Novel corneal contact lens for controlling myopia development and processing method

Abstract

The invention discloses a novel corneal contact lens for controlling myopia development and a processing method, the novel corneal contact lens comprises a lens body, and the lens body is divided into a central optical area and an annular light adding area; the central optical area is located in the middle area of the mirror body and is concentric with the mirror body, and the central optical area has accurate diopter and is used for correcting far vision of a wearer and ensuring that the wearer obtains clear central vision; the annular light adding area is located on the outer ring of the central optical area, the annular light adding area is provided with positive spherical lens additional degrees compared with the central optical area, and the positive spherical lens additional degrees are achieved by adding fuzzy patterns to the annular light adding area. And the annular light adding area is used for reducing the definition and contrast of an image formed around the retina by the light passing through the area. According to the corneal contact lens, myopic defocus is generated on the periphery of the retina at the same time, and the imaging contrast ratio and definition are reduced, so that the excessive growth of the ocular axis can be more effectively inhibited.

Description

Technical Field

[0001] The present invention relates to the technical field of corneal contact lenses, and in particular to a novel corneal contact lens for controlling the progression of myopia and a processing method thereof. Background Art

[0002] Myopia, particularly among adolescents, has become a growing global health challenge. Statistics show that myopia accounts for a significant proportion of the global population, and it is estimated that by 2050, nearly half of the world's population will be affected by it. Myopia not only affects vision, but high myopia also significantly increases the risk of blinding eye diseases such as cataracts, glaucoma, retinal detachment, and macular degeneration. Therefore, developing effective myopia control strategies is crucial.

[0003] Currently, existing optical intervention methods include orthokeratology lenses (OK lenses), multifocal soft contact lenses (MF-SCL) and frame glasses with peripheral defocus design. The core mechanism of these methods is generally believed to be based on the "peripheral defocus theory": by generating myopic defocus in the peripheral area of ​​the retina (that is, light focuses in front of the retina) rather than hyperopic defocus (light focuses behind the retina), the excessive growth of the eye axis is inhibited. Multifocal RGP contact lenses (MF-RGPCL) have also been proven to be an effective means of myopia control, especially for specific patient groups where traditional methods are ineffective or unsuitable, such as patients with high myopia or large astigmatism. MF-RGPCL has the advantages of high oxygen permeability, excellent imaging quality, and is combined with a peripheral myopic defocus design.

[0004] In recent years, in addition to regulating the focal position, regulating the "quality" of peripheral retinal imaging has also begun to attract attention. Studies have shown that reducing the contrast and clarity of peripheral imaging may become a new auxiliary strategy for myopia control. For example, frame glasses using Diffusion Optics Technology (DOT) modulate or suppress the "abnormal contrast signals" of peripheral retinal photoreceptor cells by setting light scattering centers in the treatment area around the lens, thereby slowing down the growth of the eye axis. Preliminary clinical studies have shown that DOT lenses have achieved positive results in delaying the progression of myopia.

[0005] The physiological basis of this strategy may be related to the balance between the ON and OFF pathways in the retina. Studies have shown that myopia is associated with functional defects in the ON pathway, resulting in a decrease in the retina's ability to process low-contrast information. Certain stimulation conditions that may promote the progression of myopia (such as optical blur and low light) will further weaken the response of the ON pathway. Therefore, actively introducing controlled image blur or contrast reduction in the peripheral retina may help to adjust this imbalance, thereby generating a signal to inhibit myopia. The present invention proposes to embed a blurred pattern in the peripheral light-added area of ​​the RGP lens. It is based on this concept and aims to provide a more comprehensive peripheral vision signal intervention by combining "defocus" and "blur".

[0006] Most RGP lenses currently on the market primarily aim to correct central vision in patients with irregular corneas. Relatively few are specifically designed to control myopia progression, particularly those with integrated complex peripheral optical features. Even some RGP lenses with peripheral defocus designs may face the aforementioned issue of maintaining clear peripheral images. Summary of the Invention

[0007] In response to the shortcomings of the existing technology, the present invention provides a new corneal contact lens and processing method for controlling the progression of myopia. The corneal contact lens embeds a specially designed blur pattern in the annular peripheral light-adding area of ​​the lens, which more effectively inhibits excessive growth of the eye axis by simultaneously generating myopic defocus and reducing imaging contrast and clarity in the periphery of the retina.

