Patent Application
20120277857
The invention relates to an intraocular lens (IOL), and in particular to an improved IOL with Fresnel prism that can be used to reduce the effects of age-related macular degeneration (ARMD).
The treatment of focal macular diseases, and in particular ARMD, represents a major problem. Since the intact macula provides the vision that is required for reading, driving etc (but not for peripheral vision), the fact that there is no effective treatment for its degeneration means that many people increasingly retain peripheral vision only.
In order to solve this problem, it has been proposed that the retina should be surgically repositioned in the eye. A more practical solution is to optically deviate the image of the fixation point from the macula to a point on the retina where there are healthy cells. Although these cells may not function as well as the macular cells, an adequate degree of vision may be retained.
Among other things, this is proposed in U.S. Pat. No. 6,197,057. In particular, each of FIGS. 25, 27, 31 and 33 of U.S. Pat. No. 6,197,057 discloses a supplemental ions, i.e. an intraocular lens that is provided in addition to the natural, crystalline lens or to a biconvex IOL. All these drawings show a supplemental lens that is a conventional prism. The consequence is that the image is moved, away from the macula. Elsewhere in the specification, it is suggested that a Fresnel lens should be used as the supplemental IOL (column 9 line 13), and also that the lens should be “Fresnel-shaped”, again in the context of a supplemental lens). It is unclear what form the “Fresnel-shaped” lens should take.
WO03/047466 discloses an IOL that comprises a Fresnel prism. In this way, the focusing power of the IOL can be provided by a conventional lens that is modified so that light is focused on a (healthy) part of the retina that is not the macula. Such an IOL can be used to alleviate the effects of ARMD.
However, although a lens of the type disclosed in WO03/047466 provides a compact means to achieve the desired deviation of light, it can give rise to some undesirable optical effects, including optical aberrations. Thus, there is a need for an improved IOL having the benefits of the Fresnel prism type lens, but without the disadvantages.
According to a first aspect of the present invention, there is provided an intraocular lens having an optical axis, the lens comprising, as one face thereof, a Fresnel prism comprising an array of elongate prism elements which are parallel to one another along their length, each prism element having an elongate facet which is oriented such that a perpendicular to the facet is at an angle to the optical axis,
This aspect of the invention arises from the observation that a lens of the type disclosed in WO03/047466 has an undesirable optical diffraction grating type effect due to the periodic nature of the prism spacing in a typical Fresnel prism. A solution to this problem, according to the present invention, is an intraocular lens comprising, as one face thereof, a linear Fresnel prism array whose facets have been modified to reduce this diffraction effect. In particular, by varying the pitch, which may comprise varying the size of the prism elements, the diffraction grating effect can be reduced or negated, such that light is not diffracted into undesirable orders and multiple images can be avoided. Furthermore, chromatic angular dispersion associated with the diffraction grating effect may be reduced.
It should be noted that the Fresnel prism in the lens of the present invention does not constitute a Fresnel lens or zone-plate, and there is no circular symmetry to the array of prism elements itself, although other aspects of the lens may have circular symmetry The Fresnel prism in the present invention is a linear array of elongate prism elements located at one surface of a lens, which is intended to deviate light passing through the lens. In other regards the lens may be more conventional in construction, although various constructions are possible.
In a preferred embodiment, one or more of the pitch and the size of prism elements in the array has been randomised to reduce the diffraction grating effect. A random variation in the prism size, and therefore prism pitch, can avoid the constructive interference effect which would otherwise lead to light energy being directed into diffraction orders other than the desired zero order.
The randomisation may be similar across the array or else may be different one region as compared to another, for example in a region of the array proximate the optical axis as compared to a region distal the optical axis. In any case, it is desirable to ensure the presence of randomisation the region proximate the optical axis as well as across the whole array.
Preferably, the pitch of the prism elements in the array is in the range 50 μm to 500 μm, with the variation or randomisation of the localised pitch or spacing of the prism elements resulting in the pitch lying within this range.
