CN113693779A - Diffraction type multifocal intraocular lens with targeted light field distribution - Google Patents

Diffraction type multifocal intraocular lens with targeted light field distribution Download PDF

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CN113693779A
CN113693779A CN202110610310.5A CN202110610310A CN113693779A CN 113693779 A CN113693779 A CN 113693779A CN 202110610310 A CN202110610310 A CN 202110610310A CN 113693779 A CN113693779 A CN 113693779A
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light field
intraocular lens
field distribution
phase
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CN113693779B (en
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裴秀娟
赵紫薇
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TIANJIN CENTURY KANGTAI BIO-MEDICAL ENGINEERING CO LTD
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TIANJIN CENTURY KANGTAI BIO-MEDICAL ENGINEERING CO LTD
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    • 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, corneal implants; Implanting instruments specially adapted therefor; 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
    • 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, corneal implants; Implanting instruments specially adapted therefor; 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, corneal implants; Implanting instruments specially adapted therefor; 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
    • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

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Abstract

The invention discloses a diffraction type multifocal intraocular lens with targeted light field distribution, which comprises an optical main body (1), a first supporting loop (2) and a second supporting loop (3), wherein the optical main body is provided with a phase-modulated diffraction structure optical area, so that the targeted distribution of a light field is realized, and an asymmetric and personalized trifocal visual range is generated; meanwhile, the far vision and the middle vision are continuous or the middle vision and the near vision are continuous, even the whole vision is continuous; the far, middle and near three focuses have achromatic capability, and the implanted eye can obtain better predicted white light vision; the structure can improve the utilization rate of light energy; glare is reduced, and visual comfort is improved.

Description

Diffraction type multifocal intraocular lens with targeted light field distribution
Technical Field
The invention relates to the technical field of artificial lenses, in particular to an asymmetric continuous multifocal artificial lens prepared by changing an optical surface diffraction microstructure in an optical area.
Background
Intraocular lenses and corresponding surgical techniques have been developed rapidly over decades, and the lens replacement surgery mode has been transitionally developed from the initial extracapsular cataract extraction with large incision to the current small incision phacoemulsification combined with intraocular lens implantation, with short surgery time, little tissue damage and rapid wound repair.
The treatment of cataract is also developed from traditional vision recovery surgery to more challenging refractive surgery, and the eyes of the patient need to be visible, clear and good. Thus promoting the continued development of intraocular lenses, from monofocal intraocular lenses to multifocal intraocular lenses. Monofocal intraocular lenses are the most commonly used lenses for cataract surgery, having only a fixed, clear focus, and are commonly used for distance vision. Therefore, most patients need the help of corrective glasses to complete the eye using activities at short distance (20-50 cm right in front of cornea) and middle distance (60-120 cm right in front of cornea). Multifocal intraocular lenses can achieve several independent, good vision in a range by providing multiple foci simultaneously. Studies have shown that multifocal intraocular lenses can provide far vision comparable to single-focus intraocular lenses, but can provide greater freedom of delensing for myopic eyes. Based on the number of foci, multifocal intraocular lenses are most commonly classified as bifocal and trifocal.
Trifocal intraocular lenses provide better intermediate vision than bifocal intraocular lenses, which is a particular advantage. Because of many everyday activities, such as using computers, cell phones, tablets, etc., good intermediate vision of 60 to 80cm is required. Trifocal intraocular lenses perform better than bifocal intraocular lenses, although conventional diffractive structures tend to cause optical interference compared to monofocal intraocular lenses. For the understanding of the middle distance, the kernel-seeing intelligence-seeing people under different eye-using scenes, the conventional trifocal points are all designed symmetrically, the visual middle distance is about 80cm (the straight line distance from the cornea), the visual near distance is about 40cm (the straight line distance from the cornea), and vision breakpoints exist among all visual distances, and the trifocal point design has the limit of slightly breaking through the symmetrical design of the visual distances.
Recently, a new intraocular lens was introduced, namely depth of focus Extension (EDOF). The EDOF intraocular lens utilizes an optical design to elongate a single focal point a distance to provide better intermediate vision than a single focal intraocular lens. However, the EDOF artificial lens lacks near vision, and the trouble of wearing glasses for near vision is avoided. With the progress of science and technology and the development of society, the living style professional demands of the eyes of patients are also changing, and especially the demands on personalized middle and near vision and freedom of lens removal are increasing. Thus, in anticipation of the global demand for multifocal intraocular lenses that will proliferate, related enterprises have reluctant to develop innovative, advanced trifocal intraocular lens products.
