Intraocular lens with silicone oil

Abstract

An intraocular lens (IOL) is described having an optical axis extending in an anterior-posterior direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL includes an elastic anterior face located anterior to the equator, a posterior face located posterior to the equator, and a chamber located between the anterior face and the posterior face. Wherein the anterior face and / or the posterior face comprises a poly(dimethylsiloxane) elastomer having a hardness of between about 20 Shore A to about 50 Shore A; the chamber comprises a silicone oil, the silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, the silicone oil having a maximum viscosity of about 800 cSt at 25 °C.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 053,134, filed on July 17, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to an autoaccommodating intraocular lens comprising a chamber containing silicone oil, the silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, which improves the response time of the intraocular lens. Background Technology

[0004] The human lens can be affected by one or more conditions or diseases that reduce its function and / or decrease its clarity. A common condition that occurs with age is the gradual clouding and decreased transparency of the eye's lens. This condition is known as cataracts. Surgically removing the cataracted lens and placing an artificial replacement lens (such as an intraocular lens, "IOL") inside the eye is a common surgical procedure. A suitable IOL that can provide the optical quality and autoacoustic properties offered by a young biological lens has not yet been developed.

[0005] Two main types of IOLs have been developed to attempt to overcome the lack of self-accommodating capabilities in IOLs used to replace the natural lens during cataract surgery: pseudo-autoaccommodating lenses and autoaccommodating lenses. Pseudo-autoaccommodating lenses can be multifocal lenses using a ring for the far focus and one or more central optics for the intermediate and near focuses. Other designs use diffractive optics to achieve a range of focusing or use optics to achieve extended depth of focus (EDOF). Multifocal, diffractive, and EDOF IOLs can cause detrimental optical aberrations such as glare, halos, and reduced contrast sensitivity. Central positioning of these lenses within the capsular bag is important for their optimal visual function. These lenses use non-deformable optics and do not achieve the visual quality of the human eye's natural, youthful lens. Autoaccommodating IOLs include silicone elastomer hinged lenses that allow the optics to move forward when the eye is focusing on near objects. These lenses are typically placed in the lens capsule (the remaining thin layer of the basement membrane, which is the outermost layer of the natural lens and is usually left in place when the contents of the lens are removed during cataract surgery). Due to the progressive fibrosis and sclerosis of the lens capsule after cataract extraction, the effective autoacoustic function of these lenses is known to decrease over time. In summary, these lenses may be adequate for distance and intermediate vision, but provide at most about two diopters of autoacoustic adjustment, and this value has been shown to decrease over time.

[0006] Shaped haptics, levers, or other mechanical elements have been described to convert axial compressive forces exerted by the elasticity of the lens capsule along the optical axis and / or radial compressive forces exerted by the ciliary muscle to influence the desired axial displacement of IOL optics. Further examples may provide flexible articulated regions of the haptics to facilitate axial displacement of the IOL. Several examples include annular elements in contact with the lens capsule that utilize axial compression by forces exerted by the capsule along the optical axis to influence the axial displacement of the IOL optics. However, these IOLs are typically configured to have a fixed refractive power and be aligned with the optical axis of the eye. Thus, the axial displacement of the optics of these IOLs may limit the achievable variation in refractive power. Some single or multiple optical lenses have incorporated combinations of deformable and axially displaced lenses, such as deformable optics coupled to small band contact haptics, whereby axial compression of the lens capsule along the optical axis during autoacoustic adjustment results in forward displacement of the flexible optics and compression of the lateral aspects of the optics. Other descriptions of IOLs rely on a posterior flexible region separated from the flexible anterior lens by linking members around the periphery.

[0007] Surface-deformed lenses are more likely to result in greater changes in refractive power. These lenses include those with fluid-filled chambers that rely on axial compression of the lens capsule along the optical axis to force fluid from one chamber into the central lens, thereby altering its shape and thus the refractive power of the lens's optical surface. Other lenses utilize the compressive force of the lens capsule to provide radial compressive force at the equatorial periphery of the flexible lens to change its shape. These are typically two-part systems with a circumferential tactile design, featuring a centrally fixed posterior lens mounted within the capsule, followed by separately positioned flexible optics fixed within an outer tactile ring. Compression of the "elastic" lens capsule means that the central flexible optics of the lens provide axial compressive force along the optical axis. Other IOLs use compressive force applied to a rigid tactile element to compress the flexible optics against a separate, fixed-power posterior lens. These IOLs rely on shape changes in the posterior surface of a flexible optics element pressed against a fixed optic or against a relatively rigid posterior lens capsule to alter the refractive power of the lens system. Other IOLs include skirts with capsular contact rings. This type of IOL relies on compression applied by the “elastic” lens capsule to exert compressive forces on the capsular contact ring, and the ring’s mechanical design pulls radially around the equator of the IOL’s flexible optics. Furthermore, because these IOLs rely on maintaining capsular elasticity / flexibility, and because it is generally known that the lens capsule becomes less flexible and more fibrous after cataract surgery, these lenses are unlikely to retain the ability to autoaccommodate / de-accommodate. None of the aforementioned shape-changing autoaccommodative IOLs mimics the natural human lens during autoaccommodation, nor do they effectively address the inevitable loss of lens elasticity / flexibility and the progressive fibrosis and hardening of the lens capsule.

[0008] An intraocular lens (“IOL”) may include a bulk polymeric material in which one or more fluids are disposed. For example, some autoacoustic IOLs use fluid movement within the IOL, or changes in fluid pressure within the IOL, to achieve changes in refractive power within the IOL. Silicone oil is an example of a fluid that can be used in an IOL. When a fluid such as silicone oil is used in an autoacoustic intraocular lens, the fluid may tend to expand into the bulk material over time. This can alter the physical properties of the bulk material. Therefore, it is desirable to minimize the amount that expands into the bulk material. It is also important to provide silicone oil that does not reduce the response time of the autoacoustic IOL.

