• 专利附录
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    • 专利摘要:
    Eye surgery device (1) with - a control device (3); - A user interface (5), which is at least temporarily in data communication with the control device (3); - a first measuring device (9) which is suitable and intended to determine intraoperatively at least one value (W1) which is characteristic of a surgical eye to be treated, - a second measuring device (7) which is suitable and intended for this purpose, to determine preoperatively and / or intraoperatively at least one value (W2) which is characteristic for the eye to be treated surgically, and with a first arithmetic unit which is suitable and intended for this purpose, using the intraoperatively determined value (W1) and also preoperatively and / or intraoperatively determined value (W2) to determine at least a first output value (A1) characteristic of at least one intraocular lens (IOL) to be selected, the user interface at least preferably having an output device for outputting the output value (A1) or a derived value is suitable.
    公开号:CH711513B1
    申请号:CH00170/17
    申请日:2015-08-14
    公开日:2019-07-31
    发明作者:Seesselberg Markus；Wilzbach Marco
    申请人:Zeiss Carl Meditec Ag；
    IPC主号:
    专利说明:

    Description [0001] The present invention relates to an ophthalmic surgery device and to a selection method for selecting a lens, and more particularly an intraocular lens. Many methods and devices are known in the art which serve to improve ocular surgery and in particular the use of intraocular lenses (IOL) in the eye. Thus, methods are known in which a clouded natural eye lens of a patient is surgically removed and replaced by an artificial lens (in particular an intraocular lens, IOL).
    Likewise, procedures are known in which, in addition to the remaining natural eye lens, a further lens is used to improve the vision of the eye. There are a large number of very different intraocular lenses on the market. Thus, the object of such operations is always to select a suitable type of intraocular lens of different types. These available intraocular lenses differ, for example, in terms of their refractive index, the lens material used, the radii of curvature of the lens surfaces, an axial distance of the lens surfaces, the type of haptic, the diameter and other properties.
    Furthermore, there are also different types of intraocular lenses, such as intraocular lenses with aspherical lens surfaces or lens surfaces, which are free-form surfaces without rotational symmetry. In addition, intraocular lenses with different zones or intraocular lenses with diffractive optical elements are known.
    In order for a suitable IOL to be used in a patient, it is possible to pre-select an IOL with a suitable refractive power in the case of a patient's eye in the phakic state, in order to achieve a postoperative target refraction desired by the patient in this manner. In this procedure, in particular the postoperative position of the IOL, in particular as a function of a measured capsular bag position, is predicted. The predictions can be used to better position and center the implanted IOL. Alternatively, a surgeon may be assisted in deciding whether to replace the implanted lens with an IOL that fits better into the patient's eye.
    It should be noted that initially an implantation of the IOL takes place and then - even during the operation - the eyesight of the eye is assessed. In these cases, it may be necessary to replace the IOL if the refractive power of the implanted IOL can not achieve a desired postoperative target refraction of the patient's eye. Such a change of IOL is associated with increased expense during cataract surgery. In addition, it can also be associated with medical complications. Thus, this described method is a quality control as to whether an already selected IOL also leads to the desired target refraction.
    The present invention is therefore an object of the invention to provide a device and possibly also a method available, which avoid such an exchange of the IOL and which already allow during an operation selection of an IOL to be used or an intraoperative selection enable the refractive power of an IOL, so that after implantation the desired postoperative target refraction of the eye is achieved.
    This object is achieved according to the invention by a device according to claim 1 and claim 2 and by a selection method according to claim 12. Advantageous embodiments and further developments are the subject of the dependent claims.
    An eye surgery device according to the invention has at least one control device and a user interface which is at least temporarily in data communication with the control device (i.e., at least partially can be brought into such data communication). Preferably, inputs to the control device can be input via this user interface and / or information originating from the control device or forwarded can be output. Furthermore, the eye surgery device has a first measuring device which is suitable and intended (or is designed and provided for this purpose) to determine (or to determine) intraoperatively (ie during the operation on the relevant eye) at least one value that is suitable for a surgically treated eye is characteristic.
    In addition, the eye surgery device on a second measuring device, which is suitable and intended to determine preoperatively and / or intraoperatively at least one value that is characteristic of the surgical eye to be treated.
    Preferably, the second measuring device for determining preoperative values is determined, but it would also be conceivable that only intraoperatively determined values are determined. Preferably, however, several different values are determined or determined.
    Furthermore, the eye surgery device has a first arithmetic unit, which is suitable and intended to determine at least one first output value, which is characteristic of at least one intraocular lens to be selected, using the value determined intraoperatively and the preoperatively and / or intraoperatively determined value. Furthermore, the user interface preferably has at least one output device which is suitable for outputting the output value or a value derived therefrom. This output device may be, for example, a display unit. However, this can also be designed separately or integrated in another device.
    In this case, the at least one IOL to be selected, determined by at least one first output value, preferably represents the IOL determined (in particular during the operation), which is then inserted into the eye.
    According to the invention, an eye surgery device is thus proposed by means of which the values obtained intraoperatively are used for the selection of a lens. In other words, it is conceivable that only one lens is preselected or preselected before an operation, or that no selection of a lens is made before the operation.
    Preferably, prior to surgery (i.e., preoperatively), measurements of the eye are specifically determined. Furthermore, measured values are also determined intraoperatively and then the measured values ascertained prior to the operation and the additional measured values, especially intraoperatively, are used in the aphakic eye in order to use them for the calculation, for example in order to use them in an aphotic eye model as described in more detail below. This eye model can be used in particular for modeling a refractive power of an IOL to be used or in general a lens to be used.
