Plasma diffraction type variable-focus optical surface intraocular lens and preparation method and application thereof

Abstract

The invention discloses a plasma diffraction type variable-focus optical surface intraocular lens and a preparation method and application thereof, and belongs to the technical field of ophthalmic medical instruments. The crystalline lens comprises a rear surface plasma diffraction optical layer, a front surface slow-release nanogel layer, a base material and supporting loops. The rear surface layer realizes zooming and light intensity modulation through a radial asymmetric electromagnetic field gradient and an axial photochromic refractive index; the front surface layer is an embedded long-acting slow-release nanogel organic medium film layer formed by crosslinking drug particles and macromolecules, and light waves of an organic medium cover 200-450 nm ultraviolet and blue light wave bands. The base material is made of biocompatible materials, the supporting loops are C-shaped loops and the like, and the size of the supporting loops is 6-12 mm and can be adjusted. During preparation, all the functional layers are prepared firstly, and then the functional layers are replicated to the base material through integrated nanoimprint. The crystalline lens can be implanted into a posterior atrial sac, a ciliary sulcus or an anterior chamber and other parts, has the functions of zooming, light regulation and control, ultraviolet prevention and drug sustained release, and is remarkable in clinical value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of ophthalmic medical devices, in particular to a plasma diffraction type variable focus optical surface intraocular lens and a preparation method and application thereof. BACKGROUND

[0002] Cataract and its related complications are the main causes of blindness worldwide, and the implementation of intraocular lens (IOL) replacement is one of the core measures for visual function recovery in the current cataract treatment. The traditional intraocular lens mainly plays a role in refractive correction, but has the following problems: it cannot realize automatic adjustment of light intensity self-adaptation, and is easy to cause postoperative glare phenomenon; the ultraviolet protection effect is poor, and the existing intraocular lens material can only block part of the ultraviolet band, and cannot completely prevent the damage of harmful wave band to the macular area; it lacks the function of drug release, and the control of postoperative inflammation and the supplement of nutrition rely on external drug intervention, which requires patients to take long-term local eye drops, and cannot simultaneously solve the problems of postoperative ultraviolet protection and prevention of macular degeneration.

[0003] Cataract combined with albinism, trauma or nerve damage causes the loss of pupil regulation function due to the atrophy or structural damage of iris tissue, resulting in the scattering of incident light and the distortion of optical imaging system, thereby causing long-term low-quality vision. There is no feasible iris regeneration method for this type of cataract in clinical practice, and the current artificial iris is mainly fixed by sewing it to the residual iris root or the ciliary sulcus through sewing. Due to the need for fine sewing and knotting operation in the relatively closed space of the eye, the operation is more difficult than other types of cataract and is not stable after operation, so most patients with iris damage cannot receive individualized and effective treatment. In recent years, the use of plasma materials as structural units to construct optical microstructures with subwavelength scale has provided us with a new idea for designing dynamic optical elements; at the same time, some new biodegradable nanogels have been used by more and more researchers to develop various functional coatings due to their excellent slow-release performance and good biocompatibility.

[0004] Therefore, it is of great clinical significance to develop an intraocular lens with variable focus, dynamic light intensity modulation and multifunctional slow-release function on this basis, which can solve the problems of refractive range variable focus, adaptation to large optical area of lens capsule bag, iris dynamic spectrum regulation and other problems that the current intraocular lens urgently needs to solve. SUMMARY

[0005] The purpose of the present application is to provide a plasma diffraction type variable focus optical surface intraocular lens and a preparation method and application thereof, so as to solve the problems in the background art.

[0006] To achieve the above-mentioned object, the present invention provides a plasma diffraction type variable focus optical surface intraocular lens, comprising a rear surface plasma diffraction optical layer, a front surface sustained-release nanogel layer, an intraocular lens substrate, and a support haptic structure;

[0007] Among them, the rear surface plasma diffraction optical layer is a bidirectionally modulated diffraction optical layer, the radial modulation is an asymmetric electromagnetic field gradient distribution, and the axial modulation is a photochromic refractive index modulation; the front surface sustained-release nanogel layer is an embedded long-acting sustained-release nanogel organic medium film layer formed by cross-linking reaction of sustained-release drug particles and high molecular polymers.

