Method for the optimized prediction of the postoperative anatomical position of an intraocular lens implanted in a pseudophakic eye

10709326 · 2020-07-14

Assignee

Inventors

Cpc classification

International classification

Abstract

Postoperative lens position is predicted on the basis of known measured values, such as the corneal thickness, the depth of the anterior chamber, the eye length, and the distances of the capsular bag equator and/or of the lens haptic from the anterior surface of the lens. In addition, the calculation also takes into account the attitude of the intraocular lens, for which purpose additional parameters of the pseudophakic eye are used that have not previously been taken into consideration. The proposed method is suitable for a more exact prediction of the strength and nature of an intraocular lens to be implanted in a pseudophakic eye in the context of cataract surgery or of a refractive intervention. The method is based on the use of suitable calculation methods, e.g. geometric optical formulae, or of ray tracing.

Claims

1. A method for optimized prediction of actual postoperative lens position (LP post) of an intraocular lens to be implanted in a pseudophakic eye, comprising: using known measurement values including corneal thickness (HHD), anterior chamber depth (VKT), eye length (AL) as well as a distance of a capsular bag equator (KSA) or lens haptic (LH) to an anterior surface of the lens (LV) for calculation; and including in the calculation at least one of an anatomical, postoperative position (LP an-post) of the intraocular lens (L) to be implanted, a diameter of the capsular bag or a diameter of a capsulorhexis.

2. The method according to claim 1, further comprising taking into account at least one factor selected from a group consisting of a preoperative decentration and a tilting of the eye lens, a center of the pupil range (PBM), a haptic diameter (LHD) and a haptic type (LHT) of the intraocular lens (L) used.

3. The method according to claim 1, wherein the anatomical, postoperative position (LP an-post) of the intraocular lens (L) to be implanted is included in the calculation and further comprising determining the postoperative, anatomical lens position (LP.sub.an-post) from formula (2):
LP.sub.an-post=VKTHHD+A1.sub.KSA-LV(2) VKT represents an anterior chamber depth in which HHD represents a corneal thickness and A1.sub.KSA-LV represents the distance between a capsular bag equator and an anterior surface of the lens and determining distance A1.sub.KSA-LV from formula (3):
A1.sub.KSA-LV=(LD/3A2.sub.LH-LV)+f(V1.sub.KSD-KHD)+f(V2.sub.KSD-LHD)+f(LHT)(3) in which LD represents the lens thickness, A2.sub.LH-LV represents a distance between a lens haptic and an anterior surface of the lens, f(V1.sub.KSD-KHD) represents a function of a ratio of the capsular bag to capsulorhexis diameters f(V2.sub.KSD-KHD) represents a function of a ratio of the capsular bag to the lens haptic diameters and f(LHT) represents a function of lens haptic type.

4. The method according to claim 2 wherein the anatomical, postoperative position (LP an-post) of the intraocular lens (L) to be implanted is included in the calculation and further comprising determining the postoperative, anatomical lens position (LP.sub.an-post) from formula (2):
LP.sub.an-post=VKTHHD+A1.sub.KSA-LV(2) VKT represents an anterior chamber depth in which HHD represents a corneal thickness and A1.sub.KSA-LV represents a distance between a capsular bag equator and an anterior surface of the lens.

5. The method according to claim 3, further comprising empirically determining the ratios V1.sub.KSD-KHD and V2.sub.KSD-LHD, and an influence of the lens haptics-type LHT in studies and quantifying the ratios V1.sub.KSD-KHD and V2.sub.KSD-LHD, and the influence of the lens haptics-type LHT as functions.

6. The method according to claim 4, further comprising empirically determining the ratios V1.sub.KSD-KHD and V2.sub.KSD-LHD, and an influence of the lens haptics-type LHT in studies and quantifying the ratios V1.sub.KSD-KHD and V2.sub.KSD-LHD, and the influence of the lens haptics-type LHT as functions.

7. The method according to claim 5, further comprising determining the functions f(V1.sub.KSD-KHD) and f(V2.sub.KSD-LHD) for individual lens designs or for a number of different lens designs.

