WO2002056791A2

WO2002056791A2 - Keratometric to apical radius conversion

Info

Publication number: WO2002056791A2
Application number: PCT/US2002/001274
Authority: WO
Inventors: Jack Holladay
Original assignee: Lasersight Technologies, Inc.
Priority date: 2001-01-19
Filing date: 2002-01-18
Publication date: 2002-07-25
Also published as: WO2002056791A3; AU2002243570A1

Abstract

The present invention provides apparatus (300) and techniques for performing prolate shaped corneal reshaping using an ellipsoid corneal modeler (310). In accordance with the principles of the present invention, an ellipsoid corneal modeler (130) is implemented with the well behaved conicoid, combined with a modeled surface which can be used for astigmatic treatments. An ellipsoid corneal modeler includes an ellipsoid fitter which utilizs two radii of curvature, asphericity (Q), and a surface rotation about the pupil center. Moreover, a conversion is provided to convert between measurements obtained by a keratometer, and apical radii. In a further embodiment provided by the present invention, conversion is made possible between radii measurements obtained clinically (e.g., using a keratometer) and radii measurements at the apex, i.e., keratometric to apical radius conversion.

Description

KERATOMETRIC TO APICAL RADIUS CONVERSION

This application claims priority from US Provisional Application, Serial Number 60/262,378, entitled "Keratometric to Apical Radius Conversion", filed January 19, 2001 ; and from U.S. Pat. Appl. 09/679,077, entitled "Prolate Shaped Corneal Reshaping", filed October 5, 2000, which itself claims priority from U.S. Provisional Appl. 60/223,728, entitled "Prolate Shaped Corneal Reshaping", filed August 8, 1999, and U.S. Provisional Appl. 60/157,803, entitled "Prolate Shaped Corneal Reshaping", filed October 5, 1999. All of these applications are expressly incorporated herein by reference.

This application is a continuation-in-part of U.S. Pat. Appl. 09/679,077.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to apparatus for use in reshaping the cornea of a human eye. More particularly, it relates to human corneal refractive surgery and techniques and apparatus used to model the human eye as an ellipsoid to determine a desired refractive correction.

2. Background of Related Art

First generation ablating excimer laser systems are characterized by relatively large diameter laser beams (6mm), low laser pulse repetition rates (10Hz), and mechanical means for shaping the resultant ablation profile. These older generation systems cannot achieve the accuracy required to shape the ablation profiles described in this disclosure, nor do they have the resolution necessary to achieve optimal refractive results. The excimer laser system described herein is a later generation system incorporating a small diameter laser beam (<1 mm), operating at relatively high laser pulse repetition rate (100 - 300Hz), and incorporating computer controlled x-y scanning to control the ablation pattern.

A model of the human eye is used for the initial and target shapes for corneal refractive surgery. The currently utilized technique for planning refractive surgery assumes that the human eye is a spherical globe of a certain radius of curvature r.,, as depicted in Fig. 4A. To correct refractive errors, a spherical globe of lesser or greater curvature is targeted to achieve the ideal patient refraction. The intersection between these two globes provides the amount of material to remove from the patient's cornea in order to achieve the target refraction.

Fig. 4B depicts a Munnerlyn model wherein a presumed spherical cornea is ablated to a desired spherical shape having a single radius r_Λ Using this model, the target corneal surface is always a spherical shape.

However, the cornea is not exactly spherical, and ablation systems and techniques which determined a closest fit sphere to a patient's cornea where somewhat inaccurate because of the differences between the actual shape of the cornea and the best fit sphere modeling the cornea used by the ablation system.

Corneal ablation surgery was then extended to use initial and target toroidal surfaces instead of spheres to allow for correction of astigmatic refractive error. Astigmatisms are refractive errors that occur along two different radii. A toroidal surface might be thought of as an 'inner tube' shape, with a major radius r_n (the radius of the whole tube) and a minor radius r₂ (the radius of a cross sectional area of the tube), as shown in Fig. 5A. Thus, the art had moved from models having a single radius (i.e., spheres) to models having two radii (i.e., toroids). The toroidal surface, however, makes the assumption that the eye shape is circular along any meridian through the optical center of the eye's surface. An exemplary toroidal ablation pattern is shown from above the cornea in Fig. 5B. However, in practice, this is rarely the case, and toroidal surfaces too cause inaccuracies in ablation systems due to the differences between the best fit toroidal surface and the actual shape of the patient's cornea. The human eye is perhaps best modeled by using an ellipsoid instead of a toroid or a sphere. If an ellipsoid is used to model the human eye, the prolate shapes, or surfaces, of the ellipsoid can be used to more accurately describe the true shape of the eye. A prolate shape is one having its polar axis longer than its equatorial diameter. Substituting the ellipsoid shape instead of the toroid shape can then be used to determine the corneal tissue to remove.