[0008] Preferably, the sustained-release drug particles are one of lutein particles, dexamethasone particles, and vitamin E.

[0009] Preferably, the high molecular polymer is one or more of chitosan, hyaluronic acid, collagen, polylactic acid-co-glycolic acid PLGA, polyvinyl alcohol PVA, polyethylene glycol PEG, chitosan-PLGA complex, hyaluronic acid-nanosilver composite gel, poloxamer, and polyacrylic acid derivatives.

[0010] Preferably, the light wave filtering range of the organic medium covers the ultraviolet band 200-400nm and the high-energy blue light band 400-450nm.

[0011] Preferably, the intraocular lens substrate is one of polymethyl methacrylate, hydrophobic polyacrylate, hydrophilic polyacrylate and silicone gel.

[0012] Preferably, the support loop structure is a composite loop design adapted to the physiological curvature of the human eye capsule, and is one of a C-shaped loop, a plate-shaped loop, or a three / four-loop type; the material of the support loop is hydrophobic polyacrylate or silicone gel.

[0013] Preferably, the size of the intraocular lens is 6mm-12mm.

[0014] The present invention also provides a method for preparing the above-mentioned plasma diffraction type variable focus optical surface intraocular lens, comprising the following steps:

[0015] (1) preparing a rear surface plasma diffraction optical layer by electron beam lithography, ultraviolet lithography, plasma etching, nanoimprinting or magnetron sputtering deposition;

[0016] (2) preparing the front surface sustained-release nanogel layer by solvent evaporation, emulsification-solidification, spray drying, or electrospinning;

[0017] (3) The rear surface plasma diffraction optical layer, the front surface sustained-release nanogel layer and the support loop structure are replicated onto the intraocular lens substrate using an integrated nanoimprint integral molding technology to produce an intraocular lens; wherein, the rear surface plasma diffraction optical layer is replicated onto the intraocular lens substrate to form an ultra-large optical zone, and the front surface sustained-release nanogel layer is replicated onto the intraocular lens substrate to form a front surface optical zone.

[0018] The present invention also provides the use of the above-mentioned plasma diffraction type variable-focus optical surface intraocular lens implanted in the posterior chamber capsule, ciliary sulcus or anterior chamber.

[0019] Therefore, the present invention provides a plasma diffraction type variable focus optical surface intraocular lens and its preparation method and application, and the specific beneficial effects are as follows:

[0020] (1) The intraocular lens prepared by the present invention has variable focus, dynamic light intensity modulation and multifunctional sustained release functions;

[0021] (2) The present invention uses integrated nanoimprinting integral molding technology to replicate the rear surface plasma diffraction optical layer on the rear surface of the artificial lens substrate to form an ultra-large optical zone, and replicate the front surface long-acting sustained-release nanogel layer on the front surface of the artificial lens substrate to form a front surface optical zone, thereby achieving the functions of variable focus within the refractive range, dynamic light intensity control, ultraviolet light blocking, sustained drug release, and adaptation to the ultra-large optical zone of the lens capsular bag. Specifically, for variable focus within the refractive range, the wavelength and polarization state of the incident light trigger the localized surface plasmon resonance of the plasma material, forming an adaptive diffraction order energy distribution and achieving dynamic multi-focal switching. For dynamic light intensity control, the photochromic effect of the photochromic material coated on the surface of the plasma material causes changes in the refractive index of the photochromic material due to changes in external light intensity, resulting in a gradient refractive index change in the film, enabling dynamic adjustment of the transmitted light intensity ratio. For UV light blocking and sustained drug release, the device prepares a sustained-release cross-linked nanogel, which is impermeable to wavelengths between 200 and 450 nm, effectively preventing UV rays and preventing macular degeneration. The sustained-release drug particles cross-link the gel to form nanobubbles, which are absorbed by the eye through an organic medium for lifelong sustained release. To accommodate the ultra-large optical zone of the lens capsular bag, the device uses integrated nanoimprint molding technology to match the lens capsular bag size over a wide range, achieving anti-eccentricity and preventing capsular bag shrinkage.

