WO2019236868A1 - Dispositifs et procédés de détection de déficiences visuelles - Google Patents

Dispositifs et procédés de détection de déficiences visuelles Download PDF

Info

Publication number
WO2019236868A1
WO2019236868A1 PCT/US2019/035821 US2019035821W WO2019236868A1 WO 2019236868 A1 WO2019236868 A1 WO 2019236868A1 US 2019035821 W US2019035821 W US 2019035821W WO 2019236868 A1 WO2019236868 A1 WO 2019236868A1
Authority
WO
WIPO (PCT)
Prior art keywords
image
luminance
previous
display device
images
Prior art date
Application number
PCT/US2019/035821
Other languages
English (en)
Inventor
Mathew W. MACCUMBER
Original Assignee
Maccumber Mathew W
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Maccumber Mathew W filed Critical Maccumber Mathew W
Publication of WO2019236868A1 publication Critical patent/WO2019236868A1/fr

Links

Classifications

    • 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
    • G06F3/14—Digital output to display device ; Cooperation and interconnection of the display device with other functional units
    • 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
    • A61B3/06—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for testing light sensitivity, e.g. adaptation; for testing colour vision
    • A61B3/063—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for testing light sensitivity, e.g. adaptation; for testing colour vision for testing light sensitivity, i.e. adaptation

