WO2017016440A1 - 视力矫正镜及其制备方法 - Google Patents

视力矫正镜及其制备方法 Download PDF

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Publication number
WO2017016440A1
WO2017016440A1 PCT/CN2016/090955 CN2016090955W WO2017016440A1 WO 2017016440 A1 WO2017016440 A1 WO 2017016440A1 CN 2016090955 W CN2016090955 W CN 2016090955W WO 2017016440 A1 WO2017016440 A1 WO 2017016440A1
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Prior art keywords
lens
curvature
aspherical
refractive power
aperture
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PCT/CN2016/090955
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English (en)
French (fr)
Inventor
王曌
解江冰
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爱博诺德(北京)医疗科技有限公司
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Priority claimed from CN201510441714.0A external-priority patent/CN106707542B/zh
Priority claimed from CN201520543778.7U external-priority patent/CN204964916U/zh
Priority claimed from CN201510441201.XA external-priority patent/CN106291977B/zh
Priority claimed from CN201510441713.6A external-priority patent/CN106353892B/zh
Priority claimed from CN201510440964.2A external-priority patent/CN106291976B/zh
Priority claimed from CN201520543407.9U external-priority patent/CN204964915U/zh
Priority claimed from CN201520543779.1U external-priority patent/CN204964917U/zh
Priority to JP2018522844A priority Critical patent/JP6931349B2/ja
Priority to KR1020187005094A priority patent/KR102226668B1/ko
Application filed by 爱博诺德(北京)医疗科技有限公司 filed Critical 爱博诺德(北京)医疗科技有限公司
Priority to SG11201800595QA priority patent/SG11201800595QA/en
Priority to EP16829806.5A priority patent/EP3349055A4/en
Priority to US15/746,748 priority patent/US10551636B2/en
Publication of WO2017016440A1 publication Critical patent/WO2017016440A1/zh
Priority to HK18109669.1A priority patent/HK1250262A1/zh
Priority to US16/712,377 priority patent/US11385479B2/en
Priority to US17/834,139 priority patent/US20220317478A1/en

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    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/024Methods of designing ophthalmic lenses
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • G02C7/047Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/1005Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring distances inside the eye, e.g. thickness of the cornea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/145Corneal inlays, onlays, or lenses for refractive correction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1602Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1637Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • A61F2/164Aspheric lenses
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00009Production of simple or compound lenses
    • B29D11/00038Production of contact lenses
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00951Measuring, controlling or regulating
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M11/00Testing of optical apparatus; Testing structures by optical methods not otherwise provided for
    • G01M11/02Testing optical properties
    • G01M11/0228Testing optical properties by measuring refractive power
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/024Methods of designing ophthalmic lenses
    • G02C7/028Special mathematical design techniques
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • G02C7/049Contact lenses having special fitting or structural features achieved by special materials or material structures
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/06Lenses; Lens systems ; Methods of designing lenses bifocal; multifocal ; progressive
    • G02C7/061Spectacle lenses with progressively varying focal power
    • G02C7/063Shape of the progressive surface
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/24Myopia progression prevention
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/024Methods of designing ophthalmic lenses
    • G02C7/027Methods of designing ophthalmic lenses considering wearer's parameters

Definitions

  • the invention relates to a method for preparing a vision correction mirror, in particular to a method for preparing an aspherical vision correction mirror with controllable peripheral defocus.
  • the present invention also relates to an eye-correcting scope, a Ortho-K CL and an endoscope that are prepared according to the method.
  • the present invention also relates to a diagnostic and therapeutic method for controlling and delaying the growth of myopia using myopic peripheral defocusing.
  • Defocus (out-of-focus) is the corresponding point of focus.
  • Defocus refers to the fact that the image plane is not in focus, and it is divided into front defocus (before focus) and back defocus (after focus). status.
  • the main reason for the increase in the degree of myopia is that the length of the axial length is extended, and the degree of increase is 1.00 degrees for each 1 mm extension.
  • the latest medical research confirms that the eyeball extension depends on the retinal (as shown by 10 in Figure 1).
  • the focus on the front of the retina is called myopic defocus (as shown in Figure 30).
  • the posterior retina is called hyperopic defocus (as shown at 20 in Figure 1).
  • Myopia in the center of the retina is myopic defocusing, while the periphery of the retina is hyperopic defocusing. This peripheral retinal defocusing is the main reason for the increasing degree of myopia.
  • the eyeball has the characteristics of relying on peripheral imaging of the retina to induce eyeball development, especially in young people under 18 years old. If the peripheral retinal imaging is farsighted defocus, the retina will tend to grow toward the image point, and the length of the eyeball will be prolonged if the retinal periphery is imaged. For myopic defocus, the eyeball will stop extending. If the modern medical method is used to correct the hyperopic defocus around the retina or artificially form the myopic defocus around the retina, it can prevent the increase of the degree of myopia, and at the same time find out the cause of defocusing around the retina, and can effectively prevent myopia. Occurrence and progress.
  • peripheral defocusing was sorted out and summarized in the actual clinical field of opto-optics. Initially, doctors found that the length of the axial length of the keratoplasty wearer and the growth rate of myopia were delayed, and the surrounding defocus was found. Among them, the theory of peripheral defocusing control myopia is formed. However, this theory has always been in a state of passive discovery.
  • the peripheral defocusing control mechanism of the Ortho-K CL is to use the activity of the corneal surface cells to shape the anterior surface of the cornea into the shape of the surface of the ocular lens (the spherical surface) by wearing a lens at night, thereby forming a far-sighted The surrounding is out of focus.
  • the disadvantage of Orthokeratology is that the degree of curvature of the retina is different for different patients.
  • the existing Ortho-K CL is shaped by the outer surface of the cornea as the spherical shape of the base arc region, and its refractive power distribution is only observed.
  • the distribution law of the refractive power of the spherical surface that is, the refractive power distribution of the anterior surface of the cornea after the same shaping has only a single shape.
  • the frame glasses adopt a partition structure, and the center is designed as a zero-spherical optical zone for precise imaging.
  • the edge is designed as a peripheral defocusing control zone with a higher refractive power than the central region.
  • the optical defocus soft contact lens divides the surface structure of the lens into multiple layers, which are respectively designed with different curvatures (radius of curvature), and two kinds of curvatures alternately realize the far vision defocus of the refractive power.
  • curvatures radius of curvature
  • curvatures two kinds of curvatures alternately realize the far vision defocus of the refractive power.
  • peripheral defocus control the technology that uses peripheral defocus to control the growth of myopia faces two major problems.
  • One is the lack of a clear and quantifiable implementation of peripheral defocus control; the second is the lack of effective, controlled therapeutic products. .
  • Eye-correcting scopes worn outside the eye include lenses that are in direct contact with the human eye (such as contact lenses) and lenses that do not directly contact the human eye (such as frame glasses).
  • Frame glasses are generally made of glass or resin lenses.
  • the refractive index is between 1.40 and 1.71.
  • the contact lens is a lens that is worn on the cornea of the eye to correct vision or protect the eye. According to the soft and hard of the material, it is hard, semi-rigid and soft. The rate is approximately in the range of 1.40-1.50.
  • the optical defocus soft contact lens is a peripheral defocusing control type contact lens, and the surface structure of the lens is divided into multiple layers, which are respectively designed with different curvatures (radius of curvature), and two kinds of curvatures alternately realize refractive power.
  • the near vision is defocused.
  • the existing frame glasses adopt a partition structure, and the center is designed as a zero-spherical optical zone for precise imaging, and the edge is designed as a peripheral defocus control zone with a refractive power higher than the central region.
  • the problem of this method is that the peripheral defocus only exists. Outside of the usual optical zone, it does not work in most cases, and the myopia control zone is very limited and discontinuous.
  • the Ortho-Knife Mirror adopts the "reverse geometry" design principle, and the surface (inner surface) where the whole lens is in contact with the cornea is designed as several arc segments that are connected to each other.
  • the special shape of the inner surface of the lens after wearing causes the lens and the outer surface of the cornea.
  • the hydrodynamic effect of tears pulls the epithelial cells in the center of the cornea to the middle part (peripheral).
  • the action of the eyelids causes the center of the lens to apply a certain amount to the lower cornea. pressure.
  • the "reverse geometry" design of the Ortho-K CL is proposed by Stoyan in 1989 (US 4952045).
  • the original inverted geometry design divides the Ortho-Knife into three arc zones, including the base arc zone and the inverted arc zone.
  • the surrounding arc area because of the design of the reverse arc area is very wide, the edge lift height is large, easy to cause the lens to move irregularly, has a large clinical limitations.
  • the base arc region 11 is in contact with the central region of the cornea, and the surface shape is relatively flat for flattening the corneal surface; the reverse arc region 12 is relatively steep for stabilizing the flattening effect of the base arc region 11 and ensuring A certain amount of tear storage; the positioning arc zone 13 is also called the arc area, which is mainly used to stabilize the lens; the peripheral arc zone 14 ensures the circulation of tears around the cornea and the Ortho-K CL.
  • the inner surface of the Ortho-K CL is the shaping function realization area. Most of the design is for this area.
  • the method is based on the curvature radius and width of the four arc areas, and is designed according to the patient's corneal shape and diopter requirements. .
  • arcs are connected by using multiple arcs in the reverse arc zone 12 and the positioning arc zone 13 (for example, two arcs are used in the reverse arc zone, and three arcs are used in the positioning arc zone) to make the base
  • the arc region 11 is easier to engage with the inverted arc region 12, and the positioning arc region 13 is more in conformity with the shape of the cornea (since the cornea is aspherical, a plurality of spherical surfaces are used to fit the aspherical shape).
  • the design of the aspherical positioning arc is also used in the existing design.
  • the cornea of a normal human eye is generally aspherical, and the periphery is slightly flatter than the center. After the cornea is shaped, the anterior surface of the cornea becomes a spherical surface, that is, the shape of the posterior surface of the Ortho-K CL.
  • Figure 13 is a schematic diagram showing the refractive power of the spherical cornea (shown as A in the figure) and the aspherical cornea with the same radius of curvature as shown in the figure B. It can be seen that the spherical cornea can be compared with the aspherical cornea. The periphery of the eye brings greater power.
  • the real mechanism of keratoplasty to control the growth of myopia is to wear the lens at night, and the Ortho-K CL can shape the cornea into a spherical surface (the shape of the surface of the optical area of the Orthokeratology), so that the human eye is in sight.
  • the peripheral refractive power is larger than that before shaping, which causes some wearers to form near-sighted peripheral defocus, which slows the growth of the eye axis and controls the development of myopia.
  • the base arc area of the existing Orthokeratology mirrors is spherical, and the base arc area of the spherical surface shapes the anterior surface of the cornea into a spherical surface, so that the refractive power distribution provided by the cornea conforms to the spherical surface characteristics, and the disadvantage is that for different patients, the retina The degree of curvature is different.