[0008] A new corneal contact lens for controlling the progression of myopia, comprising a lens body, wherein the lens body is divided into a central optical zone and an annular light-adding zone;

[0009] The central optical zone is located in the middle area of ​​the lens body and is concentric with the lens body. The central optical zone has precise refractive power and is used to correct the wearer's distance vision and ensure that the wearer obtains clear central vision.

[0010] The annular light-adding area is located on the outer circle of the central optical zone. Compared with the central optical zone, the annular light-adding area is designed with a positive spherical addition degree. The positive spherical addition degree is achieved by adding a blurred pattern to the annular light-adding area. The annular light-adding area is used to reduce the clarity and contrast of the image formed by the light passing through this area at the periphery of the retina.

[0011] As a preferred embodiment of the above technical solution, the mirror body is made of a hard breathable material or a soft hydrogel / silicone hydrogel material.

[0012] As a preferred embodiment of the above technical solution, the diameter of the central optical zone is not less than 3.5 mm.

[0013] As a preferred embodiment of the above technical solution, the positive spherical lens additional power range of the annular light-adding area is +1.00D to +5.00D.

[0014] As a preferred embodiment of the above technical solution, the width of the annular light-adding area is 0.5 mm to 4 mm.

[0015] As a preferred embodiment of the above technical solution, the blurred pattern is composed of micron-scale scattering or diffraction structural units.

[0016] A method for preparing any one of the novel corneal contact lenses, using any one of laser surface etching, lens internal laser processing or "sandwich" dyeing / embedding processes.

[0017] As a preferred embodiment of the above technical solution, when laser surface etching is used, the specific preparation method is: using a femtosecond laser system or an excimer laser system to directly micro-process the surface of a specified annular area of ​​a formed or semi-formed RGP lens blank to etch a preset blurred pattern.

[0018] As a preferred embodiment of the above technical solution, when using the internal laser processing method of the lens, the preparation method is as follows: utilizing the characteristics of ultrashort pulse laser, focusing the ultrashort pulse laser on the internal volume area of ​​the RGP lens material, inducing permanent physical or chemical changes inside the RGP lens material through the nonlinear absorption effect, forming a scattering or diffraction area, and this scattering or diffraction area can be used as a blurred pattern.

[0019] As a preferred embodiment of the above technical solution, when using the "sandwich" dyeing / embedding process, the preparation method is as follows: by sandwiching a dye, pigment or functional film layer with a prefabricated blurred pattern between two layers of RGP lens material, and then polymerizing and curing or pressing the entire lens, the pattern is permanently encapsulated inside the lens to form the desired blurred pattern.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. Enhanced myopia control effect:

[0022] By simultaneously introducing myopic defocus and a blurred pattern that reduces image clarity and contrast in the peripheral light-adding zone, the present invention aims to provide a more comprehensive and potent visual signal to the retinal periphery to inhibit axial eye growth. This dual mechanism of "defocus + blur" further weakens the remaining clear visual signal that could stimulate axial eye growth through blurred peripheral imaging, complementing and enhancing the inhibitory effect of peripheral defocus. This results in a more significant myopia-reducing effect than traditional myopia control lenses (including some existing RGP designs) that rely solely on a single defocus principle.

[0023] 2. Guarantee of no interference with central vision:

[0024] The central optical zone of the lens (approximately 4.5mm in diameter) is designed as a pure distance vision correction zone, without any additional power or blurring pattern. This ensures that the wearer can obtain clear, undisturbed central vision (primarily in the macula) while performing daily activities, meeting their demand for high visual quality. The peripheral blurring pattern only affects the peripheral visual field light entering through the edge of the pupil and has little effect on the clear imaging of the central field of view.

[0025] 3. Good wearing comfort and safety:

[0026] Material selection: Made of highly oxygen-permeable RGP material, it ensures that the cornea can obtain sufficient oxygen supply, reducing the risk of complications related to corneal hypoxia caused by long-term wear;

[0027] Surface treatment: For solutions using laser surface etching, subsequent surface treatment processes such as precision polishing and plasma coating can restore or improve the smoothness and wettability of the lens surface, thereby minimizing the impact on tear film stability, improving wearing comfort, and reducing protein and lipid precipitation;

[0028] Pattern embedding: For blurred patterns formed by laser processing or "sandwich" embedding technology inside the lens, since the pattern is not directly exposed to the lens surface, it will not affect the optical quality, smoothness, biocompatibility and wear resistance of the lens surface, and has minimal impact on wearing comfort and safety. The selected embedded dye or pigment material must also meet biomedical safety standards.