Definitions

  • Arrangements disclosed herein relate to devices and methods for detecting vision impairments, for example, screening devices and methods for detecting night blindness.
  • Night blindness refers to impaired visual function in dark or dim lighting due to faulty function of rod cells in the retina and is commonly associated with deficiencies in vitamin A metabolism and dietary intake.
  • rods are responsible for vision at low light levels (scotopic vision). Rods do not mediate color vision, and have a low spatial acuity.
  • Cones are active at higher light levels (photopic vision), are capable of color vision, and are responsible for high spatial acuity. The light levels where both cones and rods are operational are called mesopic.
  • vitamin A deficiency accounts for the leading cause of preventable childhood blindness, affecting 1/3 of children under age four worldwide per UNICEF report. Earlier detection or diagnosis is very important, as it often permits more preservation of vision if the condition is treated early. Dean Emeritus Alfred Sommer, ophthalmologist and world’s expert on this topic confirms there no easy screening test for night blindness due to vitamin A deficiency. In cases where night blindness is caused by vitamin A deficiency, such condition is preventable with vitamin A supplementation. But, only 64% of such cases were treated in 2016, per UNICEF. A need exists, therefore, for an easy to administer, low cost screening test for night blindness so that night blindness can be diagnosed and treated at an earlier stage of the disease.
  • nyctalopia is one of the earliest symptoms of retinal pigment epithelium 65-kD protein (RPE65)-associated and other genetically-acquired retinal dystrophies, ranging from the less severe congenital stationary night blindness to the more severe Leber's congenital amaurosis (LCA). Mutations in the gene encoding RPE65 result in the inability to properly metabolize vitamin A in photoreceptors, leading to dysfunction and atrophy of rod cells.
  • RPE65 retinal pigment epithelium 65-kD protein
  • RPE65 mutations have been identified in 10-15% of LCA cases, and recent clinical trials have yielded a gene therapy voretigene neparvovec, trade name Luxturna (TM), targeted at early-onset LCA candidates with RPE65 mutations.
  • TM trade name Luxturna
  • retinitis pigmentosa a spectrum of eye disorders causing progressive vision loss, often presents in childhood with initial nyctalopia related to inherited RPE65 and other gene mutations and worsens to include scotomas in the peripheral field, and later, within the central vision.
  • early diagnosis and identification of both vitamin A deficiency-related nyctalopia and inherited retinal diseases can prove vital to early treatment for the maintenance of vision and the prevention of progressive vision loss.
  • Diagnosis of night blindness is generally made by dark adaptation or electroretinography (ERG).
  • Dark adaptometry is not a feasible method of detecting night blindness in children under age 6 and ERG often requires anesthesia, particularly for children under age 4, making it less suitable or infeasible for many children.
  • ERG electroretinography
  • young children typically do not even know or realize that they may have night blindness and it may not be noticed by parents or caregivers thus leading to delay in diagnosis.
  • Such devices and methods can be used to screen and diagnose patients with significant vision problems, including night blindness due to inherited retinal disease, and also to identify children and pregnant mothers who are vitamin A deficient and, who, therefore, are in need of vitamin A supplementation.
  • the devices and methods disclosed herein can also be used to screen and diagnose patients for retinal dystrophies (RP, LCA), and can provide alternatives to dark adaptometry and electroretinography (ERG) which are much more labor intensive to administer, impractical in many areas of the world, and difficult if not impossible to administer to children under the age of six.
  • RP retinal dystrophies
  • ERP dark adaptometry and electroretinography
  • the devices and methods disclosed herein can be particularly important for the diagnosis and treatment of significant types of vision problems in children, where current testing protocols and equipment are typically infeasible and ineffective.
  • Arrangements disclosed herein can use fluorescent or phosphorescent images with a light source in a dimly lit or unlit room to screen for night blindness.
  • a patient can be placed in a dark or dimly lit room, and the patient is adapted to the darkness or dimness. The patient can then then screened for night blindness.
  • one or more fluorescent or phosphorescent images can be shown to the patient. It can be determined whether or not the patient can see the fluorescent or phosphorescent images based on simple gestures from the subject or responses to questions regarding the location and/or description of the images. Luminance of images can be varied in intensity to better determine dark adaptation threshold.
  • a series of images which can be of varying luminance, fluorescent intensity, and/or phosphorescent intensity (such as, for example, sequentially decreasing intensity, sequentially increasing intensity, or in a random order) can be shown to the patient to determine which images the patient or subject can see and to determine the severity of any impairments in the subject.
  • a cut-off point can be determined for what level of fluorescent or phosphorescent intensity is visible to the patient, and the degree of night blindness can be determined for the patient.
  • an image from a smartphone, computer monitor, tablet, or other electronic device can be presented to the subject.
  • any arrangements of the devices and methods disclosed herein can be administered by healthcare as well as non-healthcare personnel for screening (e.g., parents or teachers). Positive patients can then optionally be tested for dark adaptation, ERG changes, genetic testing, or vitamin A level, as indicated.
  • Arrangement 1 A method of detecting night blindness in a subject, comprising:
  • first luminance and the second luminance is within a range of from approximately 10 6 cd/m 2 to approximately 10° cd/m 2 .
  • Arrangement 2 The method of arrangement 1, wherein at least one of the first and second images comprises a fluorescent ink.