The ellipsoid shape is a surface in which all plane sections perpendicular to any axis of which are ellipses or circles. The normally flatter portions of the ellipsoid shape are considered as oblate or flattened or depressed at the poles. The steeper areas of the ellipsoid are considered as prolate or elongated in the direction of a line joining the poles. The currently applied models of the human eye utilized to plan ablation profiles result in corneal surfaces that approximate an oblate shape. Light rays refracted through the oblate surface are not confocal; i.e. they do not have the same foci.

The result of this inability to achieve a confocal condition frequently results in glare, halos, and loss of night vision.

While the advantages of ellipsoidal modeling of a cornea have been noted, conventional corneal modeling either uses a toric or biconic. The biconic requires the solution of four (4) or more parameters (e.g., two radius values, two eccentricity values). The use of the ellipsoid equation on eccentricity has not been used, only the biconic.

There is thus a need for an ablation laser system and method which utilizes accurate ellipsoidal modeling for precise and realistic refractive correction of corneas.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, an apparatus and method for modeling a cornea is provided. A radius of curvature of a cornea is measured. The measured radius is converted to an apical radius. An ellipsoid is fit to the cornea based on the apical radius. In other aspects of the present invention, a prolate corneal modeler in a corneal laser ablation system comprises a corneal measurement input module, and an ellipsoid fitter. The ellipsoid fitter generates a best ellipsoid fit to corneal data input to the ellipsoid fitter using an ellipsoid algorithm having only three degrees of freedom.

A method of modeling a corneal surface in accordance with another aspect of the present invention comprises receiving corneal measurement data, and fitting the corneal measurement data to a best fit ellipsoid having only three degrees of freedom. A method of ablating a cornea into or maintaining a prolate shape in accordance with still another aspect of the present invention comprises determining a desired ablation pattern to form a prolate shaped ellipsoid on a surface of the cornea.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become apparent to those skilled in the art from the following description with reference to the drawings, in which:

Fig. 1 shows an exemplary laser ablation system including ellipsoid modeling control, in accordance with the principles of the present invention.

Fig. 2 depicts the use of modeling in corneal refractive surgery, in accordance with the principles of the present invention.

Fig. 3 shows an exemplary protocol for performing ellipsoid prolate laser ablation, in accordance with the principles of the present invention.

Fig. 4A shows a conventional technique for performing refractive surgery which assumes that the human eye is a spherical globe of a certain radius of curvature r.,, and Fig. 4B depicts a Munnerlyn model of a cornea wherein a presumed spherical cornea is ablated to a desired spherical shape having a single radius r,'. Fig. 5A shows an advanced model of a cornea as a toroidal surface including a major radius r, and a minor radius r₂, and Fig. 5B shows an exemplary toroidal ablation pattern is shown from above the cornea in Fig. 5B.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The present invention provides apparatus and techniques for performing prolate shaped corneal reshaping. In accordance with the techniques, a spheroequivalent ellipsoid model is implemented to provide a pre- and post- operative approximation of a cornea, and a desired prolate shaped ablation profile is determined based on a desired ellipsoidal shape. In accordance with the principles of the present invention, the ellipsoid model has only three degrees of freedom (not four as in a conventional biconic) to define a desired ablation profile, providing extremely accurate and predictable long term vision correction.

To arrive at an ellipsoid model having only three numbers of freedom, a spheroequivalent (SEQ) value of eccentricity ε or asphericity Q (1 +Q_SEQ)=(1- ε_SEQ ²) where Q_SEQ = - ε_SEQ ², is generated. The eccentricity ε value replaces two numbers of freedom (i.e., eccentricities) in an otherwise conventional biconic modeling system, leaving only three (3) variables to determine for a best fit ellipsoid to a corneal surface, to make accurate prolate ellipsoidal modeling of a cornea possible (Q, r₁₍ r₂).

The disclosed embodiment of the present invention is specifically related, but not limited, to corneal refractive surgery performed with an ablating laser. An example of an ablating laser system is the LaserScan™ LSX excimer laser system available from LaserSight Technologies, Inc., Winter Park, FL. While the description of the invention is related to laser corneal ablation, the method described herein is equally applicable to other laser systems such as tempto second laser, holmium, etc., and other techniques for corneal correction that include ALK, PTK, RK, and others. The method and apparatus disclosed herein utilizes a model that plans the ablation profile based on generating a prolate shape on the corneal surface, and an excimer laser apparatus with a computer controlled scanning system to ablate the desired profile onto the corneal surface. The prolate surface refracts rays into a better focus configuration, thereby minimizing the occurrence and effects of glare, halos, and loss of night vision from aberrations inherent in an oblate shape.