[0009] Automatic accommodation IOLs utilize the eye's natural ciliary muscle movements to provide automatic accommodation. For example, some automatic accommodation IOLs are implanted within the patient's capsular bag (after the natural lens contents have been removed) and respond to radial forces applied to the lens capsule by the ciliary muscle via small bands to alter the IOL's refractive power. Some IOLs are designed to be implanted outside the lens capsule and autoacoustic in other ways. Regardless of the method of autoacoustic accommodation, silicone oil disposed within the automatic accommodation IOL can be adapted to move within the IOL as the host polymer material changes shape. Therefore, the properties of the silicone oil can affect the IOL's autoacoustic response time. Thus, there is a need for improved fluids (e.g., silicone oil) and their methods of use in automatic accommodation intraocular lenses. Summary of the Invention

[0010] This disclosure relates to ophthalmic devices including IOLs, and more specifically, to automatically accommodating intraocular lenses (automatically accommodating IOLs) comprising silicone oil disposed within a cavity of the lens. In one aspect, an intraocular lens (IOL) is provided having an optical axis extending in an anteroposterior direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL includes: an elastic anterior portion located anterior to the equator, a posterior portion located posterior to the equator, and a cavity located between the anterior and posterior portions. The anterior and / or posterior portions comprise a poly(dimethylsiloxane) elastomer with a hardness between about 20 Shore A and about 50 Shore A; the cavity comprises silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, the silicone oil having a hardness of about 800 cSt (i.e., mm) at 25°C. 2 The maximum viscosity is ( / s). In some embodiments, the IOL further includes resilient sidewalls extending across the equator and from the front to the rear.

[0011] In some embodiments, the poly(dimethylsiloxane) elastomer has a hardness of about 50 Shore A. In another embodiment, the front and back of the IOL comprise a polysiloxane, which is at least 99% poly(dimethylsiloxane) elastomer. In a further embodiment, the front and back have one or more highly smooth surfaces. In another embodiment, at least a portion of the front and back is coated with a parylene layer.

[0012] The silicone oil disposed within the cavity of the lens can have various properties. In one embodiment, the silicone oil has a viscosity of about 400 cSt to about 800 cSt at 25°C. In another embodiment, the silicone oil has a refractive index of 1.49 to 1.53. In some embodiments, the silicone oil comprises less than 0.1% of octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and dodecylcyclohexyloxyketone. In a further embodiment, the silicone oil comprises long-chain polysiloxane molecules. In a further embodiment, the polysiloxane comprises at least 10 mol% of diphenylsiloxane. In another embodiment, the silicone oil comprises about 30 mol% of diphenylsiloxane and about 70 mol% of dimethylsiloxane. In yet another embodiment, the silicone oil has an average molecular weight of about 1,000 to about 3,000 Daltons. Attached Figure Description

[0013] Figure 1 This is a three-dimensional cross-sectional view of the deformation optical element of an IOL according to one aspect of this disclosure.

[0014] Figure 2 This is a side view of a deformable optical element of an IOL according to one aspect of this disclosure.

[0015] Figure 3 This includes one aspect of the disclosure. Figure 2 and Figure 3 A three-dimensional view of the IOL (Integral Optical Component) of the deformation optical component, including a depiction of the tactile component.

[0016] Figure 4 This is a three-dimensional cross-sectional view of the IOL according to another aspect of this disclosure.

[0017] Figure 5 This is a side view of the IOL according to one aspect of this disclosure.

[0018] Figure 6 This is a side view of the IOL according to another aspect of this disclosure.

[0019] Figure 7 This is a three-dimensional cross-sectional view of the deformation optical element of an IOL according to one aspect of this disclosure.

[0020] Figure 8 This is a side cross-sectional view of a deformable optical element of an IOL according to one aspect of this disclosure.

[0021] Figure 9 This is a side cross-sectional view of a deformable optical element of an IOL according to one aspect of this disclosure.

[0022] Figure 10 This is a side view of the IOL according to another aspect of this disclosure.

[0023] Figure 11This is a side view of the IOL according to another aspect of this disclosure.

[0024] Figure 12 This is a side view of the IOL according to another aspect of this disclosure.

[0025] Figure 13 This is a side view of a deformable optical element of an IOL according to one aspect of this disclosure.

[0026] Figure 14 This is a side view of the IOL according to another aspect of this disclosure.

[0027] Figure 15 This is based on one aspect of the disclosure. Figure 14 A three-dimensional cross-sectional view of the IOL. Specific Implementation

[0028] This invention provides an intraocular lens (IOL) having an optical axis extending in an anterior-posterior direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL includes: an elastic anterior portion located anterior to the equator; a posterior portion located posterior to the equator; and a chamber located between the anterior and posterior portions. The anterior / posterior portion comprises a poly(dimethylsiloxane) elastomer having a hardness between about 20 Shore A and about 50 Shore A; the chamber comprises silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, the silicone oil having a thickness of about 800 mm at 25°C. 2 Maximum viscosity per second.

[0029] definition

[0030] The terminology set forth herein is for illustrative purposes only and should not be construed as limiting the invention as a whole. Unless otherwise stated, “a,” “an,” “the,” and “at least one” are used interchangeably. Furthermore, as used in the specification and appended claims of this invention, the singular forms “a,” “an,” and “the” include the plural forms unless disabled by the surrounding context. The connecting phrase “and / or” indicates that any one or both of the mentioned items may be present.

[0031] "Approximately / substantially" means that the shape or construction of the element does not need to have a mathematically precise description of the shape or construction of the element, but may have a shape or construction that is recognizable to those skilled in the art, such as generally or approximately having the shape or construction of the element.

[0032] As used herein, unless otherwise specified, the terms “anterior,” “posterior,” “superior,” “inferior,” “lateral,” and “medial” refer to the position of an element when the patient is in a standard anatomical position. The terms “left,” “right,” “top,” and “bottom” refer to the position of an element depicted in the accompanying drawings, and the terms “left” and “right” are interchangeable unless otherwise indicated.

[0033] The terms "first," "second," etc., are used to distinguish one element from another and are not used in a quantitative sense unless otherwise specified. Therefore, the "first" element described below may also be referred to as the "second" element. Components operatively coupled to another component may have intermediate components between them, provided that the IOL can perform the stated purpose.

[0034] "One-piece / integrated" or "comprehensive" means that the multiple components are manufactured as one or more pieces that are fixed in place during manufacturing, or that the components are inseparable by normal-sized force without damaging the integrity of any component (i.e., tearing). Normal-sized force is the amount of force a user would use to remove a component intended to be separated from another component without damaging any of the components.

[0035] Similarly, in this article, the numerical ranges listed by endpoints include all values ​​contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0036] As used herein, when referring to numerical values ​​or ranges, the term “about / approximately” means, in some embodiments, a variation of ±10% relative to the specified amount (and all percentage values ​​in between), in some embodiments, a variation of ±5% relative to the specified amount, in some embodiments, a variation of ±1% relative to the specified amount, in some embodiments, a variation of ±0.5% relative to the specified amount, and in some embodiments, a variation of ±0.1% relative to the specified amount, because such variation is appropriate for the IOL to perform its intended function.

[0037] As used herein, “subject” can refer to any animal, or a patient. Preferably, the subject is a vertebrate; more preferably, the subject is a mammal, such as a research animal (e.g., a mouse or rat) or a domesticated farm animal (e.g., a cow, horse, pig) or a pet (e.g., a dog, cat). In some embodiments, the subject is a human.