8. The method according to claim 3, wherein the diameter of the capsular bag and the diameter of the capsulorhexis are included in the calculation and further wherein f(V1.sub.KSD-KHD) results as a function from a ratio of the capsular bag to capsulorhexis diameters from formula (4):
f(V1.sub.KSD-KHD)=KHD/KSD.Math.KSD.sub.norm/KHD.sub.norm(4) in which KHD represents the diameter of the capsulorhexis KSD represents the diameter of the capsular bag KSD.sub.norm represents an individual mean diameter of the capsular bag KHD.sub.norm represents an empirically determined diameter of the capsulorhexis as a function of various parameters wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

9. The method according to claim 5, wherein the diameter of the capsular bag and the diameter of the capsulorhexis are included in the calculation and further wherein f(V1.sub.KSD-KHD) results as a function from a ratio of the capsular bag to capsulorhexis diameters from formula (4):
f(V1.sub.KSD-KHD)=KHD/KSD.Math.KSD.sub.norm/KHD.sub.norm(4) in which KHD represents the diameter of the capsulorhexis KSD represents the diameter of the capsular bag KSD.sub.norm represents an individual mean diameter of the capsular bag KHD.sub.norm represents an empirically determined diameter of the capsulorhexis as a function of various parameters wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

10. The method according to claim 5, wherein the diameter of the capsular bag and the diameter of the capsulorhexis are included in the calculation and further wherein f(V2.sub.KSD-LHD) results as a function from a ratio of the diameter of the capsular bag to the lens haptic from formula (5):
f(V2.sub.KSD-LHD)=LHD/KSD.Math.KSD.sub.norm/LHD(5) in which LHD represents a specific diameter of the lens haptic KSD represents a diameter of the capsular bag and KSD.sub.norm represents an individual mean diameter of the capsular bag wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

11. The method according to claim 1, further comprising describing an anatomical, postoperative lens orientation (LL.sub.an-post) by the following three parameters: LDZhorizontal and vertical decentration of the lens, LVKhorizontal and vertical tilting of the lens, and PBMcenter of a pupil region that can be used in the calculation.

12. The method according to claim 2, further comprising describing an anatomical, postoperative lens orientation (LL.sub.an-post) by the following three parameters: LDZhorizontal and vertical decentration of the lens, LVKhorizontal and vertical tilting of the lens, and PBMcenter of the pupil region that can be used in the calculation.

13. The method according to claim 1, further comprising determining a horizontal and vertical decentration LDZ of the lens results from formula (6):
LDZ=LDZ.sub.eye.sup.xf(LDZ.sub.eye)(6) in which LDZ.sub.eye represents horizontal and vertical decentration of an actual eye lens and f(LDZ.sub.eye) represents an empirical function of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

14. The method according to claim 2, further comprising determining a horizontal and vertical decentration LDZ of the lens results from formula (6):
LDZ=LDZ.sub.eye.sup.xf(LDZ.sub.eye)(6) in which LDZ.sub.eye represents horizontal and vertical decentration of an actual eye lens and f(LDZ.sub.eye) represents an empirical function of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

15. The method according to claim 11, further comprising determining the horizontal and vertical decentration LDZ of the lens results from formula (6):
LDZ=LDZ.sub.eye.sup.xf(LDZ.sub.eye)(6) in which LDZ.sub.eye represents horizontal and vertical decentration of an actual eye lens and f(LDZ.sub.eye) represents an empirical function of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

16. The method according to claim 1, further comprising determining a horizontal and vertical tilting LVK of the lens results from formula (7):
LVK=LVK.sub.eye.sup.xf(LVK.sub.eye)(7) whereby LVK.sub.eye represents the horizontal and vertical tilting of an actual eye lens and f(LVK.sub.eye) represents an empirical function of the tilting of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

17. The method according to claim 2, further comprising determining a horizontal and vertical tilting LVK of the lens results from formula (7):
LVK=LVK.sub.eye.sup.xf(LVK.sub.eye)(7) whereby LVK.sub.eye represents the horizontal and vertical tilting of an actual eye lens and f(LVK.sub.eye) represents an empirical function of the tilting of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

18. The method according to claim 11, further comprising determining the horizontal and vertical tilting LVK of the lens results from formula (7):
LVK=LVK.sub.eye.sup.xf(LVK.sub.eye)(7) whereby LVK.sub.eye represents the horizontal and vertical tilting of an actual eye lens and f(LVK.sub.eye) represents an empirical function of the tilting of the decentration of the actual eye lens wherein at least one of pathology, ethnic origin, sex, and age are taken into account as empirical scaling functions.

19. The method according to claim 1, further comprising determining a center of a pupil region PBM that is used for calculation from formula (8):
PBM=HHVPDZLDZ(8) in which HHV represents a corneal vertex, PDZ represents the horizontal and vertical decentration of the pupil and LDZ represents the horizontal and vertical decentration of the lens.