In conventional corneal ablation procedures, only one surface of the cornea is ablated or corrected. For instance, while the anterior corneal surface is ablated, the posterior surface remains as it was before the corrective surgery. However, the present inventors realized that when correcting for astigmatism on a corneal surface, some amount of astigmatism should essentially be left on the front surface to correct for correlating astigmatism existing on an opposite surface of the cornea and the crystalline lens.

Ellipsoidal surface modeling allows an ablation system to actually leave some astigmatism on the ablated corneal surface, e.g., on the anterior corneal surface, to neutralize astigmatism on the posterior cornea, e.g., on the posterior surface and from the crystalline lens. In particular, in the case of corneal astigmatism, it is determined that an amount of residual astigmatism (e.g., 10% of the astigmatism) is preferably left on the ablated front corneal surface to neutralize the related astigmatic error on the back corneal surface. This is particularly why spherical modeling and spherical shaped ablation patterns will not totally correct astigmatism: because it cannot correct for the astigmatic condition also existing on the posterior surface of the cornea. For instance, if a particular cornea is measured to have 10 diopters of net astigmatism (+11 diopters on the front of the cornea, and -1 diopter on the posterior surface). In such a case, a 10 diopter correction is preferred to leave +1 diopters on front surface to balance out a presumed -1 diopter astigmatism on the posterior surface of the cornea. Biconics require an eccentricity parameter in each radial direction, thus there are conventionally at least four parameters of freedom which must be determined to define a particular pre- or post-operative corneal surface (&,, Q₂, r.,, r₂). Thus, to fit a biconic to a corneal surface, at least four variables must conventionally be 'solved', and the cross-sections are not necessarily elliptical.

For instance, as pointed out in an article entitled "Ellipsoidal Fitting of Corneal Topography Data After Arcuate Keratotomies With Compression Sutures" by Achim Langenbucher, Berthold Seitz, Murat Kus, Ernesto Vilchis, and Michael Kuchle ("Langenbucher"), the problem is to fit a biconic to corneal dioptric power data. This article is expressly incorporated herein by reference.

Langenbucher implements a simplex algorithm to approximate a model biconic function defined by four (4) or more numbers of freedom to a corneal surface characterized by axial power data. The best fit is defined as a model surface minimizing the distance between the measured dioptric power data of the actual corneal surface and the dioptric power data of the model surface, e.g., using root mean square (RMS) error of the distance.

Generally speaking, the conventional four variables for which to solve, or the four numbers of freedom of the biconic function are the first radius r.,, the first eccentricity ε_1τ the second radius r₂, and the second eccentricity ε₂. The eccentricities ε.,, ε₂ essentially define the amount of ovalness to the relevant surface. The greater the eccentricity, the greater the oval. Langenbucher used all four degrees of freedom in a biconic, but didn't realize that both asphericities or eccentricities Q.,, Q₂ couldn't be specified using the ellipsoid to model the corneal surface data. The present invention appreciates that using a biconic ellipsoidal model with four (4) degrees of freedom, all four degrees can't be fully solved or ideally fit to otherwise conventional stereo topographical input data, only three (3) parameters can be used for the ellipsoid (r.,, r₂, &,). The present invention provides apparatus and techniques which provide an ellipsoidal model having only three (3) degrees of freedom. Using conventional refractive measurements (e.g., stereo topography measurements of the corneal surface), these three degrees or numbers of freedom can be accurately solved to fit conventional topographical input data to model the corneal surface.

In accordance with the principles of the present invention, the ellipsoidal model is reduced to only three (3) degrees of freedom, allowing a more accurate solution and more accurate post-operative results. Thus, a clinical target of a post operative ellipse is utilized in the biconic model to reduce the four (4) degrees of freedom in Langenbucher's system to only three (3). The biconic does not have elliptical cross-sections and does not truly reflect regular astigmatism.

In particular, the present invention utilizes apparatus and techniques which replace the two asphericities Q.,, Q₂ of the conventional ellipsoidal model with a single spheroequivalent eccentricity Q_SEQ. In accordance with the principles of the present invention, the average eccentricity of a human cornea is ε=+0.51 , or in other words, Q_SEQ = -0.26.

Using the spheroequivalent eccentricity Q_SEQ, the present invention defines and provides a 'spheroequivalent' ellipsoidal model of a cornea, which essentially is an ellipsoidal equation solved for an average human's cornea, leaving only three (3) variables to be processed for a best fit to corneal measurement data.

