DEVICE AND METHOD FOR PRODUCING CONTROL DATA FOR THE SURGICAL CORRECTION OF THE DEFECTIVE EYE VISION
20210121323 · 2021-04-29
Inventors
Cpc classification
International classification
Abstract
A device for producing control data for a laser device for the surgical correction of defective vision. The device produces the control data such that the laser emits the laser radiation such that a volume in the cornea is isolated. The device calculates a radius of curvature R.sub.CV* to determine the control data, the cornea reduced by the volume having the radius of curvature R.sub.CV* and the radius of curvature being site-specific and satisfying the following equation: R.sub.CV*(r,φ)=1/((1/R.sub.CV(r,φ))+B.sub.COR(r,φ)/(n.sub.c-1))+F, wherein R.sub.CV(r,φ) is the local radius of curvature of the cornea before the volume is removed, n.sub.c is the refractive index of the material of the cornea, F is a coefficient, and B.sub.COR(r,φ) is the local change in refractive force required for the desired correction of defective vision in a plane lying in the vertex of the cornea, and at least two radii r1 and r2 satisfy the equation B.sub.COR(r=r1,φ)≠B.sub.COR(r=r2,φ).
Claims
1. A device for generating control data for controlling a laser (L) for surgical correction of defective vision of an eye (3) of a patient (4), wherein the control data are adapted to control a laser (L) which cuts cornea tissue by irradiating laser radiation (2) into the cornea (5) of the eye (3), the device (12) generates the control data such that the laser (L), during operation according to the control data, emits the laser radiation (2) such that a volume (18) in the cornea (5) is isolated, the removal of which volume from the cornea (5) effects the desired correction of the defective vision and, to determine the control data, the device (12) calculates a radius of curvature R.sub.CV* displayed by the cornea (5) reduced by the volume (18) characterized in that the radius of curvature R.sub.CV* is locally varying and satisfies the following equation:
R.sub.CV*(r,φ)=1/((1/R.sub.CV(r,φ))+B.sub.COR(r,φ)/(n.sub.c-1))+F, wherein R.sub.CV(r,φ) is the local radius of curvature of the cornea (5) before the volume (18) is removed, n.sub.c is the refractive index of the material of the cornea (5), F is a coefficient, and B.sub.COR(r,φ) is the local change in optical refraction power in a plane lying in the vertex of the cornea (5) and required for the desired correction of the defective vision, wherein there are at least two radii, r1 and r2, for which B.sub.COR(r=r1,φ)≠B.sub.COR(=r2,φ) holds true.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0070] The invention is explained in even more detail below, by way of example, with reference to the drawings. There are shown in:
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DETAILED DESCRIPTION
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[0089] Before the treatment apparatus is used, the defective vision of the eye 3 is measured with one or more measuring devices.
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[0091] Preferably, the control data set is transmitted to the treatment apparatus 1 and more preferably, the operation of the laser L is blocked until there is a valid control data set at the laser L. A valid control data set can be a control data set which in principle is suitable for use with the laser L of the treatment device 1. Additionally, however, the validity can also be linked to the passing of further tests, for example whether details, additionally stored in the control data set, concerning the treatment apparatus 1, e.g. an appliance serial number, or concerning the patient, e.g. a patient identification number, correspond to other details that for example have been read out or input separately at the treatment device as soon as the patient is in the correct position for the operation of the laser L.
[0092] The planning unit P produces the control data set that is made available to the laser unit L for carrying out the operation from measurement data and defective-vision data which have been determined for the eye to be treated. They are supplied to the planning unit P via an interface S and, in the embodiment example represented, come from a measuring device M which has previously taken measurements of the eye of the patient 4. Naturally, the measuring device M can transfer the corresponding measurement and defective-vision data to the planning device P in any desired manner.
[0093] Transmission can be by means of memory chips (e.g. by USB or memory stick), magnetic storage (e.g. disks), by radio (e.g. WLAN, UMTS, Bluetooth) or wired connection (e.g. USB, Firewire, RS232, CAN-Bus, Ethernet etc.). The same naturally also applies with regard to the data transmission between planning device P and laser L.
[0094] A direct radio or wired connection of measurement device M to treatment device 1 with regard to data transfer which can be used in a variant has the advantage that the use of incorrect measurement and defective-eye data is excluded with the greatest possible certainty. This applies in particular if the patient is transferred from measuring device M or measuring devices to the laser L by means of a storage device (not represented in the Figure) which interacts with measuring device M or laser L such that the respective devices recognize whether the patient 4 is in the respective position for measurement or introduction of the laser radiation 2. By bringing the patient 4 from measuring device M to laser L the transmission of measurement and error-correction data to the treatment device 1 can also take place simultaneously.