[0038] As used herein, “biocompatible” means any material that, when placed in contact with a subject’s tissues, does not cause injury or death to the subject or induce adverse reactions in the subject. Adverse reactions include, for example, inflammation, infection, fibrotic tissue formation, cell death, or thrombosis. The terms “biocompatible” and “biocompatibility” are generally accepted in the art as used herein and refer to a material that is neither toxic to the subject nor degrades at a rate that produces byproducts at toxic concentrations (if it does degrade), does not cause prolonged inflammation or irritation, or induces an immune response in the host beyond the basal level.

[0039] Any estimated molecular weights described in this article are obtained relative to the standard molecular weight of polystyrene.

[0040] Intraocular lens

[0041] In one aspect, the present invention provides an intraocular lens (IOL) having an optical axis extending in an anteroposterior direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL includes: an elastic anterior portion located anterior to the equator, a posterior portion located posterior to the equator, and a chamber located between the anterior and posterior portions. The anterior and / or posterior portion comprises a poly(dimethylsiloxane) elastomer having a hardness between about 20 Shore A and about 50 Shore A. The chamber comprises silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, the silicone oil having a thickness of about 800 mm at 25°C. 2 Maximum viscosity per second.

[0042] All IOLs described herein are for medical purposes and are therefore sterile. Components of the IOLs described herein can be used with the IOLs described herein as well as other IOLs. For example, the IOLs described herein can be placed in front of existing, previously placed IOLs. IOLs include fixed refractive power, multifocal, EDOF, diffractive, and other variable focal lenses. Although the accompanying drawings show combinations of certain elements of an IOL, it should be noted that these elements may be included in other embodiments or aspects shown in other drawings or described in the specification. In other words, the various aspects and embodiments disclosed herein can be considered individually or in combination with other aspects and embodiments of this disclosure, including those of the patent applications incorporated herein by reference.

[0043] Unlike the deformable autoaccommodative IOLs described as background art, the IOL provided herein mimics the gradient elastic properties of a natural young lens during autoaccommodation and includes deformable optics, wherein components of the optics change shape as the IOL transitions from an autoaccommodative state to a de-autoaccommodative state, and vice versa. Unwilling to be limited by a specific mechanism of action, some have argued that the lens capsule "elastically" controls the lens and shapes the lens as a whole (nuclide and cortex). Based on this, the lens contents are considered flexible. However, the volume of the lens contents, compared to the thickness of the lens capsule and its known elastic modulus, suggests that the lens capsule cannot independently control and alter the shape of the lens nucleus and cortex. Finite element analysis (FEA) predicts that, compared to a natural young lens, radial tension around the equatorial region of a lens capsule filled with a soft, flexible solid or liquid will not cause significant shape changes to the anterior or posterior surfaces of the lens. A radial tension is provided specifically directed at the front of at least the auto-adjusting IOL; this tension is directed towards a point anterior to the IOL equator; the front of the IOL is more resistant to deformation than the contents of the cavity below the front; the front exhibits elasticity because it deforms when force is applied to it and returns to its original shape as the force is removed, resulting in a greater amount of front shape change than that achievable by applying a similar force at or near the IOL equator, and thus auto-adjusting refractive power changes. Furthermore, the force applied to the front at the point anterior to the IOL equator requires a smaller diameter change in the front of the IOL for refractive power changes compared to a similar force applied at or near the IOL equator, thus allowing for front shape changes in the IOL even when the amount of front diameter change is very small during transitions from auto-adjustment, de-auto-adjustment, and intermediate states.

[0044] Specifically, in one aspect, an IOL including deformable optics is provided, which can be in an auto-accommodating state, a de-auto-accommodating state, and states in between. Components of the deformable optics can be deformable such that ocular compressive forces or tensions applied to the optics by ciliary muscle contraction or relaxation cause one or more components of the optics to change shape, allowing the optics to change refractive power. Thus, when a force is applied, components of the deformable optics can deform or change shape. If one component is less resistant to deformation than another, then for a given amount of applied or removed force, the former component is more likely to deform or deform to a greater extent than the latter. If, for a given amount of applied or removed force, the former component is less likely to deform or deform to a lesser extent than the latter, then that component is more resistant to deformation than the other. It should be understood that for any given resistant component, the force applied to / removed from such a component does not exceed a force that would cause the component to break, rendering it unusable for its therapeutic purpose.

[0045] Figure 2 The diagram shows the central axis, or optical axis, extending in the anteroposterior direction, and the equator, E, extending in a plane substantially perpendicular to the central axis. The equator is an imaginary line drawn perpendicular to the optical axis around the circumference of the lens, equidistant from the anterior and posterior ends of the lens, dividing the lens into anterior and posterior halves. Reference Figures 1 to 3 The deformable optics 12 of IOL 10 may include a resilient front face 14 located in front of the equator E. The front face 14 may have a front surface 16, a rear surface 18, and an outer periphery 20. The deformable optics 12 may also include a rear face 22 having a front surface 24, a rear surface 26, and an outer periphery 28. The deformable optics 12 may also include resilient sidewalls 30 extending across the equator E and from the front face 14 to the rear face 22. A chamber 32 may be located between the front face 14 and the rear face 22 and may contain material or contents, as described in more detail below. For example, by changing the thickness of the component, the type of material used to manufacture the component, or by changing the chemical / material properties of the component material itself, the components of the deformable optics may be made to resist deformation changes to a greater or lesser degree. (See reference...) Figure 3 The IOL 10 may also include at least one tactile element 34 extending from the front periphery. At least one tactile element may also extend from the rear periphery. Alternatively, at least one tactile element may extend from both the front and rear peripheries, as described below.

[0046] Regarding specific components of the IOL, as described above, the front end can possess elastic properties. Elastic properties allow the front end to change shape with applied forces, but also allow it to return to its original configuration when the force is removed. Advantageously, the front end is more resistant to deformation changes (e.g., less flexible, more rigid) than the contents or materials contained within the cavity, because the contents of the cavity can more easily deform to allow the front end to flatten when an outward radial force is applied to it. Exemplary materials used for manufacturing the front end include silicone (i.e., polysiloxane), acrylic (hydrophobic or hydrophilic) polymers, polymethyl methacrylate (PMMA), silicone rubber, collars, suitable optical thermoplastic polymers, other suitable optical materials, and suitable combinations thereof.