The formula for defining an ellipsoid requires three parameters (along an x-axis defined as r_x, along a y-axis defined as r_y, and Q spheroequivalent asphericity. These parameters can be directly applied to a grided area centered about the origin utilizing a pseudo-code. The r_x and r_y values are given directly as the curvature values normally used by the toroid derivation. In accordance with the principles of the present invention, the additional ε parameter may be defined by the eccentricity parameter ε_SEQ.

The spheroequivalent ε_SEQ is derived as follows: The spheroequivalent ellipsoidal model requires a first keratometric value K, at a first axis (e.g., the x-axis), and a second keratometric value K₂ at a second axis (e.g., the y-axis).

Then, these constants K„ K₂ are converted into two-dimensions including the z-axis. In particular, the first constant K, value is converted to another constant in two-dimensions K_X2, and the second constant K₂ value is converted to another constant in two-dimensions K_γz. This involves rotation with respect to the x-axis and the y-axis when they are not with-the-rule (90°) or against-the-rule (180^°), which would be the case for a patient with oblique astigmatism.

In accordance with the principles of the present invention, given only the K values, the eccentricity is assumed. In the disclosed embodiments, post-operative corneal topography data is used to empirically determine a mean eccentricity value. The exemplary and preferred post- operative eccentricity value is e_SEQ=+0.51 , or Q_SEQ=-0.26.

To convert to radii, we have from the keratometric formula, the following equations (1):

and

337.5

^RYZ

^KYZ

wherein R_χγ and R_γz are radius in millimeters, and the constants K_X2 and K_Y2 are in diopters.

In accordance with the principles of the present invention, a spheroequivalent constant K value, K_SEQ, is defined as shown in the following equations (1 b):

v- _ fχxzXJXz_ The keratometric index of the keratometer used for measurement is factored in to arrive at an equation for the spheroequivalent radius R_SEQ. Note that the keratometric index is not standardized from one keratometer to another. In the disclosed embodiment, a keratometer manufactured by HUMPHREY™ was used, having a particular keratometric index of 337.5. Of course, the present invention relates to any keratometer having any keratometer index, e.g., 333.6, 333.2, etc.

The equation for the spheroequivalent radius R_SEQ using the keratometer index of the HUMPHREY™ keratometer is:

337.5

R S.EQ

K S,EO

Another equation for the spheroequivalent radius R_SEQ is:

_ 2R_χyR_yZ_

^ΛSEQ ~ _p „

J\χγ "I- I .^

Combining these last two equations for R_SEQ, we arrive at:

337.5 2Λ _EJ?_E -SEQ -*\ΛZ ^"*^" -K-Yz

Assuming the vertex of the cornea is the positive z-intercept, we have the radius values R^, R_YZ and an assumed average eccentricity e_SEQ or asphericity Q_SEQ.

The general form of an ellipsoid is shown in the following equation (2):

which equates to:

where the constraining equation that provides the proprietary ellipsoidal model form derives from average radius of a cornea, in spheroequivalent power.

This leads to equation (3a):

Using the mean value eccentricity and asphericity for the human population (Q_SEQ = -0.26, e_SEQ = +0.51 ), we have equation (3b):

Solving for z, from equation (3a) we have:

where values of x must be between -R_xz and +Rχz, and values for y must be between -R_γzand +R_Y2.

This is the final equation for a spheroequivalent ellipsoidal model for a patient with known values of K, and an assumed mean population eccentricity (asphericity) to create an ellipsoid model having only three (3) variable parameters, in accordance with the principles of the present invention.

The resulting actual asphericity in the xz and yz planes is related to the spheroequivalent eccentricity Q_SEQ by the following equations

(5a) and (5b).

R, c = xz

( + Qxz)

Slope in ZX and ZY plane are:

, _ dz _ C X , , dz and z,' = — = - = R = — and z'A ff = — dx *²z

K are also equal to K (curvature) at

vertex.

a¹ , a¹ , _ . 1 , , < v² , , ό² , 6²

R, =| — ■_^ |= — and R_yz H -— 1=| -X- 1=| 1= — K d z

R_xγ and R_xz are referred to as 'apical' radii. These variables, in practice, are measured using a keratometer. A keratometer measures a radius along a given circle about the cornea, e.g., along a 6mm circle encircling the cornea, and then associates that measured radius as the instantaneous radius at the axis, or north pole of the ellipsoidal model.

The present invention recognizes that there are errors associated with measuring a radius applicable to the 'north pole' of the ellipsoid model along a circle approximately 6mm in diameter. In other words, the instantaneous radius exactly at the center of the cornea may (and likely will) be of a different instantaneous radius at a point 3mm from the center of the cornea (i.e., along the 6mm diameter circle measured by a keratometer).