    However, the said measured values can also be used in a pseudophakic eye model, this eye model already containing an IOL or even the natural lens. These results of an eye model thus determined make it possible to select a suitable IOL so that the desired postoperative target refraction is reliably achieved. Thus, for example, it is possible for a user such as a physician to select an appropriate IOL not before the operation but during the operation, for example, immediately after the phacoemulsification and the detection of the measurement. Thus, within the scope of the invention, the IOL is selected intraoperatively and not preoperatively. In this way, the quality control described above can be dispensed with.
    The control device described above may preferably perceive different functions or be configured for it. Thus, this control device can be configured to read in preoperative (or preoperatively determined or measured) values determined by the (second) measuring device. In addition, it may also be configured to read in intraoperative values determined by the first measuring device. It should be noted that the first and the second measuring device can be the same measuring device, but (preferably) different measuring devices can also be used.
    In addition, the controller may also be configured to cause the user interface to represent a value that is characteristic of the intraocular lens. In addition, the control device can also be configured to cause the at least one or even both measuring devices to determine or determine intraoperative and / or preoperative values.
    Furthermore, the control device is preferably configured to cause the first computing unit to determine a value representing a refractive error of the eye. In this case, the preoperative measured values may be assigned to a first subset of the above-mentioned parameters of the model, and the intraoperative values of the eye to a second subset of the multiple parameters of the model.
    Furthermore, the controller may be configured to cause the user interface to represent the value representing deficient vision.
    In a further advantageous embodiment, the user interface has input means for inputting data. It is also conceivable that the control device is designed or configured such that it waits for a specific input of a user in the user interface, before the first and / or the second measuring device is caused, the preoperative values and / or intraoperative values determine.
    In a further advantageous embodiment, the eye surgery device may also have a removal device for removing a natural lens of the eye. In a further advantageous embodiment, the preoperative values are selected from a group of values including a value representing a surface geometry or thickness of the cornea of the eye, a value representing a distance between a corneal vertex of the eye and a retina of the eye and a value representing a distance between the corneal vertex of the eye and an eye lens of the eye. Advantageously, several of these values and particularly preferably all of these values are determined and / or taken into account.
    In addition, it is also possible for these stated values to be measured and / or output by the first measuring device.
    In addition, it would also be possible for the first measuring device to also determine a value that represents or is characteristic of a distance between a corneal vertex and an intraocular lens, and / or a value based at least on one in the cornea of the eye introduced incision, and / or a value representing a centering of an intraocular lens in the eye.
    Also, several of these values can be output. The IOL to be used can not only be monofocal but also bifocal or multifocal or have variable refractive power. Such accomodatable IOLs are known in the art. Compare e.g. Dissertation M. Bergemann: «New mechatronic system for the recovery
    Making the Accommodating Capability of the Human Eye "(2007, ISBN: 978-3-86644-136-1) pp. 20 to 21. However, it is advantageous if at the lower and upper limits of the variable lOL refractive power, a desired postoperative target refraction is achieved so that the variability of the IOL can be optimally utilized.
    In a further advantageous embodiment, the proposed device also has an optimization algorithm, and / or a module for producing an IOL. By means of such an optimization algorithm, as is known in the optimization of optical systems with software packages, the geometry of an IOL can be optimized so that the eye model provides the desired postoperative target refraction as parameter. Subsequently, this geometry data can be forwarded to a module for producing an IOL. This may be, for example, a 3D printer or a device for rotating (plastic) lenses.
    Furthermore, it would also be possible for a preselection of an IOL to be made even before an operation, and further values such as, for example, a refractive power of the lens are determined intraoperatively and, if necessary, a selection is corrected on the basis of these values.
    In a further advantageous embodiment, a first measuring device is suitable and determined to determine the first measured value on an aphakic eye. The method described here generally has the advantage that errors of a patient-specific eye model can be corrected. For example, it is generally not easily possible to determine the topography of the corneal back, which is adjacent to the aqueous humor.
    Since the actually measured refraction of an aphakic eye model is compared with the aphakic patient-specific eye model by means of the above-described device and the method described above, the influence of inaccurate measured values, such as the topography of the back of the cornea, can be eliminated. In other words, it is proposed to compare each measurement results of aphaken eyes and eye models with each other. In this way, even in difficult cases can reliably select a well-suited IOL for a patient's eye. Such cases may be, for example, eyes that have already been surgically treated, for example Lasik-treated eyes. In this case, the patient's cornea (cornea) has been modified, making preoperative lOL selection very difficult. With the procedures and devices described here and below, however, these corneal modifications can be taken into account.
    According to the invention, the device has a second arithmetic unit which is suitable and intended to determine at least one second output value using at least the intraoperatively ascertained or determined value and the preoperatively (or also intraoperatively) determined or determined value is characteristic of postoperative refractive error (or refraction) of the eye. In this embodiment, it is proposed that the arithmetic unit predicts an ametropia of the eye, in particular on the basis of a mathematical model using the values determined by measurement or also otherwise provided. In this case, this second arithmetic unit may include, for example, a computer module for predicting a postoperative refraction of the eye. In particular, the stated values are measured values or measured values.
    This computer module in turn may have a transfer means or an interface to transfer model data for the description of a patient-specific eye model as well as a computing unit which is suitable for radiation evaluation, e.g. an optical software, such as Code-V or Zemax. The data or the model data made available to the arithmetic unit can have preoperative measured values and / or also intraoperative measured values. In addition, values based on these values can also be used, for example values that are mathematically derived from preoperative and / or intraoperative data.
    In addition, it is also possible to use synthetic model data, which is or were obtained by calculation from preoperative and intraoperative data.