Researchers have also devised concepts for accommodating intraocular lenses, such as patents US6178878 and US 10721155. All of these accommodating intraocular lens designs use mechanical structures to achieve displacement of the intraocular lens in the human eye to achieve zooming. The complicated mechanical structure is uncontrollable in human eyes, and the safety needs to be examined; meanwhile, the function of the adjustable artificial lens depends on the biological force of ciliary muscle or zonule tissue, and the effectiveness of most presbyopia losing the adjusting ability is questioned. The products are not proved in domestic markets.
Disclosure of Invention
In view of the above problems in the prior art, the present applicant provides a diffractive multifocal intraocular lens that targets the distribution of the optical field. The optical main body is a diffraction structure with phase modulation, and the phase distribution in adjacent annular zones is 'high-low combination' and is symmetrical about a dividing point. The phase of the high-low combination in each ring band is specially modified on the basis of the phase distribution diagram of the conventional symmetrical triple focus design, and can be chamfered or rounded, or the combination of the chamfered and rounded phases. The chamfer angle ranges from-90 degrees to 90 degrees, and the radius of the chamfer angle ranges from 0mm to 999 mm. The design can realize the targeted distribution of the light field and generate an asymmetric and personalized trifocal visual range; meanwhile, the far vision and the middle vision are continuous or the middle vision and the near vision are continuous, even the whole vision is continuous; the far, middle and near three focuses have achromatic capability, and the implanted eye can obtain better predicted white light vision; the structure can improve the utilization rate of light energy; glare is reduced, and visual comfort is improved. The technical scheme of the invention is as follows:
a diffractive multifocal intraocular lens with a targeted light field distribution, the intraocular lens comprising an optical body (1), a first haptic (2) and a second haptic (3), the optical body (1) having a targeted light field distribution.
The optical main body (1), the first support loop (2) and the second support loop (3) are of an integrated structure, are made of the same material and are integrally formed.
The periphery of the optical main body (1) is provided with a 360-degree right-angle square edge, so that the generation of after cataract is effectively inhibited. The optical main body (1) consists of two optical surfaces which can be spherical surfaces or aspherical surfaces, wherein a diffraction ring-belt structure is superposed on one optical surface; the optical body (1) consists of two optical surfaces, at least one of which is an aspheric surface, which aspheric surface satisfies the following characterization equation:
Figure BDA0003095526280000031
taking the vertex of the optical surface as an origin O, taking the optical axis as a Z axis, establishing an arbitrary space rectangular coordinate system, wherein the X axis and the Y axis of the abscissa axis of the coordinate system are tangent to the optical surface, Z (X) is a curve expression of the aspheric surface on a plane X-Z of a two-dimensional coordinate system, c is the reciprocal of the curvature radius of the basic spherical surface of the aspheric surface, Y is the vertical distance between any point on the curve and the Z axis, A is the vertical distance between any point on the curve and the Z axis, B is the vertical distance between the vertex of the curve and the Z axis, C is the vertical distance between the vertex of the curve and the Z axis2iM and n are integers not less than 1 and n is aspheric high-order coefficient>And m and K are cone coefficients.
The two optical surfaces on the optical body (1) combine to produce a base power.
The optical main body (1) is provided with a diffraction ring zone structure, the diffraction ring zone structure is superposed on any optical surface of the optical main body (1), and the design formula of the diffraction ring zone structure is as follows:
Figure BDA0003095526280000032
Figure BDA0003095526280000033
where phi (r) is a phase function characterizing the diffractive structure, where lambda0Is the design wavelength, i.e., the wavelength at which a phase change of 2 π occurs at each band boundary; n is the refractive index of the lens material; f0When the illumination wavelength λ is equal to λ0A focal length of time; n' is the refractive index of the material surrounding the lens and p is expressed as 2 πInteger number of multiples of maximum phase modulation. The corresponding maximum step height of the surface of the optical surface is given by:
Figure BDA0003095526280000034
the diffraction ring belt structure on the optical main body (1) generates additional focal power, and the step height range is 4.9-5.1 um.
The diameter of an effective optical area of the optical main body (1) is 5.5-6.5 mm, and the central thickness of the lens is 0.45-1.55 mm; the thicknesses of the first support loop (2) and the second support loop (3) are 0.15-0.45 mm.