The apical radii R_xγ and R^ refer to measurements at the apex, or center of the ellipsoid (i.e., at the 'north pole'), but a keratometer's measurements relate to data actually measured at points peripheral to the apex (i.e., typically along a circle 3mm out from the 'north pole'). The equations discussed above relate to radii measured at the apexes. While conventional techniques assumed that a keratometer measured apical radii, in fact the difference between the keratometer measurements and theoretically correct apical radii can be significant.

For instance, a keratometer measures cord length between two points, e.g., 1.6 mm on either side of the center. The present invention recognized that keratometer measurements (e.g., post-operative) consistently showed a flatter curved surface than was in the elliptical model used to perform corneal ablation surgery. As much as a V diopter variance may be seen as between radii measured with a keratometer versus the apical radii R_xγ and R_xz of an elliptical model. In a further embodiment provided by the present invention, conversion is made possible between radii measurements obtained clinically (e.g., using a keratometer) and radii measurements at the apex, i.e., keratometric to apical radius conversion.

The following equations are used to show keratometric to apical radius conversion in accordance with the principles of the present invention.

The general solutions in math for curvature K, and instantaneous radius of curvature R are as follows (noting that the equation for z is given herein above):

Curvature K = ^^" | ,„ and

[l + (z')²l^3/2

1 \l + (z'ΫΫ Radius of Curvature is R = — = • ^v

K | r |

At vertex of ellipsoid (0,0,c) the slope is zero, therefore the radius of curvature is the reciprocal of the 2^nd derivative only as in the above equations.

However, as we move away from the point 0,0, these equations for Curvature K and Radius of Curvature a no longer true. In such a case, for any point on the XZ ellipse or the YZ ellipse, the 2^nd derivative, curvature and radius would be determined from the equations above as follows: (given that

A_x = 1 +Q_X and A_y = 1 + Q_y) First derivative of z:

' - dz _ c^lx

.^ and = ^ = -^ y . dx ^'aX. A_xz ^y dy b A_yz

Second derivative of z

z_x" =

Thus, plugging these derivative of z equations into the equations above, the radius of curvature at Xe and Ze becomes:

wherein R_xk and R_yk refer to the measurements with respect to a keratometer; and the value "44" refers to the average diopter power of a cornea in the human population. Also, most commercial keratometers on the market today measure between 2.6 and 3.2, and so the value of 3.0 was selected as an easy median value of commercially available keratometers. Thus, the value "3.0" refers to an estimate of the mean sample diameter that most commercial keratometers measure today on a 44D cornea. These are the equations which let us get back to the apical radius from the radius measured by a keratometer, i.e., at any point along an ellipse other than (0,0, c). Thus, a keratometric radius of curvature (ROC) and curvature K may be provided into an elliptical model with correct results as if an apical curvature K was provided.

The reverse solution from R_xk to R_xo and R_yk to R_yo is also provided. In such a case, curvature K measurements (R_xk & R_yk) are provided along with A_seq, and apical radii measurements R_x0 and R_yo may be determined therefrom. In particular, resolving the R_xk equation for z², we have the general form of the cubic equation:

J³ +py² +qy + r = 0 , where z² = y

²(3 ^l -2R_x ²,Λ •)

9 ^~ K x x² - A_x ²R_x ² _k)

substituting w-p/3 = z² = y, we have

w³ +dw + e = 0 . where d =-(3q~p²) and e = — (2p³ -9pq + 27r)

J 1.1

/a z = ² ~ QQ ^{COS —} — P > ^usually this is the correct answer, the 3y 3 others are negative. θ + 2π z _^ l^QQc sX-

3 ^P ( Ω Λ. i rr ^ z = 2j-QQco^ ⁺ *^π 1

R_xo is the apical radius corresponding R_xk, the keratometric reading at x_e R_yo is the apical radius corresponding to R_yk, the keratometric reading at y_e.

R o — _yC

In practice, pre-operative refractive measurements and keratometry or topography measurements are taken for the patient's cornea to obtain per-operative front surface power measurements. Typically, the refractive measurements include refraction, K readings, and asphericity.

Generally speaking, no two patients have the same refractive measurements.

In accordance with the principles of the present invention, these measurements are fitted into an ellipsoid having three numbers of freedom, ,, K₂ and Q_SEQ. This defines an ellipsoid (prolate) shape. Essentially no patient has a perfect ellipsoidal shaped cornea, so a best fit three (3) parameter ellipsoid is determined, defined by K,, K₂, and Q_SEQ.

A best fit ellipsoid having three (3) numbers of freedom is determined based on patient refractive measurement data, and a difference between an ideal ellipsoid and the best fit spheroequivalent ellipsoid is determined, forming the basis of the ablation profile.

