Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
  • A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
  • A61F2/1618—Multifocal lenses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
  • A61F2/1654—Diffractive lenses

Definitions

• US2004230299 presents a lens with extended depth of focus that utilizes central convex shape and a sinusoidal grating.
• the grating has a pitch that is not conforming to that of a typical multifocal, leading instead to a widened peak.
• an ophthalmic multifocal lens that is at least configured to provide a focal point for far vision.
• Said ophthalmic multifocal lens have a light transmissive lens body comprising a phase shifting structure arranged for providing vision over a range of optical power stronger than that of the distance vision, the phase shifting structure having a design that is rotationally symmetric around the optical axis.
• phase shifting structures can in general be applied to any of the two sides of the lens, since when a phase shifting structure is to be combined with a refractive baseline with some special feature it generally does not matter if they are added to the same side or if one is added to a first side and the other to a second side of the lens. Concurrently, two phase shifting structures may be combined either by super positioning on one side, or by adding them on both sides of the lens in an overlapping fashion.
• Ophthalmic lenses that are built according to the present disclosure also have the marked advantage of providing a very sharp far vision for scotopic conditions. Providing a sufficient distance vision is considered the criterion for success in surgical interventions.
• another advantage is the strong addition which is essentially achievable through small modifications to the structure of a monofocal lens.
• Figure 1 demonstrates a simplified anatomy of the human eye.
• Figure 5a demonstrates four different surface profiles, less the respective refractive baseline, for enhanced depth-of-field lenses made according to the present invention.
• Figures 5b, 5c, 5d, and 5e demonstrate the modelled relative intensity of the surface profiles in Figure 5a.
• Figure 5f demonstrates the absolute modelled intensity distributions at 3 mm lens aperture for the surface profiles in Figure 5a.
• Figures 6e and 6f demonstrate modelled absolute intensity and modelled relative intensity, respectively, of the profiles in Figure 6d.
• Figure 7a shows measurements of a lens manufactured according to the present invention, MTF measured at 50lp/mm.
• Figure 7b shows measurements of a lens manufactured according to the present invention, MTF measured at lOOIp/mm.
• One important aspect of the present invention is tuning the intensity distribution as a function of the lens aperture, from the optical axis up to a radius from where the lens is substantially behaving as a monofocal lens.
• the eye has a much larger depth of field at pupil sizes that are smaller, due to the pinhole effect.
• Pupil size not being solely dependent on the pupillary light reflex, is also dependent on the accommodation reflex, which causes the pupil to enlarge insufficiently while focusing on objects of closer proximity. Due to this, it is generally advantageous to arrange large apertures of an ophthalmological lens so that it provides far vision only, since for increasing pupil sizes the highest power the eye can make use of decreases. Thus, providing stronger power for in scotopic conditions will decrease light efficiency of the lens.
• Eye model 1 uses a neutral cornea. Eye model 1 can be used to measure either the intensity or the Through Focus Modulation Transfer Function (MTF).
• MTF Through Focus Modulation Transfer Function
• the MTF is always measured at some specific frequency, measured line pairs per millimeter (Ip/mm). It is common to compare MTF values at 50 Ip/mm or 100 Ip/mm.
• the lens 13 For a sharp and clear far field view by the eye 10, the lens 13 should be relatively flat, while for a sharp and clear near field view the lens 13 should be relatively curved.
• the curvature of the lens 13 is controlled by the ciliary muscles (not shown) that are in turn controlled from the human brain.
• a healthy eye 10 is able to accommodate, i.e. to control the lens 13, in a manner for providing a clear and sharp view of images at any distance in front of the cornea 11, between far field and near field.
• Presbyopic ophthalmic lenses e.g. multifocal lenses or lenses with enhanced depth-of-field are used to enhance or correct vision by the eye 10 for various distances.
• the ophthalmic lens is arranged for sharp and clear vision at three more or less discrete distances or focal points, often including far intermediate, and near vision, in Figure 1 indicated by reference numerals 17, 18 and 19, respectively.
• An EDOF lens might correct vision at far and intermediate vision only.
• Far vision is in optical terms when the incoming light rays are parallel or close to parallel. Light rays emanating from objects arranged at or near these distances or focal points 17, 18 and 19 are correctly focused at the retina 14, i.e.
• the amount of correction that an ophthalmic lens provides is called the optical power, OP, and is expressed in Diopter, D.
• Figures 2a and 2b demonstrate ophthalmic aphakic intraocular lens for treatment of presbyopia, as known in the art.
