U.S. patent application number 09/734401 was filed with the patent office on 2002-06-13 for iris fixated intraocular lenses.
Invention is credited to Hoffmann, Laurent G., Stenger, Donald Carrol.
Application Number | 20020072796 09/734401 |
Document ID | / |
Family ID | 24951547 |
Filed Date | 2002-06-13 |
United States Patent
Application |
20020072796 |
Kind Code |
A1 |
Hoffmann, Laurent G. ; et
al. |
June 13, 2002 |
Iris fixated intraocular lenses
Abstract
A refractive anterior chamber iris fixated intraocular lens
including an optic portion having an outer peripheral edge and two
or more but preferably two haptic elements. Each haptic element is
manufactured to have an inner portion and an outer free end portion
for supporting the optic portion in a patient's eye. The inner
portion of each haptic element is preferably permanently connected
to the outer peripheral edge of the optic portion. Each haptic
element also includes a tissue clasp for secure attachment of the
intraocular lens to the non-mobile periphery of the iris of an
eye.
Inventors: |
Hoffmann, Laurent G.;
(Foothill Ranch, CA) ; Stenger, Donald Carrol;
(Anaheim Hills, CA) |
Correspondence
Address: |
RITA D. VACCA
BAUSCH & LOMB, INC.
ONE BAUSCH & LOMB PLACE
ROCHESTER
NY
14604-2701
US
|
Family ID: |
24951547 |
Appl. No.: |
09/734401 |
Filed: |
December 11, 2000 |
Current U.S.
Class: |
623/6.43 ;
623/6.51 |
Current CPC
Class: |
A61F 2002/1681 20130101;
A61F 2220/0008 20130101; A61F 2/1605 20150401; A61F 2/1608
20150401; A61F 2/16 20130101 |
Class at
Publication: |
623/6.43 ;
623/6.51 |
International
Class: |
A61F 002/16 |
Claims
We claim:
1. An anterior chamber iris fixated intraocular lens to be
implanted within an eye generally perpendicular to the eye's
optical axis through a small incision comprising: an outer
peripheral edge defining an optic portion, two or more haptic
elements permanently connected to the outer peripheral edge, an
attachment aperture through said haptic elements, a channel void
extending a defined distance from said attachment aperture toward
said optic portion, and a tissue clasp formed to extend from a free
edge of said haptic element through to an edge defining said
attachment aperture.
2. The intraocular lens of claim 1 wherein a portion of said haptic
elements and the optic portion are formed of a foldable or
compressible material.
3. The intraocular lens of claim 1 wherein at least a portion of
said haptic elements and the optic portion are formed from
differing materials.
4. The intraocular lens of claim 1 wherein said tissue clasps and
said optic portion are formed from differing materials.
5. The intraocular lens of claim 1 wherein said tissue clasps are
made from a material relatively more rigid than that of said optic
portion.
6. The intraocular lens of claim 1 wherein said intraocular lens is
formed from one or more materials selected from the group
consisting of silicone polymers, hydrocarbon and fluorocarbon
polymers, hydrogels, soft acrylic polymers, polyester, polyamides,
polyurethane, silicone polymers with hydrophilic monomer units,
fluorine-containing polysiloxane elastomers and combinations
thereof.
7. The intraocular lens of claim 1 wherein said lens optic portion
and haptics are formed from a hydrogel material and said tissue
clasps are formed from polymethylmethacrylate.
8. The intraocular lens of claim 1 wherein said lens optic portion
is formed from an acrylic material.
9. The intraocular lens of claim 1 wherein said lens optic portion
is formed from a silicone material.
10. The intraocular lens of claim 1 wherein a glare reduction zone
is formed adjacent to the outer peripheral edge of the optic
portion.
11. The intraocular lens of claim 1 wherein said tissue clasps are
manufactured from a relatively rigid hydrogel,
polymethylmethacrylate or polyamide material.
12. The intraocular lens of claim 1 wherein said lens has two
haptic elements.
13. The intraocular lens of claim 1 wherein said tissue clasp has
smooth, serrated or toothed edges.