  • the existing Orthokeratology mirror shapes the outer surface of the cornea into the spherical shape of its base arc region, and its refractive power distribution only obeys the refractive power distribution law of the spherical surface, that is, for the same shaped posterior corneal front. In terms of surface curvature radius, its refractive power distribution has only one form.
  • the refractive power distribution can only be a condition as shown in A of Fig. 13, when the curvature of the human retina is greater than the refractive power distribution of the cornea formed.
  • the keratoconus with a spherical arc as a spherical surface cannot form a controllable and effective peripheral refractive power control. Therefore, only some patients can benefit from the control of myopia growth, and it is impossible to achieve effective control of myopia for each patient.
  • Existing Ortho-K CLs also have aspherical designs, such as Berke in US 7984988 B2, which designs the base arc of the Ortho-K CL as an elliptical surface; Sami G.EI Hage is recommended in US 5695509 based on the shape of the cornea. With the thickness of the tears, the key coordinate points are determined, and the aspherical surface fitting is performed by the coordinate points to determine the inner surface shape of the Orthokeratology mirror; Patent 201420052256.2 designs the front surface of the Ortho-K CL on an aspheric surface for the human eye to wear. Avoid nighttime interference from the ball and improve visual quality.
  • the goal of these designs is to enable the human eye to achieve better visual quality after shaping, so that the distribution of refractive power of the whole eye is kept as uniform as possible in each aperture, which leads to peripheral defocusing of hyperopia, which is closely related to peripheral defocus control.
  • the purpose and method are all contrary.
  • Endoscopic surgery mainly refers to the phakic intraocular lens (PIOL) for myopic refraction.
  • This phakic intraocular lens (PIOL) is a surgical method that implants a lens with a negative number into the cornea of the human eye. Between the lens and the lens, thereby correcting the refractive error of the human eye.
  • the phakic intraocular lens is divided into anterior chamber type and posterior chamber type according to different implantation positions.
  • the general posterior surface of the anterior chamber type is relatively flat, and the anterior surface plays a major refractive role; while the posterior chamber has a generally flat front surface.
  • the posterior surface acts as the primary refraction.
  • Patent 201520014249.8 discloses an aspherical design PIOL, which aims to maintain a constant value of the total refractive power of the human eye at different apertures, thereby achieving better visual quality.
  • Negative diopter of spherical design The refractive power provided by the lens decreases with the increase of the aperture (the absolute value increases), which causes the human eye to form hyperopia defocus, promote the growth of the axial axis, and accelerate the development of myopia; the existing aspheric design PIOL makes people
  • the refractive power of the eye is kept constant at different apertures, and compared with the curvature of the retina, hyperopic defocus is also formed, which accelerates the development of myopia.
  • an endoscope is particularly needed to solve the above existing problems.
  • An object of the present invention is to provide a method for preparing a peripheral defocusing controllable aspherical vision correction mirror, which is determined by measuring the retinal shape of the human eye or the surrounding defocus or the surrounding defocus of the wearing mirror for the defects of the prior art.
  • the refractive power distribution state of the lens is prepared as a vision correction mirror. After the human eye is used to add the refractive power to the human eye after using the vision correction mirror, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls on the Before the retina, myopia defocus is formed, which controls the growth of myopia.
  • a method for preparing a peripheral defocusing controllable aspherical vision correction mirror which comprises the following steps:
  • a vision correction mirror is prepared, and after the vision correction mirror refractive power is attached to the human eye, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls. Before the retina, myopia defocus is formed.
  • the shape of the human eye retina is measured by the ophthalmic detecting device, and if the ophthalmic detecting device regards the retina as a spherical surface, the shape of the retina is measured by the radius of curvature of the retina;
  • the detection device treats the retina as an aspherical surface, and measures the shape of the retina with the equivalent radius of curvature of the aspherical surface; the equivalent curvature radius of the aspherical surface is calculated as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point.
  • the distribution state of the whole eye refractive power (D' t ) formed by the vision correction lens and the human eye is near vision defocus with respect to the shape of the retina, which satisfies:
  • D r is the refractive power of the whole eye at a radius r
  • D 0 is the refractive power of the whole eye at a small aperture ( ⁇ axis), that is, the nominal value of the refractive power of the whole eye
  • r is the radius of the retinal plane
  • R is the retina The radius of curvature or equivalent radius of curvature.
  • the shape of the retina is measured by an optical coherence tomography OCT or similar ophthalmic detection device.
  • the amount of defocusing around the naked eye of the human eye ( ⁇ D1) and the amount of peripheral defocusing in the state of wearing the lens ( ⁇ D3) are measured by the ophthalmic detecting device, the non- The defocus amount ( ⁇ D2) of the spherical vision correction mirror is known, the peripheral defocus amount ( ⁇ D2) provided by the vision correction lens + the defocus amount ( ⁇ D1) around the naked eye of the human eye is ⁇ 0, and the human eye forms a near vision defocus;
  • the amount of defocus around the human lens ( ⁇ D3)>0 it indicates that the defocus amount of the lens of the test lens has satisfied the condition that the human eye reaches the defocus of the near vision.
  • the amount of defocusing around the human lens ( ⁇ D3) ⁇ 0 when the amount of defocusing around the human lens ( ⁇ D3) ⁇ 0, it indicates that the defocus amount of the lens still causes the human eye to be in a state of defocusing around the distance, and it is necessary to increase the distance of the lens.
  • the amount of coke is such that the human eye reaches the periphery of the near vision.
  • the increase or decrease of the defocus amount of the lens periphery can be performed according to the physiological condition of the patient and the requirement for the degree of myopia control, so as to achieve personalized vision correction.
  • a vision correction mirror is produced by an aspheric design method, and the aspherical expression is:
  • Z(y) is the expression of the curve of the aspheric surface of the vision correction lens on the YZ plane
  • c is the reciprocal of the radius of curvature of the base spherical surface of the optics
  • y is any point on the curve from the abscissa axis
  • the vertical distance, Q is an aspherical coefficient
  • a 2i is an aspherical high-order term coefficient, and each point on the aspherical surface shape is obtained by the curve being rotationally symmetrically changed around the abscissa axis (Z);
  • the surface shape of the vision correction mirror lens exhibits different equivalent curvatures in different portions in the radial direction, and the uniform curvature is uniformly and continuously changed throughout the optical region. Therefore, the vision correction lens has a refractive power suitable for the distribution state of the myopic defocusing power under different apertures, and the refractive power of the peripheral region is greater than the refractive power of the central region;
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point.
  • the method for preparing a peripheral defocusing controllable aspherical vision correction mirror of the present invention compares the surface shape and the radius of curvature of the optical zone of the mirror correction mirror with the aspherical surface to make the vision correction mirror lens in the aperture direction According to the set refractive power, the amount of defocusing changes uniformly, and the refractive power of the vision correction mirror lens increases with the increase of the aperture, providing a degree of controllable myopia defocusing for the human eye, preventing the growth of the axial axis, delaying the deepening of myopia, and realizing the present invention. the goal of.
  • Another object of the present invention is to provide an eye-correcting scope for eye-wearing.
  • the aspherical surface of the optic zone of the lens is controlled by an aspherical surface and the radius of curvature is made to have an equivalent radius of curvature at the periphery.
  • the peripheral surface shape is steeper than the spherical surface, so that it changes uniformly in the aperture direction according to the set refractive power distribution, and the refractive power of the lens increases with the increase of the aperture, providing a degree of controllable near-eye peripheral defocus for the human eye. Prevent eye shaft growth and delay myopia.
  • an aspherical vision correcting mirror prepared according to the above preparation method, the vision correcting mirror being an orthoscopic wearing correcting mirror, at least one of a convex or concave surface of the optical zone of the lens a spherical surface, when the convex surface of the optical zone of the lens is aspherical, the absolute value of the equivalent radius of curvature around the optical zone of the lens is less than the absolute value of the radius of curvature of the center of the optical zone of the lens; when the concave surface of the optical zone of the lens is aspherical The absolute value of the equivalent radius of curvature around the optical zone of the lens is greater than the curvature of the center of the optical zone of the lens.
  • the absolute value of the path when the convex surface of the optical zone of the lens is aspherical, the absolute value of the equivalent radius of curvature around the optical zone of the lens is less than the absolute value of the radius of curvature of the center of the optical zone of the lens; when the concave surface of the
  • the aspherical surface shape of the optical zone of the lens is defined by a scale factor ⁇ of an equivalent radius of curvature, and ⁇ is a ratio of r at different apertures d m and d n , where m> n:
  • the method for calculating the equivalent radius of curvature of the optical zone of the lens is as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point
  • the equivalent curvature radius of the aspherical surface has a scale factor ⁇ >1.
  • the equivalent curvature radius scale factor ⁇ 53 of the aspherical surface at 5 mm aperture and 3 mm aperture is 1.002.
  • the equivalent curvature radius of the aspherical surface is proportional to the factor ⁇ ⁇ 1, preferably, the equivalent radius of curvature of the aspherical surface at a pore diameter of 5 mm and a diameter of 3 mm ⁇ 53 is the scale factor 0.682 ⁇ 53 ⁇ 0.986;
  • the refractive power of the lens in air is ⁇ 0D
  • the refractive power of the lens increases in the radial direction as the aperture increases
  • the absolute value of the refractive power of the lens decreases as the aperture increases.
  • the difference in refractive power of the lens at 5 mm and 3 mm aperture is ⁇ D 53 ⁇ 0.005 D; preferably, the difference in refractive power of the lens at 5 mm and 3 mm aperture is 0.005D ⁇ ⁇ D 53 ⁇ 8.849D.
  • the eye-correcting mirror worn by the eye of the present invention uses the aspherical surface to control the optical shape of the lens and the radius of curvature to make the vision correcting lens uniformly change in the aperture direction according to the set refractive power distribution.
  • the refractive power of the vision correction lens increases with the increase of the aperture.
  • the absolute value of the refractive power decreases with the increase of the aperture, providing a degree of control for myopia. Defocusing around the periphery, preventing the growth of the eye axis, delaying the deepening of myopia, achieves the object of the present invention.
  • Another object of the present invention is to provide a Ortho-K CL, which utilizes an aspherical surface to control the surface area and radius of curvature of the optical zone of the lens to make the absolute value of the equivalent radius of curvature at the periphery more than the center.
  • the peripheral surface is steeper than the spherical surface, so that it changes uniformly in the radial direction according to the set refractive power distribution.
  • the refractive power of the lens increases with the increase of the aperture, providing a degree of controllable myopia defocus for the human eye. Increased axial length and delayed myopia.
