TECHNICAL FIELD
[0001] The present invention relates to an intraocular lens for use in the
5 human eye, particularly an intraocular lens of a novel structure which can improve
OOY (quality of vision), and the manufacturing method thereof.
BACKGROUND ART
[0002] As is well known, the human lens of the human eye may have a
10 decrease in characteristics such as modulation ability, transparency and the like
due to aging, disease or the like, and along with that, problems such as refractive
error, cataracts or the like occur and visual performance decreases. As a treatment
for such cases, an intraocular lens has been proposed from the past. This
intraocular lens is typically inserted within the capsule in place of the human lens
15 after the intracapsular human lens of the human eye is extracted and removed.
20
[0003] However, for the intraocular lens of the conventional structure, the
spherical lens power is set, and an intraocular lens of a spherical lens power suited
for the patient was selected and used considering the corneal curvature, ocular
axis length and the like.
[0004] However, even when an intraocular lens suited for the patient is
used, there were complaints such as, "It's hard to see," "I can't see objects well,"
and the like from patients who had the intraocular lens inserted. This kind of
vision problem refers to quality of vision (OOY), and in recent years, has been
found to be due to residual irregular astigmatism. Residual irregular astigmatism
2
•
is due to high-order aberration of the human eye, and this cannot be corrected
with conventional lenses for visual correction that correct vision using the
spherical lens power and the cylindrical lens power such as intraocular lenses,
glasses, or contact lenses.
5 [0005] To handle this kind of problem, to reduce high-order aberration in
the human eye, in Japanese Patent No. 4459501 (Patent Document 1), proposed is
an intraocular lens that gives wave aberration of the reverse code value to the
wave aberration in the human eyes of a specified population. However, with this
intraocular lens, it was difficult to say that an efficient method had been
10 established regarding selection of the specified population, measurement of the
wave aberration, setting of the reverse code value wave aberration to the
intraocular lens and the like, and putting this to practical use was extremely
difficult.
[0006] Specifically, as with the description noted in Patent Document 1,
15 prescribing for the intraocular lens optical characteristics for which reverse code
value high-order aberration is set so as to offset the high-order aberration of the
human eye to become zero maybe ideal, but making this practical is extremely
difficult. Perhaps because in addition to the fact that there are diverse high-order
aberrations with the human eye, coma aberration and the like which has a
20 particularly big adverse effect on quality of vision (OOY) has different optical
characteristics around the optical axis, so the intraocular lens set with a high-order
aberration for correction must be a custom made product, and not only the design
but also the manufacturing of these is extremely difficult and impractical.
[0007] Though it relates to contact lenses of a different technical field than
3
the intraocular lens that is the subject of the present invention, noted in Translated
Japanese Patent application of Publication No. 2006-517676 (Patent Document 2)
as a method of improving the QOV in relation to residual irregular astigmatism is
the provision of a corrective lens that uses a chart for which the level of effect on
5 the QOV is actually measured for each order of the high-order aberration
expressed by Zernike polynomials, the orders of high-order aberration important
for improvement of QOV is specified, and the specified high-order aberrations are
offset to achieve zero. However, with this Patent Document 2, as noted in
paragraphs [0097] to [0099], this is nothing more than the goal of selecting only
10 the specified high-order aberrations that adversely affect vision, and giving a
corrective lens that offsets the selected specified high-order aberrations to achieve
zero. Based on examination by the inventor of the present invention, with a
corrective lens power that makes only the specified high-order aberrations zero in
this way, the adverse effect on vision due to other residual high-order aberration is
15 large, and it was difficult to obtain sufficient QOV improvement effect.
[0008] In particular, with this method noted in Patent Document 2, when a
corrective lens is provided with a plurality of orders of high-order aberrations as
the subject, and all of those high-order aberrations are offset to reach zero, the
corrective lens design and manufacturing are extremely complex and they have to
20 be made to order, so they are not very practical, and the same kinds of problems as
those of Patent Document 1 are unavoidable. Meanwhile, when providing a
corrective lens that has only one high-order aberration (e.g. spherical aberration)
as the subject and offsetting that to reach zero, the adverse effect due to other
remaining high-order aberrations (e.g. coma aberration) is large, and it was
4
difficult to realize good vision.
