Device for surgically correcting ametropia of an eye and method for creating control data therefor
11272986 · 2022-03-15
Assignee
Inventors
Cpc classification
A61B34/10
HUMAN NECESSITIES
International classification
Abstract
A device and a method for producing control data, which are designed to control a laser machining device to surgically correct ametropia of an eye in which, in order to define a space in the cornea, defines a front cutting surface, a rear cutting surface and an edge section, which are to be produced as cutting surfaces in the cornea. The rear cutting surface has a non-circular, oval edge lying in a plane, the edge section connecting the edge to the front cutting surface and the edge section being designed as a non-rotationally symmetrical cylinder or truncated cone, the base of which is the edge.
Claims
1. A method for refractive error correction of an eye by surgery, the refractive error including astigmatism and the method comprising: applying laser radiation to enclose a volume in the cornea, the volume being bounded by an anterior surface of the volume defined by at least part of an anterior cut surface, a posterior surface of the volume defined by a posterior cut surface and an edge surface of the volume defined by a side cut in the cornea; the method further comprising: creating the posterior cut surface to comprise a non-circular, oval edge, wherein the non-circular, oval edge lies in a plane; creating the side cut that connects the non-circular, oval edge of the posterior cut surface to the anterior cut surface; creating the side cut as a lateral surface of a non-rotationally symmetric cylinder or conical frustum, the directrix of which is the non-circular oval edge; and creating the side cut such that the lateral surface meets the anterior cut surface at a circumference of the anterior surface to define a circumferential closed curve circumscribing the anterior surface of the volume and wherein the circumferential closed curve does not lie in a plane.
2. The method as claimed in claim 1, further comprising creating the posterior cut surface to comprise an elliptical edge.
3. The method as claimed in claim 1, further comprising creating the anterior surface to include a perimeter which, corresponds to the circumference and creating the side cut to connect the posterior cut surface to the perimeter of the anterior cut surface.
4. The method as claimed in claim 3, further comprising creating the anterior cut surface to be spherically curved and creating the circumference to not lie in a plane.
5. The method as claimed in claim 3, further comprising creating the anterior cut surface to comprise an elliptical circumference.
6. The method as claimed in claim 1, further comprising creating the isolated volume to have an oval outline in a plan view on the plane and to have neither of the anterior cut surface and the posterior cut surface project laterally beyond the outline or the isolated volume.
7. The method as claimed in claim 1, further comprising creating the plane of the non-circular, oval edge to be perpendicular to a principal direction of incidence of laser radiation that is used to produce the anterior cut surface and the posterior cut surface.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Below, the invention will be explained in still more detail by way of example, with reference being made to the drawings. In the drawings:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
DETAILED DESCRIPTION
(19)
(20) Before using the treatment appliance, the refractive error of the eye 3 is measured using one or more measuring devices.
(21)
(22) In an example embodiment, the control data record is transmitted to the treatment appliance 1 and, in a further example embodiment, an operation of the laser device L is blocked until a valid control data record is present at the laser device L. A valid control data record can be a control data record that, in principle, is suitable for use with the laser device L of the treatment apparatus 1. However, additionally, the validity can also be linked to further tests being passed, for example whether specifications about the treatment appliance 1, e.g., an appliance serial number, or about the patient, e.g., a patient identification number, which are additionally stored in the control data record, correspond to other specifications that, for example, are read at the treatment apparatus or entered separately as soon as the patient is in the correct position for the operation of the laser device L.
(23) The control data record, which is provided to the laser unit L for carrying out the operation, is produced by the planning unit P from measurement data and refractive error data that were established for the eye to be treated. They are supplied to the planning unit P via an interface S and, in the illustrated exemplary embodiment, originate from a measuring device M, which has previously measured the eye of the patient 4. Naturally, the measuring device M can transmit the corresponding measurement data and refractive error data to the planning device P in any suitable way.
(24) The transmission can be implemented by use of memory chips (e.g., by USB or memory stick), magnetic storage units (e.g., disks), by radio (e.g., WLAN, UMTS, Bluetooth) or in wired fashion (e.g., USB, FireWire RS232, CAN bus, Ethernet, etc.). Naturally, the same applies in respect of the data transmission between planning device P and laser device L.