  • Arrangement 3 The method of any one of the previous arrangements, wherein the first image comprises a fluorescent ink at a first density and the second image comprises a fluorescent ink at a second density, the second density being different than the first density so that the second luminance is different than the first luminance.
  • Arrangement 4 The method of any one of the previous arrangements, wherein at least one of the first and second images comprises a fluorescent ink at a density of from 2% to 45%.
  • Arrangement 6 The method of any one of the previous arrangements, wherein the first image is positioned at a first position on the display device and the second image is positioned at a second position on the display device, wherein the second position is different than the first position.
  • Arrangement 7 The method of any one of the previous arrangements, comprising illuminating at least five images on the display device.
  • Arrangement 8 The method of any one of the previous arrangements, comprising illuminating at least seven images on the display device.
  • Arrangement 9 The method of any one of the previous arrangements, comprising sequentially illuminating at least five images on the display device wherein each image has a different luminance and displays a different object.
  • Arrangement 11 The method of any one of the previous arrangements, wherein the display device comprises a plurality of test plates having a low reflectivity and luminance.
  • Arrangement 12 The method of any one of the previous arrangements, wherein the display device comprises a plurality of sheets of paper each having a matte black color which each display an image.
  • Arrangement 14 The method of any one of the previous arrangements, wherein the display device comprises an image that has 100% ink density.
  • Arrangement 15 The method of any one of the previous arrangements, wherein the display device comprises a digital display and illuminating the image on the display device using a light source comprises displaying the image on the digital display.
  • Arrangement 17 The method of any one of the previous arrangements, wherein at least one of the first luminance and the second luminance image is within a range of from approximately 10 8 cd/m 2 to approximately 10 2 cd/m 2 .
  • Arrangement 18 The method of any one of the previous arrangements, wherein at least one of the first luminance and the second luminance image is within a range of from approximately 10 4 cd/m 2 to approximately 10 2 cd/m 2 .
  • Arrangement 19 The method of any one of the previous arrangements, wherein at least one of the first luminance and the second luminance image is within a range of from approximately 10 4 cd/m 2 to approximately 10 2 cd/m 2 .
  • Arrangement 20 The method of any one of the previous arrangements, comprising placing the subject in a dark or dimly lit room for a predetermined amount of time before illuminating the first image.
  • Arrangement 21 The method of any one of the previous arrangements, comprising placing the subject in a dark or dimly lit room for at least 15 minutes before illuminating the first image.
  • Arrangement 22 The method of any one of the previous arrangements, further comprising testing the patient for one or more of dark adaptation, ERG changes, genetic testing, and/or vitamin A level.
  • Arrangement 23 The method of any one of the previous arrangements, further comprising treating the patient with voretigene neparvovec based on the determined degree of night blindness.
  • Arrangement 24 The method of any one of the previous arrangements, further comprising treating the patient with beta-carotene or vitamin A based on the determined degree of night blindness.
  • a system for detecting a vision impairment in a subject comprising:
  • a display device configured to sequentially display a plurality of images thereon
  • a light source configured to illuminate the plurality of images so that at least one of the plurality of images has a luminance within a range of from approximately
  • Arrangement 26 The device of arrangement 25, wherein the plurality of images comprises a first image and a second image and the device is configured such that the first image has a luminance that is different than a luminance of the second image when the light source illuminates the first and second images.
  • Arrangement 27 The device of any one of arrangements 25-26, wherein the plurality of images comprises a first image having a first opacity and a second image having a second opacity and wherein the second opacity is different that the first opacity.
  • Arrangement 28 The device of any one of arrangements 25-27, wherein the light source is coupled with the display device using a tether having a predetermined length.
  • Arrangement 29 The device of any one of arrangements 25-28, wherein at least one of the plurality of images comprises a fluorescent ink.
  • Arrangement 30 The device of any one of arrangements 25-29, comprising a first image comprising a fluorescent ink having a first density and a second image comprising a fluorescent ink having a second density, the second density being different than the first density so that the second luminance is different than the first luminance.
  • Arrangement 31 The device of any one of arrangements 25-30, wherein at least one of the plurality of images comprises a fluorescent ink having a density of from 2% to 45%.
  • Arrangement 32 The device of any one of arrangements 25-31 , wherein the light source emits only an ultraviolet light.
  • Arrangement 33 The device of any one of arrangements 25-32, wherein the display device comprises a plurality of test plates having low reflectivity and luminance.
  • Arrangement 34 The device of any one of arrangements 25-33, wherein the display device comprises a plurality of sheets of paper each having a matte black color which each display an image.
  • Arrangement 35 The device of any one of arrangements 25-34, wherein the display device comprises a digital display.
  • Arrangement 36 The device of any one of arrangements 25-35, wherein at least one of the plurality of images is within a scotopic range.
  • Arrangement 37 A method for early detection of night blindness, comprising:
  • Arrangement 38 The method of arrangement 37, further comprising testing the patient for one or more of dark adaptation, ERG changes, genetic testing, and/or vitamin A level.
