Ophthalmic dynamic aperture

(54) Title: DYNAMIC OPHTHALMIC OPENING (57) Summary:

(30) Unionist Priority: 23/02/2007 us 60 / 902,866,

1/14/2008 US 61 / 020,759, 2/1/2008 US 61 / 025,348, 2/23/2007

US 60 / 902,866, 2/1/2008 US 61 / 025,348, 1/14/2008 US

61 / 020,759, 02/23/2007 US 60 / 902,866, 02/01/2008 US 61 / 025,348,

02/01/2008 US 61 / 025,348 (73) Holder (s): Pixeioptics, inc.

(72) Inventor (s): Anthony Van Heugten, JOSHUAN. HADDOCK, John Hunkeler, John Hunkeler, John Hunkeler, Ronald D. Blum, William Kokonaski (74) Attorney (s): Orlando de Souza (86) International Request: pct US2008054721 of 02/22/2008 (87) International Publication: wo 2008 / i03906 from 08/28/2008

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010 with dynamic aperture provides near and intermediate vision by increasing the depth of focus

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DYNAMIC OPHTHALMIC OPENING

Inventors: Ronald D. Blum, Joshua N. Haddock, William Kokonaski, Anthony Van Heugten and John Hunkeler.

CROSS REFERENCE WITH RELATED REQUESTS

This request claims priority and incorporates by reference in its entirety the following provisional requests:

US Serial No. 60 / 902,866 filed February 23, 2007 and entitled Electro-Active Ophthalmic Device for the Correction of Refractive Errors of the Human

Eye;

US Serial No. 61 / 020,759 filed January 14, 2008 and entitled Electro-Active Ophthalmic Optic or Lens with Dynamic Aperture; and

US Serial No. 61 / 025,348 filed on February 1, 2008 and titled Range of Optical Transmission Values ​​for an Ophthalmic Lens or Optic Comprising a Central Aperture for Providing Increased Depth of Focus.

BACKGROUND OF THE INVENTION

Field of invention

The present invention relates to an intraocular optic, an intraocular lens, a corneal inlay, a corneal onlay and a contact lens. More specifically, the present invention relates to an intraocular optic, an intraocular lens, a corneal inlay, a corneal onlay and a contact lens that have a dynamic aperture for increasing depth of field that can be used in optical or integral communication with an ophthalmic lens that corrects at

2/50 less partially a conventional error (aberrations of a lower order such as myopia, hyperopia, regular astigmatism and presbyopia) and / or an unconventional error (eg aberrations of a higher order) in a user's eye. The system of the invention that has a dynamic aperture that provides an increased depth of field and is in optical or integral communication with an ophthalmic lens (which can be a single or multifocal vision lens) that corrects vision errors (for example, presbyopia) it can allow an almost continuous range of perceived foci from the near distance to the far distance.

Description of the related technique

There are two main conditions that affect an individual's ability to focus on objects at close and intermediate distance: presbyopia and aphakia. Presbyopia is the loss of accommodation of the lens of the human eye that often accompanies aging. In a pre-lesbian individual, this loss of accommodation initially results in an inability to focus objects at close range and subsequently results in an inability to focus objects at an intermediate distance. It is estimated that there are approximately 90 to 100 million lesbians in the United States. Worldwide, it is estimated that there are approximately 1.6 billion lesbians. Aphakia is the absence of the lens of the eye, usually due to surgical removal during cataract surgery. In an aphakic individual, the absence of the lens causes a complete loss of accommodation that results in the inability to focus objects at close or intermediate distance.

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For all practical purposes, a person will have cataracts if they live long enough. In addition, most individuals with cataracts will undergo cataract surgery at some point in their lives. It is estimated that approximately 1.2 million cataract surgeries are performed annually in the United States.

Standardized tools for correcting presbyopia are reading glasses, multifocal ophthalmic lenses and monocular fitting contact lenses. Reading glasses have a simple optical power to correct focusing problems for close range. A multifocal lens is a lens that has more than one focal length (that is, optical power) for correcting focusing problems over a range of distances. Multifocal lenses are used in glasses, contact lenses, corneal inlays, corneal onlays and intraocular lenses (IOLs). Multifocal ophthalmic lenses work by dividing the lens area into regions of different optical powers. Multifocal lenses can be composed of continuous surfaces that create continuous optical power in a Progressive Addition Lens (PAL). Alternatively, multifocal lenses can be composed of discontinuous surfaces that create discontinuous optical power such as bifocal or trifocal. Monocular fitting contact lenses are two contact lenses that have different optical powers. One contact lens mainly corrects focusing problems at a distance and the other contact lens mainly corrects focusing problems at a distance.

The standard tool for aphakia correction is a

4/50 intraocular lens (IOL). A first type of IOL is a single-vision or multifocal IOL that has no accommodation and does not change its optical power. A second type of IOL is an accommodating IOL that can alter its focusing power, for example, by compression, translation, mechanical deformation of a surface, or a combination of the above. Aphakia can also be corrected by using a single vision IOL in one eye and a multifocal or accommodating IOL in the other eye, or any combination of these.

Alternative approaches are also being used to correct presbyopia. One approach is a corneal inlay that provides a small, fixed diameter opening. Just as an example, the ACI 7000 corneal made by AcuFocus is approximately 3.8 mm in diameter, 10 pm thick, and contains an opaque ring with a transparent opening 1.6 mm in diameter. This opening acts to reduce the opening of the human eye to a smaller diameter than what can normally be obtained by natural pupil constriction.

As is well known in the art, limiting the diameter of the opening of an optical system increases the depth of field of the system. Depth of field is the distance in front of and behind the object's plane that appears in focus on the image plane. Although an optical system can only provide the precise focus of an object at the focal length, in a system with increased depth of field, the decrease in sharpness on both sides of the focal length is gradual. Therefore, within the depth of field, the blur produced in the. image plane is imperceptible under normal viewing conditions. An

5/50 aperture is used to increase the depth of field by eliminating at least a portion of the light rays that make a large angle with the optical axis of the lens (non-paraxial light rays). Non-paraxial light rays are only sharply focused when they originate from objects located at the focal distance. For objects located at other distances, non-paraxial light rays have the largest deviation from the image plane. By eliminating non-paraxial light rays, deviation from the image plane is minimized, and objects located within a fixed distance from the focal distance (that is, within the depth of field) appear in focus.

The small aperture counteracts some of the effects of presbyopia by creating a wide range of distances that appear in focus and allows presbytes to perform close-up viewing tasks without the need for contact lenses or multifocal glasses. ACI 7000 is manufactured with biocompatible materials whose optical properties are static, such as polyvinylidene fluoride or non-hydrogel microporous perfluorether, just as an example. Thus, once the inlay is placed inside the cornea, its refractive optical power is fixed.

Although proven to be effective, the AcuFocus corneal inlay reduces the amount of light reaching the retina. In addition, the inlay is usually only implanted in one eye, as deleterious optical effects, such as halos, double vision, light scattering, glare (glare), loss of contrast sensitivity and / or reduced light reaching the retina , are very large and may be unacceptable when the inlay is implanted in both

6/50 the eyes. These deleterious effects are caused by the size of the inlay opening and the occluded ring in relation to the size of the pupil. These effects occur especially at night, when the pupil dilates.

Another approach for correcting presbyopia is refractive corneal surgery, in which one eye is corrected for distance and the other eye is corrected for distance. Another approach is a corneal inlay that provides a multifocal effect using different optics, for example.