[0047] Regarding the posterior aspect of a deformable optic, it can be more resistant to deformation than the anterior aspect or the contents contained within the cavity of the deformable optic. The posterior aspect does not need to have the ability to change shape. When implanted, the posterior aspect may, in some respects, abut against the posterior capsule and vitreous body, and it may not be desirable to have those less predictable forces that alter the refractive power of the optic. Furthermore, a posterior aspect that is more resistant to deformation than the anterior aspect or the contents of the cavity of the deformable optic allows the posterior optic to have a relatively more fixed refractive power posterior lens, which allows for the combination of beneficial optical properties. Additionally, a posterior aspect that is more resistant to deformation when the anterior aspect changes shape in response to forces allows the contents of the cavity to reshape the sidewalls. The posterior aspect can be as follows: Figures 1 to 3 The monolithic IOL 10 shown is a part of it, or it may be as follows: Figures 4 to 6 The two-piece integrated IOL 10A are shown. In some respects, the rear is elastic. Exemplary manufacturing materials for the rear include silicone (i.e., polysiloxane), acrylic (hydrophobic or hydrophilic) polymers, polymethyl methacrylate (PMMA), silicone rubber, collagen polymers, suitable optical thermoplastic polymers, other suitable optical materials, or suitable combinations thereof. The rear may include a lens with various optical properties, such as, for example, spherical, aspherical, toric, annular, multifocal, diffractive, extended depth of focus, or combinations thereof. Figure 6 As shown, IOL 10B may include deformable optics, wherein the rear 22B has a square outer periphery 35 to reduce posterior capsule opacification by inhibiting, for example, the migration of peripheral lens epithelial cells across the rear.

[0048] In some embodiments, the front and / or back may have one or more highly smooth surfaces (i.e., with low surface roughness). The smoothness of the surface is primarily determined by the smoothness of the mold used to prepare the front and / or back. The finish on the mold should be of sufficient quality to produce a finish that meets international standards for optics used in intraocular lenses. Therefore, the finish on the mold should be at least SPI A-3, more preferably A-2, and even more preferably A-1. SPI A-1 corresponds to a particle size of 6000, SPI A-2 corresponds to a particle size of 3000, and SPI A-3 corresponds to a particle size of 1200. If the surface is not smooth, the refractive indices of the shell polymer and the silicone oil need to be matched to avoid optical interface aberrations. Smoothness or surface roughness can be measured using a contact roughness tester, atomic force microscope, white light interferometer, or laser microscope, which provides a resolution from 1 nm to 0.1 nm.

[0049] Regarding the sidewalls, as described above, the sidewalls can be elastic. In some respects, the sidewalls can be made of materials with equal or less resistance to deformation changes compared to the front. These characteristics can allow the contents housed within the cavity to expand the area of ​​the sidewalls, allowing the volume of the cavity contents to remain the same when the front is planarized. Deformable sidewalls can facilitate and allow for a greater amount of deformation of the front of the deformable optic. Exemplary materials for the sidewalls include silicone, acrylic (hydrophobic or hydrophilic) polymers, polymethyl methacrylate (PMMA), silicone rubber, collagen polymers, suitable optical thermoplastic polymers, other suitable materials, or suitable combinations thereof. The sidewalls can also be made thinner than the front or rear, with resistance to deformation changes equal to or less than that of the front or rear. Alternatively, or additionally, by having, for example, Figure 7 The corrugated structure shown allows the sidewalls 36 of the deformable optics 38 to have a resistance to deformation that is equal to or less than its ability to resist changes in shape. The bellows can be oriented horizontally or vertically, or have other orientations, to allow the outer peripheral sidewalls to expand or contract. For example... Figure 8 As shown, the sidewall 90 of the deformable optics 92 may have a flat, concave, convex or other structure so that the contents of the chamber 94 move against the sidewall 90 when the front 96 flattens.

[0050] Regarding the chamber, the chamber may be defined by a rear surface at the front, a front surface at the rear, and an inner surface of the sidewalls. The internal contents or materials of the chamber may include soft solids, gels, viscoelastic materials, flowable fluids or gases, or other suitable materials. Exemplary materials that may be contained within the chamber include: soft silicone or other soft materials subject to deformation, air or other gases, silicone oil (having various refractive indices), aqueous solutions of saline or hyaluronic acid, viscoelastic polymers, polyphenylene ether or other optical fluids, solids or gases, or suitable combinations thereof. The chamber may have an inner layer or coating to seal the contents of the chamber relative to the front, sidewalls, and / or rear. The chamber may be pre-loaded (e.g., by the manufacturer) with suitable materials. Alternatively, a clinician may load suitable materials into the chamber. For example, see [reference needed]. Figure 9 The deformation optics 40 of the IOL can define at least one port 42 (for clarity, in...) Figure 9 (Enlarged in size), its dimensions and dimensions are adapted to accommodate a needle or catheter, the dimensions and dimensions of which are adapted to deliver fluid, gel, or gas into a chamber and / or, for example, to exchange fluid with materials of different materials or materials with different refractive indices. Although Figure 9An example is shown of a port defined by the front 44, but this port may be defined by the sidewall 46 or rear 48 of the deformable optics. Having a port allows a user to add or remove material from the chamber 47 to adjust the refractive power of the lens. For example, by adding additional material to the chamber, the volume of the material in the chamber can increase, resulting in an increase in the surface curvature and total refractive power of the lens, and removing the material can reduce the volume of the material in the chamber, resulting in a decrease in the surface curvature and total refractive power of the lens. Furthermore, by replacing the material with a material having a different refractive index, the total refractive power and auto-adjustment range of the IOL can be increased or decreased.

[0051] At least one tactile element relating to the IOL, wherein the tactile element is a part of the IOL configured to interact with the lens capsule, lens septa, ciliary muscle, or other parts of the patient's eye. The at least one tactile element may be molded, formed into, integral with, or otherwise extended from the distorting optics of the IOL. Figure 3 As shown, at least one haptic element may comprise a plurality of haptic elements disposed around the outer periphery of the front of the deformable optics. At least one haptic element may be elastic, but may be more resistant to deformation changes than the front. The advantage of this is that the haptic element can be more rigid to provide a linear force from the haptic element to the outer periphery of the front. It is not desirable to be limited by any particular mechanism of action; if the haptic element is less resistant to deformation changes than the front, radial tension may result in stretching of the haptic element and less tension on the outer periphery of the front. Therefore, for a given force applied to the haptic element, the front may not change shape as much. Exemplary manufacturing materials for at least one haptic element include silicone, acrylic (hydrophobic or hydrophilic) polymers, polymethyl methacrylate (PMMA), silicone rubber, collars, suitable optical thermoplastic polymers, other suitable materials, or suitable combinations thereof.