BACKGROUND ART DOCUMENTS
[Patent Documents]
5 [0009]
Patent Document 1: JP-B-4459501
Patent Document 2: JP-A-2006-517676
SUMMARY OF THE INVENTION
PROBLEM THE INVENTION ATTEMPTS TO SOLVE
10 [0010] The present invention was created with the circumstances noted
above as the background, and its object is to provide an intraocular lens of a novel
structure and the manufacturing method thereof that is able to effectively improve
quality of vision (QOY), as well as being easy to apply to patients and having a
high level of practicality.
15 MEANS FOR SOLVING THE PROBLEM
[0011] The present invention provides an intraocular lens manufacturing
method including (a) an optical characteristics setting step of setting in an optical
portion a spherical aberration of a size corresponding to a coma aberration
remaining in a human eye of a patient from which a human lens was extracted,
20 and of a size for which the spherical aberration remaining in that human eye of
that patient will not be offset and will be made to remain; (b) a lens shape setting
step of determining a lens shape of the optical portion wherein the spherical
aberration set at the optical characteristics setting step is provided as a corrective
optical characteristic for a residual irregular astigmatism in that human eye of that
5
5
patient; and (c) a lens forming step of forming an intraocular lens having optical
characteristics in which a high-order aberration of that optical portion is
rotationally symmetrical around an optical axis, by means of forming the optical
portion to have the lens shape determined by the lens shape setting step.
[0012] From the start, the intraocular lens of the present invention has a
prerequisite of allowing coma aberration to remain in the eye of the patient, and in
regards to this point, is completely different from the concept of prior art
corrective lenses like that in Patent Document 1 which has the object of
eliminating high-order aberration as much as possible. Then, on top of that, by
10 actively giving spherical aberration of a size corresponding to the coma aberration
to the intraocular lens, the decrease in QOV due to coma aberration is reduced.
[0013] Specifically, the present invention is focused on coma aberration
among the high-order aberrations when improving vision, and in fact does not
give corrective optical characteristics that offset the coma aberration, but rather is
15 based on new knowledge of improving vision by giving spherical aberration of a
size corresponding to the coma aberration as the corrective optical characteristic.
In other words, it is not possible to avoid design and manufacturing being
extremely difficult for improving vision as long as it is based on the prior art
concept of simply achieving zero by offsetting all or specific high-order
20 aberrations in order to suppress a decrease in vision due to high-order aberration
as noted in Patent Documents 1 and 2 described previously. In contrast to this,
focusing on the coma aberration which has a big adverse effect on vision, the
present invention is established on a novel technical concept that is completely
different from the past, which is to reduce the adverse effect due to coma
6
aberration which is not rotationally symmetrical in relation to the optical center
axis, by using spherical aberration which is rotationally symmetrical in relation to
the optical center axis. In particular, with this kind of present invention, the
spherical aberration given to the lens used as the corrective optical characteristic
5 is nothing more than an optical characteristic corresponding to the coma
aberration, and therefore it goes without saying that it does not achieve zero by
offsetting the coma aberration, and it does not achieve zero by offsetting spherical
aberration, either. It should be understood that this is technology of a completely
different perspective from that of the past, which makes having coma aberration
10 and spherical aberration remain be something affirmative.
[0014] In fact, by setting spherical aberration in the intraocular lens, being
able to effectively deal with coma aberration which has a large adverse effect on
QOY has a large significance when manufacturing or handling intraocular lenses,
when doing surgery or the like, which are implementations of the present
15 invention. Specifically, with a focus only on coma aberration, to give wave
aberration of the reverse code to the coma aberration, a complex lens surface
shape that is rotationally asymmetrical must be given to the intraocular lens, and
not only is the design and manufacturing thereof extremely difficult, but when
inserting into the eye as well, it is necessary to have precise alignment in the
20 circumference direction, so this is not practical. In contrast to this, the intraocular
lens for which spherical aberration is set according to the present invention is
formed having optical characteristics that are rotationally symmetrical around the
optical axis, so it is not necessary to specify a position in the circumference
direction such as during the manufacturing process or when inserting in the eye,
7
so manufacturing and handling are easy, which makes it easy to put this to
practical use.
