Patent Description:
The crystalline lens is a complex structure, whose function has been a topic of study for centuries. It presents a gradient in its refractive index ranging from about <NUM> at the lens surface to about <NUM> at its core. This gradient is achieved thanks to a variable concentration of proteins in the cytoplasm of lens fiber cells. Despite the high presence of proteins, the healthy crystalline lens shows a high transparency due to the compact distribution of proteins. In addition, the crystalline lens has aspherical surfaces, which reduces spherical aberration in the eye. On the other hand, the design of the human eye also allows the optimization of the formation of the image at the periphery in terms of aberrations and field curvature with respect to the shape of the retina.

Cataracts are a pathological condition in which the natural crystalline lens has lost its transparency and the formation of image in the retina is deteriorated mainly due to the scattering of light. In most cases, to solve this problem, cataract surgery is performed by which the damaged lens is removed from the eye and a specific implant (an intraocular lens IOL) is placed to substitute the extracted crystalline lens.

Intraocular lenses have been used in ophthalmology for more than half a century. Since then, IOL implantation has become the most common and successful surgery, not only in the field of ophthalmology, but in the field of medicine in general. The implant is chosen to provide the refractive power needed to optimize the focal point in the fovea, the highest resolution area of the retina, thus replacing the patient's crystalline lens. The central visual field of the pseudo-phakic eye (with the lens replaced by an IOL) is characterized by good image quality, almost entirely limited by the post-operative sphero-cylindrical error, or even in some cases and depending on the type of implant used, by the induction of spherical aberration.

In most cases, the optical quality at the periphery of the visual field is not considered to be one of the most important points in the design of an IOL, since, for major eccentricities in the retina, the number of photoreceptor cells decreases and neuronal convergence increases. Due to these physiological limitations of the retina, IOL manufacturers have designed ocular implants focusing solely on image quality in the central area of the fovea, regardless of what occurs in the far periphery of the visual field. While the natural crystalline lens has properties adapted to the shape of the retina, IOLs do not contemplate this phenomenon at all. However, there are specific applications where the quality of peripheral vision can have a great impact on the quality of vision, such as detecting the direction of movement of visual patterns or even simpler activities such as detecting small peripheral objects. It is possible that the mismatch between the field curvature provided by conventional IOLs and the shape of the retina produces very low contrast and quality images that are related to accidents due to the non-detection of obstacles in various areas of the visual field.

Another common phenomenon that occurs in the distant periphery in pseudo-phakic patients, of a rather unclear etiology, is the presence of dark shadows, and is referred to as negative dysphotopsy.

Although the peripheral behaviour of pseudophakic eyes has not yet been studied in depth, there is some evidence that IOLs are not capable of reproducing the peripheral image quality that the natural crystalline lens does bring to human vision (see<NPL>)). Intraocular lenses are specifically designed to facilitate surgical techniques (such as ease of implantation), with the goal of regaining emmetropia and prioritizing central vision.

In most cases, current intraocular lenses induce problems such as increased astigmatism and other aberrations on the periphery of the pseudophakic eye's visual field. Although in principle these phenomena may be imperceptible directly by the patient (as would be the presence of blur in the central vision), there is evidence that they play a role in the patient's spatial orientation and safety.

On the other hand, there are currently several IOLs with different asphericity values, both to compensate for corneal asphericity and to extend the depth of focus and allow acceptable vision at various distances. A problem with these IOLs is that they provide a unique asphericity value. However, each patient has a cornea with a different value of spherical aberration to be considered. In addition, each patient has a different sensitivity to the final net amount of spherical aberration after implantation of the IOL.

On the other hand, objective and visual measurements on each patient can be made using adaptive optics visual simulation technology (see <NPL>)).

Many types of IOLs have already been implemented in the patent and scientific literature. For example, <CIT>) describes a generic aspherical lens for intraocular implantation that has a biconvex shape. However, in its design there is no provision for peripheral vision.

<CIT>) describes a method for selecting an intraocular lens, involving only optical and anatomical measurements that are subsequently used to calculate the power and spherical aberration of the required IOL. This invention does not consider possible arrangements for peripheral image quality and, furthermore, does not include the preoperative subjective (psychophysical) evaluation of patients.

<CIT>) describes a method for designing an intraocular lens with a given asphericity to compensate for corneal aberrations, considering the possible eccentricity of the pupil. The same principles are described in a later document by the same inventors (<CIT>)). The above mentioned invention does not include provisions for peripheral image quality.

Document <CIT>) describes a hybrid lens with at least one diffractive element that is used to control the total longitudinal chromatic aberration of the eye.

<CIT>) presents an IOL design that compensates for the spherical aberration of the cornea without mentioning its customization.

<CIT>), describes an IOL design to improve wavefront specific aberrations such as coma or astigmatism for the peripheral visual field for angles up to <NUM> degrees, without reference to peripheral image quality and distortion.

