Patent Application
20140002799
1. Field of the Invention
The present invention relates to the field of vision correction and, more particularly, to methods and systems for providing customized vision correction, and business methods associated with providing such correction. The methods and systems employ a free form custom manufacturing process to form a custom contact lens.
2. Description of Related Art
A large portion of the population is ametropic; i.e., their vision is less than optimum due at least in part to refractive abnormalities of the eye. For over 100 years, practitioners ranging from lens fitters to surgeons have engaged in the business of providing vision correction to the ametropic population, as technology permitted, through spectacles, contact lenses, intra-ocular lenses (IOLs), inlays and onlays.
Many visual defects, also commonly known as aberrations, may arise from refractive abnormalities that have an adverse impact on imaging properties of an eye. Multiple orders of aberrations that may affect vision can be described using a variety of mathematical models, an example of which are Zernike coefficients. In the recommended Zernike formulation, each Zernike coefficient gives the root-mean-square (RMS) wavefront error (in microns) contributed by the particular Zernike mode and the overall RMS error is given by the square root of the sum of the squares of the individual coefficients. A set of Zernike coefficients thus gives detailed information on the relative and absolute importance of the different aberrational defects of any particular eye for the specified conditions of measurement. In the Zernike description, first-order polynomials describe wavefront tilt (i.e., prismatic effects) and have no effect on image quality. Second-order polynomials describe the sphero-cylindrical errors of focus which can normally be negated by optical corrections, such as spectacles or contact lenses. The third-order modes include vertical and horizontal primary coma, and the fourth-order primary spherical aberration.
While spectacles, contact lenses, and the like generally help people see better, they do not and cannot correct all refractive error. For example, although many lens products on the market today correct for some of the more commonly known low to mid order aberrations such as myopia, hyperopia, and astigmatism, they do not address higher order aberration vision correction such as coma, trefoil, and higher order sphere due to current manufacturing process limitations.
Surgical treatment such as LASIK has been successful in addressing correction of some high order aberrations. However, such treatment may put the patient at risk and often can lead to other visual limitations such as glare, reduced nighttime vision, dry eye and myopia.
Technologies are being developed and refined in an attempt to address the aforementioned issues. For example, U.S. Pat. No. 6,499,843 to Bausch & Lomb Incorporated discloses a method for providing vision correction to a patient that includes engaging the patient in a practitioner's facility; obtaining a wavefront aberration measurement of an eye of the patient; providing the wavefront aberration measurement to a custom lens supply platform in a form suitable for input to the custom lens supply platform; producing a customized lens via the custom lens supply platform according to data associated with the wavefront aberration measurement; and providing the custom lens to the patient or the practitioner. U.S. Pat. No. 6,499,843 discloses that the custom lens supply platform provides for manufacturing the appropriate custom lens preferably, but not necessarily, at a location remote from the practitioner's facility by the then known manufacturing methods, including, for example, a lens laser ablation system, a lens lathing system, and a lens cast-molding system.
Laser ablation works by directing the output of a high-power laser, by computer, at the material to be cut. The material then either melts, burns, vaporizes away, or is blown away by a jet of gas. Lenses derived from laser ablation are limited in that an increase in the cuts that have to be made to obtain a desired shape results in a decrease in the optical quality of the lens.
In direct lathing, the back curve and the front surface of a lens button are machined. Lathing is time consuming and lenses derived from lathing are limited to the scope of the surface available.
Cast molding utilizes front and back curve molds that are either directly machined or injection molded. The front curve and back curve mold parts are brought together to shape the lens according to desired lens parameters. A liquid lens formulation contained within the mold is cured, for example by exposure to heat and light, to form a lens. Following cure, the mold parts are separated and the lens is removed from the mold parts. Lenses derived from cast-molding are limited to the design of the mold utilized.
U.S. Pat. No. 7,905,594 to Johnson & Johnson Vision Care, Inc. discloses a method and an apparatus for forming ophthalmic lenses. The method includes positioning a substrate having an optical quality area in contact with a liquid lens formulation; transmitting actinic radiation through the substrate to polymerize a portion of the liquid lens formulation; and forming the lens, wherein the lens has a first surface portion along the optical quality area and a second surface portion that is free-formed.
All patent publications and references cited in this disclosure are incorporated by reference in their entirety herein.
