Intraocular lens configured to be inserted into the eye and method of manufacturing the same

Abstract

The present invention relates to a guide lens configured to be inserted into the eye and a method for manufacturing the same. The lens according to the present invention is, Optical element of a flexible optical material; and It includes at least one haptic element having a connecting portion connected to an optical element and configured to connect a lens to an eye portion, and Here, the optical element has a lens refractive power profile, preferably a continuous lens refractive power profile, and the profile has at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance, outside the center of the lens when viewed in the radial direction of the lens.

Description

Technology Field

[0001] The present invention relates to an intraocular lens (IOL) to be inserted into the eye. Such a lens is typically inserted into the eye through an incision and secured therein using haptic elements. Such intraocular lenses are applied, for example, to replace the natural lens in the case of cataract surgery, or are placed in addition to the natural lens in the case of presbyopia, for example. Background Technology

[0002] Conventional guide lenses are inserted using an incision. If the lens is manufactured from a flexible material, the lens becomes foldable, and incisions of limited dimensions are possible. The lenses are equipped with optical elements and one or more haptic elements—thereby allowing the lens to be fixed inside or in the eye.

[0003] Various lenses are actually known, and they typically feature a monofocal design. Such monofocal lenses can be manufactured easily and generally provide good vision, particularly for distance vision—that is, for distances greater than 2.0 meters. To also improve intermediate vision, adapted lens power profiles have been developed. This improves intermediate vision, that is, vision from approximately 66 cm to approximately 2.0 meters from the eye. The problem here is that this is detrimental to distance vision. This is undesirable. Such adapted profiles can also have an adverse effect on preventing destructive effects, for example, regarding halos and glare. In practice, this reduces the user's comfort of the lens. Various types of multifocal lenses are actually known here. These are typically bifocal or trifocal lenses, each having two and three different zones, respectively, with their own lens refractive power profiles having their own progression. It has been found that (the above) destructive effects may occur here.

[0004] The present invention aims to provide a lens that eliminates or at least reduces the aforementioned problems and is actually usable, thereby improving intermediate vision in addition to distant vision and offsetting / compensating for adverse effects.

[0005] This objective is achieved by a guide lens configured to be inserted into the eye according to the present invention, wherein the lens is,

[0006] Optical element of a flexible optical material; and

[0007] It includes at least one haptic element having a connecting portion connected to an optical element and configured to connect a lens to an eye portion, and

[0008] Here, the optical element has a lens refractive power profile, preferably a continuous lens refractive power profile, and the profile has at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance, outside the center of the lens when viewed in the radial direction of the lens.

[0009] An induction lens (IOL) according to the present invention comprises an optical element made of a flexible optical material. Using a flexible material allows the lens to be foldable, so that the lens can be inserted into the eye in an effective manner through an incision. The lens further comprises at least one haptic element having a connecting portion configured to be connected to a portion of the eye. Such haptic elements may have different designs, particularly depending on a specific application.

[0010] An optical element has a lens power profile, which is also referred to as an optical power profile or a dioptric power profile. Such a lens power profile relates to the progression of diopters (lens power) radially across the surface of the lens. If the lens power profile is the same when viewed from the center of the lens in all directions, a reference is also made to a radial lens power profile, the diopter of which may vary in all directions if desired, thereby creating an additional toric profile. According to the present invention, the profile has at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance, outside the center of the lens when viewed radially. In a currently preferred embodiment, since such a profile is substantially the same in all radial directions, in this preferred embodiment, a reference may be made to a radial lens power profile having at least one increasing profile and at least one decreasing profile when viewed radially. Alternatively, it is also possible to provide such profiles in one or multiple directions when viewed from the center of the lens.

[0011] The lens refractive power profile of the tragus lens according to the present invention preferably has a continuous progression. By doing so, abrupt transitions in the lens refractive power profile are avoided, so that disturbances at the location of the transition(s) are offset. This continuous progression of the lens refractive power profile results in a monofocal lens in which no multifocal parts or sections exist, and in such a monofocal lens, aberrations are smoothly and autonomously optimized without compensating for corneal aberrations.