  • an aspherical vision correction mirror prepared according to the above preparation method, the vision correction mirror being a Orthokeratology mirror, characterized in that the aspherical surface of the base arc region of the lens
  • the shape is defined by a scale factor ⁇ of the equivalent radius of curvature, the scale factor of the equivalent radius of curvature of the aspheric surface is ⁇ 1; preferably the aspheric surface of the lens base arc region is at a face shape of 5 mm aperture and 3 mm aperture
  • the scale factor ⁇ of the equivalent radius of curvature is 0.67 ⁇ ⁇ 53 ⁇ 1; more preferably, the scale factor ⁇ of the equivalent radius of curvature of the aspheric surface of the lens base arc region at 5 mm aperture and 3 mm aperture is 0.67 ⁇ 53 ⁇ 0.998;
  • the scale factor ⁇ is the ratio of the different diameters of the lenses d m and d n , m > n:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point.
  • the Ortho-K CL is used to control the surface shape and radius of curvature of the base arc region of the lens by using an aspheric surface, so that the absolute value of the equivalent curvature radius at the periphery is smaller than the center, and the peripheral surface ratio is smaller.
  • the spherical surface is steeper, and the anterior surface of the cornea is shaped into the shape of the base area of the Orthokeratology mirror by one night wearing, so as to provide a degree of controllable myopia defocus, prevent the growth of the eye axis, and delay the deepening of myopia.
  • the object of the invention is achieved.
  • Another object of the present invention is to provide an endoscope which, in view of the deficiencies of the prior art, utilizes an aspherical surface to control the shape and radius of curvature of the optical zone of the lens so that the radius of curvature changes uniformly at different apertures.
  • the absolute value of the equivalent radius of curvature is larger than the half-absolute value of the equivalent curvature of the center, so that the peripheral refractive power is larger than the central refractive power (the absolute value of the peripheral refractive power is smaller than the absolute value of the central refractive power), and the refractive power distribution exhibits a uniform change.
  • the distribution of myopic peripheral defocusing, the degree of myopia control of myopia patients is deepened.
  • an aspherical vision correction mirror prepared according to the above preparation method, the vision correction mirror being an endoscope, characterized in that the front surface or the rear surface of the optical zone of the lens is at least One is an aspherical surface, and the lens uniformly changes in the aperture direction according to the set dioptric force.
  • the refractive power of the lens increases as the aperture increases, and the absolute value of the refractive power decreases as the aperture increases.
  • the refractive power in the aqueous humor is ⁇ 0D.
  • the aspherical surface shape of the optical zone of the lens is defined by a scale factor ⁇ of an equivalent radius of curvature, and a scale factor ⁇ >1 of the equivalent radius of curvature of the aspherical surface; preferably, The scale factor ⁇ of the equivalent radius of curvature of the aspherical surface of the lens optical zone at 4 mm aperture and 3 mm aperture is ⁇ 43 ⁇ 1.005; more preferably, the aspheric surface of the optical zone of the lens is at 4 mm aperture and 3 mm aperture The scale factor ⁇ of the equivalent radius of curvature is 1.002 ⁇ ⁇ 43 ⁇ 1.09;
  • the method for calculating the equivalent radius of curvature of the optical zone of the lens is as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point.
  • the endoscope of the present invention has an aspherical surface structure compared with the prior art.
  • the aspherical surface is used to control the surface shape and radius of curvature of the optical zone of the lens so that the radius of curvature varies uniformly at different apertures, and the absolute value of the equivalent radius of curvature at the periphery is greater than the absolute value of the equivalent radius of curvature of the center.
  • the refractive power in the periphery is greater than the central refractive power
  • the absolute value of the peripheral refractive power is smaller than the absolute value of the central refractive power
  • the refractive power distribution exhibits a uniform distribution of myopic peripheral defocusing
  • the myopia degree of the myopic patient is controlled to deepen.
  • a diagnostic treatment method for controlling and delaying the growth of myopia using myopic peripheral defocusing is provided, characterized in that the diagnostic treatment method is corrected by using aspheric vision prepared according to the above preparation method. Mirror to achieve.
  • Figure 1 is a schematic view of the retina, myopic defocus, and hyperopic defocus;
  • FIG. 2 is a schematic view showing a near-focus peripheral defocus diopter distribution curve of the present invention
  • FIG. 3 is a schematic diagram of an aspheric curve expression of the present invention.
  • FIG. 4 is a schematic diagram of a scale factor ⁇ related to parameters of the present invention.
  • FIG. 5 is a schematic structural view of Embodiment 1 of the present invention.
  • Fig. 6 is a schematic structural view of a second embodiment of the present invention.
  • Figure 7 is a radial schematic view of the lens of the present invention.
  • FIG. 8 is a schematic flow chart of a method for diagnosis and treatment of a vision correction mirror according to the present invention.
  • Figure 9 is a schematic illustration of the retinal and refractive power distribution of the present invention.
  • Figure 10 is a schematic flow chart of Embodiment 3 of the present invention.
  • FIG 11 is a flow chart showing Embodiment 4 of the present invention.
  • Figure 12 is a schematic illustration of a longitudinal center section of a prior art Ortho-Knife Mirror with an inner surface of a four-arc design.
  • Fig. 13 is a schematic view showing the distribution of refractive power of a spherical cornea with a refractive power of 42.25D and an aspherical cornea having an aspheric coefficient Q of -0.25 and a refractive power of 42.25D at different apertures.
  • Figure 14 is a schematic view showing the structure of a Ortho-K CL.
  • Figure 15 is a schematic view showing the structure of an endoscope according to the present invention.
  • Figure 16 is a side view of Figure 15.
  • Figure 17 is a schematic view showing the structure of another endoscope of the present invention.
  • Figure 18 is a side view of Figure 17 .
  • Figure 19 is a schematic illustration of the refractive power distribution of the present invention and the prior art refractive power distribution.
  • Figure 20 is a schematic view showing the aspherical surface of the present invention and the aspherical surface of the prior art.
  • myopic peripheral defocus as used in this application means that the peripheral region has a greater refractive power than the central region.
  • the peripheral region's image points fall before the retina, at which point the peripheral defocus is defined.
  • distal peripheral defocus means that the peripheral area refractive power is smaller than the central area refractive power.
  • refractive power is a measure of the magnitude of the refractive power of a lens with respect to light.
  • optical zone refers to the portion of the central region of the lens that has optical properties to enable the primary function of adjusting the diopter of the lens.
  • or "support ⁇ ” as used in this application refers to the portion that is connected to the optic portion of the lens to function to support the optic to position the lens in the human eye.
  • radial refers to a linear direction from the center of the lens along a radius or diameter.
  • pore size refers to the radial diameter of the surface of the lens.
  • Terms, such as “front” and “back”, used in this application to indicate azimuthal relationship are relative to the distance of the corneal surface of the eye.
  • the "optical portion rear surface” is an optical surface that is closer to the cornea than the "optical front surface”.
  • base spherical refers to an ideal spherical surface having the same radius of curvature design value corresponding to the various shapes employed for the front and back surfaces of the optic portion of the lens.
  • the ideal spherical surface is collectively referred to as a "base spherical surface”.
  • the terms “steep” and “flat” refer to a description of the degree of equivalent radius of curvature of a lens, for example, for the purposes of this application, “shorter than spherical” refers to the equivalent radius of curvature of a lens.
  • the absolute value is smaller relative to the absolute value of the radius of curvature of the base sphere, and “flatter than the sphere” means that the absolute value of the equivalent radius of curvature of the lens is greater than the absolute value of the radius of curvature of the base sphere.
  • convex refers to a cut surface at any point on the surface, and the surface is always below the cut surface; “concave surface” means any point on the surface that is cut, and the surface is always above the cut surface.
  • an eye-wearing vision correction mirror includes a lens, at least one of the convex surface 101 or the concave surface 102 of the optical zone 100 of the lens being aspherical, when the optical zone of the lens
  • the equivalent radius of curvature of the periphery of the optical zone 100 of the lens is smaller than the radius of curvature of the center of the optical zone 100 of the lens;
  • the concave surface 102 of the optical zone 100 of the lens is non-spherical
  • the equivalent radius of curvature of the periphery of the optical zone 100 of the lens is greater than the radius of curvature of the center of the optical zone 100 of the lens
  • the refractive power of the lens in air is ⁇ 0D
  • the refractive power of the lens increases in the radial direction as the aperture increases, and the absolute value of the refractive power of the lens decreases as the aperture increases.
  • Fig. 7 is a radial schematic view of a lens of the present invention, wherein A is a front view of the lens of the present invention, and B is a radial direction of the lens of the present invention.
  • the difference in refractive power of the lens at 5 mm and 3 mm aperture is ⁇ D 53 ⁇ 0.005 D; preferably, the difference in refractive power of the lens at 5 mm and 3 mm aperture is 0.005D ⁇ ⁇ D 53 ⁇ 8.849D.
  • the aspherical expression of the optical zone 100 of the lens is:
  • c is the reciprocal of the radius of curvature of the base spherical surface of the optics
  • y is the vertical distance from any point on the curve to the abscissa axis (Z)
  • Q is the aspheric coefficient
  • a 2i is the aspheric high order coefficient
  • the aspherical surface is obtained by the aspherical curve by rotationally symmetrically changing about the abscissa axis (Z).
  • the aspherical surface shape of the optical zone 100 of the lens is defined by a scale factor ⁇ of the equivalent curvature radius, and ⁇ is the ratio of r at different apertures d m and d n , where m > n :
  • the equivalent radius of curvature of the aspherical surface has a scale factor ⁇ >1;
  • the convex surface 101 of the optical zone 100 of the lens is aspherical, the aspherical Equivalent radius of curvature scale factor ⁇ 1;
  • the method for calculating the equivalent radius of curvature of the optical zone 100 of the lens is as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point.
  • the optical zone of the concave surface 102 of lens 100 is aspherical, preferably, the aspherical surface at the aperture of 3mm and 5mm aperture equivalent radius of curvature to the scaling factor ⁇ 53 1.002 ⁇ 53 ⁇ 1.086.
  • the optical zone of the lens are aspheric convex surface 101,100, preferably, the aspherical surface at the aperture of 3mm and 5mm aperture equivalent radius of curvature to the scaling factor ⁇ 53 0.682 ⁇ 53 ⁇ 0.986.
  • the vision correction mirror is a contact lens
  • the concave shape of the concave surface 102' (the surface directly contacting the cornea) of the lens optical zone 100' is consistent with the shape of the cornea.
  • the spherical surface or the aspheric surface conforming to the corneal morphology, the convex surface 101' of the lens optical zone 100' is the aspherical structure of the present invention, and the aspherical structure of the present invention is as described above.
  • the aspheric surface is shaped in a scale factor equivalent radius of curvature at an aperture of 3mm and 5mm aperture ⁇ 53 is 0.682 ⁇ 53 ⁇ 0.986; the difference of the refractive power of 0.130D ⁇ D 53 ⁇ 4.779D.