[0095] Preferably it is ensured by suitable means that the planning device P always produces the control data set belonging to the patient 4 and an erroneous use of a false control data set for a patient 4 is as good as excluded.
[0096] The mode of operation of the laser beam 2 is indicated schematically in
[0097] Alternatively, a tissue-cutting effect can also be produced by the pulsed laser radiation by sending several laser radiation pulses into a region, wherein the spots 6 overlap for several laser radiation pulses. Several laser radiation pulses then act together to achieve a tissue-cutting effect.
[0098] The type of tissue cutting which the treatment apparatus 1 uses is, however, no further relevant for the description below, although pulsed treatment laser radiation 2 is described in this description. For example a treatment apparatus 1 such as is described in WO 2004/032810 A2 can be used. A large number of laser-pulse foci forms a cut surface in the tissue, the form of which depends on the pattern with which the laser-pulse foci are/become arranged in the tissue. The pattern specifies target points for the focus position at which one or more laser pulse(s) is (are) emitted and defines the form and position of the cut surface.
[0099] In order now to carry out a correction of defective vision, material is removed from a region within the cornea 5 by means of the pulsed laser radiation by cutting tissue layers thus isolating the material and then make it possible for material to be removed. The removal of material effects a change in the volume of the cornea which results in a change in the optical imaging effect of the cornea 5, which change is calculated exactly such that the previously determined defective vision thus is/becomes corrected as much as possible. To isolate the volume to be removed, the focus of the laser radiation 2 is directed towards target points in the cornea 5, generally in an area which is located beneath the epithelium and the Bowman's membrane and above the Decemet's membrane and the endothelium. For this purpose the treatment apparatus 1 has a mechanism for shifting the position of the focus of the laser radiation 2 in the cornea 5. This is shown schematically in
[0100] In
[0101] The allocation of the individual coordinates to the spatial directions is not essential for the operating principle of the treatment apparatus 1; but to simplify the description, in the following the coordinate along the optical axis of incidence of the laser radiation 2 is always designated z, and x and y designate two coordinates orthogonal to one another in a plane perpendicular to the direction of incidence of the laser beam. It is naturally known to a person skilled in the art that the position of the focus 7 in the cornea 5 can also be described three-dimensionally by other coordinate systems, in particular that the coordinate system need not be a rectangular system of coordinates. Thus it is not essential for the xy scanner 9 to deflect around axes that are at right angles to one another; rather, any scanner capable of shifting the focus 7 in a plane in which the incidence axis of the optical radiation does not lie can be used. Oblique-angled coordinate systems are thus also possible.
[0102] Further, non-Cartesian coordinate systems can also be used to describe, or control, the position of the focus 7, as will also be explained further below. Examples of such coordinate systems are spherical coordinates as well as cylindrical coordinates.
[0103] To control the position of the focus 7, the xy scanner 9 as well as the z scanner 11, which together realize a specific example of a three-dimensional focus-shifting device, are controlled by a control apparatus 12 via lines not described in more detail. The same applies to the laser 8. The control apparatus 3 ensures a suitably synchronous operation of the laser 8 as well as the three-dimensional focus-shifting device, realized by way of example by the xy scanner 9 and the z scanner 11, with the result that the position of the focus 7 is shifted in the cornea 5 such that, ultimately, a specific volume of material is isolated, wherein the subsequent volume removal effects a desired correction of defective vision.
[0104] The control apparatus 12 operates according to predetermined control data which predetermine the target points for shifting the focus. The control data are generally collected in a control data set. In one embodiment, this predetermines the coordinates of the target points as a pattern, wherein the sequence of the target points in the control data set fixes the serial arrangement of the focus positions alongside one another and thus, ultimately, a path curve (also referred to here in short as a path). In one embodiment, the control data set contains the target points as specific reference values for the focus-shifting mechanism, e.g. for the xy scanner 9 and the z scanner 11. To prepare the eye-surgery procedure, thus before the actual operation can be carried out, the target points and preferably also their order are determined in the pattern. There must be pre-planning of the surgical procedure to determine the control data for the treatment apparatus 1, the application of which then achieves an optimal correction of defective vision for the patient 4.
