Abstract:
Non-surgical therapeutic methods and devices for the treatment of myopia are presented. The eyeball of a patient suffering from myopia is elongated causing refracted light to fall onto a spot in-front of the retina. Studies have shown that the reshaping of the cornea (i.e. through contact lenses or laser surgery) improves the vision of patients. Methods and devices proposed herein mainly target restoring the proper eyeball shape in order to allow the refracted light to fall on the retina, and providing a treatment regime for a patient suffering from myopia to apply a mild but sustained pressure to one or two eyeballs for a sustained period of time. The patient may repeat this process multiple times as needed until their vision improves.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims priority to co-pending U.S. provisional patent application No. 61/831,868 filed Jun. 6, 2013, and entitled “NOVEL METHODS AND DEVICES FOR THE THERAPEUTIC TREATMENT OF MYOPIA”. The entire contents of the above-referenced patent applications are incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to methods, systems, and devices for the therapeutic treatment of myopia. More specifically, the invention relates to devices and methods of treating myopia by applying a desired amount of pressure onto one or both eyeballs of a patient over a period of time. 
       BACKGROUND 
       [0003]    In a healthy human eye, light enters through the cornea and is refracted to pass through the pupil. After light enters through the pupil, it is passed through a lens which focuses the light towards the retina located at the back of the eye. The retina contains millions of nerve cells capable of converting the light to electrical signals which can be processed by the brain. 
         [0004]    Refractive vision errors are the leading cause of vision related problems for people around the world. Besides the curvature problem of the cornea, refractive errors frequently occur when changes in the eye&#39;s length or shape affects the cornea&#39;s ability to properly focus light onto the retina. Patients suffering from refractive errors have a difficult time viewing fine details and their vision often appears blurry. 
         [0005]    A common type of refractive error is myopia which is often called nearsightedness and affects roughly 30% of the US population. A patient suffering from myopia can usually see objects up close but has difficulty focusing on objects at a distance. Myopia occurs when the physical shape of the eye is longer in length than the normal, healthy eye. This condition causes light to be focused at a point in front of or otherwise away from the retina resulting in a blurred image. 
         [0006]    Numerous methods have been proposed for the treatment of myopia. Patients suffering from myopia will typically wear eye glasses or contact lenses to properly shift the focus of light onto the retina. Alternative methods to treat myopia include laser surgery (e.g. LASIK) wherein a laser is used to flatten the cornea to facilitate focusing light properly onto the retina. Another option for treating nearsightedness is orthokeratology (ortho-k), also known as corneal refractive therapy. It is a non-surgical procedure that involves wearing a series of specially designed rigid contact lenses to gradually reshape the curvature of your cornea. The lenses place pressure on the cornea to flatten it. Thus changing how light entering the eye is focused. 
         [0007]    It has been reported that varying types of pressure on the eyeball (i.e. by the eyelid) affects the shape of the cornea and impacts vision leading to refractive errors. It is further reported that reshaping the cornea by applying pressure to the eyeball can be used to treat myopia. However, currently available solutions for the corrective treatment of myopia require the use of complicated and expensive laser surgery or uncomfortable and expensive contact lenses which act as a temporary treatment of the symptoms and not the underlying condition causing this disorder. There are currently no cost effective devices or treatment methods available to treat the underlying cause of myopia and improve the vision of patients. 
         [0008]    There is therefore a great need in the field for a method, system, and device to treat myopia from outside the eye by applying mild but sustained pressure to the eyeball and slowly restoring both the cornea and the eyeball shape overtime thereby improving the vision of patients. 
       BRIEF SUMMARY OF THE INVENTION 
       [0009]    The present invention comprises non-surgical therapeutic methods, systems, and devices for the treatment of myopia. The eyeball of a patient suffering from myopia is elongated causing the refract light to fall onto a spot in-front of the retina. Studies have shown that the reshaping of the cornea (i.e. through contact lenses or LASIK) improves the vision of patients. Methods proposed herein mainly target restoring the proper eyeball shape in order to allow the refracted light to fall on the retina, and provide a treatment regime for a patient suffering from myopia to apply a mild but sustained pressure to one or two eyeballs for a period of time. The patient may repeat this process multiple times as needed until their vision improves. The patient may reduce the frequency of this procedure to maintain the shape the eyeball to achieve long term benefit. 