  • Arrangement 39 The method of arrangement 37 or 38, further comprising treating the patient with voretigene neparvovec based on the determined degree of night blindness.
  • Arrangement 40 The method of arrangement 37 or 38, further comprising treating the patient with beta-carotene or vitamin A based on the determined degree of night blindness.
  • Figure 1 is a photograph of a non-limiting arrangement of a screening device, wherein an image of a cat is displayed by the display device.
  • Figure 2 is a photograph of the arrangement of the screening device shown in Figure 1, wherein an image of a dog is displayed by the display device.
  • Figure 3 is a photograph of the arrangement of the screening device shown in Figure 1, wherein an image of a dog having a higher luminance than the dog image shown in Figure 2 is displayed by the display device.
  • Figure 4 is a photograph of the arrangement of the screening device shown in Figure 1, wherein an image of an owl is displayed by the display device.
  • Figure 5 is a photograph of the arrangement of the screening device shown in Figure 1, wherein an image of an owl having a low luminance is displayed by the display device.
  • Figure 6 is a photograph of the arrangement of the screening device shown in Figure 5, wherein the image of the owl displayed by the display device is being illuminated by a light source.
  • Figure 7 is a photograph of the arrangement of the screening device shown in Figure 1, wherein an image of a dog having a low luminance is displayed by the display device.
  • Figure 8 is a photograph of the arrangement of the screening device shown in Figure 7, wherein the image of the dog displayed by the display device is being illuminated by a light source.
  • Figure 9 shows the results from a screening test performed by seven different subjects.
  • vision screening devices or methods or diagnosis devices and methods for the diagnosis of significant vision problems.
  • the vision screening device and method arrangements disclosed herein provide an important solution for diagnosing vision impairments that are difficult and/or infeasible to detect using current equipment and methodologies.
  • Such devices and methods disclosed herein can be particularly important for children under the age of six or for children with language impairments, for which current testing protocols and devices are generally ineffective for detecting.
  • Some arrangements are directed to an easy in-office or in the field test for night blindness to detect inherited retinal disease, vitamin A deficiency, and/or other vision impairments. Based on preliminary luminance testing of the vision screening devices and methods disclosed herein, arrangements of such devices and methods are very effective in detecting and diagnosing patients for nyctalopia, or night blindness. Such arrangements can be used to identify children at young ages with night blindness due to inherited retinal disease and/or vitamin A deficiency. Earlier detection could mean earlier initiation of treatment, which could be vital in the management and prevention of progressive vision loss.
  • the patient can be a mammal - optionally a human patient.
  • the vision screening devices and methods disclosed herein can be used for any person and generally at any age range.
  • the vision screening devices and methods can be applied to patients at any age, or at ages of 15 years and below, or 8 years and above, 7 years and above, 6 years and above, 5 years and above, 4 years and above, 3 years and above, 2 years and above, or 1 year and above.
  • the vision screening devices and methods can be applied to any patient who is a child, or optionally to any patient who can communicate, or to any patient can communicate at a basic level verbally or non-verbally, such as through finger and/or hand gestures.
  • any arrangements of the vision screening devices and methods can be applied to any patient who can communicate or signal the existence of an object under testing conditions, including children who are 2 years old or younger. Therefore, arrangements disclosed herein can be used for diagnosing vision impairments in a subject who is under 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 year of age.
  • the methods and devices provided herein can allow a parent, caregiver, or medical practitioner such as a doctor, physician or nurse, to detect night blindness in the patient.
  • a method is provided for detecting, identifying, or diagnosing whether a patient or child has night blindness. In some arrangements, the method identifies a patient not having night blindness.
  • the screening device 100 can include a display device 102 having one or more (or, optionally, a plurality of) test plates 104 (also referred to herein as pages or plates) and a light source 106.
  • the test plates 104 can be made using any suitable substrate such as paper, cardboard, plastic, or otherwise, and can have a dark color, such as black, brown, purple, maroon, magenta, gray, or any such color that has a low reflectivity (for example, matte black).
  • any background color can be used, including but not limited to grey, dark grey, dark blue, or brown.
  • the test plate 102 can optionally be made using a thick or stiff sheet of paper (for example and without limitation, a 100 lb dull white cover sheet, or from an 80 lb to 110 lb sheet of paper), thin sheet of cardboard, or even thinner paper or plastic sheets.
  • the test plate can comprise a paper substrate having one or more or two or more coats of matte black ink (optionally, a UV black ink) thereon, or three or more coats of black ink thereon, or wherein the substrate of the paper or the background ink or coating is configured to prevent the ink used for the image from bleeding into the background ink or substrate or from blurring at the edges.
  • the background ink or substrate can be a low emissivity or low reflectivity ink, such as a matte black ink that reflects approximately 3% or less of the light that it receives, or approximately 5% or less, or from approximately 2% or less to approximately 10% or more, of the light that it receives, or between any values within these ranges.
  • Each of the test plates 104 can have one or more images or objects 108 on a first surface of the test plate or page.
  • the plurality of test plates or pages 104 can optionally be bound together in a book, with a binding of metal wire coil, plastic coil, adhesive binding, or using any other suitable binding materials or methods.