  • Rp and Qp are the radius of curvature and aspherical coefficient of the convex surface of the contact lens (the surface in direct contact with the cornea); Ra, Qa, A4, A6, and A8 are the front surfaces of the contact lens, respectively.
  • the vision correction mirror is a frame glasses, and at least one of the convex surface 101 or the concave surface 102 of the lens optical zone 100 is the aspherical structure of the present invention, and the aspherical structure of the present invention is as described above.
  • the convex surface 101 of the lens optical zone 100 is an aspherical structure of the present invention, and its structure is similar to that of Embodiment 1.
  • the peripheral equivalent curvature radius is smaller than the center, and the peripheral surface shape is steeper than the spherical surface, so that it is pressed in the aperture direction.
  • the set refractive power distribution changes uniformly.
  • the aspherical structure of the present invention when the aspherical structure of the present invention is located on the concave surface 102 of the optical zone 100 of the lens, since the surface on which the aspherical surface is located provides a negative refractive power to the lens, in this case, the absolute value of the refractive power of the lens at the large aperture. It should be smaller than the small aperture to obtain the same refractive power distribution state as the lens of the present invention. Obviously, in order to achieve the same refractive power control, the peripheral surface shape should be flatter than the spherical surface.
  • the aspheric surface is shaped in a scale factor equivalent radius of curvature at an aperture of 3mm and 5mm aperture ⁇ 53 is 1.002 ⁇ 53 ⁇ 1.086; the difference of the refractive power of 0.005D ⁇ D 53 ⁇ 8.849D.
  • Rp and Qp are the radius of curvature and the aspherical coefficient of the convex surface of the contact lens (the surface in direct contact with the cornea); Ra, Qa, A4, A6, and A8 are the curvatures of the convex surface of the contact lens, respectively.
  • the convex surface and the concave surface of the lens may have only one side as the aspherical structure of the present invention, and both sides may be the aspherical structure of the present invention, which will not be described herein.
  • the absolute value of the refractive power of the lens under the large aperture can be larger than that under the small aperture by the opposite deformation control of the lens.
  • the absolute value of refractive power enables the human eye to achieve far-sighted peripheral defocusing, thereby treating hyperopia by actively promoting axial growth.
  • a method for preparing a peripheral defocusing controllable aspheric vision correction mirror includes the following steps:
  • a vision correction mirror is prepared, and after the vision correction mirror refractive power is attached to the human eye, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls. Before the retina, myopia defocus is formed.
  • B is the retina
  • C is the refractive power distribution curve formed on the retina by the whole eye; the shape of the retina, the amount of defocus around the naked eye of the human eye, and the amount of defocus around the human eye can be passed through the ophthalmology. Test equipment measurements.
  • the shape of the retina of the human eye is measured by an ophthalmic detection device (such as an optical coherence tomography apparatus OCT), and the ophthalmic detection device regards the retina as a spherical surface, and the shape of the retina is measured by the radius of curvature of the retina.
  • OCT optical coherence tomography apparatus
  • the shape of the retina of the human eye is measured by an ophthalmic detection device, and the ophthalmic detection device regards the retina as an aspherical surface, and the shape of the retina is measured by the equivalent curvature radius of the aspherical surface;
  • the calculation method of the equivalent curvature radius of the aspherical surface is as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point .
  • the distribution of refractive power of the vision correction lens and the human eye is satisfied:
  • the distribution of the refractive power of the whole eye formed by the vision correction lens and the human eye is myopic defocus with respect to the shape of the retina, which satisfies:
  • D r is the refractive power of the whole eye at a radius r
  • D 0 is the refractive power of the whole eye at a small aperture ( ⁇ axis), that is, the nominal value of the refractive power of the whole eye
  • r is the radius of the retinal plane
  • R is the retina The radius of curvature or equivalent radius of curvature.
  • the refractive power distribution of the whole eye on the retina is as shown by curve C in FIG.
  • the aspherical design can be used to match the difference between the lens edge power and the central refractive power. The above requirements.
  • the vision correction mirror is made by the aspherical design method, so that the refractive power of the vision correction mirror lens is in a myopic defocusing distribution at different apertures, that is, the refractive power increases with the increase of the aperture (as shown in the figure). 2 stated).
  • the amount of defocus around the naked eye of the human eye can be measured by ophthalmic detection equipment (such as OCT, corneal topographer, wavefront aberrometer, etc.), and the peripheral defocus amount ( ⁇ D2) provided by the vision correction lens + the naked eye of the human eye
  • ophthalmic detection equipment such as OCT, corneal topographer, wavefront aberrometer, etc.
  • ⁇ D2 peripheral defocus amount provided by the vision correction lens + the naked eye of the human eye
  • the human eye can wear a fitting lens with a known diopter and refractive power distribution state, and the amount of defocus around the human lens ( ⁇ D3) can be checked under the wearing state, and the amount of defocus around the human lens ( ⁇ D3) can be detected by ophthalmology.
  • Equipment measurement when the amount of defocus around the human lens ( ⁇ D3)>0, it indicates that the defocus amount of the lens of the test lens has met the conditions for the human eye to reach the defocus of the near vision, which can be used as a vision correction mirror.
  • the amount of defocusing around the lens can be increased or decreased to achieve personalized vision correction.
  • the vision correction mirror is made by the aspherical design method, so that the refractive power of the vision correction mirror lens is in a myopic defocusing distribution at different apertures, that is, the refractive power increases with the increase of the aperture;
  • the expression of the aspheric surface (as shown in Figure 3, where D is a spherical curve and E is an aspheric curve):
  • Z(y) is the expression of the curve of the aspheric surface of the vision correction lens on the YZ plane
  • c is the reciprocal of the radius of curvature of the base spherical surface of the optics
  • y is any point on the curve from the abscissa axis
  • the vertical distance, Q is an aspheric coefficient
  • a 2i is an aspherical high-order term coefficient, and each point on the aspherical surface shape is obtained by the curve being rotationally symmetrically changed around the abscissa axis (Z);
  • the surface shape of the vision correction mirror lens exhibits different equivalent curvatures in different portions in the radial direction, and is realized in the entire optical region.
  • the equivalent curvature is uniform and continuous, so that the vision correction lens has the refractive power suitable for the distribution of the myopic defocusing power under different apertures, and the refractive power of the peripheral region is greater than the refractive power of the central region.
  • the above also includes a control method of an aspherical surface shape, which is described by a scale factor ⁇ of an equivalent radius of curvature (as shown in FIG. 4), wherein:
  • is the ratio of r at different apertures d m and d n , m>n;
  • 1; for an aspheric surface whose periphery is flatter than the center, ⁇ >1; for an aspheric surface whose periphery is steeper than the center, ⁇ 1, designed by controlling the proportional factor of the equivalent curvature radius
  • the equivalent radius of curvature of the aspherical surface at each aperture which in turn makes the refractive power distribution of the lens meet the requirements for near-focusing of the near vision.
  • the invention also provides an aspherical vision correction mirror, comprising an eye-correcting scope, a Ortho-K CL and an endoscope, the aspherical vision correction mirror is prepared by using the aspherical vision correction mirror of the invention. Method to make.
  • the present invention also provides a diagnostic treatment method for controlling and delaying the growth of myopia by using near-peripheral peripheral defocusing, which is aspherical vision correction prepared by using the preparation method of the aspherical vision correction mirror according to the present invention. Mirror to achieve.
  • the vision correction mirror is a vision correction mirror (such as frame glasses) worn outside the eye.
  • the method for preparing the peripheral defocusing control aspherical vision correcting mirror of the present invention includes the following steps:
  • a vision correction mirror is prepared, and after the vision correction mirror refractive power is attached to the human eye, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls. Before the retina, myopia defocus is formed.
  • the vision correction mirror is a Ortho-K CL.
  • the basic design method of the Ortho-K CL is the same as the existing method, but the shape of the base arc region is determined by the curvature of the retina, and the refractive power of the retina of the human eye is calculated according to the curvature of the retina.
  • the distribution state ensures that the refractive power of the human eye becomes larger as the aperture becomes larger than the curvature of the retina, forming a far-sighted peripheral defocus, thereby preventing the human visual axis from extending and controlling the growth of myopia.
  • the surface design of the inner surface of the Orthokeratology base arc area
  • the shaping mirror Since the principle of the shaping mirror is that the human eye is wearing the shaping mirror, the shape of the cornea becomes the base mirror of the shaping mirror.
  • the shape of the zone, so the shape of the arc of the shaping mirror is the shape of the cornea to achieve optical function.
  • the preparation method of the peripheral defocusing control aspherical vision correction mirror of the present invention comprises the following steps:
  • a vision correction mirror is prepared, and after the vision correction mirror refractive power is attached to the human eye, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls. Before the retina, myopia defocus is formed.
  • the vision correction mirror is an endoscope.
  • Endoscopic surgery mainly refers to the phakic intraocular lens (PIOL) for myopic refraction.
  • PIOL phakic intraocular lens
  • the endoscopic lens is divided into the anterior chamber type and the posterior chamber type according to the different implantation positions.
  • the PIOL of the anterior chamber type generally has a flat rear surface, and the front surface has a main refractive effect; while the posterior chamber PIOL generally has a flat front surface, and the rear surface is The main refractive effect also represents two extreme and typical design directions for negative lenses.
  • the method for preparing an aspherical vision correcting mirror controllable by the peripheral defocusing of the present invention comprises the following steps:
  • a vision correction mirror is prepared, and after the vision correction mirror refractive power is attached to the human eye, the refractive power of the whole eye refractive power formed on the retina is distributed in the peripheral region larger than the central region, and falls. Before the retina, myopia defocus is formed.
  • the aspherical surface of the optic zone of the lens is controlled by aspherical surface to make the radius of curvature change uniformly under different apertures, so that the refractive power in the periphery is greater than the central refractive power, and the refractive power distribution is presented.
  • the uniformly distributed hyperopic peripheral defocusing distribution state controls the myopia degree of myopic patients to deepen.
  • peripheral defocusing control idea and the diagnosis and treatment method opposite to the present invention can achieve the far vision peripheral defocusing of the human eye, thereby actively promoting the axial growth. Treat hyperopia.
  • a Ortho-Knife Mirror includes a lens 100 in which a base arc region 101 (an optical region of a face in contact with a cornea) is aspherical, and the aspheric surface is a lens 100.
  • the absolute value of the equivalent radius of curvature around the base arc region 101 is smaller than the lens The absolute value of the radius of curvature of the center of the base arc region 101 of 100.
  • the aspherical expression of the base arc region 101 of the lens 100 is:
  • c is the reciprocal of the radius of curvature of the base spherical surface of the optics
  • y is the vertical distance from any point on the curve to the abscissa axis (Z)
  • Q is the aspheric coefficient
  • a 2i is the aspheric high order coefficient
  • the aspherical surface is obtained by the aspherical curve by rotationally symmetrically changing about the abscissa axis (Z).
