Abstract:
A new and novel method for determining post procedural treatment is disclosed herein. In one embodiment, a method for a treating a patient following a surgical procedure on at least one eye comprises determining a depth at which the surgical procedure is to be performed or was performed, and providing instructions for administering medication for a length of time to the at least one eye of the patient, the length of time based at least in part upon the depth.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. application Ser. No. 11/253373 filed on Oct. 19, 2005, entitled “Mazaheri Lasik Method for Visual Enhancement,” the entire contents of which are incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure is directed, in general, to a surgical procedure and post-operative treatment and, more particularly, to customized post-operative treatment protocol following a surgical procedure to improve the visual acuity of a patient. 
       BACKGROUND 
       [0003]    There are a number of types of photorefractive surgical procedures now being used for vision correction. Included among these procedures is LASIK (Laser-Assisted In Situ Keratomileusis). LASIK is a procedure used to permanently change the shape of the cornea with an Excimer laser. A flap is cut in the cornea and folded back revealing the stroma, which is the middlesection of the cornea. Pulses from a computer-controlled Eximer laser are used to ablate or vaporize a portion of the interior of the stroma and reshape the corneal tissue. The flap is then replaced over the reshaped area to conform to the new corneal shape. 
         [0004]    Some patients, however, are not suitable candidates for LASIK. Those patients that have extremely thin corneas are better served using a procedure other than LASIK. Advanced surface ablations techniques provide a suitable alternative in such cases. These techniques involve the removal of the very surface layer of the cornea, known as the epithelium, and lasering the exposed corneal bed. This keeps the laser from ablating or vaporizing too deep into the tissue of the cornea and reduces the risk of ectasia, or de-stabilization of the cornea. 
         [0005]    Both LASIK and the various surface ablation techniques can be grouped under the general umbrella of laser eye surgery, but each is a little different with respect to their advantages and disadvantages. The great advantage of LASIK over a surface ablation technique, is that, as soon as the flap created during the LASIK procedure is replaced, the cornea begins to heal and will naturally seal itself to the rest of the cornea. This greatly speeds the overall healing process when compared to surface ablation techniques, which leaves the reshaped area generally more exposed or open. With surface ablation, improvement is more gradual and the eye may take a few days or even a month or two to stabilize. In general, most surgeons prefer LASIK except for patients with thin corneas, in which case a surface ablation technique is preferred. Patient satisfaction is another reason surgeons prefer LASIK, because the patient can quickly see clearly and his or her anxiety is significantly reduced. 
         [0006]    Several potential problems are inherent in LASIK. The three most common problems are: (1) under correction, where not enough tissue is removed during the procedure; (2) over correction, where too much tissue is removed during the procedure; and (3) wrinkling of the corneal flap, where a small fold or wrinkle occurs during replacement which causes a small blurry area in the patients vision. In most cases each of these problems can be easily corrected with a second surgical procedure. Of course, if the under or over correction is very slight, the surgeon will most likely advise against any attempt to refine the patient&#39;s vision any further. In fact, many recipients of laser eye surgery, although they may never achieve normal vision, view the procedure as a success if they are able to achieve a significant reduction in their corrective-lens prescription. 
         [0007]    In addition to the more common surgical type of problems listed above, there is also a potential for certain side effects to occur with respect to LASIK. Such side effects include dryness, blurred vision, halos around lights, increased light sensitivity, diffuse lamellar keratitis, torn flaps, incomplete flaps, and even double vision. There is also a chance that damage or scarring to the cornea can occur with the resultant partial or complete loss of vision. 
         [0008]    Accordingly, what is needed in the art to overcome the problems set forth above is a procedure that combines the benefits of LASIK with a surface ablation technique along with an appropriate post-operative treatment. 
       SUMMARY 
       [0009]    The present disclosure provides methods for performing refractive correction on a patient&#39;s eyes and methods for treating a patient following a surgical procedure, such as refractive correction, on at least one eye. In one embodiment, a method for a treating a patient following a surgical procedure on at least one eye comprises determining a depth at which the surgical procedure is to be performed or was performed, and providing instructions for administering medication for a length of time to the at least one eye of the patient, the length of time based at least in part upon the depth. 