[0052] Regarding the haptic elements, in some aspects, each of the plurality of haptic elements is non-rotatable in response to axial compression along the optical axis on the deformable optics. In some aspects, each haptic element has an outer periphery having a rear and a front, wherein the rear is curved. In other aspects, each of the inner portions of the plurality of haptic elements extends from and connects to the outer periphery of the front, such that the plurality of haptic elements change the shape of the front by applying a radial force to the outer periphery of the front in a direction perpendicular to the optical axis, without by axial compressive force along the optical axis on the deformable optics or by axial compressive force on the haptic element.

[0053] Figures 3 to 6An example of an IOL is illustrated, wherein at least one tactile element extends anteriorly from a deformable optics element. The deformable optics element can change shape in response to eye forces, particularly forces generated by the contraction or relaxation of the ciliary muscle of the patient's eye. When the ciliary muscle relaxes and applies radially outward tension to the lens capsule via the lens sac, at least one tactile element interacting with the lens capsule can apply radially outward tension anteriorly. At least one tactile element may be elastic, but may be equal to or more resistant to deformation changes than the anterior element.

[0054] Figure 3 An example is illustrated of multiple tactile elements extending circumferentially from a deformable optics element. Upon implantation and when the ciliary muscle of the patient's eye is relaxed (e.g., when the eye is in a state of deaccommodation), the ciliary muscle applies tension to the multiple tactile elements (e.g., via the lens capsule, with a small lens band appendage between the lens capsule and the ciliary muscle). The multiple tactile elements can then apply tension to the anterior periphery at various points (referred to herein as "extension points") extending from the anterior periphery of the tactile elements. This is achieved by having, for example... Figure 3 and Figure 4 The multiple tactile components shown can ultimately result in a front end that extends from several locations (such as, for example, ...). Figure 3 The eight extended portions (shown) are pulled outwards, and functionally result in a relatively symmetrical radial tension applied to the front periphery of the deformable optics. (Reference) Figure 10 In some aspects, the IOL 70 includes at least one tactile element 72 extending from the rear end 74 of the deformable optic 76. Deformation of the optic can be achieved independently of or in combination with a force applied to the rear end. (Reference) Figure 11 In other respects, the IOL 78 includes at least one tactile element 80 extending from the front 82 and rear 84 of the deformable optics 86. If a force is applied to both the rear and the front, the total refractive power change of the IOL can be increased for a given force. In other words, if a force is applied to both the front and the rear, shape changes on both surfaces can be achieved, thereby increasing overall autoadjustment.

[0055] At least one tactile element can engage with the inner surface of the lens capsule or the outer surface of the lens capsule. (Reference) Figures 3 to 6 The outer periphery of at least one tactile element 34 may include, for example: Figures 3 to 6The ridge 50 shown is configured to engage the inner surface of the lens capsule. For example, the ridge 50 can interact with the lens capsule to stabilize the tactile element within it. The ridge can also allow the tactile element to interact and be fixed to the lens capsule. This allows the IOL to be placed within the capsular bag while still allowing for changes in tension / relaxation of the lens capsule (via the lenticular loops and ciliary body) during autoaccommodation / de-accommodation of the lens. Current tactile element designs do not allow the tactile element to be positioned within the lens capsule while fixing it to allow for tension / relaxation on the lens capsule, thus transmitting force to the tactile element. Current tactile element designs are smooth and allow the capsule and the tactile element to slide past each other, which does not allow for translation of forces applied to the peripheral lens capsule (via the lenticular loops and ciliary muscle). When the IOL is placed within the capsular bag, the ridges (one or more) can be configured to allow the IOL to rotate until the desired rotational position of the IOL is achieved. Once the IOL is rotated to its desired position, the forces on the tactile element fix the lateral portion of the tactile element to the inner outer periphery of the lens capsule. The ridge then provides resistance to these forces and facilitates the forces from the ciliary body, lesser zonules, and lens capsule becoming forces on the tactile element.

[0056] Regarding at least one tactile element that engages with the outer surface of the lens capsule, when the IOL is placed in front of an existing previously implanted IOL, or when placed in front of the lens capsule, the at least one tactile element can engage with the outer surface of the lens capsule. (See reference...) Figure 12 The peripheral portion of the tactile element 52 of the IOL 53 may include a hook-shaped / generally J-shaped configuration to engage with or bend around the outer surface of the lens capsule. The peripheral ends of the peripheral portion may be injury-preventing ends, ensuring they do not damage the lenticular lens or the lens capsule. At least one tactile element (e.g., the right tactile element and / or the left tactile element) may each include multiple hooks. Hooked or generally J-shaped tactile elements allow the IOL to utilize forces transmitted from the ciliary muscle via the lenticular lens to the lens capsule without requiring the tactile element to be placed on elements of the ciliary muscle. This embodiment avoids known potential complications of tactile elements placed against the ciliary muscle, such as uveitis, glaucoma, and hemorrhage (e.g., hyphema). This embodiment can be implemented in patients who have already had an IOL implanted or in patients who do not have an IOL implanted.

[0057] refer to Figure 13The deformable optics themselves can define ridges to engage the inner surface of the lens capsule. For example, deformable optics 56 can include an expandable chamber 57 having an integrated tactile element with ridges 58 and 60 on the outer periphery 59 of the anterior 62 and / or the outer periphery 61 of the posterior 64. When tension is placed on the lens capsule via a small band (e.g., when the ciliary muscle relaxes), forces can be specifically transferred to the anterior and posterior (through the ridges engaging the capsule), rather than simply to the entire lens in general. The anterior, posterior, and / or lateral walls can be more resistant to deformation than the contents of the chamber. This configuration allows forces from the lens capsule to provide radial tension to the tactile element, thus providing radial tension anteriorly, which is in front of the lens equator; and / or radial tension posteriorly, which is behind the lens equator. The lateral walls can be configured to allow material in the chamber, displaced by the flattening of the anterior and / or posterior, to expand into the regions of the lateral walls, thus allowing the volume of material within the chamber to remain constant.

[0058] refer to Figure 14 and Figure 15 In some respects, an IOL 100 is provided, wherein the bottom of the tactile element 102 defines a recess 104. This recess can accommodate a stabilizing ring 106, for example, to prevent the tactile element from retaining the lens capsule fibrosis inward. The stabilizing ring can be made of any of the materials described above for the front and / or rear of the deformable optics.

[0059] An IOL includes an optical axis extending in a front-to-back direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL may also include an elastic front end located in front of the equator and a rear end located behind the equator. The front and / or rear end may comprise a poly(dimethylsiloxane) elastomer with a hardness between about 20 Shore A and about 70 Shore A, where hardness is a measure of the material's stiffness. Hardness is related to resistance to deformation changes; therefore, the higher the Shore A value, the greater the material's resistance to deformation. In some embodiments, the elastomer has a hardness between about 20 Shore A and about 50 Shore A. In a further embodiment, the hardness may be between about 30 Shore A and about 50 Shore A. In yet another embodiment, the hardness may be about 50 Shore A. Providing a front and rear end with appropriate hardness allows the material to be hard enough to displace fluid in the chamber, strong enough to not tear, and elastic enough to be smoothly reshaped on the surface. In some embodiments, the front and rear end are made of a material with a tensile strength of about 1.8 mPa to about 8.6 mPa, more preferably about 4 mPa to about 6 mPa.