    These values may be, for example, a number tuple, which describes a postoperative geometry of the cornea of the patient's eye, which was preferably also obtained by means of computational simulation based on a preoperatively determined corneal geometry and intraoperatively made incisions (incisions).
    These model data of a patient-specific eye model advantageously describe in each case the associated state of the patient's eye, and the calculated parameters describe the refraction of the eye. Depending on the model data used, it is thus possible to determine the refraction of a phakic, aphakic or pseudophakic eye via the associated characteristic variables, with boundary conditions such as intraocular pressure (IOP or intraocular pressure) or also the deformation of the cornea by the lens block being preferred.
    The parameters can be used for the selection of a suitable IOL so that preferably the refraction of the patient's eye in the postoperative state comes close to the postoperative target fraction.
    The arithmetic unit preferably calculates the abovementioned values on the basis of an eye model. Both preoperatively determined (i.e., determined) values and intraoperatively determined (i.e., determined) values of the eye can be used as parameters of this eye model. On the basis of these values, a refractive error of the eye which results postoperatively can be predicted. This prediction can already be done during the procedure, i. be performed intraoperatively, so that appropriate adjustments can be made depending on the determined postoperative ametropia preferred.
    The values used by the arithmetic unit or in a corresponding method, which represent properties of the eye, and parameters of the eye model, which represent properties of the eye model, can be scalar values or even tuples, which are themselves multiple scalar values Have values. For example, the value representing the curvature of the cornea of the eye may be a radius of a sphere approximating the shape of the cornea of the eye. Likewise, this value may also be an inverse radius of this sphere. In addition, this value, particularly in the context of astigmatic refractive errors of the eye, may be a tuple of two individual values representing curvatures along different planes of the cornea. Furthermore, the value representing the curvature of the cornea may be a tuple having, for example, a plurality of zerni-ke coefficients, which in a manner known per se represent an aspheric shape of the cornea up to a predetermined order.
    The value representing the distance between the corneal vertex of the eye and the eye lens of the eye, for example, can be measured directly preoperatively. In addition, however, other provisions would be possible. For example, it would be possible to measure the distance between the corneal vertex and the retina of the eye, and subtract from this measured value the measured value of the distance between the crystalline lens and the retina.
    In this way, the tuple of the value of the distance between the corneal vertex of the eye and the retina (and possibly also the tuple from the value of the distance between the eye lens and the retina) is a value of the distance between the Corneal vertex of the eye and the eye lens represented. Furthermore, the value representing the distance between the corneal vertex of the eye and the eye lens may refer to the principal plane of the eye lens, the apex of the anterior lens surface, or the apex of the posterior lens surface, or any other physically or mathematically thought element of the lens his. This can be used to determine one of these values, which is characteristic for the distance that is relevant here.
    In a first alternative embodiment according to the invention and an advantageous embodiment of a second alternative embodiment according to the invention, the second arithmetic unit determines the output value based on a model of the eye. This means that a calculation model as described above is used, which preferably has or contains a large number of parameters. These can be preoperative as well as intraoperative measured values, preferably patient-specific measured values. In the second alternative embodiment according to the invention, this second arithmetic unit is designed such that it determines the second output value taking into account physical properties of a preselected IOL.
    This model preferably has several parameters. Furthermore, the model is based in particular on preoperatively and intraoperatively determined measured values. Furthermore, it is preferably a patient-specific model.
    So it would be possible that a specific IOL is selected in advance, but this is not yet used in the operation. On the basis of the physical (and / or optical) properties of this IOL as well as of the measured values measured, a correspondingly resulting ametropia (or a characteristic value for this purpose) is then calculated. If this ametropia is very close to a desired sight deficiency, the preselected lens can actually be used. If, however, the thus determined refractive error deviates more than desired from a target sighting ability or refractive error, can be recalculated, and conclusions can be drawn from the result, in which respect the IOL is to be modified.
    In a further embodiment, it is possible that in an aphaken state of the eye, a measurement of the back of the capsular bag is made and from the effective lens position (ELP) is determined, which determines the position of the implanted IOL in the patient's eye describes (or a future position of an implanted IOL). The ELP thus determined belongs here to the group of intraoperative model data. In addition, the eye length AL and the corneal topography can be used as preoperative model data.
    Furthermore, as a preoperative model data preferably data of a preoperatively selected IOL mentioned above are used, such as their refractive index, topography, thickness and haptics. If only the refractive power of a preoperatively selected IOL is known, it is possible to choose the refractive index, the topography and the thickness in such a way that they approximately describe the effect of this IOL. For the sake of simplicity, it is assumed for the following illustration that the patient's eye is rotationally symmetrical and an ideally suited rotationally symmetric IOL is to be selected.
    It is first provided by the computing unit an intraoperatively created eye model, which describes the postoperative patient eye. Table 1, reproduced below, shows model data for such a model. In this case, this eye model is preferably created at a time when the patient's eye is aphakic and an IOL has not yet been implanted. The model data includes a curvature of the retina as well as a thickness of the vitreous body following the retina and a corresponding refractive index.
    Furthermore, data of the capsular bag are indicated, as again a curvature and a thickness. Furthermore, the data of the IOL, i. Here, the IOL used for approximation purposes first in the intraoperatively created eye model indicated.
    Finally, the corresponding data of the cornea are still indicated. The above-mentioned ELP is included in the thickness data of the aqueous humor, which belong to rows 3 and 5 of Table 1. On the basis of these data, a result can now be output which describes whether a lens has been correctly selected. Furthermore, it would also be possible to represent a lens incision of an eye or an eye model with an IOL according to the data used in the intraoperative eye model accordingly. This will be explained below with reference to the figures.