  • the aspherical surface shape of the base arc region 101 of the lens 100 is defined by a scale factor ⁇ of the equivalent curvature radius, and the proportional radius of the equivalent curvature radius of the aspheric surface is ⁇ 1;
  • 1; for an aspheric surface whose periphery is flatter than the center, ⁇ >1; for an aspheric surface whose periphery is steeper than the center, ⁇ 1.
  • the radius of curvature of the aspheric surface cannot be represented by the radius of curvature of a conventional spherical surface, but by the equivalent radius of curvature.
  • the method for calculating the equivalent radius of curvature of the base arc region 101 of the lens 100 is as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point .
  • the scale factor ⁇ of the equivalent radius of curvature of the aspherical surface of the base arc region 101 of the lens 100 at a pore diameter of 5 mm and a pore diameter of 3 mm is 0.67 ⁇ ⁇ 53 ⁇ 1.
  • the scale factor ⁇ of the equivalent radius of curvature of the aspherical surface of the base arc region 101 of the lens 100 at a 5 mm aperture and a 3 mm aperture is 0.67 ⁇ ⁇ 53 ⁇ 0.998.
  • the scale factor ⁇ of the equivalent curvature radius of the aspherical surface of the base arc region 101 of the lens 100 at a pore diameter of 5 mm and a pore diameter of 3 mm is 0.67 ⁇ ⁇ 53 ⁇ 0.991.
  • the lens can be made at a large aperture by the deformation control of the lens base arc region and the opposite of the present invention.
  • the absolute value of the effective radius of curvature is greater than the absolute value of the equivalent radius of curvature at the small aperture, so that the human eye achieves the far vision peripheral defocus, thereby actively promoting the growth of the eye axis and treating hyperopia.
  • an endoscope according to one aspect of the present invention includes an optical zone 100 of a lens and a support weir 110, the front surface 101 or the back surface 102 of the optic zone 100 of the lens being at least One is an aspherical surface, and the absolute value of the equivalent radius of curvature of the periphery of the optical zone 100 where the aspherical surface is the lens is greater than the absolute value of the radius of curvature of the center of the optical zone 100 of the lens.
  • the lens uniformly changes in the aperture direction according to the set refractive power.
  • the refractive power of the lens increases with the increase of the aperture, and the absolute value of the refractive power increases with the aperture. Decrease, the refractive power of the lens in the aqueous humor is ⁇ 0D.
  • A is the refractive power distribution curve of the spherical lens
  • B is the refractive power distribution curve of the conventional aspherical lens
  • C is the refractive power distribution curve of the lens of the endoscope of the present invention.
  • the aspherical expression of the optical zone 100 of the lens is:
  • c is the reciprocal of the radius of curvature of the base spherical surface of the optics
  • y is the vertical distance of any point on the curve from the abscissa axis (Z)
  • Q is the aspheric coefficient
  • a 2i is the aspherical higher order coefficient
  • the aspherical surface is obtained by the aspherical curve by rotationally symmetrically changing about the abscissa axis (Z).
  • A' is a spherical base curve
  • B' is a conventional aspheric base curve
  • C' is an aspherical base curve of the present invention.
  • the aspherical surface shape of the optical zone 100 of the lens is defined by a scale factor ⁇ of the equivalent curvature radius, and the proportional radius of the equivalent radius of curvature of the aspheric surface is ⁇ >1;
  • 1; for an aspheric surface whose periphery is flatter than the center, ⁇ >1; for an aspheric surface whose periphery is steeper than the center, ⁇ 1.
  • the equivalent radius of curvature of the optical zone 100 of the lens is calculated as follows:
  • d m is the measured aperture
  • M is the point at the aperture d m
  • h m is the vector height of the M point, ie the height difference between the M point and the vertex of the aspheric surface
  • r m is the equivalent radius of curvature of the M point .
  • the scale factor ⁇ of the equivalent radius of curvature of the aspherical surface of the optic zone of the lens at 4 mm aperture and 3 mm aperture is ⁇ 43 ⁇ 1.005.
  • the scale factor ⁇ of the equivalent radius of curvature of the aspheric surface of the optical zone of the lens at 4 mm aperture and 3 mm aperture is 1.002 ⁇ ⁇ 43 ⁇ 1.09.
  • the scale factor ⁇ of the equivalent radius of curvature of the aspherical surface of the optical zone of the lens at 4 mm aperture and 3 mm aperture is 1.01 ⁇ ⁇ 43 ⁇ 1.09.
  • Table 5 which refers to embodiments in which the parameters of Rp, Qp, A4, A6, and A8 are aspherical on the back surface of the lens, and Rp is the radius of curvature of the back surface base sphere, Qp, A4, A6.
  • A8 is an aspheric coefficient.
  • Embodiments involving parameters such as Ra, Qa, A4, A6, and A8 are aspherical on the front surface of the lens, Ra is the radius of curvature of the spherical surface of the rear surface, and Qa, A4, A6, and A8 are aspherical coefficients.
  • ⁇ 43 is the scale factor of the equivalent radius of curvature of the lens at 4 mm aperture and 3 mm aperture.
  • the absolute value of the equivalent radius of curvature of the aspherical surface of the optical zone 100 of the lens at a large aperture is greater than the absolute value of the equivalent radius of curvature of the small aperture, and the aspherical surface may be located at the front and back surfaces. On either side, or both sides are aspheric.
