THATTHE TOUT UNTUK TAUS ON20170354324A1 AINA KA NA MAMA MAI MARI ANTURI ( 19) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2017/ 0354324 A1 Bennett (43 ) Pub . Date : Dec . 14 , 2017 (54 ) VISION TEST FOR DETERMINING Publication Classification RETINAL DISEASE PROGRESSION (51 ) Int . CI. A61B 3 / 032 (2006 .01 ) ( 71 ) Applicant: The Trustees of the University of A61B 3 / 06 (2006 .01 ) Pennsylvania , Philadelphia , PA (US ) A61B 3 / 00 (2006 .01 ) (52 ) U . S . CI. (72 ) Inventor : Jean Bennett , Bryn Mawr, PA (US ) CPC . .. .. .. .. A61B 3 / 032 ( 2013 .01 ) ; A61B 3 / 0041 (2013 .01 ) ; A61B 3 / 06 ( 2013 .01 ) ; A61B 37063 (21 ) Appl. No. : 15 /524 , 126 ( 2013 . 01 ) (22 ) PCT Filed : Nov. 4 , 2015 (57 ) ABSTRACT The present invention provides a reading test to measure ( 86 ) PCT No. : PCT/ US15 /58958 vision loss . In one embodiment, the vision loss is due to $ 371 ( c ) ( 1 ) , disease progression . The tests are useful in evaluating the ( 2 ) Date : May 3, 2017 effects of intervention in vision deterioration . The tests are non - invasive , simple , quick , sensitive , reproducible , and easy to administer. The tests measure the subject' s reading speed and accuracy under defined conditions of illumination Related U . S . Application Data and contrast . The results of these tests may be used to (60 ) Provisional application No .62 / 077 ,286 , filed on Nov. determine if treatment of a disease should be initiated , 9 , 2014 terminated , altered , or remain unchanged . US 2017 /0354324 A1 Dec . 14 , 2017 VISION TEST FOR DETERMINING that incorporates measures of brightness and contrast and RETINAL DISEASE PROGRESSION also reflects the effects of peripheral visual field loss . 100041 What is needed in the art is a more reliable , BACKGROUND sensitive , rapid , reproducible and informative set of data [0001 ] Gene therapy using adeno - associated virus (AAV ) relating to an activity ( reading ) that contributes enormously delivered to the retina is an effective strategy for ameliora to independence , knowledge accumulation , security , social tion or even of reversal of retinal and visual dysfunction . A interactions, and personal fulfillment. challenge in demonstrating efficacy of retinal gene therapy for severe retinal degenerative disease , however, has been a SUMMARY OF THE INVENTION lack of relevant outcome measures. Only one outcome [ 0005 ] In one aspect, a method for examining the vision of measure has been defined as a " clinically meaningful” a subject is provided and includes ( i ) the subject reading a outcome measure - visual acuity ( reading the eye chart ) . first passage of text on a screen , wherein the text is displayed Visual acuity determines the efficacy of experimental treat on the screen at high image contrast, high illumination , or a ments for a variety of retinal disorders. However, in many combination thereof, ( ii ) the subject reading a second pas blinding conditions , visual acuity is irrelevant, either sage of text on the screen , wherein the text is displayed on because it is preserved until very late in the disease , or that the screen at low image contrast, low illumination , or a it is so poor, that the person is unable to read any letters at combination thereof, and ( iii ) scoring results obtained from all , i . e ., " off chart " . steps ( i ) and ( ii ) . 0002 ] In addition to eye charts , there are other tests that [0006 ] In another aspect , a method for examining the can be used to measure retinal or visual function but most of vision of a subject is provided and includes , ( i ) displaying a these measure aspects of the retina or vision that are not first passage of text at high image contrast , high illumina deemed clinically meaningful. For example , non - invasive tion , or a combination thereof, on a screen , wherein the imaging can be used to measure the thickness of the retina subject reads the first passage of text, ( ii ) displaying a before and after treatment, but that measure is not deemed second passage of text at low image contrast , low illumina " clinically meaningful. ” The Salisbury Eye Evaluation study tion , or a combination thereof, on the screen , the wherein the measures reading rates in individuals with or without glau subject reads the second passage of text, and ( iii ) scoring coma on a computer screen and correlates reading speed and results obtained from steps ( i) and ( ii ) . disease progression . There are a number of different reading [0007 ] In a further aspect , a method for examining the charts that have been described , including the MNREAD vision of a subject is provided and includes exposing the chart , Radner reading charts , and International Reading subject to a flash of light to ' bleach ' the photoreceptors and