14. The intraocular lens of claim 1 wherein said haptic elements
may be compressed to open said tissue clasp.
15. The intraocular lens of claim 1 wherein said haptic elements
may be compressed to eliminate a void defined by said channel void
and thus open said tissue clasps.
16. The intraocular lens of claim 1 wherein said tissue clasp may
be opened by applying a force to attachment aperture and said lens
may be attached within an eye by eliminating said force and
allowing said tissue clasp to close with iris tissue therein.
17. A method of manufacturing the intraocular lens of claim 1
comprising: forming a disk from one or more suitable materials,
machining said lens from said disk.
18. A method of manufacturing the intraocular lens of claim 1
comprising: molding said lens from one or more suitable materials
in removable molds, and removing said lens from said molds.
19. A method of using the intraocular lens of claim 1 comprising:
creating an incision in a cornea of an eye, inserting said
intraocular lens in an anterior chamber of said eye, and securing
said intraocular lens within the anterior chamber.
20. A method of using the intraocular lens of claim 1 comprising:
creating an incision in a cornea of an eye, inserting said
intraocular lens in an anterior chamber of said eye using an
inserter, and securing said intraocular lens within the anterior
chamber using tissue clasps.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to intraocular lenses (IOLs)
and a method for making and using the same. More particularly, the
present invention relates to anterior chamber iris fixated IOLs
designed primarily for refractive correction in phakic eyes where
the eye's natural lens remains intact.
BACKGROUND OF THE INVENTION
[0002] Visual acuity deficiencies such as myopia (nearsightedness),
hyperopia (farsightedness), presbyopia (age-related
farsightedness), aphakia (absence of the crystalline lens of the
eye) and astigmatism (irregular conformation of the cornea of the
eye) are typically corrected through the use of refractive lenses
such as spectacles or contact lenses. Although these types of
lenses are effective in correcting a wearer's eyesight, many
wearers consider the lenses inconvenient. The lenses must be
located, worn at certain times, removed periodically and may be
lost or misplaced. The lenses may also be dangerous or cumbersome
if the wearer participates in athletic activities or suffers an
impact in an area near the eyes.
[0003] The use of surgically implanted anterior chamber IOLs as a
permanent form of refractive correction has been gaining in
popularity. IOL implants have been used for years in the anterior
or posterior chamber of aphakic eyes as replacements for surgically
removed natural crystalline lenses, which is common in the case of
cataracts. Many different IOL designs have been developed over past
years and proven successful for use in aphakic eyes. The successful
IOL designs to date primarily include an optic portion with
supports therefor, called haptics, connected to and surrounding at
least a part of the optic portion. The haptic elements of an IOL
are designed to support the optic portion of the IOL in the lens
capsule, anterior chamber or posterior chamber of an eye once
implanted.
[0004] Commercially successful IOLs have been made from a variety
of biocompatible materials, ranging from more rigid materials such
as polymethylmethacrylate (PMMA) to softer, more flexible materials
capable of being folded or compressed such as silicones, certain
acrylics, and hydrogels. Haptic portions of the IOLs have been
formed separately from the optic portion and later connected
thereto through processes such as heat, physical staking and/or
chemical bonding. Haptics have also been formed as an integral part
of the optic portion in what is commonly referred to as
"single-piece" IOLs.
[0005] Softer, more flexible IOLs have gained in popularity in
recent years due to their ability to be compressed, folded, rolled
or otherwise deformed. Such softer IOLs may be deformed prior to
insertion thereof through an incision in the cornea of an eye.
Following insertion of the IOL in an eye, the IOL returns to its
original pre-deformed shape due to the memory characteristics of
the soft material. Softer, more flexible IOLs as just described may
be implanted into an eye through an incision that is much smaller,
i.e., 2.8 to 3.2 mm, than that necessary for more rigid IOLs, i.e.,
4.8 to 6.0 mm. A larger incision is necessary for more rigid IOLs
because the lens must be inserted through an incision in the cornea
slightly larger than that of the diameter of the inflexible IOL
optic portion. Accordingly, more rigid IOLs have become less
popular in the market since larger incisions have been found to be
associated with an increased incidence of postoperative
complications, such as induced astigmatism.