In some embodiments, it is preferred that the pitch of the prism elements in the array varies by an amount in the range 0 μm to 50 μm. It should be noted that this is the variation in pitch, not the absolute value of the pitch. In other embodiments, it is preferred that the pitch of the prism elements in the array varies by an amount in the range 0 μm to 130 μm. A larger variation can more effectively reduce the diffraction grating effect and is desirable, providing the corresponding size of the prism elements is compatible with a given application and fabrication technique.
Without wishing to be bound by theory, when a prism is used in a converging light beam, it adds optical aberrations to the beam (astigmatism and coma). This is true for a single prism and for a Fresnel prism array. The astigmatism results in a separation of the sagittal and tangential foci of the converging rays. Therefore, rays in the plane of deviation now come to a focus closer to the IOL than those in the orthogonal plane. It is therefore also desirable to compensate for this astigmatism.
Therefore, in some embodiments of the invention it is preferred that a facet angle of prism elements is nonuniform across the array and is selected to compensate for astigmatism that would otherwise result from the presence of the Fresnel prism. The prism angle can be varied across the diameter of the lens, which can prevent the prism focusing power addition that occurs in converging light. Varying the angle can also have an additional effect. If each of the individual prisms has a very slightly different angle, tuned depending on the predicted angle of the ray that will hit it, it may be possible to ensure that all the rays exiting each prism surface converge at a single point, thereby correcting astigmatism.
It should be noted that, although the variation or tuning of the prism facet angle has been discussed in the context of the first aspect of the invention, this feature may have independent utility in the context of an IOL comprising a Fresnel prism.
According to a second aspect of the present invention, there is provided an intraocular lens having an optical axis, the lens comprising, as one face thereof, a Fresnel prism comprising an array of elongate prism elements which are parallel to ore another along their length, each prism element having an elongate facet which is oriented such that a perpendicular to the facet is at an angle to the optical axis,
Preferably, the facet angles vary monotonically across at least a portion of the array to compensate for the astigmatism.
In one particular embodiment, the angle of the facets is in the range 37.5 to 38.5 degrees, although any other suitable angle or range of angles may be used according to the specific application. The mean facet angle will generally be determined by the angular deviation that the Fresnel prism is required to provide when implanted in a patient's eye. This, in turn, will be determined by selection of a point on the retina where there are healthy cells and to which the image of the fixation point is to be deviated from the macula. The variation in facet angle, including the range of variation, will largely be determined by the requirement to compensate for the astigmatism that would otherwise result from the presence of the Fresnel prism.
In a further preferred embodiment, an intraocular lens of the invention comprises also a toric lens surface. This may correct the prism power addition. By pre-calculating the additional focusing power added by the rear prism surface in one axis, the optical front surface can be made with the correct optical power in both axes, that is to say a toric surface with less optical power in the axis of beam deviation. The toric lens surface can be used in combination with either or both of the first and second aspects of the invention.
The prism elements may be formed on a planar surface. Alternatively, the prism elements may be formed on a non-planar or curved surface.
The Fresnel prism component itself may have any of a variety of suitable designs. These include planar (flat disc), cylindrical (curved disc) and spherical (meniscus disc).
Preferably, in an IOL of the invention, the Fresnel prism is on the anterior surface, when in use. In this embodiment, the focus power addition is not so great, since the prism surface is in a less convergent beam.
The lens may be used in the eye, in either orientation, but it is generally preferred that a smooth face should face the posterior capsule. That face of the lens having the Fresnel prism may be made smooth, by covering it with a translucent material.
A lens used in this invention may be of conventional size and may be made of any suitable material. General characteristics of such lenses are known. The lens may he made of a rigid or foldable material. Suitable materials are those used for intraocular lenses and include both hydrophobic and hydrophilic polymers containing acrylate and methacrylate such as polymethyl methacrylate, and silicone elastomers such as dimethylsiloxane.
If necessary or desired, a lens of the invention may include one, two or more haptics. As is known, they may be attached to the body of the lens at its perimeter, and may extend radially or tangentially.
A lens used in this invention will usually have only one power. A range of lenses may be produced, each having a different power. Alternatively, the inclusion of a supplementary lens may be used to achieve the correct dioptric power for each eye.
According to a third aspect of the present invention, there is provided a combination of an intraocular lens according to according to the first or second aspect, and a second intraocular lens.