The range of the additional focal power of the optical body (1) is +1.0D to + 6.0D.
The diffractive multifocal intraocular lens with targeted light field distribution is characterized in that the optical body (1) generates an asymmetric/symmetric, personalized trifocal visual range:
Figure BDA0003095526280000041
the optical main body (1) is provided with a diffraction ring-shaped structure, the diffraction order of the diffraction ring-shaped structure is-1 order, 0 order, +1 order, +2 order or more, wherein the 0 order does not participate in imaging, all imaging focuses have achromatic capability, and the optical main body can be implanted into eyes to obtain better predicted white light vision;
the optical main body (1) is provided with a diffraction annular structure, and the diffraction annular structure adopts a phase modulation technology: the phase distribution in adjacent zones is 'high-low combination' and is symmetrical about the dividing point. The distribution of the targeted light field is realized, the utilization rate of light energy is improved, glare is reduced, and the visual comfort level is improved.
The preparation method of the diffraction type multifocal intraocular lens with the targeted light field distribution comprises the following design and preparation steps:
1. the personalized eye using requirements, namely the eye using distances L0 (corresponding to far vision), L1 (corresponding to middle vision) and L2 (corresponding to near vision) of the patient are determined. Generally, L0 is about 4m, L1 is in the range of 60-120 cm, and L2 is in the range of 20-50 cm;
2. reversely deducing the personalized additional optical power, and reversely deducing the optical parameters of the additional optical power, namely the additional optical power ADD1 (corresponding to the middle focal point L1) and the additional optical power ADD2 (corresponding to the near focal point L2) according to the requirements of the step 1;
3. determining diffraction orders, wherein the total number n of the diffraction orders is ADD2/0.8+1, and n is a positive integer. Taking 0.8D as the minimum additional power unit, when n is a positive integer even number, all diffraction orders are-n/2 +1 … -2, -1, 0, 1, 2 … n/2, the order corresponding to the far focus L0 is-n/2 +1, the order corresponding to the middle focus is n/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is n/2; when n is a positive integer odd number, all diffraction orders are- (n-1)/2 … -2, -1, 0, 1, 2 … (n-1)/2, the order corresponding to the far focus L0 is (n-1)/2, the order corresponding to the middle focus is (n-1)/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is (n-1)/2, 4.
4. In the ZEMAX optical design software, Binary2 Binary surfaces are used for replacing approximate diffraction zone structures, and according to the additional power position in the step 3, the image quality is optimized to obtain the optimal phase coefficient, and then the phi (r) expression is obtained.
5. And obtaining a phase distribution diagram of the conventional 'symmetrical' triple focus design according to the phi (r) expression.
6. The key to the "asymmetric" trifocal design is phase modulation, the "high-low combination" of phase distributions in adjacent zones and symmetry about the dividing point. The phase of the high-low combination in each ring band is specially modified on the basis of the phase distribution diagram of the conventional symmetrical triple focus design, and can be chamfered or rounded, or the combination of the chamfered and rounded phases. The chamfer angle ranges from-90 degrees to 90 degrees, and the radius of the chamfer angle ranges from 0mm to 999 mm.
7. Determining the step height, diffraction efficiency and surface profile. The profile of the surface is the final processing surface. The lathing track is consistent with the surface profile.
8. Lathe, milling machine, polishing processing. The hydrophobic acrylate base for processing is obtained by adopting a mould pressing mode and has a biconvex structure, wherein the periphery of the rear surface (the optical surface close to the capsular bag after being implanted) is provided with a 360-degree right-angle square edge, so that the generation of the after-cataract is effectively inhibited. For hydrophobic acrylates, the material reaches the glassy state at low temperatures, and the diffractive zone structure is machined on the front surface of the wafer (the optical surface near the cornea after implantation) using optical cold working methods and diamond single point machining techniques.
9. Optically detecting, measuring the defocusing MTF curve in an ISO simulated eye/Model eye2, respectively testing white light and 546nm monochromatic light, and ensuring that the MTF @50lp/mm between a far focus and a middle focus is greater than 0.09, or the MTF @50lp/mm between a middle focus and a near focus is greater than 0.09, or the MTFs @50lp/mm between every two focuses are greater than 0.09 in the ISO simulated eye at 546 nm. And meanwhile, the position of the imaging focus is ensured to meet the setting requirements in the steps 1 and 2.