[0006] After IOL implantation, both softer and more rigid IOLs
positioned within the angle of the anterior chamber of the eye are
subject to compressive forces exerted on the outer edges thereof,
which typically occur when an individual squints or rubs the eye.
Such compressive forces on angle positioned IOLs in either aphakic
or phakic eyes may result in tissue damage, decentration of the IOL
and/or distortion of the visual image. Compressive forces exerted
on an angle positioned IOL may also tend to cause movement of the
IOL haptics and axial displacement of the IOL along the optical
axis of an eye. Haptic movement and broad haptic contact in the
angle of the anterior chamber of an eye has the potential to cause
damage to delicate structures within the eye such as the peripheral
corneal endothelium, the trabecular meshwork and/or the iris.
Movement of an IOL along the optical axis of an eye has the
potential to cause the IOL to contact and damage the delicate
corneal endothelial cell layer of the eye. Also, angle positioned
IOLs of current designs, whether formed of either softer or more
rigid materials, tend to deflect along the optical axis of an eye
when the haptics are compressed. IOL manufacturers provide a wide
range of IOL sizes to more precisely fit IOLs to each particular
patient's eye size. Providing a wide range of IOL sizes is an
attempt to minimize the potential for haptic compression and the
associated axial displacement of the IOL optic along the optical
axis of an eye.
[0007] Because of the noted shortcomings of current IOL designs,
there is a need for aphakic and phakic anterior chamber IOLs
designed to eliminate haptic contact and movement in the angle of
the anterior chamber and eliminate axial displacement of the IOL
optic portion along the optical axis of the eye when compressive
forces are exerted against the outer edges thereof. By eliminating
an IOL's haptic and optic movement within the angle and within the
anterior chamber, more certain refractive correction may be
achieved and the risk of delicate tissue damage may be reduced.
SUMMARY OF THE INVENTION
[0008] An anterior chamber iris fixated intraocular lens (IOL) made
in accordance with the present invention has an optic portion with
an outer peripheral edge and two or more but preferably two haptic
elements for supporting the optic portion in a patient's eye. Two
haptic elements are preferred in the present invention to provide
IOL stability and to minimized points of fixation on the iris. A
lens having two haptic elements is balanced or stabilized by having
one haptic element formed on one edge of the optic portion and the
second haptic element formed on an opposite edge of the optic
portion. Both of the haptic elements on the optic portion are
preferably of a plate-like form designed to allow the IOL to be
easily folded, rolled and/or compressed for implantation thereof
within an eye through a relatively small incision preferably using
an inserter. Each haptic element is manufactured with an attachment
aperture preferably centered in an outer free end portion thereof,
an attachment slot formed in conjunction with the attachment
aperture and a tissue clasp formed in conjunction with the
attachment aperture for ease in securely attaching the tissue clasp
on the anterior surface of the iris of an eye. The tissue clasps
are designed to secure the IOL within the anterior chamber of an
eye by securely engaging the relatively non-mobile outer peripheral
edge of the iris of an eye. Each haptic element also has an inner
portion opposite the outer free end portion. The inner portion of
the haptic element is preferably connected to or integrally formed
with the outer peripheral edge of the optic portion of the IOL.
[0009] Accordingly, it is an object of the present invention to
provide intraocular lenses for use in aphakic and phakic eyes.
[0010] Another object of the present invention is to provide
intraocular lenses for use in aphakic and phakic eyes, which
eliminate anterior chamber angle contact.
[0011] Another object of the present invention is to provide
intraocular lenses for use in aphakic and phakic eyes, which
minimize axial displacement of the optic portions of the lenses
along the optical axis of the eyes.
[0012] Another object of the present invention is to provide
intraocular lenses that allow for increased ease of implantation
thereof.
[0013] Another object of the present invention is to provide
intraocular lenses that allow for implantation using an
inserter.
[0014] Another object of the present invention is to provide
intraocular lenses for use in aphakic and phakic eyes, which
minimize damage to tissues in the interior of the eyes.