Preferably, the second lens has a toric shape to compensate for astigmatism in the lens combination.
According to a fourth aspect of the present invention, there is provided a method for the treatment of a macular condition requiring a change of focused image position, which comprises replacing a patient's crystalline lens by a lens according to the first or second aspects of the invention or a lens combination according to the third aspect of the invention.
According to a fifth aspect of the present invention, there is provided a method for the treatment of a macular condition requiring a change of focused image position, which comprises implanting into a patient's eye a lens according to the first or second aspects of the invention or a lens combination according to the third aspect of the invention in order to supplement the patient's crystalline lens or an existing intraocular lens or lens combination.
The methods of the fourth and fifth aspect of the invention are particularly applicable where the macular condition is age-related macular degeneration.
A lens of the invention may be used, following removal of the crystalline lens, for the treatment of any macular condition requiring a change of focused image position on the retina. The lens is particularly useful for treatment of ARMD. Its function may be visualised by substituting such a lens for the crystalline lens/IOL plus supplementary lens shown in FIGS. 25, 27, 31 and 33 of U.S. Pat. No. 6,197,057.
As will be appreciated by those skilled in the art, the present invention provides for a much improved design of IOL based on a Fresnel prism, and which addresses a number of problems that may arise in known Fresnel prism intra-ocular lenses. Moreover, optimised design of the prism elements in the Fresnel prism array, together with careful design of other lens surfaces, allow a high performance lens to be customised for implantation in a patient's eye.
Examples of the present invention will now be described in detail with reference to the accompanying drawings, in which;
3A and 13B show the results of a similar calculation to those of
The invention will now be illustrated by way of example only with reference to the accompanying drawings.
It should be noted that., if the intraocular lens surfaces are exchanged, one for the other, a similar aberration will occur. Moreover, it should be noted that if the IOL were rotated in the eye, then the two planes defined above would also be rotated by the same amount. Thus, orientation of the lens determines the direction in which light is deviated by the Fresnel prism, and this can he selected in accordance with an off-axis point on the retina, which has been predetermined as suitable in view of the patient ARMD.
In addition to the problem of optical aberrations, there are also optical effects associated with the presence of an array of elements of a size end spacing on the order of the wavelength of light or less. Without wishing to be bound by theory, the lens shown in
The diffraction grating effect has two main effects on the image: a) chromatic angular dispersion due to the sensitivity of diffraction angle with wavelength: and b) multiple images from the different diffraction orders. The angular separation of each order is given by m.λ=n.d. sin θ, where m is diffraction order, λ is wavelength of light, n is the surrounding medium refractive index, d is the grating spacing, and θ is the angle of diffraction. It is therefore an object of the invention to remove or mitigate the diffraction grating effect, and thereby the image quality can be increased and multiple images avoided or reduced to an imperceptibly low level of intensity. There are a number of ways in which this may be achieved.
In order to simulate the performance of an IOL using the present invention, it was necessary to develop models of the Fresnel Prism lens for calculating the expected performance purposes and also an optical bench system for simulating the performance of an IOL in a patient eye, such that representative imaging tests could be performed. Such tools would allow the performance of a conventional Fresnel prism IOL to be analysed as a baseline measurement and then compared to the performance of an improved Fresnel prism IOL according to the invention.
A number of experimental techniques were employed to investigate the Fresnel prism IOL. A Nickon microscope was used for visual inspection of prism structure. Laser spot imaging (using a 532 nm laser) enabled experimental visualisation of diffraction effects to determine the level of diffraction with a Fresnel prism IOL. As will be described below, a model “eye” with imaging CCD camera allowed image formation to simulated and the quality assessed. Finally, the use of a band-pass filter (10 nm band-pass centred at 546 nm) allowed me range of wavelengths entering the simulated eye to be reduced considerably, thereby allowing both monochromatic and chromatic effects to be observed and isolated.
It is clear from
In practice, a certain level of diffraction could be tolerated, as the retina in a real human eye would simply ignore the additional image, if it is below a certain intensity when compared to the rest of the image on the retina. Moreover, before application to a real patient, additional information about the visual acuity of the retina as a function of distance from the visual axis would be required. In particular, an understanding of the patient condition in terms of the limit of the macular degeneration and whether the degeneration stable. Ideally, the Fresnel prism IOL would be designed for an image offset that is as small as possible to ensure the best visual acuity.