Methods and systems that provide customized vision correction are desired. Preferably, such methods and systems allow patients to identify one or more contact lens products that provide more tailored vision correction than currently available contact lens products. Such methods and systems should be simple to understand and use, yet provide for patient preference and/or needs matching. The methods and systems of the present invention are particularly well suited to assist the selection of contact lens products particularly suited to provide a given patient optimum vision correction.
Methods and systems that addresses the issues and concerns identified above are set forth by the present invention.
The term “vision correction” as used in the description of the invention refers both to a measured improvement in vision over that provided by conventional refractive correction and to the subjective evaluation of “seeing better” by the patient. The term “practitioner” or “eye care practitioner” as used herein refers appropriately to anyone qualified to fit, prescribe, or dispense vision correction devices such as spectacles, contact lenses and the like, or medically attend to a patient particularly with respect to the patient's eyes.
In accordance with an embodiment of the invention, a method for providing vision correction to a patient is disclosed. The method comprises:
In accordance with another embodiment, a method for providing vision correction to a patient is disclosed. The method comprises:
In accordance with yet another embodiment, a method for providing vision correction to a patient is disclosed. The method comprises:
In the instant embodiments, the custom lens may be a contact lens, an inlay, an onlay, or an IOL. In these and the embodiments to follow, the free form custom lens manufacturing system may provide for manufacture of the appropriate custom lens at a remote manufacturing facility, on-site at a retail store, at a kiosk, in a vehicle equipped with appropriate equipment, at an eye care practitioners' office, etc.
Moreover, in these and the embodiments to follow, the bare eye data measurement, the habitual lens data measurement and the fitting lens data measurement may each be obtained by suitable means known to those skilled in the art for obtaining bare eye data measurements, habitual lens data measurements and/or fitting lens data measurements. In an aspect of these embodiments, the bare eye data measurements, the habitual lens data measurements and/or the fitting lens data measurements are obtained from the patient in the practitioner's facility; the bare eye data measurements, the habitual lens data measurements and/or the fitting lens data measurements are transmitted to a free form custom lens manufacturing system; and a custom lens is manufactured by the free form custom lens manufacturing system. In another aspect of this embodiment, practice of the invention will provide the patient with vision correction and resulting visual performance from the custom lens that is better than that which would be provided to the patient using conventional means.
Another embodiment of the invention provides a method for vision correction including engaging the patient in a practitioner's facility; obtaining a bare eye data measurement and/or a habitual lens data measurement and/or a fitting lens data measurement of the patient's eye; and providing a display of either a picture, a computer simulation or a graphic display. In a preferred aspect of this embodiment, the display is in a form that allows the patient to make a subjective evaluation of the product options which will lead to the subjective evaluation of better vision. A related aspect involves transmitting the bare eye data measurement, the habitual lens data measurement and/or the fitting lens data measurement to a free form custom lens manufacturing system in a form readable by the free form custom lens manufacturing system for producing a custom lens.
In a related embodiment, obtaining the bare eye data measurement, the habitual lens data measurement and/or the fitting lens data measurement and patient information and presenting the simulated display of custom lens options to the patient may be accomplished automatically outside of a practitioner's facility, in similar fashion, for example, to obtaining blood pressure readings from devices located in supermarkets, at the workplace, at home, etc. The desired information could then be transmitted automatically to a practitioner (e.g., for diagnostic purposes) or to a free form custom lens manufacturing system for making lenses for the patient if desired.
In another related embodiment, a method for providing vision correction to a patient involves measuring an ocular characteristic of the patient's eye, either by a practitioner in the practitioner's facility or remotely without practitioner intervention. The measurement includes topography data and/or wavefront aberration data. This measured data is evaluated and the evaluation produces an option matrix that compares, among other things, prospective vision correction as a function of a prospective eye treatment, cost of treatment options, etc. Based upon the evaluation, the patient can select his/her treatment option, and lens manufacturing can occur automatically upon selection.
It will be appreciated by those skilled in the art that any data transmission referred to above could be in the form of telecom or datacom, and could be sent via wire-based (optical fiber, cable, etc.) or wireless services. A preferable interface would be Internet based.
Other features and advantages of the present invention will be apparent from the detailed description of the invention and from the claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the description, serve to explain the objects, advantages and principles of the invention.
As used herein, “bare eye data” means the data and information taken of a patient's eye when the patient is not using any vision correction devices. A series of exams can be performed to collect bare eye data, including, e.g., a physiology exam, a topographical exam, a wavefront exam, and a refraction exam.
