METHOD AND APPARATUS FOR TREATING DIPLOPIA AND CONVERGENCE INSUFFICIENCY DISORDER

Abstract

A method of assessing a presence and/or severity of at least one of diplopia and convergence insufficiency disorder of a patient; it includes providing a patient with an image pair configured to present a first image to a first eye of the patient and a second image to a second eye of the patient; obtaining performance information of the patient when the patient performs a task requiring the perceiving of the information content of the first image and the information content of the second image; adjusting, based on the performance information, the difference of the at least one image parameter between the first image and the second image; and assessing the degree of at least one of the diplopia and convergence insufficiency disorder of the patient based on performance information of the patient when the patient performs the task following the adjusting.

Claims

1. A method of assessing a degree of at least one of diplopia and convergence insufficiency disorder of a patient comprising: providing a patient having a condition of diplopia or convergence insufficiency disorder with an image pair configured to present a first image to a first eye of said patient and a second image to a second eye of said patient, wherein information content of said first image that is perceivable by said first eye is different from information content of said second image that is perceivable by said second eye, and wherein at least one image parameter is different between said first image and said second image; obtaining performance information of said patient when said patient performs a task requiring perceiving said information content of said first image and said information content of said second image; adjusting, based on said performance information, wherein said performance of said task depends on the degree of at least one of said diplopia and convergence sufficiency disorder of said patient and said difference of said at least one image parameter between said first image and said second image, said difference of said at least one image parameter between said first image and said second image; and assessing said degree of at least one of said diplopia and convergence insufficiency disorder of said patient based at least on performance information of said patient when said patient performs said task following said adjusting.

2. The method as defined in claim 1, wherein perceptibility of said information content of said first image is increased in comparison to perceptibility of said information content of said second image as a result of said difference in at least one image parameter of said first image and said second image, and wherein said first eye is a weak eye and said second eye is a dominant eye.

3. The method as defined in claim 2, wherein said difference in perceptibility affects only a portion of at least one of said first image and said second image.

4. The method as defined in any one of claims 1 to 3, wherein said at least one image parameter comprises an image offset of said first image with respect to said second image that affects the perceived position of at least one of said information content of said first image and said perceived position of said information content of said second image, and wherein said adjusting comprises adjusting said image offset based on said performance information until said patient is capable of performing said task, and wherein said performance information depends on said patient perceiving said information content from said first image and said information content from said second image, and wherein perceived position of said information content of said first image and perceived position of said information content of said second image by said patient impacts the performance of said task.

5. The method as defined in any one of claims 1 to 3, wherein said image pair is generated from a single image source configured to be used with anaglyphic glasses, wherein said patient wearing said anaglyphic glasses results in the presenting of said first image to said first eye of said patient and said second image to said second eye of said patient.

6. The method as defined in any one of claims 1 to 4, wherein said image pair comprises a first image source for generating said first image presented to said first eye and a second image source for generating said second image presented to said second eye.

7. The method as defined in any one of claims 1 to 5, wherein said image pair is generated from an image source configured to generate an image stream.

8. The method as defined in any one of claims 1 to 7, wherein said at least one image parameter comprises the number of objects appearing in said first image and the number of objects appearing in said second image.

9. The method as defined in any one of claims 1 to 8, wherein said at least parameter comprises the contrast of said first image and said second image.

10. The method as defined in any one of claims 1 to 9, wherein said task is established within the context of a video game.

11. The method as defined in any one of claims 1 to 4 and 6 to 10, wherein said image pair is provided while said patient is wearing an augmented reality headset.

12. The method as defined in claim 11, wherein said information content of said first image is layered over a live stream of images generated from a camera.

13. The method as defined in claim 11, wherein said at least one image parameter affects objects appearing in the live stream of images generated from a camera.

14. The method as defined in any one of claims 1 to 4 and 6 to 10, wherein said image pair is provided while said patient is wearing a virtual reality headset or virtual reality glasses.

15. The method as defined in claim 14, wherein said information content of said first image is layered over a live stream of images generated from a camera.

16. The method as defined in claim 14, wherein said at least one image parameter affects objects appearing in the live stream of images generated from a camera.

17. The method as defined in any one of claims 1 to 16, wherein said patient has diplopia.

18. The method as defined in any one of claims 1 to 17, wherein said patient has convergence insufficiency disorder.

19. The method as defined in any one of claims 1 to 10, wherein said at least one image parameter affects objects of stream of images of a motion picture.

20. The method as defined in any one of claims 1 to 19, further comprising obtaining eye tracking information on the first eye and the second eye during the performance of said task, and wherein said performance information comprises at least said eye tracking information indicative of said patient performing said task.