[0105] Firstly, the volume to be isolated in the cornea 5 and later removed must be defined. As already described with reference to
[0106] With regard to the nomenclature used in this description it may be noted that the addition of an asterisk to values indicates that these are values which are obtained after a correction. On the justified assumption that a change in thickness of the cornea 5 substantially modifies the radius of curvature of the front face 15 of the cornea facing the air, but not the radius of curvature of the rear 16 of the cornea adjacent to the inside of the eye, the radius of curvature R.sub.CV of the front of the cornea 15 is modified by the volume removal. Because of the modified curvature of the front having changed cornea surface 15*, the cornea 5 reduced by the volume has a correspondingly modified imaging effect, with the result that there is now a corrected focus on the retina 14.
[0107] To determine the pattern of the target points, the curvature to be achieved R.sub.CV* of the cornea front surface 15* is therefore determined.
[0108] Using the value B.sub.COR, the curvature of the modified cornea front surface 15* is now 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)
[0109] In equation (1) n.sub.c denotes the optical refraction power of the material of the cornea. The proper value is usually 1.376; B.sub.COR denotes a change in optical refraction power which is necessary to correct defective vision. B.sub.COR is radially dependent. By radial dependence is meant that there are two values r1 and r2 for the radius r for which the change in optical refraction power has different values at all angles φ.
[0110] Examples of possible patterns of changes in optical refraction power are shown by way of example in
[0111] Ka is the conventional refractive index of spectacles from the state of the art according to DE 102006053120 A1, but already referenced to the plane of the vertex of the cornea in the representation of
[0112] The correction of optical refraction power then drops again from pupil radius r.sub.s. The unstepped drop in the correction of optical refraction power to zero is advantageous from an anatomical point of view. It allows, at the edge of the corrected range, i.e. at the edge of the volume to be removed, an adaptation of the corrected cornea front radius which is set, on the basis of the correction, to the original radius of curvature of the cornea, i.e. the pre-operative radius. Reverting to the representation of
[0113] The drop in the correction of optical refraction power to zero takes place preferably in an area outside the darkened pupil radius, thus in an area of the cornea no longer relevant for vision.
[0114] The curve Kd shows a similar pattern, but here there is a smooth transition from the first value of the change in optical refraction power below r.sub.p to the second value at r.sub.s. Also, by way of example, the first value here is lower than the second value. This can naturally also be used for the curve Kc, depending on the desired requirement for correction. Curve Ke shows a continuous decline.
[0115] The locally varying changes in optical refraction power, described with reference to
[0116] The coefficient F expresses the optical effect of the change in thickness which the cornea experiences as a result of the surgical procedure and can be seen in a first approximation as a constant coefficient which can be determined e.g. experimentally in advance. For a highly accurate correction the coefficient can be calculated according to the following equation:
F=(1-1/n.sub.c).Math.Δz(r=0,φ) (2)
[0117] Δz(r=0, φ) is the central thickness of the volume to be removed.
[0118] For a precise determination, R.sub.CV* is iteratively calculated by determining in an nth calculation step the value Δz(r=0,φ) from the difference 1/R.sub.CV*(r=0,φ)−1/R.sub.CV Δr=0,φ) and using the corresponding result obtained from this for the change in thickness in the (n+1)th calculation step as new value for R*cv. This can be carried out until an abort criterion is met, for example if the difference in the result for the change in thickness in two successive iterations lies below a suitably fixed limit. This limit can for example be set as a constant difference which corresponds to an accuracy of the refraction correction that is appropriate to the treatment.
[0119] In general the method represented in
[0120] The local optical refraction power of the cornea is determined in a step S3.
[0121] The required local change in optical refraction power B.sub.COR is determined from data relating to the desired refractive correction in a step S4 and the local optical refraction power desired after the correction determined from this local change in optical refraction power.
[0122] The new local radius of curvature R*.sub.CV(r,φ) is generated then in step S5. Instead of the calculation of the local optical refraction power B.sub.CV in step S3, calculation can also take place directly with the local curvature R.sub.CV from step S2 if the above equation (1) is used. It should be pointed out quite basically that optical refraction power and radius of curvature can be transformed into each other by a simple equation. Thus: B=(n.sub.C-1)/R, wherein B is the optical refraction power and R the radius allocated to this optical refraction power. Thus, within the framework of the invention, it is possible at any time to alternate between radius approach and optical refraction power approach or representation. The equation to be used when determining control data in optical refraction power representations is:
[0123] When the radius of the cornea surface is mentioned here, the optical refraction power can also be used completely analogously, with the result that all statements made here in connection with the radius of the cornea surface self-evidently also apply analogously to the representation or consideration of the optical refraction power if R is replaced by B according to the named dependency.