However, each of these approaches for correcting presbyopia and / or aphakia has disadvantages. Of course, some of these disadvantages are more serious than others. For example, although glasses are able to correct vision for a person's distance, near and intermediate distances, this approach requires the use of a device that departs from a person's natural appearance. In addition, in some cases, certain multifocal lenses can make the user perceive distortion and experience dizziness.

Approaches for correcting presbyopia and / or aphakia that include wearing contact lenses can cause discomfort and can also result in one or more of: halos, double vision, light scattering, glare, loss of contrast sensitivity, limited amplitude of focus and / or reduction of light reaching the retina. Approaches that include the use of IOLs can result in one or more of: light scattering, glare, halos, shadow vision, loss of contrast sensitivity, limited range of focus and / or reduced light reaching the retina.

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These disadvantages, or impairments to a person's vision, can be very problematic, especially, just as an example, when driving at night, when driving in the rain, or when working on a computer. Therefore, there is a need for a superior correction mode for presbyopia and / or aphakia.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, an ophthalmic device may include an electroactive element which may include an almost transparent dynamic aperture having an alterable diameter and an almost opaque ring to provide an increased depth of field, where the ophthalmic device is in optical communication. with an intraocular lens, a corneal inlay, a corneal onlay, a contact lens or an eyeglass lens that has an optical power to provide at least a partial correction of a refractive error in a user's eye.

In an embodiment of the present invention, an ophthalmic device may include an electroactive element which may include an almost transparent dynamic aperture having an alterable diameter and an almost opaque ring to provide an increased depth of field, wherein the electroactive element is integral with a intraocular lens, a corneal inlay, a corneal onlay or a contact lens that has an optical power to provide at least a partial correction of a refractive error in a user's eye.

In an embodiment of the present invention, an ophthalmic device can include a first electroactive element that has an optical power to provide at least

8/50 a partial correction of a refractive error in a user's eye. The ophthalmic device may further include a second electroactive element which has substantially no optical power which may include an almost transparent dynamic aperture having an alterable diameter and an almost opaque ring to provide an increased depth of field, wherein the first and the second electroactive elements are in optical communication between them.

In an embodiment of the present invention, an ophthalmic device may include an electro-active element which may include an almost transparent dynamic aperture having an alterable diameter and an almost opaque ring to provide an increased depth of field, where the center of the dynamic aperture may be. relocated to a user’s visual axis.

BRIEF DESCRIPTION OF THE DRAWINGS

The modalities of the invention will be understood and observed more fully from the following detailed description together with the figures, which are not to scale, in which similar reference numerals indicate corresponding, analogous or similar elements, and in which:

Figure 1 shows a cross section of a healthy human eye1;

Figure 2A shows an expanded view of a lateral cross-section of an electroactive element modality that has a dynamic opening;

Figure 2B shows a reduced view of a lateral cross-section of the electroactive element of Figure 2A;

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Figure 3 shows several operable rings for creating a dynamic opening;

Figure 4A shows an expanded cross-sectional view of an electrode modality with an electroactive element cut that has a dynamic opening;

Figure 4B shows a reduced view of a lateral cross-section of the electroactive element of Figure 4A;

Figure 5 shows various arrangements of the electrode rings shown in Figure 3 in which the geometric center of a dynamic opening can be repositioned in relation to the geometric center of a person's pupil according to an embodiment of the present invention;

Figure 6 shows a stack of five electroactive elements in which each can be used for the different ring electrode arrays shown in Figure 5 according to an embodiment of the present invention;

Figures 7A, 7B and 7C show modalities of the invention that have a dynamic aperture that are useful as a corneal inlay, corneal onlay or contact lens;

Figure 8 shows an OIO located in an anterior chamber of an eye and in optical communication with a healthy pristine lens according to an embodiment of the present invention;

Figure 9 shows an OIO located in an anterior chamber of an eye and in optical communication with an IOL according to an embodiment of the present invention;

Figure 10 shows an OIO located in an anterior chamber of an eye and in optical communication with an IOL that corrects only the vision for the distance from a distance according to an embodiment of the present invention;

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Figure 11 shows an OIO located in an anterior chamber of an eye and in optical communication with an IOL that corrects vision for long-distance and near-distance vision according to an embodiment of the present invention, Figure 12 shows an OIO located in a posterior chamber of an eye and in optical communication with an IOL according to an embodiment of the present invention;

Figure 13 shows an IOL that has a dynamic opening in the portion of the IOL closest to the pupil of the eye according to an embodiment of the present invention;

Figure 14 shows an IOL that has a dynamic opening in the middle portion of the IOL according to an embodiment of the present invention;

Figure 15 shows an IOL that has a dynamic opening in the portion of the IOL closest to the retina of the eye according to an embodiment of the present invention;

Figure 16 shows a corneal inlay that has a dynamic aperture in optical communication with a healthy pristine lens according to an embodiment of the present invention;

Figure 17 shows a corneal inlay that has a dynamic aperture in optical communication with an IOL according to an embodiment of the present invention;

Figure 18 shows that, during the day, or in light, when a user's pupil is contracted, a sensor perceives the increase in light and a controller can cause a dynamic opening in an electroactive element to contract according to a embodiment of the present invention;

Figure 19 shows that, at night, or in the dark, when

11/50 a user's pupil is dilated, a sensor perceives the dark and a controller can cause a dynamic opening in an electroactive element to dilate or remain dilated according to one embodiment of the present invention;

Figure 20 shows the normal operation of a sensor and a controller that have been canceled in which a dynamic opening in an electroactive element is contracted for tasks at close range in dark lighting conditions, even though a user's pupil is dilated by according to an embodiment of the present invention; and

Figure 21 shows a folded lens or optics of the invention that has one or more electroactive elements according to an embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

An electroactive element is a device with an optical property that is changeable with the application of electrical energy. The changeable optical property can be, for example, optical power, focal length, diffraction efficiency, depth of field, transmittance, coloring, opacity, or a combination of the above. An electroactive element can be constructed by two substrates. An electroactive material can be arranged between the two substrates. The substrates can be modeled and sized to ensure that the electroactive material is contained within the substrates cannot overflow. One or more electrodes can be placed on each surface of the substrates that are in contact with the electroactive material. The electroactive element can include a power source operationally connected to a controller. The controller may be connected

12/50 operationally to the electrodes by means of electrical connections to apply one or more voltages to each of the electrodes. When electrical energy is applied to the electroactive material, it can use electrodes, the optical property of the electroactive material can be changed. For example, when electrical energy is applied to the electroactive material through the electrodes, the refractive index of the electroactive material can be altered, thereby changing the optical power of the electroactive element.