  • the shape of the support haptics 110 of the lens can also be any shape that performs the same function.
  • the absolute value of the refractive power of the lens under the large aperture can be larger than that under the small aperture by the opposite deformation control of the lens.
  • the absolute value of refractive power enables the human eye to achieve far-sighted peripheral defocusing, thereby treating hyperopia by actively promoting axial growth.

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Abstract

一种周边离焦可控的非球面视力矫正镜的制备方法,包括以下步骤:通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;根据得到的视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。还公开了根据这种方法制备的眼外佩戴的视力矫正镜、角膜塑形镜和眼内镜。

Description

视力矫正镜及其制备方法 技术领域
本发明涉及视力矫正镜的制备方法,具体地涉及周边离焦可控的非球面视力矫正镜的制备方法。本发明还涉及根据该方法制备的眼外佩戴的视力矫正镜、角膜塑形镜和眼内镜。本发明还涉及利用近视性周边离焦来控制和延缓近视增长的诊断治疗方法。
背景技术
离焦(Defocus、out-of-focus)是聚焦(focus)的相对应词,离焦是指像面不在焦点上,分为前离焦(焦前)和后离焦(焦后)两种状态。
近视眼度数增加的主要原因是眼轴长度延长,每延长1mm增加度数3.00度。最新医学研究证实,眼球延长依赖视网膜(如图1中10所示)周边离焦,按照屈光学概念,焦点落在视网膜前面者称为近视性离焦(如图1中30所示),落在视网膜后面者称为远视性离焦(如图1中20所示)。近视眼的视网膜中央呈近视性离焦,而视网膜周边呈远视性离焦,这种视网膜周边远视性离焦是促进近视眼度数不断增加的主要原因。
眼球具有依赖视网膜周边成像诱导眼球发育的特点,尤其是18岁以下青少年近视眼,如果视网膜周边成像为远视性离焦,视网膜会倾向于向像点生长,眼球长度就将延长,如果视网膜周边成像为近视性离焦,眼球就将停止延长。如果通过现代医疗方法,矫正视网膜周边远视性离焦或者人工形成视网膜周边近视性离焦,就可以阻止近视眼度数的不断增加,同时查明引起视网膜周边离焦原因,还可以有效预防近视眼的发生和进展。
周边离焦的概念是在视光学领域的实际临床中被整理和总结出来的,最初医生发现,部分的角膜塑形镜佩戴者的眼轴长度和近视增长速度被延缓,进而发现周边离焦在其中的作用,形成了周边离焦控制近视的理论。然而这种理论一直处于一种被动发现的状态,行业内医生与研究人员的相关讨论停留在大量统计和分析人眼的周边离焦状态,而没有形成有效的、可以量化的治疗实施方案;企业、研究机构 等则停留在提出一些初级的、周边离焦程度无法控制的产品,比如除了角膜塑形镜以外,后期又出现的采用分区结构的框架眼镜和光学离焦软性隐形眼镜。
角膜塑形镜的周边离焦控制机理是利用角膜表面细胞的活性,通过夜间配戴镜片将角膜前表面面形塑造成角膜塑形镜光学区内表面的形状(球面),进而形成远视化的周边离焦。
角膜塑形镜的缺点在于,对于不同患者而言,视网膜的弯曲程度是不一样的,现有的角膜塑形镜将角膜的外表面塑造为其基弧区的球面形状,其屈光力分布只遵守球面的屈光力分布规律,即对于相同的塑形后角膜前表面曲率半径而言,其屈光力分布只有一种单一的形态,当人眼视网膜的弯曲度大于角膜形成的屈光力分布弯曲度时,将无法形成近视性周边离焦,进而无法起到控制近视增长的目的;因此,基弧区为球面的角膜塑形镜无法形成程度可控的、有效的周边屈光力控制,仅能使部分患者受益控制近视增长,而无法做到使每位患者都实现近视的有效控制。
框架眼镜,采用分区结构,将中心设计为精确成像的0球差光学区,边缘设计为屈光力高于中心区域的周边离焦控制区,这种方式的问题在于,周边离焦只存在于常用光学区以外,在大部分情况下并不起作用,近视控制区十分有限且不连续。
光学离焦软性隐形眼镜,将镜片表面结构分为多层,分别设计为不同的弧度(曲率半径),2种弧度交替实现屈光力的远视化离焦。但是,这种实现周边离焦控制的方式存在两个问题,首先由于镜片只含有两种弧度,光学成像过程类似于分区的多焦点镜片,各焦点存在相互干扰,形成光晕现象;其次,由于各个弧段之间的曲率半径不同,环与环之间衔接会的造成大量的杂散光,因此这种镜片最大的问题在于成像受到光学区多层结构的干扰,视觉质量较差。
迄今为止,利用周边离焦来控制近视增长的这项技术面临两大问题,一是缺少一种明确的、可以量化的周边离焦控制实施方案;二是缺少有效的、程度可控的治疗产品。
因此,特别需要一种周边离焦可控的非球面视力矫正镜的制备方法,能根据患者的自身生理和屈光状态,来个性化地提供定量的、程度可控的周边离焦量产品,以解决上述现有存在的问题。
眼外佩戴的视力矫正镜包括与人眼直接发生接触的镜片(如角膜接触镜)和不与人眼直接发生接触的镜片(如框架眼镜)两种,框架眼镜一般由玻璃或树脂镜片制成,折射率大约在1.40-1.71之间;角膜接触镜是一种戴在眼球角膜上,用以矫正视力或保护眼睛的镜片,根据材料的软硬包括硬性、半硬性、软性三种,折射率大约在1.40-1.50范围内。
现有技术中,光学离焦软性隐形眼镜为周边离焦控制型的角膜接触镜,将镜片表面结构分为多层,分别设计为不同的弧度(曲率半径),2种弧度交替实现屈光力的近视化周边离焦。这种实现周边离焦控制的方式存在两个问题,首先由于镜片只含有两种弧度,光学成像过程类似于分区的多焦点镜片,各焦点存在相互干扰,形成光晕现象;其次,由于各个弧段之间的曲率半径不同,环与环之间衔接会的造成大量的杂散光,因此这种镜片最大的问题在于成像受到光学区多层结构的干扰,视觉质量较差。
现有的框架眼镜,采用分区结构,将中心设计为精确成像的0球差光学区,边缘设计为屈光力高于中心区域的周边离焦控制区,这种方式的问题在于,周边离焦只存在于常用光学区以外,在大部分情况下并不起作用,近视控制区十分有限且不连续。
因此,特别需要一种眼外佩戴的视力矫正镜,以解决上述现有存在的问题。
角膜塑形镜采用“反转几何”设计原理,将整个镜片与角膜接触的面(内表面)设计为几个相互衔接的弧段,佩戴后镜片内表面的特殊形状导致镜片与角膜外表面之间夹着一层分布不均匀的泪液,泪液的流体力学效应将角膜中央的上皮细胞向中周部(外围)拉;同时,闭眼时,眼睑的作用使得镜片中央对下方角膜施以一定的压力。这两种效应导致角膜中央曲率变平,角膜形状趋于角膜塑形镜内表面基弧区的形状,摘镜后,人眼屈光状态发生改变,视物成像点向靠近视网膜方向移动,矫正近视。
角膜塑形镜的“反转几何”设计是由Stoyan在1989年提出的(US 4952045),最初的反转几何设计将角膜塑形镜分成三个弧区,包括基弧区、反转弧区和周边弧区,由于这种设计的反转弧区很宽,边缘翘起高度较大,容易引发镜片无规则移动,在临床上具有较大的局限性。
现代“反转几何”设计的角膜塑形镜对反转几何区进行了改进,一般分为四个区域。如图12中所示,基弧区11接触角膜中央区域,面形较为平坦,用于压平角膜表面;反转弧区12较为陡峭,用于稳固基弧区11的压平效果,并保证一定的泪液储存量;定位弧区13又叫配适弧区,主要用于稳定镜片;周边弧区14保证角膜与角膜塑形镜周边泪液的流通。
角膜塑形镜的内表面是塑形功能实现区域,大部分的设计针对这个区域进行,方法是针对四个弧区的曲率半径和宽度两个变量,根据患者角膜形状和屈光度的要求分别进行设计。
目前,广泛应用于生产的设计一般采用4-7个或5-7个不同曲率半径的圆弧衔接而成。如图12中所示,四弧区是最基本的设计,四个弧区采用四个不同的曲率半径的球面,在各弧区衔接处进行倒角,使各弧段自然衔接。5-7个圆弧衔接是指在反转弧区12和定位弧区13用多个圆弧(如反转弧区使用两个圆弧,定位弧区使用三个圆弧),以使基弧区11与反转弧区12衔接更容易,并使定位弧区13与角膜形状更契合(由于角膜是非球面,采用多个球面来拟合非球面的形态)。现有的设计中也有采用非球面定位弧的设计。
由于角膜细胞的活性,角膜塑形镜带来的角膜形状的改变只是暂时的,当停戴角膜塑形镜后,角膜会回到原来的形态,因此最初的角膜塑形镜仅被视作一种用于暂时矫正近视的治疗手段。然而后续多年的临床研究发现,配戴角膜塑形镜能使一部分青少年眼轴增长速度减缓,进而对近视发展起到控制作用,临床研究指向,佩戴角膜塑形镜后人眼形成近视化的周边离焦是角膜塑形镜起作用的机制。
正常人眼的角膜一般是非球面,周边比中心略平坦,角膜塑形后,角膜前表面变为球面,即角膜塑形镜后表面的形状。图13为相同曲率半径的球面角膜(如图中A所示)与非球面角膜的屈光力(如图中B所示)随孔径变化的示意图,可见,球面角膜与非球面角膜相比,能为人眼周边带来更大的屈光力。因此,角膜塑形镜控制近视增长的真正机理在于通过夜间配戴镜片,角膜塑形镜将角膜塑造成了球面(角膜塑形镜光学区内表面的形状),从而使人眼在视物时周边的屈光力比塑形前更大,使部分佩戴者形成近视化周边离焦,进而减缓眼轴增长,控制近视发展。
现有的角膜塑形镜基弧区均为球面,球面的基弧区会将角膜前表面塑造为球面,使角膜提供的屈光力分布符合球面特征,其缺点在于,对于不同患者而言,视网膜的弯曲程度是不一样的,现有的角膜塑形镜将角膜的外表面塑造为其基弧区的球面形状,其屈光力分布只遵守该球面的屈光力分布规律,即对于相同的塑形后角膜前表面曲率半径而言,其屈光力分布只有一种形态。例如,对于塑形后角膜曲率半径为42.25D的角膜,其屈光力分布只能是如图13中A所示的一种情况,当人眼视网膜的弯曲度大于图示的角膜形成的屈光力分布弯曲度时,将无法形成近视性周边离焦,进而无法起到控制近视增长的目的。因此,基弧为球面的角膜塑形镜无法形成程度可控的、有效的周边屈光力控制,因此仅能使部分患者受益控制近视增长,而无法做到使每位患者都实现近视的有效控制。
现有的角膜塑形镜也有一些采用非球面的设计,如Berke在US 7984988 B2中,将角膜塑形镜的基弧区设计为椭圆面;Sami G.EI Hage在US 5695509中建议根据角膜形状与泪液厚度,确定关键坐标点,用坐标点进行非球面拟合,确定角膜塑形镜内表面面形;专利201420052256.2将角膜塑形镜的前表面设计为非球面,用于使人眼佩戴后夜间免受球差的干扰,提高视觉质量。这些设计的目标都是使角膜在塑形后人眼能够达到更优秀的视觉质量,使全眼屈光力分布尽量在各个孔径保持一致,进而导致远视化的周边离焦,这与周边离焦控制近视的目的和方法都是背道而驰的。
因此,特别需要一种基弧区为特殊非球面的角膜塑形镜,实现程度可控的近视化周边离焦,以解决上述现有存在的问题。
眼内镜主要指用于近视屈光的有晶体眼人工晶状体(PIOL),这种有晶体眼人工晶状体(PIOL)是通过手术的方式,把带有负度数的镜片植入到人眼的角膜与晶状体之间,从而矫正人眼的屈光不正。
有晶体眼人工晶状体(PIOL)根据植入位置的不同,分为前房型和后房型,前房型的一般后表面较为平坦,前表面起主要的屈光作用;而后房型的一般前表面较为平坦,后表面起主要的屈光作用。
市面上现有的PIOL为球面设计,专利201520014249.8中披露了一种非球面设计的PIOL,其目的在于使人眼在不同的孔径下总屈光力保持一个恒定的值,从而达到更好的视觉质量。球面设计的负屈光度 镜片提供的屈光力随孔径的增大而减小(绝对值增大),会使人眼形成远视性离焦,促进眼轴增长,进而使近视发展加速;现有的非球面设计的PIOL使人眼在不同孔径下屈光力保持恒定值,与视网膜的弯曲度相比,也会形成远视性离焦,进而使近视发展加速。
因此,特别需要一种眼内镜,以解决上述现有存在的问题。
发明内容
本发明的一个目的在于提供一种周边离焦可控的非球面视力矫正镜的制备方法,针对现有技术的不足,通过测量人眼的视网膜形状或周边离焦或戴镜周边离焦来确定镜片的屈光力分布状态,制备成视力矫正镜,人眼在使用视力矫正镜后,使其屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦,控制近视增长。
根据本发明的第一方面,提供了一种周边离焦可控的非球面视力矫正镜的制备方法,它包括如下步骤:
(1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
(2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
(3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
在本发明的一个实施例中,在上述步骤(1)中,人眼视网膜形状通过眼科检测设备测量,如果眼科检测设备将视网膜视为球面,则以视网膜的曲率半径衡量视网膜的形状;如果眼科检测设备将视网膜视为非球面,则以非球面的等效曲率半径衡量视网膜的形状;非球面的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000001