21. A computer readable medium comprising program code that, when executed by a processor, causes the processor to: provide a patient having a condition of diplopia or convergence insufficiency disorder with an image pair configured to present a first image to a first eye of said patient and a second image to a second eye of said patient, wherein information content of said first image that is perceivable by said first eye is different from information content of said second image that is perceivable by said second eye, and wherein at least one image parameter is different between said first image and said second image; obtain performance information of said patient when said patient performs a task requiring perceiving said information content of said first image and said information content of said second image; adjust, based on said performance information, wherein said performance of said task depends on the degree of at least one of said diplopia and convergence sufficiency disorder of said patient and said difference of said at least one image parameter between said first image and said second image, said difference of said at least one image parameter between said first image and said second image; and provide assessment information on a degree of at least one of said diplopia and convergence insufficiency disorder of said patient based at least on performance information of said patient when said patient performs said task following said adjusting.

22. A computing device for treating a patient with at least one of diplopia and convergence insufficiency disorder comprising: a user input interface; a display; a processor; memory configured to store program code that, when said executed by said processor, causes said processor to: provide a patient having a condition of diplopia or convergence insufficiency disorder on said display with an image pair configured to present a first image to a first eye of said patient and a second image to a second eye of said patient, wherein information content of said first image that is perceivable by said first eye is different from information content of said second image that is perceivable by said second eye, and wherein at least one image parameter is different between said first image and said second image; obtain performance information of said patient from said user input interface when said patient performs a task requiring perceiving said information content of said first image and said information content of said second image; and adjust, based on said performance information, wherein said performance of said task depends on the degree of at least one of said diplopia and convergence sufficiency disorder of said patient and said difference of said at least one image parameter between said first image and said second image, said difference of said at least one image parameter between said first image and said second image.

23. The computing device as defined in claim 22, further comprising an eye tracker configured to provide information on a position of the first eye and a position of the second eye.

24. The computing device as defined in claim 22 or claim 23, further comprising a physician information adapted to receive input from a physician for adjusting said at least one image parameter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The invention will be better understood by way of the following detailed description of embodiments of the invention with reference to the appended drawings, in which:

[0046] FIG. 1 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects between the ages of 13 years old and less than 17 years old as reported by the subjects;

[0047] FIG. 2 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects between the ages of 5 years old and less than 13 years old as reported by the subjects;

[0048] FIG. 3 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects between the ages of 13 years old and less than 17 years old as reported by the parents of subjects;

[0049] FIG. 4 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects between the ages of 5 years old and less than 13 years old as reported by the parents of the subjects;

[0050] FIG. 5 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects of all age groups as reported by the subjects;

[0051] FIG. 6 is a graph illustrating a distribution of reports of diplopia as a function of hours of gameplay over subjects of all age groups as reported by the parents of the subjects;

[0052] FIG. 7 is a block diagram of an exemplary apparatus for treating diplopia and/or CID; and

[0053] FIG. 8 is a flowchart diagram of an exemplary method of treating (and or assessing the presence and/or severity of) diplopia and/or CID.

DETAILED DESCRIPTION

[0054] The present disclosure relates to an apparatus and methods for treating diplopia and/or CID. The disclosure pertains to training both eyes to function together or a first eye (e.g. a wandering eye) to function along with the dominant eye. The training includes presenting a first image to a first eye and a complementary second image to the second eye (i.e. image pairs). The patient is asked, based on the image pairs, to perform a task. Information content contained in at least the image presented to the weak eye is required to perform the task. If the patient is not picking up on the information content presented to the weak eye, or if the information content to be perceived by at least one eye is not being perceived the patient at the proper position (e.g. due to double vision), the patient cannot complete the task. The ability of the patient to perform the task is an indication of the patient's processing the information presented to both eyes, processed in the proper position. If the patient is not capable of performing the task, and is therefore not picking up on the information presented to the weak eye, then image parameters of the first image and/or the second image may be adjusted. For example, contrast and/or luminance may be adjusted such that the information content of the image presented to the weak eye is sharper and/or more vivid than the information content presented to the second eye. The offset of one or both images may be adjusted in the case of binocular diplopia. The adjustment may be furthered until the patient is picking up on the information content presented to both the first eye and the second eye (e.g. both the first image and the second image). At these image parameters, the patient is then asked to carry out the task.

[0055] The physician may periodically adjust the image parameters as the patient comfortably completes the task over time, indicative of strengthening of the first eye, such that both the perceived first image and the perceived second image have increasingly similar properties. This adjustment may be continued until both the perceived first image and the second image have identical image parameters. If the patient is capable of performing the tasks successfully when both images have identical parameters, this is indicative of the patient having regained function of the first eye.

[0056] It will be understood that in the present disclosure, what is meant by a first image and a second image is that the first eye of the patient is perceiving an image that is different from the image perceived by the second eye of the patient. However, in some examples, this may not mean that an image (e.g. on a first screen) is presented to a first eye and a second distinct image (e.g. on a separate screen) is presented to the second eye. A single screen presenting a single image may be viewed by both eyes (e.g. on a handheld device). However, the image appearing on the screen may be adapted to be viewed anaglyphically (e.g. where the patient may be wearing anaglyphic glasses). In this example, the result is that the patient is perceiving with the first eye an image that is different from the image perceived by the second eye due to the properties of the image appearing on the screen and the anaglyphic glasses.