The electroactive element can be embedded in or attached to a surface of an ophthalmic lens to form an electroactive lens. Alternatively, the electroactive element can be embedded in or attached to a surface of an optics that substantially does not provide any optical power to form an electroactive optics. In this case, the electroactive element may be in optical communication with an ophthalmic lens, but separate or apart or not integral with the ophthalmic lens. The ophthalmic lens can be a substrate or an optical lens. A lens is any device or portion of a device that causes light to converge or diverge (that is, a lens is capable of focusing light). A lens can be refractive or diffractive, or a combination of these. A lens can be concave, convex or flat on one or both surfaces. A lens can be spherical, cylindrical, prismatic, or a combination of these. A lens can be made of optical glass, plastic, thermoplastic resins, thermoset resins, a composite of glass and resin, or a composite of different resins or optical grade plastics. It should be noted that, within the optical industry, a

13/50 device can be called a lens even if it has zero optical power (known as flat or no power

<td>optical). At the</td><td colspan="2">However, in this case,</td><td colspan="2">the lens is</td><td>normally</td>

<td>named</td><td>an</td><td>flat lens.</td><td>An</td><td>lens</td><td>Can be</td>

<td>conventional</td><td>or</td><td>Not conventional.</td><td>An</td><td>lens</td><td>conventional</td>

corrects conventional eye errors, including lower order aberrations such as myopia, farsightedness, presbyopia and regular astigmatism. An unconventional lens corrects unconventional eye errors, including higher-order aberrations that can be caused by irregularities or abnormalities of the eye layer. The lens can be a single-focus lens or a multifocal lens, such as a Progressive Addition Lens or a bifocal or trifocal lens. In contrast, an optic, as used here, has substantially no optical power and is unable to focus light (by refraction or diffraction). The term refractive error can refer to conventional or unconventional errors of the eye. It should be noted that the redirection of light is not equivalent to the correction of a refractive error in the eye. Therefore, redirecting light to a healthy portion of the retina, for example, does not correct a refractive error in the eye.

The electroactive element can be located in the entire visualization area of ​​the lens or electroactive optics or only in a portion of it. The electroactive element can be located near the upper, middle or lower portion of the lens or optics. It should be noted that the electroactive element may be able to focus the light on its own, and does not need to be combined with a substrate or an optical lens.

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Figure 1 shows a cross section of a healthy human eye 100. The white portion of the eye is known as the sclera 110. The sclera is covered by a transparent membrane known as the conjunctiva 120. The central transparent portion of the eye that provides most of the optical power of the eye is the cornea 130. Iris 140 is the pigmented portion of the eye and forms pupil 150. The sphincter muscles contract the pupil and the dilator muscles dilate the pupil. The pupil is the natural opening of the eye. The anterior chamber 160 is the liquid-filled space between the iris and the innermost surface of the cornea. Lens 170 is held in lens 175 capsule and provides the rest of the optical power of the eye. A healthy lens is able to alter its optical power in such a way that the eye is able to focus on distances from far, intermediate and near, a process known as accommodation. The posterior chamber 180 is the space between the posterior surface of the iris and the frontal surface of the retina 190. The retina is the plane of the image of the eye and is connected to the optic nerve 195 that carries visual information to the brain.

A small static (not dynamic) aperture can have the benefit of a great depth of field, but it also has the disadvantage of decreasing light transmission through the lens or optics. Likewise, a large static aperture can have the benefit of increasing light transmission through the lens or optics, but it has the disadvantage of decreasing the depth of field.

Modalities of the present invention include an ophthalmic device (which can be a lens or a

15/50 optics) which includes an electroactive element that has a dynamic aperture (and may be referred to herein as a lens or optics of the invention). The dynamic opening is an opening that has a changeable diameter. The opening diameter of the dynamic opening may be able to change between two or more diameters, for example, between a first diameter and a second diameter. The dynamic opening can change between diameters continuously (that is, in a smooth transition) or discontinuously (that is, in different steps). The dynamic opening may have a minimum non-zero diameter of the opening or may be able to close completely in such a way that the diameter of the opening is zero. Dynamic opening can create openings that have a circular shape, an elliptical shape, or any shape.

Modalities of the present invention may have a dynamic aperture that is capable of switching between a decreased size for increased depth of field (and decreased light transmission) and an increased size for increased light transmission (and decreased depth of field). In one embodiment, the size of the dynamic aperture can be decreased for near distance and / or intermediate distance viewing when a large depth of field is most beneficial to a user. The dynamic aperture can be increased in size from the appropriate diameter for correct vision for the near distance to a larger suitable diameter for correct vision for the intermediate distance. The diameter of the dynamic aperture can also be increased in size for a correct view from a distance to allow an increased light transmission when a depth of

16/50 larger field is not critical for vision for the distance from a distance.

As used herein, an intraocular optic (OIO) is an optic (which has substantially no optical power) that is inserted or implanted in the eye. An intraocular optic can be inserted or implanted in the anterior or posterior chamber of the eye, in the stroma of the cornea (similar to a corneal inlay), or in the epithelial layer of the cornea (similar to a corneal onlay), or within any anatomical structure of the eye. An intraocular optic has substantially zero optical power and therefore does not focus on light. Instead, an intraocular optic, in embodiments of the present invention, may have a dynamic aperture and may only be able to provide an increased depth of field.

As used herein, an intraocular lens (IOL) is a lens (which has optical power) that is inserted or implanted in the eye. An intraocular lens can be inserted or implanted in the anterior or posterior chamber of the eye, in the stroma of the cornea (similar to a corneal inlay), or in the epithelial layer of the cornea (similar to a corneal onlay), or within any anatomical structure of the eye. An intraocular lens has one or more optical powers and, in embodiments of the present invention, it may or may not also have a dynamic aperture. When the IOL has a dynamic aperture, it may be able to provide an increased depth of field.

As used herein, a corneal inlay is an optic (which has substantially no optical power) or a lens (which has optical power) that is inserted or

17/50 implanted within the stroma of the cornea. When we refer specifically to a corneal inlay optics, the terms corneal inlay optics or used. When flat 'can be corneal inlay we refer specifically to a corneal inlay lens, the terms' corneal inlay' can be used. As used herein, a corneal onlay is an optic (which has substantially no optical power) or a lens (which has optical power) that is inserted or implanted within the corneal epithelial layer. When specifically referring to a corneal onlay optics, the terms corneal onlay optics or flat corneal onlay can be used. When referring specifically to a corneal onlay lens, the terms corneal onlay lens or corneal onlay focusing can be used. As used here, a contact lens is an optical (which has substantially no optical power) or a lens (which has optical power) that is removably placed over the cornea. When we specifically refer to a contact lens optic, the terms contact lens optics or flat contact lens can be used. When we refer specifically to a contact lens that is a lens, the term focusing contact lens can be used.

In embodiments of the present invention, an electroactive element that has a dynamic opening can be integral with (i.e., embedded in or attached to) a contact lens, a corneal inlay, a corneal onlay, an OIO or an IOL. The OIO or IOL can be inserted or implanted in the anterior chamber or in the posterior chamber of the

18/50 eye, in the corneal strorum (like a corneal inlay) or in the corneal epithelial layer (like a corneal inlay). The corneal inlay, the corneal onlay and the contact lens can be a lens capable of focusing light (and therefore having optical power) or an optic unable to focus light (and therefore having substantially none) optical power). Modalities of the present invention can provide an increased depth of field. Some embodiments of the present invention can provide an increased depth of field and can correct, at least partially, a conventional and / or unconventional error in a user's eye. Modalities of the present invention can be used in optical communication with one or more of the following devices that are capable of focusing light and can correct, at least partially, a conventional and / or unconventional error in a user's eye: a spectacle lens , a contact lens, a corneal inlay, a corneal onlay or an intraocular lens. Modalities of the present invention can also provide a system of the invention that has a dynamic aperture that provides an increased depth of field and is in optical and / or integral communication with an ophthalmic lens (which can be a single or multifocal vision lens) that corrects vision errors (eg, presbyopia). The system of the invention can allow an almost continuous range of perceived foci from the near distance to the far distance (that is, the dynamic aperture provides increased depth of field that serves to provide a continuous range of foci between the fixed or corrective powers). of the ophthalmic lens). The range

19/50 more continuous foci can go from a close distance to a long distance, from a close distance to an intermediate distance, from an intermediate distance to a long distance, or between any range of distances.