         [0010]    In another embodiment, a method for treating a patient needing correction on at least one eye comprises performing a surface ablation corrective procedure on a corneal surface of one or more of the patient&#39;s eyes. The method further includes determining a depth at which the performing the surface ablation is to be performed or was performed, and providing instructions for administering medication for a length of time to the one or more of the patient&#39;s eyes, the length of time based at least in part upon said depth. 
         [0011]    In yet another embodiment there is disclosed a treatment protocol for a patient following a surgical procedure on at least one eye at a depth. The treatment protocol comprises determining a length of time for post-operative treatment based on the depth, the length of time including at least a first, second, third, and fourth interval; determining a medicine dosage and frequency for each of the first, second, third, and fourth intervals based on the depth; and instructing the patient to administer the medication according to the determining medicine dosage and medicine frequency. The medicine frequency may vary and decrease for each of the first, second, third, and fourth time intervals. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    For a more complete understanding of the disclosure, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which: 
           [0013]      FIG. 1  illustrates a cross sectional view of a human eye showing its major components; 
           [0014]      FIG. 2  illustrates a representational cross-sectional view of a cornea of an eye showing its layers; 
           [0015]      FIG. 3  illustrates a flow chart of an embodiment of a method for performing refractive correction of a patient&#39;s eyesight in accordance with the present disclosure; 
           [0016]      FIG. 4  illustrates a flow chart of the perform surface ablation of non-dominate eye step, as illustrated in  FIG. 3 , wherein an epithelium flap is formed before surface ablation; 
           [0017]      FIG. 5  illustrates a cross-sectional view of a patient&#39;s non-dominant eye on which surface ablation is performed in accordance with the present disclosure; 
           [0018]      FIG. 6  illustrates a cross-sectional view of a patient&#39;s non-dominant eye where an epithelium flap is formed prior to performing surface ablation in accordance with the present disclosure; 
           [0019]      FIGS. 7A-7C  illustrate the reshaping of a corneal stroma of a patient&#39;s dominant eye in accordance with the present disclosure; and 
           [0020]      FIG. 8  is a chart illustrating an example of post-procedural treatment protocol in accordance with the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    Referring initially to  FIG. 1 , illustrated is a cross sectional view of a human eye  100  showing its major components. As light enters the eye it first passes through a lubricating tear film that coats the cornea  110 , which covers the front of the eye  100  and helps to focus incoming light. After light passes through the cornea  110  it travels through a clear, watery fluid called the aqueous humor  120 . The aqueous humor  120  circulates throughout the front part of the eye  100 , maintaining a constant pressure inside the eye  100 . The amount of light permitted to enter the eye  100  is controlled by the iris  130 , which is the colored part of the eye. As light conditions change, the iris  130  may dilate to make the pupil  135  bigger or constrict to make the pupil  135  smaller to allow more or less light into the eye  100 . After light travels through the pupil  135 , it must pass through the lens  140 . Much like the lens of a camera, the human lens  140  is responsible for focusing light by changing its shape to focus on nearby or distant objects. After the light is focused by the lens  140 , the light passes through the center of the eye  100  on its way to the retina  150 . The center of the eye  100  is filled with a clear, jelly-like substance called the vitreous  160 . The retina  150  is a thin, light-sensitive tissue lining the back of the eye  100  on which the light must be properly focused. The surface of the retina  150  must be flat, smooth, and in good working order to produce a clear image. At the back of the eye  100  is the optic nerve  170 , which is a bundle of nerve fibers that carries visual information from the eye  100  to the brain. Protecting the inner workings of the eye  100  is a tough, fibrous tissue called the sclera  180 . This is the white part of the eye  100 . 