[0057] In the present disclosure, by degree of diplopia and/or CID, it is meant the presence, severity, improvement and/or deterioration of diplopia and/or CID in a patient.

[0058] Reference is made to FIG. 7, illustrating an exemplary apparatus 100 for treating diplopia and/or CID.

[0059] The apparatus 100 has a processor 101, a user input interface 103, a memory 105 and a display 102. The apparatus 100 may also have a physician interface 104.

[0060] The memory 105 may contain program code for execution by the processor 101. Therefore, the memory 105 stores program instructions and data used by the processor 101. The computer readable memory 105, though shown as unitary for simplicity in the present example, may comprise multiple memory modules and/or cashing. In particular, it may comprise several layers of memory such as a hard drive, external drive (e.g. SD card storage) or the like and a faster and smaller RAM module. The RAM module may store data and/or program code currently being, recently being or soon to be processed by the processor 101 as well as cache data and/or program code from a hard drive.

[0061] The processor 101 is a general-purpose programmable processor. In this example, the processor 101 is shown as being unitary, but the processor may also be multicore, or distributed (e.g. a multi-processor). The processor 101 may be a micro-processor.

[0062] The user input interface 103 is an interface that allows the user to provide specific input, such as buttons to allow a user to play a game. For instance, the user input interface 103 may be a keyboard, a joystick, a controller, a touchpad, a microphone combined with a voice processor, a movement detector, etc. In some examples, the user input interface 103 may also provide for an option for the user to control the image parameters. In other examples, the image parameters may be controlled by a supervising physician.

[0063] In some examples where the user input interface 103 includes a microphone combined with a voice processor, the voice processor may carry out the commands pronounced by the patient. For instance, the apparatus 100 may be running with the Alexa application program, where Alexa may be configured to adjust certain parameters of the image pairs presented to the patient as a result of received input, or, e.g., transmit data to the supervising physician in response to a verbal request made by the patient.

[0064] In some examples, the apparatus 100 has a physician interface 104 configured to receive input from a medical practitioner or supervising physician. In some embodiments, the physician may control certain of the image parameters using the physician interface 104. In some embodiments, the physician interface 104 may also be configured to transmit information to the physician (e.g. via a wired or wireless connection) regarding, e.g., the patient's performance of the task, such as the patient's results, the settings of the apparatus 100, the game that is being played, comments provided by the patient, etc. In some examples, the physician interface 104 may be a transceiver, a transmitter and/or a receiver.

[0065] In some examples, the memory 105 stores the program code for the exercises and tasks to be carried out by the patient (e.g. the game). The program code may also include the instructions to generate the two images for a corresponding task.

[0066] The display 102 is a display that is used to present an image pair (i.e. a first image with different information content than that of the second image), where the first image is configured to be presented to a first eye of the patient; and the second image is configured to be presented to a second eye of the patient). In some examples, the difference in information content may be achieved between both images by using anaglyphic glasses (using the same image, but where some of the objects are configured to only appear to one eye, and some of the features are configured to only be perceived by the other eye), or by generating two distinct images, each with different information content. The display 102 may be, in some examples, a virtual reality headset, a headset display, augmented reality glasses such as Vuzic Blade AR Glasses, the screen of a portable computing device such as a tablet or smartphone, a desktop display, a television set, etc. The display 102 may have a wired connection to the processor 101.

[0067] In some examples, the display 102 may be adapted to be viewed using anaglyphic glasses.

[0068] The memory 105 and the processor 101 may have a BUS connection. The user input interface 103 and the physician interface 104 may be connected to the processor via a wired connection.

[0069] The apparatus 100 may be used to treat a patient with diplopia or CID.

[0070] The patient is provided with the apparatus 100. The apparatus 100 generates an image pair to be perceived visually by the patient, where each of the perceivable images provides each of the eyes with different information content with respect to one another. In one example, the image parameters are adjusted in at least one image such that the image content to be perceived by the first eye is more perceivable than the image content to be perceived by the second eye (e.g. by adjusting the contrast, the brightness of one image). The image parameters may be adjusted until the patient processes the information content from both images. In one example, this adjustment of parameters may be performed during a calibration phase. In one example, the image parameters may also be adjusted as the patient is performing the given task.

[0071] The patient's ability to perform the task provides an indication that the images received by both eyes are being processed by the brain, and in some cases, indicative that the processed images result in the objects of the images appearing in the accurate perceived space (i.e. no double-vision). Image parameters may be adjusted throughout the course of treatment, and as the patient's vision improves. For instance, patients with CID may notice that the first eye has less of a tendency to wander. Patients suffering from diplopia may notice that the diplopia-related symptoms, double-vision, begin to fade or not to present themselves during the course of treatment. Therefore, as the patient continues to perform the tasks during treatment, less will the symptoms of diplopia present themselves.