    Therefore, the second arithmetic unit preferably determines the second output value based on a model of the eye. The second arithmetic unit preferably determines the second output value taking into account physical properties of a preselected IOL. This means that these physical data or parameters of a preselected IOL, e.g. is used for a first approximation, flow into the model or be taken into account by the second processing unit.
    In a further advantageous embodiment, the device has a comparison device which compares the second output value with a further value or desired value. This desired value may be, for example, a desired target refraction or a desired target defective vision of the eye. The comparator compares the computationally determined output value (which in particular also stands for a refraction) with this setpoint value, and on the basis of this comparison it can be determined whether the originally selected lens is suitable for the operation.
    If, for example, the determined output values lie within a certain range or within certain limit values compared to the desired value (here, for example, a difference of these values or a ratio can be formed), the originally selected lens can be considered suitable and used accordingly , If there are deviations beyond this, it can be determined from these deviations in which direction modifications must be made, for example, whether a lens with higher or lower refractive power should be used.
    In this case, it would be possible for other values to be retained with respect to this further lens, and for instance only one refractive power to be adapted. These steps can be carried out several times, in particular until a suitable selection of an IOL has been made.
    In a further advantageous embodiment, the first or the second arithmetic unit determines the characteristic value using a beam path predicting device. Thus, for example, the arithmetic unit, which determines the postoperative refraction, as mentioned above, use a beam path predicting device, such as a Raytrace method. In this case, for example, a suitable software such as code V or Zemax can be used. Using Raytrace, it is possible to calculate the aberrations of the eye model also intraoperatively and in particular before the implantation of an IOL and, for example, to predict parameters such as a sphere, an axis and a cylinder. In addition, however, other parameters such as Zernike coefficients of the eye model could be determined.
    In general, the model of the eye can be realized in many ways. For example, the model of the eye can be simulated with the aid of optical software on a computer. Examples of such optical software are Code V or Zemax as mentioned above. Typically, such software is supplied with parameter sets in a suitable format which matches the optical properties of the simulated object, i. of the eye, define.
    In particular, these parameters also include parameters which represent the distances of interfaces, the refractive indices of the media present between the interfaces and the curvatures of the interfaces. A variety of such models have already been developed for the human eye, such as the eye model by Gullstrand.
    In such an eye model, in particular, the shape of the cornea can be calculated, in which case a finite element model can be used. This calculation can be done before it flows into the eye model or the calculation of the shape of the cornea can be an intrinsic part of the eye model. The preferred use of such finite element models makes it possible to take account of incisions in the cornea which are used for introducing surgical tools into the eye, for introducing the intraocular lens or for correcting defective vision.
    Thus, the parameters of the eye model are preferably assigned both preoperatively determined (i.e., determined) values and intraoperatively determined (i.e., determined) values to determine the postoperative refractive error of the eye by performing calculations on the eye model. In a preferred embodiment, the intraoperatively determined (i.e., determined) values of the eye also include a value that can be obtained by a wavefront measurement on the eye. Based on such a value, it is possible to immediately deduce the refractive error of the eye during surgery, or this value can be used to check the consistency of an eye model already in use. If necessary, it would also be conceivable to change certain parameters of the model as a function of values, such as the values determined by the wavefront measurement. Preferably, the wavefront measurement is performed prior to insertion of the intraocular lens.
    However, it would also be possible, if necessary, to additionally perform calculations after the onset of the IOL.
    When inserting an intraocular lens with astigmatic effect, it is particularly advantageous if intraoperatively certain (ie determined) values of the eye also include those values which were obtained by a wavefront measurement on the eye, since it can be deduced from a value obtained in this way whether the orientation of the inserted intraocular lens should be changed or not.
    The actual insertion of the intraocular lens has still further method steps, such as the attachment of a lens lock on the eye, in particular before insertion of the intraocular lens into the eye, and the removal of this lens barrier, in particular after the correction of a position or the orientation of the inserted intraocular lens. The eyelid barrier is attached to the eye to keep it open during the procedure. However, this eyelid barrier exerts some pressure on the cornea so that it can be deformed by the pressure of the eyelid barrier. Such a deformed cornea may cause wavefront measurements on the eye to reveal a perceived ametropia, which may lead to unnecessary changes in the planning of the procedure.
    In a preferred approach, such problems due to the deformation of the cornea by the eyelid barrier can be avoided by a preoperatively determined value of the curvature of the cornea in the eye model used to determine the post-operative ametropia of the eye is used as a parameter.
    In a further advantageous embodiment, the first measuring device is a measuring device which is selected from a group of measuring devices, which devices for refraction measurement, keratometers for topography measurement, devices for measuring the position of incisions, devices for (in particular contactless ) Measurement of intraocular pressure (IOP), devices for measuring layer boundaries (eg an OCT), an analog or digital ophthalmic surgical microscope, a device for measuring distances between eye structures, combinations thereof and the like. Advantageously, the first measuring device can also have several of these measuring devices.
    In a further advantageous embodiment, a measuring device which determines a value which characterizes the curvature of the cornea of the eye is a keratoscope or an OCT measuring device.
    In a further advantageous embodiment, the measuring device for determining the value, which represents the distance between the corneal vertex of the eye and the retina of the eye, is an OCT measuring device, an ultrasound measuring device or a slice boundary measuring device.
    In a further advantageous embodiment, it is a measuring device which determines a value representing the distance between the corneal vertex of the eye and the eye lens, and / or in a device which has a value which is the distance between the corneal vertex of the eye and an intraocular lens to an OCT meter or a slice boundary gauge.
    In a further advantageous embodiment, the measuring device which has a value which represents a centering of the intraocular lens in the eye is a wavefront measuring device or an ametropy measuring device.