[0015] In other words, in addition to finding that it is possible to reduce
the decrease in QOV due to coma aberration by using spherical aberration, focus
5 was placed on being able to perform setting of spherical aberration in the
intraocular lens with the intraocular lens optical characteristics left being
rotationally symmetrical, and the present invention was completed by combining
these with each other. Then, if the present invention which was completed based
on this kind of novel basic concept is followed, it became possible to provide a
10 novel intraocular lens which can reduce the decrease in QOV due to coma
aberration which is one type of high-order aberration for which a practical
countermeasure was extremely difficult in the past, and to give good QOV, while
being sufficiently practical in terms of manufacturing and implementation.
[0016] With the present invention, to deal with the decrease in QOV due
15 to coma aberration remaining in the human eye from which the human lens was
extracted, the fact that it is effective to actively give spherical aberration using the
intraocular lens has been objectively confirmed by comparison between examples
and comparative examples in the embodiment described later. When examined by
the inventor of the present invention, at least the subjective focal depth is made
20 deeper by giving spherical aberration, and it is thought that this is an item for
which one technical basis is acknowledged. In particular, the QOV improvement
effect exhibited by the intraocular lens according to the present invention is also
clear from the example data described later.
[0017] However, the spherical aberration with the intraocular lens of the
8
present invention is set at a size corresponding to the coma aberration, and if the
coma aberration is large, then large spherical aberration is set, and if the coma
aberration is small, then small spherical aberration is set. Here, the specific
correlation of the setting value of the spherical aberration of the intraocular lens in
5 relation to the coma aberration remaining in the eye of the patient can be
determined considering not only objective optical characteristics of the patient's
eye, but also subjective vision preferences of the patient or the like.
[0018] For this kind of determination method, a device that can easily
measure the spherical aberration for not only the lens optical system but also the
10 human eye optical system is disclosed in Japanese Patent No. 4652558, the
specification of U.S. Patent No. 7,078,665 and the like, and for example since the
OPAL 300 (product name) made by Spot Optics Corp. is available on the market
as a wave aberration measurement device using the Shack-Hartmann Method, a
person skilled in the art could implement this easily. In particular, when
15 determining the value of the spherical aberration corresponding to the coma
aberration with the eye optical system, it is not necessary to match both items, as
described above. For example, even when dealing with contact lenses or glasses,
prescription is ultimately left to the subjective vision sense of the user, or is
selected based on consideration of the application. From this point of view,
20 determination of the value of the spherical aberration should be handled by the
person skilled in the art by referencing the user's opinion, the eye optical system
objective measurement information or the like. Thus, compared to the prior art
structure contact lenses as noted in Patent Documents 1 and 2, for example,
implementing the present invention does not involve an impractical level of
9
difficulty. Of course, with the present invention, to make it possible to more easily
and quickly determine the spherical aberration, it is effective to further narrow the
selection range of the spherical aberration, and from that objective, it is preferable
to use the optical characteristics selection technology given by the formulas and
5 the like noted hereafter.
[0019] Specifically, with the human eye, even in a state with the human
lens extracted, there are cases when there is spherical aberration due to the shape
of the cornea and the like, for example. In that case, the spherical aberration set
for the intraocular lens of the present invention is designed considering the
10 spherical aberration remaining in the human eye with the human lens extracted. In
specific terms, at the optical characteristics setting step, the spherical aberration of
the optical portion with the intraocular lens (RMS value) is preferably set with an
RMS value that satisfies any of the following formulas in relation to the coma
aberration remaining in the eye after the human lens is extracted (RMS value).
15 [0020] Intraocular lens spherical aberration 2: Coma aberration remaining
in the eye after lens extraction - 0.37 ~m
Intraocular lens spherical aberration ~ Coma aberration remaining in the
eye after lens extraction - 0.17 ~m
[0021] The RMS value is the value (unit: ~m) for which the wave
20 aberration in the pupil area of the human eye optical system is put into numerical
form (displayed as root mean square) using a wave aberration analysis device
(wave sensor). According to the formulas noted above, by giving spherical
aberration corresponding to the coma aberration of the patient eye to the
intraocular lens, it is easy to obtain good QOV that also considers the spherical
10
aberration remaining in the cornea.