[0072] In some embodiments, the apparatus 100 may include a camera to conduct eye tracking of the patient during the performance of the cognitive task in order to assess if at least one eye is wandering.

[0073] It will be understood that in some examples, the apparatus 100 may be, for example, a smartphone, tablet, or computer, having stored in memory and/or running an application program configured to present an image pair as described herein (e.g. the application program may be played over the Internet, accessible via, e.g., a webpage, or downloaded and stored in memory on the computer device).

[0074] Examples of tasks to be performed may be in the context of a game. For instance, a first game may be to click on the bad monsters and avoid the good monsters. The bad monsters perceivable in a first image may be configured to only be perceived by the first eye, where the good monsters perceivable in a second image may be configured to only be perceived by the second eye eye. The patient's brain has to process the image perceived by the first eye showing the bad monsters to complete the task of the game. Such may be achieved by adjusting the image parameters as explained herein.

[0075] The position of the objects may also be important for the user to complete the task (e.g. game). For instance, in the examples of VR or AR, failure of the patient to move his hand or finger to the proper position (or other body movements) where an object is located may indicate that the patient is still seeing double-vision, where certain of the objects are not being perceived at a proper location. In such an example, the offset of one image or both images may be adjusted, and the patient may be asked to perform again the performance task.

[0076] As such, it will be understood that the apparatus and method described herein may also be used to assess the degree of diplopia or CID of the patient, where the difference in one or more image parameters between both images necessary to achieve stereopsis in a patient is an indicator of the degree of diplopia or CID of the patient (stereopsis assessed based on, e.g. the performance information).

[0077] When the apparatus 100 is assessing the presence and or the severity of diplopia or CID of a patient, the apparatus 100 may provide assessment information on the degree of diplopia or CID of the patient (i.e. information that indicates the presence and/or the severity of diplopia or CID, such as an index score, a percentage of functioning of both eyes, etc., where this assessment information may be further interpreted by the patient).

[0078] In another example, the game may be one to jump over moving obstacles that are on a track as the obstacles approach a visible controllable character as the game progresses. The character may be perceivable by the second eye (e.g. dominant eye), where the obstacles may be perceivable by the first eye. The patient has to process the information content present on both images in order to perform the task of the game.

[0079] In some examples, the apparatus may also include an eye tracker 106 to verify during the course of the patient performing the task the relative position of one eye with respect to the other. The eye tracker 106 may be used to verify the degree of improvement of diplopia and/or CID, and/or to provide information on the functioning of one eye with respect to the other.

[0080] The eye tracker 106 may include a camera that can capture images or an image stream of the face (or at least the eyes) of the patient, and may include an application program stored in memory 105 of the apparatus 100 that, when executed by the processor 101, uses the captured images or image stream to determine the eye position and/or the eye movement of each of the eyes. The generated eye tracking information may be transmitted back provided to the physician via the physician interface 104, or used as input by the apparatus 100 to further adjust the difference of image parameters of the images.

[0081] In a passive example where a patient is, for example, watching television, the eye tracking information may be received by the apparatus 100 to assess if both eyes are functioning to achieve stereopsis, where performance information may not be available as the user is not performing a task. The image parameters may then be adjusted as a function of the eye tracking information, if the patient does not have stereopsis, or if stereopsis is achieved but a lesser difference in image parameters would be beneficial to continue treating the patient as the patient continues with the passive activity.

[0082] In fact, in some examples, the performance information may be, or may include, information gathered by the eye tracker when a user performs a task (e.g. that the eyes are moving to where objects are supposed to be perceived based on the game configurations).

[0083] Method of Treating Diplopia and/or CID:

[0084] Reference is now made to FIG. 8, illustrating an exemplary method 800 of treating (and/or assessing the degree of) diplopia and/or CID of a patient. The exemplary method 800 may employ an exemplary apparatus 100 as described herein. For the purposes of illustration, reference is made, when describing exemplary method 800, to exemplary apparatus 100. However, it will be understood that an apparatus other than exemplary apparatus 100 may be used.

[0085] The apparatus 100 is first calibrated at step 810 in order to set the image parameters of the image pair presented to the patient. The image parameters are adjusted based on the extent of the visual condition of the patient. For instance, there may be, during the calibration phase, an exercise requesting that the patient position a first arrow, apparent in one of the perceived images, vis--vis a second arrow, apparent in the second perceived image. The patient or the supervising physician may adjust the image parameters until both arrows are perceived by the patient. In some examples, a program code may be executed by the processor of the apparatus to gradually adjust the image parameters until both arrows are perceptible (e.g. perceptibility indicated from input received from the user). For example, the patient may then indicate, for instance, by using the input interface, that both arrows can be perceived. At this stage, the image parameters may be set. The image parameters may be adjusted for one image, or for both images.