[0124] For the volume whose removal effects the above change in curvature of the cornea front surface 15 the boundary surface isolating the volume is now defined in a step S6. Account is to be taken of what basic form the volume is to have.
[0125] In a first variant by numerical methods known to a person skilled in the art a free from surface is defined which circumscribes the volume whose removal effects the change in curvature. The volume thickness required for the desired modification in curvature is determined along the z axis. This gives the volume a function of r, φ (in cylinder coordinates) and the boundary surface is defined based on the volume.
[0126] On the other hand an analytical calculation is delivered by the following variant, already discussed in DE 102006053120 A1, in which the boundary surface of the volume is essentially built up from two surface parts, an anterior surface part facing the cornea surface 15 and an opposite posterior surface part.
[0127] The anterior cut surface 19 is preferably spherical as then a radius of curvature which is smaller by the thickness of a lamella d.sub.F than the radius of curvature R.sub.CV can be defined.
[0128] To the rear the volume 18 which is to be removed from the cornea 5 is limited by a posterior cut surface 20 which already basically cannot be at a constant distance from the cornea front surface 15. The posterior cut surface 20 is therefore formed such that the volume 18 has the form of a lenticle, which is why the posterior cut surface 20 is also called lenticle surface. This surface is shown in
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[0130] Due to the constant distance between cornea front surface 15 and flap surface 19, the lenticle surface 20 defines the curvature of the cornea front surface 15* after the volume 18 has been removed.
[0131] If the coefficient F is to be taken into account during calculation, in step S7 the change in topography of the cornea are considered, too, i.e. the current central thickness is computed. Using the resulting value for the coefficient F, steps S4 to S6 or S5 to S6 can then be carried out once again or repeatedly in the form of an iteration.
[0132] The formation shown in the figures of the volume 18, as limited by a flap surface 19 at a constant distance from the cornea front surface 15 and a lenticle surface 20, is only one variant for limiting the volume 18. However, it has the advantage that the optical correction is given essentially by only one surface (the lenticle surface 20), with the result that the analytical description of the other surface part of the boundary surface is simple.
[0133] Furthermore, safety margins with regard to the distance between the volume and cornea front surface 15 and cornea back surface 16 are optimal. The residual thickness d.sub.F between flap surface 19 and cornea front surface 15 can be set to a constant value, e.g. 50 to 200 μm. In particular it can be chosen such that the pain-sensitive epithelium remains in the lamella which is formed by the flap surface 19 beneath the cornea front surface 15. The formation of the spherical flap surface 19 is also continuous with previous keratometer sections which is advantageous in terms of acceptance of the method.
[0134] After producing the cut surfaces 19 and 20 the thus-isolated volume 18 is then removed from the cornea 5. This is represented schematically in
[0135] Alternatively in a simplified embodiment, however, merely the flap surface 19 can also be formed, by means of pulsed laser radiation, by target points which define the curved cut surface 19 at a constant distance from the cornea front surface 15, and the volume 18 is removed by laser ablation, for example by using an excimer laser beam. For this, the lenticle surface 20 can be defined as boundary surface of the area removed, although this is not essential. The treatment apparatus 1 then operates like a known laser keratome, but the cut surface 19 is produced using curved cornea. The previously or subsequently described features are also possible in such variants, in particular as regards the determination of the boundary surface, its geometric definition and determining control parameters.
[0136] If both the lenticle surface 20 and the flap surface 19 are produced by means of pulsed laser radiation it is expedient to form the lenticle surface 20 prior to the flap surface 19, as the optical result is better with the lenticle surface 20 (if not achievably only then) if there has still been no change in the cornea 5 above the lenticle surface 20.
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[0138] To isolate the volume 18, firstly the flap surface 19 and also the lenticle surface 20 is produced in the cornea 5 in the manner described. A correction surface is produced which is non-rotation-symmetrical in order to correct higher aberrations, thus the curvature of the front side 15 of the cornea 5 is to be changed after removal of the volume 18 not just with regard to sphericity. As the top view 33 on the lenticle surface 20 shows, this correction surface is produced by a spiral 32 which runs outwards from the inside of the correction surface. The spiral defines a path curve for shifting the position of the laser-beam focus. The centre of the spiral preferably (but not necessarily) lies at the highest point of the correction surface. The spiral is based on contour lines, whereby the z position (position along the main direction of incidence A of the laser radiation) of the focus position is continuously shifted. Instead of a group of closed scan lines which never intersect there is a continuous scan line. Local varying corrections of an optical refraction power B(r, φ) can be easily represented and obtained by modulation of an angle-dependent radial function r(φ) by a thus radially “deformed” spiral.