• Such presbyopic lenses can for example make use of a diffractive grating, a refractive zonal construction, a phase shaping structure or spherical aberration that varies with lens aperture.
• Figure 2a shows a top view of a typical ophthalmic multifocal aphakic intraocular lens 30, and
• Figure 2b shows a side view of the lens 30.
• the lens 30 comprises a light transmissive circular disk-shaped lens body 31 and a pair of haptics 32, that extend outwardly from the lens body 31, for supporting the lens 30 in the human eye.
• the optic diameter 37 of the lens body 31 is about 5 - 7 mm, while the total outer diameter 38 of the lens 30 including the haptics 31 is about 12- 14 mm.
• the lens 30 may have a center thickness 39 of about 1 mm.
• the haptics 32 at the lens body 31 are not provided, while the lens body 31 may have a plano-convex, a biconcave or plano-concave shape, or combinations of convex and concave shapes.
• the lens body may comprise any of Hydrophobic Acrylic, Hydrophilic Acrylic, Silicone materials, or any other suitable light transmissive material for use in the human eye in case of an aphakic ophthalmic lens.
• the anterior surface 52 is formed as a summation of a phase shifting structure 51 and a refractive baseline.
• the refractive baseline is substantially monofocal and any substantially monofocal design can be used. It is of course well-known that any monofocal design takes into consideration both the anterior and posterior sides. The point being that any useful monofocal design can be used to define the refractive baselines of the current invention. It is obvious to the skilled person that this is only one possible configuration. It is possible, for example, to place the phase shifting structure 51 on the posterior side to distribute the phase shifting structure over both sides or superposition the phase shifting structure to either side of a plano-convex or plano-concave lens.
• the full lens aperture is in intraocular lenses often 6 mm, that is a distance of 3 mm from optical axis to lens edge. To better show the patterned central part of the lens only the central 3 mm aperture is shown, but it is assumed for all lens profiles in this document that the peripheral part of the lens that starts at a lens radius smaller than 1.5 mm continues out the edge of the lens (i.e., to the edge of the optic). This peripheral part is in all cases substantially monofocal and coincides with the refractive baseline.
• the refractive baseline can of course for example be a sphere of suitable power. Often the refractive baseline will be a chosen asphere to either limit the added positive spherical aberration or to negate corneal spherical aberration.
• Figure 4b shows the modelled absolute intensity distributions at two different apertures for the two profiles shown in Figure 4a.
• the intensity distributions are calculated using MATLAB TM -based simulation software. Those skilled in the art will appreciate that these optical powers or focal points may differ for actual lenses, dependent on the target focal points.
• the light intensity is expressed in arbitrary units, but the exact same arbitrary scale is used for all graphs in this document showing absolute simulated intensity.
• the far focus can here be assumed be around 20D.
• Profile 4.1 provides for a 2.5 mm lens aperture a peak intensity at an addition of about 0.48D. The intensity is generally decreasing with increasing power. There is also a relatively large undesired peak at 19.55D.
• Figure 4c demonstrates two lens profiles less the refractive baseline, Profiles 4.3 and 4.4. Both surface profiles are designed for a lens having a refractive power of 20D and a refractive index of the lens material of 1.525. Profile 4.3 illustrates a lens profile that uses a central shape that protrudes at its peak 1.50 pm over the refractive baseline, this peak coincides with the optical axis.
• This central shape decreases monotonically until it reaches the refractive baseline at a 0.66 mm radius.
• the central protrusion in Profile 4.3 and Profile 4.4 is different than the one used in Profiles 4.1 and 4.2. While the central protrusion in Profiles 4.3 and 4.4 is still decreases monotonically with increasing aperture this profile features a more complex central protrusion where a convex portion coinciding with the optical axis is circumscribed by a concave part, which in turn is circumscribed by a second convex part.
• This gives a more complex structure which might be slightly more difficult to manufacture well and might be slightly less desirable to some doctors because of aesthetic considerations, but on the other hand it gives additional design freedom to distribute the light, as it will be demonstrated.
• the central protrusion is also here circumscribed by a trough, this time with its lowest point at a radius of 0.66 mm, to which trough it is smoothly linked for Profile 4.3.
• This trough is in turn circumscribed by a smooth ridge that has its highest peak at a radius of 0.84 mm, and it connects to the refractive baseline at a radius of 0.91 mm. Note that the refractive baseline is 0.16 pm higher in Profile 4.4 compared to Profile 4.3.