10. And judging that if the map in the step 9 does not meet the design requirement, returning to the step 6, and modulating the phase again until the requirement in the step 9 is met, thus completing the design.
The beneficial technical effects of the invention are as follows:
the optical main body of the invention is provided with a diffraction structure optical area with phase modulation, realizes the target distribution of an optical field and generates an asymmetric and personalized trifocal visual range.
The optical main body of the invention is provided with a diffraction structure optical area with phase modulation, and the following conclusion is obtained by combining the technical design scheme: the smooth phase enables the energy utilization rate of the diffraction order to be larger than 81%, and the influence of glare is reduced; the continuity between the far vision and the middle vision or the continuity between the middle vision and the near vision, even the continuity of the whole vision is realized; the far, middle and near three focuses have achromatic capability, and the implanted eye can obtain better predicted white light vision; the structure can improve the utilization rate of light energy; glare is reduced, and visual comfort is improved.
After the optical main body is imaged, the light energy utilization rate is over 90 percent, and the diffraction loss is reduced. After the artificial lens is implanted, the image quality under natural light is better. Can individualize the middle and near vision visual range according to the eye using requirement of the patient
Drawings
FIG. 1 is a schematic structural view of example 1 of the present invention;
FIG. 2 is a schematic structural diagram of embodiment 2 of the present invention;
FIG. 3 is a schematic structural diagram according to embodiment 3 of the present invention;
FIG. 4 is a conventional trifocal design phase distribution function;
FIG. 5 is a phase distribution function of embodiment 1 of the present invention;
FIG. 6 is a phase distribution function according to embodiment 2 of the present invention;
FIG. 7 is a phase distribution function according to embodiment 3 of the present invention;
FIG. 8 is a distribution diagram of the through focus MTF curve of embodiment 1 of the present invention;
FIG. 9 is a distribution diagram of the through focus MTF curve of embodiment 2 of the present invention;
FIG. 10 is a distribution diagram of the through focus MTF curve of embodiment 3 of the present invention.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings and examples.
Example 1
As shown in fig. 1, a diffractive multifocal intraocular lens with a targeted light field distribution, the intraocular lens comprising an optical body (1), a first haptic (2) and a second haptic (3), the optical body (1) having a targeted light field distribution.
The optical main body (1), the first support loop (2) and the second support loop (3) are of an integrated structure, are made of the same material and are integrally formed.
The periphery of the optical main body (1) is provided with a 360-degree right-angle square edge, so that the generation of after cataract is effectively inhibited. The optical main body (1) consists of two optical surfaces which can be spherical surfaces or aspherical surfaces, wherein a diffraction ring-belt structure is superposed on one optical surface;
the diameter of the effective optical area of the optical main body (1) is 6.0mm, and the central thickness of the effective optical area is 0.80 mm; the thicknesses of the first support loop (2) and the second support loop (3) are both 0.35 mm;
the optical main body 1 is made of hydrophobic polyacrylate with the refractive index of 1.45-1.55 and the dispersion coefficient of 45-55.
The preparation method of the artificial lens comprises the following steps:
1. the personalized eye demand is determined, namely the eye distance L0 of the patient is 4m (corresponding to far vision), L1 of the patient is 60cm (corresponding to middle vision), and L2 of the patient is 40cm (corresponding to near vision).
2. Reversely deducing the individualized additional optical power, namely reversely deducing the additional optical power of the optical parameters, namely the additional optical power ADD1 is 2.22D (corresponding to the middle focus L1) and the additional optical power ADD2 is 3.33 (corresponding to the near focus L2) according to the requirement of the step 1;
3. determining diffraction orders, wherein the total number n of the diffraction orders is ADD2/0.8+1, and n is a positive integer. Taking 0.8D as the minimum additional power unit, when n is a positive integer even number, all diffraction orders are-n/2 +1 … -2, -1, 0, 1, 2 … n/2, the order corresponding to the far focus L0 is-n/2 +1, the order corresponding to the middle focus is n/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is n/2; when n is a positive integer odd number, all diffraction orders are- (n-1)/2 … -2, -1, 0, 1, 2 … (n-1)/2, the order corresponding to the far focus L0 is (n-1)/2, the order corresponding to the middle focus is (n-1)/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is (n-1)/2, 4.
4. In ZEMAX optical design software, Binary2 Binary surfaces are used for replacing approximate diffraction zone structures, and according to the additional power position in the step 3, the image quality is optimized to obtain a phase coefficient, and a phi (r) expression is obtained.