[0015] Still another object of the present invention is to provide
intraocular lenses, which are resistant to decentration within the
eyes.
[0016] These and other objectives and advantages of the present
invention, some of which are specifically described and others that
are not, will become apparent from the detailed description,
drawings and claims that follow, wherein like features are
designated by like numerals.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a schematic representation of the interior of a
phakic human eye including a natural lens and a refractive IOL
implanted in the anterior chamber of the eye;
[0018] FIG. 2 is a plan view of an IOL with two haptics made in
accordance with the present invention;
[0019] FIG. 3 is a side cross-sectional view of the IOL of FIG. 2
taken along line 3-3;
[0020] FIG. 4 is a plan view of an IOL with four haptics made in
accordance with the present invention;
[0021] FIG. 5 is a side cross-sectional view of the IOL of FIG. 4
taken along line 5-5;
[0022] FIG. 6 is a perspective view of a surgical forceps; and
[0023] FIG. 7 is a perspective view of the IOL of FIG. 2 with the
surgical forceps of FIG. 6 used to open a tissue clasp.
DETAILED DESCRIPTION OF THE INVENTION
[0024] FIG. 1 illustrates a simplified diagram of an eye 10 showing
landmark structures relevant to the implantation of an intraocular
lens of the present invention. Eye 10 includes an optically clear
cornea 12 and an iris 14 with a relatively non-mobile peripheral
edge 40. A natural crystalline lens 16 and a retina 18 are located
behind iris 14 of eye 10. Eye 10 also includes anterior chamber 6
with angle 7 located in front of iris 14 and a posterior chamber 8
located between iris 14 and natural lens 16. An IOL 26, such as
that of the present invention, is preferably implanted in anterior
chamber 6 to correct refractive errors while healthy natural lens
16 remains in place (phakic application). However, IOL 26 likewise
may be implanted in anterior chamber 6 of aphakic eyes where the
natural lens 16 has been removed. Eye 10 also includes an optical
axis OA-OA that is an imaginary line that passes through the
optical center 20 of anterior surface 22 and posterior surface 24
of lens 16. Optical axis OA-OA in the human eye 10 is generally
perpendicular to a portion of cornea 12, natural lens 16 and retina
18.
[0025] The IOL of the present invention, as best illustrated in
FIGS. 2 and 4 identified by reference numeral 26, is designed for
implantation in anterior chamber 6 of a patient's aphakic or phakic
eye 10. IOL 26 has an optic portion 28 with an outer peripheral
edge 30. Preferably integrally formed on peripheral edge 30 of
optic portion 28 are two or more but preferably two separate
plate-like haptic elements 32. Each haptic element 32 is
manufactured to have an inner portion 34 and an outer free end
portion 36. Inner portions 34 of haptic elements 32 are preferably
integrally formed with and permanently connected to outer
peripheral edge 30 of optic portion 28. Alternatively however,
inner portions 34 of haptic elements 32 may be attached to optic
portion 28 by staking, chemical polymerization or other methods
known to those skilled in the art. Each haptic element 32 also
includes at outer free end portion 36, a tissue clasp 38 designed
to engage relatively non-mobile outer peripheral edge 40 of iris 14
in anterior chamber 6. In accordance with the present invention,
IOL 26 is securely held in proper position in anterior chamber 6
through constant compressive forces exerted by tissue clasp 38 on
relatively non-mobile outer peripheral edge 40 of iris 14. Iris
fixation of IOL 26 is desired to avoid haptic element 32 contact
and damage to delicate tissues within angle 7 of eye 10.