<CIT>, referred to "Ophthalmic implants with extended depth of field and enhanced distance visual acuity", discloses a lens configured for implantation into an eye of a human that can include an optic including transparent material. The optic can have an anterior surface and a posterior surface. The anterior surface can be convex and the posterior surface can be concave such that the optic is meniscus shaped. Each of the convex anterior surface and the concave posterior surface can have a surface vertex. The optic can have an optical axis through the surface vertices and a thickness along the optical axis that is between about <NUM>-<NUM> micrometers. The lens can also include haptic portions disposed about the optic to affix the optic in the eye when implanted therein. The anterior and posterior surfaces can include aspheric surfaces.

<CIT> discloses a method and system for simulating/emulating vision using intraocular lenses or devices prior to surgery.

There is currently a need in the intraocular lens market for an implant that provides an optimization of field curvature to fit it to the shape of the retina to optimize image quality in the far periphery of the visual field. In addition, it is desirable that the lenses have a range of spherical net aberration values to be customized to increase the depth of field customized to each patient.

The object of the present invention is to provide an intraocular lens that solves the aforementioned inconveniences.

The invention provides an intraocular lens comprising a central part and a peripheral part, the central part being the optical part and the peripheral part comprising haptics, in which the central part comprises:.

This intraocular lens, when implanted in the posterior chamber of the eye, simulates the natural imaging formation properties of the crystalline lens, especially in the far periphery of the visual field, optimizing the field curvature of the implanted eye to adapt it appropriately to the shape of the retina.

This intraocular lens results in an improved image formation in terms of sharpness, peripheral refraction and geometric distortion.

The invention also provides methods for optimizing depth of focus and image quality in the periphery of the visual field using said intraocular lens, according to claim <NUM>.

Other characteristics and advantages of the present invention will be derived from the detailed description that follows from an illustrative embodiment of its object in relation to the accompanying figures.

The object of the present invention will be illustrated below in a non-limiting way, making reference to the drawings that are accompanied, in which:.

<FIG> shows a section of the human eye. The light <NUM> entering through the pupil is focused by the cornea <NUM> and the lens of the crystalline <NUM> on the retina <NUM>. Objects in the center of the visual field are focused on the central part <NUM> of the retina, while objects on the periphery of the visual field are focused on a peripheral point <NUM> of the retina.

<FIG> shows an eye with a prior art intraocular lens <NUM> implanted in the posterior chamber of the eye. The light <NUM> entering through the pupil is focused by the cornea <NUM> on the retina <NUM>. The intraocular lens <NUM> has an anterior surface <NUM>, a posterior surface <NUM> and haptics <NUM>. Objects in the center of the visual field are focused on the central part <NUM> of the retina, while objects on the periphery of the visual field are focused on a peripheral point <NUM> of the retina. This peripheral point <NUM> is generally different from the peripheral focus point <NUM> prior to cataract surgery. In addition, rays entering the eye from the periphery of the visual field are strongly aberrated and the image at peripheral point <NUM> is out of focus.

<FIG> shows an intraocular lens <NUM> of the invention implanted in the posterior chamber of the eye. An eye is depicted with an improved intraocular lens <NUM>, implanted in the posterior chamber. The light <NUM> entering through the pupil is focused by the cornea <NUM> on the retina <NUM>. The intraocular lens <NUM> has an anterior surface <NUM>, a posterior surface <NUM>, an optical zone <NUM>, and haptics <NUM>. Objects in the center of the visual field are focused on the central part <NUM> of the retina, while objects in the periphery of the visual field are focused on a peripheral point <NUM> of the retina. This peripheral point <NUM> is close to the peripheral focus point <NUM> prior to cataract surgery. In addition, rays entering the eye from the periphery of the visual field are less aberrated and the image at peripheral point <NUM> is more focused.

<FIG> show two embodiments of intraocular lenses of the invention. <FIG> shows the intraocular lens <NUM>, with an anterior zone <NUM> that is concave and a posterior zone <NUM> that is convex, its optical zone <NUM>, about <NUM> in diameter, and the haptics <NUM>. <FIG> shows the haptics <NUM> with a certain angle <NUM> to a plane passing through the junctions between the central part and the peripheral part. This plane shall be perpendicular to the optical axis of the eye in which the lens is intended to be implanted.

<FIG> shows an adaptive optics visual simulator <NUM>, which simulates different profiles of intraocular lenses <NUM> for a patient <NUM>. The patient <NUM> evaluates the results of the simulations <NUM> through a visual test at different distances (i.e. far, intermediate, close) and chooses the most optimal result <NUM> according to his/her visual necessities. This is used to determine the net value of asphericity on the IOL to be implanted.