(25) A direct radio or wired link of the measuring device M to the treatment device 1 in respect of the data transmission, which can be used in one variant, is advantageous in that the use of incorrect measurement data and refractive error data can be excluded with the greatest possible reliability. This applies, in particular, if the transfer of the patient from the measuring device M or the measuring devices to the laser device L is implemented by use of the bearing device (not illustrated in the figure), which interacts with the measuring device M and/or with the laser device L in such a way that the respective devices recognize whether the patient 4 is in the respective position for measuring or introducing laser radiation 2. Here, when the patient 4 is moved from the measuring device M to the laser device L, the measurement data and refractive error data can be transferred to the treatment apparatus 1 at the same time.
(26) In an example embodiment, suitable safeguards ensure that the planning device P always produces the control data record belonging to the patient 4 and an erroneous use of an incorrect control data record for a patient 4 is virtually excluded.
(27) The mode of operation of the laser beam 2 is schematically indicated in
(28) Alternatively, a tissue-separating effect by the pulsed laser radiation can also be produced by virtue of a plurality of laser radiation pulses being emitted into a region, with the spots 6 overlapping for a plurality of laser radiation pulses. Then, a plurality of laser radiation pulses interact in order to obtain a tissue-separating effect.
(29) However, the type of tissue separation employed by the treatment appliance 1 has no further relevance for the subsequent description, even though pulsed treatment laser radiation 2 is presented in this description. By way of example, use can be made of a treatment appliance 1 as described in WO 2004/032810 A2. A multiplicity of laser pulse focuses forms a cut surface in the tissue, the form of which depends on the pattern with which the laser pulse focuses are arranged in the tissue. The pattern provides target points for the focal positions at which one or more laser pulse(s) is(are) emitted and defines the form and position of the cut surface.
(30) In order now to carry out the refractive error correction, material is removed out of the region within the cornea 5 by application of the pulsed laser radiation by virtue of tissue layers being separated there, said tissue layers isolating the material and then facilitating a material removal. The removal of material brings about a change in volume in the cornea, which has as a consequence a change in the optical imaging effect of the cornea 5, which is dimensioned precisely in such a way that the previously established refractive error is corrected to the best possible extent. For the purposes of isolating the volume to be removed, the focus of the laser radiation 2 is directed to targets in the cornea 5, as a rule, in a region that lies below the epithelium and Bowman's membrane and above Descemet's membrane and the endothelium. To this end, the treatment appliance 1 comprises a mechanism for adjusting the position of the focus of the laser radiation 2 in the cornea 5. This is shown schematically in
(31)
(32) The assignment of the individual coordinates to spatial directions is not essential for the functional principle of the treatment appliance 1; however, for the purposes of simpler description, z always denotes the coordinate along the optical axis of incidence of the laser radiation 2 below and x and y denote two mutually orthogonal coordinates in a plane perpendicular to the direction of incidence of the laser beam. Naturally, a person skilled in the art knows that the position of the focus 7 in the cornea 5 can also be described in three dimensions by other coordinate systems; in particular, this need not necessarily be an orthogonal coordinate system. Thus, it is not mandatory for the xy-scanner 9 to deflect about axes that are orthogonal to one another; rather, it is possible to use any scanner that is able to adjust the focus 7 in a plane not containing the axis of incidence of the optical radiation. Consequently, skew coordinate systems are also possible.
(33) Further, it is also possible to use non-Cartesian coordinate systems for describing or controlling the position of the focus 7, as will also still be explained below. Examples of such coordinate systems are spherical coordinates and cylindrical coordinates.
(34) For the purposes of controlling the position of the focus 7, the xy-scanner 9 and the z-scanner 11, which together realize a specific example of a three-dimensional focus adjustment device, are actuated by a controller 12 via lines not denoted in any more detail. The same applies to the laser 8. The controller 3 ensures a suitable synchronized operation of the laser 8 and of the three-dimensional focus adjustment device, realized in exemplary fashion by the xy-scanner 9 and the z-scanner 11, and so the position of the focus 7 in the cornea 5 is adjusted in such a way that, ultimately, a material of a certain volume is isolated, with the subsequent volume removal bringing about a desired refractive error correction.