  • the images can be optionally be painted or printed on one or more of the test plates 104 in any desired location and/or size.
  • a first image can be of an owl and can be printed in an upper left portion of the page.
  • the image(s) can optionally be in an upper middle portion, an upper right portion, a middle left portion (i.e., vertically centered, but on left side of the page), a middle portion, a middle right portion, a lower left portion, a lower middle portion, and/or a lower right portion.
  • Any arrangements of the screening device 100 can have more than one image 108 on a test plate, including two or more images, three or more images, four or more images, or more, each at a different location on the test plate.
  • any of the objects printed on the pages can be animals or other living creatures or things including but not limited to trees, insects, fish, reptiles, or otherwise, any shapes such as ovals, circles, squares, triangles, rectangles, pentagons, hexagons, or other polygons, articles of fruit or vegetables such as bananas, oranges, apples, pineapples, or any other desired type of food, any desired objects such as houses, vehicles, or otherwise.
  • the images can also optionally be numbers, letters, or other characters.
  • one or more of the images can comprise phosphorescent ink (such as, for example, a glow-in-the-dark ink), fluorescent ink, or otherwise, of any desired color.
  • the ink used for the images can be a fluorescent UV yellow ink, or can optionally be any desired color.
  • a satin, aqueous coating can be applied over at least one of the UV ink used for the images and the ink used for the background.
  • the images can be presented on light emitting displays, such as images on a black or dark background on a tablet, a computer monitor or television screen, a liquid crystal display (LCD), a light emitting diode (LED) display, or other electronic device.
  • the mobile phone or other device can have a neutral density filter over the display if, for example, the lowest luminance setting on mobile phone or other device is higher than the optimal luminance range for the testing.
  • Different filters can be used to display or test different luminance ranges, and the brightness of the electronic device can also be adjusted to display or test different luminance ranges.
  • An interactive smartphone app can measure a dark adaptation threshold of the patient by showing one or more images via a user interface, and receiving user input based on whether or not the user can see the images.
  • a neutral density filter (which, in any arrangements disclosed herein, can be a lOOOx or other neutral density filter) can be applied over the display of the electronic device to reduce the light emitted by the display of the electronic device to generate a dimmer image for the test.
  • Any arrangements of the digital test device can have any of the layout details, luminance parameters, image size, and other components, parameters, or details of any of the non-digital vision screening devices and methods arrangements disclosed herein.
  • the vision screening devices and methods can include a black-background photopaper book with commonly-recognized animals printed using a range of fluorescent ink densities.
  • the ink can be a fluorescent UV ink, as mentioned above.
  • a commonly available UV light calibrated and dimmed with filters can be used to reduce the amount of light reflected (luminance) of the fluorescent ink to within wavelengths detected by human vision photoreceptors.
  • the ink density of any of the images can be one or more of the following densities: 2%, 5%, 10%, 12%, 15%, 25%, 35%, 45%, 55%, 65%, 75%, 85%, 95%, and/or 100%, including any values between those listed.
  • the ink densities less than 100% can be achieved using a halftone printing process, or other process wherein the ink density can be decreased.
  • a size of the dots on the test plate used to create the images can be decreased so as to decrease the ink density of the image. Screens can be used to achieve lower densities in the half-tone process.
  • the ink can be diluted using diluting agents or substances, which can optionally be water.
  • diluting agents or substances can optionally be water.
  • a 50% density ink would include 50% undiluted ink and 50% diluting agent by volume
  • a 2% density ink would include 2% undiluted ink and 98% diluting agent by volume.
  • the diluting agent can be any suitable diluting agent for fluorescent UV ink, optionally water.
  • a level of luminance of the image can be varied by increasing or decreasing the ink density, and/or by increasing or decreasing an intensity of the light source directed to the image.
  • the cat image 108 of the display device 102 shown in Figure 1 has a higher ink density than the dog image 108 of the display device 102 shown in Figure 2 such that, under the same illumination by the light source 106, the cat image 108 will have a higher luminance than the dog image 108.
  • the ink density can correlate with an opacity level or with a luminance level of the images.
  • the display device can be configured to display a plurality of images, each of which can have any of the following opacity or luminance levels: 2%, 5%, 10%, 12%, 15%, 25%, 35%, 45%, 55%, 65%, 75%, 85%, 95%, and/or 100% (or any value therebetween), wherein 100% is the highest luminance that can be achieved for the particular ink being used and results from the undiluted ink.
  • the display device 102 can have a plurality of images 108 arranged sequentially on a plurality of test plates 104 of the display device 102.
  • each of the sequentially arranged images can have an increasing (or decreasing) level of ink density, opacity and/or luminance or a decreasing level of ink density, opacity and/or luminance, or can be arranged randomly with respect to density, opacity and/or luminance.
  • the display device 100 can also have a one or more images at 100% ink density so that a user can learn what the images look like prior to being exposed to the lower luminance images under testing conditions.
  • Luminance ranges at the lowest ink density percentage (2%) can approach thresholds of rod photoreceptor sensitivity (the photoreceptors used to see in the dark), indicating that the vision screening devices and methods arrangements disclosed herein can be used to differentiate rod from cone function.
