Ultraviolet blocking type corneal contact lens for regional crosslinking and preparation method thereof

Abstract

The invention belongs to the technical field of corneal contact lenses, and provides an ultraviolet blocking type corneal contact lens for regional crosslinking and a preparation method of the ultraviolet blocking type corneal contact lens. The ultraviolet blocking type corneal contact lens comprises a substrate layer, a functional pattern layer and an outer surface layer which are sequentially stacked, the functional pattern layer comprises a blocking area and a light-transmitting area, the light-transmitting area allows ultraviolet light to accurately irradiate a target area so as to induce cross-linking strengthening, and the blocking area shields the ultraviolet light. According to the corneal contact lens, the shapes and position distribution of the light-transmitting area and the blocking area in the functional pattern layer are designed in a personalized mode, selective personalized corneal cross-linking of a local lesion area can be achieved, a non-treatment area is protected against excessive irradiation, and the risk of excessive cross-linking of the cornea is reduced. A safe and controllable technical scheme is provided for regionalized precise treatment of the cornea.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of contact lens technology, and particularly relates to an ultraviolet blocking type contact lens for regional cross-linking and a preparation method thereof. BACKGROUND

[0002] Conventional corneal cross-linking (CXL) is a treatment method that combines ultraviolet light irradiation with riboflavin solution to enhance the cross-linking of the corneal stroma. This technology was initially used to treat corneal ectatic diseases (such as keratoconus and infectious keratitis (such as corneal ulcer), and achieved remarkable results in improving the biomechanical strength of the cornea. The specific process is to irradiate ultraviolet light (UVA) onto the surface of the cornea while applying the photosensitizer riboflavin, and to excite the chemical reaction between riboflavin and the corneal stroma by ultraviolet light irradiation, thereby enhancing the cross-linking degree of the corneal stroma and improving the biomechanical strength and shape of the cornea. However, the traditional corneal cross-linking method has some limitations, and the existing technology usually adopts a uniform full corneal irradiation method, which cannot achieve spatial selective control of ultraviolet light irradiation, is prone to cause excessive cross-linking in non-diseased areas, affects the optical quality and biological safety of the cornea, and also makes it difficult to achieve precise strengthening irradiation in local areas. SUMMARY

[0003] Therefore, the present application aims to provide an ultraviolet blocking type contact lens for regional cross-linking and a preparation method thereof, to solve the bottleneck problem that the traditional corneal cross-linking technology cannot achieve personalized and regional treatment. The contact lens provided by the present application innovatively sets a functional pattern layer, and by accurately designing the distribution shape and position of the light transmission area and the blocking area in the functional pattern layer, selective transmission and shielding of ultraviolet light on the corneal surface can be achieved, thereby achieving regional directional irradiation and cross-linking strengthening of the cornea in corneal cross-linking treatment, and effectively protecting healthy areas from excessive irradiation. The outstanding advantage is that the pattern can be completely personalized according to the patient's corneal lesion characteristics, such as the cone top position and range of keratoconus, the axis of astigmatism, and the lesion morphology of corneal ulcer, through computer-aided design (CAD) according to the requirements. The present application provides a safe and controllable new technical path for precise and regional corneal treatment.

[0004] In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions: The present application provides an ultraviolet blocking type contact lens for regional cross-linking, comprising a substrate layer, a functional pattern layer and an outer surface layer which are sequentially stacked. The functional pattern layer comprises a blocking area and a light transmission area. The ultraviolet light transmittance of the blocking area is ≤10%. The ultraviolet light transmittance of the light transmission area is ≥90%.

[0005] Preferably, the thickness of the substrate layer is 30~200μm.

[0006] Preferably, the ultraviolet light transmittance of the substrate layer is ≥90%; The substrate layer is made of one or more of poly(2-hydroxyethyl methacrylate), hydroxyethyl methacrylate, and polydimethylsiloxane.

[0007] Preferably, the thickness of the functional pattern layer is 5~30μm.

[0008] Preferably, the material of the barrier region includes inorganic materials and / or benzophenone-based ultraviolet-absorbing polymers; the inorganic materials include titanium dioxide and / or zinc oxide; the benzophenone-based ultraviolet-absorbing polymers include one or more of 2,4-dihydroxybenzophenone, 2-hydroxy-4-methoxybenzophenone, and 2,2'-dihydroxy-4,4'-dimethoxybenzophenone.

[0009] Preferably, the thickness of the outer layer is 1~20μm.

[0010] Preferably, the ultraviolet light transmittance of the outer layer is ≥90%, and the material of the outer layer includes one or more of polyhydroxyethyl methacrylate, hydroxyethyl methacrylate, polyvinyl alcohol, polyethylene glycol, sodium polyacrylate, sodium hyaluronate, polysiloxane, polymethyl methacrylate, and polyethylene glycol diacrylate.