[0029] 4. Flexibility and feasibility of manufacturing process:

[0030] The present invention provides multiple technical paths for achieving embedded blur patterns, including laser surface etching, laser processing inside the lens, and "sandwich" dyeing / embedding processes, providing flexible options for actual production.

[0031] Laser processing (surface etching and internal processing) is characterized by high precision and high controllability, making it suitable for manufacturing fine diffraction or scattering microstructures. It is also easy to implement digital design and automated production. Femtosecond laser technology, in particular, has shown great potential in the field of precision micro-nano manufacturing due to its "cold processing" characteristics.

[0032] The "sandwich" embedding process draws on the mature technology of colored contact lenses. The process is relatively mature and suitable for batch replication and production of patterns.

[0033] The compatibility of multiple process methods makes the present invention have good manufacturability and industrialization prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a structural schematic diagram of the present invention.

[0035] Figure 2 Schematic diagram of the microstructure formed by the laser beam on the surface of the RGP lens when using laser surface etching.

[0036] Figure 3 This is a schematic diagram of the modified area structure formed inside the lens by the laser focus when the internal laser processing method of the lens is adopted.

[0037] Figure 4 Schematic diagram of the structure in which the pattern layer is sandwiched between two layers of lens material when using the "sandwich" dyeing / embedding process. DETAILED DESCRIPTION

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0039] The present invention is described in further detail below with reference to the accompanying drawings:

[0040] like Figure 1 The novel corneal contact lens for controlling the progression of myopia comprises a lens body 1, wherein the lens body 1 is divided into a central optical zone 101 and an annular light-adding zone 102;

[0041] The central optical zone 10 is located in the middle area of ​​the lens body 1 and is concentric with the lens body 1. The central optical zone 101 has precise refractive power and is used to correct the wearer's distance vision and ensure that the wearer obtains clear central vision.

[0042] The annular light-adding area 102 is located on the outer circle of the central optical zone 101. Compared with the central optical zone 101, the annular light-adding area 102 is designed with a positive spherical addition degree. The positive spherical addition degree is achieved by adding a blur pattern 2 to the annular light-adding area 102. The annular light-adding area 102 is used to reduce the clarity and contrast of the image formed by the light passing through this area at the periphery of the retina.

[0043] In this embodiment, the mirror body 1 is made of a hard breathable material or a soft hydrogel / silicone hydrogel material.

[0044] In this embodiment, the diameter of the central optical zone 101 is not less than 3.5 mm.

[0045] In this embodiment, the positive spherical lens addition power of the annular light-adding area 102 ranges from +1.00D to +5.00D.

[0046] In this embodiment, the width of the annular light-adding area 102 is 0.5 mm to 4 mm.

[0047] In this embodiment, the blur pattern 2 is composed of micron-scale scattering or diffraction structural units. In this embodiment, the blur pattern 2 preferably adopts a "photon sieve" annular distribution structure. Specifically, the "photon sieve" annular distribution structure is a special diffraction element that achieves the effect of superimposing and changing the diopter through diffraction. This effectively achieves the superposition of two focal points based on current lenses. In addition to the focal point at the prescribed angle, the other focal point is in a defocused state, thus producing a blurred effect.

[0048] In this embodiment, the lens body 1 is made of high oxygen permeability fluorosilicone acrylate RGP material (Dk value>100), and the total diameter of the lens body 1 is 10.6mm, of which the diameter of the central optical zone 101 is 4.5mm, and its distance diopter can be determined according to the wearer's refractive error prescription. The inner diameter of the annular light addition area 102 is 4mm and the outer diameter is 5.0mm. This area has a positive spherical addition power of +2.00D relative to the central optical zone 101.

[0049] Blur pattern 2 design: A "photon sieve" blur pattern 2 is designed within the peripheral annular light-adding area 102 on the front surface. Blur pattern 2 is composed of multiple concentric circles of micro-pits. Three circles of pit arrays can be set, with a depth of 1μm to 5μm. This produces the desired scattering and diffraction blurring effects.