[0022] Based on this, the present invention has developed an intraocular lens with adaptive optics, dynamic spectral regulation and multifunctional sustained-release function that has important clinical significance.

[0023] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Schematic diagram of the overall structure of the plasma diffraction type variable focus optical surface intraocular lens produced by the present invention, wherein (a) is a front view; (b) is a side view;

[0025] Figure 2 Schematic diagram of the structure of the plasma diffraction optical layer of the present invention;

[0026] Figure 3 Schematic diagram of the plasma micro-nano structure of the present invention;

[0027] Figure 4 Schematic diagram of the coating layer particles of the present invention with a sustained-release nanogel layer on the front surface;

[0028] Figure 5 Schematic diagram of the self-focusing of the plasma diffraction optical layer of the present invention;

[0029] Reference numerals:

[0030] 1. Ultra-large optical zone; 2. Support loop structure; 3. Front surface sustained-release nanogel layer; 4. Back surface plasma diffraction optical layer; 5. Photochromic material layer; 6. Plasma micro-nanostructure layer. DETAILED DESCRIPTION

[0031] The present invention provides a plasma diffraction type variable focus optical surface intraocular lens such as Figure 1 As shown, the device comprises a rear surface plasmon diffraction optical layer 4, an anterior surface sustained-release nanogel layer 3, an intraocular lens substrate, and a support haptic structure 2 (C-shaped haptics). The rear surface plasmon diffraction optical layer is replicated onto the intraocular lens substrate to form the ultra-large optical zone 1, while the anterior surface sustained-release nanogel layer is replicated onto the intraocular lens substrate to form the anterior surface optical zone. Both the anterior and posterior surfaces utilize a gradient aspheric curvature to offset corneal positive spherical aberration, reducing glare and improving contrast sensitivity.

[0032] Among them, such as Figure 2As shown, the rear surface plasma diffraction optical layer is a bidirectional modulation diffraction optical layer, and its structure includes two key components: the lower plasma micro-nanostructure layer 5 realizes radial asymmetric electromagnetic field gradient distribution, which is the core carrier of variable focus and multi-focus switching, and the upper photochromic material layer 6 realizes axial photochromic refractive index modulation, which is responsible for dynamic light intensity control. Specifically, the rear surface plasma diffraction optical layer is a variable focus diffraction optical surface with variable focus and dynamic light intensity control functions. The variable focus diffraction optical surface is a plasma structure with localized surface plasma resonance effect; its radial modulation is an asymmetric electromagnetic field gradient distribution. Under the condition of external natural light incidence, the wavelength and polarization state of the incident light trigger the localized surface plasma resonance of the plasma material, forming an adaptive diffraction order energy distribution, and realizing multi-focus dynamic switching; the axial modulation is photochromic refractive index modulation, and the plasma micro-nanostructure is as shown. Figure 3 As shown, the surface of the material is wrapped with a photochromic layer. Changes in external light intensity cause changes in the refractive index of the photochromic material, resulting in a gradient refractive index change in the film, thereby achieving dynamic adjustment of the transmitted light intensity ratio, as shown in FIG. Figure 5 The front surface sustained-release nanogel layer is an embedded, long-lasting, sustained-release nanogel organic medium film layer formed by a cross-linking reaction between sustained-release drug particles and a high molecular weight polymer. The sustained-release drug particles are continuously released through the microbubble wall, maintaining lifelong photoprotection for the human macular region. The organic medium's light wave filtering range covers the ultraviolet band of 200-400nm and the high-energy blue light band of 400-450nm, meaning it is impermeable to wavelengths between 200-450nm. This reduces the risk of macular degeneration by blocking ultraviolet radiation and effectively mitigates damage caused by ultraviolet radiation.