5. According to the phi (r) expression, a phase distribution diagram of a conventional 'symmetrical' triple focus design is obtained, as shown in FIG. 4.
6. The key to the "asymmetric" trifocal design is phase modulation, where the first set of zones is combined as "high + low" and the second set of zones is modulated as "low + high". As in fig. 5, the phase profile of the second set of zones (dashed portions in fig. 5) of the phase profile of the conventional "symmetric" trifocal design is symmetric with respect to radial position.
7. Determining the step height, diffraction efficiency and surface profile.
8. Lathe, milling machine, polishing processing. The hydrophobic acrylate base for processing is obtained by adopting a mould pressing mode and has a biconvex structure, wherein the periphery of the rear surface (the optical surface close to the capsular bag after being implanted) is provided with a 360-degree right-angle square edge, so that the generation of the after-cataract is effectively inhibited. For hydrophobic acrylates, the material reaches the glassy state at low temperatures, and the diffractive zone structure is machined on the front surface of the wafer (the optical surface near the cornea after implantation) using optical cold working methods and diamond single point machining techniques.
9. Optically detecting, measuring the defocusing MTF curve in an ISO simulated eye/Model eye2, respectively testing white light and 546nm monochromatic light, and ensuring that the MTF @50lp/mm between a far focus and a middle focus is greater than 0.09, or the MTF @50lp/mm between a middle focus and a near focus is greater than 0.09, or the MTFs @50lp/mm between every two focuses are greater than 0.09 in the ISO simulated eye at 546 nm. Meanwhile, the position of the imaging focus is ensured to meet the setting requirements in the steps 1 and 2, and the test result is shown in figure 8.
10. And judging that if the map in the step 9 does not meet the design requirement, returning to the step 6, and modulating the phase again until the requirement in the step 9 is met, thus completing the design.
Analysis and discussion of results:
the smoothed phase diffraction structure was further analyzed using scalar diffraction theory, c (r) exp [ j φ (r) ]
And (r) is the complex transmittance function of the diffractive structure, x representing the longitudinal and transverse coordinates in mm.
Figure BDA0003095526280000091
m is the diffraction order, ηmThe diffraction efficiency of each order can be obtained for the diffraction efficiency corresponding to the mth diffraction order, and the total diffraction efficiency is about 89%, which is significantly improved compared with the conventional sawtooth-shaped phase distribution (diffraction efficiency of 81%).
The through focus MTF curves in FIG. 8 were obtained by testing the IOL of example 1 in an eye model as required in ISO11979-2 using optical equipment. As can be seen in the figure, the far focus MTF @50lp/mm is approximately 0.4, the mid focus MTF @50lp/mm is approximately 0.14, and the near focus MTF @50lp/mm is approximately 0.18. The position of the far focus is set to 0D, the position of the middle focus is set to about 2.22D, and the position of the near focus is set to about 3.33D. This is consistent with the original design requirements.
Example 2
As shown in fig. 2, a diffractive multifocal intraocular lens with a targeted light field distribution, comprising an optical body (1), a first haptic (2) and a second haptic (3), the optical body (1) having a targeted light field distribution.
The optical main body (1), the first support loop (2) and the second support loop (3) are of an integrated structure, are made of the same material and are integrally formed.
The periphery of the optical main body (1) is provided with a 360-degree right-angle square edge, so that the generation of after cataract is effectively inhibited. The optical main body (1) consists of two optical surfaces which can be spherical surfaces or aspherical surfaces, wherein a diffraction ring-belt structure is superposed on one optical surface;
the diameter of the effective optical area of the optical main body (1) is 6.0mm, and the central thickness of the effective optical area is 0.80 mm; the thicknesses of the first support loop (2) and the second support loop (3) are both 0.35 mm;
the optical main body 1 is made of hydrophobic polyacrylate with the refractive index of 1.45-1.55 and the dispersion coefficient of 45-55.
The preparation method of the artificial lens comprises the following steps:
1. the personalized eye demand is determined, namely the eye distance L0 of the patient is 4m (corresponding to far vision), L1 of the patient is 35cm (corresponding to middle vision), and L2 of the patient is 25cm (corresponding to near vision).