[0011] The present invention also provides a method for preparing the ultraviolet-blocking corneal contact lens for regional crosslinking as described in the above technical solution, comprising the following steps: A functional patterned layer and an outer surface layer are sequentially prepared on the base layer and integrally molded to obtain the ultraviolet-blocking corneal contact lens for regional crosslinking.

[0012] Preferably, the method for preparing the functional pattern layer is inkjet printing, screen printing, in-mold transfer printing, or piezoelectric inkjet printing.

[0013] Preferably, the substrate layer is prepared by molding, injection molding, or 3D printing; the outer surface layer is prepared by spraying, dip coating, spin coating, plasma-assisted spraying, plasma-assisted dip coating, or plasma-assisted spin coating.

[0014] This invention provides an ultraviolet-blocking corneal contact lens for regional crosslinking.

[0015] The corneal contact lens provided by this invention features a functional pattern layer. This layer is customized with transparent and blocking zones according to actual needs. The transparent zones allow ultraviolet light to pass through and irradiate the cornea, achieving regional cross-linking and improving the aspheric morphology of the cornea, thus treating refractive errors and corneal diseases. The blocking zones prevent ultraviolet light from irradiating non-treatment areas, reducing the risk of excessive corneal cross-linking. The functional pattern layer in this invention's ultraviolet-blocking contact lens for regional cross-linking can be customized according to the characteristics of corneal lesions. For localized disease areas (such as the convex areas of keratoconus or localized areas of infectious corneal ulcers), it achieves precise guidance of ultraviolet light, avoiding excessive or insufficient cross-linking and improving treatment efficacy. By precisely designing the distribution shape and position of the transparent and blocking zones in the functional pattern layer, this invention achieves selective transmission and shielding of ultraviolet light on the corneal surface. This allows for regional directional irradiation and enhanced cross-linking of the cornea during corneal cross-linking treatment, while effectively protecting healthy areas from excessive irradiation. This invention provides a safe and controllable new technical approach for precise and regionalized corneal treatment. Attached Figure Description

[0016] Figure 1 A schematic diagram of the structure of the ultraviolet-blocking corneal contact lens for regional cross-linking provided by the present invention; Figure 2 The working principle of the ultraviolet-blocking corneal contact lens for regional cross-linking provided by the present invention. Detailed Implementation

[0017] Figure 1 This is a schematic diagram of the structure of the ultraviolet-blocking corneal contact lens for regional crosslinking provided by the present invention. The following is in conjunction with... Figure 1 The structure of the ultraviolet-blocking contact lens for regional crosslinking provided by the present invention is described in detail.

[0018] The present invention provides an ultraviolet-blocking corneal contact lens for regional cross-linking, comprising a base layer, a functional pattern layer and an outer surface layer stacked sequentially. The functional pattern layer includes a barrier area and a light-transmitting area; The ultraviolet light transmittance of the barrier region is ≤10%; The ultraviolet light transmittance of the light-transmitting area is ≥90%.

[0019] Unless otherwise specified, the raw materials used in this invention are preferably commercially available products.

[0020] The corneal contact lens provided by this invention includes a base layer. In this invention, the thickness of the base layer is preferably 30-200 μm, more preferably 55-65 μm, and specifically preferably 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, or 200 μm; the diameter is preferably 12-15 mm, and specifically preferably 12 mm, 13 mm, 14 mm, or 15 mm. In this invention, the ultraviolet (UVA) transmittance of the substrate layer is preferably ≥90%, more preferably ≥95%, and specifically preferably 90%, 91%, 92%, 93%, 94%, 95%, 96%, 96.2%, 96.8%, 97%, 98%, 99%, or 99.5%, wherein the wavelength of the ultraviolet light is 315~400nm. In this invention, the material of the substrate layer is preferably one or more of poly(2-hydroxyethyl methacrylate) (pHEMA), hydroxyethyl methacrylate (HEMA), and polydimethylsiloxane (PDMS). In this invention, the substrate layer has good biocompatibility, optical transparency, and high oxygen and ultraviolet transmittance.