(35) The controller 12 operates according to predetermined control data, which predetermine the target points for the focal adjustment. As a rule, the control data are combined in a control data record. In one embodiment, the latter predetermines the coordinates of the target points as a pattern, wherein the sequence of the target points in the control data record sets the stringing together of the focal positions and hence, consequently, a trajectory (also referred to as path here). In one embodiment, the control data record contains the target points as specific manipulated variables for the focal position adjustment mechanism, e.g., for the xy-scanner 9 and the z-scanner 11. For the purposes of preparing the ophthalmic surgical method, i.e., before the actual operation method can be carried out, the target points and for example also the sequence thereof in the pattern are determined. The surgical intervention must be planned in advance to the effect of establishing control data for the treatment appliance 1, the application of which then obtains an optimal refractive error correction for the patient 4.
(36) The initial goal is to set the volume to be isolated in the cornea 5 and to be removed subsequently. As already explained on the basis of
(37) In respect of the nomenclature used in this description, it should be noted that the attachment of an asterisk to variables clarifies that this relates to variables that are obtained after a correction. Under the justified assumption that a change in thickness of the cornea 5 substantially modifies the radius of curvature of the corneal front side 15 that faces the air but does not modify the radius of curvature of the corneal back side 16 that faces the interior of the eye, the radius of curvature R.sub.CV of the corneal front side 15 is modified by removing the volume. The cornea 5 that is reduced by the volume and that has a modified corneal surface 15* has a correspondingly modified imaging effect on account of the modified front side curvature, and so a corrected focus lies on the retina 14.
(38) Therefore, the curvature R*.sub.CV of the modified corneal front surface 15* to be achieved is established for determining the pattern of the target points.
(39) Now, using the value B.sub.COR, the curvature of the modified corneal front surface 15* is set as follows:
R.sub.CV*(r,φ)=1/((1/R.sub.CV(r,φ))+B.sub.COR(r,φ)/(n.sub.c−1))+F, (1)
(40) In equation (1), n.sub.c denotes the refractive power of the material of the cornea. The corresponding value usually lies at 1.376; B.sub.COR denotes the refractive power change that is required to correct the refractive error. B.sub.COR has a radial dependence. Here, radial dependence is understood to mean that there are two values r1 and r2 for the radius r, for which the refractive power change has different values at all angles φ.
(41) Examples of possible curves of the refractive power change are shown in exemplary fashion in
(42) Ka is a conventional refractive index of spectacles according to the prior art as per DE 102006053120 A1, albeit already related to the plane of the corneal vertex in the illustration of
(43) Then the refractive power correction drops further beyond the pupil radius r.sub.s. The non-discontinuous drop in the refractive power correction to the value of zero is advantageous from an anatomical point of view. It allows matching of the corrected corneal front side radius, which sets in on account of the correction, to the original corneal radius of curvature, i.e., the preoperative radius, at the edge of the corrected region, i.e., at the edge of the volume to be removed. In relation to the illustration of
(44) The drop of the refractive power correction to the value of zero is for example implemented in a region outside of the dark-adapted pupil radius, i.e., in a region of the cornea of the eye that has no further relevance for vision.
(45) A similar profile is shown by the curve Kd; however, there is a smooth transition in this case from the first value of the refractive power change below r.sub.p to the second value present at r.sub.s. Moreover, the first value is lower here in an exemplary fashion than the second value. Naturally, this can also be used in this way for the curve Kc, depending on the desired correction requirements. Curve Ke shows a smooth profile that continuously decreases.
(46) The locally dependent refractive power changes with a radial dependence, explained on the basis of
(47) The factor F expresses the optical effect of the change in thickness which is experienced by the cornea as a result of the surgical intervention and, to a first approximation, it can be considered to be a constant factor which, for example, can be determined in advance by experiment. For a highly accurate correction, the factor can be calculated according to the following equation:
F=(1−1/n.sub.c).Math.Δz(r=0,φ) (2)
(48) Here, Δz(r=0, φ) is the central thickness of the volume to be removed.