[0012] The lens refractive power profile of the guide lens according to the present invention preferably further comprises a profile configured at or near the center of the lens for distant vision targeting a distance greater than 2.0 meters from the eye, wherein the portion of the lens positioned between the center and the edge is at least partially intended to improve intermediate vision related to a distance of about 66 cm to 2.0 m from the eye.

[0013] According to the present invention, a first radial distance is provided within this range between the center and the edge of the lens, wherein the refractive power of the lens increases when viewed radially from the center of the lens, and a second radial distance is provided in which the refractive power decreases.

[0014] Tests have shown that this significantly improves intermediate distance vision in particular. The lens refractive power profile of the intraocular lens according to the present invention improves intermediate distance vision, in particular, without any substantial loss of distance vision. An additional effect of such a lens refractive power profile is that spherical aberration is avoided or at least optimized. This makes the lens highly suitable for practical use in various applications, particularly for ophthalmic applications to replace cataracts and eyeglasses. In such applications, the natural lens is completely removed and replaced with the intraocular lens according to the present invention. In alternative applications, for example, in the case of presbyopia, the lens according to the present invention may also be used.

[0015] It has been further revealed that the lens according to the present invention is less affected by so-called halo or glare effects, thereby causing better neuro-adaptation for the user. This further improves the ease of use / comfort for the user of the guiding lens according to the present invention.

[0016] The (continuous) lens refractive power profile of the tragus lens according to the present invention preferably has a smooth progression. The aforementioned disturbances and adverse effects are offset or even completely prevented by this smooth progression, that is, by the absence of abrupt transitions in the lens refractive power profile. This eliminates the need for (segmented) corneal compensation in the lens according to the present invention, and conversely, the use of spherical deformation of the surface of the (monofocal) lens results in a continuous and smoothly shifting focus (smooth diopter change).

[0017] In a currently preferred embodiment according to the present invention, the smooth progression of the (continuous) lens refractive power profile is induced by the continuous progression of the first derivative of the lens refractive power profile. Since the first derivative of the lens refractive power profile has a continuous progression across the lens, abrupt transitions are avoided. If desired, this effect can be further enhanced by also imparting a continuous progression to higher derivatives, such as the second and / or third derivative of the lens refractive power profile.

[0018] In an advantageous embodiment according to the present invention, the first radial distance and the second radial distance are located in the range of 0.5 to 2.5 mm from the center of the lens.

[0019] Providing first and second radial distances within the above range achieves that the center of the lens can be used for distant vision and that undesirable effects near the outer edge of the lens are avoided.

[0020] In a currently preferred embodiment according to the present invention, a first radial distance at which the refractive power (diopter) of the lens increases, for example, to a value greater than 1.0 D is first located when viewed from the center of the lens, and thereafter the first radial distance is transitioned to a second radial distance at which the refractive power of the lens decreases, for example, to 0 D and preferably further decreases to a negative value, for example, -0.5 D.

[0021] The transitions between the first radial distance and the second radial distance, and the transitions between the remaining changes in lens refractive power, are preferably implemented gradually so that abrupt transitions are avoided, as already indicated above. Such abrupt transitions appear as bend points in the lens refractive power profile. By realizing a gradual change in lens refractive power in the currently preferred embodiments, bend points and any associated adverse effects are avoided. This increases user comfort of the guiding lens in such embodiments according to the present invention.

[0022] The first and second radial distances are preferably in the range of 1.0 to 2.0 mm when viewed from the center of the lens. The advantages mentioned above are further enhanced in this preferred embodiment in that any adverse effects occurring, such as spherical aberration, are particularly further optimized. The offsetting of such adverse effects can be further enhanced by avoiding the aforementioned "curvature" in the lens refractive power profile as much as possible.

[0023] In a currently preferred embodiment, the lens refractive power profile has increasing intensity over a first radial distance in the range of 0.5 to 1.5 mm, more preferably in the range of 1.0 to 1.5 mm, when viewed from the center of the lens.