[0021] The corneal contact lens provided by the present invention includes a functional pattern layer stacked on the base layer. The thickness of the functional pattern layer is preferably 5~30μm, and more specifically 5μm, 10μm, 15μm, 20μm, 25μm or 30μm. In this invention, the functional pattern layer includes a blocking region and a light-transmitting region; the ultraviolet (UVA) transmittance of the blocking region is ≤10%, preferably ≤5%, more preferably ≤1%, and specifically preferably 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.4%, 0.35%, 0.33%, 0.3%, 0.25%, 0.23%, 0.2%, 0.15%, 0.1%, or 0.05%; the ultraviolet (UVA) transmittance of the light-transmitting region is ≥90%, preferably ≥95%, and specifically preferably 90%, 91%, 92%, 93%, 94%, 95%, 96%, 96.2%, 96.8%, 97%, 98%, 99%, or 99.5%. In this invention, the wavelength of the ultraviolet light is preferably 315~400nm. In this invention, the material of the blocking region preferably includes inorganic materials and / or benzophenone-based ultraviolet absorbing polymers, and more preferably inorganic materials. In this invention, the inorganic material preferably includes titanium dioxide (TiO2) and / or zinc oxide (ZnO). In this invention, the benzophenone-based ultraviolet-absorbing polymer preferably includes one or more of 2,4-dihydroxybenzophenone, 2-hydroxy-4-methoxybenzophenone, and 2,2'-dihydroxy-4,4'-dimethoxybenzophenone (UV-214). In this invention, the inorganic material and / or benzophenone-based ultraviolet-absorbing polymer in the blocking region can absorb ultraviolet light, effectively preventing ultraviolet light transmission; and the inorganic material and / or benzophenone-based ultraviolet-absorbing polymer will not cause excessive stimulation to the cornea during long-term wear. In this invention, the shape and strength of the blocking region are preferably adjusted according to the actual corneal morphology and refractive power requirements.

[0022] In this invention, the material of the light-transmitting region preferably includes one or more of poly(2-hydroxyethyl methacrylate) (pHEMA), hydroxyethyl methacrylate (HEMA), and polydimethylsiloxane (PDMS). In this invention, the material of the light-transmitting region is consistent with or compatible with the material of the substrate layer to ensure good optical continuity, interfacial adhesion, and biocompatibility between the functional pattern layer and the substrate layer. The material of the light-transmitting region of this invention has good optical transparency (UVA transmittance ≥90%), appropriate mechanical flexibility, and oxygen permeability, ensuring effective transmission of ultraviolet light in the 315~400nm wavelength range without significant scattering or absorption.

[0023] In this invention, when the material of the substrate layer is preferably polydimethylsiloxane (PDMS), the material of the light-transmitting area is preferably polydimethylsiloxane (PDMS); the substrate layer and the light-transmitting layer are made of the same or compatible materials, which further improves the flexibility and interfacial adhesion of the overall structure.

[0024] In this invention, when the substrate layer is preferably made of hydroxyethyl methacrylate (HEMA) or polydimethylsiloxane (PDMS), the light-transmitting area is also preferably made of hydroxyethyl methacrylate (HEMA) or polydimethylsiloxane (PDMS). In this invention, the substrate layer and the light-transmitting area are constructed using the same monomer or its prepolymer through in-situ polymerization, ensuring chemical bonding between the coatings.

[0025] In this invention, the material of the light-transmitting area does not contain ultraviolet-absorbing functional groups, allowing for sufficient ultraviolet light transmission for therapeutic irradiation while maintaining optical clarity at the boundary with the blocking area, avoiding halo or boundary effects. Furthermore, the material of the light-transmitting area exhibits good swelling properties, hydrogel characteristics, and biocompatibility, meeting the requirements for long-term wear and adaptation to the corneal physiological environment. In this invention, the pattern accuracy boundary error of the functional pattern layer is preferably ≤±20μm; the pattern accuracy boundary error of the functional pattern layer is ≤±20μm to ensure accurate ultraviolet light irradiation of the target area. This invention does not specifically limit the shape of the light-transmitting and blocking areas in the functional pattern layer; those skilled in the art can customize them according to actual needs. In this invention, the ratio, shape, and size of the blocking and transparent areas in the functional pattern layer are preferably customized using computer-aided design (CAD).

[0026] In this invention, the light-transmitting area allows ultraviolet light to pass through and irradiate the corneal surface, while the blocking area blocks ultraviolet light. The combination of the light-transmitting area and the ultraviolet blocking area constitutes a personalized ultraviolet energy distribution pattern, which is used to guide ultraviolet energy to form a preset irradiation area on the corneal surface.

[0027] In this invention, the configuration of the barrier and transparent areas in the functional pattern layer ensures that ultraviolet light irradiates specific areas (transparent areas) of the cornea without affecting the corneal structure of other areas (barrier areas), thereby achieving regional cross-linking and improving the aspheric morphology of the cornea, thus achieving the effect of treating refractive errors and corneal diseases; at the same time, it reduces the potential damage to healthy areas (barrier areas) caused by ultraviolet radiation.