[0022] Also, the optical characteristics of the human eye tend to change as
age increases. In light of that, using the optical characteristics of the cornea or the
like, for example, it is possible to estimate the coma aberration remaining in the
5 patient after the human lens is extracted according to the age of the patient. From
this perspective, as a result of additional examination by the inventor of the
present invention, with the optical characteristics setting step, setting the spherical
aberration set for the optical portion in the intraocular lens (RMS value) using the
patient age corresponding to the coma aberration as an index based on the
10 following formulas is also effective for obtaining good QOV.
[0023] Intraocular lens spherical aberration = A + B x Patient age
-0.4 :s A (~m) :s -0.1
0.003 :s B (~m):S 0.004
[0024] Furthermore, considering the fact that coma aberration, which IS
15 one human eye optical characteristic, changes according to age, additional
examination was made by the inventor of the present invention. As a result, it
was found that from human eye optical characteristics measurement data for the
population of the same age bracket as the patient for which the human lens has
been extracted, it is possible to find an intraocular lens spherical aberration that
20 will give good QOV to that patient. Specifically, with the optical characteristics
setting step, using an intraocular lens for which the spherical aberration for the
optical portion is set using the difference between the average value of the
measurement data of the human eye spherical aberration for the same age bracket
population as the patient and the spherical aberration of the cornea of that patient
11
is effective for obtaining good aoy.
[0025] Also, the present invention provides an intraocular lens for which
the spherical aberration of a size corresponding to the coma aberration remaining
in the human eye of a patient from which the human lens has been extracted, and
5 of a size for which the spherical aberration will not be offset and will be made to
remain in the human eye of that patient is set for the optical portion as the
corrective optical characteristic for residual irregular astigmatism in the human
eye of that patient, and for which the high-order aberration for the optical portion
is rotationally symmetrical around the optical axis.
10 [0026] As is clear from the description above, the intraocular lens with
this kind of structure can give good aov to patients, and in fact the design and
manufacturing can be realized easily, so it is easy to provide on the market and put
to practical use. The intraocular lens of this kind of structure according to the
present invention is preferably manufactured using the method of the present
15 invention described above. Also, each preferred mode noted in the description of
the manufacturing method above can be applied to the intraocular lens of the
present invention as long as it is structurally feasible.
[0027] Also, with the intraocular lens of the present invention, it is
preferable that at least one of the spherical aberration value set according to the
20 method of the present invention as described above or the RMS value is displayed
on at least one of the lens main unit, its individual package, the housing package
or the housing box.
EFFECT OF THE INVENTION
[0028] If the present invention is followed, the aov is improved by
12
applying spherical aberration, which is an optical characteristic that is rotationally
symmetrical around the optical axis, in relation to coma aberration having a big
adverse effect on QOV and for which it is difficult to realize an intraocular lens
having optical characteristics that offset the coma aberration. Accordingly, it is
5 possible to realize an intraocular lens of a novel structure for which design,
manufacturing, and handling are easy, and practical usability is excellent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029]
FIG. 1 is a front view showing an intraocular lens as one embodiment of
10 the present invention.
15
FIG. 2 is a vertical cross section explanatory view of a human eye in which
the intraocular lens shown in FIG. 1 is inserted.
FIG. 3 is a graph for explaining the change with aging of the spherical
aberration of the cornea in the human eye.
FIG. 4 is a graph for explaining the change with aging of the coma
aberration of the cornea in the human eye.
FIG. 5 is a simulation optical image showing the vision during application
to the human eye of the same patient for the intraocular lens as the first through
fifth examples of the present invention as well as for a comparative example 1 for
20 which spherical aberration was set to zero.
FIG. 6 is a simulation optical image showing the vision during application
to the human eye of the same patient for the intraocular lens as the sixth through
eighth examples of the present invention as well as for a comparative example 2
for which spherical aberration was set to zero.
13
5
EMBODIMENTS FOR CARRYING OUT THE INVENTION
[0030] Following, we will describe an embodiment of the present
invention while referring to the drawings. First, in FIG. 1, an intraocular lens 10 is
shown as an embodiment of the present invention.
[0031 ] This intraocular lens 10 is constituted including an optical portion
12 that gives optical characteristics constituting the lens main unit, and a pair of
support units 14, 14 extending out from the optical portion 12. The optical portion
12 is equipped with a front surface and back surface for which respectively
roughl y spherical convex surface shapes are the lens surfaces, these front and
10 back surfaces are refractive surfaces, and designated optical characteristics are set.