2. Reversely deducing the individualized additional optical power, namely reversely deducing the additional optical power of the optical parameters, namely the additional optical power ADD1 is 3.81D (corresponding to the middle focus L1) and the additional optical power ADD2 is 5.33 (corresponding to the near focus L2) according to the requirement of the step 1;
3. determining diffraction orders, wherein the total number n of the diffraction orders is ADD2/0.8+1, and n is a positive integer. Taking 0.8D as the minimum additional power unit, when n is a positive integer even number, all diffraction orders are-n/2 +1 … -2, -1, 0, 1, 2 … n/2, the order corresponding to the far focus L0 is-n/2 +1, the order corresponding to the middle focus is n/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is n/2; when n is a positive integer odd number, all diffraction orders are- (n-1)/2 … -2, -1, 0, 1, 2 … (n-1)/2, the order corresponding to the far focus L0 is (n-1)/2, the order corresponding to the middle focus is (n-1)/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is (n-1)/2, 4.
4. In ZEMAX optical design software, Binary2 Binary surfaces are used for replacing approximate diffraction zone structures, and according to the additional power position in the step 3, the image quality is optimized to obtain a phase coefficient, and a phi (r) expression is obtained.
5. According to the phi (r) expression, a phase distribution diagram of a conventional 'symmetrical' triple focus design is obtained, as shown in FIG. 4.
6. The key to the "asymmetric" trifocal design is phase modulation, where the first set of zones is combined as "high + low" and the second set of zones is modulated as "low + high". As shown in fig. 6, the phase of the second group of annuli of the phase profile of the conventional "symmetric" trifocal design is symmetric with respect to the radial position, and the acute angle of the phase structure is rounded with a radius r of 0.5mm on the basis of example 1.
7. Determining the step height, diffraction efficiency and surface profile.
8. Lathe, milling machine, polishing processing. The hydrophobic acrylate base for processing is obtained by adopting a mould pressing mode and has a biconvex structure, wherein the periphery of the rear surface (the optical surface close to the capsular bag after being implanted) is provided with a 360-degree right-angle square edge, so that the generation of the after-cataract is effectively inhibited. For hydrophobic acrylates, the material reaches the glassy state at low temperatures, and the diffractive zone structure is machined on the front surface of the wafer (the optical surface near the cornea after implantation) using optical cold working methods and diamond single point machining techniques.
9. Optically detecting, measuring the defocusing MTF curve in an ISO simulated eye/Model eye2, respectively testing white light and 546nm monochromatic light, and ensuring that the MTF @50lp/mm between a far focus and a middle focus is greater than 0.09, or the MTF @50lp/mm between a middle focus and a near focus is greater than 0.09, or the MTFs @50lp/mm between every two focuses are greater than 0.09 in the ISO simulated eye at 546 nm. Meanwhile, the position of the imaging focus is ensured to meet the setting requirements in the steps 1 and 2, and the test result is shown in figure 9.
10. And judging that if the map in the step 9 does not meet the design requirement, returning to the step 6, and modulating the phase again until the requirement in the step 9 is met, thus completing the design.
Analysis and discussion of results:
the smooth phase diffraction structure is further analyzed using scalar diffraction theory,
c(r)＝exp[jφ(r)]
and (r) is the complex transmittance function of the diffractive structure, x representing the longitudinal and transverse coordinates in mm.
Figure BDA0003095526280000111
m is the diffraction order, ηmThe diffraction efficiency of each order can be obtained for the diffraction efficiency corresponding to the mth diffraction order, and the total diffraction efficiency is about 90%, which is significantly improved compared with the conventional sawtooth-shaped phase distribution (diffraction efficiency of 81%).
The through focus MTF curves in FIG. 9 were obtained by testing the IOL of example 1 in an eye model as required in ISO11979-2 using optical equipment. As can be seen in the figure, the far focus MTF @50lp/mm is approximately 0.35, the mid focus MTF @50lp/mm is approximately 0.15, and the near focus MTF @50lp/mm is approximately 0.15. The position of the far focus is set to 0D, the position of the middle focus is set to about 3.81D, and the position of the near focus is set to about 5.33D. This is consistent with the original design requirements.
Example 3
As shown in fig. 3, a diffractive multifocal intraocular lens with a targeted light field distribution, comprising an optical body (1), a first haptic (2) and a second haptic (3), the optical body (1) having a targeted light field distribution.
The optical main body (1), the first support loop (2) and the second support loop (3) are of an integrated structure, are made of the same material and are integrally formed.