[0028] The corneal contact lens provided by this invention includes an outer surface layer stacked on the functional pattern layer. In this invention, the thickness of the outer surface layer is preferably 1-20 μm, more preferably 4.5-5.5 μm, and specifically preferably 1 μm, 5 μm, 6 μm, 10 μm, 15 μm, or 20 μm. In this invention, the ultraviolet (UVA) transmittance of the outer surface layer is preferably ≥90%, more preferably ≥95%, and specifically preferably 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 97.9%, 98%, 98.3%, 99%, or 99.5%; the wavelength of the ultraviolet light is preferably 315-400 nm. In this invention, the material of the outer layer preferably includes one or more of polyhydroxyethyl methacrylate (pHEMA), hydroxyethyl methacrylate (HEMA), polyvinyl alcohol (PVA), polyethylene glycol (PEG), sodium polyacrylate (PAAS), sodium hyaluronate (SH), polysiloxane, polymethyl methacrylate (PMMA), and polyethylene glycol diacrylate (PEGDA); the polysiloxane is preferably polydimethylsiloxane (PDMS). In this invention, the outer layer is a transparent protective coating with high optical transmittance and good biocompatibility.

[0029] In this invention, the ultraviolet-blocking contact lens for regional crosslinking is preferably customized according to the refractive state of the patient's cornea, corneal curvature, thickness, and the specific condition of the lesion area to ensure regional ultraviolet irradiation.

[0030] In this invention, the periphery of the UV-blocking contact lens for regional crosslinking is preferably provided with an axis identification mark, which is used for precise alignment of the contact lens with the corneal axis during wearing or treatment. In this invention, the axis identification mark is preferably located at the edge of the non-optical zone, preferably at the 6 o'clock or 12 o'clock position on the periphery of the UV-blocking contact lens for regional crosslinking. In this invention, the axis identification mark is preferably a concave dot, a laser-etched mark, or a small stained dot.

[0031] Figure 2 The working principle of the ultraviolet-blocking corneal contact lens for regional cross-linking provided by the present invention is as follows: ultraviolet light passes through the light-transmitting area in the functional pattern layer and irradiates a specific area to achieve regional cross-linking; the setting of the blocking area in the functional pattern layer can block ultraviolet light from irradiating non-treatment areas, thereby reducing the risk of excessive corneal cross-linking.

[0032] The present invention also provides a method for preparing the ultraviolet-blocking corneal contact lens for regional crosslinking as described in the above technical solution, comprising the following steps: A functional patterned layer and an outer surface layer are sequentially prepared on the base layer and integrally molded to obtain the ultraviolet-blocking corneal contact lens for regional crosslinking.

[0033] In this invention, the base coating used to prepare the base layer preferably comprises the following components by weight percentage: 8-40% polymer and 60-92% solvent. The polymer preferably comprises one or more of polyhydroxyethyl methacrylate (pHEMA), hydroxyethyl methacrylate (HEMA), or polydimethylsiloxane (PDMS). The solvent preferably comprises one or more of dipropylene glycol methyl ether (DPM), propylene glycol methyl ether acetate (PMA), and propylene glycol phenyl ether (PPH). In one specific embodiment of this invention, the base coating is preferably a pHEMA prepolymer, specifically Contamac Optimum™, catalog number CM-H38. In this invention, the base coating exhibits excellent flexibility and adaptability, ensuring that the contact lens can closely conform to patients with different corneal shapes, avoiding pressure or displacement of the cornea by the contact lens. In this invention, the base layer is preferably prepared by molding, injection molding, or 3D printing, more preferably by molding. In one specific embodiment of the present invention, the mold used for molding is preferably made of optical-grade stainless steel or quartz glass; the use of optical-grade stainless steel or quartz glass in the mold ensures the surface forming accuracy of the corneal contact lens. In the present invention, the surface roughness Ra of the mold is preferably less than or equal to 0.1 ≤ 0.1 μm. In the present invention, the radius of curvature of the mold is preferably 7.0~9.0 mm. In one specific embodiment of the present invention, the molding preparation of the base layer preferably includes the following steps: injecting the base coating into the mold and pre-curing it. In the present invention, during the injection process, the thickness of the lower mold is preferably 55~65 μm. In the present invention, the pre-curing temperature is preferably 60~70℃, more preferably 65℃; the pressure is preferably 0.9~1.1 MPa, more preferably 1 MPa; and the time is preferably 2~4 min, more preferably 3 min. In the present invention, the pre-curing enables the base coating to form a semi-cured state, possessing a certain supporting force to support the functional pattern layer.