[0086] When the image parameter includes an image offset (e.g. an adjustment of the position of one or more image along at least one axis), the offset of one image with respect to the other can be increased or decreased until the patient perceives the objects of both images in their proper position (e.g. the patient perceives the objects of both the first image and the second image merged into a single image with the information content of both images in their proper position).

[0087] An image pair (e.g. which may be an image stream configured such that a first image is perceived by a first eye and a second image is perceived by a second eye) is generated at step 820 with the image parameters set in accordance with those established during the calibration step 810. It will be understood that, in some examples, the image parameters may be set by applying a filter (e.g. an optical filter) over an image, or portions of the image.

[0088] For instance, in some examples, the image pair may be provided when the patient is wearing an augmented reality headset. In these examples, an image stream is being taken of a real-life event, where, for instance, certain objects in the image stream are either altered to be removed or some objects added, where certain objects are perceivable by one eye and other objects are perceivable by the other eye. In some embodiments, the information content of the first image may be layered over a live stream of images generated from a camera (e.g. computer renderings of monsters are layered over the live stream of images). The image parameters may also affect certain of the objects appearing in the live steam of images generated by the camera.

[0089] In some examples, the image pair may be provided while the patient is wearing a virtual reality headset or virtual reality glasses. In some cases, the information content of the first image may be layered (e.g. an overlay of certain critters to avoid in the game, or powerups to collect in the game, etc.) over a live stream of images generated from a camera.

[0090] In some examples, one or more image parameters may affect objects appearing in the live stream of images generated from a camera (e.g. a filter, or changing the colour of certain trees perceived in the game such that they appear blue, where the patient would have to either select or avoid the blue trees, etc.)

[0091] The patient is then requested to perform a task while utilizing at least the information content of the image perceived by the first eye at step 830. For instance, the task may be that of completing a video game, where information (e.g. objects, characters) perceivable only from the image presented to the first eye is necessary to complete the game. In some examples, information presented in both images may be necessary to complete the game.

[0092] The patient's performance when completing the game may be recorded at step 840. The performance may be stored in memory of the apparatus 100. The performance may also be transmitted to a supervising physician (e.g. via a wired or wireless connection).

[0093] In accordance with the patient's observed or recorded performance, the image parameters of the image pair may be adjusted at step 850. The adjustment may take place on a timely basis (such as every week), where the program code, when executed by the processor, results in periodic adjustments of the image parameters as a function of the recorded results (e.g. the score obtained by the patient when performing the game). In some examples, the adjustments may also be performed by the supervising physician.

[0094] If the patient is successfully completing the task, the adjustment may be such that the difference in the image parameters is reduced. For instance, if the contrast results in the information content of the image presented to the first eye being sharper than that of the image presented to the second eye, the adjustment may result in reducing the difference in contrast between the two perceived images. The offset between the first image and the second image may also be reduced. However, the difference in contrast between the two perceived images may be increased if the patient is having difficulty accomplishing the designated task.

[0095] Once the image parameters adjusted, steps 820 to 850 may be repeated with the adjusted image parameters. As such, as the training progresses and the difference in image parameters between the two perceived images of the image pairs is reduced as a function of the patient's capacity to accomplish the designated task, so will the patient improve the patient's diplopia and/or CID condition during the course of treatment.

[0096] Exemplary Study:

[0097] The following exemplary study demonstrates that the present apparatus (e.g. apparatus 100) may be used to treat and/or reduce the instances of diplopia in patients. The study shows that using the apparatus reduces the instances of diplopia in patients (e.g. in some cases, the patients may also use the technology to correct amblyopia). The subjects were treated and observed throughout the study to measure improvements of diplopia by reporting diplopia therethrough. The results presented herein relate to the improvement and, in some cases, disappearance of diplopia during the course of the study as the subjects were treated.

[0098] The study was designed to measure the treatment of amblyopia. However, it was shown, during the course of the study, that the use of the apparatus unexpectedly also improved diplopia amongst the patients having this condition. This is contrary to what was expected based on what was previously known in the art, as it was believed that the use of the apparatus would worsen diplopia and/or CID amongst the patients, and not improve these ocular conditions.