  • any arrangements of the vision screening devices and methods disclosed herein can have luminance values or intensities that are in the lower mesopic or scotopic vision ranges. Given that mesopic vision is also commonly affected in inherited retinal diseases, including some images that test for both cone and rod function (i.e., within the mesopic range) may be beneficial for further screening use.
  • the light source 104 can be a portable UV light source such as, without limitation, a small UV flashlight.
  • the light source 104 can optionally be a 395 nm UV flashlight, or optionally a 398 nm UV flashlight, or any UV light source between about 350 nm and about 450 nm.
  • the light source (which can include one or more neutral density filters) can configured to produce light at wavelengths (for example, in scotopic range) that rods are sensitive to, and which cones are not as sensitive to or not able to detect.
  • the light source 104 can optionally comprise a 395 nm UV flashlight having a neutral density filter or other optical dimmer on it to reduce the brightness or intensity of the light source 104.
  • the light source can optionally use a 385 nm wavelength UV bulb.
  • the luminance levels can be reduced to be within or close to rod-exclusive, or scotopic, luminance ranges using the fluorescent ink, a 395 nm UV light source, and a 1 OOOx neutral density filter.
  • the light source can have a lOOOx, a 2000x, or from a 500x or less to a 3 OOOx or more neutral density filter.
  • any arrangements of the vision screening devices and methods disclosed herein can be configured to provide an image having a luminance within a scotopic range, or within a lower mesopic, or within a lower mesopic and/or scotopic range, or from approximately 10 6 cd/m 2 (or as low as 10 8 cd/m 2 ) to approximately 10° cd/m 2 , or from approximately 10 4 cd/m 2 to approximately 10 1 cd/m 2 , or from approximately 10 3 cd/m 2 to approximately 10 1 cd/m 2 , or from approximately 10 4 cd/m 2 to approximately 10 1 cd/m 2 , or from or to any values within any of the foregoing ranges.
  • the light source 104 can optionally be coupled with the plurality of test plates 102 using a tether 112, which can be a string, a chain, a thin strap, or other material.
  • the tether 112 can have a predetermined or standardized length, such as approximately 10 inches (approximately 25 cm), or from approximately 8 inches to approximately 14 inches or more, or from approximately 8 inches to approximately 20 inches or more, or between any values within these ranges.
  • the tether 112 can optionally be substantially non-stretchable and/or non-elastic so as to provide a maximum distance (or predetermined distance) that the light source 104 can be moved away from the test plate 102 so that the light source 104 can be a fixed distance from every test plate 102 for consistency by moving the light source 104 away from the test plate until the tether 112 is taut.
  • the light source 104 can be positioned to shine light from the light source 104 on the image 108 from a set and consistent distance by moving the light source 104 away from the test plate 102 as far as the tether 112 will permit. Therefore, in any arrangements, the light source 104 can be configured to illuminate the one or more images on any of the test plates, with the light source being at a predetermined distance from the test plate or object.
  • any arrangements of the vision screening devices and methods disclosed herein can include one or more of the following steps, in any desired combination:
  • the first three example test plates can have a thicker layer of ink on the test plates so as to be more visible and identifiable, for instructional purposes (i.e., to facilitate explaining the steps of the test).
  • the subject’ s vision through the first eye.
  • the first eye can be the left eye or, alternatively, the right eye.
  • An eye patch, an occluder, the patient’s hand, or other device or object can optionally be used to selectively block the subject’s eye.
  • the subject can use both eyes for the test. Illuminate the first object printed on the first test plate using the UV light source, with the UV light source at a predetermined distance from the test plate or object. a. In some arrangements, the predetermined distance can be approximately 25 cm, or from approximately 20 cm or less to approximately 50 cm or more.
  • a string, tether, or other object coupling the light source to the test book can have a predetermined length which can, when fully extended, position the light source at the predetermined distance.
  • any arrangements of the devices or methods disclosed herein can be configured such that the luminance level of the image is within the lower mesopic range or, optionally, in the scotopic range.
  • the UV light should not be shined in the subject’s eyes.
  • the first object can have a first level of opacity or any desired level of opacity.
  • Any arrangements of the vision screening devices and methods disclosed herein can have seven test plates, or from four or less to ten or more test plates, or any desired number of test plates in total or in the first section. Record the results for each test plate including which eye was tested and whether the subject correctly identified the object and/or the location of the object.
  • the second eye can be the right eye or whichever eye was not covered earlier in the test.
  • the eighth object can have any desired level of opacity.
  • Any arrangements of the vision screening devices and methods disclosed herein can have seven test plates, or from four or less to ten or more test plates, or any desired number of test plates in total or in the second section of the test book.
  • an ink density or luminance level is as low as 2%
  • subjects with healthy eyesight should be able to correctly identify 6 of 7 of the images for each eye, since the 2% luminance image may be difficult for most healthy eyes to detect.
  • the subject may have night blindness, the severity of which can be determined by the number of images that were not detected and the luminance level of such images.
  • Any arrangements of the protocol or steps for using or applying the vision screening devices and methods can be modified for use with subjects with communication impairments or deficiencies by providing other verbal and non-verbal cues and/or instructions to instruct the subject how to proceed with the use of the vision screening devices and methods.