[0034] In this invention, the barrier coating in the barrier region of the functional pattern layer preferably comprises the following components by mass percentage: 20-30% inorganic materials and / or benzophenone-based UV-absorbing polymers, with the balance being a carrier. Specifically, the mass percentage of inorganic materials and / or benzophenone-based UV-absorbing polymers in the barrier coating is preferably 20%, 25%, or 30%. The particle size of the inorganic materials is preferably 20-40 nm, specifically preferably 30 nm. The carrier preferably comprises a silica gel carrier, specifically preferably NuSil MED-6640. The viscosity of the barrier coating is preferably 10-15 cP (25°C), more preferably 10-14 cP (25°C).

[0035] In this invention, the light-transmitting coating in the light-transmitting area of ​​the functional pattern layer preferably comprises the following components by weight percentage: 8-40 wt% polymer and 60-92 wt% solvent. In this invention, the polymer preferably comprises one or more of polyhydroxyethyl methacrylate (pHEMA), hydroxyethyl methacrylate (HEMA), and polydimethylsiloxane (PDMS). In this invention, the solvent preferably comprises one or more of ethylene glycol butyl ether, propylene glycol phenyl ether (PPH), and tetrahydrofuranol (THFA). In one specific embodiment of this invention, the base coating is preferably a pHEMA prepolymer, and the pHEMA prepolymer is preferably Contamac Optimum™, product number CM-H38.

[0036] In this invention, the method for preparing the functional patterned layer is preferably inkjet printing, screen printing, in-mold transfer, or piezoelectric inkjet printing, and more preferably piezoelectric inkjet printing. In a specific embodiment of this invention, the preparation of the functional patterned layer using piezoelectric inkjet printing preferably includes the following steps: using a barrier coating as raw material, based on the distribution of barrier and light-transmitting areas, spraying using piezoelectric inkjet printing, and then curing. In this invention, the curing method is preferably a first curing or a second curing. In this invention, the first curing is preferably NIR instantaneous curing, the light source for the NIR instantaneous curing is preferably a laser, the wavelength of the laser is preferably 808 nm, the intensity of the laser is preferably 2~4 W / cm², more preferably 3 W / cm²; the time of the NIR instantaneous curing is preferably 0.6~1 s, more preferably 0.8 s. In this invention, the temperature of the second curing is preferably 60~70℃, more preferably 65℃; the pressure is preferably 0.9~1.1 MPa, more preferably 1 MPa; and the time is preferably 2~4 min, more preferably 3 min.

[0037] In this invention, the surface coating used to prepare the outer surface layer preferably comprises the following components by mass percentage: 4-6% polymer, with the balance being solvent. Specifically, the mass percentage of the polymer in the surface coating is preferably 5%. The polymer preferably comprises one or more of polyhydroxyethyl methacrylate (pHEMA), hydroxyethyl methacrylate (HEMA), polyvinyl alcohol (PVA), polyethylene glycol (PEG), sodium polyacrylate (PAAS), sodium hyaluronate (SH), polysiloxane, polymethyl methacrylate (PMMA), and polyethylene glycol diacrylate (PEGDA), wherein the polysiloxane is preferably polydimethylsiloxane (PDMS). The solvent preferably comprises one or more of dipropylene glycol dimethyl ether (DPDM), γ-butyrolactone (GBL), and propylene glycol methyl ether acetate (PMA). The method for preparing the outer surface layer is preferably spraying, dip coating, spin coating, plasma-assisted spraying, plasma-assisted dip coating, or plasma-assisted spin coating, and more preferably spin coating. In this invention, the spin coating speed is preferably 3000-4000 rpm, more preferably 3500 rpm; the time is preferably 20-40 s, more preferably 30 s. In this invention, the preparation of the outer surface layer by spin coating preferably includes the following steps: spin coating the outer surface layer coating and then performing ultraviolet curing. In this invention, the wavelength of the ultraviolet light used for ultraviolet curing is preferably 405 nm, the intensity of the ultraviolet light is preferably 40-60 mW / cm², more preferably 50 mW / cm², and the ultraviolet curing time is preferably 8-12 s, more preferably 10 s. In this invention, the ultraviolet curing is preferably carried out under a nitrogen atmosphere.

[0038] In this invention, the integral molding preferably includes sequential vacuum lamination and hot-press curing. In this invention, the vacuum lamination pressure is preferably 0.05~0.15 Pa, more preferably 0.1 Pa. In this invention, the hot-press curing temperature is preferably 60~70℃, more preferably 65℃; the pressure is preferably 2~4 MPa, more preferably 3 MPa; and the time is preferably 4~6 min, more preferably 5 min.

[0039] After the overall molding is completed, the present invention preferably further includes the fabrication of axis identification marks and post-processing to obtain the corneal contact lens.

[0040] In this invention, the method for preparing the axis identification mark preferably includes the following steps: A recess is created and stained to form the axis identification mark.