As used herein, “custom product” means a product having one or more parameters that are not ordinarily available in products employing standard settings.
As used herein, “DMD” or “digital micromirror device” means a bistable spatial light modulator consisting of an array of movable micromirrors functionally mounted over a CMOS SRAM. Each mirror is independently controlled by loading data into the memory cell below the mirror to steer reflected light, spatially mapping a pixel of video data to a pixel on a display. The data electrostatically controls the mirror's tilt angle in a binary fashion, where the mirror states are either +X degrees (on) or −X degrees (off). For current devices, X can be either 10 degrees or 12 degrees (nominal). Light reflected by the on mirrors then is passed through a projection lens and onto a screen. Light is reflected off to create a dark field, and defines the black-level floor for the image. Images are created by gray-scale modulation between on and off levels at a rate fast enough to be integrated by the observer.
As used herein, “DMD script” means a control protocol for a spatial light modulator and also to the control signals of any system component, such as, for example, a light source or filter wheel either of which may include a series of command sequences in time.
As used herein, “DMD start show” means a collection of time based instructional data points that may be used to control activation of mirrors on a DMD to enable a lens to be fabricated. DMD start shows may contain data associated with a regularly or irregularly spaced grid.
As used herein, “fiducial marks” are marks employed for reference or comparison. Fiducial marks enable the determination of orientation, rotation, centration and movement of a lens. Details regarding contact lenses with fiducial marks can be found in U.S. Published Application No. 20110025979.
As used herein, “fiducialized lens” means a lens that contains one or more features that assist with determining orientation, rotation, centration, and movement of the lens. A fiducialized lens may contain fiducial marks on the lens. It may also be a lens with edge features that are detectable optically, for example, a non round lens, or a lens with notches in the edge.
As used herein, “fitting lens” means a standard, preferably stabilized contact lens that is designed to aid a manufacturer in designing a custom lens. The fitting lens may have stability and measuring points incorporated in the lens to assist with measuring the rotational position of the lens and the decentration of the eye in relation to the patients eye.
As used herein, “fitting lens data” means the data and information taken of a patient's eye when the patient is using a fitting lens vision correction device. A series of exams can be performed to collect fitting lens data, including, e.g., a physiology exam, a topographical exam, a wavefront exam, and a refraction exam.
As used herein, “fixing radiation” means actinic radiation sufficient to one or more of: polymerize and crosslink essentially all fluent lens reactive media.
As used herein, “free form” means surface that is formed by crosslinking of a lens reactive mixture and is not shaped according to a cast mold.
As used herein, “habitual lens” means a lens worn by the patient on a regular basis, e.g., daily.
As used herein, “habitual lens data” means the data and information taken of a patient's eye when the patient is using a habitual lens vision correction device. A series of exams can be performed to collect habitual lens data, including, e.g., a physiology exam, a topographical exam, a wavefront exam, and a refraction exam.
As used herein, “hardware-based” means interaction to reach information contained, formulated, and delivered entirely via non-electric or electronic means. Hardware can be static (i.e., a flow chart or matrix chart), or dynamic (i.e., one or more dials, slides, drums, or the like, moved into a particular arrangement or place so as to produce one or more instructions or selections for the user).
As used herein, “fluent lens reactive media” means a reactive mixture that is flowable in either its native form, reacted form, or partially reacted form and is formed upon further processing into a part of an ophthalmic lens.
As used herein, “mechanical choices” means those choices that are visible or tangible. Mechanical choices may include base curve, diameter, center thickness, and stabilization profiles.
As used herein, “metrology” includes both theoretical and practical aspects of measurement and “metrology equipment” includes equipment capable of measuring optical and material characteristics of materials.
As used herein, “optical choices” means those choices most beneficial to improving a patient's vision. Optical choices may include low order optical aberration correction (e.g., 2nd order, 3rd order), custom low to mid order optical aberration correction (e.g., 4th order, 5th order), and custom mid to high order optical aberration correction (e.g., 6th order, 7th order).
As used herein, “physiology exam” means an exam that observes the physical appearance of the eye. Physiology exam includes, but is not limited to, a glaucoma test (e.g., tonometry test, ophthalmoscopy, optic nerve computer imaging techniques, etc.), a retinal exam (e.g., ophthalmoscopy, papillary dilation test, optomap retinal exam, etc.), checking for ulcers, a tear production test to check for dry eye syndrome (e.g., Schirmer test), checking for eye infections, etc.