[0099] Study Design:

[0100] The subjects of the study met the following criteria: [0101] Age 5 to <17 years [0102] Amblyopia associated with anisometropia, strabismus (10 at near measured by PACT), or both [0103] No amblyopia treatment (atropine, patching, Bangerter, vision therapy) in the past 2 weeks [0104] Spectacles (if required) worn for at least 16 weeks, or demonstrated stability of visual acuity (<0.1 log MAR change by the same testing method measured on 2 exams at least 4 weeks apart) [0105] Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS) [0106] Visual acuity in the fellow eye 20/25 or better (78 letters if E-ETDRS) [0107] Interocular difference 3 log MAR lines (15 letters if E-ETDRS) [0108] No myopia greater than 6.00 D spherical equivalent in either eye [0109] Ability to align the nonius cross on binocular game system. Heterotropia or heterophoria (total ocular deviation) 10 by PACT at near is allowed, as long as the subject is able to align the nonius cross. [0110] Demonstrate in-office ability to play Tetris game (on easy setting) under binocular conditions (with red-green glasses) by scoring at least one line

[0111] Subjects were randomly assigned (1:1) to either: [0112] Binocular treatment group: binocular computer game play prescribed 1 hour per day 7 days a week, with a minimum of 4 days for children unable to play 7 days a week (treatment time can be split into shorter sessions totaling 1 hour) [0113] Patching group: patching 2 hours per day for 7 days per week.

[0114] The sample sizes were as follows: [0115] 336 children aged 5 to <13 years (younger cohort) [0116] 166 children aged 13 to <17 years (older cohort)

[0117] The visit schedule is as follows (timed from randomization): [0118] Enrollment exam [0119] 1 week phone call (7 to 13 days) to inquire about issues with the computer games (only for those assigned to binocular treatment and to be completed by site personnel) [0120] 4 weeks1 week [0121] 8 weeks1 week [0122] 12 weeks1 week [0123] 16 weeks1 week (primary outcome)

[0124] All subjects were seen at 4, 8, 12, and 16 weeks. Subjects achieving amblyopic-eye visual acuity equal to or better than the fellow-eye visual acuity (0 lines or more lines better, 0 letters or more better if E-ETDRS) and at least 20/25 (or >78 letters if E-ETDRS) visual acuity in both eyes is considered to have resolved and treatment is discontinued, although these subjects still returned for all remaining follow-up exams. If at a subsequent visit there is regression of amblyopia (2 log MAR lines or 10 letters), treatment is restarted.

[0125] At each follow-up visit, distance visual acuity is assessed in each eye using ATS-HOTV for children <7 years at enrollment and the E-ETDRS for children 7 years at enrollment. Stereoacuity is also assessed using the Randot Butterfly Stereoacuity test and Randot Preschool Stereoacuity test, history of diplopia, and ocular alignment by cover uncover test, simultaneous prism cover test (SPCT) (if deviation present), and prism and alternate cover test (PACT). A child and parental questionnaire to assess the impact of amblyopia treatment and diplopia is completed at 4 and 16 weeks.

[0126] Treatment and Follow-Up:

[0127] All subjects in the study played a Tetris-style game presented on an iPad while wearing red/green (anaglyph) glasses (over current spectacles, if applicable) with the green filter placed over the amblyopic eye. The subject is instructed to hold the iPad at his/her usual reading distance. Some boxes are only visible to the fellow eye viewing through the red lens, while other boxes are only visible to the amblyopic eye viewing through the green lens. Image contrast varies depending on depth of amblyopia to ensure stimulation of the amblyopic eye and binocular game play.

[0128] Contrast of Tetris shapes in the amblyopic eye (e.g. the weak eye) is at 100% throughout the study. Contrast of shapes seen by the fellow eye will begin at 20% at the start of the study and will increase or decrease automatically in 10% increments from the last contrast level (e.g., 20% to 22%) in a 24-hour period based on the subject's performance and duration of game play. As the ability of the subject to use the amblyopic eye or weak eye improves, game performance is expected to increase, and therefore the contrast setting in the fellow-eye will increase. The lower limit of fellow-eye contrast is set at 10%, which corresponds to the lower limit of the visible threshold for viewing objects on the screen. If the game settings remain at 10% for a period of 7 days, the game shows an alert for parents to contact their eye care provider.

[0129] Binocular Treatment Group

[0130] Subjects assigned to the binocular treatment group is prescribed a Tetris-style game to play for 1 hour per day, 7 days a week (with a minimum of 4 days a week for children unable to play 7 days a week) for 16 weeks. Parents of subjects are instructed that the 1 hour of daily treatment should be completed in a single 60-minute session, but if this is not possible for whatever reason, the treatment may have been divided into shorter sessions totaling 1 hour. The difficulty setting (easy, medium, or hard) is at the discretion of the child.

[0131] Patching Group

[0132] Subjects assigned to the patching group wear an adhesive patch over the fellow eye for 2 hours per day, 7 days per week for 16 weeks.

[0133] Compliance

[0134] Parents are asked to complete a compliance calendar by manually recording the number of minutes that the child played the game each day or how long the patch was worn. Calendars are reviewed by the investigator at each follow-up visit. The amount of time the game is played is also recorded automatically during game play by the iPad. These data are downloaded at the site during each follow-up visit when the iPad is brought to the study visit.

[0135] Phone Call for those Assigned to Binocular Treatment

[0136] For those assigned to binocular treatment, site personnel call at 1 week (7 to 13 days) to confirm that there are no technical problems playing the binocular game and to address any questions.