[0026] The required functional characteristics of haptic elements
32 to enable single-handed implantation and to maintain adequate
compressive forces on iris 14, are achieved through the unique
design thereof. Haptic elements 32, as best illustrated in FIGS. 2
through 5, are formed with an inner portion 34, an outer free end
portion 36, a tangential haptic edge 42 that is formed tangent to
outer peripheral edge 30 of optic portion 28 and an opposed
parallel haptic edge 44 that is formed to be parallel with
tangential haptic edge 42. The width of outer free end portion 36
if measured in plane 70-70 is preferably between 15 to 40 percent
of the diameter of optic portion 28, but preferably approximately
1.5 mm. Haptic elements 32 are offset to be tangent to outer
peripheral edge 30 and significantly smaller than the diameter of
optic portion 28 to allow IOL 26 to pass relatively easily through
an injector nozzle while avoiding folding of haptic elements 32 at
tissue clasps 38 formed therein. In using an injector to implant
IOL 26, offset haptic elements 32 allow space for an injector
plunger to avoid haptic elements 32 and contact outer peripheral
edge 30 of optic portion 28 during the injector insertion process.
Injector plunger contact and force on peripheral edge 30 of optic
portion 28 adjacent to parallel haptic edge 44 is desirable to
avoid and prevent damage to haptic element 32 during implantation.
Alternatively, IOL 26 may be folded and implanted into an eye using
forceps 60 by folding IOL 26 optic portion 28 along an axis
adjacent to parallel haptic edges 44 to avoid folding or
manipulation of haptic elements 32 to prevent damage thereto.
Formed in outer free end portion 36 of haptic element 32,
preferably an equal distance between tangential haptic edge 42 and
parallel haptic edge 44, is an attachment aperture 46 defined by
aperture edge 50. An optional but preferred channel void 52 is
likewise formed in haptic element 32 to extend a defined distance
of approximately 0.25 to 2.0 mm but preferably approximately 1.0 mm
from aperture edge 50 toward optic portion 28. Extending through
haptic elements 32 from free haptic edge 48 of outer free end
portion 36 through aperture edge 50 is tissue clasp 38. Tissue
clasp 38 may be separated or spread apart in plane 70-70 by
compressing inner portion 34 of haptic elements 32 with surgical
forceps 60 as illustrated in FIGS. 6 and 7. Upon compression of
inner portion 34 of haptic elements 32, interior surfaces 54 of
channel void 52 are forced into direct contact thus eliminating the
approximately 1.0 mm void 56 defined by channel void 52. In
eliminating void 56, fissure edges 58 of tissue clasp 38 are
correspondingly spread apart or separated. Alternatively, fissure
edges 58 of tissue clasp 38 may be opened or separated by applying
a force in plane 70-70 to free haptic edge 48 or aperture edge 50,
or by applying a shearing force in plane 72-72 to tissue clasp 38,
using surgical forceps 60. Once smooth, serrated or toothed fissure
edges 58 of tissue clasps 38 are separated or opened, the same may
be placed on or in contact with the relatively non-mobile
peripheral edge 40 of iris 14 and allowed to return to their
original closed position to impart a suitable attachment or
fixation force of approximately 5 to 250 millinewtons on iris 14.
The fixation force of IOL 26 will vary depending on the
characteristic degree of rigidity/flexibility of the material or
materials forming haptic elements 32. The more rigid the material,
the greater the fixation force. The more flexible the material, the
weaker the fixation force. Fissure edges 58 of tissue clasps 38 may
close completely, although not preferred, to pierce relatively
non-mobile peripheral edge 40 of iris 14 or close partially to a
distance of approximately 0.100 mm between fissure edges 58 to
pinch relatively non-mobile peripheral edge 40 of iris 14 for
reliable secure attachment thereto. Preferably fissure edges 58 of
fixation clamps 38 are oriented in a plane perpendicular to the
optical axis OA-OA of eye 10 when secured to iris 14 for better
tolerance by iris 14 and easier surgical handling during the
implantation process. Because haptic elements 32 are relatively
small in size, IOL 26 may be implanted in an eye 10 through a
relatively small incision, such as less than 4.0 mm, using an
inserter.
[0027] The subject IOL 26 is preferably produced having an optic
portion 28 approximately 4.5 to 9.0 mm, but preferably
approximately 5.0 to 6.0 mm and most preferably 5.5 mm in diameter
and approximately 0.5 mm to 1.0 mm, but preferably approximately
0.6 to 0.8 mm and most preferably 0.7 mm in thickness at peripheral
edge 30. Haptic elements 32 extend in a substantially plate-like
configuration and will increase or decrease in length depending
upon the diameter of optic portion 28. As the diameter of optic
portion 28 increases, the length of haptic elements 32 decrease.