Speed Texts . The Radner reading chart is a visual acuity test then conducting the reading test as described herein . This in which the text in different cards is displayed with different method includes measuring the amount of time required for sizes . The Radner test uses standardized language and is the subject ' s photoreceptors to recover from the flash suf administered with hand -held cards . The Radner test is cum ficiently to permit an adequate performance on the reading bersome to administer as the tester must juggle various test , and associating recovery time with ocular disease , activities simultaneously such as holding the test cards , ocular disease progression or the efficacy of therapy for assuring that that the distances are maintained between the ocular disease . card and the reader ' s eyes, presenting the cards, writing [0008 ] In a further aspect , a method for monitoring vision down the answers , and scoring the responses . There is thus loss in a subject having an ocular disease is provided and likely to be variability in terms of the distance of the card includes (i ) the subject reading a first passage of text on a form the subject ' s face , angle of the card presented to the screen , wherein the text is displayed on the screen at high subject, and the movement of the card as the clinician writes image contrast, high illumination , or a combination thereof, down the responses . In the MNREAD reading test and the ( ii ) the subject reading a second passage of text on the Radnor Reading test, the size of the print decreases as the screen , wherein the text is displayed on the screen at low test proceeds , aiming to identify the visual acuity of the image contrast, low illumination , or a combination thereof , patient, not the ease of reading . The Colenbrander mixed and ( iii ) scoring the results of steps ( i) and (ii ). One contrast card set displays individual letters ( not text ) with embodiment further comprises performing the ' bleach ' test high contrast on the left and low contrast on the right. described above in conjunction with this method . Because the letters are bunched together on the Colen [ 0009 ] In still another aspect , a method for monitoring brander cards , there is little effect of peripheral visual field treatment of an ocular disease is provided and includes ( i ) deficits on the performance . Further, this test suffers from treating a subject for vision loss related to the disease, (ii ) the the same problems as the Radner test in that it is hand -held subject reading a first passage of text on a screen , wherein and there are no controls on the level of illumination . This the text is displayed on the screen at high image contrast , test does not evaluate the speed or accuracy of reading high illumination , or a combination thereof , ( iii ) the subject passages, i . e . , it does not reflect reading skills . reading a second passage of text on the screen , wherein the [ 0003 ] When peripheral vision is impaired or lost, it text is displayed on the screen at low image contrast , low becomes very difficult for the individual to move his /her illumination , or a combination thereof, and ( iv ) scoring the eyes from the end of one line of text to the beginning of the results of steps ( ii ) and ( iii ) . One embodiment further succeeding line of text. This slows down the reading speed comprises performing the ‘ bleach ' test described above in and reduces reading accuracy . Reading speed and accuracy conjunction with this method . are also impaired due to disease processes due to decreased [0010 ]. In yet a further aspect , a method for monitoring light perception and contrast sensitivity . The reading tests treatment of an ocular disease is provided and includes ( i ) that are currently available concentrate on visual acuity, i . e ., treating a subject for vision loss related to the disease , ( ii ) foveal function only . However, there is no test on the market displaying a first passage of text at high image contrast , high US 2017 /0354324 A1 Dec . 14 , 2017 illumination , or a combination thereof, on a screen , wherein data using a second passage of text displayed at low image the subject reads the first passage of text , ( iii) displaying a contrast, low illumination , or a combination thereof, on the second passage of text at low image contrast , low illumina screen by the subject reading the second passage of text, and tion , or a combination thereof, on the screen , wherein the calculate a score from the data , wherein the score is the subject reads the second passage of text, and ( iv ) scoring percentage of errors in the text. results obtained from steps ( ii ) and ( iii) . In one embodiment , 0017 ] Other aspects and advantages of the invention