The periphery of the optical main body (1) is provided with a 360-degree right-angle square edge, so that the generation of after cataract is effectively inhibited. The optical main body (1) consists of two optical surfaces which can be spherical surfaces or aspherical surfaces, wherein a diffraction ring-belt structure is superposed on one optical surface;
the diameter of the effective optical area of the optical main body (1) is 6.0mm, and the central thickness of the effective optical area is 0.80 mm; the thicknesses of the first support loop (2) and the second support loop (3) are both 0.35 mm;
the optical main body 1 is made of hydrophobic polyacrylate with the refractive index of 1.45-1.55 and the dispersion coefficient of 45-55.
The preparation method of the artificial lens comprises the following steps:
1. the personalized eye demand is determined, namely the eye distance L0 of the patient is 4m (corresponding to far vision), L1 of the patient is 70cm (corresponding to middle vision), and L2 of the patient is 30cm (corresponding to near vision).
2. Reversely deducing the individualized additional optical power, namely reversely deducing the additional optical power of the optical parameters, namely the additional optical power ADD1 is 1.90D (corresponding to the middle focus L1) and the additional optical power ADD2 is 4.44 (corresponding to the near focus L2) according to the requirement of the step 1;
3. determining diffraction orders, wherein the total number n of the diffraction orders is ADD2/0.8+1, and n is a positive integer. Taking 0.8D as the minimum additional power unit, when n is a positive integer even number, all diffraction orders are-n/2 +1 … -2, -1, 0, 1, 2 … n/2, the order corresponding to the far focus L0 is-n/2 +1, the order corresponding to the middle focus is n/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is n/2; when n is a positive integer odd number, all diffraction orders are- (n-1)/2 … -2, -1, 0, 1, 2 … (n-1)/2, the order corresponding to the far focus L0 is (n-1)/2, the order corresponding to the middle focus is (n-1)/2- (ADD2-ADD1)/0.8, and the order corresponding to the near focus L2 is (n-1)/2, 4.
4. In ZEMAX optical design software, Binary2 Binary surfaces are used for replacing approximate diffraction zone structures, and according to the additional power position in the step 3, the image quality is optimized to obtain a phase coefficient, and a phi (r) expression is obtained.
5. According to the phi (r) expression, a phase distribution diagram of a conventional 'symmetrical' triple focus design is obtained, as shown in FIG. 4.
6. The key to the "asymmetric" trifocal design is phase modulation, where the first set of zones is combined as "high + low" and the second set of zones is modulated as "low + high". As shown in fig. 7, the phase of the second group of annuli of the phase profile of the conventional "symmetric" trifocal design is symmetric with respect to the radial position, and a combination of rounding with a radius r of 0.5mm and chamfering with an angle of-10 ° is made on the acute angle of the phase structure on the basis of example 2.
7. Determining the step height, diffraction efficiency and surface profile.
8. Lathe, milling machine, polishing processing. The hydrophobic acrylate base for processing is obtained by adopting a mould pressing mode and has a biconvex structure, wherein the periphery of the rear surface (the optical surface close to the capsular bag after being implanted) is provided with a 360-degree right-angle square edge, so that the generation of the after-cataract is effectively inhibited. For hydrophobic acrylates, the material reaches the glassy state at low temperatures, and the diffractive zone structure is machined on the front surface of the wafer (the optical surface near the cornea after implantation) using optical cold working methods and diamond single point machining techniques.
9. Optically detecting, measuring the defocusing MTF curve in an ISO simulated eye/Model eye2, respectively testing white light and 546nm monochromatic light, and ensuring that the MTF @50lp/mm between a far focus and a middle focus is greater than 0.09, or the MTF @50lp/mm between a middle focus and a near focus is greater than 0.09, or the MTFs @50lp/mm between every two focuses are greater than 0.09 in the ISO simulated eye at 546 nm. Meanwhile, the position of the imaging focus is ensured to meet the setting requirements in the steps 1 and 2, and the test result is shown in FIG. 10.
10. And judging that if the map in the step 9 does not meet the design requirement, returning to the step 6, and modulating the phase again until the requirement in the step 9 is met, thus completing the design.
Analysis and discussion of results:
the smooth phase diffraction structure is further analyzed using scalar diffraction theory,
c(r)＝exp[jφ(r)]
and (r) is the complex transmittance function of the diffractive structure, x representing the longitudinal and transverse coordinates in mm.
Figure BDA0003095526280000131
m is the diffraction order, ηmThe diffraction efficiency of each order can be obtained for the diffraction efficiency corresponding to the mth diffraction order, the total diffraction efficiency is about 90 percent, and compared with the traditional sawtooth-shaped phase componentThe cloth (diffraction efficiency 81%) is significantly improved.