[0137] Follow-up Visit Schedule

[0138] The follow-up schedule is timed from randomization as follows: [0139] 4 weeks1 week [0140] 8 weeks1 week [0141] 12 weeks1 week [0142] 16 weeks1 week

[0143] Subjects achieving amblyopic-eye visual acuity equal to or better than the fellow-eye visual acuity (0 lines or more lines better, 0 letters or more better if E-ETDRS) and at least 20/25 (or >78 letters if E-ETDRS) visual acuity in both eyes are considered to have resolved and will discontinue treatment, although these subjects will still return for all remaining follow-up exams. If at a subsequent visit there is regression of amblyopia (2 log MAR lines or 10 letters), treatment is restarted.

[0144] Additional non-study visits can be performed at the discretion of the investigator.

[0145] Follow-up Visit Testing Procedures

[0146] Subjects are at follow-up visits. Distance visual acuity and stereoacuity testing at these visits must be completed by a Masked Examiner. All procedures are performed with the subject's current refractive correction. If a subject currently wears spectacles but is not wearing them at the follow-up examination for whatever reason, testing must be performed in trial frames.

[0147] Prior to the Masked Examiner entering the room, subjects and parents are instructed not to discuss their treatment with the Masked Examiner.

[0148] The following procedures is performed in the following sequential order at each visit:

[0149] 1. Impact of Amblyopia Treatment Questionnaire [0150] The child and parent completed a short questionnaire to assess the impact of amblyopia treatment (to be completed only at the 4-week and 16-week visit) [0151] For the parent, the questionnaire can be either self-administered or administered by the site staff; for the child, the questionnaire will be administered by site staff. [0152] The questionnaire should be completed prior to the investigator's examination of the subject. [0153] The questionnaire is meant for the child's parent or guardian who is responsible for administering the patching or overseeing binocular treatment. If the child is brought to the visit by an individual who is not involved in the treatment, this is indicated on the questionnaire, and the questionnaire is not completed.

[0154] 2. Distance Visual Acuity Testing (masked): [0155] Monocular distance visual acuity testing will be performed in habitual refractive correction in each eye using the same visual acuity testing method that was used at enrollment, as described in the ATS Testing Procedures Manual [0156] Testing must be completed without cycloplegia.

[0157] 3. Stereoacuity Testing (masked): [0158] Stereoacuity is tested in habitual current refractive correction using the Randot Butterfly test and Randot Preschool Stereoacuity test at near ( meter).

[0159] 4. Ocular Alignment Testing: [0160] Ocular alignment is assessed in habitual refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near ( meter) as outlined in the ATS Procedures Manual

[0161] 5. History of Diplopia

[0162] The child and parent(s) are specifically questioned regarding the presence and frequency of any diplopia since the last study visit using a standardized diplopia assessment (see ATS Miscellaneous Testing Procedures Manual).

[0163] Results with Respect to Diplopia:

[0164] Data was collected on the subjects with respect to diplopia based on observations and reports made by the subjects and/or the parents of the subjects during the course of the study. The patients and/or the parents of the patients were asked to report incidents of diplopia during the course of the study. It was observed that the patients who completed more gameplay during the course of the study had less of a chance to develop diplopia than the patients who performed less gameplay.

[0165] Table 1 relates to the instances of diplopia perceived by the subjects that are part of the study cohort between the ages of 13 to less than 17 years old during the course of treatment. The data is also presented in the graph FIG. 1, demonstrating that as the subjects performed more gameplay, so did the instances of diplopia reduce.

TABLE-US-00001 TABLE 1 diplopia perceived by the subjects that are part of the study cohort between the ages of 13 to less than 17 years old. Table of PtSeeDoubleOftenMax by TrtGroup PtSeeDoubleOftenMax(Particpant: Max Frequency of Diplopia) TrtGroup(Treatment Group) Frequency Col Pct IPAD PATCHING Total A)Never 37 52 89 92.50 86.67 B)Less than once a week 1 1 2 2.50 1.67 C)Once a week 0 3 3 0.00 5.00 D)Once a day 2 3 5 5.00 5.00 E)Up to 10 times a day 0 1 1 0.00 1.67 Total 40 60 100

[0166] Diplopia was more recurrent amongst the subjects using the patch that those using the apparatus to perform gameplay.

[0167] Table 2 relates to the instances of diplopia perceived by the subjects that are part of the study cohort between the ages of 5 to less than 13 years old during the course of treatment. The data is also presented in the graph of FIG. 2, demonstrating that as the subjects performed more gameplay, so did the instances of diplopia reduce.