[0060] The IOL may further include a chamber located between the front and rear sections, and may include a silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units. The polysiloxane may include end-capping groups of trimethylsiloxane. The silicone oil may have approximately 800 mm at 25°C. 2 Maximum viscosity per second, including approximately 400 mm at 25°C. 2 / s to approximately 800mm at 25℃ 2 The viscosity is approximately 1.5 g / s. In some embodiments, the silicone oil may have an average molecular weight of less than about 3,000 Daltons. It should be noted that the embodiments described herein may include all features and aspects described in all other embodiments and aspects of the invention.

[0061] IOLs with this characteristic have several advantages. As background, in a natural, healthy eye, the lens capsule deforms due to the deformation of the lens cells, causing deformation of the lens cortex and lens nucleus (the contents of the lens). This is because the cytosol within each individual lens cell is free-flowing, and when aggregated, the lens contents act like a fluid. Therefore, the lower the viscosity of the fluid within the IOL's cavity, the easier it is to move in response to forces applied from the front and / or back of the IOL. Thus, taking the front as an example, this includes a poly(dimethylsiloxane) containing a hardness between about 20 Shore A and about 50 Shore A, and contains silicone oil (which has a viscosity of about 800 mm at 25°C). 2 The combination of chambers with a maximum viscosity of / s and an average molecular weight of less than about 3,000 Daltons makes the contents of the anterior chamber more resistant to deformation than those of the chamber below it. This allows the anterior chamber to exhibit elastic properties, such as deforming when force is applied to it and returning to its original shape when the force is removed, resulting in an effective amount of anterior shape change and thus autoaccommodating refractive power changes. This IOL more closely mimics the elastic gradient of a natural young lens during autoaccommodation, especially when the radial tension is specifically directed at at least the anterior and at the point anterior to the equator of the IOL. Furthermore, the anterior and / or posterior chambers, comprising poly(dimethylsiloxane) with a hardness between about 20 Shore A and about 50 Shore A, have sufficient tear strength necessary for molding the lens during manufacturing. In some embodiments, the IOL may include elastic sidewalls extending across the equator and from the anterior to the posterior chamber. In addition to having this range of hardness values ​​for the anterior and / or posterior chambers, the elastic sidewalls may also have a hardness between about 20 Shore A and about 50 Shore A.

[0062] In some aspects, this disclosure provides an IOL having an optical axis extending in a front-to-back direction and an equator extending in a plane substantially perpendicular to the optical axis. The IOL may include an elastic front end located in front of the equator and a rear end located behind the equator. The front and / or rear end may include a polysiloxane as at least 99% poly(dimethylsiloxane) elastomer. In other words, the polysiloxane may be free of phenyl units, contain trace amounts of phenyl units, or have an immeasurable amount of phenyl units, such that the IOL achieves its desired functionality as described herein. The IOL may further include a chamber located between the front and rear ends. The chamber may include a silicone oil comprising a polysiloxane containing diphenylsiloxane and dimethylsiloxane units. In some embodiments, the polysiloxane contains at least about 30 mol% diphenylsiloxane because phenyl-free polymer chains can be absorbed into the poly(dimethylsiloxane). In some embodiments, the IOL may further include resilient sidewalls extending across the equator and from the front to the rear, wherein the resilient sidewalls also include a polysiloxane comprising at least 99% poly(dimethylsiloxane), except that the rear and / or front sidewalls also contain this percentage of poly(dimethylsiloxane). It should be noted that the described embodiments may include all features and aspects described in all other embodiments and aspects of this disclosure. The inclusion of a polysiloxane comprising at least 99% poly(dimethylsiloxane) in the front, rear, and / or sidewalls minimizes the amount of silicone oil described herein absorbed by the front, rear, and / or sidewalls. This is crucial because the absorption of silicone oil into the front, rear, and / or sidewalls can increase the thickness and weight of the front, rear, and / or sidewalls. This alters the mechanical and optical properties of the front, rear, and / or sidewalls, such as the elastic properties, optical transparency, and refractive index of the IOL.

[0063] In some embodiments, at least a portion of the front and rear surfaces are coated with a parylene layer. In some embodiments, the entire front and rear surfaces are coated with a parylene layer, while in other embodiments, only the surfaces in contact with the silicone oil are coated with parylene. Parylene is a polymer whose main chain consists of p-phenylenediyl rings linked by 1,2-ethanediyl bridges. Examples of parylene include parylene N, chlorinated parylene, fluorinated parylene, and alkyl-substituted parylene. Preferably, only a thin layer of parylene is coated onto the optical surfaces in contact with the silicone oil. Parylene provides a barrier against the absorption of fluids and / or oils into the silicone.

[0064] The various aspects and embodiments disclosed herein can be considered individually or in combination with other aspects and embodiments, and with respect to other intraocular lenses, such as those disclosed in U.S. Patent Application No. 10,898,316, which are incorporated herein by reference in their entirety. Furthermore, the orientation of deformable optics can be modified. For example, when implanted, the lens can be flipped so that the anterior face faces posteriorly and the posterior face faces anteriorly. Further, the IOL can be configured to be foldable for insertion. Further, while certain features of embodiments may only be shown in some figures, these features may be incorporated into other embodiments shown in other figures or otherwise disclosed in the specification, or may be omitted from other embodiments. Additionally, when a scope is described, all points within that scope are included in this disclosure.

[0065] One aspect of this disclosure is a method for manufacturing an intraocular lens by assembling a host polymeric material and silicone oil to form an intraocular lens. The assembly step may include: propelling silicone oil into a fluid chamber within the host material of the intraocular lens. The silicone oil may be purified to have an average molecular weight of about 1,000 Daltons to about 3,000 Daltons. In some embodiments, the refractive index of the silicone oil is at least 0.2 greater than the refractive index of the host polymeric material.

[0066] Silicone oil for IOL chambers

[0067] This disclosure generally relates to fluids, such as silicone oil, for use in intraocular lenses. While silicone oil for autoacoustic IOLs is described primarily herein, any silicone oil can be used in de-autoacoustic IOLs. For example, a de-autoacoustic IOL may have a relatively rigid outer polymer shell surrounding a silicone oil core. In some embodiments, silicone oil is used in autoacoustic intraocular lenses that utilize the movement of a bulk polymeric material encapsulating the silicone oil to achieve changes in refractive power within the IOL. However, silicone oil can also be used in de-autoacoustic intraocular lenses.