    In a further advantageous embodiment, the model of the eye takes into account at least one parameter which represents a position and in particular an orientation and / or length of at least one incision in the cornea of the eye. Such a cut can be made in particular before the onset of the IOL.
    Preferably, the model also takes into account a parameter that represents the position and in particular the orientation and / or the length of the at least one incision in the cornea of the eye. This parameter may be assigned a value that is determined based on the at least one incision made in the cornea of the eye.
    In a further advantageous embodiment, the above-mentioned output value for a refractive power of the intraocular lens to be selected is characteristic. It is possible that, as mentioned above, other data or parameters of the intraocular lens to be selected are maintained and only a refractive power is adjusted. For example, the computing device may be configured to determine the value representing the intraocular lens using the Haigis formula, the Hoffer formula, the Holladay formula or SRK / T formula, or some other method of calculation.
    The value characterizing the intraocular lens may be, for example, the refractive index or a material name of the material used for the lens of the intraocular lens. This may also be a radius of curvature of one of the two surfaces or else both surfaces of the intraocular lens, or it may be a name for a type of intraocular lens to be used, under which the intraocular lens in question is marketed commercially.
    The present invention is further directed to a selection method for selecting lenses, and more particularly intraocular lenses. At least a first value is provided which is characteristic for a surgically treated eye. Furthermore, at least a second value is provided which is characteristic for an eye to be aphaked and to be selected with an intraocular lens to be selected. Furthermore, at least the first value and the second value and / or values derived therefrom are input to a computing unit, and at least one of them is input
    Output value which is characteristic of an intraocular lens to be selected. The values can be measured values, but it would also be possible to use calculated values.
    Preferably, the first value and the second value are values characteristic of the same patient, and more particularly to the same eye of the same patient. It should be noted that it is irrelevant to the present method how the respective (measured) values are obtained, for example by measurement, or by simulation or the like. Also, it is not necessarily required that these values be obtained by a treating physician. However, it is again decisive for the method according to the invention that a selection of the IOL takes place on the basis of these values.
    According to the invention, on the basis of the first value and the second value, at least one output value is determined which is characteristic of a defective vision of an eye to be equipped with a given lens. Preferably, at least one value, and in particular the first value, is a value describing an aphakic eye.
    In a further advantageous embodiment, the output value is compared with a value that is characteristic of a preselected IOL. It is preferably decided on the basis of this comparison whether the preselected IOL can be used definitively and in particular for an operation already in progress or future.
    In a further preferred embodiment, the currently available types of IOLs of the eye surgery device may be known and stored, for example, in a database to which the control device and / or the first computing device have access.
    It is possible that prior to engagement with the second measuring device, measurements are made on the eye in order to determine preoperative values. These preoperative values each represent characteristics of the eye before the procedure.
    Furthermore, a plurality of values can preferably be generated by measurements. In particular, this may be a value representing the curvature of the cornea, a value representing the distance between the corneal vertex and the lens of the eye, and a value representing a distance between the corneal vertex and the retina of the eye.
    Further advantages and embodiments will be apparent from the attached figures. It shows:
    Fig. 1 is a schematic representation of an eye surgery device according to the present invention;
    FIG. 2 is an illustration of a calculated eye model; FIG.
    3 is an illustration of a modified calculated eye model;
    4 shows an illustration of a procedure or the procedure for determining an IOL according to a first embodiment;
    5 is an illustration of a corresponding sequence or the procedure for determining an IOL according to a further embodiment.
    1 shows a schematic representation of an eye surgery device 1 according to the invention. With the aid of this eye surgery device 1, a further method explained in the figures for inserting an intraocular lens into an eye can be carried out. For this purpose, the eye surgery device 1 has a control device 3 and a user interface 5. This user interface 5 can communicate with the control device 3 and / or exchange signals or data with it. Furthermore, the device has a first measuring device 9 for determining intraoperative values W1 (or values to be determined intraoperatively) of an eye, and a second measuring device 7 for determining preoperative and / or intraoperative values W2 (ie values to be determined preoperatively and / or intraoperatively ) of an eye. In addition, a first arithmetic unit 11 is provided to select an intraocular lens and a second arithmetic unit 13 to determine a postoperative defective vision. Reference numeral 16 denotes a display means for displaying values, such as an output value, characteristic of an IOL to be selected.
    It would be possible that the device shown in Fig. 1 is constructed as a distributed system, for example, by the first measuring device and the second measuring device are separate devices which are provided at different locations and / or at different times and under circumstances also be used by different operators, in particular to make the measurements on the eye of a patient. The measured values W1 detected by the first measuring device 9 and the measured values W2 detected by the second measuring device 7 are transmitted to the control device 3 as measured data. The control device 3 transmits the measured values or data or values derived therefrom to the two computing units 11, 13.
    Advantageously, the control device 3 has a memory device 32 which is suitable and intended for storing these measured values or data derived from these measured values. However, this memory device 32 may also be present in the respective measuring devices, or a memory device may additionally be present. Also, the control device 3, as shown schematically in Fig. 1, be designed as a distributed system and at least partially integrated in the individual measuring devices 7 and 9.
    For example, the user interface 5 may include a display device such as a display 16 suitable for displaying and outputting data. In addition, the user interface 5 may include an input device, such as a keyboard or a mouse, through which the user may enter data. Furthermore, it is also possible that the user interface 5 is constructed as a distributed system. Thus, a part of the functionality in the respective measuring devices 7 and 9 may be integrated and / or other parts in not shown further system components. In particular, the screen 16 may also be a microdisplay whose image information can be reflected in eyepieces of an optical observation system.