[0041] In this invention, the method of creating the recess is preferably laser etching or mold forming, and more preferably laser etching. In this invention, the laser used for laser etching is preferably a 355nm ultraviolet pulsed laser, and the pulse width of the laser is preferably 10ns. In this invention, the scanning time of the laser etching is preferably less than 0.1s; controlling the scanning time of the laser etching to less than 0.1s ensures that the risk of thermal deformation of the corneal contact lens is controllable.

[0042] In this invention, the diameter of the recess is preferably 0.1~0.3 mm, specifically preferably 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm or 0.3 mm; the depth is preferably 3~5 μm, more preferably 4 μm.

[0043] In this invention, the dyeing method is preferably inkjet printing or dye dotting. The dye used in this invention preferably conforms to medical-grade dyeing material standards.

[0044] After creating the axis identification mark, the present invention preferably further includes cleaning and sterilization. The present invention does not specifically limit the cleaning and sterilization operations; operations well known to those skilled in the art can be used.

[0045] In this invention, the axis identification mark is made stably, visually visible, and does not interfere with the wearing and treatment functions.

[0046] In this invention, the post-processing preferably includes sequential edge polishing, cleaning, and sterilization. The edge polishing method is preferably CNC precision carving, with a precision of ±10 μm. The cleaning reagent is preferably water, preferably ultrapure water; the cleaning is preferably performed under ultrasonic conditions, with a frequency of 30-50 kHz, more preferably 40 kHz; the cleaning time is preferably 5-15 min, more preferably 10 min. The sterilization gas is preferably ethylene oxide gas; the sterilization temperature is preferably 50-60℃, more preferably 55℃; the humidity is preferably 50-70%, more preferably 60%; and the time is preferably 3-5 h, more preferably 4 h.

[0047] The present invention also provides a method for using the ultraviolet-blocking contact lens for regional crosslinking as described in the above technical solution, comprising the following steps: After adding riboflavin, the patient wears the UV-blocking contact lens for regional crosslinking and is then exposed to ultraviolet light.

[0048] In this invention, the riboflavin is preferably used in the form of riboflavin eye drops. In this invention, the mass concentration of riboflavin in the riboflavin eye drops is preferably 0.1%. This invention does not specifically limit the other components and composition of the riboflavin eye drops; eye drop components well known to those skilled in the art can be used.

[0049] In this invention, the wavelength of the ultraviolet light is preferably 365 nm, and the intensity is preferably 5~20 mW / cm², specifically preferably 9 mW / cm² or 18 mW / cm². In this invention, the irradiation time is preferably 5~10 min, specifically preferably 5 min or 10 min.

[0050] In this invention, the ultraviolet light irradiation can pass through the light-transmitting area in the functional pattern layer. The cornea corresponding to the light-transmitting area undergoes a cross-linking reaction under the irradiation of riboflavin and ultraviolet light to improve corneal morphology and refractive power, and ultimately promote the reshaping of the aspheric morphology of the cornea.

[0051] After ultraviolet light irradiation, the present invention preferably further includes removing the ultraviolet-blocking contact lens used for regional cross-linking and instilling antibiotics and artificial tears. The present invention does not specifically limit the type and amount of antibiotics, or the type and amount of artificial tears.

[0052] The following detailed description, in conjunction with embodiments, of the ultraviolet-blocking corneal contact lens for regional crosslinking provided by the present invention and its preparation method, should not be construed as limiting the scope of protection of the present invention.

[0053] Example 1 The preparation method of a regionally cross-linked ultraviolet-blocking corneal contact lens includes the following steps: Step 1: Mold Preparation Mold curvature radius: 7.0~9.0mm (adapted to corneal K-value); Surface roughness: Ra≤0.1μm (ISO 1302); The mold is made of optical-grade stainless steel or quartz glass to ensure the surface forming precision of the corneal contact lens.

[0054] Step 2: Preparation of the base layer Base coating: pHEMA prepolymer (Contamac Optimum™, part number CM-H38); Injection mold thickness: 60±5μm; Pre-curing: Hot pressing at 65℃ for 3 minutes (pressure 1MPa) → forming a semi-cured state with a certain mechanical support to support the construction of the intermediate functional pattern layer; the ultraviolet light (UVA) transmittance of the formed base layer is 96.5±0.3%.

