Vision test for determining retinal disease progression

Patent metadata

Field	Value
Publication number	US-11206977-B2
Application number	US-201515524126-A
Country	US
Kind code	B2
Filing date	Nov 4, 2015
Priority date	Nov 9, 2014
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

Abstract

The present invention provides a reading test to measure vision loss. In one embodiment, the vision loss is due to disease progression. The tests are useful in evaluating the 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 and contrast. The results of these tests may be used to determine if treatment of a disease should be initiated, terminated, altered, or remain unchanged.

First claim

What is claimed is:

1. A method for examining the vision of a subject or monitoring the progression or treatment of an ocular disease in said subject, said method comprising:
displaying a first passage of text at high image contrast from 1.70 to about 2.25 log units, high illumination from about 200 to about 500 cd/m 2 , or a combination thereof on a screen to a subject having peripheral-to-central vision loss, central-to-peripheral vision loss, cone-rod photoreceptor degeneration, rod-cone photoreceptor degeneration, or rod-cone photoreceptor vision loss; wherein said subject reads said first passage of text;
(ii) displaying a second passage of text at low image contrast from about 0.0 to about 1.35 log units, low illumination from about 1 to about 50 cd/m 2 , or a combination thereof on said screen; wherein said subject reads said second passage of text; and
(iii) scoring results obtained from steps (i) and (ii),
wherein the subject's head is in a fixed position while reading said first and second passages to evaluate the subject's field of vision.

2. The method according to claim 1 , wherein said screen is a computer monitor, TV monitor, snellen chart, projection screen, projection goggles, optical head-mounted display or a high resolution monitor.

3. The method according to claim 1 , further comprising applying one or more conditions to the subject selected from:
(a) positioning said subject about 0.5 to about 4 m from said screen;
(b) preventing movement of the subject during the method;
(c) allowing the eyes of said subject to be not dilated;
(d) allowing said subject to wear optical correction; or
(e) covering said subject's contralateral eye.

4. The method according to claim 1 , further comprising examining one eye individually or examining both eyes simultaneously.

5. The method according to claim 1 , wherein said text is displayed in serif, sans serif, slab serif, semi-serif, monospace, script, blackletter, nonlatin, Unicode, dingbat/symbol, or display/decorative; or said text comprises optotypes or the geometric proportions of said text are constant.

6. The method according to claim 1 , wherein said scoring comprises compiling the results of steps (i) and (ii), quantitating the compiled results, and weighting the quantitated results to provide a cumulative score; or wherein step (iii) is based on accuracy and reading speed of said subject.

7. The method according to claim 1 , further comprising
displaying to the subject a flash of light at a suitable intensity and for a suitable duration to temporarily bleach the subject's photoreceptors prior to displaying the first passage, and measuring the time required for the photoreceptors to recover so that the subject can read the first passage, and
measuring visual acuity, light sensitivity or contrast sensitivity of said subject.

8. The method according to claim 1 , further comprising:
treating said subject for vision loss prior to or after conducting steps (i), (ii) and (iii); or
adjusting said subject's treatment of said disease after conducting steps (i), (ii) and (iii).

9. The method according to claim 8 , further comprising displaying to the subject a flash of light at a suitable intensity and for a suitable duration to temporarily bleach the subject's photoreceptors prior to displaying the first passage, and measuring the time required for the photoreceptors to recover so that the subject can read the first passage; and measuring visual acuity, light sensitivity or contrast sensitivity of said subject.

10. The method according to claim 8 , wherein said treating comprises gene therapy, cell therapy, pharmaceutical therapy, or device intervention or said device intervention comprises retinal neurostimulus chip implant or a light stimulation unit.

11. The method according to claim 10 , wherein said cell therapy comprises transplantation of fetal-derived retinal progenitor cells, induced pluripotent stem cells, embryonic stem cells, retinal pigment epithelium cells, or cells encased in a capsule; or wherein said pharmaceutical therapy comprises administering one or more of acetazolamide, apraclonidine HCl, betaxolol HCl, bimatoprost, brimonidine tartrate, brinzolamide, carbachol, dorzolamide HCl, latanoprost levobunolol HCl, methazolamide, metipranolol, pilocarpine HCl, timolol maleate, timolol hemihydrate, tafluprost, travaprost, prednisolone, moxifloxacin, vitamin A, beta-carotene, docosahexaenoic acid, acetazolamide, corticosteroid, calcium channel blocker, lutein, zeaxanthin, valproic acid, aspirin, anti-inflammatory agents, warfarin, heparin, alteplase, fibrinolytic agent, corticosteroid, alteplase, ranibizumab, aflibercept, triamcinolone, bevacizumab, or dexamethasone; or wherein said device intervention comprises oxygen therapy, surgery, cryotherapy, photocoagulation, diathermy, isovolemic hemodilution, or plasmapheresis; or wherein said gene therapy comprises adeno-associated virus therapy, lentivirus therapy, adenovirus therapy, or non-viral gene delivery.

12. The method of claim 1 , wherein the ocular disease is choroideremia.

13. An electronic system for clinical examination of vision system functioning of a subject, said system comprising:
a first unit configured to display a first passage of text at high image contrast from 1.7 to about 2.25 log units, high illumination from about 200 to about 500 cd/m 2 , or a combination thereof, and to display a second passage of text at low contrast from about 0.0 to about 1.35 log units and low illumination from about 1 to about 50 cd/m 2 , or a combination thereof;
a second unit configured to receive feedback from said subject;
a first processor configured to receive said feedback;
a second processor configured to calculate the number of errors in said feedback and provide a score; and
a means for displaying a flash of light to the subject prior to displaying text and a processor configured to measure recovery time from the occurrence of the flash to the time the subject is able to read the text.

14. The electronic system according to claim 13 , further comprising:
(a) said first unit configured to project instructions to said subject;
(b) said second unit comprising recordable media or voice recognition software;
(c) said first unit configured to display text comprising 2 to about 24 passages;
(d) said first unit configured to display passages of text sequentially;
(e) said second passage of text comprising 2 to about 24 passages of text;
(f) a means for instructing said first unit to project said text, wherein said means comprises a mechanical button adjacent to said first unit and connected to said first unit through a first conduit or a computer-generated button; or
(g) any combination of two or more of (a) through (f).

15. An electronic vision testing device, said device comprising at least one processing unit configured to:
acquire data using a first passage of text displayed at high image contrast from 1.7 to about 2.25 log units, high illumination from about 200 to about 500 cd/m 2 , or a combination thereof, on a screen;
acquire data using a second passage of text displayed at low image contrast from about 0.0 to about 1.35 log units, low illumination from about 1 to about 50 cd/m 2 from about 1 to about 50 cd/m 2 , or a combination thereof on said screen; and
calculate a score from said data, wherein said score is the percentage of errors in said data;
wherein said processing unit is configured to acquire data from a bleaching step and correlate the subject's recovery time from the bleaching effect to said score.

16. The electronic vision testin

Assignees

• Univ Pennsylvania
• The Trustees Of The Univ Of Pennyslvania

Inventors

• Bennett Jean

Classifications

• A61B3/06

  for testing light sensitivity, e.g. adaptation; for testing colour vision · CPC title

• A61B3/032 Primary

  Devices for presenting test symbols or characters, e.g. test chart projectors (A61B3/036 takes precedence) · CPC title

• A61B3/0041

  characterised by display arrangements · CPC title

• A61B3/063

  for testing light sensitivity, i.e. adaptation · CPC title