Patent Document

FIELD OF THE INVENTION 
       [0001]    The present invention pertains generally to ophthalmic diagnostic equipment and procedures. More particularly, the present invention pertains to diagnostic systems and methods that employ mathematical models of the cornea for diagnosing corneal diseases, such as keratoconus. The present invention is particularly, but not exclusively, useful as a system and method for making an early diagnosis of keratoconus, to determine whether a cornea is a proper candidate for subsequent refractive surgical procedures. 
       BACKGROUND OF THE INVENTION 
       [0002]    By definition, keratoconus is a non-inflammatory, usually bilateral protrusion of the cornea, the apex being displaced downward and nasally. Essentially, keratoconus is caused by a thinning of the cornea that will typically result in asymmetric astigmatism. Another aspect of the disease, however, also deserves consideration. Specifically, this consideration is the fact that keratoconus causes a loss of corneal tissue that may effectively preclude an individual from pursuing particular refractive surgical procedures for vision correction. For example, due to the inherent loss of corneal tissue, keratoconus would be contraindicative for procedures that involve the removal of corneal tissue (e.g. the well-known LASIK surgery). 
         [0003]    In the early stages of the disease, keratoconus is not easily detected. Specifically, the pronounced change in the shape of the cornea that is characteristic of advanced keratoconus, is not noticeably evident in the early stages. Nevertheless, there are structural weaknesses in the corneal tissue, caused by lamella crossover in the early stages of the disease, that portend the disease. It is extremely difficult, however, if not impossible to locate and directly measure the biomechanical stresses and strains that are characteristic of these weaknesses. 
         [0004]    Anatomically, the cornea of an eye comprises five identifiable layers of tissue. In an anterior-posterior direction these layers are: epithelium, Bowman&#39;s membrane, stroma, Descemet&#39;s membrane, and endothelium. The stroma forms about 90% of the corneal thickness, with Bowman&#39;s membrane forming most of the remaining thickness. Though smaller than the stroma, Bowman&#39;s membrane is around five times stronger and is more elastic than is stromal tissue. The remaining layers (i.e. epithelium, Descemet&#39;s membrane, and endothelium) provide negligible structural strength for the cornea. Accordingly, based on layer thickness and relative structural considerations (i.e. biomechanical parameters) for Bowman&#39;s membrane and the stroma, a mathematical model of a cornea can be established using well known mathematical techniques. 
         [0005]    Unlike the difficulties mentioned above that are encountered in measuring biomechanical characteristics of corneal tissue, surfaces of the cornea can be more easily defined. In particular, respective topographies for the anterior and posterior surfaces of a cornea can be obtained using known imaging techniques (e.g. second harmonic generation imaging). Further, it is known that the shape of a cornea, as determined by its surface topographies, is a consequence of the stress-strain relationships experienced by tissues inside the cornea. 
         [0006]    In light of the above, it is an object of the present invention to provide a system and method for diagnosing a keratoconic cornea at the onset of the disease, prior to any observably noticeable change in the anatomical shape of the cornea. Another object of the present invention is to provide a system and method for determining whether a cornea is a proper candidate for subsequent refractive surgical procedures. Yet another object of the present invention is to provide a system and method for diagnosing a keratoconic cornea that is simple to employ, is easy to use and is comparatively cost effective. 
       SUMMARY OF THE INVENTION 
       [0007]    In accordance with the present invention, a system and method for diagnosing the onset of keratoconus in a cornea requires mapping the anterior surface of the cornea of an eye. Once the eye has been mapped, the resultant topography is fitted onto a finite element model (FEM), and the consequent tissue parameters are evaluated. Preferably, the mapping is accomplished while the eye is subjected to an externally imposed pressure that will be less than about 14 kPa. Mapping, however, can also be made with no added pressure, or at a series of different pressures. In any event, if employed, pressure is used to change the shape of the cornea and thereby enhance the resultant topography measurements. The mapped topographies are then fitted on a mathematical model of the cornea and biomechanical parameters in the cornea are taken from the model for the respective corneal configurations. Next, a computer is used to evaluate the biomechanical parameters. Based on this evaluation, a diagnosis is made as to whether the cornea is keratoconic. In this context, a topography mapped while the eye is under pressure may be more likely to give accurate information and, though mapping only one topography may suffice, additional information from different pressure topographies will improve precision. 