[0055] Step 3: Construction of the functional pattern layer The design of the blocking and translucent areas in the functional pattern layer can be customized according to the patient's condition. For example, for people with astigmatism, a translucent area can be designed at the astigmatic axis to specifically enhance the correction of astigmatism. Alternatively, the area can be selected according to the need to strengthen the cross-linking of the cone apex region in keratoconus, or other situations can be personalized to generate the pattern design of the translucent and blocking areas (e.g.) Figure 2 The barrier layer pattern is designed based on the treatment zone boundary (red curve) identified by corneal topography and corneal curvature thermography. The functional patterned layer is prepared by piezoelectric inkjet printing (Fujifilm Dimatix DMP-2850), in which the barrier coating is deposited on the surface of the substrate layer according to the preset pattern, and the substrate layer area without coating is naturally formed as the light-transmitting area. Formulation of the barrier coating: UV absorber: 25wt% rutile TiO2 (Alfa Aesar, 30nm), balance silica gel carrier (NuSil MED-6640); viscosity of the barrier coating: 12±2cP (25℃); curing: NIR instantaneous curing (808nm laser, 3W / cm²×0.8s); UVA transmittance of the barrier area formed after curing: 0.28±0.05%; The light-transmitting area is directly formed from the surface of the unprinted substrate layer (pHEMA prepolymer); no additional filler material is required, and its optical properties are consistent with those of the substrate layer; UVA transmittance: 96.5±0.3%; Then, a second curing process is performed (65℃ / 1MPa / 2min) to ensure a stable bond between the barrier zone and the base layer (i.e., the light-transmitting zone).

[0056] Step 4: Preparation of the outer surface layer The outer coating is a 5wt% PEGDA solution (solvent is dipropylene glycol dimethyl ether); The preparation method is as follows: spin coating (3500 rpm × 30 s); UV curing in a nitrogen atmosphere (405 nm, 50 mW / cm² × 10 s); thickness: 5.0 ± 0.5 μm; the UVA transmittance of the outer surface layer formed after curing is 98.1 ± 0.2%.

[0057] Step 5: Overall molding Parameters: Vacuum lamination (0.1Pa) + hot pressing curing (65℃ / 3MPa / 5min).

[0058] Step 6: Creating Axial Marks To achieve precise alignment between the lens and the cornea, this embodiment features axis identification marks on the lens edge, preferably located at the 6 o'clock and 12 o'clock positions. These marks are fabricated using laser etching, with the specific steps as follows: Use a 355nm ultraviolet pulsed laser (pulse width 10ns). After the lens is formed, it is positioned using a CCD-assisted alignment platform; Two micro-dimples, approximately 150 μm in diameter and 4 μm in depth, were etched in the non-optical area at the edge. The laser scanning time for each marker point is less than 0.1 seconds, ensuring that the risk of thermal deformation of the lens is controllable; After laser processing, the lens is cleaned and sterilized, resulting in stable and visually visible markings that do not interfere with wearing or treatment functions.

[0059] Step 6: Post-processing Edge polishing: CNC precision carving (accuracy ±10μm); Cleaning: Ultrapure water + ultrasonic (40kHz, 10min); Sterilization: Ethylene oxide gas (55℃, 60% humidity, 4h).

[0060] Application Example 1 The application of UV-blocking contact lenses for regional crosslinking in the corneal crosslinking process to achieve regional guidance of UV light energy and directional reshaping of corneal morphology, the steps are as follows: Step 1: Preoperative preparation 1.1 Patient Assessment Corneal structural data and the extent of lesions are obtained through imaging techniques such as corneal topography, corneal thickness measurement, and OCT. Based on the measurement results, CAD software can be used to design the distribution pattern of the blocking and transparent areas in the functional pattern layer.

[0061] 1.2 Lens Customization According to individual corneal parameters and treatment needs, the ultraviolet-blocking contact lens for regional crosslinking of the present invention is customized. The materials and preparation methods of the basal layer and the outer edge layer are the same as in Example 1. The functional pattern layer is set according to the evaluation structure. The ultraviolet-blocking contact lens for regional crosslinking is prepared according to the process of Example 1.

[0062] Step 2: Preoperative medication application for corneal cross-linking Riboflavin eye drops are routinely used, with a riboflavin concentration of 0.1%. If de-epithelialization and corneal cross-linking are performed, corneal epithelium removal is also required. Instillation can be done every 2 minutes for approximately 30 minutes, allowing the riboflavin to penetrate into the corneal stroma (the soaking and instillation regimen can be adjusted according to clinical needs).

[0063] Step 3: Lens Placement and Positioning Place the sterilized UV-blocking contact lens for regional crosslinking onto the patient's corneal surface and gently align it; identify the 6 o'clock and 12 o'clock positions using axial markings (such as etched dimples) to ensure accurate alignment between the light-transmitting area and the area to be treated; adjust the position of the UV-blocking contact lens for regional crosslinking to confirm good fit and no obvious air bubbles or displacement.

[0064] Step 4: Ultraviolet irradiation (regional crosslinking) Turn on the ultraviolet irradiation system (wavelength 365nm); set the irradiation intensity and time (e.g., 9mW / cm²×10min, or 18mW / cm²×5min, the protocol can be adjusted according to clinical needs); ultraviolet light shines through the light-transmitting zone to the target area, triggering the excited state of riboflavin and generating singlet oxygen and free radicals; the blocking zone effectively shields the non-treatment area, preventing cross-linked ultraviolet light from affecting the tissue in this area.