         [0022]    Turning now to  FIG. 2 , illustrated is a representational cross-sectional view of a cornea  200  of an eye  100  showing its layers. As those of ordinary skill in the pertinent art will readily understand, neither the drawing nor the depicted layers are to scale. The purpose is to illustrate the relative positions of the various layers with respect to each other in order to facilitate an understanding of the present disclosure. The cornea  200  is a transparent, dome-shaped window covering the front of the eye  100  and is a powerful refracting surface, providing about two-thirds of the eye&#39;s  100  focusing power. Thus, the focal length of the eye  100  can be significantly changed by means of a surgical alteration of the shape of the cornea  200 . The adult cornea  200  is about one-half a millimeter thick and is comprised of five layers: epithelium  210 , Bowman&#39;s membrane  220 , stroma  230 , Descemet&#39;s membrane  240  and the endothelium  250 . 
         [0023]    The epithelium  210  is the cornea&#39;s  200  outermost region, comprising about ten percent of its thickness. It is about 5-6 cell layers thick and quickly regenerates when the cornea  200  is injured. If the injury penetrates more deeply into the cornea  200 , it may result in scarring and leave opaque areas, causing the cornea  200  to lose its clarity and luster. Bowman&#39;s membrane  220  lies just beneath the epithelium  210  and, because is tough and difficult to penetrate, protects the cornea  200  from injury. Once injured, however, Bowman&#39;s membrane  220  can scar as it heals. If these scars are large and centrally located, some vision loss can occur. 
         [0024]    Beneath Bowman&#39;s membrane  220  is the stroma  230 , which makes up about ninety percent of the thickness of the cornea  200 . The thickness of the stroma  230  offers the best opportunity to surgically improve a patient&#39;s vision. Beneath the stroma  230  is Descemet&#39;s membrane  240 , a thin layer of very strong tissue that serves as a protective barrier against infection and injuries. Finally, underlying Descemet&#39;s membrane  240  is the endothelium  250 , which is only one cell layer thick. 
         [0025]    When an individual&#39;s eye  100  is focusing on an object, if the eye  100  is too short or the lens  140  is too flat or inflexible, the light entering the eye  100 , particularly those from nearby objects, will not be focused by the time it strikes the retina  150 . This is called farsightedness, or hypermetropia. In the case of eyeglass wearers, convex lenses are used to correct the problem. If the eye  100  is too long or the lens  140  is too spherical, the image of distant objects is brought to a focus in front of the retina  150  and is again out of focus. This condition is known as myopia and is corrected, in the case of eyeglass wearers, by prescribing eyeglasses with concave lenses to cause a divergence of the light rays before they enter the eye  100 . 
         [0026]    To overcome these types of vision problems, the focal length of the eye  100  can be modified by surgically changing the shape of the eye. This is done by reshaping the cornea  110 , usually with a laser although it can also be done using other techniques, such as making radial cuts with a knife. Several different types of surgical techniques for vision correction are well known, all of which have their own advantages and disadvantage. The present disclosure introduces a new and novel surgical technique that minimizes some of the disadvantages of these other techniques. 
         [0027]    Turning now to  FIG. 3 , illustrated is a flow chart of an embodiment of a method  300  for performing refractive correction of a patient&#39;s eyesight in accordance with the present disclosure. The method commences with a start step  310 . In a determine dominant eye step  320 , the patient&#39;s dominant eye is determined, which also means that the non-dominant eye is determined. Of course, as will be readily understood by those skilled in the pertinent art, during the course of determining the patient&#39;s dominant and non-dominant eye other determinations are also being made with respect to the patient, including a determination of how much of a surgical correction can and needs to be made to improve the patient&#39;s vision. 
         [0028]    In a perform surface ablation on non dominant eye step  330 , a surface ablation corrective procedure is performed on the corneal surface of the patient&#39;s non-dominant eye. Such correction, for safety measures and at the option of the surgeon, may be an under correction in order to avoid any complications that could be caused by an over correction. While conducting the perform surface ablation on non-dominant eye step  330 , the surgeon will also be able to make a more accurate assessment of whether the patient suffers from an epithelial or Bowman membrane disease that will impede healing or cause in-growth. As will be understood by those of ordinary skill in the pertinent art, a laser device will be used to perform the surface ablation on non-dominant eye step  330 . Although present technology calls for the use of a laser device, it is the intent of the present disclosure to cover other now known or later discovered technologies by which the present disclosure may be implemented, even if such technologies do not use or contemplate the use of a laser device. 