Very basic diffraction calculations (light and dark strips at the prism spacing) had suggested that the diffraction efficiency for a periodic Fresnel prism array would be very low, for example 106 times less energy in the +1-diffraction order compared to the (zero) 0-order, and that therefore diffraction might not be a significant problem. However, as described above, initial experimental results showed that diffraction is occurring in a conventional Fresnel prism IOL and that there is significant energy in the diffracted light. In this regard, it was noted that a very important diffraction efficiency parameter for diffraction gratings is the grating blaze angle. In the Fresnel prism IOLs under test, the prism faces, or equivalently grating facets, are set at about 40 degrees. This high blaze angle will force energy into the higher diffraction orders, as was noted.
To back up the theory, simulations were performed using diffraction calculations, based on a coupled-wave model as formulated by M. G. Moharam, E. B. Grann, D. A. Pommet, and T. K. Gaylord in “Formulation for stable and efficient implementation of the rigorous coupled-wave analysis of binary gratings,” J. Opt. Soc. Am. A, vol. 12, pp. 1068-1076, May 1995, and by M. G. Moharam, E. B. Grann, D. A. Pommet, and T, K. Gaylord in “Stable implementation of the rigorous coupled-wave analysis of surface-relief gratings: enhanced transmittance matrix approach,” J. Opt. Soc. Am. A, vol. 12, pp. 1068-1076, May 1995.
The results of the calculation are shown in Table 1 in terms of the percentage of fight (diffraction efficiency) diffracted into a given order. As shown, taking an incident ray angle of 4 degrees (@633 nm), the diffraction efficiency was highest around −10 order.
It is also notable that there is a significant split of energy between two diffraction orders. As noted previously, the angular separation of each order is given by m.λ=n.d. sin θ, where m is diffraction order, λ is wavelength of light, n is the surrounding medium refractive index, d is the grating spacing, and θ is the angle of diffraction. This calculation appears to correspond well with laser (532 nm) spot images, as shown in
The diffraction efficiency was also sensitive to the incident angle of the rays hitting the prisms. When the lens is in the capsular bag, the prism surface will be exposed to a range of angles determined by the size of the pupil and the focal length of the lens (i.e. roughly the distance from prism surface to retina). This range of angles will spread the light out over a range of diffraction orders. Also the diffraction angle is very sensitive to wavelength. Therefore, even if the incident polychromatic light were to hit the prism surface at a single angle, the light would be chromatically separated at the retina. This results in a very blurred image on the retina, as shown in
This investigation required several different designs for the prism surface to allow diffraction effects to be compared. The prism lenses were generally compression molded from PMMA, although the high cost of producing mold tools makes this process expensive for test sample volumes. One alternative method for producing linear structures on a lathe is to use a fly-cutter configuration (where the cutting tool is mounted on the lathe spindle and the work piece is attached to the bed).
Diffraction at the prism surface will produce multiple output beams. In the ideal case with zero diffraction efficiency there would only be a single output beam, and this beam would be deviated from the input beam by an angle determined by the prism angles and refractive indices of the optic and surrounding medium. As diffraction efficiency increases, there will be noticeable additional beams either side of the central non-diffracted beam and increasing amounts of energy will be present in the additional beams, as diffraction efficiency continues to increase.
In order to investigate the behaviour of the Fresnel prism surface, a relatively simple model was adopted to simulate interference effects, in which the array of prism elements was modelled as a set of discrete spherical wave emitters, or point sources, each located at the centre of each prism face. This model does not incorporate diffraction theory but was been chosen as a simple and fast test model to investigate the effect of randomising the prism spacing on constructive interference of the point sources.