With this embodiment, the geometric center axis of the optical portion 12 and the
optical axis (optical center axis) are set to be the same, and this is used as a lens
center axis 15. Meanwhile, the pair of support units 14, 14 are formed extending
out facing the direction mutually opposite from two locations positioned facing
15 mutually opposite in the radial direction of the outer circumference edge part on
the optical portion 12. Also, the tip part of each support unit 14 is a free edge that
extends curving in the circumference direction of the optical portion 12.
[0032] Then, as shown in FIG. 2, this intraocular lens 10 is installed in
place of the human lens by being inserted inside a human lens capsule 18 after
20 removal of the human lens for a human eye 16 of the patient. Under these
circumstances, the tip part of the support units 14, 14 abut the circumference edge
part of the human lens capsule 18, and the optical portion 12 is held in a
designated position of the center inside the human lens capsule 18.
[0033] The material of the intraocular lens 10 is not limited by the present
14
invention, and it is possible to use polymethyl methacrylate (PMMA), silicone
rubber or the like known from the past as the material of the optical portion 12. It
is also possible to use known various synthetic resin materials for the support
units 14, 14 as well, but it is also possible to have a one piece structure with the
5 optical portion 12 and the support units 14, 14 formed as an integrated unit.
[0034] However, with the intraocular lens 10 of this embodiment,
spherical aberration is actively given to the optical portion 12. Specifically, as the
original function of the intraocular lens, the intraocular lens 10 of the present
invention has as the optical characteristics spherical aberration in addition to the
10 spherical lens power (D) that replaces the human lens.
[0035] As is well known, the value of the spherical lens power (D) is
determined based on the ocular axis length and corneal shape of the patient, and
typically a value of approximately + 10 to 25D is set. In most cases, the spherical
lens power is set as a single focal point, but it is also acceptable to have multiple
15 focal points set.
[0036] Meanwhile, the spherical aberration for the optical portion 12 of
the intraocular lens 10 is set at a size corresponding to the value of the coma
aberration remaining in the human eye 16 of the patient for which the human lens
was extracted, and of a size such that the spherical aberration will not be offset
20 and will be made to remain in the human eye 16 of the patient. In specific terms,
with the human eye 16 of the patient for which the intraocular lens has been
inserted, the spherical aberration is set for the optical portion 12 of the intraocular
lens so that the size of the coma aberration is roughly the same level as the
spherical aberration. In this way, the manufacturing method of the intraocular lens
15
10 with this embodiment is constituted including the optical characteristics setting
step. The coma aberration and the spherical aberration values can both be
represented by RMS values ([Am). In other words, the volume of skew in the light
ray direction by the actual wave surface in relation to the virtual wave surface
5 orthogonal to the light rays expresses each aberration as a value expressed in root
mean square on that virtual wave surface. Also, the coma aberration existing in
the human eye 16 of the patient in which the intraocular lens 10 is inserted is
almost all according to the cornea with the present invention using the intraocular
lens 10 having optical characteristics rotationally symmetrical around the optical
10 axis. The coma aberration of the cornea of the patient can be found based on
cornea topography measurement values obtained using, for example, a
keratometer, a reflex keratometer, or a wave surface sensor. For example, the C3
1
and C:l-1 terms are the horizontal coma aberration and vertical coma aberration
with Zernike polynomials obtained by performing wave aberration analysis, for
15 example, and the coma aberration is expressed as a synthetic vector volume of the
horizontal coma aberration and the vertical coma aberration.
[0037] At that time, spherical aberration by an ocular tissue other than the
intraocular lens 10 exists in the human eye 16 in which the intraocular lens has
been inserted. Almost all the spherical aberration remaining in the human eye 16
20 after the human lens is extracted is due to the cornea. Because of that, the
spherical aberration of the intraocular lens 10 itself is determined considering the
spherical aberration of the cornea of the patient. The spherical aberration of the
cornea of the patient can be found based on measurement values by the same kind
of measurement devices as the coma aberration noted above. For example, the C4
0
16
term with a Zernike polynomial obtained by performing wave aberration analysis
is used as the spherical aberration. Therefore, the spherical aberration value set for
the intraocular lens 10 can be found based on the formula below.