    The reference numeral 11 denotes a first arithmetic unit which is intended for determining an intraocular lens to be selected. This first arithmetic unit is preferably realized as a software module which is implemented in a computer or in several computers. In this case, however, other software may be provided in these computers, which functions of the control device 3, the user interface 5 and the two measuring devices 7, 9 provides. This first arithmetic unit 11 can determine a first output value A1 and / or output to the control unit 3, which is characteristic of an IOL to be selected. Preferably, this is a value that uniquely characterizes this IOL, such as an identification number or certain physical properties that are characteristic of this IOL. This first output value A1 can also be output by the control device 3 to the user interface 5 and can also be displayed by the display device 16.
    The second arithmetic unit 13 can also be designed as a software module. In this case, this second arithmetic unit 13 takes into account at least the measured values of the first measuring device 9 and the second measuring device 7. It would, however, be possible that under certain circumstances only measurements on an apid eye are made and all relevant data are obtained from these measured values. The second arithmetic unit 13 can output a second output value A2, which is characteristic of the ametropia of the eye. This second output value A2 can also be transmitted to the control device 3 and also output (in particular by the control device 3) to the user interface 5 and / or displayed by the display device 16.
    The reference numeral 34 designates a comparator which compares the output value A2 output from the second arithmetic unit 13, which is characteristic of a defective vision of the eye using the preselected IOL, with a target value S and a target refraction, respectively. This desired value S can preferably be input via the user interface 5.
    Reference numeral 36 denotes a calculating unit which outputs a value V characteristic of this comparison, such as a difference or a ratio of the values compared with each other. Reference numeral 42 denotes a beam path predicting device such as a ray tracing module.
    FIGS. 2 and 3 serve to explain a device according to the invention and a method according to the invention. As already mentioned above, it is an object of the invention to provide a device and a method with which a correct lens can be selected intraoperatively. According to an example illustrated by FIGS. 3 and 4, a patient's eye is chosen for which a postoperative target refraction of -1 diopters of myopia has been agreed with the patient, so that the patient has optimal visual comfort at a distance of 1 meter without glasses. For this patient, a bi-convex symmetrical IOL with a curvature p = 1 / 12.1 mm = 0.082645 mm and a thickness of 1.3 mm and a refractive index of 1.464 was selected preoperatively in a preoperative examination.
    In the aphaken state, a measurement of the rear side of the capsular bag is made and, together with other data, the effective lens position (ELP) is determined therefrom. FIG. 3 now shows a lens section which was produced by means of the data record contained in Table 1. In this case, the reference numeral 12 refers to the cornea, the reference numeral 10 to the IOL and the reference numeral 14 to the capsular bag. Between the lens 10 and the cornea is aqueous humor and also between the IOL and the capsular bag 14. The reference numeral 6 denotes the vitreous of the eye and the reference numeral 18 the retina. This data set of the above-mentioned data can be transferred to a computer module for predicting the postoperative refraction, so that parameters can be determined for evaluating the refractive error of the eye model, which simultaneously represents a prognosis of defective vision of the postoperative eye, if the corresponding IOL would be implanted.
    Table 1 below shows the data set for describing the eye model in this embodiment.
    In general, if the prognosis of ametropia is close enough to the postoperative target refraction (eg if the difference between predicted refractive error and postoperative target refraction is less than 1 diopter, preferably less than 0.4 diopter and more preferably less than 0.2 diopters, then the intraoperatively selected IOL is identical to the preoperatively selected IOL and the process of intraoperative IOL selection is complete, in which case the preoperatively selected IOL that is not or only slightly different from the determined IOL deviates from being used.
    If the amount of said difference is too far away from the desired postoperative target refraction, a more suitable IOL type with different parameters is selected. From the sign of this difference, it can be deduced whether an IOL with higher or lower refractive index is selected for the next iteration. Subsequently, those model data from Table 1 are modified according to the newly selected IOL so that they describe the newly selected IOL and its position in the patient's eye.
    Subsequently, the associated defective vision parameters are determined from the model data, as well as the difference between the predicted refractive error and the postoperative target refraction. In the next step, it is decided whether the amount of this difference is sufficiently small or whether another iteration has to occur.
    In the illustration of Fig. 2 and the data set out in Table 1, it would appear that the rays shown converge about 40 cm (to the right) away from the cornea and therefore form optimal vision in this area. As mentioned above, however, the optimal vision should be in the range of 1 meter. In other words, in the case of the model data from Table 1, for the preoperatively selected IOL, for example, a myopic refractive error of -2.46 diopters results. The presbyopia of 2.46 diopters, which is predicted for the postoperative eye, differs by 1.46 from the -1 postoperative target refraction, so that the postoperative target refraction is better achieved when an IOL with a lower refractive power is implanted.
    By the interaction of the arithmetic units 11 and 13 of the device according to the invention is now selected from the available lOLs the one in which the associated created patient-specific eye model as a parameter for the defective vision provides a value that is sufficiently close to the desired postoperative target refraction , In this embodiment, this intraoperatively selected IOL is described by the following information: biconvex, curvature p = 1 / 13.3 mm = 0.075188 mm, thickness 1.1 mm and refractive power n = 1.464. Table 2 below shows the corresponding model data.
    Fig. 3 shows an associated sectional image. As a parameter for the refractive error, a value of -1.11 diopters is calculated, so that only a small deviation results from the postoperative target refraction of -1 dioptres. The user or surgeon is now informed via the user interface 5 that the desired postoperative target refraction is achieved when using this IOL for the patient. In the illustration of Fig. 4, the rays would converge to the right approximately at a distance of one meter to the cornea, which would correspond to the desired specifications. It will be appreciated that the selected IOLs shown in Figs. 3 and 4 differ from each other.