The input measurement data may be smoothed prior to computing a best fit ellipsoid. For instance, a bivariate Fourier series smoothing program provides adequate smoothing of topographical input data in the disclosed embodiments to present more uniform input data to a best fit three (3) parameter ellipsoid module to arrive at a more accurate ellipsoidal model. An exemplary Fourier series bivariate may use either two variable 2^nd order to two variable 5^th order smoothing.

Alternatively, or additionally, the smoothing may be performed on the difference data between the pre-operative refractive measurement data and the ideal three (3) parameter spheroequivalent ellipsoid, to generate an irregular difference matrix from the best fit preoperative ellipse.

Additional or alternative smoothing may be performed, e.g., by visually reviewing three-dimensional graphical results to look for sports or outlying data points and/or high frequency components. In the given embodiment, the final smoothed difference matrix determines a custom ablation component, i.e., the desired ablation profile.

Then, the ablation of the difference is performed. Post operation, the resulting corneal shape is measured topographically. The resulting corneal shape should ideally fit the ideal spheroequivalent ellipsoid as programmed into the ablation system. However, outside factors may and do influence the actual ablation profile (e.g., poor height data, interference from ablation plumes, moisture buildup on the cornea, etc.) In particular, the low resolution of height data is believed to be a major factor in delta measurements between the desired ideal ellipsoidal shape and the actual post-operative ellipsoidal shape of the cornea. For instance, calibration

EYESYS™ 2000, Humphrey Atlas, surfaces are therefore ASTRA_MAX, etc. used to determine the precision of the instruments. Commercially available topographical units such as EYESYS™ 2000, Humphrey Atlas, etc., are found to provide adequate corneal surface height data, particularly when augmented by integration between the 51x51 matrix of measurement points using curvature data to provide integrated height data between measurement points.

However, in accordance with the principles of the present invention, these differences are repeatable and predictable, and can generally be overcome with the inclusion of a calibration matrix corresponding to the ablation area to increase or decrease ablation in certain areas of the surface. For instance, in one embodiment of the present invention, a delta Q_SEQ correction factor matrix is established to compensate for differences between the ideal three (3) parameter ellipsoid and the shape of the post-operative cornea. The Q_SEQ correction factor matrix preferably corresponds to each of the points of measurement of the measurement system (e.g., topographical input data matrix), and relates to a depth of ablation difference at each measurement point between what was expected of the scanning ablation system and what actually results from patient to patient, essentially 'correcting' each of the measurement points taken pre- operatively. Different depths of ablation have different delta Q_SEQ's. In this way, an ablation profile will be established by the ablation system based on actual pre-operative data and adjusted per the Q_SEQ correction factor matrix to result in the ideally shaped cornea post-operatively.

The Q_SEQ correction factor matrix may be established empirically. Current embodiments utilize topographical height data and a 51 x 51 point correction matrix. While this correction matrix is described herein as being performed in an EYESYS™ 2000, ASTRA_MAX system, the same can be implemented in any topographer within the principles of the present invention. Empirical information can be used to refine the correction matrix. For instance, an 'average' compensation factor can be derived for each of the 51 x 51 points based on a difference between expected ablation depth (i.e., pre-operation value) and actual ablation depth (i.e., post-operation value), and a compensation factor can be used to correct the expected ablation depth to be equal to the presumed actual ablation depth. The compensation factors form a transfer function matrix.

For instance, in some refractive procedures it was seen that an ablation system induced slightly more oblateness from the ideal ellipsoid. Use of a correction factor matrix can refine the amount of induced oblateness to result more closely in the desired prolate ellipsoidal shape. The correction factor matrix may be refined empirically for particular laser ablation systems by adjusting initial K-values and/or Q-values in addition to the amount of treatment.

Prolate ablation using accurate three (3) parameter ellipsoid modeling provides important advantages, particularly over conventional spherical, toric and biconic techniques. For instance, if a person's scotopic pupil is above about 3.0 mm, use of spherical modeling is not as preferred because the spherical aberration is too great and not sufficiently accurate. If the pupil is greater than about 3.0 mm, use of spherical modeling of the cornea is not sufficiently accurate and may degrade the optics of the eye, resulting in spherical aberration, halos and glare.

Prolate ablation using ellipsoidal modeling with three (3) degrees of freedom in accordance with the principles of the present invention is best for corneal modeling. As discussed, bi-conic modeling is disadvantageous because the four (4) degrees of freedom can produce a shape whose cross-section is not an ellipse and cannot be corrected to sphero-cylindric lenses (i.e., regular astigmatism).