[0068] When selecting silicone oils for IOLs, the expansion of the host polymer material must be considered. When silicone oils are used in autoconditioned IOLs with host materials such as polymers, some oil components can enter the host material, causing it to expand. Silicone oils typically need to be selected or designed in a way that avoids unfavorable interactions with the surrounding host IOL material, such as expansion, atomization, dissolution, or reaction with the material (e.g., polyacrylate) in some IOLs. The solubility of silicone oil in the host material depends on its chemical structure and molecular weight distribution. Other parameters affecting this interaction are the composition and properties of the host material, such as homogeneity, chemical structure, hydrophobicity, modulus, and crosslinking density. Therefore, silicone oils should have a different composition from the host polymer to reduce mixing. For example, if the host polymer is a phenyl-free dimethylsiloxane and the silicone oil is a dimethyl / diphenylsiloxane, such that the percentage increase in the number of molecules in the silicone oil contains phenyl groups, the expansion of the host dimethylsiloxane material is minimized.

[0069] The silicone oil included in the IOL should be selected or manufactured to provide one or more advantages, such as avoiding interaction (e.g., swelling) with the main dimethyl polymer material of the intraocular lens. Various properties of the silicone oil can be selected to avoid interaction with the main dimethyl polymer material. These include: an increased percentage of diphenylsiloxane, silicone oils with very low levels of impurities, increased amounts of long-chain silicone molecules, different molecular weights, and viscosity and / or refractive index within a preferred range.

[0070] Some IOLs rely on or can benefit from silicone oils containing diphenyl units. Chain polysiloxanes consist of bifunctional units. The framing group (R) is an H or organic group, and the terminal group is typically -OR or a monofunctional siloxy unit. Chain polysiloxanes, such as poly-(dimethylsiloxane), are synthesized by the hydrolysis of dichlorodimethylsilane. In the case where the R group is phenyl, the diphenyl can be included in the polysiloxane using essentially the same chemical reaction. The chemical structures of polysiloxanes including both dimethylsiloxane and diphenylsiloxane are shown in Scheme 1.

[0071]

[0072] Dimethyl / diphenyl silicone oils can be prepared by increasing the percentage of molecules with attached phenyl groups and / or by increasing the number of phenyl groups in each molecule. In some embodiments, each dimethyl / diphenyl copolymer includes at least one phenyl group. Silicone oils containing an increased percentage of phenyl-containing polysiloxanes can be used with pure dimethyl host polymers. When the increased percentage of silicone oil includes diphenyl units, the tendency for the silicone oil to be absorbed (swell) into the surrounding dimethyl polysiloxane host material is reduced.

[0073] Compared to the dimethyl units present in polysiloxanes, silicone oils comprising diphenyl units can have a variety of different molar percentages of diphenyl units. In some embodiments, the polysiloxane comprises at least 1 mol% diphenylsiloxane, at least 2 mol% diphenylsiloxane, at least 5 mol% diphenylsiloxane, at least 10 mol% diphenylsiloxane, at least 15 mol% diphenylsiloxane, at least 20 mol% diphenylsiloxane, at least 25 mol% diphenylsiloxane, at least 30 mol% diphenylsiloxane, at least 35 mol% diphenylsiloxane, at least 40 mol% diphenylsiloxane, at least 45 mol% diphenylsiloxane, or at least 50 mol% diphenylsiloxane.

[0074] The relative amount of diphenyl units contained in the polysiloxane can also be expressed as a range, with the remainder of the polysiloxane consisting of dimethyl units. In some embodiments, the silicone oil comprises about 1 mol% to about 50 mol% of biphenyl units, about 1 mol% to about 30 mol% of biphenyl units, about 2 mol% to about 50 mol%, about 2 mol% to about 40 mol%, about 5 mol% to about 40 mol%, about 10 mol% to about 40 mol%, about 20 mol% to about 40 mol%, or about 25 mol% to about 35 mol%. In some embodiments, the silicone oil comprises about 30 mol% of diphenylsiloxane and about 70 mol% of dimethylsiloxane.

[0075] Silicone oils preferably also include low or very low levels of impurities. In some embodiments, the silicone oils described herein have very low concentrations of small-cyclic volatile methylsiloxane (cVMS) molecules (e.g., D4-D6 molecules), comprising small amounts (e.g., 4-6) siloxane groups. Specific chemical names for D4-D6 molecules are octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecylcyclosiloxane (D6). Silicone oils containing less than 0.1% of small-cyclic substances (D4-D6 molecules) are desirable. In some embodiments, the silicone oil contains less than 0.05% of small-cyclic substances (D4-D6 molecules). Furthermore, the silicone oil should be transparent and colorless, have less than about 10 ppm of heavy metals and other insoluble inorganic contaminants, and be substantially free of silanols.

[0076] By exposing silicone oil to a large amount of IOL material or other materials selected for this purpose, the silicone oil components dissolved into the host IOL material over time (e.g., during storage) can be removed. When stored with appropriate materials, the silicone oil components dissolved in the host IOL polymeric material can be removed by adjusting the ratio of silicone oil to polymeric adsorbent to retain sufficiently low levels of those materials in the oil.

[0077] Including some long-chain polysiloxane molecules in silicone oil is also desirable. Long-chain or very long-chain polysiloxane molecules can help stabilize silicone oil and reduce the likelihood of emulsification. Therefore, in some embodiments, silicone oil contains long-chain or very long-chain polysiloxane molecules. In some embodiments, silicone oil comprises about 5% to about 10% by weight of long-chain polysiloxane molecules. Long-chain polysiloxane molecules (i.e., long-chain aralkyl silicone oil) are available from various commercial sources, such as Iota Silicone Oil Ltd.

[0078] In some embodiments, a silicone oil comprising a smaller polymer having an average molecular weight of less than about 3,000 Daltons, or from about 1,000 to about 3,000 Daltons, is provided. Generally, smaller molecular size silicone oil polymers are associated with lower viscosity silicone oils. Viscosity relates to the ease with which molecules in a fluid can move past each other, and smaller molecules with lower molecular weights interact less, resulting in lower viscosity. Low-viscosity silicone oils are desirable in the fluid chambers of an auto-regulating IOL to allow for faster response times during auto-regulation / de-regulation. In some embodiments, the silicone oil has an average molecular weight of less than about 2,500 Daltons. In a further embodiment, the silicone oil has an average molecular weight of less than about 2,000 Daltons. In a further embodiment, a silicone oil with an average molecular weight between about 1,500 and about 3,000 Daltons is provided. In yet another embodiment, the silicone oil has an average molecular weight between about 2,000 and about 3,000 Daltons. In yet another embodiment, the silicone oil has an average molecular weight between about 1,500 and about 2,500 Daltons. In another embodiment, the silicone oil has an average molecular weight of about 1,750 to about 2,750 Daltons. In yet another embodiment, the silicone oil has an average molecular weight of about 2,000 to about 2,500 Daltons. Higher molecular weight silicone oils can have correspondingly higher viscosity, which can reduce the response time of the auto-adjusting IOL. The use of silicone oils with lower molecular weights is particularly effective when paired with relatively robust host polymeric materials, such as poly(dimethylsiloxane) elastomers having a hardness between about 20 Shore A and about 50 Shore A.