[0038] Intraocular lens spherical aberration ;:::; "Coma aberration remaining
5 in the eye after lens extraction" - "Cornea spherical aberration"
[0039] However, with the formula above, "Intraocular lens spherical
aberration" is not necessarily optimally perfectly matched to the right side of the
equation ("coma aberration remaining in the eye after lens extraction"' - "cornea
spherical aberration"'). Perhaps this is because the vision (OGY) is a subjective
10 item and there is a big individual difference, and for example the intraocular lens
spherical aberration judged to be optimum may be different between a patient who
senses that having a big difference in sharpness due to a difference in the distance
from the subject item is not desirable, and a patient who thinks he'd like to
observe only objects of a specified distance at the highest level of sharpness.
15 [0040] Also, as shown in FIG. 3, the corneal spherical aberration of the
human eye 16 almost doesn't change at all with aging, and it is possible to
estimate the average spherical aberration across all ages to be 0.27 /-lm (RMS).
Considering this fact, it is possible to use the following formulas to express the
preferable setting range of the spherical aberration (RMS value) for the optical
20 portion 12 of the intraocular lens 10 set with the optical characteristics setting
process described previously.
[0041 ] Intraocular lens spherical aberration ~ Coma aberration remaining
in the eye after lens extraction - 0.37 /-lm
Intraocular lens spherical aberration :s Coma aberration remaining in the
17
eye after lens extraction - 0.17 !-lm
[0042] Furthermore, the coma aberration remaining in the eye after lens
extraction is almost all due to the cornea, and as shown in FIG. 4, that cornea
coma aberration changes as a linear function according to aging in a range of
5 roughly 0.2 to 0.3 !-lm. Considering this fact, the preferable setting range of the
spherical aberration (RMS value) with the optical portion 12 of the intraocular
lens 10 set during the optical characteristics setting process described previously
can be expressed using the following formulas for which A and B are each
constants.
10 [0043] Intraocular lens spherical aberration = A + B x Patient age
---0.4 SA (/lm) S ---0.1
0.003 S B (/lm) S 0.004
[0044] Also, with a different approach considering that the human eye
optical characteristics change with aging, it is also preferable to set the spherical
15 aberration value for the optical portion 12 of the intraocular lens 10 set during the
optical characteristics setting process described previously within a specific range
determined based on the human eye optical characteristics of the population when
a plurality of healthy persons in the same age level as the patient is set as the
population.
20 [0045] In specific terms, the difference between the average value of the
spherical aberration measurement data of the human eye (entire eye optical
system including the cornea and the human lens) with the population noted above
and the spherical aberration of the cornea of the patient is set as the spherical
aberration of the intraocular lens 10 used for that patient. The fact that the
18
5
intraocular lens 10 spherical aberration set in this way is roughly equal to the
spherical aberration that the human lens has in the human eye of a healthy person
which is the population noted above was discovered by the inventor of the present
invention.
[0046] As described above, in the preferred setting range, the spherical
aberration determined considering the coma aberration and the spherical
aberration remaining in the human eye 16 of the patient for which the human lens
was extracted, specifically, the spherical aberration having the corrective optical
characteristics for residual irregular astigmatism set with the optical
10 characteristics setting process described previously and the spherical lens power
corresponding to the spherical power remaining in the human eye 16 of the patient
for which the human lens was extracted are both set as optical characteristics that
are rotationally symmetrical around the optical axis, and by doing this, the lens
shape setting process that determines the target optical characteristics (lens shape)
15 of the intraocular lens 10 is performed. As is well known by a person skilled in the
art involved in the design of optical lenses, if the setting values of the optical
characteristics are determined in this way, the specific shape of the intraocular
lens 10 (shape of the refractive surface) can be set using various types of well
known lens design software using a ray tracing algorithm based on Snell's Law,
20 for example. The shape of this intraocular lens 10 is specified by a multi-linear
function or the like as the radial direction cross section shape of the lens front and
back, for example. After that, the optical portion 12 of the lens shape based on the
design information determined with the lens shape setting process described
previously is formed by a lens forming process using a specific lens material and
19
using a well known molding method, lathe turning method or the like, and the
intraocular lens 10 having the target optical characteristics is manufactured.