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
在本发明的一个实施例中,在上述步骤(2)中,视力矫正镜片与人眼形成的整眼屈光力(D′t)的分布状态相对于视网膜的形状为近视性离焦,满足:
Figure PCTCN2016090955-appb-000002
其中,Dr为整眼在半径为r时的屈光力,D0为整眼在小孔径时(傍轴)的屈光力,即整眼屈光力的标称值,r为视网膜平面的半径,R为视网膜的曲率半径或者等效曲率半径。
在本发明的一个实施例中,视网膜的形状通过光学相干断层成像仪OCT或类似眼科检测设备测量。
在本发明的一个实施例中,在上述步骤(1)中,人眼裸眼周边离焦量(ΔD1)与戴镜状态下的周边离焦量(ΔD3)均通过眼科检测设备测量,所述非球面视力矫正镜的离焦量(ΔD2)已知,在视力矫正镜片提供的周边离焦量(ΔD2)+人眼裸眼周边离焦量(ΔD1)≥0,人眼形成近视化周边离焦;当人眼戴镜周边离焦量(ΔD3)>0时,表明试戴片镜片的离焦量已满足使人眼达到近视化周边离焦的条件。
在本发明的一个实施例中,当人眼戴镜周边离焦量(ΔD3)≤0时,表明镜片的离焦量仍然使人眼处于远视化周边离焦的状态,需要加大镜片的离焦量,使人眼达到近视化周边离焦。
在本发明的一个实施例中,可以根据患者自身的生理条件及对近视控制程度的要求,进行镜片周边离焦量的增大或减小,达到个性化的视力矫正。
在本发明的一个实施例中,在上述步骤(3)中,根据步骤(2)得到的屈光力分布方案,通过非球面设计方法制作成视力矫正镜,所述非球面的表达式:
Figure PCTCN2016090955-appb-000003
其中,Z(y)为视力矫正镜镜片的非球面在YZ平面上的曲线的表达式,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何一点距横坐标轴(Z)的垂直距离,Q为非球面系数,A2i为非球面高次项系数,所述非球面面形上的各点由所述曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到;
通过调整视力矫正镜镜片的Q值、各非球面系数,使视力矫正镜镜片的面形在径向不同部位表现为不同的等效曲率,在整个光学区实现等效曲率均匀、连续的变化,从而使视力矫正镜镜片在不同的孔径下具备与近视性离焦屈光力分布状态相适应的屈光力,周边区域屈光力大于中心区域屈光力;
等效曲率半径通过:
Figure PCTCN2016090955-appb-000004
描述,
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
本发明的周边离焦可控的非球面视力矫正镜的制备方法,与现有技术相比,利用非球面控制视力矫正镜镜片光学区的面形和曲率半径,使视力矫正镜镜片在孔径方向按所设定的屈光力周边离焦量均匀变化,视力矫正镜镜片屈光力随孔径增大而增大,为人眼提供程度可控的近视化离焦,防止眼轴增长,延缓近视加深,实现本发明的目的。
本发明的另一个目的在于提供一种眼外佩戴的视力矫正镜,针对现有技术的不足,利用非球面控制镜片光学区的面形和曲率半径,使其在周边的等效曲率半径比中心更小,周边面形比球面更陡峭,从而使其在孔径方向按所设定的屈光力分布均匀变化,镜片屈光力随孔径增大而增大,为人眼提供程度可控的近视化周边离焦,防止眼轴增长,延缓近视加深。
根据本发明的第二方面,提供了一种根据上述制备方法制备的非球面视力矫正镜,所述视力矫正镜是眼外佩戴的矫正镜,所述镜片光学区的凸面或者凹面至少一个为非球面,当所述镜片光学区的凸面为非球面时,镜片光学区周边的等效曲率半径的绝对值小于镜片光学区中心的曲率半径的绝对值;当所述镜片光学区的凹面为非球面时,镜片光学区周边的等效曲率半径的绝对值大于镜片光学区中心的曲率半 径的绝对值。
在本发明的一个实施例中,所述镜片光学区的非球面的面形通过等效曲率半径的比例因子η限定,η为不同孔径dm、dn下的r之比,其中,m>n:
Figure PCTCN2016090955-appb-000005
所述镜片光学区的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000006
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径;
当所述镜片光学区的凹面为非球面时,则非球面的等效曲率半径比例因子η>1,优选的,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为1.002≤η53≤1.086;当所述镜片光学区的凸面为非球面时,则非球面的等效曲率半径比例因子η<1,优选的,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为0.682≤η53≤0.986;
在本发明的一个实施例中,所述镜片在空气中的屈光力≤0D,所述镜片屈光力在径向随孔径增大而增大,所述镜片屈光力绝对值随孔径增大而减小。
在本发明的一个实施例中,所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为ΔD53≥0.005D;优选地,所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为0.005D≤ΔD53≤8.849D。
本发明的眼外佩戴的视力矫正镜,与现有技术相比,利用非球面控制镜片光学区的面形和曲率半径,使视力矫正镜镜片在孔径方向按所设定的屈光力分布均匀变化,视力矫正镜镜片屈光力随孔径增大而增大,屈光力绝对值随孔径增大而减小,为人眼提供程度可控的近视 化周边离焦,防止眼轴增长,延缓近视加深,实现本发明的目的。
本发明的另一个目的在于提供一种角膜塑形镜,针对现有技术的不足,利用非球面控制镜片光学区的面形和曲率半径,使其在周边的等效曲率半径绝对值比中心更小,周边面形比球面更陡峭,从而使其在径向按所设定的屈光力分布方式均匀变化,镜片屈光力随孔径增大而增大,为人眼提供程度可控的近视化离焦,防止眼轴增长,延缓近视加深。
根据本发明的第三方面,提供了一种根据上述制备方法制备的非球面视力矫正镜,所述视力矫正镜是角膜塑形镜,其特征在于,所述镜片基弧区的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η<1;优选的所述镜片基弧区的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53<1;更优选的,所述镜片基弧区的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53≤0.998;
比例因子η为镜片不同直径dm、dn下的r之比,m>n:
Figure PCTCN2016090955-appb-000007
所述镜片基弧区的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000008
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
本发明的角膜塑形镜,与现有技术相比,利用非球面控制镜片基弧区的面形和曲率半径,使其在周边的等效曲率半径绝对值比中心更小,周边面形比球面更陡峭,通过一晚上的配戴,将人眼角膜前表面塑造为角膜塑形镜基弧区的形状,从而为人眼提供程度可控的近视化离焦,防止眼轴增长,延缓近视加深,实现本发明的目的。
本发明的另一个目的在于提供一种眼内镜,针对现有技术的不足,利用非球面控制镜片光学区的面形和曲率半径,使其在不同的孔径下曲率半径呈均匀变化,在周边的等效曲率半径绝对值比中心的等效曲率半绝对值径大,从而使其在周边的屈光力比中心屈光力更大(周边屈光力绝对值比中心屈光力绝对值小),屈光力分布呈现均匀变化的近视性周边离焦的分布状态,控制近视患者的近视度数加深。
根据本发明的第四方面,提供了一种根据上述制备方法制备的非球面视力矫正镜,所述视力矫正镜是眼内镜,其特征在于,所述镜片光学区的前表面或者后表面至少一个为非球面,镜片在孔径方向按所设定的屈光力周边离焦量均匀变化,所述镜片的屈光力随孔径增大而增大,屈光力的绝对值随孔径增大而减小,所述镜片在房水中的屈光力为≤0D。
在本发明的一个实施例中,所述镜片光学区的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η>1;优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为η43≥1.005;更优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为1.002≤η43≤1.09;
比例因子η为镜片不同直径dm、dn下的r之比,m>n,则有:
Figure PCTCN2016090955-appb-000009
所述镜片光学区的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000010
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
本发明的眼内镜,与现有技术相比,通过非球面的面形结构,利 用非球面控制镜片光学区的面形和曲率半径,使其在不同的孔径下曲率半径呈均匀变化,在周边的等效曲率半径的绝对值比中心的等效曲率半径的绝对值大,从而使其在周边的屈光力比中心屈光力更大,周边屈光力的绝对值比中心屈光力的绝对值小,屈光力分布呈现均匀变化的近视性周边离焦的分布状态,控制近视患者的近视度数加深,实现本发明的目的。
根据本发明的第五方面,提供了一种利用近视性周边离焦来控制和延缓近视增长的诊断治疗方法,其特征在于,所述诊断治疗方法通过使用根据上述制备方法制备的非球面视力矫正镜来实现。
本发明的特点可参阅本案图示及以下较好实施方式的详细说明而获得清楚的了解。
附图说明
图1为视网膜、近视性离焦和远视性离焦的示意图;
图2为本发明的近视化周边离焦屈光度分布曲线的示意图;
图3为本发明的非球面曲线表达式的示意图;
图4为本发明的比例因子η涉及参数的示意图;
图5为本发明的实施例1的结构示意图;
图6为本发明的实施例2的结构示意图。
图7为本发明的镜片的径向示意图。
图8为本发明的视力矫正镜诊断治疗方法的流程示意图。
图9为本发明的视网膜与屈光力分布的示意图。
图10为本发明的实施例3的流程示意图。
图11为本发明的实施例4的流程示意图。
图12为内表面为四弧区设计的现有角膜塑形镜的纵向中心剖面的示意图。
图13为现有的屈光力42.25D的球面角膜及非球面系数Q值为-0.25、屈光力为42.25D的非球面角膜在不同孔径下的屈光力分布情况的示意图。
图14为本发明的角膜塑形镜的结构示意图。
图15为本发明的一种眼内镜的结构示意图。
图16为图15的侧视图。
图17为本发明的另一种眼内镜的结构示意图。
图18为图17的侧视图。
图19为本发明的屈光力分布与现有技术的屈光力分布示意图。
图20为本发明的非球面面形与现有技术的非球面面形示意图。
具体实施方式
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体图示,进一步阐述本发明。
术语定义:
在本申请中使用的术语“近视性周边离焦”是指周边区域屈光力大于中心区域屈光力,当中心像点落于视网膜上时,周边区域的像点落于视网膜之前,此时定义周边离焦量ΔD>0。
在本申请中使用的术语“远视性周边离焦”是指周边区域屈光力小于中心区域屈光力,当中心像点落于视网膜上时,周边区域的像点落于视网膜之后,此时定义周边离焦量ΔD<0。
在本申请中使用的术语“屈光力”是镜片对于光线的折射强度大小的度量,“屈光度”是对屈光力大小的度量,屈光度有正有负,符号同样参与大小的对比,比如对于D1=10.0D,D2=15.0D,则D1<D2;对于D3=-10.0D,D4=-15.0D,则D3>D4。
在本申请中使用的术语“光学区”指的是位于镜片中心区域的具有光学特性从而能够实现调节镜片屈光度的主要功能的部分。
在本申请中使用的术语“襻”或“支撑襻”指的是与镜片光学部相连、起到支撑光学部,使镜片在人眼中定位的作用的部分。
在本申请中使用的术语“径向”指的是从镜片中心沿半径或直径的直线方向。
在本申请中使用的术语“孔径”指的是镜片表面径向的直径大小。
在本申请中所使用表示方位关系的术语例如“前”、“后”是相对于眼睛角膜表面的远近而言的。例如,对于本申请的镜片而言,“光学部后表面”是比“光学部前表面”距离眼睛角膜更近的光学面。
在本申请中使用的术语“基础球面”指的是与镜片的光学部的前、后表面所采用的各种面形所相对应的具有相同曲率半径设计值的理想球面。在本申请中,为了统一用语,将该理想球面统一称作“基础球面”。
在本申请中使用的术语“陡峭”和“平坦”指的是对镜片的等效曲率半径大小程度的描述,例如,对于本申请而言,“比球面更陡峭”指镜片的等效曲率半径的绝对值相对基础球面的曲率半径绝对值而言更小,“比球面更平坦”指镜片的等效曲率半径绝对值相对基础球面的曲率半径绝对值而言更大。