[0050] Specifically, the calculation formula for the "photon sieve" parameters is as follows:

[0051] The core calculation of a single photon sieve element involves its radial position R n and semi-diameter (s):

[0052] 1. Radial position of the nth ring (R n )

[0053] The radial position of the center of the nth ring is given by:

[0054]

[0055] Where: R n : radial position of the nth ring; n: order of the ring (integer); f: focal length of the photon sieve (unit: mm, calculated as 1000 / power); λ: wavelength of light (unit: mm);

[0056] 2. From the radial position (R n )Calculate the order (n)

[0057] On the contrary, if the radial position R is known n , and want to find the approximate order n:

[0058]

[0059] 3. The width of the nth ring (w n )

[0060] The width w of the nth ring n (The difference between the starting radius of the (n+1)th ring and the starting radius of the nth ring) is:

[0061] w n =R n+1 -R n

[0062] where R n+1 Use with R n The same formula is used for calculation, but the order is n+1.

[0063] 4. Semi-diameter of the disk (s)

[0064] The semi-diameter s of the hole in the nth ring is determined by the following formula:

[0065]

[0066] Where: w n : width of the nth ring (as defined above); dw ratio : is the equation The precomputed roots of , where J0 is a Bessel function of the first kind of order zero.

[0067] 5. Cartesian coordinates of the hole (x,y)

[0068] The (x,y) position of a particular hole on the ring R at angle θ is:

[0069] x=R·sin(θ)y=R·cos(θ)

[0070] Where: R: radial position of the ring where the hole is located (i.e. a certain R_n); θ: angular position of the hole on the ring.

[0071] A method for preparing any one of the novel corneal contact lenses, using any one of laser surface etching, lens internal laser processing or "sandwich" dyeing / embedding processes.

[0072] In this embodiment, when laser surface etching is used, the specific preparation method is: using a femtosecond laser system or an excimer laser system to directly micro-process the surface of a specified annular area of ​​a formed or semi-formed RGP lens blank to etch a preset blurred pattern 2, such as Figure 2 shown.

[0073] Specifically, the technical principle and process: Under computer control, a laser beam precisely acts on the lens surface, removing or modifying extremely small volumes of material through photochemical ablation (such as with excimer lasers) or micro-explosion / phase transition induced by multiphoton absorption (such as with femtosecond lasers), forming structures such as micro-pits, micro-bumps, micro-holes, or diffraction gratings. Due to its ultrashort pulse characteristics, femtosecond lasers can achieve "cold processing" with a minimal heat-affected zone, resulting in extremely high processing precision and excellent surface quality while avoiding significant thermal damage to surrounding materials.

[0074] Realizable microstructures: Regular or irregular dot arrays and line arrays with sizes ranging from submicron to tens of microns, as well as more complex diffractive optical element (DOE) surface reliefs, can be manufactured. These microstructures reduce image clarity and contrast through the diffraction and scattering effects of light.

[0075] In this embodiment, when the internal laser processing method of the lens is used, the preparation method is as follows: utilizing the characteristics of ultrashort pulse laser, the ultrashort pulse laser is focused on the internal volume area of ​​the RGP lens material, and the nonlinear absorption effect is used to induce permanent physical or chemical changes in the RGP lens material, forming a scattering or diffraction area. This scattering or diffraction area can be used as the blurred pattern 2, such as Figure 3 shown.

[0076] Specifically, the technical principle and process are as follows: When a high-energy femtosecond laser pulse is focused within a transparent medium, the energy density at the focal point is sufficient to trigger nonlinear processes such as multiphoton absorption and tunneling ionization. This can cause localized micro-explosions in the material, the formation of microcavitation bubbles, density changes, or chemical decomposition, thereby altering the refractive index of that microregion or forming scatterers. By precisely controlling the scanning path of the laser focus in three-dimensional space, a predetermined three-dimensional blurred pattern can be "written" into the lens.

[0077] Formable structures: Micropores, microbubbles, regions with periodic changes in refractive index (similar to volume gratings), or arrays of discrete scattering centers can be formed inside the lens. These internal microstructures act as the units of the blurring pattern.

[0078] In this embodiment, when a "sandwich" dyeing / embedding process is used, the preparation method is as follows: a dye, pigment, or functional film layer with a prefabricated blur pattern is sandwiched between two layers of RGP lens material, and then the whole is polymerized, cured, or pressed together, thereby permanently encapsulating the pattern inside the lens to form the desired blur pattern 2, such as Figure 4 shown.