• Figure 4d shows the modelled absolute intensity distributions at two different apertures for the two profiles shown in Figure 4c.
• the intensity distributions are calculated using MATLAB TM -based simulation software. Those skilled in the art will appreciate that these optical powers or focal points may differ for actual lenses, dependent on the target focal points.
• the light intensity is expressed in arbitrary units, but the exact same arbitrary scale is used for all graphs in this document showing absolute simulated intensity.
• the far focus can here be assumed be around 20D.
• Profile 4.3 provides for a 2.5 mm lens aperture a peak far intensity at an addition of about 0.33D. The intensity is generally decreasing with increasing power. There is also a relatively large undesired peak at 19.42D.
• the 4.2 profile creates a typical intermediate addition of 1.7D, but with retained continuous vision between the far focus and the intermediate.
• This lens has a very good peak broadening, very strong far and very little undesired light.
• the addition of the even such a small smooth edge tunes the intensity distribution so that more light is directed toward far vision and the prioritized intermediate power, while the main undesired peak is reduced.
• the combination of a trough and smooth ridge can be used to shape of the broadening of the peak.
• a higher smooth ridge will give higher intensity to the main intermediate peak.
• the horizontal placement of the ridge will affect the power of the intermediate peak.
• Figure 5a demonstrates four different surface profiles, less the respective refractive baseline, for EDOF lenses. All four surface profiles are designed for a lens having a refractive power of 20D and a refractive index of the lens material of 1.525. These four profiles are structurally similar to Profiles 4.2 and 4.4, each has a central protrusion that decreases in height monotonically into a trough, the trough being circumscribed by a smooth ridge.
• Profile 5.1 has a relatively simple convex shape at the center of the lens, that then turns into a concave shape that leads into the trough.
• the peak of the central protrusion corresponds to 0.87*n modulation of 550 nm light.
• the trough is placed at a radius of 0.67 mm
• the peak of the smooth ridge is placed a radius of 0.87 mm
• a has a height corresponding to a 0.73*n modulation of 550 nm light.
• Figure 5b For smaller apertures this lens has a very strong peak corresponding to intermediate vision, even stronger than the far peak at 2 mm aperture.
• the lens behaves more and more like a monofocal lens, however at 3 mm good continuous vision is provided for additions of 0.6D to 1.8D, but with a strong dip in intensity at around 0.4D addition. This is due to the smooth ridge being relatively high. This lens still functions as an EDOF lens, as the dip is narrow.
• This type of lens can be preferred when it is a priority to provide a strong intermediate peak, as in absolute terms the intermediate vision peak has higher intensity than for any of the Profiles 5.2, 5.3, or 5.4, the same is true for the peak for far vision.
• Figure 5f shows a comparison of the modelled absolute intensity distribution for 3 mm lens aperture for the four profiles.
• Profile 5.1 provides strong peaks for far and intermediate vision, with significant broadening of the intermediate peak, but less of the peak for far vision. It also has a relatively strong undesired peak between 18D and 19D, but as can be seen in Figure 5f this is further away from far vision than the other profiles, so the placement is an advantage.
• Profile 5.2 features a complex central protrusion where a convex portion coincides with the optical axis, circumscribed by a concave part, in turn is circumscribed by a second convex part, before leading into the trough.
• the peak of the central protrusion corresponds to 1.1 l*n modulation of 550 nm light.
• the trough is placed at a radius of 0.65 mm, and the peak of the smooth ridge is placed at a radius of 0.843 mm, with a height corresponding to a 0.33 n modulation of 550 nm light. Its modelled, relative intensity distribution at several lens apertures is shown in Figure 5c.
• the more complex shape of the central protrusion gives the ability to further fine tune the intensity distribution, by changing the curvatures of each portion.
• this profile has a more balanced behavior at a 2 mm aperture, that is more far-centric.
• this lens provides a plateau behavior, where a strong peak for far vision is combined with a vision plateau all the way up to an addition of 2.4D. This is very desirous EDOF behavior.
• the undesired peak around 19D is slightly strong, but becomes greatly reduced for larger apertures.
• Profile 5.3 has a relatively simple convex shape at the center of the lens, which then transitions into a concave shape that leads into the trough.
• the peak of the central protrusion corresponds to 1.08*n modulation of 550 nm light.
• the trough is placed at a radius of 0.7 mm, and the peak of the smooth ridge is placed at a radius of 0.88 mm, with a height corresponding to a 0.38*n modulation of 550 nm light slightly too strong for the 2 mm aperture, but quickly recede for larger apertures.