[0024] By making the first radial distance start from 0.5 mm from the center of the lens, or preferably even 1.0 mm, the lens refractive power profile does not affect distance vision, and this distance vision is substantially determined by the center of the lens and its immediate vicinity using the lens according to the present invention.

[0025] The second radial distance is preferably provided at a radial distance greater than the first radial distance with respect to the center, preferably in the range of 1.5 to 2.5 mm from the center of the lens, more preferably in the range of 1.5 to 2.0 mm from the center of the lens. This prevents peripheral effects at the outer periphery of the lens.

[0026] In a currently preferred embodiment according to the present invention, the refractive power of the lens at the edge or near the edge of the guide lens is at least the same as the refractive power of the lens at the center or near the center of the lens.

[0027] By making the lens refractive power at the edge or near the edge equal to or even greater than the lens refractive power at the center or near the center of the lens, the natural aberrations of the eye can be utilized without compensating for the cornea. By doing so, the effect on contrast remains unaffected, and light energy within the bandwidth of the so-called circle of confusion in the eye is redistributed during the moment of pupil dilation. According to the lens of the present preferred embodiment of the invention, the supply of projected light energy is reinforced immediately in front of and behind the macula, thereby allowing users to experience a greater depth of field, which is actually utilized by the visual cortex.

[0028] In an advantageous embodiment according to the present invention, the lens refractive power profile has a peak outside the center of the lens, which is preferably located about 1.5 mm from the center of the lens at the transition from a first radial distance to a second radial distance. The peak preferably has a value in the range of 1.0 to 1.5 D. The peak more preferably has a value of about 1.2 D. It will be apparent that the absolute value for the lens refractive power depends on additional characteristics of the lens, including the circumstances for application of the lens and the dimensions and materials.

[0029] In an advantageous embodiment according to the present invention, the lens refractive power profile has a third radial distance, wherein the third radial distance has increasing refractive power when viewed radially from the center of the lens.

[0030] Providing a third radial distance having increasing lens refractive power, preferably directly connected to a second radial distance having decreasing refractive power, allows intermediate distance vision to be improved while spherical aberration can be further optimized. In such a preferred embodiment, the profile has a valley associated with lens refractive power located outside the center of the lens. Such a valley is preferably located at the transition from the second radial distance to the third radial distance, and preferably within the range of 1.5 to 2.0 mm from the center of the lens. Such a valley preferably corresponds to the minimum lens refractive power of the lens, which in the present preferred embodiment is lower than -0.3 D, and preferably within the range of -0.3 to -1.0 D. The lens refractive power more preferably has a valley within the range of -0.3 to -0.55 D, for example, corresponding to -0.4 D. The increase in lens refractive power at the third radial distance preferably leads from the valley to the "base" lens refractive power, which is preferably substantially the same as the lens refractive power at the center of the lens. According to the present invention, it will be apparent that other lens refractive powers and other profiles can also be conceived.

[0031] Tests indicated that undesirable effects, including spherical aberration particularly during twilight or nighttime periods, are further offset or compensated for by this. It was specifically revealed that the lens's positive aberrations (diopters)—which produce positive addition—are compensated by negative aberrations (diopters), allowing the lens to perform better at variable (large and small) iris apertures without causing double vision, such as that occurring in multifocal lenses (bifocal and trifocal lenses).

[0032] In a further advantageous embodiment according to the present invention, the connecting portion of the haptic element is configured to connect a lens to the eye portion to replace the natural lens.

[0033] Configuring haptic elements to connect a lens to the eye, specifically to that part of the eye, provides an option to replace the natural lens. This can occur, for example, during so-called cataract surgery.

[0034] The present invention also relates to a method for manufacturing a guide lens, wherein the method is,

[0035] A step of providing an optical element of a flexible optical material;

[0036] Step of providing at least one haptic element — the haptic element having a connecting portion for connecting the haptic element to an optical element —; and

[0037] The method includes the step of arranging a lens refractive power profile, wherein the profile comprises, in the radial direction of the lens, at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance.