Using a design of Fresnel prism array with uniform prism size and spacing as a starting point, and placing a point source emitter at the centre of each prism face, we have 8 mm optic diameter and 0.04 mm prism depth with 38 degree prism face angle. This gives a prism spacing of 0.051 mm, calculated from 0.04/arctan(38°). This corresponds to about 118 prisms across the optic, calculated from 6 mm/0.051 mm. Therefore, the initial simulations were performed for a wavelength of 546 nm using 100 emitters in air, and spaced at 51 microns. The calculated angular intensity profile at some distance from the source plane is shown in
As can be seen in
Now, recalculating the interference profile of
A periodic and randomised structure with surface profile similar to
The next step was to have a high-quality prism surface machined in PMMA using a fly-cutter arrangement. The manufacturing was a two-stage process. First the curved lens surface was machined, and the medical grade PMMA part was re-blocked (in a standard wax filled insert). The second side was then profiled to leave a raised central diameter into which the prism structure could be machined. The PMMA parts, still held in the blanks were then transferred for prism machining.
As the earlier prism lenses were compression moulded, two lens designs were machined from PMMA using a fly-cutter arrangement. One design comprised regular prism spacing; as with the compression moulded lenses. This was produced to allow a comparison between the two different manufacturing processes and to ensure the machined regular spacing prism lens exhibited the same optical effects as the tested moulded lenses. The second design incorporated a randomised prism spacing, with spacing varying by an amount of 51 μm+(0 μm to 50 μm), i.e. the prism spacing ΔX varied in the range 51 μm≦ΔX≦101 μm. Tables 2A and 2B list the actual prism spacing Xn used for prisms X1 to X100 in the array. The spacing and resulting interference pattern side-lobe intensities were then calculated using the model simulation.
Due to the degrees of freedom available for automated adjustment on the lathe/fly-cutter, the depth of the cut remained constant. Therefore, as the prism spacing varied so the prism height varied. That is to say, the base of each prism was located at the same height, and so the apex heights varied with pitch. An example of the resulting Fresnel prism lens is illustrated in
Once again, the lenses were tested using the optical bench arrangement described with reference to
The simulation was then run repeatedly whilst monitoring the interference for both the entire surface and just the central 3 mm diameter. An additional important point is that the number of prisms (emitters) is tuned for the model, such that the total distance covered by the prisms matches that of the area of the optic onto which they will be machined. This ensured that the central 3 mm of the model matches the ‘real lens’ central 3 mm.
In
From the work described above, and as might be expected, the observed diffraction effect was lower for the larger prisms with larger associated randomised spacing. Therefore, in order to improve the performance of the Fresnel prism IOL of the present invention, the next step was to investigate a 21 D prism lens design with a 130 micron prism pitch and up to 130 microns of pitch randomisation. The exact prism pitch used for adjacent prisms X1-X40 is given in Tables 3A-3D. Furthermore, in this improved design, a toric lens (−5.5 D) was also placed just in front of the prism lens to provide for additional correction and remove the effect of the additional focusing power that is introduced by the prism surface operating in a converging beam. The −5.5 D was aligned to act in the same plane as the prism deviation. For the final IOL, the toric surface would be included in the IOL optic, such that the front surface will be 21 D parallel to prism rulings and 15.5 D perpendicular to prism rulings.
As is apparent, whilst the image quality produced by the randomised Fresnel prism array IOL with toric anterior surface may not be quite as good as produced by a conventional spherical lens, it is far superior to the regularly-spaced Fresnel prism array IOL. Moreover, as can be seen by comparing to
Thus, as has been demonstrated, in an IOL according to the present invention with randomised prism spacing, the image quality is greatly improved, as compared to the known Fresnel prism IOL design. When a toric lens or lens surface is added, the image quality is improved further, and the astigmatic aberration almost eliminated. In some designs of a Fresnel prism IOL according to the invention, such toric surface can be supplemented or replaced by suitable variation in the facet angle of the prisms in the array, such that astigmatism that would otherwise be introduced by the prism elements is compensated for.
The improved imaging quality of a Fresnel prism IOL according to the present invention makes such a lens a very promising candidate for the surgical treatment of macular degeneration conditions, including age-related macular degeneration (ARMD). Careful design of the lens should enable a customised lens to be produced for the treatment of a patient with such a condition by enabling the point of image formation to be deviated to a healthy part of the retina, whilst retaining a high quality of image formation at the deviated position.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0920505.5 | Nov 2009 | GB | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/GB10/51944 | 11/23/2010 | WO | 00 | 5/23/2012 |