[0033] In the present invention, the sustained-release drug particles are one of lutein particles, dexamethasone particles or vitamin E particles, and their main effects include but are not limited to anti-inflammatory, nutritional and other effects.

[0034] In the present invention, the polymers include natural polymers such as chitosan, hyaluronic acid, and collagen; synthetic polymers such as polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA), and polyethylene glycol (PEG); composite functional materials such as chitosan-PLGA complexes and hyaluronic acid-nanosilver composite gels; and intelligent responsive materials such as temperature-sensitive gels such as poloxamers and pH-sensitive gels such as polyacrylic acid derivatives. Encapsulation techniques include, but are not limited to, solvent evaporation, emulsification-solidification, spray drying, and electrospinning. Post-encapsulation treatment methods for removing impurities include, but are not limited to, filtration, centrifugation, and washing.

[0035] In the present invention, the intraocular lens substrate is one of materials selected from the group consisting of polymethyl methacrylate, hydrophobic polyacrylate, hydrophilic polyacrylate and silicone gel.

[0036] In the present application, the support haptic structure is a composite haptic design matching the physiological curvature of the human lens capsule bag, which is one of C-shaped haptic, plate-shaped haptic or three / four haptic; the material of the support haptic is hydrophobic polyacrylate or silicone gel type material, and the elastic modulus matches the biomechanical properties of the lens capsule bag tissue.

[0037] In the present application, the size of the artificial lens prepared is adjustable from 6mm to 12mm, which is suitable for the size of different lens capsule bags.

[0038] The present application also provides a preparation method of the above-mentioned plasma diffraction type variable focus optical surface artificial lens, which comprises the following steps:

[0039] (1) preparing a back surface plasma diffraction optical layer by electron beam lithography, ultraviolet lithography, plasma etching, nanoimprint or magnetron sputtering deposition method;

[0040] (2) preparing a front surface slow-release nanogel layer by solvent evaporation method, emulsification-curing method, spray drying method or electrospinning method;

[0041] (3) integrally molding the back surface plasma diffraction optical layer, the front surface slow-release nanogel layer and the support haptic structure to the artificial lens substrate by an integrated nanoimprint molding technology to obtain the artificial lens; wherein the back surface plasma diffraction optical layer is molded on the artificial lens substrate to form a super large optical area, which can match the size of the lens capsule bag in a large range, obtain the anti-eccentric effect and prevent the capsule bag from shrinking, and the front surface slow-release nanogel layer is molded on the artificial lens substrate to form a front surface optical area.

[0042] The present application also provides the application of the above-mentioned plasma diffraction type variable focus optical surface artificial lens in the posterior chamber capsule bag, ciliary sulcus or anterior chamber implantation, the curvature of the support haptic structure dynamically matches the contraction post physiological morphology of the targeted implantation site, and the elastic modulus matches the biomechanical properties of the targeted tissue.

[0043] The technical solutions of the present application are further described below by means of the accompanying drawings and examples. It should be understood that these examples are only used to illustrate the present application and are not used to limit the scope of the present application, and any changes, modifications, substitutions, combinations, simplifications made without deviating from the spirit and principles of the present application are equivalent replacement methods, which are all included in the protection scope of the present application. In addition, it should be understood that after reading the content of the present application, those skilled in the art can make various modifications or modifications to the present application, and these equivalent forms also fall within the scope defined by the appended claims of the present application, and all belong to the protection scope of the present application.

[0044] References to "embodiments" herein mean that the specific features, structures, or characteristics described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the word "embodiment" in various places in the specification does not necessarily refer to the same embodiment, nor does it particularly limit its independence or relevance to other embodiments. In principle, in this application, as long as there are no technical contradictions or conflicts, the various technical features mentioned in the embodiments can be combined in any manner to form a corresponding implementable technical solution.

[0045] Unless otherwise defined, the technical terms used herein have the same meanings as those generally understood by those skilled in the art to which this application belongs; the use of relevant terms herein is only for describing specific embodiments and is not intended to limit this application.