  • Any devices disclosed herein can be low cost and, therefore, affordable and feasible for use in poorer countries or poorer populations.
  • any of the steps described above can be modified or adapated (within the scope of one of ordinary skill in the art or as described herein) to be performed using a digital display device or other electronic device that can have a digital display, as described in more detail above.
  • a liquid crystal display (LCD) and/or a light emitting diode (LED) display can be used as the display device in any arrangements disclosed herein, which display device can be configured to display the images at any desired varying levels of luminance.
  • the electronic device can be configured such that any of the steps of the method or protocol performed above can be performed using the electronic device.
  • Figure 9 shows the results from a screening test performed or taken by seven different subjects.
  • the arrangement of a screening device used for the test had seven different images.
  • the light source used for the test was a 395 nm wavelength ultraviolet light with a lOOOx neutral density filter.
  • the test results reveal that all seven subjects identified the 45% ink density image displayed by the display device of the screening device and that none of the subjects was able to identify the 2% ink density image.
  • the test results reveal the accuracy of the arrangements of the screening test devices and methods disclosed herein in diagnosing subjects with advanced cone-rod dystrophy.
  • subjects #4 and #7, both of whom have advanced cone-rod dystrophy were not able to see any of the images having an ink density less than 45% and, therefore, were correctly diagnosed using an arrangement of the screening device of this disclosure.
  • night blindness can be caused by a homozygous mutation in Retinal pigment epithelium-specific 65 kDa protein (also known as retinoid isomerohydrolase or RPE65).
  • RPE65 Retinal pigment epithelium-specific 65 kDa protein
  • the patient can have a homozygous mutation in RPE65 that causes a disease that includes night blindness.
  • Voretigene neparvovec (LUXTURNA) is currently FDA approved for children 1 year of age or older.
  • Early diagnosis of night blindness or homozygous RPE65 mutations by the methods or devices provided herein can permit preservation of vision that would be lost by later detection of the night blindness or homozygous RPE65 mutations.
  • a child or adult patient is treated with voretigene neparvovec.
  • the treatment can be based on a detection or diagnosis of night blindness by the methods or devices described herein.
  • the treatment can include a dose of voretigene neparvovec at about 1.5 x 10 11 vector genomes (vg), including doses ranging from about 1.5 x 10 7 to about 1.5 x 10 13 vg.
  • the dose of voretigene neparvovec is administered in liquid diluent such as sterile water or saline solution at total volume of 0.3 mL (e.g., about 0.1 to about 1.0 mL).
  • the dose of voretigene neparvovec is injected into one eye of the patient. In some arrangements, the dose of voretigene neparvovec is injected into a second eye of the patient. In some arrangements, the injection is subretinal. In some arrangements, the diluent includes sterile water containing 180 mM sodium chloride, 10 mM sodium phosphate, and/or 0.001% Poloxamer 188, and may be at pH 7.3.
  • the condition can be caused by a vitamin A deficiency, which can be treated with beta-carotene or vitamin A.
  • Beta-carotene or vitamin A can be provided to the patient at a dose of 25,000, 15,000, 5,000, 2500, 1000, 500, 250, 100, or 50 IU/kg body weight.
  • multiple doses of vitamin A can be provided.
  • an easy to use screening test for night blindness as provided herein helps identify children in need of vitamin A supplementation, advantageously, at an earlier time-point that other methods currently in practice, which allows for a potentially improved prognosis based on an earlier administration of therapy.
  • the night blindness can be caused by Leber’s congnital amaurosis, retinitis pigmentosa, retinal detachment, a medication such as a phenothiazine, Oguchi disease, pathological myopia, a cataract (peripheral cortical), a refractive surgery (LASIK, photorefractive keratectomy, or radial keratotomy), Sorsby's Fundus Dystrophy (macular degeneration), vitamin A deficiency, choroideremia, glaucoma, or any combination of such diseases.
  • LASIK refractive surgery
  • Sorsby's Fundus Dystrophy macular degeneration
  • vitamin A deficiency choroideremia
  • glaucoma or any combination of such diseases.
  • a drug, supplement, vitamin, or treatment is provided based on whether a patient is identified to have night blindness as provided herein.
  • the drug, supplement, vitamin, or treatment can be provided once, twice, three times, four times, or five times per day.
  • One or more doses of the drug, supplement, vitamin, or treatment are provided over a course of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or 31 days.
  • One or more doses of the drug, supplement, vitamin, or treatment can be provided over a course of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 months.
  • One or more doses of the drug, supplement, vitamin, or treatment can be provided over a course of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 years.
  • the drug, supplement, vitamin, or treatment can be provided by injection, intravenously, subcutaneously, intradermally, or orally, which can be provided as a pill, capsule, or liquid.
  • actions such as“administering an antigen-binding protein” include“instructing the administration of an antigen-binding protein.”
  • actions such as“administering an antigen-binding protein” include“instructing the administration of an antigen-binding protein.”
  • the indefinite article“a” or“an” does not exclude a plurality.
  • the term “about” as used herein to, for example, define the values and ranges of molecular weights means that the indicated values and/or range limits can vary within ⁇ 20%, e.g., within ⁇ 10%.
  • the use of“about” before a number includes the number itself.
  • “about 5” provides express support for“5”.
  • Numbers provided in ranges include overlapping ranges and integers in between; for example a range of 1-4 and 5-7 includes for example, 1-7, 1-6, 1-5, 2- 5, 2-7, 4-7, 1, 2, 3, 4, 5, 6 and 7.