(49) For an accurate determination, R.sub.CV* is calculated iteratively by virtue of the variable Δz(r=0,φ) being deduced in the i-th calculation from the difference 1/R.sub.CV*(r=0,φ)−1/R.sub.CV (r=0,φ) and the corresponding result obtained therefrom being applied to the change in thickness in the (i+1)-th calculation of R*.sub.CV. This can be carried out until a termination criterion is satisfied, for example if the difference of the result for the change in thickness in two successive iterations steps lies below an accordingly set limit. By way of example, this limit can be set by way of a constant difference that corresponds to an accuracy of the refractive correction that is appropriate for the treatment.
(50) In general, the method illustrated in
(51) The local refractive power of the cornea is established in a step S3.
(52) In a step S4, the required local refractive power change B.sub.COR is determined from the data of the desired refractive correction and the local refractive power desired after the correction is determined from the local refractive power using said local refractive power change.
(53) The new local radius of curvature R*.sub.CV(r, φ) emerges therefrom in step S5. Instead of calculating the local refractive power B.sub.CV in step S3, calculations can also be carried out directly using the local curvature R.sub.CV from step S2 if equation (1) above is used. Here, quite fundamentally, reference should be made to the fact that refractive power and radius of curvature can be converted into one another using a simple equation. The following holds true: B=(n.sub.C−1)/R, where B is the refractive power and R is the radius assigned to this refractive power. Thus, within the scope of the invention, it is possible to switch between the consideration or representation of the radius and the refractive power at all times. The equation to be used when establishing the control data in the case of refractive power representations is:
(54)
(55) To the extent that reference is made here to the radius of the corneal front surface, use can also be made, quite analogously, of the refractive power, and so all explanations provided here in conjunction with the radius of the corneal front surface naturally also apply analogously to the refractive power representation or perspective if R is replaced by B according to the aforementioned relationship.
(56) For the volume whose removal brings about the aforementioned change of curvature of the corneal front surface 15, the boundary surface isolating the volume is now set in a step S6. Here, the intended basic form of the volume should be taken into account.
(57) In a first variant, a free-form surface that circumscribes the volume whose removal brings about the change in curvature is defined by application of numerical methods known to a person skilled in the art. To this end, the volume thickness required for the desired modification of curvature is established along the z-axis. From this, the volume emerges as a function of r, φ (in cylindrical coordinates) and, in turn, the boundary surface emerges therefrom.
(58) By contrast, an analytical calculation supplies the following variant, already mentioned in DE 102006053120 A1, in which the boundary surface of the volume is substantially constructed by two partial surfaces, and an anterior partial surface lying toward the corneal surface 15 and an opposing posterior partial surface. The corresponding relationships are shown in
(59) The anterior cut surface 19 is for example spherical since a radius of curvature can then be specified therefor, said radius of curvature being less than the radius of curvature R.sub.CV by the lamella thickness d.sub.F.
(60) In the posterior direction, the volume 18 that should be removed from the cornea 5 is delimited by a posterior cut surface 20 which already cannot be at a constant distance from the corneal front surface 15 as a matter of principle because otherwise virtually no corrective effect would occur. Therefore, the posterior cut surface 20 is embodied in such a way that the volume 18 is present in the form of a lenticule, which is why the posterior cut surface 20 is also referred to as lenticule surface. In
(61)
(62) On account of the constant distance between the corneal front surface 15 and anterior cut surface 19, the posterior cut surface 20 sets the curvature profile of the corneal front surface 15* after the removal of the volume 18.
(63) If the factor F should be taken into account during the calculation, the change in the topography of the cornea is also taken into account in step S7, i.e., the current central thickness is calculated. With the value for the factor F emerging therefrom, steps S4 to S6 or S5 to S6 can be run through again or can be run through multiple times in the form of an iteration.