Figure 2 A shows an expanded view of a lateral cross-section of an embodiment of an electroactive element 200 that has a dynamic opening. Figure 2B shows a reduced view of a lateral cross-section of the electroactive element of Figure 2A. One or more electroactive elements 200 may be usable in a contact lens, a corneal inlay, a corneal onlay, an OIO or an IOL. If more than one electroactive element is used, the electroactive elements can be stacked on top of each other if there is adequate insulation between the elements.

An electroactive element 200 may comprise two optical substrates 210 or may be connected to two optical substrates. The two substrates can be substantially flat and parallel, curved and parallel, or one substrate can have a diffractive pattern of surface relief and the other substrate can be substantially smooth. The substrates may provide optical power or the substrates may have no optical power. Each substrate can have a thickness of 200 pm or less. In general, thinner substrates allow a greater degree of flexibility to the electroactive element, which may be important in certain embodiments of the present invention that are inserted or implanted in the eye. An optically continuous transparent electrode 220 that provides a ground

20/50 electrical that can be arranged on one of the substrates and one or more optically transparent electrodes individually located 225 can be arranged on the second substrate. The electrodes 225 can determine the properties of the dynamic aperture, for example, the size, shape and / or diameters of the dynamic aperture. Electrodes 220 and 225 can, for example, comprise any of the known transparent conductive oxides (such as, for example, ITO) or a conductive organic material (for example, PEDOT: PSS or carbon nanotubes). The thickness of the optically transparent electrodes can be, for example, less than 1 pm, but it is preferred to be less than 0.1 pm. Electrodes 220 and 225 can be coated with an alignment layer 230. Alternatively, only one of the electrodes is coated with the alignment layer. An electroactive material 240 is disposed between the alignment layers. The thickness of the electroactive material can be between 1 pm and 10 pm, but is preferably less than 5 pm. The electroactive material can be a liquid crystalline material. The liquid crystalline material can be a nematic liquid crystal, a twisted nematic liquid crystal, a super-twisted nematic liquid crystal, a cholesteric liquid crystal, a bistable emetic liquid crystal, or any other type of liquid crystalline material. An alignment layer is a thin film, which, just as an example, can be less than 100 nanometers thick and made of a polyimide material. The thin film is applied to the surface of substrates that come into direct contact with the liquid crystalline material. Before mounting the electroactive element, the thin film is polished

21/50 was a direction (the direction of alignment) with a fabric, for example, velvet. When liquid crystal molecules come into contact with the polished polyimide layer, the liquid crystal molecules preferably rest on the plane of the substrate and are aligned in the direction in which the polyimide layer was polished (that is, parallel to the surface of the substrate) . Alternatively, the alignment layer can be constructed with a photosensitive material that, when exposed to linearly polarized UV light, generates the same result as when a polished alignment layer is used.

A controller 250 connected to electrodes 220 and 225 through electrical connections 255 is capable of generating an electric field between the electrodes by applying one or more voltages to each electrode. In some embodiments, the controller is part of the electroactive element. In other modalities, the controller is located outside the electroactive element and connects to the electrodes using electrical contact points on the electroactive element. The controller can be connected to a power source, sensors, or any other necessary electronics. In the absence of an electric field between the electrodes, the liquid crystal molecules align in the same direction as the direction of alignment. In the presence of an electric field between the electrodes, the liquid crystal molecules orient themselves towards the electric field. In an electroactive element, the electric field is perpendicular to the alignment layer. Thus, if the electric field is strong enough, the orientation of the liquid crystal molecules will be perpendicular to the direction of alignment. If the electric field

22/50 is not strong enough, the orientation of the liquid crystal molecules will be in a direction somewhere between the direction of alignment and perpendicular to the direction of alignment. It should be noted that the substrates can be as wide as or wider than the electrodes, the alignment layers and the electroactive material.

The electroactive element may have an opening 260 through which the light passes and a ring 270 in which the light is absorbed and / or dispersed. A change in the size of the dynamic aperture is typically inversely proportional to a change in the depth of field of the electroactive element, and is directly proportional to a change in light transmission through the electroactive element, as is known in the art. The opening may be dynamic and may be able to change between one or more diameters. The ring can be positioned on the peripheral edge of the electroactive element, or it can be spaced from the peripheral edge. The ring can extend to the radial center of the electroactive element. The opening may be positioned at the geometric center of the electroactive element, and may be able to extend all the way to the peripheral edge of the electroactive element, up to a fixed distance from the peripheral edge, or up to a radial distance from the geometric center of the electroactive element. . In other embodiments, the opening may be able to be re-located in such a way that the center of the opening is not the same as the geometric center of the electroactive element. The ring typically frames the opening and defines the outer limits and size of the opening. As will be described in more detail here, the aperture can be changed to obtain

23/50 any diameter size in a continuous or distinct range of diameter sizes.

The electroactive material may include a layer of liquid crystal neutralized with a dye material, such as a dichroic dye. By neutralizing the liquid crystal molecules with the dye material, the dye molecules themselves align with the liquid crystal molecules. The dye molecules are polar and rotate to align with an applied electric field. The optical absorption of the dye material depends on the orientation of the individual dye molecules with respect to an incident optical wave. In a deactivated state with homogeneous (horizontal) alignment of the liquid crystal molecules, when the electric field between the electrodes is not strong enough, the dye molecules align with the alignment layers and the absorption of light through the liquid crystal is maximized . In an activated state with homogeneous (horizontal) alignment of liquid crystal molecules, when the electric field between the electrodes is strong enough, the dye molecules rotate and align with the orientation of the electric field, perpendicular to the direction of alignment. In this orientation, the absorption of light through the liquid crystal is minimized. The opposite can occur when a homeotropic (vertical) alignment of the liquid crystal is used in such a way that absorption is minimized in a deactivated state and maximized in an activated state. A ferroelectric liquid crystalline material can also be used.

Figure 3 shows several electrode rings 300 operable to create a dynamic opening. The rings

24/50 electrodes can be useful as optically transparent electrodes 225 in the electroactive element 200. In such an embodiment, the electroactive material 240 can be a liquid crystal neutralized with a dichroic dye. The electrode rings 300 can be composed of several electrodes with annular shape 310, 320, 330 and 340. Of course, fewer or more electrodes are possible. Each electrode is individually located. The center of the electrode rings can be concentric with respect to a pupillary axis after the electroactive element is placed inside or over the eye. The gap between the electrodes can be approximately 5 μπι to 10 μπι, but it can be smaller. The inner diameter of electrode 310 is rl, the outer diameter of electrode 310 is r2, the outer diameter of electrode 320 is r3, the outer diameter of electrode 330 is r4, and the outer diameter of electrode 340 is r5. The inner diameter of each electrode can define a different opening size.

An electrode can be activated if a sufficiently strong electric field is applied between the electrode and a ground electrode, if a voltage above a threshold is applied to the electrode, or if a condition that places an electroactive material between the electrode and the electrode is satisfied. ground electrode in an activated state. An electrode may be deactivated if a sufficiently strong electric field is not applied between the electrode and a ground electrode, if a voltage below a threshold is applied to the electrode, or if a condition that places an electroactive material between the electrode and the ground electrode in a deactivated state.

In an embodiment of the present invention that uses a

25/50 liquid crystalline material, the liquid crystalline material can be activated when a voltage above a threshold of approximately 10 volts is applied between the electrodes, and can be deactivated when a voltage below a threshold of approximately 10 volts is applied between the electrodes. The electrical energy used is that of approximately 1 microwatt. It should be noted that the electrical potential can be, for example, 1 volt or less, 5 volts or less, 10 volts or less, or above 10 volts.