         [0010]    Also disclosed herein is a myopia correction device configured to place a desired amount of pressure against one or more eyeballs for a desired amount of time. In some embodiments, the device is in the form of goggles with an elastic strap to be worn around the head of a user thereby holding padding material against each eyeball. In some further embodiments, the device includes multiple layers of padding material which can be added or removed to adjust the level of pressure to be applied to each eyeball. By wearing the myopia correction device over a period of time, a patient may slowly reshape each eyeball and correct their vision. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The present invention is illustrated by way of example and not limited by the figures of the accompanying drawings, in which like references may indicate similar elements and in which: 
           [0012]      FIG. 1A  shows an example of the normal human eyeball. 
           [0013]      FIG. 1B  shows an an example of an elongated (myopic) eyeball. 
           [0014]      FIG. 2  illustrates a front view of one example of a myopia correction device as worn by a user in accordance with embodiments presented herein. 
           [0015]      FIG. 3  shows a side view of one example of a myopia correction device as worn by a user in accordance with embodiments presented herein. 
           [0016]      FIG. 4  illustrates a side view of one example of a myopia correction device showing an example of an interior padding member in accordance with embodiments presented herein. 
           [0017]      FIG. 5  shows a cross sectional view of an example of a myopia correction device in direct contact with the eye of a user in accordance with embodiments presented herein. 
           [0018]      FIG. 6  shows a cross sectional view of an example of a myopia correction device spaced apart from the eye of a user in accordance with embodiments presented herein. 
           [0019]      FIG. 7  shows the human eye (left side) and an example of multiple padding members of a myopia correction device in accordance with embodiments presented herein. 
           [0020]      FIG. 8  illustrates a side perspective view of an example of a myopia correction device in accordance with embodiments presented herein. 
           [0021]      FIG. 9  illustrates a side perspective view of an example of a myopia correction device in accordance with embodiments presented herein. 
           [0022]      FIG. 10  shows an example of a method to correct refractive vision errors using a system and myopia correction device in accordance with embodiments presented herein. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. 
         [0024]    Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. 
         [0025]    In describing the invention, it will be understood that a number of techniques and steps are disclosed. Each of these has individual benefit and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of the invention and the claims. 
         [0026]    New methods, systems, and devices for the treatment of myopia are described herein. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art that the present invention may be practiced without these specific details. 
         [0027]    As perhaps best shown by  FIG. 1A , the normal human eyeball  100  is generally more spherical in shape compared to the myopic eye ( FIG. 1B ) in configuration and comprises a cornea  101  on the outside of the eyeball which refracts light  104  (broken lines) entering into the eye through the pupil  102  and focuses the light onto the retina  103 . In the normal eyeball  100 , light  104  is focused by the cornea  101  into a spot  105  at the retina  103 . The retina  103  converts the light  104  into electrical signals and transports those signals to the brain through nerve cells (not shown). 
         [0028]    As shown in  FIG. 1B , patients suffering from myopia (also called “nearsightedness”), have an eyeball  110  which is elongated to varying degrees compared to the normal eyeball  100  ( FIG. 1A ). Because of this elongation, the cornea  111  of the myopic eye focuses light  104  at a spot  112  in front of the retina  103  instead of onto the retina  103  causing blurred vision and other symptoms. 
         [0029]    In some embodiments, the present invention comprises novel methods, systems, and devices of treating myopia by slowly and non-surgically reshaping the eyeballs of a user and in some embodiments the methods, systems, and devices of the invention reshape the cornea of a user. In some specific embodiments, the present invention comprises methods of applying a desired degree of pressure onto the eyeballs of a user over a period of time (also known as a “treatment schedule”). In one example, a treatment schedule may include applying a first level or degree of pressure to the right eyeball and a second level of pressure (or the same level of pressure) to the left eyeball for a period of time (i.e. overnight while the user is sleeping) (also called a “first period of time”). The user will typically wait for a second period of time (i.e. one or more days) (also called a “second period of time”) before re-applying pressure to the right and left eyeball for a period of time (i.e. overnight while the user is sleeping). In some additional embodiments, the user may increase the level of pressure applied to each eyeball at the same time or at different times. This general treatment schedule may be repeated as often as necessary to reshape the eyeballs into the proper spherical like configuration to allow the cornea to refract light directly onto the retina and thereby improving vision. Table 1 provides one non-limiting example of a possible treatment schedule according to the present disclosure: 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 week 
                 Pressure Right Eye 
                 Pressure Left Eye 
                 Treatment Time 
               