[0047] Then, the intraocular lens 10 for which the shape was determined
in this way is roughly in a disk shape, and is equipped with rotationally
5 symmetrical optical characteristics with the lens center axis 15 as the rotational
center axis. Also, with the optical portion 12 of the intraocular lens 10, the
high-order aberration is rotationally symmetrical around the lens center axis 15,
and since asymmetrical optical characteristics are not set in the circumference
direction around the lens center axis 15 such as coma aberration or the like, in
10 typical cases when a prerequisite is using a uniform lens material, the lens front
and back shape is also a rotating body shape with the lens center axis 15 as the
rotation center axis. By doing this, with the intraocular lens 10, at any stage,
including manufacturing, handling, insertion into the human eye 16 or the like, it
is possible to easily perform design and manufacturing as well as do surgery
15 without specially considering alignment in the circumference direction.
[0048] Incidentally, as described above, a number of the simulation results
performed to confirm that good QOY was given by the intraocular lens 10 with
this embodiment are shown hereafter as examples of the present invention.
[0049] First, FIG. 5 shows the simulation results when the intraocular lens
20 manufactured according to the present invention was used for a 60 year old
patient. With this simulation, using optical design software ZEMAX (product
name, made by Zemax Development Corp. of the U.S.), as an eyeball model of a
60 year old patient, an item with coma aberration (vertical coma aberration
volume of the C3-
J term with a Zernike polynomial) of 0.24 !-lm was constructed,
20
and optical characteristics of the eye optical system correlating to the optical area
applicable to a pupil of 6 mm were evaluated with a Landolt ring simulation
optical image. Specifically, examples 1 through 5 and comparative example 1 all
correlate to a human eye in which the intraocular lens is inserted, and are thought
5 to be items for which coma aberration of 0.24 ~m remains. Then, for each model
of these examples 1 through 5 and comparative example 1, with the point for
which the focal point position by spherical lens power is optimum (0.00 D) as a
reference, a simulation optical image of each position when the focal point
position is skewed in the near direction by a distance correlating to 0.50 D and
10 1.00 D from there was obtained, and the vision (QOV) was assessed using those.
[0050] For that human eye, with comparative example 1, according to the
technical concept as noted in Patent Document 1, for example, this correlates to a
case when the intraocular lens was inserted so as to have the spherical aberration
(spherical aberration volume of the C40 term with a Zernike polynomial) become
15 zero (namely, for which spherical aberration of the reverse code was set so as to
offset the spherical aberration remaining in the cornea). Meanwhile, with
examples 1 through 5, in all cases, this correlates to a case when the intraocular
lens was inserted with optical characteristics for which spherical aberration was
set actively according to the present invention. In particular, the example 3
20 correlates to a case when the spherical aberration of the intraocular lens was set
considering the spherical aberration of the cornea so that spherical aberration of
the same RMS value as the coma aberration remaining in the human eye is set.
[0051 ] From the results of the simulation optical image shown in FIG. 5, it
is clear that compared to a case when the spherical aberration is offset and set to
21
zero, the case of actively setting spherical aberration in the human eye suppresses
changes in vision (image quality) that come with changes in the focal point
position. Specifically, with comparative example 1, with the optimum focal point
position (0.00 D), the image clarity is high, but as that is moved away from, there
5 is a sudden drop in vision, and at a position changed by 1.00 D, it is almost
impossible to see, and it is only possible to see items of a specified distance, so we
can understand that ensuring quality of vision is difficult. Also, not only with
example 3 for which the spherical aberration was set optimally, but particularly
with the items of examples 2 and 4, even at a position changed by 1.00 D, it is
10 clear that the quality of the image is ensured well compared to comparative
example 1.
[0052] Also, FIG. 6 shows the simulation results when using an intraocular
lens manufactured according to the present invention for a 20 year old patient.
With this simulation, the same as with examples 1 through 5 noted above, using
15 ZEMAX, as the eyeball model of a 20 year old patient, an item of coma aberration
(vertical coma aberration volume of the C3 - 1 term with the Zernike polynomial) of
0.14 !-lm was constructed, and for optical characteristics of the eye optical system
correlating to the optical area corresponding to a pupil of 6 mm, a Landolt ring
simulation optical image was obtained and vision was assessed.