20. The method according to claim 2, further comprising determining a center of a pupil region PBM that is used for the calculation from formula (8):
PBM=HHVPDZLDZ(8) in which HHV represents the corneal vertex, PDZ represents the horizontal and vertical decentration of the pupil and LDZ represents the horizontal and vertical decentration of the lens.

21. The method according to claim 11, further comprising determining a center of a pupil region PBM that is used for the calculation from formula (8):
PBM=HHVPDZLDZ(8) in which HHV represents the corneal vertex, PDZ represents the horizontal and vertical decentration of the pupil and LDZ represents the horizontal and vertical decentration of the lens.

22. The method according to claim 11, wherein a center of a pupil region PBM that can be used for the calculation can refer to various pupil apertures, including for photopic, scotopic, or mesopic vision.

23. The method according to claim 13, wherein a center of a pupil region PBM that can be used for the calculation can refer to various pupil apertures, including for photopic, scotopic, or mesopic vision.

24. The method according to claim 1, further comprising using geometric-optical formulas or ray tracing to calculate the intraocular lens (L) to be implanted in the pseudophakic eye.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

(2) FIG. 1 depicts a schematic diagram of the anterior eye segments with the corresponding parameters.

(3) FIG. 2 depicts a sample representation of the dependency of the anatomical lens position on the ratio of the capsular bag diameter to capsulorhexis.

(4) FIG. 3 depicts a sample representation of the dependency of the anatomical lens position on the ratio of the capsular bag diameter to the haptic.

(5) While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION OF THE DRAWINGS

(6) In the method according to the invention for optimally predicting the postoperative lens position (LP.sub.an-post) of an intraocular lens (L) to be implanted in a pseudophakic eye by application of known measurement values, such as the corneal thickness (HHD), the anterior chamber depth (VKT), the eye length (AL) as well as the distances of the capsular bag equator (KSA) and the lens haptics (LH) of the anterior surface of the lens (LV), besides the anatomical, postoperative position (LP.sub.an-post) of the intraocular lens (L) to be implanted, their orientation (LL.sub.an-post) is also included in the calculation, for which purpose additional, not yet considered parameters of the pseudophakic eye are used. As additional parameters of the pseudophakic eye, the diameter of the capsular bag and capsulorhexis, the preoperative decentration, and tilting of the eye lens, the center of the pupil region (PBM), as well as the haptic diameter (LHD) and the haptic-type (LHT) of the used intraocular lens (L) are taken into account.

(7) To this end, FIG. 1 depicts a schematic diagram of the anterior eye segments with their components and the corresponding parameters. An overview of the abbreviations used is provided in the list of reference signs.

(8) In a first embodiment of the method according to the invention, the postoperative, anatomical lens position LP.sub.an-post results from the following formula:
LP.sub.an-post.sup.=VKTHHD+A1.sub.KSA-LV(2)

(9) in which VKT characterizes the anterior chamber

(10) HHD characterizes the corneal thickness and

(11) A1.sub.KSA-LV characterizes the distance between the capsular bag equator and the anterior surface of the lens and distance A1.sub.KSA-LV stems from the following formula:
A1.sub.KSA-LV=(LD/3A2.sub.LH-LV)+f(V1.sub.KSD-KHD)+f(V2.sub.KSD-LHD)+f(LHT)(3)

(12) in which LD characterizes the lens thickness, A2.sub.LH-LV characterizes the distance between lens haptics and the anterior surface of the lens f(V1.sub.KSD-KHD) characterizes a function of the ratio of the capsule sack diameter to the capsulorhexis, f(V2.sub.KSD-KHD) characterizes a function of the ratio of the capsular bag diameter to the lens haptic and f(LHT) characterizes a function of the lens haptic-type

(13) Accordingly, the ratios V1.sub.KSD-KHD and V2.sub.KSD-LHD, as well as the influence of the lens haptic-type LHT used are determined empirically in studies and quantified as a function.

(14) Accordingly, it is possible that the functions f (V1.sub.KSD-KHD) and f (V2.sub.KSD-LHD) are determined for individual or also for a number of different lens designs.