• Its modelled, relative intensity distribution at several lens apertures is shown in Figure 5d.
• This profile with a simpler central protrusion behaves in a very similar fashion to Profile 5.2.
• the main difference is that Profile 5.3 provides a slightly less flat plateau, with an increased intensity distribution for additions between 1.2D and 2.0D.
• Profile 5.4 exhibits a complex central protrusion characterized by a complex central protrusion where a convex portion coinciding with the optical axis is circumscribed by a concave part, in turn circumscribed by a second convex part.
• the peak of the central protrusion corresponds to 1.40*n modulation of 550 nm light.
• the trough is placed at a radius of 0.63 mm, and the peak of the smooth ridge is placed at a radius of 0.79 mm, with a height corresponding to a 0.43*n modulation of 550 nm light. Its modelled, relative intensity distribution at several lens apertures is shown in Figure 5e.
• Profile 5.4 has a very wide distribution of light intensity, useful to a user in a very wide variety of conditions. It exhibits an increased intensity distribution for additions between 1.7D and 3. ID, while maintaining a continuous vision from the far peak through intermediate vision, having a main secondary intensity peak at an addition of 2.4D.
• a lens using this profile will for photopic and scotopic vision have strong far and intermediate vision, but also a functional or even relatively good near vision (depending on the eye of the user).
• the undesired secondary peaks are very low in this design, as the lens is very efficient.
• the comparative drawback of this design can be seen in Figure 5f; the far vision is weaker at the 3 mm lens aperture. For larger apertures this is not a problem, as also this lens behaves more and more as a monofocal lens for large apertures.
• Figure 6a demonstrates four different possible surface profiles for EDOF lenses. These four profiles all have identical central protrusions, identical troughs, and identical placement of the peak of the smooth ridge, the difference between them is in the height of the smooth ridge at which the refractive baseline connects.
• Each of the four surface profiles are designed for a lens having a refractive power of 20D and a refractive index of the lens material of 1.525. These profiles have a relatively simple convex shape at the center of the lens, that then turns into a concave shape that leads into the trough. If calculated over the trough, the peak of the central protrusion corresponds to 0.93*n modulation of 550 nm light.
• the trough is placed at a radius of 0.65 mm, while the peak of the smooth ridge is placed at a radius of 0.83 mm with a height corresponding to a 0.29*n modulation of 550 nm light.
• Figure 6b demonstrates the absolute modelled intensity distributions of the four profiles, 6.1, 6.2, 6.3, and 6.4 at a lens aperture of 2.5 mm.
• Figure 6c demonstrates the relative modelled intensity distribution of the same four profiles at a lens aperture of 3.5 mm.
• the refractive baseline is higher than in the other examples and connects to the smooth ridge close to the peak of the ridge, at 0.35 pm above the bottom of the trough.
• the corresponding values for Profiles 6.2, 6.3, and 6.4 are 0.16 pm, 0 pm, and - 0.21 pm, respectively. This means that in Profiles 6.1 and 6.2 the refractive baseline is placed above the bottom of the trough, while Profile 6.3 is placed in line with the bottom of the trough, while the refractive baseline in Profile 6.4 is placed below the trough.
• Figure 6b shows that when the connection point of the refractive baseline to the smooth ridge is lowered, the intensity is decreased from the most undesired region (here around 19 D to 19.5 D) as well as from around ID positive addition (around 21D in the graph), while intensity is increased for far vision and for the main intermediate peak at around 2D addition.
• the undesired peak around 18.6D is close to identical, but it increases slightly for Profile 6.4.
• Figure 6c shows, in relative terms, that for this larger aperture, when the connection point of the refractive baseline to the smooth ridge is lowered the main effects are peak broadening of the far vision towards the usable side as well as increased intensity for the intermediate vision. It should be noted that in absolute terms for this apertures (not shown) peak intensity for far vision is increasing with lowered height of the connection point, the opposite of what is the case for the 2.5 mm aperture.
• Figure 6d demonstrates four different possible surface profiles for EDOF lenses, specifically Profiles 6.5, 6.6, 6.7, and 6.8. These profiles all have identical central protrusions, identical troughs, and identical placement of the peak of the smooth ridge, with the difference between them being the height of the smooth ridge at which the refractive baseline connects.
• Each of these surface profiles is designed for a lens having a refractive power of 20D and a refractive index of the lens material of 1.525.
• These profiles exhibit a complex central protrusion where a convex portion coinciding with the optical axis is circumscribed by a concave part, in turn circumscribed by a second convex part leading into the trough.