20 [0053] Specifically, the same as with comparative example 1, comparative
ex~mple 2 correlates to a case of offsetting the cornea spherical aberration with
the intraocular lens spherical aberration and having the spherical aberration of the
eye optical system be zero. Meanwhile, with examples 6 through 8, all of these
correlate to cases for which an intraocular lens was inserted with optical
22
characteristics for which spherical aberration of the eye optical system was set
actively according to the present invention. In particular, example 7 is an item for
which spherical aberration of roughly the same RMS value as the coma aberration
of the eye optical system was set.
5 [0054] From the results of the simulation optical image shown in FIG. 6,
as shown In examples 6 through 8, compared to a case when the spherical
aberration is offset and set to zero, a case when spherical aberration corresponding
to the remaining coma aberration is actively set can be understood to be
advantageous in ensuring overall quality of vision by being able to suppress
10 changes in vision (image quality) that come with changes in the focal point
position.
KEYS TO SYMBOLS
[0055J
10: Intraocular lens
15 12: Optical portion
16: Human eye
23
5
10

CLAIMS
We Claim:
1. An intraocular lens manufacturing method comprising:
an optical characteristics setting step of setting in an optical portion a
spherical aberration of a size corresponding to a coma aberration remaining in a
human eye of a patient from which a human lens was extracted, and of a size for
which the spherical aberration remaining in that human eye of that patient will not
be offset and will be made to remain;
a lens shape setting step of determining a lens shape of the optical portion
wherein the spherical aberration set at the optical characteristics setting step is
provided as a corrective optical characteristic for a residual irregular astigmatism
in that human eye of that patient; and
a lens forming step of forming an intraocular lens having optical
15 characteristics in which a high-order aberration of that optical portion is
rotationally symmetrical around an optical axis, by means of forming the optical
portion to have the lens shape determined by the lens shape setting step.
2. The intraocular lens manufacturing method according to claim 1, wherein
20 at the optical characteristics setting step, the spherical aberration of the optical
portion is set with an RMS value that satisfies both of the following formulas:
Intraocular lens spherical aberration ~ Coma aberration remaining in the eye after
lens extraction - 0.37 lAm; and
Intraocular lens spherical aberration :s Coma aberration remaining in the eye after
24
lens extraction - 0.17 f!m.
3. The intraocular lens manufacturing method according to claim 1 or 2,
wherein at the optical characteristics setting step, the spherical aberration set for
5 the optical portion is set with an RMS value that satisfies all of the following
formulas, where A and B are constants:
10
Intraocular lens spherical aberration = A + B x Patient age;
-0.4 :s A (/lm) :s -0.1; and
0.003 :s B (/lm) :s 0.004.
4. The intraocular lens manufacturing method according to anyone of claims
1-3, wherein at the optical characteristics setting step, the spherical aberration set
for the optical portion is set by using a difference between an average value of
measurement data of human eye spherical aberrations of a population of a
15 same-age bracket with the patient and the spherical aberration of a cornea of the
patient.
5. An intraocular lens comprising:
an optical portion being set with a spherical aberration as a corrective
20 optical characteristic for a residual irregular astigmatism in a human eye of a
patient, the spherical aberration being of a size corresponding to a coma
aberration remaining in the human eye of the patient from which a human lens
was extracted, and of a size for which the spherical aberration remaining in that
human eye of that patient will not be offset and will be made to remain,
25
wherein a high-order aberration of the optical portion IS rotationally
symmetrical around an optical axis.
6. The intraocular lens according to claim 5, wherein the spherical aberration
5 set for the optical portion has an RMS value that satisfies both of the following
formulas:
Intraocular lens spherical aberration 2: Coma aberration remaining in the eye after
lens extraction - 0.37 !-tm; and
Intraocular lens spherical aberration :s Coma aberration remaining in the eye after
10 lens extraction - 0.17 !-tm.
7. The intraocular lens according to claim 5 or 6, wherein the spherical
aberration set for the optical portion has an RMS value that satisfies all of the
following formulas, where A and B are constants:
15 Intraocular lens spherical aberration = A + B x Patient age;
-O.4 :S A (/lm) :s -0.1; and
0.003 :s B (/lm) :s 0.004.
8. The intraocular lens according to anyone of claims 5-7, wherein the
20 spherical aberration set for the optical portion is set by using a difference between
an average value of measurement data of human eye spherical aberrations of a
population of a same-age bracket with the patient and the spherical aberration of a
cornea of the patient.