratic, cubic, or fractional-rational Bezier curves; Bernstein polynomials; Polynomials greater than or equal to 2nd degree; Polygons; polygons determined by the De Casteljau algorithm; other algebraic curves, in particular power, root, rational and fractional-rational, transcended functions, in particular exponential, logarithmic, trigonometric, hyperbolic, arcing and area functions.
  • Diagnostic method wherein at least one camera for identification of the subject and / or for determining in which eye the quantitative detection of disorders of the visual field is to take place.
  • a diagnostic method wherein covering means are used for the eye not to be tested.
  • Diagnostic method wherein retina and / or iris scans are used for identification of the subject and for a one-to-one assignment of the examined eye to the subject.
  • a diagnostic method wherein an eye tracking system is used for fixation control.
  • Diagnostic method according to embodiment 1, wherein an ultrasonic sensor for distance measurement screen - user is used.
  • Diagnostic method wherein the determination of the transformation-related geometric deviations is independent of the limiting function.
  • Diagnostic method according to embodiment 1, wherein a distortion index / metamorphopsia index and / or a visual field failure index (scotoma index) is calculated from the determined horizontal and vertical deviations.
  • a diagnostic method wherein the distortion index and the scotoma index are weighted as a function of the distance to the fixation point, with greater weighting of disturbances closer to the fixation point.
  • Diagnostic method can receive and evaluate the data by encrypted e-mail, as well as a warning automatically goes to the evaluator and / or the patient after exceeding a threshold.
  • Diagnostic method can be represented by equation (1):
  • a diagnostic method wherein as a device for performing the diagnostic method, a PC, a notebook, a tablet computer or a smartphone is used.
  • a diagnostic method wherein the disorders of the visual field of an eye are caused by: eye diseases leading to macular edema, age-related macular degeneration (AMD), diabetic macular edema, edema after retinal vein thrombosis, myocardial retardation due to myopia, macular edema after cataract surgery and in inflammatory diseases (uveitis, retinitis centralis serosa).
  • AMD age-related macular degeneration
  • a diagnostic method is formed according to the following rule:
  • Fb field width (width of the grid)
  • Wi distortion amplitude
  • n number of displayed fields, resp. Number of vertical or horizontal lines
  • DOG, B., ROG The Anti-VEGF Therapy in Neovascular Age-Related Macular Degeneration: Therapeutic Strategies 2014.
  • Ciaessens, D. Comparison of vision-related quality of life and visual acuity after intravitreal anti-VEGF therapy in age-related wet macular degeneration 2010.

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Abstract

La présente invention concerne un dispositif et un procédé de détection quantitative de troubles du champ visuel d'un œil d'un sujet, en particulier dans le cas de maladies oculaires liés à un œdème maculaire. Une grille carrée est affichée sur un dispositif d'affichage. Les lignes de la grille, qui sont perçues incurvées par le sujet, peuvent être modifiées de manière à voir à nouveau une grille orthogonale. De telles lignes perçues incurvées peuvent être modifiées par des signaux d'entrée qui modifient les courbes de limitation définies par les fonctions de délimitation de façon à percevoir de nouveau la grille linéaire initialement affichée. Les écarts géométriques, induits par la transformation, des zones perçues incurvées de la grille carrée sont déterminées par les carrés initialement présents de manière quantitative comme la somme des valeurs des écarts horizontaux et comme la somme des valeurs des écarts verticaux.
EP16753878.4A 2015-08-14 2016-08-11 Dispositif et procédé de détection quantitative de troubles du champ visuel Withdrawn EP3334327A1 (fr)

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US5589897A (en) * 1995-05-01 1996-12-31 Stephen H. Sinclair Method and apparatus for central visual field mapping and optimization of image presentation based upon mapped parameters
US5892570A (en) 1997-11-24 1999-04-06 State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of The University Of Oregon Method and apparatus for measuring and correcting metamorphopsia
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US20160089272A1 (en) * 2013-01-18 2016-03-31 Conghua Li Methods and apparatus for partial obstruction of vision for treating forward head posture and related conditions
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