• the peak of the central protrusion corresponds to 1.25*n modulation of 550 nm light.
• the trough is placed at a radius of 0.585 mm, while the peak of the smooth ridge is positioned at a radius of 0.768 mm with a height corresponding to a 0.46*n modulation of 550 nm light.
• Figure 6e demonstrates the absolute modeled intensity distributions of the four profiles, 6.5, 6.6, 6.7, and 6.8 at a lens aperture of 2.5 mm.
• Figure 6f demonstrates the relative modeled intensity distribution of the same four profiles at a lens aperture of 3.5 mm.
• Figure 6f shows, in relative terms, that for this larger aperture, when the connection point of the refractive baseline to the smooth ridge is lowered, the main effects are peak broadening of the far vision towards the usable side as well as increased intensity for the intermediate vision. It should be noted that in absolute terms for this aperture (not shown), peak intensity for far vision is increasing with lowered height of the connection point, the opposite of what is the case for the 2.5 mm aperture.
• connection point is a very useful tool for tuning the performance of the EDOF lens.
• a connection point close to the peak of the smooth ridge has a relatively high degree of undesired light, but at the same time, often too low a broadening of the intensity peak for far vision in the desired direction (towards stronger power).
• a lower connection point leads to less monofocal behaviour.
• Lowering the connection point, at least down to the bottom of the trough decreases undesired light. It also helps strengthen the intermediate peak, generally increases far vision for smaller apertures, but makes the lens retain more EDOF behavior for mesopic and mesopic/scotopic conditions.
• connection point that is too low might lead to a bifocal behavior for photopic and mesopic conditions. It is observed that the connection point should preferably always be chosen to be below the peak of the smooth ridge. As a rule of thumb, it is also true that the best design is often found by choosing a connection point above the bottom of the trough.
• Figures 7a and 7b contain measurements of a lens constructed according to the patent.
• the measured lens uses a refractive base with a power of 24.6 D, a refractive index of 1.4618 and a profile that with same intended behavior as Profile 6.2, as explained in Figures 6a, 6b, and 6c, the present profile, however, recalculated for the lower refractive index.
• the peak height, coinciding with the optical axis, is for this profile is 2.0 pm above the trough.
• Figure 7a demonstrates measurements for 50 line-pairs per millimeter (Ip/mm), while Figure 7b demonstrates measurements for 100 Ip/mm.
• an ophthalmic multifocal intraocular lens arranged to provide far vision, and at least one other usable vision at most at a range of 1 m, said lens having a light transmissive lens body with an optical axis, an anterior and a posterior surface and a refractive baseline that extends over at least a part of the lens body is proposed.
• At least one of the anterior surface and the posterior surface of said ophthalmic lens comprises a first zone extending from the optical axis to a first radius, and a second zone that extends from the first radius to the edge of the lens body.
• said first zone comprises a central shape protruding above the refractive baseline and further comprises at least two radii of curvature.
• said first zone comprises a trough circumscribing the central shape.
• said first zone comprises a smooth ridge circumscribing the trough, said smooth ridge configured to protrude above the refractive baseline while having a peak height over the refractive baseline lower than that of the central shape.
• the smooth ridge of the first zone connects at the first radius to the second zone, the second zone being configured to coincide with the refractive baseline and to be substantially monofocal, providing far vision.
• said trough circumscribing the central shape is configured to extend below the refractive baseline.
• said central shape is configured such that it comprises a concave portion and at least two convex portions, wherein said concave portion is set in between said at least two convex portions.
• said central shape is configured such that the peak with the second highest intensity is between 1.2D and 2.5D when measured at 50 line pairs per millimeter.
• said lens is configured to provide, at an aperture corresponding to mesopic conditions, an MTF of at least 0.15 measured at 50 Ip/mm.
• said first radius is larger than 0.7 mm and smaller than 1.3 mm.
• said smooth ridge is configured to have a height that is less than half the height of the central shape.
• said convex portion of said central shape is configured such that its height is less than 2n for a wavelength of 550 nm.
• said central shape is further configured such that its height is greater than 0.5n for a wavelength of 550 nm.
• said lens is a phakic lens, whereas according to at least one other embodiment said lens is an aphakic lens.

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• 2023
  • 2023-06-09 EP EP23761631.3A patent/EP4724009A1/de active Pending
  • 2023-06-09 WO PCT/TR2023/050546 patent/WO2024253607A1/en not_active Ceased

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