               
                   
               
             
             
               
                 Week 1 
                 Level 1 
                 Level 3 
                 6-9 hours nightly 
               
               
                 Week 2 
                 Level 1 
                 Level 3 
                 6-9 hours nightly 
               
               
                 Week 3 
                 Level 1 
                 Level 3 
                 6-9 hours nightly 
               
               
                 Week 4 
                 Level 2 
                 Level 4 
                 6-9 hours nightly 
               
               
                 Week 5 
                 Level 2 
                 Level 4 
                 6-9 hours nightly 
               
               
                 Week 6 
                 Level 2 
                 Level 4 
                 6-9 hours nightly 
               
               
                 Week 7 
                 Level 3 
                 Level 5 
                 6-9 hours nightly 
               
               
                 Week 8 
                 Level 3 
                 Level 5 
                 6-9 hours nightly 
               
               
                 Week 9 
                 Level 3 
                 Level 5 
                 6-9 hours nightly 
               
               
                 Week 10 
                 Level 3 
                 Level 5 
                 6-9 hours nightly 
               
               
                 Week 11 
                 Level 3 
                 Level 5 
                 6-9 hours nightly 
               
               
                 Etc. 
                 Etc. 
                 Etc. 
                 Etc. 
               
               
                   
               
             
          
         
       
     