[0046] Unless otherwise specified in the present invention, the reagents, instruments, equipment and performance testing methods used are those commonly used by those skilled in the art.

[0047] Example 1

[0048] This embodiment provides a method for preparing a plasma diffraction type variable focus optical surface intraocular lens, which specifically includes the following steps:

[0049] (1) A silicon substrate is used as the base material. After cleaning, a silicon oxide etching mask layer (thickness 200nm) is deposited, followed by spin coating of electron beam resist and electron beam lithography to define the nanostructure pattern; the resist in the exposed area is removed by developer, and the pattern is transferred to the silicon oxide mask layer by reactive ion etching; the silicon substrate is then vertically etched by deep reactive ion etching to form a cylindrical plasma nanopillar array structure with a depth of 200nm and a period of 100-200nm; after removing the residual silicon oxide mask layer, a gold layer is deposited on the surface of the nanopillar and the base by magnetron sputtering to form a gold nanopillar plasma array, thereby obtaining a rear surface plasma diffraction optical layer.

[0050] By adjusting the mask pattern design and etching parameters, the nanopillar diameter, spacer layer thickness, and array period can be precisely controlled. This process is suitable for the mass production of dynamic focusing of intraocular lenses, biosensors, and metasurface optical devices.

[0051] (2) Chitosan-PLGA complex (mass ratio 1:3) and 15wt% poloxamer 407 were selected as polymer matrix materials, and dexamethasone nanocrystals with a particle size of 150nm were embedded using the emulsification-solidification method; PLGA was dissolved in dichloromethane (10% w / v), then mixed with chitosan acetic acid solution (2% w / v), and after adding drug crystals, it was homogenized at 12000rpm for 5 minutes to form a W / O emulsion; it was slowly dripped into petroleum ether containing 1% Span 80 for solidification, and after centrifugation, the microparticles were collected and cross-linked with 0.1% glutaraldehyde solution at 25℃ for 12 hours; finally, it was washed three times with deionized water (centrifugal speed 8000rpm, 10 minutes) to remove free drugs and solvent residues to obtain the front surface sustained-release nanogel layer.

[0052] This process achieves temperature / enzyme dual-responsive release function by regulating the chitosan-PLGA ratio (1:1 to 1:5) and the poloxamer content.

[0053] (3) The rear surface plasma diffraction optical layer, the front surface sustained-release nanogel layer and the C-shaped loop structure are replicated on polymethyl methacrylate using an integrated nanoimprint integral molding technology to produce an intraocular lens; wherein, the rear surface plasma diffraction optical layer is replicated on the intraocular lens substrate to form an ultra-large optical zone, and the front surface sustained-release nanogel layer is replicated on the intraocular lens substrate to form a front surface optical zone.

[0054] like Figure 1 As shown, the intraocular lens produced in this embodiment features a plasma diffractive optical surface as its core functional layer. Electron beam lithography is used to construct a periodic plasmonic nanopillar array on the rear surface of the intraocular lens, combined with integrated nanoimprint molding technology. This enables the manufacture of an ultra-large optical zone intraocular lens with a diameter of 6-12 mm, accommodating the anatomical size requirement of a lens capsular bag of 9.0-10.5 mm. The key technical processes involve the fabrication of the rear surface plasma diffractive optical surface and the preparation of the sustained-release nanogel layer on the front surface.

[0055] Example 2

[0056] This embodiment provides a method for preparing a plasma diffraction type variable focus optical surface intraocular lens, which specifically includes the following steps:

[0057] (1) A silicon substrate after ultrasonic cleaning was selected, and a negative SU-8 photoresist was spin-coated to a thickness of 5 μm. The substrate was then pre-baked at 95°C and exposed through a UV mask (period 2 μm, line width 500 nm) (wavelength 365 nm; propylene glycol methyl ether acetate was used for development). After 2 minutes, a CF4 / O2 mixed gas (gas flow rate 20 / 5 sccm) was used for plasma-enhanced etching at a power of 150 W to prepare a nanopillar array with a depth of 200 nm. Subsequently, a 100 nm thick gold layer was deposited by magnetron sputtering technology to obtain a surface plasmon resonance nanostructure, namely a rear surface plasmon diffraction optical layer.