(64) The embodiment of the volume 18 delimited by an anterior cut surface 19 with a constant distance from the corneal front surface 15 and a posterior cut surface 20, as shown in the figures, is only one variant for delimiting the volume 18. However, it is advantageous in that the optical correction is substantially only set by one surface (the posterior cut surface 20), and so the analytical description of the other partial surface of the boundary surface is simple.
(65) Furthermore, optimal safety margins in respect of the distance of the volume from the corneal front surface 15 and corneal back surface 16 are provided. The residual thickness d.sub.F between the anterior cut surface 19 and the corneal front surface 15 can be set to be constant at a value of 50 to 200 μm, for example. In particular, it can be chosen in such a way that the pain-sensitive epithelium remains in the lamella, the latter being formed by the anterior cut surface 19 under the corneal front surface 15. Also, the embodiment of the spherical anterior cut surface 19 has continuity with previous keratometer cuts, which is advantageous for the acceptance of the method.
(66) After the cut surfaces 19 and 20 are produced, the volume 18 isolated thus is then removed from the cornea 5. This is illustrated schematically in
(67) The features described above and below are also possible in these variants, particularly in relation to determining the boundary surface, the geometric definition thereof and the establishment of control parameters.
(68) If both the posterior cut surface 20 and the anterior cut surface 19 are produced by application of pulsed laser radiation, it is expedient to form the posterior cut surface 20 before the anterior cut surface 19 since the optical result in the posterior cut surface 20 can be achieved better (or even only be achieved at all) if there has not yet been a change in the cornea 5 above the posterior cut surface 20.
(69)
(70) For the purposes of isolating the volume 18, both the anterior cut surface 19 and the posterior cut surface 20 are produced in the cornea 5 of the eye in the manner described above. In the process, a correction surface is produced which, in a plan view, is non-circular and oval—elliptical in this case for the purposes of correcting an astigmatism. As the plan view 33 on the posterior cut surface 20 shows, this correction surface is produced by a spiral 32 which, for example, runs from the interior of the correction surface to the outside. The spiral 32 defines a trajectory for adjusting the position of the laser beam focus. Here, the center of the spiral 32 for example (but not necessarily) lies at the highest point of the correction surface. The spiral 32 is based on height contours, as a result of which the z-position (position along the principal direction of incidence A of the laser radiation) of the focal position is adjusted continuously. Instead of a group of closed scan lines that never intersect, a continuous scan line is present. Local spatially dependent refractive power corrections B(r, φ) can easily be represented and produced by the modulation of the angle-dependent radial function r(φ) by way of a spiral 32 that is radially “deformed” in this way.
(71) In contrast to the prior art according to
(72) In
(73) In the embodiment of
(74) The embodiments of
(75) The volume 18 assembled from the posterior cut surface 20, the anterior cut surface 19 and the side cut 30 is identifiable in the cross section in
(76) Optionally, the posterior cut surface 20 is an ellipse, which can be described by the principal axes H1 and H2. If the anterior cut surface 19 comprises a circumferential line that coincides with the top edge 42 of the side cut 30, the anterior cut surface 19 can be described by the same principal axes H1 and H2. This is shown in
(77) In all embodiments in which the side cut 30 directly connects the edge 38 of the posterior cut surface 20 to the circumferential line of the anterior cut surface 19, none of the cut surfaces protrudes laterally beyond the oval volume 18 in the plan view and all cut surfaces are involved in delimiting the oval volume 19 over their entire extent.
(78) The embodiment of the volume 18 to be removed shown in
(79) The use of pulsed laser radiation is not the only way in which the surgical refraction correction can be carried out. Rather, the determination of control data for operating the apparatus described here can be used in virtually any surgical method in which a volume is removed from the cornea 5 of the eye by application of an apparatus under the control of control data or added thereto, as already explained in the general part of the description.
(80) All statements in relation to curvatures of the cut surfaces relate to the state of the material to be treated at the time of introducing the laser beam. In the case of the cornea of the eye, this may be a state in which the cornea is deformed by a contact glass, for example into a spherically curved or planar corneal front side.