Fig. 1 shows an exemplary laser ablation system including spheroequivalent ellipsoid modeling control, in accordance with the principles of the present invention. In particular, Fig. 1 shows a ellipsoid prolate laser ablation system 300 including a scanning ablation laser 380, a pre-operative ellipsoid fitter 320, a smoothing module 330, a post-operative spheroequivalent ellipsoid determiner 340, a prolate ablation profiler 350, and a custom prolate ablation profiler 360. The scanning ablation laser 380 (e.g., an excimer laser, 193 nm fundamental wavelength, 10 mJ/pulse max output at fundamental wavelength). An otherwise conventional scanning ablation laser 380 such as in LaserScan™ LSX excimer laser system available from LaserSight Technologies, Inc. includes an exemplary ablation laser 380. The prolate laser ablation system 300 further includes a prolate corneal modeler controller 302, including a suitable processor (e.g., microprocessor, microcontroller, or digital signal processor (DSP)), such as the laser ablation system controller found in the LaserScan™ LSX excimer laser system.

In accordance with the principles of the present invention, the prolate corneal modeler controller 302 controls software based modules capable of determining an ellipsoidal ablation pattern and directing prolate- shaped corneal refractive surgery. While shown as separate modules in Fig. 1 , spheroequivalent refractive surgery may be directed with combined modules and/or separated modules, in accordance with the principles of the present invention. In the exemplary separation of modules shown in Fig. 1 , the prolate corneal modeler controller 302 communicates with a refractive measurement input module 310. The refractive measurement input module 310 may be any suitable input device (e.g., keyboard, serial or parallel link to corneal topography equipment, etc.) which allows input of refractive measurement data.

In particular, as shown in Fig. 2, a corneal surface 130 is refractively measured pre-operatively using, e.g., topographical measurements, checkered placido measurements, refractive measurements, etc. A cross-sectional view of a measured corneal surface 130 is depicted in

Fig. 2.

Referring back to Fig. 1 , preferably, the refractive measurement input module 310 includes a suitable measurement input program to extract three (3) or more (up to ten (10) or more if necessary) preoperative exams to run on, e.g., an Eyesys 2000 system.

In the disclosed embodiment, the refractive measurement input

^• module 310 may be adapted to also or alternatively accept three (3) or more exported exams if sent to "Custom Ablation Center" for evaluation. The resultant refractive measurement data may result in a matrix, e.g., a 51 X 51 point array in patient orientation with means and standard deviations. Preferably, standard deviations are less than 1 micron. The center point (26, 26) of the 51 x 51 point should be the vertex zero, and all other points should relate to a mean "drop" in height from vertex in microns. Preferably, only real values are given in the 51 x 51 point array. If no value is given for a particular point, it is preferably left "blank", and not input as a negative number (e.g., not -1 ).

The pre-operative spheroequivalent ellipsoid fitter 320 utilizes the three (3) number of freedom ellipsoid modeling techniques disclosed herein to determine a best fit ellipsoid 100 to the pre-operative refractive measurements, as shown in Fig. 2. The smoothing and/or frequency filter module 330 may utilize, e.g., a Fourier Series Bivariate using either 2 variable 2^nd order to 2 variable 5^th order. The smoothing in the disclosed embodiment was performed on the difference in each matrix point between the measured preoperative refractive measurement data and the ideal ellipsoid. This generates an "irregular difference" matrix from the best fit preoperative ellipse. The final smoothed difference matrix determines the custom ablation component, and when combined in the transfer MATRIX results in the ablation profile.

The post-operative spheroequivalent ellipsoid determiner 340 determines a desired postoperative ellipse 150 (Fig. 2) from vector analysis using the preoperative K's, preoperative refraction, desired postoperative refraction and vertex distances. All calculations are preferably calculated at the corneal plane after vertexing.

The ideal asphericity preferably maintains the Q-value. However, acceptable results are obtained when the value of Q_SEQ for a best fit spheroequivalent ellipsoid having three (3) degrees of freedom fit to postoperative refractive measurements is between -0.25 and -0.50 postoperatively.

The prolate ablation profiler 350 determines a desired ablation profile. To compensate for oblateness due to a particular laser ablation system, the predicted oblateness from the spheroequivalent ellipsoid equation may be added to the actual pre-operative value of Q_SEQ to give the initial Q- value for the pre-operative cornea. This may also be corrected with a correction matrix in accordance with the principles of the present invention.

For example, if the resulting cornea is more oblate from the ideal, expected spheroequivalent ellipsoidal shape by +1.00 and the patient is -0.25, a pre-operative Q-value would be +0.75, with a post-operative target of -0.25.