         [0029]    In a reshape corneal stroma of dominant eye  340 , the stroma is reshaped to provide the requisite visual correction. 
         [0030]    This step includes, a make lamillar cut to create a flap step  341 , wherein a micro-kerotome, or other cutting instrument, is used to make a lamillar circular incision in the corneal surface of the eye while leaving an edge attached to create a flap. This incision cuts through the epithelium  210  and Bowman&#39;s layer  220  and into the outer surface of the stroma  230 . The flap is then folded back in a fold flap back step  342  to reveal the interior portion of the corneal stroma  230 . In an ablate corneal stroma step  343 , a portion of the stroma  230  is ablated to produce the desired vision correction. Of course, as will be understood by those skilled in the pertinent art, the ablation will most likely be done using a laser device, although the present disclosure is intended to be applicable to other ablation techniques, whether now known or subsequently discovered. If a laser device is being used, those skilled in the pertinent art will also understand that the laser device may one of several different types with different computer operating systems. After the surgeon has completed ablation of the stroma  230 , the corneal flap is replaced by folding it back into place in a replace corneal flap step  344 . The method concludes with an end step  350 . 
         [0031]    The forgoing method or procedure can be usefully employed to correct myopic vision as well as hypermetropia. The method can also be utilized to reshape the cornea to correct certain types of astigmatism. The described technique also has the added benefit of permitting the surgeon to enhance the refractive correction on the patient&#39;s dominant eye, which enhancement can be achieved by a further reshaping of the corneal stroma. 
         [0032]    Turning now to  FIG. 4 , illustrated is a flow chart  400  of the perform surface ablation of non-dominate eye step  330 , as illustrated in  FIG. 3 , wherein an epithelium flap is formed before the surface ablation. This procedure is identical to that illustrated in  FIG. 3 , except for the following described refinement to the perform surface ablation on non-dominant eye step  330 . The perform surface ablation step on non-dominate eye step  330  includes a start step  331  followed by a cut to epithelium depth to form an epithelium flap step  332 . Following the cut to epithelium depth to form epithelium flap step  332 , in a fold back epithelium flap step  333 , the epithelium flap is folded back to expose the surface of the corneal stroma. Then in a perform surface ablation on stroma step  334 , surface ablation is performed on the stroma by the surgeon to effect a vision correction. Then in a replace epithelium flap step  335 , the epithelium flap is folded back. This refinement of the perform surface ablation on the non-dominant eye step  330  concludes with an end step  336 . 
         [0033]    Turning now to  FIG. 5 , illustrates a cross-sectional view of a patient&#39;s non-dominant eye  500  on which surface ablation is performed. The cornea  510  of the non-dominant eye  500  is subjected to in-situ surface ablation to modify the curvature of the cornea  510  to a value determined by the surgeon. The ablation is performed with a laser device or any other method suitable for the removal of tissue with the parameters defined by the surgeon. In this procedure, the epithelium and Bowman&#39;s layer are removed. 
         [0034]    Turning now to  FIG. 6 , illustrates a cross-sectional view of a patient&#39;s non-dominant eye  600  where an epithelium flap  610  is formed prior to performing surface ablation in accordance with the present disclosure. In this embodiment, a cut is made through the epithelium layer of the eye to form a flap  610 . The flap  610  is folded back to expose the stroma surface  620 . The stroma surface  620  is then subjected to in-situ surface ablation  630  to modify the curvature to a value determined by the surgeon. As noted previously, ablation is performed using a laser device or any other method suitable for the removal of tissue within the parameters defined by the surgeon. After completion of in-situ surface ablation  630  to modify the stroma surface  620 , the epithelium flap  610  is replaced. In this procedure, the epithelium layer is retained. 