[0038] Such a method provides advantages and effects similar to those described for the lens. The lens is preferably provided in one of the embodiments according to the present invention. Additionally, if desired, it will be apparent that the method may include different steps for arranging the profile as described above in relation to the guide lens. It is desirable to arrange the lens refractive power, which, when viewed radially from the center of the lens toward the outer periphery of the lens, shows an increase in lens refractive power over a first radial distance, after reaching a peak, is followed by a second radial distance that causes negative lens refractive power, and after reaching such a valley, shows an increase in lens refractive power over a third radial distance to a "base" lens refractive power—which is preferably substantially the same as the lens refractive power at the center of the lens. It will be apparent that other lens refractive powers and other profiles may also be conceived according to the present invention. Brief explanation of the drawing

[0039] Further advantages, features, and details of the present invention are described based on preferred embodiments thereof, with reference to the accompanying drawings: FIG. 1 illustrates a view of a guide lens according to the present invention. Figure 2a shows a 3D view of a conventional lens refractive power profile. FIG. 2b illustrates a 3D view of a lens refractive power profile in one embodiment according to the present invention. Figure 3a illustrates a conventional lens refractive power profile as shown in Figure 2a. FIG. 3b illustrates a lens refractive power profile in one embodiment according to the present invention as shown in FIG. 2b. FIG. 3c illustrates an additional lens refractive power profile in one embodiment of the lens according to the present invention. Figure 4 illustrates the results using the lens refractive power profile according to Figure 3b. FIGS. 5a to 5c illustrate test results using a guide lens according to the present invention. Specific details for implementing the invention

[0040] A guide lens (2) (Fig. 1) comprises an optical system (4) having a lens center (8), a peripheral edge (6), and haptic elements (10). In the illustrated embodiment of the lens (2), the haptic elements (10) take a curved shape. According to the present invention, it will be apparent that it is also possible to apply haptic elements (10) of different shapes. For example, it is further possible to change the number of haptic elements (10) by using a single haptic element.

[0041] The material of the lens (2), in particular, the material of its optical system (4) is preferably a hydrophobic or hydrophilic material, for example, a silicone material and / or a hydrophilic or hydrophobic acrylate. The haptic element (10) may be provided from the same material or a different material, preferably from a more rigid or harder material, for example, (compression-molded) PMMA (polymethyl methacrylate) or PES (polyethersulfone), or other suitable materials.

[0042] A conventional lens (12) (Fig. 2a) comprises an optical system (14), an outer edge (16), a center (18), and haptic elements (20). A 3D lens refractive power profile (11) consists of a peak (11a) at the center (18) and a lens refractive power that decreases toward the outer edge (16) that follows (Fig. 3a). In the illustrated embodiment, the profile (11) has a lens refractive power that decreases continuously, wherein a plurality of additional inflection points (11b) are also arranged in the lens refractive power profile (11).

[0043] A lens (2) according to one embodiment of the present invention has a lens refractive power profile (21) (Figs. 2b and 3b), the lens refractive power profile having a base lens refractive power level (22) near the center (8), and in the illustrated embodiment, this base lens refractive power level is maintained constant over a distance slightly exceeding 1 mm in the radial direction (r), after which the lens refractive power increases over a first radial distance (24) to a peak (26). In the illustrated embodiment, the peak (26) is about 1.2 D. From the peak (26), the lens refractive power decreases over a distance (28) to a valley (30). In the illustrated embodiment, the valley (30) is located at about -0.6 D. The lens refractive power subsequently increases over a third radial distance (32) until it reaches the base level (22) again. In this illustrated embodiment, this occurs at about 2.0 mm from the center (8) of the lens (2).

[0044] In the illustrated embodiment of the lens (2), the base level (22) is particularly associated with distant vision, that is, particularly with distances greater than 2.0 m. The base level (22) extends from the center (8) of the lens (2) to the beginning of a first radial distance (24) at about 1.2 mm from the center (8). At the first radial distance (24), the lens refractive power rises to a peak (26) at about 1.35 mm from the center (8). This particularly improves intermediate vision, that is, particularly improves vision at distances from 66 cm to 2.0 m from the eye. A third radial distance (32), ending at about 2.0 mm from the center (8) of the lens (2), begins at a valley (30) at about 1.6 mm from the center.