(15) The ratio of the capsular bag to capsulorhexis diameters results hereby as function f(V1.sub.KSD-KHD) from the following formula:
f(V1.sub.KSD-KHD)=KHD/KSD.Math.KSD.sub.norm/KHD.sub.norm(4)

(16) in which KHD characterizes the diameter of the capsulorhexis, KSD characterizes the diameter of the capsular bag, KSD.sub.norm characterizes the individual mean diameter of the capsular bag and KHD.sub.norm characterizes the capsulorhexis diameter empirically determined as a function of various parameters

(17) wherein for example the pathology, ethnic origin, sex, and age can be taken into account as an empirical scaling function.

(18) To this end, FIG. 2 depicts a sample representation of the dependency of the anatomical lens position through the ratio of the capsular bag diameter to the capsulorhexis diameter. This dependency is to be determined empirically in studies and quantified as a function, whereby the resulting function can change according to the selected scaling function, e.g., the pathology, ethnic origin, sex, age or similar. Accordingly, it is also possible that no function can be quantified.

(19) The representation for example purposes shows distance A1.sub.KSA-LV resulting as a function of the ratio of the capsular bag diameter to the capsulorhexis diameter, said distance included as a correction value via formula (3) in formula (2), from which an optimized value thus results for the postoperative, anatomical lens position LP.sub.an-post.

(20) Correspondingly, the ratio of the capsular bag diameter to the lens haptic diameter as a function f(V2.sub.KSD-LHD) results from the following formula:
f(V2.sub.KSD-LHD)=LHD/KSD.Math.KSD.sub.norm/LHD(5)

(21) in which: LHD characterizes the specific diameter of the lens haptic, KSD characterizes the diameter of the capsular bag and KSD.sub.norm characterizes an individual mean diameter of the capsular bag

(22) wherein in turn for example the pathology, ethnic origin, sex, and age can be taken into account as empirical scaling functions.

(23) To this end, FIG. 3 depicts a sample representation of the dependency of the anatomic lens position on the ratio of the capsular bag diameter to the haptic diameter. This dependency is also to be determined empirically in studies and quantified as a function, wherein the resulting function can in turn change depending on the selected scaling function, e.g., the pathology, ethnic origin, sex, age or similar. Here too, it is possible that no function can be quantified.

(24) The representation for example purposes shows distance A1.sub.KSA-LV resulting as a function of the ratio of the capsular bag diameter to the haptic diameter, said distance included as a correction value via formula (3) in formula (2), from which an optimized value thus results for the postoperative, anatomical lens position LP.sub.an-post.

(25) If in contrast to the representations depicted in FIGS. 2 and 3, no dependencies can be discerned in the ratios of the capsular bag diameter to the capsulorhexis diameter V1.sub.KSD-KHD or capsular bag diameter to lens haptic diameter V2.sub.KSD-LHD, then f(V1.sub.KSD-KHD) and f(V2.sub.KSD-LHD) each take on the value of zero.

(26) In a second embodiment of the method according to the invention, the postoperative, anatomic lens orientation (LL.sub.an-post) can be described by the following three parameters: LDZhorizontal and vertical decentration of the lens, LVKvhorizontal and vertical tilting of the lens and PBMcenter of the pupil region that can be used in the calculation.

(27) Accordingly, the horizontal and vertical decentration LDZ of the lens results from the following formula:
LDZ=LDZ.sub.eye.sup.Xf(LDZ.sub.eye)(6)

(28) in which LDZ.sub.eye characterizes the horizontal and vertical decentration of the actual eye lens and f(LDZ.sub.eye) characterizes an empirical function of the decentration of the actual eye lens

(29) wherein for example the pathology, the ethnic origin, sex, and age can be taken into account as empirical scaling functions.

(30) Correspondingly, the horizontal and vertical tilting LVK of the lens results from the following formula:
LVK=LVK.sub.eye.sup.Xf(LVK.sub.eye)(7)

(31) in which LVK.sub.eye characterizes the horizontal and vertical tilting of the actual eye lens and f(LVK.sub.eye) characterizes an empirical function of the tilting of the decentration of the actual eye lens

(32) wherein in turn the pathology, ethnic origin, sex, and age for example can be taken into account as empirical scaling functions.

(33) The center of pupil region PBM that can be used for the calculation stems in contrast from the following formula:
PBM=HHVPDZLDZ(8)

(34) in which HHV characterizes the corneal vertex, PDZ characterizes the horizontal and vertical decentration of the pupil and LDZ characterizes the horizontal and vertical decentration of the lens

(35) Accordingly, it is here also possible that the empirically determined scaling functions are determined for individual or also a number of different lens designs.