Landscapes

  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Theoretical Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Human Computer Interaction (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Spectrometry And Color Measurement (AREA)

Abstract

L'invention concerne des dispositifs et des procédés permettant de détecter une cécité nocturne chez un sujet, consistant à éclairer une première image sur un dispositif d'affichage à l'aide d'une source de lumière de telle sorte que la première image a une première luminance, à déterminer si le sujet peut voir la première image, à éclairer une seconde image sur le dispositif d'affichage à l'aide de la source de lumière de telle sorte que la seconde image a une seconde luminance qui est différente de la première luminance, et à déterminer si le sujet peut voir la seconde image. La première ou la seconde image peut avoir une luminance dans une plage allant d'environ 10-8 cd/m2 à environ 10-1 cd/m2.
PCT/US2019/035821 2018-06-08 2019-06-06 Dispositifs et procédés de détection de déficiences visuelles WO2019236868A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862682684P 2018-06-08 2018-06-08
US62/682,684 2018-06-08
US201862695666P 2018-07-09 2018-07-09
US62/695,666 2018-07-09

Publications (1)

Publication Number Publication Date
WO2019236868A1 true WO2019236868A1 (fr) 2019-12-12

Family

ID=67003719

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/035821 WO2019236868A1 (fr) 2018-06-08 2019-06-06 Dispositifs et procédés de détection de déficiences visuelles

Country Status (1)

Country Link
WO (1) WO2019236868A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB530308A (en) * 1939-03-09 1940-12-10 American Optical Corp Improved apparatus for testing eyes
WO2012022938A1 (fr) * 2010-08-18 2012-02-23 The University Of Manchester Procédé et appareil de mesure d'une propriété d'un œil d'un sujet
WO2016081978A1 (fr) * 2014-11-25 2016-06-02 Medmont International Pty Ltd Dispositif et procédé de photoblanchiment, ainsi que dispositif et procédé d'examen de périmétrie adaptée à l'obscurité
US9833137B1 (en) * 2014-05-02 2017-12-05 Innova Systems, Inc. Method and apparatus for administering a low luminance visual dysfunction test

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB530308A (en) * 1939-03-09 1940-12-10 American Optical Corp Improved apparatus for testing eyes
WO2012022938A1 (fr) * 2010-08-18 2012-02-23 The University Of Manchester Procédé et appareil de mesure d'une propriété d'un œil d'un sujet
US9833137B1 (en) * 2014-05-02 2017-12-05 Innova Systems, Inc. Method and apparatus for administering a low luminance visual dysfunction test
WO2016081978A1 (fr) * 2014-11-25 2016-06-02 Medmont International Pty Ltd Dispositif et procédé de photoblanchiment, ainsi que dispositif et procédé d'examen de périmétrie adaptée à l'obscurité

Similar Documents

Publication Publication Date Title
Nolan et al. The impact of macular pigment augmentation on visual performance in normal subjects: COMPASS
Taylor et al. Handbook of retinal screening in diabetes: diagnosis and management
Gouras et al. Retinitis pigmentosa in abetalipoproteinemia: Effects of vitamin A
Nolan et al. The impact of supplemental macular carotenoids in Alzheimer's disease: a randomized clinical trial
Berson et al. Progressive cone-rod degeneration
Enoch et al. Forever young: visual functions not affected or minimally affected by aging: a review
Gorin et al. Detection of the carrier state of X-linked retinoschisis
Henderson Inherited retinal dystrophies
Neelam et al. Carotenoids and co-antioxidants in age-related maculopathy: design and methods
Sanabria et al. Measurement of carotenoids in perifovea using the macular pigment reflectometer
Chawla et al. Retinal dystrophies
Sawicka-Pierko et al. Nutritional optic neuropathy following bariatric surgery
RU2514348C1 (ru) Способ диагностики глазных заболеваний
WO2019236868A1 (fr) Dispositifs et procédés de détection de déficiences visuelles
Keltner et al. Automated and Manual Periemetry-A Six-Year Overview: Special Emphasis on Neuro-ophthalmic Problems
Zlatkova et al. The effect of simulated lens yellowing and opacification on blue-on-yellow acuity and contrast sensitivity
Eisenbarth et al. Characteristics of dynamic processing in the visual field of patients with age-related maculopathy
Castro et al. Impairment of color spatial vision in chronic alcoholism measured by psychophysical methods
Taylor Handbook of retinal screening in diabetes
JP3665763B2 (ja) 糖尿病網膜症の眼球模型
Synek et al. Epidemiology and quality of life of patients with age-related macular degeneration
Feret et al. Macular degeneration: types, causes, and possible interventions
RU2777211C1 (ru) Способ выявления палочкового монохроматизма у детей
Rahi et al. Childhood eye disorders and visual impairment
Vasavada et al. Contrast sensitivity assessment in pediatric cataract surgery: Comparison of preoperative and early postoperative outcomes

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19733312

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19733312

Country of ref document: EP

Kind code of ref document: A1