Likewise, as the diameter of optic portion 28 decreases, the length
of haptic elements 32 increase. In general, haptic elements 32 are
formed to be approximately 0.5 to 3.0 mm, but preferably
approximately 1.0 to 2.0 mm and most preferably approximately 1.5
mm in length measuring parallel to tangential haptic edge 42 from
the center of inner portion 34 to free haptic edge 48. The overall
diameter of IOL 26 is approximately 6.0 to 10.0 mm, but preferably
approximately 7.0 to 9.0 mm, and most preferably approximately 8.5
mm. Haptic elements 32 are preferably vaulted as illustrated in
FIGS. 3 and 5 so optic portion 28 lies in a different but parallel
plane to that of free haptic edge 48 of haptic elements 32. Such
vaulting of IOL 26 allows appropriate fixation thereof to
relatively non-mobile peripheral edge 40 of iris 14 while avoiding
contact between the posterior surface 62 of optic portion 28 and
mobile portions 9 of iris 14. A vault of approximately 0.5 to 1.0
mm, but preferably 0.75 mm measuring between posterior surface 62
of optic portion 28 and free haptic edge 48 of haptic elements 32
is preferred for central placement of IOL 26 between iris 14 and
corneal endothelium 4. Haptic elements 32 vary in thickness in
plane 72-72 along the length thereof. Haptic elements 32 are
approximately 0.100 to 0.300 mm, but preferably approximately 0.150
mm in thickness at free haptic edge 48 and approximately 0.150 to
1.000 mm, but preferably approximately 0.725 mm in thickness at
outer peripheral edge 30. Haptic elements 32 at tissue clasp 38 is
approximately 0.100 to 0.400 mm in width in plane 70-70 measuring
from free haptic edge 48 to aperture edge 50, but preferably
approximately 0.200 mm in width.
[0028] Suitable materials for the production of the subject IOL 26
include but are not limited to foldable or compressible materials,
such as but not limited to silicone polymers, hydrocarbon and
fluorocarbon polymers, hydrogels, soft acrylic polymers,
polyesters, polyamides, polyurethane, silicone polymers with
hydrophilic monomer units, fluorine-containing polysiloxane
elastomers and combinations thereof. It is preferred that IOL 26 is
manufactured from a bicomposite material as described in U.S. Pat.
Nos. 5,217,491 and 5,326,506 incorporated herein in their entirety
by reference. In such a case, optic portion 28 and at least a
portion of haptic elements 32 such as inner portions 34 are
manufactured from a foldable or compressible material such as but
not limited to silicone polymers, hydrocarbon and fluorocarbon
polymers, hydrogels, soft acrylic polymers, polyesters, polyamides,
polyurethane, silicone polymers with hydrophilic monomer units,
fluorine-containing polysiloxane elastomers or combinations
thereof. Selecting a compressible, foldable material having a high
refractive index is a desirable feature in the production of IOLs
to impart high optical power with a minimum of optic thickness. By
using a material with a high refractive index, visual acuity
deficiencies may be corrected using a thinner IOL. A thin IOL, such
as that of IOL 26, is particularly desirable in phakic applications
to minimize potentially harmful contact between the IOL 26 and the
iris 14 and/or the corneal endothelium 4. Poly(HEMA-co-HOHEXMA) is
also a desirable material in the production of IOLs 26 due to its
relatively high refractive index and mechanical strength, which is
suitable to withstand considerable physical manipulation.
Poly(HEMA-co-HOHEXMA) also has desirable memory properties suitable
for IOL 26 use. IOLs 26 manufactured from a material possessing
good memory properties such as those of poly(HEMA-co-HOHEXMA)
unfold in a controlled manner in an eye 10, rather than
explosively, to its predetermined shape. Explosive unfolding of
IOLs 26 is undesirable due to potential damage to delicate tissues
within the eye 10. The remaining portion of haptic elements 32 but
most importantly outer free end portion 36 and tissue clasps 38 are
preferably manufactured from a relatively more rigid material such
as but not limited to a relatively more rigid hydrogel, PMMA or a
polyimide. Outer free end portion 36 and tissue clasps 38 are
preferably manufactured from a more rigid material to ensure secure
attachment to non-mobile peripheral edge 40 of iris 14.