         [0008]    In greater detail, to perform a diagnostic procedure in accordance with the present invention, a topography “T a ” of the anterior surface of the cornea is mapped and recorded. As mentioned above, this is preferably done while the eye is under pressure. If desired, a respective topography of the posterior surface of the cornea, “T p ” can also be similarly mapped and recorded. Once the topographies “T a ”, and “T p ” (if used), have been mapped and recorded, they are appropriately fitted onto a mathematical model of a cornea. For purposes of the present invention, the model preferably comprises a plurality of finite elements, wherein each element corresponds to a particular location in the actual cornea, and each element is defined by a plurality of parameters. Thus, for example, fitting “T a ”, and possibly “T p ”, onto the model obtains a set of parameters for the model. Importantly, these parameters are representative of the cornea in a configuration, when the eye is under conditions established by a predetermined intraocular pressure. Preferably, this pressure is less than 14 kPa. Further, each parameter is indicative of a biomechanical property (characteristic) of tissue at a particular location in the cornea. Collectively they can be used to evaluate the eye. 
         [0009]    As indicated above, additional sets of parameters can be obtained at different pressure levels in the eye. Also, each parameter in each of these sets is indicative of a biomechanical property (characteristic) of tissue at a particular location in the cornea, at the particular pressure. Typically, these conditions are established with representative intraocular pressures that are less than approximately 14 kPa. Importantly, each parameter in a set of parameters corresponds to a respective parameter at a same location in another set of parameters. Thus, using a computer, the different sets of parameters are compared with each other to evaluate changes in biomechanical properties of the cornea. In turn, these changes are used for diagnosing whether the cornea is keratoconic. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0011]      FIG. 1  is a schematic representation of the system of the present invention; 
           [0012]      FIG. 2  is a cross section view of a cornea of an eye; 
           [0013]      FIG. 3  is a cross section view of a cornea of an eye under a first pressure condition, with a view of the cornea under a second pressure condition superposed thereon; 
           [0014]      FIG. 4  is a logic chart for the operation of the system of the present invention; 
           [0015]      FIG. 5  is a graph showing the relationship of stresses in a healthy eye and in a keratoconic eye; and 
           [0016]      FIG. 6  is a graph showing the relationship of strains in a healthy eye and in a keratoconic eye. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    Referring initially to  FIG. 1 , a system for diagnosing keratoconus in accordance with the present invention is shown and is generally designated  10 . As shown, the system  10  includes a computer  12  that is electronically interconnected with a mathematical model  14 . Also interconnected with the computer  12  are an imaging device  16  and a pressure device  18 . As indicated in  FIG. 1 , the imaging device  16  and the pressure device  18  are positioned to interact with an eye  20  of a patient (not shown). More particularly, the devices  16  and  18  are positioned to interact with the cornea  22  of the eye  20 . 
         [0018]    In  FIG. 2 , a cross section of the cornea  22  shows that, anatomically, the cornea  22  has five different identifiable layers of tissue. Between the anterior surface  24  and the posterior surface  26  of the cornea  22 , and going in an anterior-posterior direction, the layers of the cornea  22  are: epithelium  28 ; Bowman&#39;s membrane  30 ; stroma  32 ; Descemet&#39;s membrane  34 ; and endothelium  36 . Structurally, Bowman&#39;s membrane  30  and the stroma  32  of cornea  22  are much more significant than the other three layers. So much so that, for strength considerations, the epithelium  28 , Descemet&#39;s membrane  34  and the endothelium  36  can be considered mathematically negligible. 
         [0019]    For purposes of the present invention, the model  14  is a mathematical model of the cornea  22 . Preferably, the model  14  is a finite element model that includes a plurality of different elements, wherein each element in the model  14  is defined by a plurality of mathematical parameters. And, importantly, each parameter in every element of the model  14  is representative of tissue qualities (i.e. biomechanical characteristics) in the cornea  22 . Further, it is important that each element of the model  14  corresponds to a particular anatomical location in the cornea  22 . In a preferred embodiment of the model  14 , elements are included that will represent both Bowman&#39;s membrane  30  and the stroma  32 . The actual set-up for the model  14  can be accomplished using well-known mathematical techniques. 
         [0020]    As mentioned above, the system  10  is to be primarily used for diagnosing keratoconus of the eye  20  prior to the onset of the disease. As also mentioned above, even before the disease is observably noticeable, weaknesses in the cornea  22  are present. Accordingly, these weaknesses can be expected to be manifested under certain conditions. Specifically, the present invention envisions that a proper disclosure of these weaknesses can be obtained by imposing a differential in the intraocular pressure against the posterior surface  26  of the cornea  22 . Such a pressure differential is indicated by the arrow  38  in  FIG. 2 . The result is an observable change in the shape (i.e. topography) of the cornea  22 . It is the nature and the extent of this change, however, that is of value for diagnosing keratoconus. 