To reduce energy consumption, a bistable liquid crystalline material can be used. A bistable liquid crystalline material can change between one of two stable stages with the application of electrical energy (with one state being an activated state and the other state being a disabled state). The bistable liquid crystalline material remains in the stable stage until sufficient electrical energy is applied to move the bistable liquid crystalline material to the other stable stage. In this way, electricity is only needed to change from one state to the next, not to remain in one state. The bistable liquid crystalline material can change to a first state when +5 volts or more is applied between the electrodes, and can change to a second state when -5 volts or less is applied between the electrodes. Of course, other voltages, both higher and lower, are possible.

In an embodiment of the present invention, if electrodes 310, 320, 330 and 340 are activated, an opaque ring 270 will be formed between rl and r5 and an opening 260 will be formed between the center of the electrodes and rl. If the

26/50 electrode 310 is deactivated, the opaque ring will now be formed between the inner diameter of electrode 320 and r5 and the opening 260 will now be formed between the center of the electrodes and the inner diameter of electrode 320. If electrodes 310, 320, 330 and 340 are disabled, there will be no opaque ring 270 and the opening 260 will now be formed between the center of the electrodes and r5. The opening can be increased by first deactivating electrode 310, then electrode 320, then electrode 330 and finally electrode 340. The opening can be reduced by first activating electrode 340, then electrode 330, then the electrode 320 and finally, electrode 310. Thus, as shown in Figure 3, there are 5 possible opening stops. However, less or more opening stops are possible. As with a camera, each opening stop can provide an opening that is twice the area of ​​the next smallest opening size. In other words, there may be a square root of two relationships between the inner diameters of each electrode. Of course, other opening sizes are possible. When fully contracted, the diameter of the opening may be between approximately 1.0 mm and approximately 3.0 mm, and may preferably be between approximately 1.0 mm and approximately 2.5 mm and, more preferably, may be between approximately 1, 0 mm and approximately 2.0 mm. When fully dilated, the opening diameter can be approximately 7.0 mm or larger. In certain embodiments, there may be no opening (that is, there is no ring, such that the pupil of the eye serves as the natural opening) in the dark or in low light.

27/50

In embodiments of the present invention, the outer edge of the ring may extend beyond the outer edge of the pupil (whether it is fully dilated or contracted). If there is a gap between the outer edge of the ring and the outer edge of the pupil, deleterious effects may occur, such as, for example, halos, light scattering, and reduced contrast sensitivity.

In one embodiment, each of the electrode rings is activated at approximately the same time for an instant change in the opening. In another mode, for a progressive increase and decrease effect that gradually reduces and increases the dynamic opening, each of the electrode rings is activated and / or deactivated sequentially. For example, the outermost electrode ring can be activated first and disabled last, and the innermost electrode ring can be activated last and disabled first. In one embodiment, the electrodes can be activated or deactivated in less than approximately 1 second, and can preferably be activated or deactivated in less than approximately 0.5 second.

In another embodiment of the present invention, electrodes 225 can be several individually located electrodes arranged on a screen. Each electrode can be called a pixel (the electrodes, in this case, can be called pixelated). The pixel can be any size or shape. By selectively activating or deactivating the pixels electrically, aperture 260 and ring 270 can be formed.

Figure 4A shows an expanded view of a side cross-section of an element modality

28/50 electroactive 400 that has a dynamic opening. Figure 4B shows a reduced view of a lateral cross-section of the electroactive element of Figure 4A. Similar to the electroactive element 200, the electroactive element 400 comprises two optical substrates 210. An optically continuous transparent electrode 220 that provides an electrical ground can be disposed on one of the substrates, and one or more individually located optically transparent electrodes 225 can be disposed on the second substrate. The electrodes 225 can determine the properties of the dynamic aperture, for example, the size, shape and / or diameters of the dynamic aperture. Electrodes 220 and 225 can be coated with an alignment layer 230. The alignment layers have an offset of the direction of alignment 90 degrees between them, but other values, such as 180, 270, 360 degrees, or more, are possible. An electroactive material 240 is disposed between the alignment layers. The electroactive material may be a liquid crystalline material, preferably one of a nematic, cholesteric or smectic bistable liquid crystalline material. The liquid crystalline material can be neutralized with a dichroic dye and become a liquid dichroic crystalline material. A controller 250 connects to electrodes 220 and 225 through electrical connections 255 and is capable of generating an electric field between the electrodes. The electroactive element may have an opening 260 through which the light passes and a ring 270 in which the light is absorbed and / or dispersed. The electroactive element 400 can also include two polarizers 280 positioned on one side of the electroactive material (for example, outside the

29/50 electrodes). The polarizers can also be located on the outer surfaces of the substrates (the electrodes are located on the innermost surface of the substrates). Each of the polarizers can have a direction of polarization parallel to the director of the liquid crystal layer on their respective external surfaces (i.e., parallel to the direction of alignment of the nearest alignment layer). Polarizers have relative directions of polarization offset by, for example, 90 degrees. These displacement polarizers can be called cross polarizers.

In a deactivated state, when the electric field between the electrodes is not strong enough, the alignment layers guide the liquid crystal steering layer to align with the polarizers on the outer surfaces. In this orientation, the light that enters the first polarizer (that is, the light that is polarized parallel to the polarization direction of the first polarizer) is rotated 90 degrees through the liquid crystal and can now pass through the second polarizer (that is, the light is now polarized parallel to the polarization direction of the second polarizer). Therefore, in a deactivated state, the absorption of light through the electroactive element is minimized. In an activated state, when the electric field between the electrodes is strong enough, the liquid crystal molecules align with the orientation of the electric field, perpendicular to the direction of alignment. In this orientation, the light that enters the first polarizer (that is, the light that is polarized parallel to the polarization direction of the first polarizer) is not rotated and is blocked by the second polarizer (or

30/50 (ie, the light is polarized orthogonal to the polarization direction of the second polarizer). Therefore, in an activated state, the absorption of light through the liquid crystal is maximized.

The electrode rings shown in Figure 3 can be useful as optically transparent electrodes 225 on the electroactive element 400. As above, if electrodes 310, 320, 330 and 340 are activated, the opaque ring 27 0 will be formed between rl and r5, and opening 260 will be formed between the center of the electrodes and rl. If electrode 310 is disabled, the opaque ring will now be formed between the inner diameter of electrode 320 and r5, and opening 260 will now be formed between the center of the electrodes and the inner diameter of electrode 320. If electrodes 310, 320, 330 and 340 are disabled, there will be no opaque ring 270 and the opening 260 will now be formed 'between the center of the electrodes and r5.

A disadvantage of the above embodiment is that polarizing films absorb approximately 50% of the incident light. Therefore, using these films in a real device would limit the amount of light reaching the retina. In one embodiment of the present invention, a region concentric with the annular electrodes is physically removed from one or both of the polarizers. The removed region can be of any size or shape, but, in a preferred embodiment, it is equal to the inner diameter of the smallest ring electrode. By removing this central region, one or more polarizers can be used, increasing, at the same time, the global transmission through the electroactive element. In such a modality, the functionality of the dynamic aperture is not affected and the overall transmission is increased.