The present invention refers to the design of a new posterior chamber intraocular lens <NUM> that simulates the image formation properties of the natural crystalline lens, in the specific referring to the induced field curvature and to the improvement of the visual quality on the far periphery of the retina. Moreover, it can offer extended depth of focus both for central and peripheral vision and therefore reduce the dependence on spectacles postoperatively as well as allow for variability of the shape of peripheral retina. The IOL <NUM> is manufactured from one of the existing materials suitable of intraocular implantation such as hydrophobic acrylic, hydrophilic acrylic, silicone and can be produced either by machining or by molding.

The intraocular lens <NUM> has a central part with a diameter between <NUM> and <NUM> (preferably around <NUM>), with the required optical properties, and a peripheral part that extends to a diameter between approximately <NUM> and <NUM> (the haptics <NUM>) that help center and stabilize the intraocular lens <NUM> in the lens capsule once the cataract crystalline lens has been removed. The haptics <NUM> are selected from a range of designs established in the scientific literature. In the surgical process, the lens <NUM> is bent and injected into the prepared capsule through a small incision in the limbus or peripheral cornea.

In an embodiment of the intraocular lens <NUM>, it is manufactured by molding acrylic hydrophobic material with a refractive index of approximately <NUM>. The anterior surface <NUM> of the intraocular lens <NUM> is concave aspherical, and the posterior surface <NUM> is convex aspherical. The optical part <NUM> of the lens <NUM> is circular and has a diameter of approximately <NUM>. The anterior surface <NUM> has a negative power when submerged in the aqueous humour of the eye (or a similar aqueous solution, such as saline solution), while the posterior surface <NUM> has a positive power. The combination of these two surfaces produces a refractive power of the order of <NUM> D when the intraocular lens <NUM> is immersed in the aqueous humour of the eye (or a similar aqueous solution, such as saline). The radius of curvature of the anterior surface <NUM> can be changed to produce intraocular lenses <NUM> of the same type, but with different diopter powers, as required in cataract surgery. The posterior surface <NUM> has an appropriate conical constant such that the spherical aberration of the lens <NUM> compensates for the spherical aberration of the average cornea of a human eye. In this embodiment, the total spherical aberration of the eye is practically zero, achieving optimal image quality for central and peripheral vision. The haptics <NUM> form an angle <NUM> (see <FIG>) with respect to a plane passing through the junctions between the central part and the peripheral part and which is perpendicular to the optical axis of the eye in which the lens <NUM> of approximately <NUM> degrees is intended to be implanted.

In another embodiment of the present invention, the intraocular lens <NUM> is manufactured by machining or molding hydrophobic acrylic material with a refractive index of between about <NUM> to about <NUM>. The anterior surface <NUM> of the intraocular lens <NUM> is concave aspherical and the posterior surface <NUM> is convex aspherical. The optical part <NUM> of the lens <NUM> is circular and has a diameter of approximately <NUM> to <NUM>. The anterior surface <NUM> has a negative power when submerged in the aqueous humour of the eye (or a similar aqueous solution, such as saline solution), while the posterior surface <NUM> has a positive power. The combination of these two surfaces produces a refractive power of the order of <NUM> D when the intraocular lens <NUM> is immersed in the aqueous humour of the eye (or a similar aqueous solution, such as saline). The radius of curvature of the anterior surface <NUM> can be changed to produce intraocular lenses <NUM> of the same type, but with different diopter powers, as required in cataract surgery. The posterior surface <NUM> has an appropriate conical constant such that the total power of the intraocular lens <NUM> remains constant, but that the negative spherical aberration of the lens <NUM> induces a concrete value equal to or greater (in absolute value) than that of the average cornea of a human eye. In this embodiment, the total spherical aberration of the eye can be adjusted between values close to zero and a negative value approximately <NUM> times greater (in magnitude) than that of the average cornea of a human eye. In this way, a greater compromise between image quality and depth of focus can be achieved. The optical part <NUM> has a diameter of approximately <NUM> and the haptics <NUM> form an angle <NUM> with respect to a plane that passes through the joints between the central part and the peripheral part and that is perpendicular to the optical axis of the eye in which the lens <NUM> is to be implanted, which varies between <NUM> and approximately 10º.