         [0021]    An example of the consequence of a pressure differential  38  on the cornea  22  of a keratoconic eye  20  can be seen with reference to  FIG. 3 . There it is to be appreciated that prior to imposing the pressure differential  38 , the cornea  22  is subjected to a normal intraocular pressure (e.g. 2 kPa). Under this normal pressure, the anterior surface  24  and the posterior surface  26  of the cornea  22  will be substantially as shown by the solid lines in  FIG. 3 . If the eye  20  is keratoconic, a topography indicative of this condition may not be discernable. Under the influence of the pressure differential  38 , however, (e.g. 10 kPa), the anterior surface  24 ′ and the posterior surface  26 ′ are forced into another configuration where a keratoconic condition is more pronounced. On this point, empirical data indicates that tissue parameters of a normal eye are as much as five times greater than corresponding parameters for a keratoconic eye. A consequence of this difference for a keratoconic eye  20  is shown in  FIG. 3  where a pressured configuration (i.e. dashed lines) is shown superposed on an unpressurized configuration (i.e. solid lines). In contrast with this, a normal eye will not exhibit a discernable configuration change in its topography at different pressure levels. 
         [0022]    The logic chart that is generally designated  40  in  FIG. 4 , is exemplary of an operation of the system  10  of the present invention. To begin, the eye  20  is maintained in its first configuration wherein it is subjected to a first pressure “p 1 ”. Note: this first pressure “p 1 ” may, in fact, result from no externally applied pressure on the eye  20 . This condition is indicated by the block  42  of chart  40 . Typically, “p 1 ” will be the normal anatomical intraocular pressure of the eye  20 . As indicated by block  44 , while the eye  20  is in its first configuration, the topography “T” of the anterior surface  24  of the eye  20  is mapped (in this case “T 1a ”). Preferably, this mapping is accomplished by an imaging device  16  of a type well known in the pertinent art. If desired, the topography of the posterior surface  26 , “T p ”, may also be mapped. For purposes of this disclosure, however, the discussion hereinafter is directed primarily to the anterior surface  24 . With this in mind, block  46  of chart  40  indicates that the topography “T 1a ” is fitted onto the model  14 . Once “T 1a ” is so fitted, mathematical parameters (i.e. numerical representations of biomechanical characteristics at locations in the cornea  22 ) can be obtained from finite elements of the model  14  (see block  48 ). 
         [0023]    Inquiry blocks  50  and  52  in chart  40  together indicate that once all of the mathematical parameters for the cornea  22  have been obtained for the cornea  22  in its first configuration, consideration can then given to the second configuration. Specifically, inquiry block  54  questions whether a second pressure “p 2 ” has been established. From the above disclosure it will be appreciated that the second pressure “p 2 ” is provided by the pressure device  18 , and results from an exertion of the pressure differential  38  (e.g. 10 kPa) against the posterior surface  26  of the cornea  22 . Preferably, as the pressure differential  38  is imposed, the second pressure “p 2 ” will be less than about 14 kPa. In any event, this moves the cornea  22  into a second configuration. Block  56  then indicates that the second pressure “p 2 ” is maintained while a second corneal topography “T 2a ” is mapped. Specifically, in this case, a topography “T 2a ” is mapped for the anterior surface  24 . Again, if desired, a topography “T p ” for the posterior surface  26  can also be mapped. As was previously done with “T 1a ”, blocks  44  and  46  indicate the topography “T 2a ” is fitted to the model  14 . This time, mathematical parameters (biomechanical characteristics) are obtained for the cornea  22  while it is in its second configuration. Block  52  then indicates that when the tasks of fitting of “T 1a ” and “T 2a ” onto model  14  have been completed, and mathematical parameters are obtained for both the first and second configurations, the operation of system  10  moves to block  58  for an analysis of the collected data  60  (see  FIG. 1 ). Specifically, this is done by comparing various parameters with each other, and with empirical data indicative of a keratoconic condition. It is, of course, possible to obtain a plurality of topographies for the eye  20  under respective pressure conditions. If so, parameters obtained when these topographies are fitted onto the model  14  can be more reliably refined and used with increased precision to obtain a more accurate diagnosis. 
         [0024]    In  FIGS. 5 and 6 , superposed graphs are shown for the biomechanical stresses ( FIG. 5 ) and strains ( FIG. 6 ) that are respectively expected for a healthy eye  20  and for a keratoconic eye  20 . Specifically, the dimpled line  62  in  FIG. 5  is indicative of stress changes in the cornea  22 , relative to latitude, for a healthy eye  20 . On the other hand, the solid line  64  is indicative of stress changes for a keratoconic eye  20 . Similarly, the dimpled line  66  in  FIG. 6  is indicative of strain changes in the cornea  22 , relative to latitude, for a healthy eye  20 . And, the solid line  68  in  FIG. 6  is indicative of strain changes for a keratoconic eye  20 . As intended for the present invention, the data  60  is compared (see block  58  of chart  40  in  FIG. 4 ) by the computer  12 . Depending on any correspondence in this comparison with the graphs shown in  FIGS. 5 and 6 , a determination can be made for the purpose of diagnosing whether the eye  20  is keratoconic. 
         [0025]    While the particular Finite Element Model of a Keratoconic Cornea as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.

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