The through focus MTF curves in FIG. 10 were obtained by testing the IOL of example 1 in an eye model as required in ISO11979-2 using an optical device. As can be seen in the figure, the far focus MTF @50lp/mm is approximately 0.35, the mid focus MTF @50lp/mm is approximately 0.15, and the near focus MTF @50lp/mm is approximately 0.18. The position of the far focus is set to 0D, the position of the middle focus is set to about 1.90D, and the position of the near focus is set to about 4.44D. This is consistent with the original design requirements.

Claims (10)

1. A diffractive multifocal intraocular lens with a targeted light field distribution, the intraocular lens comprising an optical body (1), a first haptic (2) and a second haptic (3), characterized in that the optical body (1) has a targeted light field distribution.
2. Diffractive multifocal intraocular lens with targeted light field distribution according to claim 1 characterized in that the optical body (1), the first haptics (2) and the second haptics (3) are of unitary construction, of the same material, integrally molded.
3. The diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the periphery of the optical body (1) has a 360 ° square edge, effectively inhibiting the development of secondary cataracts.
4. Diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the optical body (1) consists of two optical surfaces, at least one of which is aspherical, the aspherical surface satisfying the following characterization equation:
Figure FDA0003095526270000011
establishing an arbitrary space rectangular coordinate system by taking the vertex of the optical surface as an origin O and the optical axis as a Z axis, and setting the coordinate system to be horizontalThe X axis of the standard axis and the Y axis of the coordinate axis are tangent to the optical surface, Z (X) is a curve expression of the aspheric surface on a plane X-Z of a two-dimensional coordinate system, c is the reciprocal of the curvature radius of the basic spherical surface of the aspheric surface, Y is the vertical distance between any point on the curve and the Z axis of the coordinate axis, A2iM and n are integers not less than 1 and n is aspheric high-order coefficient>m and K are cone coefficients,
the two optical surfaces on the optical body (1) combine to produce a base power.
5. Diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the optical body (1) has a diffractive annular structure superimposed on any of the optical faces of the optical body (1), the design formula of the diffractive annular structure being:
Figure FDA0003095526270000012
Figure FDA0003095526270000013
where phi (r) is a phase function characterizing the diffractive structure, where lambda0Is the design wavelength, i.e., the wavelength at which a phase change of 2 π occurs at each band boundary; n is the refractive index of the lens material; f0When the illumination wavelength λ is equal to λ0A focal length of time; n' is the refractive index of the material surrounding the lens and p is an integer representing the maximum phase modulation as a multiple of 2 pi, the corresponding maximum step height of the surface of the optical surface being given by:
Figure FDA0003095526270000021
the diffraction ring belt structure on the optical main body (1) generates additional focal power, and the step height range is 4.5-5.5 um.
6. The diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized by a lenticular/meniscus lens sheet with a diameter of the effective optical zone of the optical body (1) of 5.5 to 6.5mm, a central thickness of 0.45 to 1.55 mm; the thicknesses of the first support loop (2) and the second support loop (3) are 0.15-0.45 mm.
7. The diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the additional optical power of the optical body (1) ranges from +1.0D to + 6.0D.
8. The diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the optical body (1) produces an asymmetric/symmetric, personalized trifocal visual range:
Figure FDA0003095526270000022
Figure FDA0003095526270000031
9. the diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the optical body (1) has a diffractive annular structure with diffraction orders of-1, 0, +1, +2 or more, wherein 0 does not participate in imaging, so that all foci have achromatic power and the implanted eye can obtain better predicted white vision.
10. Diffractive multifocal intraocular lens with targeted light field distribution according to claim 1, characterized in that the optical body (1) has a diffractive annular structure employing a phase modulation technique: the phase distribution 'high-low combination' in the adjacent annular zones is symmetrical about a dividing point, the phase of the 'high-low combination' in each annular zone is specially corrected on the basis of a phase distribution diagram designed by a conventional 'symmetrical' triple focus, and the phase can be chamfered or rounded, or the combination of the phase distribution diagram and the conventional 'symmetrical' triple focus, the chamfer range is-90 degrees, and the radius range of the rounding is 0-999 mm, so that the light energy utilization rate is improved, the glare is reduced, and the visual comfort level is improved while the targeted light field distribution is realized.
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