         [0035]    Turning now to  FIGS. 7A-7C , illustrated is the reshaping of a corneal stroma  710  of a patient&#39;s dominant eye  700  in accordance with the present disclosure. The reshaping includes making a lamillar cut using a kerotome or other suitable surgical instrument in the surface of the cornea of the dominant eye  700  to create a flap  720 . The flap  720  is then folded back to reveal the mid-section of the corneal stroma  710 . The corneal stroma  720  is then subjected to ablation to modify the curvature to a value determined by the surgeon. Again, as previously noted, ablation is performed using a laser device or any other method suitable for the removal of tissue within the parameters defined by the surgeon. After ablating a portion of the corneal stroma  710 , the flap  720 , which includes both the epithelium and Bowman&#39;s layer, is replaced over the corneal stroma  710 . 
         [0036]    An advantage of the above-described technique is that the surgery can be productively enhanced. The healing of the dominant eye  700  is usually quite rapid. If the surgeon needs to enhance the correction, the flap  720  can be lifted again or cut anew and the shape of the interior portion of the corneal stroma  710  can be further refined. 
         [0037]      FIG. 8  provides a chart illustrating an example of a post-operative (post op) treatment protocol that may be used following surgery. After surgery, an anti-inflammatory medication is often prescribed to be administered by drops into the treated eye, such as, for example, ophthalmic steroids. While traditional protocols included a general prescription amount of medication, the present disclosure provides a treatment protocol customized according to several factors, including, but not limited to, the patient&#39;s age, depth of treatment (e.g., cut) in the eye, and the time of administration of the medicine relative to the surgical procedure. 
         [0000]      FIG. 8  illustrates one example of post-operative treatment protocol, wherein the length of post-operative treatment, medicine dosage and/or frequency are based on the depth at which a patient&#39;s eye is going to be or was treated, such as, for example, an ablation depth on an eye needing refractive correction. In certain embodiments the depth is determined prior to the procedure, for example by way of preparation, and in other embodiments is determined during the procedure itself. The procedure, among others covered, includes a surface ablation corrective procedure on a corneal surface of one or more of a patient&#39;s eyes. By customizing a treatment plan based on the depth (e.g., ablation depth), the outcome of the procedure, post-operative pain, and healing time are improved over traditional post-operative treatment protocols. For example, a patient with an ablation depth of 20 microns, might be prescribed ophthalmic steroids, such as LOTEMAX® eye drops, for a period of 2.5 months, or about 10 weeks after surgery. For the first three weeks, the prescription might call for 1 drop, four times per day. For the next three weeks, the prescription might call for 1 drop, three times per day. For the following three weeks, the prescription might call for 1 drop, twice per day, and the last week of treatment will be prescribed 1 drop, only once per day. However, if the ablation depth is deeper, such as 60-70 microns, the treatment protocol might be different, for example longer (e.g., for about 8 months after surgery). For the first 8 weeks, in this embodiment, the prescription might call for 1 drop, four times per day. For each week increment, the number of times per day for each drop might decrease by one until the final 8 weeks of treatment, during which the prescription will call for 1 drop, only once per day. In addition, for patients under 27 years of age, the surgeon may add 1 week of treatment for improved results. Similarly, for patients over 55 years of age, the surgeon may subtract 1 week from treatment. 
         [0038]    While the foregoing treatment protocol illustrates one example of a treatment protocol prescribed after an eye surgery as described in the present disclosure, the customization of post-operative treatment protocols based on a treatment depth may be applied to other types of eye treatments and procedures. Further, as surgical and medical procedures continue to evolve and new medications are developed and improved, the amount of medication and treatment time may be adjusted accordingly. 
         [0039]    While the example and description reference ophthalmic steroids, such as LOTEMAX® eye drops, other ophthalmic medications, both prescriptive and over the counter, may be used in conjunction with or as an alternative to of an ophthalmic steroid, according to the procedure performed on the eye. 
         [0040]    Although the disclosed embodiments have been described in detail, those skilled in the pertinent art should understand that they various changes, substitutions and alterations may be made in addition to the details provided in the present disclosure without departing from the spirit and scope of the disclosure in its broadest form.