TABLE-US-00002 TABLE 2 diplopia perceived by the subjects that are part of the study cohort between the ages of 5 to less than 13 years old. Table of PtSeeDoubleOftenMax by TrtGroup PtSeeDoubleOftenMax(Particpant: Max Frequency of Diplopia) TrtGroup(Treatment Group) Frequency Col Pct IPAD PATCHING Total A)Never 157 172 329 84.41 89.12 B)Less than once a week 6 10 16 3.23 5.18 C)Once a week 10 4 14 5.38 2.07 D)Once a day 8 5 13 4.30 2.59 E)Up to 10 times a day 3 2 5 1.61 1.04 F)>10 times a day 1 0 1 0.54 0.00 G)All the time 1 0 1 0.54 0.00 Total 186 193 379 Frequency Missing = 6

[0168] Diplopia was more recurrent amongst the subjects between the ages of 5 to less than 13 years old using the patch that those using the apparatus to perform gameplay.

[0169] Table 3 relates to the instances of diplopia perceived by the parents of the subjects that are part of the study cohort between the ages of 13 to less than 17 years old during the course of treatment. The data is also presented in the graph FIG. 3, demonstrating that as the subjects performed more gameplay, so did the instances of diplopia reduce.

TABLE-US-00003 TABLE 3 diplopia perceived by the parents that are part of the study cohort between the ages of 13 to less than 17 years old. Table of PrSeeDoubleOftenMax by TrtGroup PrSeeDoubleOftenMax(Parent: Max Frequency of Diplopia) TrtGroup(Treatment Group) Frequency Col Pct IPAD PATCHING Total A)Never 39 56 95 97.50 93.33 B)Less than once a week 0 2 2 0.00 3.33 C)Once a week 1 1 2 2.50 1.67 D)Once a day 0 1 1 0.00 1.67 Total 40 60 100

[0170] Diplopia was more recurrent amongst the subjects using the patch that those using the apparatus to perform gameplay, as observed by the parents.

[0171] Table 4 relates to the instances of diplopia perceived by the parents of the subjects that are part of the study cohort between the ages of 5 to less than 13 years old during the course of treatment. The data is also presented in the graph of FIG. 4, demonstrating that as the subjects performed more gameplay, so did the instances of diplopia reduce.

TABLE-US-00004 TABLE 4 diplopia perceived by the parents that are part of the study cohort between the ages of 5 to less than 13 years old. Table of PrSeeDoubleOftenMax by TrtGroup PrSeeDoubleOftenMax(Parent: Max Frequency of Diplopia) TrtGroup(Treatment Group) Frequency Col Pct IPAD PATCHING Total A)Never 176 187 363 94.62 96.89 B)Less than once a week 6 4 10 3.23 2.07 C)Once a week 2 1 3 1.08 0.52 D)Once a day 2 0 2 1.08 0.00 E)Up to 10 times a day 0 1 1 0.00 0.52 Total 186 193 379 Frequency Missing = 6

[0172] Diplopia was more recurrent amongst the subjects using the patch that those using the apparatus to perform gameplay as perceived by the parents.

[0173] FIG. 5 illustrates the reports of diplopia as a function of gameplay over all age groups as perceived by the subjects.

[0174] FIG. 6 illustrates the reports of diplopia as a function of gameplay over all age groups as perceived by the parents of the subjects.

[0175] As shown in FIGS. 1-6, the more the subjects played the games using an apparatus as described herein, lower were the chances that the patients developed diplopia. The patients that played more of the game prescribed by the treatment had less of a chance of developing diplopia than those that played less of the game as shown in FIGS. 1 through 6. Similarly, it will be understood that the patients who performed more gameplay would also experience less cases of CID, as a wandering eye leads to double vision, and less double-vision would result in the eye having less of a tendency to wander. It may be submitted that the performance of the gameplay strengthens the extraocular muscles, which may reduce the instances of diplopia and CID.

[0176] These results are unexpected as it has been postulated by persons skilled in the art that use of such an apparatus as apparatus 100 and/or as described in the present study, would in fact cause diplopia. However, for example, as observed in the present study, it has been demonstrated that such an apparatus reduces the symptoms of diplopia and/or CID, and may in fact be used to treat either one or both of these conditions.

[0177] Representative, non-limiting examples of the present invention were described above in detail with reference to the attached drawings. This detailed description is merely intended to teach a person of skill in the art further details for practicing preferred aspects of the present teachings and is not intended to limit the scope of the invention. Furthermore, each of the additional features and teachings disclosed above and below may be utilized separately or in conjunction with other features and teachings to provide useful apparatuses and methods of treatment using the same.

[0178] Moreover, combinations of features and steps disclosed in the above detailed description, as well as in the experimental examples, may not be necessary to practice the invention in the broadest sense, and are instead taught merely to particularly describe representative examples of the invention. Furthermore, various features of the above-described representative examples, as well as the various independent and dependent claims below, may be combined in ways that are not specifically and explicitly enumerated in order to provide additional useful embodiments of the present teachings.

[0179] All features disclosed in the description and/or the claims are intended to be disclosed separately and independently from each other for the purpose of original written disclosure, as well as for the purpose of restricting the claimed subject matter, independent of the compositions of the features in the embodiments and/or the claims.