[0058] By adjusting the mask pattern and the ratio of etching gas, the diameter and array density of the nanocolumns can be controlled. This method is compatible with the mass production process of ultraviolet lithography and complements electron beam lithography technology.

[0059] (2) A degradable polylactic acid-glycolic acid copolymer (PLGA) having an intrinsic viscosity in the range of 0.2-0.3 dL / g and a molar ratio of lactic acid to glycolic acid of 75:25 was synthesized, accurately weighed with a precision electronic balance, and dissolved in dichloromethane with a purity of not less than 99.5% to prepare a solution with a mass concentration of 10%. At the same time, the dexamethasone concentration was accurately controlled to 5 mg / mL by high performance liquid chromatography, and then its aqueous solution was prepared; then, a KQ-500DE type numerically controlled ultrasonic cleaner was used to drop the dexamethasone aqueous solution into the dichloromethane solution of PLGA at a drop rate of 0.5 mL / min, and it was emulsified at an ultrasonic power of 100 W for 5 minutes to form an oil-in-water (W / O) emulsion. The average particle size of the water droplets in the emulsion was detected by a laser particle size analyzer in the range of 100-150 nm. ; Then, a solution with a mass concentration of 2% was prepared, and a polyvinyl alcohol (PVA) aqueous solution with a degree of polymerization in the range of 1750±50 was used as a stabilizer. The W / O type emulsion was added dropwise at a speed of 1 mL / min using a peristaltic pump. At the same time, the stirring speed was 500 r / min for 30 minutes to allow the dichloromethane to evaporate, thereby obtaining nano-scale PLGA microspheres with a particle size distribution between 200 and 300 nm. The drug was encapsulated inside the microspheres; finally, a glutaraldehyde aqueous solution with a mass concentration of 0.5% and a purity of ≥25% was prepared as a cross-linking agent, and the nano-scale PLGA microspheres were dispersed inside. The pH value was adjusted to 7.0 with the help of a pH meter, and the reaction was carried out in a constant temperature shaker at 37°C for 2 hours. The aldehyde group of glutaraldehyde reacted with the hydroxyl group on the surface of the PLGA microspheres to undergo a cross-linking reaction. The Fourier transform infrared spectrometer was used to confirm that the 1730 cm -1 The characteristic absorption peak of ester carbonyl appears at the bottom, and the front surface sustained-release nanogel layer is obtained after the cross-linking reaction is completed.

[0060] Then the dynamic light scattering instrument was used to detect the cross-linked nanogel coating particles. Figure 4 The average particle size shown is between 300-400 nm, with good dispersion stability. In vitro drug release experiments have shown that under an environment simulating human physiological conditions, the cumulative release rate of dexamethasone is 40%-50%, which can inhibit postoperative inflammatory reactions.

[0061] (3) The rear surface plasma diffraction optical layer, the front surface sustained-release nanogel layer and the C-shaped loop structure are replicated on polymethyl methacrylate using an integrated nanoimprint integral molding technology to produce an intraocular lens; wherein, the rear surface plasma diffraction optical layer is replicated on the intraocular lens substrate to form an ultra-large optical zone, and the front surface sustained-release nanogel layer is replicated on the intraocular lens substrate to form a front surface optical zone.

[0062] The intraocular lens produced in this example utilizes a plasma diffractive optical surface as its core functional layer, combined with integrated nanoimprint lithography technology to achieve the production of an ultra-large optic zone intraocular lens with a diameter of 6-12 mm, accommodating the anatomical capsular size of 9.0-10.5 mm. The key technical processes involve the fabrication of the plasma diffractive optical surface on the rear surface and the preparation of the sustained-release nanogel layer on the front surface.