    4 shows a method which can be carried out by means of a device according to the invention in accordance with a first variant. Accordingly, first preoperative and intraoperative readings are provided. These can be determined by measurements, but it would also be conceivable other ways to determine this data. Also, these data can be predetermined by a doctor, but it would also be possible that they are determined only by the use of equipment or machines and it does not require the involvement of a doctor.
    In the method in the first variant, preoperative measured values W2 and intraoperative measured values W1 as well as data L of a lens not yet inserted are provided in a method step I. These data are output data used for a calculation. In this case, however, data, for example from a transparent film, could also be adopted.
    In a method step II, an expected refractive error of the eye is determined using the measured values W1 and W2 and the data L. Again, the measured values are, for example, the preoperative values, such as the curvature of the cornea, or the distance from the corneal vertex to the retina. The now determined defective vision is compared with a desired nominal refractive error (method step III). In a further method step IV, a deviation between a determined defective vision and the desired refractive error is determined, and it is checked whether this deviation is acceptable.
    For example, if only a deviation occurs in a range of 0.2 diopter or less, it may be decided that this deviation is acceptable. In this case, the preselected IOL can be used. If the deviation between the determined defective vision and desired refractive error (method step IV) is not acceptable, a new IOL with changed data L can be determined on the basis of the deviation.
    The changed data L of this IOL are again, as illustrated by the arrow P1, used in step II to (instead of the output data for the preselected IOL) in a further course of steps II and III to determine the ametropia. According to method step IV, the query is again made as to whether the deviation between the determined defective vision and the desired refractive error is acceptable. These method steps I to IV are repeated until finally the deviation is acceptable and the now determined lens can be used for the operation. Thus, the method shown here is based on an iteration of a computational test, whether a preselected IOL is suitable for use. It should be noted that no measurements need to be made on the patient's eye for these steps. Thus, while the above-mentioned values W1 and W2 are determined in particular by measurements, in the context of the steps or iterations described here preferably no further measurements are carried out, but in a predetermined number of steps approximations to a desired result, for example a desired one, are obtained Refraction, made.
    In Fig. 4, it has been assumed that the lenses used are a rotationally symmetrical lens. If the preoperative corneal geometry deviates from rotational symmetry, a toric IOL can also be formed preoperatively. In this case, as an additional step, the coordinate system used is oriented such that the Z axis corresponds to an optical axis of the eye and that the main curvatures of the cornea of the XZ plane and the YZ plane are recorded. Also in this case, the model data can be described similarly as in the above-mentioned tables. However, in addition, the curvatures in the X and Y directions deviate from each other here. In this case, it is also advantageous if the correct orientation of the IOL in the patient's eye is taken into account in the model data, on which in turn the calculation with the parameter is based. In these cases, it would be possible to supplement the above-mentioned table with model data.
    Besides, it would also be possible to use synthetic, i. not directly measured model data, for example, to use as the corneal topography of the eye model the topography obtained by considering the deformation of the corneal topography by the incisions made. It is also possible that these incisions are deliberately set so that deviations of the corneal topography of the rotational symmetry are reduced. This procedure is referred to as "limbal relaxing incision" (LRI).
    In addition, it would also be possible to use synthetic model data which predicts the corneal topography of the eye model after the healing, in particular in the postoperative state.
    Finally, FIG. 5 shows a further sequence of a method by means of the device according to the invention. In this method, preoperative values W2 are provided (method step I). In the example now shown, a method is described by means of which the postoperative refraction of the patient is closer to the postoperative target refraction.
    The preoperative data may be corneal topography, eye length, corneal thickness, etc. This results in a preoperative lOL selection, in which case in particular a patient-specific eye model can be used, as described above with reference to FIG. 1 (method step II). However, an expected aphakic refraction of the eye is now determined using these (measurement) values. In other words, the aphakic refraction is predicted with an individual patient-specific eye model.
    In a further method step, intraoperative (measurement) values W1 are provided which describe an aphakic eye (method step III). In this case, an intraoperative aphakic refraction measurement can take place. In this case, troublesome effects such as e.g. a pressure of the eyelid barrier on the cornea or influences of intraocular pressure, be corrected.
    Similar to the above-described variant, a deviation between the determined aphakic refractive error in the above-mentioned steps II and III is again determined, and it is determined whether these deviations are acceptable. If the deviations are acceptable, the selected IOL can be used. Again, if the results are unacceptable, a new IOL can be determined based on the deviation, with its refractive power different from the preselected IOL according to the theoretical deviations from step IV. Preferably, a new selection of an IOL is carried out, wherein particularly preferably only one refractive index is varied.
    It is again pointed out that for the time being no lens is used in this process. Only if the lens meets the specifications after a certain number of iterations can this be used or used.
    [0108] I ophthalmic surgical device 3 control device 5 user interface 6 vitreous body 7 second measuring device 9 first measuring device 10 intraocular lens II first arithmetic unit 12 cornea 13 second arithmetic unit 14 capsular bag 16 display device 18 retina 32 storage device 34 comparison device 36 calculation unit W1, W2 (measurement) values A1, A2 Output values S setpoint, target refraction V Value for comparison
    L Data of a preselected but not yet used IOL
    权利要求:
    Claims (12)
    [1]
    claims
    1. eye surgery device (1) with - a control device (3); - A user interface (5), which is at least temporarily in data communication with the control device (3); a first measuring device (9) which is suitable and intended to determine intraoperatively at least one value (W1) which is characteristic of a surgically treated eye, a second measuring device (7) which is suitable and intended for this purpose, determine preoperatively and / or intraoperatively at least one value (W2) that is characteristic for the eye to be treated surgically, and with - a first arithmetic unit (11) which is suitable and intended for this purpose, using the intraoperatively determined value (W1) and the preoperatively and / or intraoperatively determined value (W2) to determine at least one first output value (A1) characteristic of at least one intraocular lens (IOL) to be selected, the user interface preferably comprising at least one output device (16) for outputting the Output value (A1) or a value derived therefrom, characterized in that the device (1) e a second arithmetic unit (13), which is suitable and intended to determine at least one second output value (A2) using the intraoperatively determined value (W1) and the preoperatively determined value (W2) on the basis of a model of the eye Postoperative ametropia of the eye is characteristic.