[0079] Specific technical principles and processes:

[0080] Pattern preparation: First, a fuzzy pattern composed of biocompatible fine dye or pigment particles (such as the aforementioned photon sieve array) is formed on a thin polymer substrate film compatible with the RGP material by printing (such as screen printing, inkjet printing), photolithography or other microfabrication techniques. These particles themselves have scattering or partial light-shielding properties;

[0081] Sandwich embedding: This patterned film is placed between two layers of incompletely polymerized RGP lens materials (monomer mixture or prepolymer), or between a molded RGP substrate concave surface and a matching mold surface;

[0082] Curing molding: Through molding, casting or spin coating, the multi-layer structure is tightly combined and polymerized and cured to form a whole RGP lens. The blur pattern is firmly embedded in the lens.

[0083] Subsequent processing: The cured lens blank is subjected to conventional turning, polishing and other processes to produce the final optical surface and edge profile.

[0084] Expanded Application to Soft Contact Lenses: This "sandwich" or lamination embedding technique is also widely used in the manufacture of patterned soft contact lenses (SCLs). For SCLs, a patterned layer is typically polymerized together with a hydrogel or silicone hydrogel material in a mold. Therefore, the "sandwich dyeing" technique mentioned in this invention, as an auxiliary method, based on its technical principles and practical experience, can be easily expanded to the patterned manufacturing of soft contact lenses, including specialized optical patterns for myopia control.

[0085] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A novel corneal contact lens for controlling the progression of myopia, characterized by: The mirror body comprises a central optical area and an annular light-adding area; The central optical zone is located in the middle area of ​​the lens body and is concentric with the lens body. The central optical zone has precise refractive power and is used to correct the wearer's distance vision and ensure that the wearer obtains clear central vision. The annular light-adding area is located on the outer circle of the central optical zone. Compared with the central optical zone, the annular light-adding area is designed with a positive spherical addition degree. The positive spherical addition degree is achieved by adding a blurred pattern to the annular light-adding area. The annular light-adding area is used to reduce the clarity and contrast of the image formed by the light passing through this area at the periphery of the retina.

2. The novel corneal contact lens for controlling myopia progression according to claim 1, characterized in that: The mirror body is made of a hard breathable material or a soft hydrogel / silicon hydrogel material.

3. A novel corneal contact lens for controlling myopia progression according to claim 1, characterized in that The diameter of the central optical zone is not less than 3.5 mm.

4. The novel corneal contact lens for controlling myopia progression according to claim 1, characterized in that: The positive spherical lens addition power range of the annular light-adding area is +1.00D to +5.00D.

5. The novel corneal contact lens for controlling myopia progression according to claim 1, characterized in that: The width of the annular light-adding area is 0.5 mm to 4 mm.

6. The novel corneal contact lens for controlling myopia progression according to claim 1, characterized in that: The blurred pattern is composed of micron-scale scattering or diffraction structural units.

7. A method for preparing the novel corneal contact lens according to any one of claims 1 to 6, characterized in that: Use any of the following methods: laser surface etching, internal lens laser processing, or "sandwich" dyeing / embedding.

8. The preparation method according to claim 7, characterized in that: When using the laser surface etching method, the specific preparation method is: using a femtosecond laser system or an excimer laser system to directly micro-process the surface of a specified annular area of ​​a formed or semi-formed RGP lens blank to etch a preset blurred pattern.

9. The preparation method according to claim 7, characterized in that: When using the internal laser processing method of the lens, the preparation method is: utilizing the characteristics of ultrashort pulse laser, focusing the ultrashort pulse laser on the internal volume area of ​​the RGP lens material, inducing permanent physical or chemical changes inside the RGP lens material through the nonlinear absorption effect, forming a scattering or diffraction area, and this scattering or diffraction area can be used as a blurred pattern.

10. The preparation method according to claim 7, characterized in that: When using the "sandwich" dyeing / embedding process, the preparation method is: by sandwiching a dye, pigment or functional film layer with a pre-made blurred pattern between two layers of RGP lens material, and then polymerizing and curing or pressing the entire body, the pattern is permanently encapsulated inside the lens to form the desired blurred pattern.

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