[0063] Therefore, the present invention realizes multi-focal adaptive switching triggered by the wavelength / polarization of incident light through a plasma diffraction optical plane, breaking through the problems of fixed focusing function and glare of traditional intraocular lenses (IOLs); combined with the 200-450nm full-band UV-blue light filtering of the nanogel layer and the lifelong sustained-release function of sustained-release drug particles, it simultaneously provides light protection and anti-inflammatory treatment; adopts an ultra-large optical zone (6-12mm) and a biocompatible support loop design to match the shape of the capsular bag after contraction, avoiding the risks of suture surgery, and providing a universal solution for complex cases such as iris defects.

[0064] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit the same. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that they can still modify or replace the technical solutions of the present invention with equivalents, and these modifications or equivalent replacements cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A plasma diffraction type variable focus optical surface intraocular lens, characterized by: It includes a rear surface plasma diffraction optical layer, a front surface sustained-release nanogel layer, an intraocular lens substrate, and a support haptic structure; Among them, the rear surface plasma diffraction optical layer is a bidirectionally modulated diffraction optical layer, the radial modulation is an asymmetric electromagnetic field gradient distribution, and the axial modulation is a photochromic refractive index modulation; the front surface sustained-release nanogel layer is an embedded long-acting sustained-release nanogel organic medium film layer formed by cross-linking reaction of sustained-release drug particles and high molecular polymers.

2. The plasma diffraction variable focus optical surface intraocular lens according to claim 1, characterized in that: The sustained-release drug particles are one of lutein particles, dexamethasone particles, and vitamin E particles.

3. The plasma diffraction variable focus optical surface intraocular lens according to claim 1, characterized in that: The high molecular polymer is one or more of chitosan, hyaluronic acid, collagen, polylactic acid-glycolic acid copolymer PLGA, polyvinyl alcohol PVA, polyethylene glycol PEG, chitosan-PLGA complex, hyaluronic acid-nanosilver composite gel, poloxamer, and polyacrylic acid derivatives.

4. The plasma diffraction type variable focus optical surface intraocular lens according to claim 1, characterized in that: The light wave filtering range of the organic medium covers the ultraviolet band 200-400nm and the high-energy blue light band 400-450nm.

5. The plasma diffraction type variable focus optical surface intraocular lens according to claim 1, characterized in that: The intraocular lens substrate is one of polymethyl methacrylate, hydrophobic polyacrylate, hydrophilic polyacrylate and silicone gel.

6. The plasma diffraction type variable focus optical surface intraocular lens according to claim 1, characterized in that: The support loop structure is one of a C-shaped loop, a plate-shaped loop or a three / four-loop type; the material of the support loop is hydrophobic polyacrylate or silicone gel.

7. The plasma diffraction type variable focus optical surface intraocular lens according to claim 1, characterized in that: The sizes of intraocular lenses range from 6mm to 12mm.

8. The method for preparing a plasma diffraction type variable focus optical surface intraocular lens according to any one of claims 1 to 7, characterized in that: The following steps are involved: (1) preparing a rear surface plasma diffraction optical layer by electron beam lithography, ultraviolet lithography, plasma etching, nanoimprinting or magnetron sputtering deposition; (2) preparing the front surface sustained-release nanogel layer by solvent evaporation, emulsification-solidification, spray drying, or electrospinning; (3) The rear surface plasma diffraction optical layer, the front surface sustained-release nanogel layer and the support loop structure are replicated onto the intraocular lens substrate using an integrated nanoimprint integral molding technology to produce an intraocular lens; wherein, the rear surface plasma diffraction optical layer is replicated onto the intraocular lens substrate to form an ultra-large optical zone, and the front surface sustained-release nanogel layer is replicated onto the intraocular lens substrate to form a front surface optical zone.

9. Use of a plasma diffraction type variable focus optical surface intraocular lens according to any one of claims 1 to 7, characterized in that: IOLs are implanted in the posterior chamber capsular bag, ciliary sulcus, or anterior chamber.

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