         [0030]    Table 1 above shows one possible example of a treatment schedule for myopia as contemplated herein. According to this example, a patient applies a first level of pressure (i.e. Level 1) to their right eyeball and a second level of pressure (i.e. Level 3) to their left eyeball for 6-9 hours each night while they are sleeping on Week 1 and increases the level of pressure on Week 4 and again on Week 7. It should be noted that the treatment schedule provided above is meant to illustrate only one example of the methods of the present invention. 
         [0031]    In some alternative embodiments, methods of the present invention comprise applying only one fixed level of sustained pressure to each eyeball for a period of time or multiple periods of time (e.g. the levels of pressure do not change with each application). 
         [0032]    In some embodiments, the present invention also comprises a novel apparatus to apply a desired amount of pressure onto the eyeballs of a patient suffering from myopia. In some embodiments this apparatus shall be referred to as a “myopia correction device” or simply the “device”. 
         [0033]    As used herein the term “myopia correction device”  200  or “device” shall preferably mean a non-invasive, non-surgical apparatus worn over the eyes of a patient suffering from myopia. The device  200  is generally configured to assert a customized level of mild pressure onto each eyeball of a person and thereby slowly changing the shape of each eyeball and in some examples each cornea as needed to correct vision. In some embodiments perhaps best shown by  FIGS. 2 and 3 , the myopia correction device  200  is in the form of goggles or similar design but configured to apply direct but mild pressure to one or both eyeballs. In other embodiments as perhaps best shown by  FIGS. 8 and 9 , the myopia correction device  200  is in the form of an eye mask, or headband, or similar design but configured to apply direct but mild pressure to one or both eyeballs. It should be noted that various other forms of myopia correction devices  200  are contemplated herein and the examples described below are meant for illustrative purposes only and should not be used to limit the scope of the invention. 
         [0034]    As perhaps best illustrated by  FIG. 2 ,  FIG. 3 , and  FIG. 4 , one example of a myopia correction device  200  is shown. In this example a myopia correction device  200  is configured as a pair of eye goggles or eye mask with two opaque lens like units known as eye covers (also referred to as “eye covering members”)  201  configured to cover the eyes of a user. The eye covers  201  have an outer portion and an inner portion with said inner portion preferably configured to contain a soft or padding material such as inner padding members  203  to be placed against the eyes of a user and to assert a mild degree of pressure against each myopic eyeball through the eyelid  120 . 
         [0035]    A securing mechanism such as a strap  202  may be attached to each side of the device  200  at or near the eye covers  201  (i.e. proximate to the eye covers  201 ) and is configured to secure the device  200  around the head of a user. The strap  202  may be a single band or two or more bands as shown by the figures and may include adjustment and fastening mechanisms such as buckles, Velcro, snaps, and the like used to secure the strap in place and adjust it to a comfortable fit. The strap  202  may be made from an elastic material offering a secure fit around the head of a user, but not obstructive when the person is lying on a pillow. 
         [0036]    As shown by  FIGS. 5 and 6 , a cross sectional view (from the direction shown in  FIG. 2 ) of an exemplary myopia correction device  200  is placed against the myopic eye  110  to apply pressure to the outside of the eyeball through the eyelid  120  and force its shape from an elongated configuration to a more spherical configuration. By changing the configuration of the eyeball, the cornea  111  may more properly focus light through the pupil  102  onto the retina (not shown). In this example, a single padding member  203  makes direct contact with the eyelid  120  and the eyelash  121  and applies pressure from outside of the eye against the exterior surface of the eyelid  120 . 
         [0037]    In some embodiments, the myopia correction device  200  comprises an eyeball pressure adjustment mechanism or eyeball pressure adjustment means to adjust the level of pressure applied to each eyeball of a person wearing the device by adjusting the tension of the strap(s) (i.e. by tightening the strap through buckles) or by adding or removing layers of padding members  203 . 
         [0038]    In some embodiments perhaps best shown by  FIG. 7 , the myopia correction device  200  and in particular the eyeball pressure adjustment mechanism comprise one, two, three, four, or even five separate pieces of padding members (known collectively as “padding members” or individually as a “padding member”)  203 . The example shown in  FIG. 7  provides three padding members  203  labeled as  203   a,    203   b,  and  203   c.  In some embodiments, the invention comprises one or more padding members of equal size. In other embodiments, the present invention comprises one or more padding members of different sizes an in particular the thickness of each padding member  203  may be different allowing more pressure to be applied by using a padding member  203  of greater thickness or width. The padding member(s)  203  may be constructed from fabric, foam, plastic, or similar material and are configured to be rigid enough to apply pressure to the eyeball yet soft on their exterior to reduce pain or irritation when being worn by a user. The padding members  203  are further configured to be attached to the inside (facing the eyeball) of the eye covers  201  and may also be attached or connected to each other. In this embodiment, a user may adjust the degree or level of pressure asserted onto each eyeball as needed by adding or removing padding members  203 . Padding members  203  may comprise a temporary attachment mechanism such as a hook and loop style fastener (i.e. Velcro) to removably connect a first padding member  203  to a second padding member  203  or a padding member  203  to the device  200 . 