(36) According to a third advantageous embodiment of the method according to the invention, it is hereby possible that the postoperative, anatomic lens orientation LL.sub.an-post or the center of the pupil region PBM usable for the calculation can be determined on various pupil apertures, such as photopic, scotopic, or mesopic vision.

(37) According to another example embodiment of the method according to the invention for optimally predicting the anatomical, postoperative position LP.sub.an-post of an intraocular lens to be implanted in a pseudophakic eye, calculation methods, such as geometric-optical formulas or ray tracing, can be used to calculate the intraocular lens L to be implanted.

(38) The method according to the invention is based on the assumption that the postoperative positioning or displacement of the (IOL) lens is determined within the scope of the healing process by the fit-ability of the preoperative capsular bag to the size and shape of the (IOL) lens haptic as well as the capsulorhexis.

(39) By the possible inclusion of additional parameters that describe the insertion of the lens in the capsular bag, a more exact prediction of the anatomical, postoperative lens position is made possible.

(40) The parameters listed in FIG. 1 of the reference sign list can be directly determined only to a partial degree using today's conventional technology. For example, the capsular bag diameter and the distance of the capsular bag equator to the cornea cannot be determined by optical means. For that reason, a component of the solution is the use of an image of the eye section that comprises at least the anterior corneal surface all the way to the rear surface of the capsular bag. Such an image can be obtained by means of Scheimpflug photography or OCT technology. From the parts, made visible in this image of the posterior and anterior lens surface and suitable software algorithms, the image can be completed to the capsular bag equator so that the distance of the cornea to the capsular bag equator, as well as the capsular bag diameter can be determined.

(41) In addition, it shall be assumed that the natural human lens is generally tilted and decentered due to physiological reasons. For that reason, an additional assumption underlying the solution is that the implanted intraocular lens is also positioned in the eye in a tilted and decentered manner and that the pre- and postoperative decentering and tilting correlate.

(42) With the solution according to the invention, a method for predicting the anatomical, postoperative position of an intraocular lens to be implanted in a pseudophakic eye is provided, with which, in addition to the lens position, the lens orientation of the intraocular lens to be implanted can be predicted in a more optimized and thus more precise manner.

(43) Predicting or optimizing the prediction of the anatomical, postoperative lens position is achieved by application of parameters not taken into account to date and is thus independent of the postoperative refraction result. Erroneous postoperative refraction results, which are not caused by an erroneous anatomical lens position, are not taken into account in predicting the anatomical lens position.

(44) For the prediction, not only are the capsular bag equator and the distance of the lens haptic to the anterior surface of the lens take into account in the prediction, but also the capsular bag diameter, the capsulorhexis diameter, the corneal thickness, the preoperative lens decentration, and lens tilting, as well as the haptic diameter and haptic type of the (IOL) lens.

(45) By application of the method according to the invention, the exact prediction of the anatomical, postoperative position of the intraocular lens to be implanted is possible for each individual eye.

REFERENCE LIST

(46) L (IOL) lens LP.sub.an-post anatomical, postoperative position of the (IOL) lens LL.sub.an-post anatomical, postoperative orientation of the (IOL) lens HHD corneal thickness HHV corneal vertex VKT anterior chamber depth KS capsular bag KSA capsular bag equator KSD capsular bag diameter KSD.sub.norm mean diameter of capsular bag KH capsulorhexis KHD capsulorhexis diameter KHD.sub.norm empirically determined diameter of capsulorhexis LD lens thickness (of the IOL) LH lens haptic (of the IOL) LHD lens haptic diameter LHT lens haptic-type LV anterior surface of lens (IOL) A1.sub.KSA-LV distance A1 between the capsular bag equator and the anterior surface of the lens A2.sub.LH-LV distance A2 between the lens haptic and the anterior surface of the lens V1.sub.KSA-KHD ratio of the capsular bag and capsulorhexis diameters V2.sub.KSD-LHD ratio of the capsular bag to the lens haptic LDZ horizontal and vertical decentration of the (IOL) lens LDZ.sub.eye horizontal and vertical decentration of the actual eye lens LVK horizontal and vertical tilting of the (IOL) lens LVK.sub.eye horizontal and vertical tilting of the actual eye lens PD pupil diameter PDZ horizontal and vertical decentration of the pupil PBM center of the pupil region that can be used for the calculation

(47) Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

(48) Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

(49) Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

(50) Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

(51) For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) are not to be invoked unless the specific terms means for or step for are recited in a claim.