As used herein, “refraction exam” means an exam wherein a patient's vision is refracted using a device that contains hundreds of combinations of lenses to determine any possible refractive error such as nearsightedness, farsightedness, astigmatism, or presbyopia. An over-refraction exam is where a similar exam is taken but with the patient wearing a contact lens.
As used herein, “software-based” means interaction to reach information contained, formulated, and delivered with devices in which one or more are electric or electronic in construction and require software code for operation. The software can be locally installed into one or more devices or remotely located.
As used herein, “store-based” means an interaction between the patient and information utilizing devices or information source elements occurring at the point of purchase (e.g., practitioner's office, pharmacy, retail store, on-line, kiosk, mobile van, etc.).
As used herein, “topographical exam” means an exam that looks at the surface features of an eye. Topographical exam includes, but is not limited to, curvature of a cornea and surface of a retina, which may help in determining certain characteristics such as: base curve measurement of a patient's eye, limbal measurements, pupil size, line of sight measurement, pupil center measurement, geometric center measurement, etc.
As used herein, “wavefront exam” means an exam that looks at the way that the light travels in an eye. A wavefront exam, which may be performed with an aberrometer, creates an optical aberration map, which is sometimes called an “optical fingerprint”, and identifies optical aberrations or distortions of a patient's eye (e.g., low order, medium order, high order, Zernike, other functions or descriptors, etc.). Examples of low order optical aberrations include nearsightedness, farsightedness, and astigmatism. Examples of high order optical aberrations include coma, trefoil, and spherical aberration.
As used herein, “web-based” means an interaction between a practitioner and/or a patient and information based on communication, either in near real time or by delayed transmission, between two points, in which this connection uses in part the Internet, commonly referred to as the World-Wide-Web, where a practitioner and/or a patient is at one of the points. The practitioner and/or the patient located point can be a store or non-store location (i.e., home or office) for such a web-based interaction.
Certain information regarding a patient may be used to assist the patient in the selection of a contact lens product. The method of the present invention centers on the ability to properly identify the needs and preferences of a patient and to match these needs and preferences with an appropriate contact lens product.
Specifically, certain pieces of information regarding the patient can be used to assist the patient in the selection of contact lens products that is/are particularly adapted to satisfy the patient's needs and preferences. The methods and systems of the invention can increase the acceptance of such products by patients compared to self-selection without use of such methods and systems.
In accordance with the invention, a free form custom lens manufacturing system where a custom lens based upon the bare eye data, habitual lens data and/or fitting lens data can be made and packaged for delivery to the practitioner or the patient is provided. According to an embodiment, diagnostic equipment is designed to automatically output the appropriate information in suitable form for the free form custom lens manufacturing system. The patient data is such that it can be converted into data that can be used to create a desired lens profile. The information can be transmitted via the Internet, however, any supporting transmission mode and transmission medium can be used. For example, the information can be transmitted by, e.g., computer, mail, wireless device, telephone, or any other modes imaginable that may be used for data transmission. Manufacture can take place at the practitioner's office or remotely. Lens design and DMD script creation can also take place at the practitioner's office or remotely.
The free form custom lens manufacturing system is suitably equipped to produce an appropriate custom lens. Accordingly, a custom contact lens, a custom inlay, a custom onlay, or a custom IOL can be made. A specific quantity of custom lenses, e.g., contact lenses, may be produced for the patient so as to be used over an extended period of time. The lenses will preferably be packaged in a customized manner for the patient. The package can then be delivered to the patient or practitioner as appropriate.
In an aspect of the embodiment, the patient is shown, to the extent possible, what their improved vision could be as provided by one or more custom lenses as compared to no vision correction and/or currently available lenses.
Vision diagnostic information, including wavefront measurement data, personal history, practitioner information and whatever other information may be useful for constructing or maintaining one or more databases for future use is collected. The vision diagnostic information is sent via the internet to a service platform that illustratively includes an information storage server, a lens design interface, and a lens manufacturing interface. Lens design and manufacturing information is sent to and received by a custom lens platform Custom lens information is used by lens platform to produce custom packaged lens products for the patient which can be shipped to the patient at home, for example, or to the practitioner's office for fitting and/or delivery to the patient. Certain ocular characteristics of the patient will be measured, preferably wavefront aberration and possibly, in conjunction therewith, topography measurements will be obtained. The evaluation may be in the form of an option matrix so to speak wherein information about prospective vision correction and cost, among other things, can be compared against different types of eye treatment or no treatment at all. An eye treatment option can then be selected by the patient and/or the practitioner, and upon selection, the appropriate information such as wavefront aberration data, for example, can be automatically sent to the appropriate platform (in the illustrated case, a free form custom lens manufacturing system for processing.