31/50

In addition, the transmission contrast ratio (the ratio of the light transmitted through the aperture to the light transmitted through the ring) between the aperture and the ring is increased, thereby making the dynamic aperture more efficient in providing depth of field. In another embodiment, instead of removing the region, the region may instead be made up of a thinner or less efficient polarizing film used to increase transmission, thereby favoring performance in the transmission state over to the opaque state. These modalities increase the proportion of transmission contrast between the dark area of ​​the ring and a region of the opening.

It is practically impossible to have a corneal inlay, corneal onlay, OIO or IOL implant perfectly centered with the optical axis of the eye, as the eye is asymmetrical in the normal anatomical configuration. The most desired position of an implant is aligned with the central axis of the pupil. However, approximately 0.1 mm or 0.2 mm of eye deviation from the center of the eye's pupil should be provided, even under normal anatomical circumstances. This is also true in the case of a contact lens that is not surgically implanted, but that must rest on the cornea or the tear layer of the cornea.

Figure 5 shows various electrode ring arrangements shown in Figure 3 according to an embodiment of the present invention in which the geometric center of a dynamic opening can be repositioned in relation to the geometric center of a person's pupil. Arrangement A has the geometric center of the ring electrodes aligned

32/50 with the geometric center of the substrates of the electroactive element. Arrangements B, C, D and E have the geometric center of the ring electrodes aligned to the left, to the right, above and below, respectively, with the geometric center of the substrates of the electroactive element. Each of Arrangements A, B, C, D and E can be used in a separate electroactive element. Figure 6 shows a stack of five electroactive elements in which each can be used for the different ring electrode arrangements shown in Figure 5 according to an embodiment of the present invention. Each electroactive element is adequately isolated from the other electroactive elements. The distance between the geometric center of the ring electrodes and the geometric center of the substrates can be between approximately 0.0 mm and approximately 1 mm and, more approximately 0.0 mm and

It should be noted that other alignments at any angle between the two centers are possible. This modality allows the possibility of changing the center of the dynamic opening through a remote adjustment after the implant of the invention has been surgically implanted. One or more of the ring electrode arrays can be activated until the exclusion of the other array to realign the center of the dynamic aperture in relation to the user's visual axis. This is important when the implant of the invention is surgically implanted out of alignment with the visual axis of the user. Certain retinal diseases or trauma, such as, for example, macular degeneration, retinal tears or retinal detachments, can damage a region of the retina. This embodiment can also preferably be between approximately 0.5 mm.

33/50 be useful for realigning the user's visual axis away from a damaged region of the retina to a healthy region of the retina.

In embodiments of the present invention in which electrodes 225 are several individually located electrodes arranged on a screen, individual pixels can be selectively activated or deactivated to reposition the geometric center of aperture 260 and ring 270 in relation to the geometric center of the substrates or â eye pupil.

An electroactive element may be able to switch between a first optical power and a second optical power. The electroactive element can have the first optical power in a disabled state and can have the second optical power in an activated state. The electroactive element can be in a deactivated state when one or more voltages applied to the electrodes of the electroactive element are below a predetermined first threshold. The electroactive element can be in an activated state when one or more voltages applied to the electrodes of the electroactive element are above a second predetermined threshold. Alternatively, the electroactive element may be able to adjust its optical power in such a way that the electroactive element is capable of providing a continuous, or substantially continuous, change in optical power between the first optical power and the second optical power.

Electro-active lenses can be used to correct conventional or unconventional eye errors. The correction can be created by the electroactive element, by its optical substrate or by the ophthalmic lens, or by a

34/50 combination of the two.

In an embodiment of the present invention, an electroactive element that has a dynamic opening is attached or embedded within an optical fiber, optic or substrate that does not refract or diffract light in order to correct errors in the eye's vision and, thus, does not provide focusing power. In certain embodiments of the invention, an electroactive element that has a dynamic opening is attached or embedded within an ophthalmic lens that corrects a user's refractive error caused by natural anatomical conditions and / or caused by the removal of a healthy cataract or lens. The ophthalmic lens can also correct any or all of the conventional and / or unconventional errors in a user's eye. In this way, the dynamic aperture can be integral with a focusing lens. Alternatively, an electroactive lens can have a first electroactive element that has a dynamic aperture. The first electroactive element or a second electroactive element in optical communication with the first electroactive element may be able to correct any or all of the conventional and / or unconventional errors in a user's eye. The above modalities can be a contact lens, a corneal onlay, a corneal inlay, an OIO or an IOL. The above modalities can be used in optical communication with a focusing lens such as, for example, an IOL, a lens, a corneal inlay, a corneal onlay, a contact lens or an eyeglass lens. The focusing lens can be static (unable to change its optical power) or dynamic (able to change its optical power).

35/50

Figures 7A, 7B, and 7C show modalities of the invention that have a dynamic aperture that are useful as a corneal inlay, corneal onlay or contact lens. The modalities shown in Figures 7A, 7B and 7C can be modified slightly, for example, by adding stabilizing haptics, for use as an anterior or posterior chamber IOL or IOL of the invention that has a dynamic opening. The optic or lens 500 may have one or more electroactive elements 510. The electroactive element 510 may be similar to the electroactive elements 200 or 400 or may not have a dynamic opening, and may, instead, provide a changeable optical power. The electroactive element may be embedded in or attached to the 520 substrates. The substrates may have no optical power or may have one or more optical powers. The substrates and / or electroactive elements may be able to correct at least a portion of any or all of the conventional and / or unconventional errors of the eye. A 530 controller can be electrically connected to the electrodes on the electroactive elements by electrical connections 535. The electrodes can define an almost transparent opening 540 and an almost opaque ring 545. The term almost transparent means approximately 50% or more of optical transmission (and preferably 75% or more) and does not necessarily mean 100% optical transmission. The term almost opaque means approximately 50% or less of optical transmission (and preferably 35% or less) and does not necessarily mean 0% of optical transmission.

The substrates can have one or more openings 550 and / or pores 555 to allow nutrients and / or debris

36/50 cells pass through the substrates and / or the electroactive elements. The openings and / or pores can be created, just as an example, by a laser, or they can be machined or stamped. Typically, the openings and pores are located in non-electrical or otherwise non-critical areas of the lens or optics of the invention, such as, for example, within a central region where the electrodes do not extend or apply energy. These characteristics are especially important when the lens or optics of the invention that has a dynamic aperture is used as a corneal inlay or a corneal onlay.

The controller can draw at least a portion of its electrical power from a 560 power source. The power source can be attached and integral with the substrates, or attached, but not integral, with the substrates. The power source can be a thin film rechargeable battery such as those manufactured by Excellatron. The thin-film rechargeable battery may be capable of cycling in excess of 45,000 cycles. This can provide a usable life of 20-25 years on the lens or optics of the invention. In one embodiment of the present invention, two rechargeable thin film batteries can be used and they can be stacked on top of each other. In this mode, one battery can be used for 20-25 years and the other battery can be changed when the first battery is no longer operable. Alternatively, the other battery can be changed by a signal sent remotely to the controller. This can extend the life of the lens or optics of the invention up to 40-50 years. The power source can also be a capacitor. The power source can be

37/50 charged remotely, just as an example, by induction.