From these two ellipsoids, a desired ablation profile for programming into the ablation laser system may be determined for, e.g., a 6.5 mm optical zone. A spheroequivalent ellipsoid having three (3) degrees of freedom in accordance with the principles of the present invention is capable of being used for any treatment diameter from 5 to 9 mm, where the optical zone and the blend zone equal the treatment zone.

The present invention may or may not be used in conjunction with custom ablation techniques. For instance, while the disclosed embodiments relate to the use of corneal topography to provide customized cornea data, the principles of the present invention relate equally to prolate ablation using only refractive measurements of the subject cornea.

In the case of custom ablation, the custom prolate ablation profiler 360 may smooth the irregular difference matrix, and/or multiplied by a correction factor transfer function based on a machine-specific calibration factor matrix 370.

The transferred smooth irregular difference matrix may then be added to the prolate ablation profile to arrive at a desired custom prolate ablation profile.

In the given example, the custom prolate ablation profile matrix may be smoothed in a particular ablation region, e.g., between the 6 and 7 mm zone, the result being a final custom prolate ablation profile matrix which is imported into the laser ablation system. Fig. 3 shows an exemplary protocol for performing ellipsoid prolate laser ablation, in accordance with the principles of the present invention. An exemplary method of implementing the Keratometric to Apical radius conversion is as follows, using a commercially available Eyesys 2000 system, together with a Colvard pupillometer, Orbscan, stereo optical vision tester, and automated keratometer. 1. Use spheroequivalent (SEQ) ellipsoid formulas to generate 3 ellipsoids: a. Ellipsoid from Automated keratometer, PreK1@axis1 , PreK2@axis2, PreQseq, b. Ellipsoid from EYESYS™ 2000. c. Ellipsoid from Orbscan II commercially available from

Humphrey Atlas.

2. Calculate height data from above for all three and compare with Orbscan Actual.

3. Take Best Refraction and Target Post Refraction and vertex each to cornea.

4. Calculate desired SIRC from #3 at corneal plane.

5. Calculate Pre R1 and Pre R2 from K1 and K2, using 1.3375.

6. Calculate Pre Front Surface Power (FSP) PreFSKI and PreFSK2 using 1.376. 7. Express Pre FSP as vector, e.g., 50.00 +2.50@90. Note use power notation.

8. Calculate desired FSP (DFSK 1 and DFSK2) = PreFSP + Desired SIRC. Vector calculation with probable new axis.

9. Calculate radii DPostRI and DPostR2. 10. Plug DpostRI and DpostR2 back into ellipsoid model setting desired postQseq to preQseq.

11. Calculate height data of desired post op cornea from #10.

12. Determine treatment matrix (height removal matrix) for each of three models (1a, b & c). 13. Examine differences in 3 difference matrices.

14. Determine final treatment matrix. After review #13. While the invention has been described with reference to the exemplary embodiments thereof, those skilled, in the art will be able to make various modifications to the described embodiments of the invention without departing from the true spirit and scope of the invention.

Claims

CLAIMSWhat is claimed is:

1. A method of modeling a cornea, comprising: measuring a radius of curvature of a cornea; converting said measured radius to an apical radius; and fitting an ellipsoid to said cornea based on said apical radius.

2. The method of modeling a cornea according to claim 1 , wherein: said measurement of radius of said cornea is obtained with a keratometer.

3. The method of modeling a cornea according to claim 1 , wherein: said fitting an ellipsoid is performed using only three variable parameters.

4. The method of modeling a cornea according to claim 3, wherein: said only three variable parameters are two apical radius values and only one eccentricity value.

5. The method of modeling a cornea according to claim 4, wherein: said only one eccentricity value is a spheroequivalent eccentricy value.

6. The method of modeling a cornea according to claim 3, wherein: said three parameters include a spheroequivalent eccentricity value.

7. The method of modeling a cornea according to claim 1 , wherein: said measurements relate to an optical property of said cornea.

8. A method of modeling a cornea, comprising: measuring a radius of curvature of a cornea; converting said measured radius to an apical radius; and fitting an ellipsoid to said cornea based on said apical radius.

9. The method of modeling a cornea according to claim 1 , wherein: said measurement of radius of said cornea is obtained with a keratometer.

10. The method of modeling a cornea according to claim 1 , wherein: said fitting an ellipsoid is performed using only three variable parameters.

11. The method of modeling a cornea according to claim 10, wherein: said only three variable parameters are two apical radius values and only one eccentricity value.

12. The method of modeling a cornea according to claim 1 1 , wherein: said only one eccentricity value is a spheroequivalent eccentricy value.

13. The method of modeling a cornea according to claim 10, wherein: said three parameters include a spheroequivalent eccentricity value.

14. The method of modeling a cornea according to claim 1 , wherein: said measurements relate to an optical property of said cornea.