[0045] In the illustrated embodiment, the radial distances (24, 28, 32) are provided in direct succession to one another. This makes the gradual transition between individual parts relatively simple. It will be apparent that alternative embodiments are also possible, for example, by applying something similar to platforms at the locations of the peak (26), valley (30), and / or intermediate parts. The gradual transition(s) in the illustrated profile (21) offset / compensate for adverse effects as much as possible. Realizing a second radial distance and decreasing lens power—which ends in the valley (30) at negative lens power—and then realizing a third radial distance (32)—whereby the lens power returns to the base level (22)—further optimizes adverse effects such as spherical aberration.

[0046] In the alternative lens refractive power profile (41) (Fig. 3c), when viewed from the center toward the edge, there is a flat, increasing, decreasing, increasing, and once more flat profile, where there are no abrupt transitions or inflection points. At least the first derivative of the profile (41) is continuous. From region A to B, the profile (41) increases and improves intermediate vision, and slightly decreases (long-distance) vision. From region B to C, it completely or at least mostly restores the (long-distance) vision reduced by region AB. In the illustrated embodiment of the profile (41), the lens refractive power in regions ABC is completely or at least largely interdependent and complements each other. This characteristic continuous shape and positioning of at least one sinusoidal period in the lens resulted in a unique link independent of the pupil. By this, the shared characteristics of the overall shape of the lens refractive power profile (21, 41) in regions ABC optimize image quality in a changing pupil aperture. In the illustrated embodiment, the lens refractive power at the edge is at least the same as the lens refractive power at the center. If desired, the lens refractive power at the edge may be higher / greater than the lens refractive power at the center.

[0047] The lens (2) was tested in various experiments. In these experiments, among other things, the so-called modulation transfer function (MTF) was examined. This through-focus MTF is typically used when testing guiding lenses. In many of these experiments, the lens (21) was compared to a conventional single-focus lens. Both lenses were preheated to 35°C on a hot plate within a margin of ±2°C. The lenses were measured with a Nimo VISU equipped with an IOL Mentor. In the results of one of the experiments discussed here, the (pupil) aperture is 4 mm and the aberration is +0.28 μm. MATLAB was used for data analysis, and the results shown here (Fig. 4) are configured so that the peaks at infinity distance are set to 0.0 D defocuses. The shown MTF values ​​are average MTF values ​​for frequencies of 10 to 15 lp / mm.

[0048] In the results (Fig. 4), the characteristic difference in the defocus results is indicated by the EdoF arrow (extended depth of focus). This difference ranges from approximately -0.85 D to 1.75 D. These results show improved EdoF for the lens (2), which results in better vision, particularly mid-range vision. Thus, the use of the lens (2) produces improved mid-range vision without any associated loss of (long-range) distance vision. Adverse effects such as spherical aberration are also offset / optimized. This also results in improved comfort for the user of the lens (2).

[0049] In additional tests comparing the lens (2) with a conventional single-focus lens, in addition to the MTF graph and through-focus MTF graph, so-called postoperative logMAR visual acuity (VA) is also obtained as a measure of surgical success. Tests were performed at 3.0 and 4.5 mm (pupil) apertures and at +0.28 μm aberration at 5.15 mm. Tests were further performed at defocus in the range of +1.0 to -2 D. To determine the size of the halos at the 4.5 mm aperture, the so-called polychromatic point spread function (PSF) was used. The results are shown in FIGS. 5a through 5c. For the 4.5 mm (pupil) aperture, the MTF graph for optimal focus (Fig. 5a) shows significant similarity between the two lenses with respect to distance vision. The through-focus MTF graph at 50 lp / mm (Fig. 5b) shows that for a 3.0 mm (pupil) aperture, lens (2) has a larger through-focus range and a larger peak width compared to the conventional lens, with a secondary peak at about -1.5 D. The logMAR VA graph (Fig. 5c) shows similar results for both lenses at long distances, with a peak near -0.1 logMAR. However, lens (2) exhibits better performance in the defocus range of -0.50 D to -2.0 D, where lens (2) shows a VA improvement of about 0.08 logMAR at about -1.5 D. Studies of halo effects indicated that lens (2) is less sensitive to them than the conventional lens.