A 565 photosensitive cell and piezoelectric materials can also be used to supplement and or increase the electrical energy of the energy source. Alternatively, a photosensitive cell and / or piezoelectric materials can do without an energy source. The photosensitive cell can be a solar cell. Alternatively, the photosensitive cell can be a 1.5 μπι photovoltaic cell. The photovoltaic cell is used and located outside the user's visual axis and, more preferably, used and located peripherally at the pupil's edge when partially dilated by the dark, but not fully dilated. The lens or optics of the invention can, therefore, be charged using an eye-safe laser capable of energizing the 1.5 μιη cell or photovoltaic cells. The user can position the chin and forehead on a device that applies a safe laser energy to the eye needed to energize the 1.5 μτη cell or photovoltaic cells. This can be achieved at home once a day or as needed. Adequate energy can be provided through a normally dilated pupil or a fully unmedicated dilated pupil caused by a very dark room or by the device that blocks any visible ambient light. When using a 1.5 μπι photovoltaic cell or cells within the lens or optics of the invention, the cell or cells in most, but not all, modalities need to be capable of flexing. When using a 1.5 μπι photovoltaic cell that is not capable of flexing, several cells are used and placed in a pattern that

38/50 allow the lens or optics of the invention to be folded or rolled over or around cells before insertion into the eye.

In one embodiment of the present invention, the photosensitive cell 565 can be a solar cell. The solar cell can be located in front (closest to the cornea of ​​the eye) and arranged separately from a portion of a user's eye iris. Thin electrical wiring can operationally connect the solar cell to the lens or optics controller of the invention. The electrical wiring can pass through the pupil, without touching the iris, and operationally connect the OIO or IOL of the invention in the anterior or posterior chamber of the eye. The solar cell can be large enough to provide enough electrical energy to dispense with the need for a separate energy source. Fine electrical wiring may not conduct electricity and may have a form factor that has adequate voltage resistance to hold the solar cell in place. In certain embodiments of the present invention, one or more small holes in the iris can be made by an ophthalmic laser such that the fine electrical wiring connects the solar cell to the OIO or IOL that houses an electroactive element.

The lens or optics of the invention may include the 570 memory metal material to re-establish the proper shape, positioning and alignment of the device after being folded and inserted into an eye. A memory metal remembers its shape and tries to regain its original geometry after being deformed (for example, when it is bent in preparation for insertion into the eye). The memory metal

39/50 can also function as an antenna to inductively charge the lens or optics of the invention or to receive signals from a transmitter. The transmitter can send a signal to the lens or optics of the invention to change the diameter of the dynamic aperture or to change the optical power of the lens of the invention.

The lens or optics of the invention can include a 580 sensor. The sensor can be a rangefinder to detect a distance at which the user is trying to focus. The sensor can be a 565 photosensitive cell to detect ambient light and / or incident to the lens or optics of the invention. The sensor can include, for example, one or more of the following devices: a photodetector, the photovoltaic or photosensitive cell to UV, a tilt switch, a light sensor, a passive telemetry device, a flight time telemetry device, an eye tracker, a visualization detector that detects where the user can be viewing, an accelerometer, a proximity switch, a physical switch, a manual priority control, a capacitive switch that switches when the user touches the nose bridge of a pair of glasses, a pupillary diameter detector, a feedback device connected to an eye muscle or nerve, or the like. The sensor can also include one or more micro-gyroscopes of an electro-mechanical system (MEMS) adapted to detect an inclination of the user's head or cyclotrotation of the user's eye.

The sensor can be operationally connected to the controller. The sensor can detect sensory information and send a signal to the controller that triggers the activation

40/50 and / or deactivation of one or more dynamic components of the lens or optics of the invention. When the lens or optics of the invention includes an electroactive element that has a dynamic aperture, the sensor, for example only, will be able to detect the light intensity and communicate this information to the controller. In one embodiment of the present invention, the sensor may be a photodetector and may be located in a peripheral region of the lens or optics of the invention and located behind the iris. This location can be useful for the perception of increases and / or decreases in the available light caused by the constriction and dilation of the user's pupil. Figure 19 shows that at night, or in the dark, when the user's pupil is dilated, the sensor perceives the dark and the controller can cause the dynamic aperture to widen or remain dilated. Figure 18 shows that during the day, or in the light, when the user's pupil is contracted, the sensor perceives the increase in light and the controller can cause the dynamic opening to contract. The dynamic aperture may remain constricted until the sensor perceives the dark or the absence of available light below a certain threshold, at which point the controller can cause the dynamic aperture to expand. It should be noted that the invention contemplates the location of the sensor in any region of the lens or optics of the invention that works optimally. In certain embodiments of the present invention, the controller may have a delay feature that ensures that a change in light intensity is not temporary (i.e., it lasts longer than the delay of the delay feature). That way, when the user blinks, the aperture size will not be

41/50 changed, since the delay of the delay circuit is longer than the time elapsed in the flashing. The delay may take more than approximately 0.0 seconds and, preferably, 1.0 seconds or more.

In another embodiment of the present invention, the sensor, for example, can detect the distance at which the person is focusing. If the sensor detects that the user is focusing within a close range, the controller can cause the dynamic aperture to count to produce an increased depth of field. If the sensor detects that the user is focusing beyond the close range, the controller may cause the dynamic aperture to expand. In one embodiment of the present invention, the sensor may include two or more arrays of photodetectors with a focusing lens placed over each array. Each focusing lens can have a focal length suitable for a specific distance from the wearer's eye. For example, three arrays of photodetectors can be used, the first having a focusing lens that focuses properly for the near distance, the second having a focusing lens that focuses properly for the intermediate distance, and the third having a focusing lens that focuses properly for the distance from far away. A sum of difference algorithms can be used to determine which arrangement has the highest contrast ratio (and thus provides the best focus). The arrangement with the highest contrast ratio can therefore be used to determine the user's distance from an object on which the user is focusing.

42/50

It should be noted that, in certain embodiments of the lens or optics of the invention, the sensor and the controller can be activated by a manually operated remote control. The remote control can send a signal via wireless communication, acoustic communication, vibration communication or light communication as, for example, infrared. Just as an example, if the sensor perceives a dark room, for example, a restaurant with low lighting, the controller can cause the dynamic opening to expand to allow more light to reach the retina. However, this can interfere with the user's ability to perform tasks at close range, such as reading a menu. The user could remotely control the dynamic aperture of the lens or optics of the invention to contract the aperture in order to increase the depth of field and increase the user's ability to read the menu. Figure 20 shows the normal operation of a sensor and a controller that have been canceled in which a dynamic aperture is contracted for tasks at close range in dark lighting conditions, even though the user's pupil is dilated. When the task at close range is completed, the user can remotely allow the sensor and controller to automatically expand the opening once again, thus allowing the user to have a better view in the restaurant with low lighting regarding tasks at a distance that is not close. When activated, the remote control signal can be received, just as an example, through the lens or optics of the invention through an antenna formed by the

43/50 570 memory metallic material.

The lens or optical substrates of the invention can be coated with materials that are biocompatible with anatomical objects in the eye. Biocompatible materials can include, for example, polyvinylidene fluoride or non-hydrogel microporous perfluorether. The substrates and the various electronics that are affixed or embedded within the substrates can optionally be coated so that they are hermetically sealed to prevent or delay overflow. Additionally, the substrates can be designed to encapsulate the various electronics in such a way that they are buried within the substrates.

In one embodiment of the present invention, the lens or optics of the invention can be flexible, foldable and / or capable of being rolled up for adjustment during insertion through a small incision of approximately 1 mm to 3 mm. A syringe-like device commonly used for implanting IOLs that have a piston can be used as an insertion tool that allows the folded or rolled lens or optics of the invention to be placed properly where desired, in the anterior or posterior chamber of the eye. Figure 21 shows a folded lens or optics of the invention that has one or more electroactive elements. It should also be noted that the flat contact lens and the focusing contact lens of the invention can be flexible.