[0065] Step 5: Postoperative care After irradiation is stopped, remove the UV-blocking contact lens used for regional crosslinking; administer antibiotics and artificial tears; and wear a protective bandage lens as needed.

[0066] 5. Safety and stability The UV-blocking contact lens for regional cross-linking of this invention effectively prevents UV light from irradiating non-treatment areas of the cornea during treatment, thereby reducing the risk of excessive corneal cross-linking. Furthermore, the UV-blocking contact lens for regional cross-linking exhibits good biocompatibility, high comfort during wear, and is less likely to cause allergic or discomfort reactions. Through precise personalized design, it can be adjusted according to the different needs of patients, ensuring the safety and stability of the treatment process.

[0067] This invention also demonstrates, through continuous clinical research and verification, the effectiveness of ultraviolet-blocking contact lenses for regional cross-linking in the treatment of refractive errors and corneal lesions, which can effectively improve treatment outcomes and reduce potential side effects during treatment.

[0068] Contact lenses and colored contact lenses are widely used in ophthalmology. However, contact lenses have a single-layer, uniform structure, primarily for vision correction. Colored contact lenses have a sandwich structure with decorative dye patterns, focusing mainly on aesthetics. Neither can achieve regional cross-linking under ultraviolet light. This invention provides an ultraviolet-blocking contact lens for regional cross-linking. Through a personalized blocking zone, it precisely guides ultraviolet energy during corneal cross-linking, optimizing and improving the cross-linking process. This ultraviolet-blocking contact lens for regional cross-linking has broad application prospects in corneal cross-linking treatment, providing a new solution for personalized treatment of refractive errors and corneal diseases.

[0069] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A UV-blocking corneal contact lens for regional crosslinking, characterized in that, It includes a base layer, a functional pattern layer, and an outer layer that are stacked in sequence; The functional pattern layer includes a barrier area and a light-transmitting area; The ultraviolet light transmittance of the barrier region is ≤10%; The ultraviolet light transmittance of the light-transmitting area is ≥90%.

2. The ultraviolet-blocking corneal contact lens according to claim 1, characterized in that, The thickness of the substrate layer is 30~200μm.

3. The ultraviolet-blocking corneal contact lens according to claim 1 or 2, characterized in that, The ultraviolet light transmittance of the substrate layer is ≥90%; The substrate layer is made of one or more of poly(2-hydroxyethyl methacrylate), hydroxyethyl methacrylate, and polydimethylsiloxane.

4. The ultraviolet-blocking corneal contact lens according to claim 1, characterized in that, The thickness of the functional patterned layer is 5~30μm.

5. The ultraviolet-blocking corneal contact lens according to claim 1 or 4, characterized in that, The material of the barrier region includes inorganic materials and / or benzophenone-based ultraviolet-absorbing polymers; the inorganic materials include titanium dioxide and / or zinc oxide; the benzophenone-based ultraviolet-absorbing polymers include one or more of 2,4-dihydroxybenzophenone, 2-hydroxy-4-methoxybenzophenone, and 2,2'-dihydroxy-4,4'-dimethoxybenzophenone.

6. The ultraviolet-blocking corneal contact lens according to claim 1, characterized in that, The thickness of the outermost layer is 1~20μm.

7. The ultraviolet-blocking corneal contact lens according to claim 1 or 6, characterized in that, The outer surface layer has an ultraviolet light transmittance of ≥90%, and the material of the outer surface layer includes one or more of polyhydroxyethyl methacrylate, hydroxyethyl methacrylate, polyvinyl alcohol, polyethylene glycol, sodium polyacrylate, sodium hyaluronate, polysiloxane, polymethyl methacrylate, and polyethylene glycol diacrylate.

8. The method for preparing a UV-blocking corneal contact lens for regional crosslinking according to any one of claims 1 to 7, characterized in that, Includes the following steps: A functional patterned layer and an outer surface layer are sequentially prepared on the base layer and integrally molded to obtain the ultraviolet-blocking corneal contact lens for regional crosslinking.

9. The preparation method according to claim 8, characterized in that, Therefore, the preparation methods for functional patterned layers are inkjet printing, screen printing, in-mold transfer printing, or piezoelectric inkjet printing.

10. The preparation method according to claim 8, characterized in that, The base layer is prepared by molding, injection molding, or 3D printing; the outer surface layer is prepared by spraying, dip coating, spin coating, plasma-assisted spraying, plasma-assisted dip coating, or plasma-assisted spin coating.

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