    [2]
    2. eye surgery device (1) with - a control device (3); - A user interface (5), which is at least temporarily in data communication with the control device (3); a first measuring device (9) which is suitable and intended to determine intraoperatively at least one value (W1) which is characteristic of a surgically treated eye, a second measuring device (7) which is suitable and intended for this purpose, determine preoperatively and / or intraoperatively at least one value (W2) that is characteristic for the eye to be treated surgically, and with - a first arithmetic unit (11) which is suitable and intended for this purpose, using the intraoperatively determined value (W1) and the preoperatively and / or intraoperatively determined value (W2) to determine at least one first output value (A1) characteristic of at least one intraocular lens (IOL) to be selected, the user interface preferably comprising at least one output device (16) for outputting the Output value (A1) or a value derived therefrom, characterized in that the device (1) e ine second arithmetic unit (13), which is suitable and determined to determine at least a second output value (A2) using the intraoperatively determined value (W1) and the preoperatively determined value (W2), which is characteristic of a postoperative refractive error of the eye wherein the second arithmetic unit (13) determines the second output value (A2) taking into account physical properties of a preselected IOL.
    [3]
    3. eye surgery device (1) according to claim 1 or 2, characterized in that the first measuring device (9) is suitable and intended to determine the first value (W1) on an aphakic eye.
    [4]
    4. eye surgery device (1) according to claim 2, characterized in that the second computing unit (13) determines the second output value (A2) based on a model of the eye.
    [5]
    5. eye surgery device (1) according to one of the preceding claims 1 to 4, characterized in that the eye surgery device (1) comprises a comparison device (34) which compares the second output value (A2) with a desired value.
    [6]
    6. eye surgery device (1) according to any one of the preceding claims, characterized in that the first computing unit (11) determines the value using a beam path predicting means (42).
    [7]
    7. eye surgery device (1) according to one of the preceding claims, characterized in that the first measuring device (9) and / or the second measuring device (7) comprises at least one measuring device, which is selected from a group of measuring devices, which devices for refraction measurement, Keratometer for topography measurement, devices for measuring the position of incisions, devices for contactless measurement of intraocular pressure, devices for measuring layer boundaries, an ophthalmic surgical microscope, combinations thereof or the like.
    [8]
    Eye surgery device (1) according to claim 1, characterized in that the model of the eye takes into account at least one parameter representing a position and in particular an orientation and / or a length of at least one incision in the cornea of the eye.
    [9]
    9. eye surgery device (1) according to claim 1, characterized in that the model of the eye takes into account at least one parameter representing a centering of the intraocular lens in the eye.
    [10]
    10. eye surgery device (1) according to any one of the preceding claims, characterized in that the output value (A1) for a refractive power of the intraocular lens (IOL) to be selected is characteristic.
    [11]
    11. The ophthalmological surgical device (1) according to any one of the preceding claims, characterized in that the control device (3) is designed such that it waits for a predetermined input of the user in the user interface before at least one measuring device is initiated, intraoperative and / or preoperative measurements to determine.
    [12]
    A selection method for selecting an intraocular lens comprising the steps of: providing at least a first value (W1) characteristic of a surgical eye to be treated; Providing at least a second value (W2) characteristic of an eye to be aphaked and to be selected with an intraocular lens to be selected, inputting at least the first value (W1) and the second value (W2) into a computing unit and determining at least one output value (A1), which is characteristic for an intraocular lens to be selected, characterized in that based on the first value (W1) and the second value (W2) and taking into account physical properties of a preselected IOL at least one value is determined, which for a defective vision with This preselected IOL is characteristic of the populating eye.
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    同族专利:
    公开号 | 公开日
    DE102014111630A1|2016-02-18|
    US10159406B2|2018-12-25|
    US20170156583A1|2017-06-08|
    WO2016024017A1|2016-02-18|
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    US7556378B1|2003-04-10|2009-07-07|Tsontcho Ianchulev|Intraoperative estimation of intraocular lens power|
    US8398236B2|2010-06-14|2013-03-19|Alcon Lensx, Inc.|Image-guided docking for ophthalmic surgical systems|
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    DE102013002293A1|2013-02-08|2014-08-14|Carl Zeiss Meditec Ag|Eye surgery systems and methods for inserting intro-cular lenses|
    US9844321B1|2016-08-04|2017-12-19|Novartis Ag|Enhanced ophthalmic surgical experience using a virtual reality head-mounted display|US20210093446A1|2019-09-27|2021-04-01|Alcon Inc.|Systems and methods for providing a graphical user interface for intraocular lens implantation planning|
    法律状态:
    2018-09-14| AZW| Rejection (application)|
    优先权:
    申请号 | 申请日 | 专利标题
    DE102014111630.5A|DE102014111630A1|2014-08-14|2014-08-14|Eye surgery device for inserting intraocular lenses into eyes|
    PCT/EP2015/068771|WO2016024017A1|2014-08-14|2015-08-14|Ophthalmic surgical apparatus for inserting intraocular lenses into eyes|
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