         [0039]    In some cases, an eyeball with worse vision (more myopic) will require a longer treatment time and/or higher level of pressure to correct the myopic shape of that eye and thus may require more padding members  203  attached to the eye cover  201  which will be placed against that specific myopic eyeball  110 . 
         [0040]    In some further embodiments shown by  FIGS. 8 and 9 , the myopia correction device  200  is in the configuration of a mask commonly known as a sleep mask as known in the field. In this embodiment, the device  200  has two eye covering pieces of fabric or similar material configured to cover the eyes of a user and connected by an elastic strap to be worn around the head. The device  200  in this embodiment may include one or more padding members  203  as described above attached to the inside of the eye covering pieces and configured to be held in place against the eye of a user. 
         [0041]    In some embodiments, the myopia correction device  200  may include a pressure applying assembly (not shown in figures) configured apply pressure onto the eyeball of a user. In this embodiment, the pressure applying assembly may take the form of a sealed elastic pocket or pouch placed on the inside (facing the eyeball) of the device  200 . The sealed elastic pocked may be filled with air, liquid, or other padding materials to expand the pocket thereby applying more pressure onto the eyeball when worn by a user. In a further embodiment, the pressure applying assembly may include a gauge (not shown) to measure the level of pressure inside of the assembly to provide the user with a means to measure a desired amount of pressure to be placed against their eye when in use. 
         [0042]    Referring now to  FIG. 10 , and exemplary system  300  is shown to treat refractive errors such as myopia. In this embodiment, the system  300  comprises a treatment method ( FIG. 10 ) as well as a myopia correction device  200  ( FIGS. 2-9 ). A user such as a patient suffering from myopia may first start the method  301  and determine the degree of refractive error in each eye  302  (i.e. by conducting a vision test either at home or at a doctor&#39;s office). The user may next determine an appropriate treatment plan based on proposed treatments schedules  303 . Said treatment schedules may be updated from time to time and a sample schedule is provided herein in Table 1. To begin the treatment process, the user may select and apply a first degree of pressure to one or both eyes for a period of time (e.g. minutes or hours)  303  said degree of pressure customizable through a pressure adjustment means of a myopia correction device  200 . The user may then wait without applying pressure for a period of time  305 . A vision test may be conducted to determine if refractive errors still exist  306 , if the errors have been corrected, the user may end the method  309 . If the errors are still present, the user may change the pressure adjustment means  307  for example by adding additional padding members  203  to the myopia correction device  200 . The user may then apply the increased second degree of pressure to one or both eyes for a period of time  308  using the myopia correction device  200 . The user may then wait without applying pressure for a period of time  305 . A vision test may be conducted to determine if refractive errors still exist  306 , if the errors have been corrected, the user may end the method  309 . 
       NON LIMITING EXAMPLE 
       [0043]    The following example is meant to illustrate one method and one device  200  as described herein. 
         [0044]    According to some embodiments of the present disclosure, a user suffering from myopia may refer to a customized treatment schedule (see table 1 above for example) to select a desired amount of pressure to be placed onto each eyeball through a myopia correction device as shown by  FIG. 4 . The user may customize their myopia correction device  200  to assert a chosen degree of pressure to be applied to each eyeball by either adding or removing one or more padding members  203  as shown by example in  FIG. 7 . The user will then wear the device  200  for a first period of time (for example overnight while they are sleeping). The user may next wait for a second period of time (for example 1 day) without wearing the device  200 . Next, a user may then add one or more padding members  203  to the device  200  to add more pressure to each eyeball and wear the device for a third period of time (for example overnight). The user may repeat this process and change the amount of pressure applied to each eyeball as needed to correct their vision. 
       REFERENCES (INCORPORATED HEREIN BY REFERENCE) 
       [0045]    1. Scott A. Reed et al., The Morphology of the Palpebral Fissure in Different Directions of Vertical Gaze, Optometry &amp; Vision Science, Volume 83, Issue 10, October 2006, Pages 715-722 
         [0046]    2. John Yee, Correcting mild myopia by means of orthoculogy, Medical Hypotheses, Volume 76, Issue 3, March 2011, Pages 332-335