[0139] The edge line of the lenticle surface 20 is to be a circular line which lies in z direction which, as usual, is the main direction of incidence A of the treatment laser radiation. Thus z=const for the edge r.sub.MAX′ (f.sub.P, φ) of the lenticle surface 20. The correction surface which is required for optical correction is defined in a correction area 34. Here, the path curve is shown continuous. The edge of this correction area is naturally not rotation-symmetrical—but is level, as the spiral is based on contour lines. Therefore there is a modification of the spiral in a transition area 35 such that, within a limited number of revolutions, the angle-dependent distance relative to the path is modulated such that the non-rotation-symmetrical edge of the correction surface changes to a circle. The radial modulation is thus reduced to zero over a specific number of revolutions. For example this can take place by choosing the number of revolutions of the spiral in the transition area such that it corresponds to the quotient from the difference in radii and the desired distance between the spiral paths. The difference in radii is the difference between the minimum radius of the correction surface and the radius of the desired circular edge which is preferably equal to, or only slightly larger than, the maximum radius of the correction surface.
[0140] This continuation of the spiral in the transition area 34 continues the correction surface, which is the cut surface geometry in the correction area 34, such that it terminates in a circular edge. This can be clearly seen in the relationships of the sectional representations in which dot-dashed reference lines are drawn-in for illustration. Furthermore, the continuation of the correction surface in the transition area is represented in the sectional representation by the same dotted line as the corresponding spiral revolutions in the top view 33 of the lenticle surface 20. The sectional representation shows that the rim of the lenticle surface 20 lies in a plane. Furthermore, it is circular. Therefore, the connection between the lenticle surface 20 and the spherical flap surface 19 can be produced by a simple lenticle edge surface 30 in the shape of a circle cone envelope.
[0141] There are no sections of the lenticle edge surface 30 or of the flap surface 19 which would be introduced into the cornea and which are not required for connection to the lenticle surface 20.
[0142] It is essential, to understand the embodiments described here, to distinguish between the transition area 35 and the lenticle-edge area 31 (corresponding to the cut surfaces 36 and 30). The transition zone thus adapts the otherwise non-rotation-symmetrical correction surface such that the lenticle surface 20 as a whole has a rotation-symmetrical edge. This edge is not lower, i.e. more posterior, than that of the correction surface (corresponding to the cutting line) but also not higher, i.e. more anterior. The plane in which the circular edge is formed by the transition area 35 thus cuts the correction surface or lies at least on the maximum or minimum of this surface. The correction surface is thus complemented by the transition zone, but is to be distinguished from the lenticle edge surface which, as simple circular cylindrical or cone-envelope-shaped cut surface produces the connection between two rotation-symmetrical edges, namely that of the lenticle surface 20 which has been reached through the transition zone 35, and that of the flap surface 19 (already spherical, in any case, in the described embodiment).
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[0144] In
[0145] Thus there is in the transition zone 35 a spiral with a constant distance relative to the path which is guided from the smallest radius of the correction surface in the correction zone 34 as far as the radius of the rotation-symmetrical edge which, expediently, is equated with the largest radius of the edge of the correction zone 34. However, the transition zone can optionally be overmeasured to a certain degree, thus the chosen radius of the rotation-symmetrical edge can be larger by an overmeasure than the largest radius of the correction surface in the correction zone 34.
[0146] When shifting along this spiral with a constant path distance, however, a laser treatment is suppressed at those path sections whose positions would lie within the correction zone or within the periphery of the correction zone 34. In the case of laser treatment by pulsed laser radiation for example according to the concept of DE 10358927 A1 the disclosure of which in this regard is incorporated in its entirety, the laser radiation pulse is made “harmless” with regard to its processing effect. It is shown in the sectional representation of
[0147] The representation in
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[0149] The transition zone 35 is thus a planar spiral with a constant distance relative to the path which runs from the small semiaxis H1 as far as the large semiaxis H2 of the elliptical correction zone 34 to reach the circular edge.
[0150] In the embodiment of
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[0152] Equally, the invention of the first variant does not realize the embodiment of
[0153] The use of pulsed laser radiation is not the only way in which surgical refraction correction can be carried out. The determination, described here, of control data for operating the device can be used for almost any operating procedure in which, by means of a device, with control by control data, a volume is removed from the cornea or added to it, as already explained in the general section of the description.