Modalities of the present invention that have a dynamic opening can be adapted or implanted in a monocular (only in one eye of the user) or binocular (in both eyes of the user). As the dynamic opening

44/50 can be programmed to expand to a larger size at night or in low light conditions, when the user's pupil diameter would naturally widen, glare, halos, shadow vision and reduced light reaching the user's retina are widely available. deleted. Therefore, the invention allows for a binocular approach, unlike other IOLs, corneal onlays, corneal inlays and conventional contact lenses that do not have a dynamic aperture and are therefore sometimes adapted for distance correction in an eye and for correction of close distance in the other eye due to glare, halos, shadow vision etc. It should be noted that the lens or optics of the invention can also be implanted or adapted in a monocular way, if desired. In addition, the lens or optics of the invention disclosed herein can be designed and manufactured in such a way that the central point of the dynamic aperture can be remotely re-located in relation to the center of the optics or lens after being implanted into or over the eye to in order to better align with the central axis of the dynamic opening of the user's visual axis.

The lens or optics of the invention can be used in optical communication with a healthy but pristine lens, a single-focus IOL with full or underperforming performance, a static multifocal IOL, a dynamic focusing IOL (such as an IOL electroactive focusing) or an accommodating IOL without a dynamic opening, an eye with an iris that has been traumatized and torn, has an orifice or does not contract or dilate properly, an iris devoid of pigment, such as the iris of certain albinos, an

45/50 multifocal or single vision contact lens with full performance or underperformance without a dynamic aperture, a corneal inlay or a multifocal corneal inlay or simple vision with full performance or underperformance without a dynamic aperture, a multifocal or spectacle lens simple vision with full performance or underperformance without a dynamic opening, or an eye that has undergone refractive surgery.

A full-performance lens is able to properly focus light on the retina. An underperforming lens is unable to properly focus light on the retina. In most cases, the lens or optics of the invention will improve the quality of visual acuity perceived by the user when used in combination and in optical communication with the various examples provided in the preceding paragraph. When used with a fully formed lens, the dynamic aperture increases the depth of field and acts to inhibit or remove some or most of the upper aberrations from a user's eye.

The lens or optics of the invention that houses an electroactive element disclosed herein can be composed of ophthalmic materials that are well known in the art and are used for IOLs, contact lenses or corneal inlays. Materials can be flexible or non-flexible. In one embodiment of the invention (not shown), an OIO of the invention is made up of two layers of approximately 100 μπι of a polysulfone material that has the appropriate electrodes, liquid crystalline material (which can be neutralized with a dichroic dye), layers of optional polarization, power source, controller, sensor and other electronics

46/50 required. Each 100 pm layer is used to form a flexible envelope that forms a sandwich and houses electronics and electroactive material. The total thickness of the work optics is approximately 500 pm or less. The external diameter of this particular modality is approximately 9.0 mm (not including any haptics). The OIO of the invention may be able to be folded and inserted into the eye through a small surgical incision of approximately 2 mm or less. In certain embodiments of the invention, a thin layer of memory metal is used as part of the OIO of the invention to assist in opening the OIO to its proper shape and location after being inserted into the anterior or posterior chamber of the eye.

In some embodiments of the present invention, a color or filter can be incorporated into the lens or optics of the invention to filter out high-energy blue light and / or ultraviolet light. The filter or color can also be used to increase the contrast sensitivity perceived by the user.

The diameter of the OIO or IOL is between approximately 5 mm and approximately 10 mm (not including haptics), depending on the desired application for the lens or optics of the invention. Other dimensions are also possible.

When used as a corneal inlay, the diameter of the lens or optics of the invention that has a dynamic aperture should be less than the diameter of the cornea. When used as a contact lens, the lens or optics of the invention can have a diameter between approximately 5 mm and approximately 14 mm. In some embodiments of the invention, the external surface of the substrates can be curved up to

47/50 substantially match the curvature of the cornea (when used in a corneal inlay) or with the surface of the eye (when used in a contact lens). In other embodiments, the outer surface of substrates may be flat.

Figure 8 shows a 010 located in an anterior chamber of an eye and in optical communication with a healthy pristine lens according to an embodiment of the present invention. Figure 9 shows a 010 located in an anterior chamber of an eye and in optical communication with an IOL according to an embodiment of the present invention. Figure 10 shows an OIO located in an anterior chamber of an eye and in optical communication with an IOL that corrects only the vision for the distance from a distance according to an embodiment of the present invention. The modality shown in Figure 10 can be useful to provide a depth of field, increased to provide correction for the near and / or intermediate distance. Figure 11 shows an OIO located in an anterior chamber of an eye and in optical communication with an IOL that corrects vision for long-distance and near-distance vision according to an embodiment of the present invention. The modality shown in Figure 11 can be useful to provide an increased depth of field to provide correction for the intermediate distance. Figure 12 shows an OIO located in a posterior chamber of an eye and in optical communication with an IOL according to an embodiment of the present invention. Figure 13 shows an IOL that has a dynamic opening in the portion of the IOL closest to the pupil of the eye according to one embodiment of the present

48/50 invention. Figure 14 shows an IOL that has a dynamic opening in the middle portion of the IOL according to an embodiment of the present invention. Figure 15 shows an IOL that has a dynamic opening in the portion of the IOL closest to the retina of the eye according to an embodiment of the present invention. Figure 16 shows a corneal inlay that has a dynamic aperture in optical communication with a healthy pristine lens according to an embodiment of the present invention. Figure 17 shows a corneal inlay that has a dynamic aperture in optical communication with an IOL according to an embodiment of the present invention. It should be noted that it is not possible to show all possible modalities, combinations and settings of the present invention. For example, a contact lens modality and a corneal inlay that has a dynamic aperture are not shown. However, these modalities will be evident to those skilled in the art.

The OIO or IOL of the invention can be surgically inserted during the initial surgical procedure that inserts a conventional IOL without a dynamic opening. Alternatively, the OIO or IOL of the invention can be surgically inserted into a surgical procedure within hours, days, weeks, months or years after the initial IOL surgery.

The successful operation of the lens or optics of the invention depends on obtaining the maximum possible transmission through the almost transparent aperture and the minimum possible transmission through the almost opaque annular region. Experiments were carried out with neutral density (ND) optical filters with ND values ​​between 0 and 1.0 in which they were formed

49/50 holes with a diameter of 1.5 mm for creating openings. In some experiments, a second filter was placed over the opening to simulate the transmittance through the opening. Neutral density is the measure of light transmittance based on a logarithmic scale and is related to transmission (T) through the following relationship:

T = IO '™ Equation 1

In the experiment, the filter was kept in front of and very close to the eye of an uncorrected +2.50 D pre-treated patient. The pre-treated patient looked at a target in close view approximately 33 centimeters from the patient's eye through the opening. Such an opening has been found to increase depth of field by providing good visual acuity and sensitivity to contrast, but only under certain conditions.

In general, the best results were obtained when the ND value of the almost transparent aperture was less than approximately 0.1 (T greater than approximately 80%) and the difference in the ND values ​​between the almost transparent aperture and the ring almost opaque was greater than approximately 0.3. In a preferred embodiment of the invention, the ND value for the almost transparent aperture can be less than approximately 0.04 (T greater than approximately 90%) and the ND value of the almost opaque ring is greater than approximately 1, 0 (T less than approximately 10%). Although increasing the difference in ND values ​​between the almost transparent aperture and the almost opaque ring can compensate for a high ND value in the almost transparent aperture, it will produce a

50/50 undesirable decrease in global light transmission to the retina.

1/4