[0079] Another characteristic of silicone oils is their polydispersity index (PDI), which is a measure of the distribution of molecular weight (i.e., the inhomogeneity of polymer molecule size) in the silicone oil. A higher PDI indicates a wider range of polymer molecular weights. The silicone oil used in the IOL described herein may have a PDI value of 1.5 or higher, or 2.0 or higher. In some embodiments, the silicone oil has a PDI value of about 1.5 to about 2.0, about 2.0 to about 3.0, or about 1.5 to about 2.5. In further embodiments, the silicone oil has a PDI value of about 2.3 to about 2.7.

[0080] In embodiments where the bulk polymeric material changes shape in response to ciliary muscle forces applied to the lens capsule via a small band and automatically adjusts the dynamic operation of the IOL, the IOL must have an appropriate response time. This requires the silicone oil viscosity to have certain defined characteristics. Therefore, in some embodiments, the silicone oil viscosity is less than about 800 centistokes (cSt) at 25°C; in other embodiments, the silicone oil viscosity is from about 600 cSt to about 800 cSt at 25°C; and in further embodiments, the silicone oil viscosity is from about 400 cSt to about 800 cSt at 25°C. The viscosity of the silicone oil can be determined using, for example, a digital viscometer.

[0081] In some cases, it is desirable for the refractive index of the silicone oil to be greater than that of the host polymer. In some embodiments, it is desirable for the silicone oil to have a refractive index at least 0.2 greater than that of the host polymer. It should be noted that poly(dimethylsiloxane), which can be used as the host polymer, has a refractive index of 1.41. The higher refractive index of the silicone oil increases the refractive power of the IOL, thereby allowing for a lower profile (smaller AP dimension). Refractive power is a measure of the convergence or divergence of light produced by the lens or optical system. Furthermore, the higher refractive index of the silicone oil allows for small variations in the shape of the host polymer, resulting in larger variations in the refractive power of the IOL during autoaccommodation / de-accommodation. The higher refractive index of the silicone oil also allows for a smaller anterior-posterior profile of the IOL, which facilitates placement of the IOL in the eye through a smaller incision in the eye. Examples suitable for use with a poly(dimethylsiloxane) shell would include silicone oils having a refractive index of about 1.45 to about 1.55, or about 1.49 to about 1.53. The refractive index can be determined using a refractometer.

[0082] Using silicone oils with a higher relative diphenyl content provides silicone oils with a higher refractive index and also allows for silicone oils with lower viscosity, which is beneficial for a fast response time to auto-adjustment / de-auto-adjustment.

[0083] In some embodiments, the silicone oil has a dispersion of less than or equal to about 0.035 refractive index units in the visible light range of 400 nm to 750 nm at 35°C. In some embodiments, the silicone oil components are completely miscible with each other without any signs of phase separation (i.e., turbidity or suspension). In some embodiments, for a fluid sample about 1 cm thick, the silicone oil has a transmittance greater than 85% in the range of 400 nm to 1100 nm.

[0084] Silicone oils can have several of the characteristics described herein. For example, an autoacoustic intraocular lens comprising a main dimethyl polymeric material may include silicone oil, which comprises diphenylsiloxane and dimethylsiloxane, having a refractive index between about 1.49 and about 1.53, an average molecular weight between about 1,000 Daltons and about 3,000 Daltons, and a viscosity of less than about 800 cSt at about 25°C.

[0085] All patents, patent applications, publications, and electronically available materials cited herein are incorporated herein by reference in their entirety. Any inconsistencies between the incorporated material and the specification shall be resolved in favor of the specification. The detailed descriptions and examples given above are provided for clarity only and should not be construed as unnecessarily limiting. The invention is not limited to the specific details shown and described, and all variations that will be apparent to those skilled in the art are included within the scope of the invention as defined by the claims.

Claims

1. An intraocular lens having an optical axis extending in an anteroposterior direction and an equator extending in a plane substantially perpendicular to said optical axis, said intraocular lens comprising: Located in front of the elastic front, Located behind the equator, and The chamber located between the front and the rear; Wherein, the front and / or the rear include a poly(dimethylsiloxane) elastomer, the poly(dimethylsiloxane) elastomer having a hardness between 20 Shore A and 50 Shore A; Furthermore, the chamber comprises silicone oil, which comprises a polysiloxane containing diphenylsiloxane and dimethylsiloxane units, the silicone oil having a maximum viscosity of 800 cSt at 25°C, and the silicone oil having an average molecular weight of 1000 to 3000 Daltons.

2. The intraocular lens according to claim 1, wherein, The poly(dimethylsiloxane) elastomer has a hardness of 50 Shore A.

3. The intraocular lens according to claim 1, further comprising: An elastic sidewall, wherein the elastic sidewall extends across the equator and from the front to the rear.

4. The intraocular lens according to claim 1, wherein, The anterior and posterior portions of the intraocular lens comprise polysiloxane, which is at least 99% poly(dimethylsiloxane) elastomer.

5. The intraocular lens according to claim 1, wherein, The front and the rear have one or more highly smooth surfaces.

6. The intraocular lens according to claim 1, wherein, At least a portion of the front and rear sides are coated with a parylene layer.

7. The intraocular lens according to claim 1, wherein, The polysiloxane comprises at least 10 mol% diphenylsiloxane.

8. The intraocular lens according to claim 1, wherein, The silicone oil comprises 30 mol% diphenylsiloxane and 70 mol% dimethylsiloxane.

9. The intraocular lens according to claim 1, wherein, The silicone oil comprises 5% to 10% by weight of long-chain polysiloxane molecules.

10. The intraocular lens according to claim 1, wherein, The silicone oil has a viscosity of 400 cSt to 800 cSt at 25°C.

11. The intraocular lens according to claim 1, wherein, The silicone oil has a refractive index between 1.49 and 1.

53.

12. The intraocular lens according to claim 1, wherein, The silicone oil comprises less than 0.1% of octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and dodecylcyclohexyloxyketone.

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