In another embodiment, the intraocular lens <NUM> is manufactured by machining or molding any material in the hydrophobic acrylic, hydrophilic acrylic, or silicone group that has refractive indices typically between approximately <NUM> and approximately <NUM>. The anterior surface <NUM> of the intraocular lens <NUM> is concave aspherical and the posterior surface <NUM> is aspherical convex. The optical part <NUM> of the lens <NUM> is circular and has a diameter ranging from approximately <NUM> to <NUM>. The anterior surface <NUM> has a negative power when submerged in the aqueous humour of the eye (or a similar aqueous solution, such as saline solution), while the posterior surface <NUM> has a positive power. The combination of these two surfaces produces a refractive power of the order of <NUM> D when the intraocular lens <NUM> is immersed in the aqueous humour of the eye (or a similar aqueous solution, such as saline). The radius of curvature of the anterior surface <NUM> can be changed to produce intraocular lenses <NUM> of the same type, but with different diopter powers, as required in cataract surgery. The balance of diopter power between the anterior <NUM> and posterior <NUM> surfaces can be changed to compensate for total or partial peripheral astigmatism in the eye. Both surfaces, anterior <NUM> and posterior <NUM>, may have conical constants defined in such a way that the power of the intraocular lens <NUM> remains almost constant but the negative spherical aberration of the lens <NUM> has a particular value equal to or greater (in absolute value) than that of the average human cornea. In this embodiment, the total spherical aberration in the eye can be adjusted from practically zero to a value approximately <NUM> times greater than the spherical aberration value of the normal eye (in absolute value). In this way, the best compromise between image quality and depth of focus is achieved. The optical zone <NUM> has a diameter of approximately <NUM> and the haptics <NUM> form an angle <NUM> with respect to a plane passing through the joints between the central part and the peripheral part and which is perpendicular to the optical axis of the eye in which the lens <NUM> is to be implanted, which varies between approximately <NUM> and approximately <NUM> degrees. The angulation <NUM> of the <NUM> haptics <NUM> controls the axial depth at which the intraocular lens <NUM> is implanted into the lens capsule. This adjustment, combined with the power balance between the anterior surface <NUM> and the posterior surface <NUM> can be varied to control the shape of the field curvature in the eye and make it match the shape of the retina. This adjustment helps correct peripheral refractive errors in the eye, a task that may be of particular importance for the control of myopia development following congenital cataract surgery. In a similar embodiment, the optical part <NUM> of the lens <NUM> can be oval. The longest axis of the oval would be implanted horizontally to reduce the phenomena associated with light diffusion and glare produced by the edge of the lens <NUM> in the distant temporal field of vision.

In another embodiment, the lens <NUM> is manufactured with one of the materials mentioned above, the anterior surface <NUM> of the lens <NUM> being concave aspherical and the posterior surface <NUM> being convex aspherical. The optical part <NUM> of the lens <NUM> is circular and has a diameter between approximately <NUM> and <NUM>. The central and peripheral refraction of a patient <NUM> is measured, as well as the topography of his cornea and the central and peripheral biometries. Corneal topography information, the axial placement provided for the intraocular lens <NUM> during implantation, as well as central and peripheral biometries are used to select from a range the angulation <NUM> of the haptics <NUM> and the balance between the anterior <NUM> and posterior <NUM> surface curvature radii to induce a desired central and peripheral post operative refraction.

In another embodiment, the lens <NUM> is manufactured with one of the materials mentioned above, the anterior surface <NUM> of the lens <NUM> being concave aspherical and the posterior surface <NUM> being convex aspherical. The optical part <NUM> of the lens <NUM> is circular and has a diameter of between approximately <NUM> to approximately <NUM>. The vision of patient <NUM> can be evaluated thanks to an adaptive optics simulator <NUM>, in which a specific amount of spherical aberration (typically negative) is determined to optimize each patient individually. The optimization aims at maximizing the depth of focus without significantly sacrificing the quality of distant vision. When this value is determined, the patient's corneal topography and biometry are used to select from a range of available intraocular lenses <NUM> that have different conical constants on at least one of the surfaces <NUM> or <NUM>, to provide adequate post-operative refraction and depth of field.

A method for optimizing depth of focus and the image quality in the periphery of the visual field uses intraocular lenses <NUM> of those described above and comprises the following steps (<FIG>):.

Another method for optimizing depth of focus and image quality at the periphery of the visual field uses intraocular lenses <NUM> of those described above and comprises the following steps:.

Claim 1:
Intraocular lens (<NUM>), comprising a central part and a peripheral part, the central part being the optical part (<NUM>) and the peripheral part comprising haptics (<NUM>),
the central part comprising:
- an aspherical concave anterior surface (<NUM>), which is the surface closest to the iris of the eye once the lens (<NUM>) has been implanted in the eye, and
- an aspherical convex posterior surface (<NUM>), which is the surface closest to the retina of the eye once the lens (<NUM>) has been implanted in the eye,
characterized in that:
- the radius of curvature of the posterior surface (<NUM>) of the central part is smaller than the radius of curvature of the anterior surface (<NUM>) of the central part, with a ratio between radii of between <NUM> and <NUM>, and
- the haptics (<NUM>) are arranged at an angle (<NUM>) of between <NUM>° and <NUM>° with respect to a plane passing through the joints between the central part and the peripheral part and which is perpendicular to the optical axis of the eye in which the lens (<NUM>) is intended to be implanted.