The lens may be formed in accordance with the method disclosed in U.S. Pat. No. 7,905,594. In accordance with this method, patient's lens parameters are input into a computer or other processor; the computer or other processor executes an algorithmic calculation to correlate the lens parameters to a lens to be produced; a DMD script based on the parameters is communicated to a DMD; the DMD controls transmission of actinic radiation to a reactive mixture; and a portion of the volume of the reaction mixture is polymerized to form the lens.
In another embodiment of the invention for providing vision correction to a patient, the patient situates himself in a practitioner's office. At the office, a diagnostic lens is selected and fitted to the eye. The diagnostic lens will be of similar design to that which will eventually be prescribed as the custom contact lens.
In a further embodiment according to the invention, a patient may engage herself with a diagnostic platform including a bare eye data measuring device, without initial practitioner intervention, that is located as a stand-alone platform. The device would be equipped with telecom or datacom capability to accept input and transmit output regarding patient data, ordering data, etc. to an appropriate respective platform. In addition, the diagnostic platform would be capable of providing the bare eye data aberration and, preferably, correction information in a display format suitable for subjective evaluation by the patient. If so desired, the patient could direct the diagnostic platform to transmit the information to a practitioner and/or to a free form custom contact lens manufacturing system where a supply of custom contact lenses could be manufactured and packaged, and shipped to the patient or the patient's practitioner.
In cases where it is determined that modification of the wet lens design may be necessary, an off eye wet lens design may be generated 110 and a manufacturability assessment may be conducted 111. A new design may be wrapped to an eye and a simulation of on-eye performance may be shown to the patient and practitioner. In cases where the modified design simulated performance is acceptable to the patient, at 103, the patient and the practitioner can revisit a product choice method step. In cases where a modified design simulated performance is acceptable to the patient and practitioner, modified design data may be temporarily or permanently stored in various embodiments.
A trial lens fit 112 may be performed to determine, e.g., one or more of the following: centration, rotation, and movement of the trial lens on the patient's eye 112. The trial lens fit may be done, e.g., with one or more of the following: a fiducialized lens, a non-fiducialized lens, a currently available product and a custom product. An order for a diagnostic custom lens may then be placed 113.
Referring to
Information regarding a patient's bare eye data is provided; and two or more available vision options are selected and displayed. The patient can select based on need and preference, and can optionally purchase a custom lens. In certain embodiments of the present invention, the basic steps of requesting information from a patient and selecting an appropriate option are performed in a substantially continuous, interactive process.
For example, a store display could be equipped with an interactive computer which can prompt the user to answer questions, keep track of the answers, provide new questions and/or selections based upon the answers provided, and select an appropriate classification based on those answers as described above. In alternative embodiments, the information may be collected from a patient though the use of an interactive site on the World Wide Web, an interactive menu-driven phone system, and the like. Charts, tables or other figures may be used as devices for requesting information from a patient and taking the patient through the preference process as described above. Similarly, charts, figures, and the like, can be distributed via e-mail, or via a network such as the World Wide Web, and the like.
It is also possible for information regarding the selection of vision correction options in accordance with the methods of the present invention to be distributed to eye care practitioners, merchants, or other persons and/or places likely to be engaged in the recommendation, retail sale, promotion, distribution, giveaway, or trade of eye care products. The interaction described in the present application could take place between a patient, a patient's caretaker, a patient's parent, a patient's eye care practitioner, merchant, or other person engaged in the sale of eye care products. Further, selection may occur proximate to a display case containing one or more of the vision correction options available within each of any available classifications.
The foregoing examples are not intended to limit the scope of the present invention, which may be set out in the claims. In particular, various equivalents and substitutions will be recognized by those skilled in the art in view of the foregoing disclosure and these are contemplated to be within the scope of the invention.
This application is a Non-Provisional of U.S. Ser. No. 61/664,963 filed Jun. 27, 2012. The complete disclosure of the aforementioned related U.S. patent application(s) is hereby incorporated herein by reference for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 61664963 | Jun 2012 | US |