[0029] Although the teachings of the present invention are
preferably applied to soft or foldable IOLs 26 formed of a foldable
or compressible material, the same may also be applied to harder,
less flexible lenses formed of one or more relatively rigid
materials such as but not limited to polymethylmethacrylate (PMMA)
if implantation thereof through a relatively small incision or
through an inserter such as that described in U.S. Pat. Nos.
5,873,879, 5,860,986 and 5,810,834, incorporated herein in their
entirety by reference, is not desired.
[0030] Optic portion 28 of IOL 26 can be a positive powered lens
from 0 to approximately +40 diopters or a negative powered lens
from 0 to approximately -30 diopters. Optic portion 28 may be
biconvex, piano-convex, plano-concave, biconcave or concave-convex
(meniscus), depending upon the power required to achieve the
appropriate central and peripheral thickness for efficient
handling.
[0031] Optic portion 28 of the subject IOL 26 may optionally be
formed with a glare reduction zone 64 of approximately 0.25 to 0.75
mm but more preferably approximately 0.3 to 0.6 mm and most
preferably 0.5 mm in width adjacent outer peripheral edge 30 for
reducing glare when outer peripheral edge 30 of IOL 26 is struck by
light entering eye 10 during high light or at other times when
pupil 66 is dilated. Glare reduction zone 64 is typically
fabricated of the same material as optic portion 28, but may be
opaque, roughened, textured, colored or patterned in a conventional
manner to block or diffuse light in plane with optical axis
OA-OA.
[0032] The subject IOL 26 may be molded using removable molds as
known to those skilled in the art. Alternatively, IOL 26 may be
manufactured by first producing discs from one or more materials of
choice as described in U.S. Pat. Nos. 5,217,491 and 5,326,506 each
incorporated herein in its entirety by reference. IOL 26 may then
be machined from the material discs in a conventional manner. Once
machined, IOL 26 may be polished, cleaned, sterilized and packaged
by a conventional method known to those skilled in the art.
[0033] The subject IOL 26 is used in eye 10 by creating an incision
in cornea 12, inserting IOL 26 in anterior chamber 6 preferably
using an inserter if desired, opening smooth, serrated or toothed
fissure edges 58 of tissue clasp 38 with a surgical instrument,
allowing smooth, serrated or toothed fissure edges 58 to close and
pinch and/or pierce relatively non-mobile peripheral edge 40 and
closing the incision in accordance with methods known to those
skilled in the art.
[0034] IOL 26 of the present invention provides for a refractive
lens suitable for use in anterior chamber 6 of eye 10. IOL 26 has
haptic elements 32 with functional characteristics that minimize or
eliminate axial displacement along optical axis OA-OA of eye 10 and
lens contact in the angle 7 of anterior chamber 6 thereby
preventing damage to delicate eye tissues such as the trabecular
meshwork 17 and the corneal endothelium 4. IOL 26 designed as
described herein is also advantageous because one or a few lens
sizes suitably fit eyes 10 of most sizes since the position of
attachment to iris 14 may be varied slightly. By providing a
"universal" lens such as that of the present invention, clinical
risks to patients due to improperly sized lenses in angle 7 are
minimized. Likewise, manufacturers' need to produce IOLs of many
sizes to fit eyes of many sizes is eliminated, thus reducing
production and inventory costs associated therewith.
Ophthalmologists also benefit from subject IOL 26 in that time is
saved by eliminating the need to determine each patient's
particular eye size and costs associated with maintaining large
inventories of varying sized lenses.
[0035] While there is shown and described herein certain specific
embodiments of the present invention, it will be manifest to those
skilled in the art that various modifications may be made without
departing from the spirit and scope of the underlying inventive
concept and that the same is not limited to the particular forms
herein shown and described except insofar as indicated by the scope
of the appended claims.
* * * * *