[0050] To manufacture the lens (2), an optical system from a suitable base material is selected and provided to have the desired optical system (4). Haptic elements (10) are also arranged. The optical system (4) is provided with a lens refractive power profile (21). During insertion of the lens (2), it is preferable to fold and / or roll it up before placement, thereby requiring only a limited length in the incision of the eye. After the lens (2) is inserted into the eye through the incision, the lens (2) can be unfolded and positioned using the haptic elements (10).

[0051] The present invention is not limited to the embodiments described above. Claimed rights are defined by the following claims, and many modifications may be conceived within the scope thereof.

Claims

Claim 1 An intraocular lens configured to be inserted into an eye, comprising: an optical element of a flexible optical material; and at least one haptic element connected to the optical element and configured to connect the lens to a portion of the eye, wherein the optical element has a lens power profile, preferably a continuous lens power profile, and the profile has at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance, outside the center of the lens when viewed in the radial direction of the lens. Claim 2 In claim 1, the lens refractive power profile is a guide lens having a smooth progression. Claim 3 A guide lens according to paragraph 2, wherein the smooth progression comprises a continuous progression of the derivative of the lens refractive power profile. Claim 4 A guide lens according to claim 1, 2, or 3, wherein the first radial distance and the second radial distance are positioned within a range of 0.5 to 2.5 mm from the center of the lens. Claim 5 A guide lens according to any one of claims 1 to 4, wherein the first radial distance and the second radial distance are positioned within a range of 1.0 to 2.0 mm from the center of the lens. Claim 6 A guide lens according to any one of claims 1 to 5, wherein the profile has an increasing intensity over a first radial distance in the range of 0.5 to 1.5 mm from the center of the lens, preferably in the range of 1.0 to 1.5 mm from the center of the lens. Claim 7 A guide lens according to any one of claims 1 to 6, wherein the profile has a decreasing strength over a second radial distance in the range of 1.5 to 2.5 mm from the center of the lens, preferably in the range of 1.5 to 2.0 mm from the center of the lens. Claim 8 A guide lens according to any one of claims 1 to 7, wherein the refractive power of the edge or near the edge of the guide lens is at least the same as the refractive power of the center or near the center of the lens. Claim 9 A guide lens according to any one of claims 1 to 8, wherein the profile has a peak outside the center of the lens. Claim 10 In claim 9, the guide lens, wherein the peak has a value in the range of 1.0 to 1.5 D. Claim 11 A guide lens according to claim 9 or 10, wherein the peak is positioned at the transition portion from the first radial distance to the second radial distance. Claim 12 A guide lens according to any one of claims 1 to 11, wherein the profile has a third radial distance, and the third radial distance has increasing refractive power. Claim 13 A guide lens according to any one of claims 1 to 12, wherein the profile has a valley outside the center of the lens. Claim 14 In claim 13, the above-mentioned valley has a value of at least -0.3 D, preferably in the range of -0.3 to -1.0 D, more preferably in the range of -0.3 to -0.55 D, a guide lens. Claim 15 A guide lens according to any one of claims 1 to 14, wherein the connecting portion of the haptic element is configured to connect the lens to the eye portion to replace the natural lens. Claim 16 A method for manufacturing a guide lens, comprising: providing an optical element of a flexible optical material; providing at least one haptic element, wherein the haptic element has a connecting portion for connecting the haptic element to the optical element; and arranging a lens refractive power profile, wherein the profile comprises, in the radial direction of the lens, at least one increasing profile over a first radial distance and at least one decreasing profile over a second radial distance. Claim 17 A method according to claim 16, wherein the step of arranging the lens refractive power profile further comprises the step of arranging the profile according to any one of claims 1 to 15.

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