在本申请中使用的术语“凸面”指过面上任意一点做切面,表面总是在切面的下方;“凹面”是指过面上任意一点做切面,表面总是在切面的上方。
类似于图6所示,根据本发明的一个方面的眼外佩戴的视力矫正镜包括镜片,所述镜片的光学区100的凸面101或者凹面102至少一个为非球面,当所述镜片的光学区100的凸面101为非球面时,所述镜片的光学区100的周边的等效曲率半径小于所述镜片的光学区100的中心的曲率半径;当所述镜片的光学区100的凹面102为非球面时,所述镜片的光学区100的周边的等效曲率半径大于所述镜片的光学区100的中心的曲率半径
如图2所示,所述镜片在空气中的屈光力≤0D,所述镜片屈光力在径向随孔径增大而增大,所述镜片屈光力绝对值随孔径增大而减小。
图7为本发明的镜片的径向示意图,图中A所示为本发明的镜片的正视图,图中B所示为本发明的镜片的径向。
所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为ΔD53≥0.005D;优选地,所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为0.005D≤ΔD53≤8.849D。
如图3所示,所述镜片的光学区100的非球面的表达式为:
Figure PCTCN2016090955-appb-000011
其中,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何一点距横坐标轴(Z)的垂直距离,Q为非球系数,A2i为非球面高次项系数,且所述非球面由所述非球面曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到。
如图4所示,所述镜片的光学区100的非球面的面形通过等效曲 率半径的比例因子η限定,η为不同孔径dm、dn下的r之比,其中,m>n:
Figure PCTCN2016090955-appb-000012
当所述镜片的光学区100的凹面102为非球面时,则非球面的等效曲率半径比例因子η>1;当所述镜片的光学区100的凸面101为非球面时,则非球面的等效曲率半径比例因子η<1;
所述镜片的光学区100的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000013
其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
当所述镜片的光学区100的凹面102为非球面时,优选地,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为1.002≤η53≤1.086。
当所述镜片的光学区100的凸面101为非球面时,优选地,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为0.682≤η53≤0.986。
实施例1
如图5所示,在本实施例中,所述视力矫正镜为角膜接触镜,其镜片光学区100’的凹面102’(与角膜直接接触的面)的面形与角膜的面形相一致,球面或与角膜形态一致的非球面,其镜片光学区100’的凸面101’为本发明的非球面结构,本发明的非球面结构如上所述。
在本实施例中,优选地,所述非球面的面形在5mm孔径和3mm孔径下的等效曲率半径的比例因子η53为0.682≤η53≤0.986;屈光力之差为0.130D≤ΔD53≤4.779D。
具体的实施例参见表1,表1中Rp、Qp为接触镜的凸面(与角膜直接接触的面)的曲率半径和非球面系数;Ra、Qa、A4、A6、A8分别为接触镜前表面的曲率半径、非球面系数、高阶非球面系数;ΔD53为5mm、3mm孔径下镜片的屈光力之差;η53为镜片的非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子。
表1 角膜接触镜实施例
Figure PCTCN2016090955-appb-000014
Figure PCTCN2016090955-appb-000015
实施例2
在本实施例中,所述视力矫正镜为框架眼镜,其镜片光学区100的凸面101或者凹面102至少一个为本发明的非球面结构,本发明的非球面结构如上所述。
其镜片光学区100的凸面101为本发明的非球面结构,其结构与实施例1类似,周边的等效曲率半径比中心更小,周边面形比球面更陡峭,从而使其在孔径方向按所设定的屈光力分布均匀变化。
如图6所示,本发明的非球面结构位于镜片光学区100的凹面102时,由于非球面所在的表面为镜片提供负的屈光力,在这种情况下,镜片在大孔径提供的屈光力绝对值应比小孔径小,才能使镜片获得与本发明相同的屈光力分布状态,显然,为了达到相同的屈光力控制,周边面形应比球面更平坦。
在本实施例中,优选地,所述非球面的面形在5mm孔径和3mm孔径下的等效曲率半径的比例因子η53为1.002≤η53≤1.086;屈光力之差为0.005D≤ΔD53≤8.849D。
具体的实施例参见表2,表2中Rp、Qp为接触镜凸面(与角膜直接接触的面)的曲率半径和非球面系数;Ra、Qa、A4、A6、A8分别为接触镜凸面的曲率半径、非球面系数、高阶非球面系数;ΔD53为5mm、3mm孔径下镜片的屈光力之差;η53为镜片的非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子。
表2 框架眼镜实施例
折射率 Ra Rp Qp A4 A6 A8 ΔD53 η53
1.43 10.428 6.869 -0.727 -3.81E-04 -1.33E-06 2.85E-08 3.047 1.036
1.43 10.428 6.869 -1.000 0 0 0 1.040 1.021
1.43 10.428 6.869 -2.000 0 0 0 3.429 1.040
1.43 10.428 6.869 -5.000 0 0 0 7.939 1.086
1.50 9.773 7.000 -5.000 0 0 0 8.662 1.083
1.70 8.807 7.000 -5.000 0 0 0 8.849 1.083
1.43 8.368 5.502 0.215 -7.247E-04 -1.067E-05 -1.003E-06 0.392 1.024
1.55 7.724 5.954 -0.157 -2.029E-04 -2.378E-06 -9.978E-08 0.227 1.014
1.71 7.275 5.964 -0.123 -1.562E-04 -1.820E-06 -9.407E-08 0.225 1.011
1.71 6.203 5.996 -0.019 -2.161E-05 -1.861E-07 -2.286E-08 0.005 1.002
当然,对于框架眼镜而言,镜片的凸面和凹面除了可以只有一面为本发明的非球面结构,也可以两面均为本发明的非球面结构,在此就不赘述了。
在本发明近视性周边离焦控制近视增长以及镜片的非球面设计思路下,本领域人员也可以想到,可以通过镜片相反的变形控制来使镜片在大孔径下的屈光力绝对值大于小孔径下的屈光力绝对值,使人眼达到远视性周边离焦,从而通过主动促进眼轴增长,治疗远视。
如图8所示,根据本发明的一个方面的周边离焦可控的非球面视力矫正镜的制备方法包括如下步骤:
(1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
(2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
(3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
如图9所示,图中B为视网膜,图中C为整眼在视网膜上形成的屈光力分布曲线;视网膜形状、人眼裸眼周边离焦量和人眼戴镜周边离焦量均可通过眼科检测设备测量。
人眼视网膜形状通过眼科检测设备测量(如光学相干断层成像仪OCT),眼科检测设备将视网膜视为球面,则以视网膜的曲率半径衡量视网膜的形状。
人眼视网膜形状通过眼科检测设备测量,眼科检测设备将视网膜视为非球面,则以非球面的等效曲率半径衡量视网膜的形状;非球面的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000016
其中,其中dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
视力矫正镜片与人眼形成的整眼屈光力分布满足:
Figure PCTCN2016090955-appb-000017
视力矫正镜片与人眼形成的整眼屈光力分布状态相对于视网膜的形状为近视性离焦,则满足:
Figure PCTCN2016090955-appb-000018
其中,Dr为整眼在半径为r时的屈光力,D0为整眼在小孔径时(傍轴)的屈光力,即整眼屈光力的标称值,r为视网膜平面的半径,R为视网膜的曲率半径或者等效曲率半径。
在上述条件下,整眼在视网膜上形成的屈光力分布如图9中的曲线C。可以通过非球面设计,使镜片边缘屈光力与中心屈光力之差符合 上述要求。
根据得到的屈光力分布满足的条件关系,通过非球面设计方法制作成视力矫正镜,使视力矫正镜镜片的屈光力在不同孔径呈近视化离焦分布,即屈光力随孔径增大而增大(如图2所述)。
人眼裸眼周边离焦量(ΔD1)可以通过眼科检测设备测量(如OCT、角膜地形图仪、波前像差仪等),在视力矫正镜片提供的周边离焦量(ΔD2)+人眼裸眼周边离焦量(ΔD1)≥0时,人眼形成近视化周边离焦。
人眼可以配戴已知屈光度和屈光力分布状态的试戴镜片,在戴镜状态下检查人眼戴镜周边离焦量(ΔD3),人眼戴镜周边离焦量(ΔD3)可以通过眼科检测设备测量;当人眼戴镜周边离焦量(ΔD3)>0时,表明试戴片镜片的离焦量已满足使人眼达到近视化周边离焦的条件,可以以此制作成视力矫正镜;当人眼戴镜周边离焦量(ΔD3)≤0时,表明镜片的离焦量仍然使人眼处于远视化周边离焦的状态,需要加大镜片的离焦量,使人眼达到近视化周边离焦。
可以根据患者自身的生理条件及对近视控制程度的要求,进行镜片周边离焦量的增大或减小,达到个性化的视力矫正。
根据步骤(2)得到的屈光力分布方案,通过非球面设计方法制作成视力矫正镜,使视力矫正镜镜片的屈光力在不同孔径呈近视化离焦分布,即屈光力随孔径增大而增大;所述非球面(如图3所示,图中D为球面曲线,图中E为非球面曲线)的表达式:
Figure PCTCN2016090955-appb-000019
其中,Z(y)为视力矫正镜镜片的非球面在YZ平面上的曲线的表达式,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何一点距横坐标轴(Z)的垂直距离,Q为非球系数,A2i为非球面高次项系数,所述非球面面形上的各点由所述曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到;
通过调整视力矫正镜镜片的Q值、各非球面系数,使视力矫正镜镜片的面形在径向不同部位表现为不同的等效曲率,在整个光学区实 现等效曲率均匀、连续的变化,从而使视力矫正镜镜片在不同的孔径下具备与近视性离焦屈光力分布状态相适应的屈光力,周边区域屈光力大于中心区域屈光力。
在上述还包括一非球面面形的控制方法,所述控制方法为通过等效曲率半径的比例因子η进行描述(如图4所示),则有:
Figure PCTCN2016090955-appb-000020
η为不同孔径dm、dn下的r之比,m>n;
对于球面,则η=1;对于周边比中心平坦的非球面,则η>1;对于周边比中心陡峭的非球面,则η<1,通过对等效曲率半径的比例因子的控制,来设计非球面在每个孔径下的等效曲率半径,进而使镜片的屈光力分布满足近视化周边离焦的要求。
用镜片在空气中的不同孔径的屈光力之差表示:
ΔDm,n=Dm-Dn
表示孔径分别为m和n的情况下,镜片的屈光力之差,其中m>n。
本发明还提供一种非球面视力矫正镜,包括眼外佩戴的视力矫正镜、角膜塑形镜和眼内镜,所述非球面视力矫正镜使用本发明所述的非球面视力矫正镜的制备方法来制成。
本发明还提供一种利用近视性周边离焦来控制和延缓近视增长的诊断治疗方法,所述诊断治疗方法通过使用本发明所述的非球面视力矫正镜的制备方法中制备的非球面视力矫正镜来实现。
实施例3
在本实施例中,所述视力矫正镜为眼外佩戴的视力矫正镜(如框架眼镜)。
如图10所示,在本实施例中,除了RGP、框架眼镜现有的验配方式以外,还包括本发明的周边离焦可控的非球面视力矫正镜的制备方法,它包括如下步骤:
(1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
(2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
(3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
其他内容同上,在此就不赘述了。
实施例4
在本实施例中,所述视力矫正镜为角膜塑形镜。
如图11所示,在本实施例中,角膜塑形镜的基本设计方法与现有方法相同,但基弧区的面形由视网膜弯度决定,根据视网膜的弯度计算人眼视网膜需要达到的屈光力分布状态,保证人眼的屈光力随着孔径变大而变大的趋势大于视网膜弯度,形成远视性周边离焦,从而防止人眼视轴延长,控制近视增长。根据人眼的屈光力分布,进行角膜塑形镜内表面(基弧区)的面形设计,由于塑形镜的原理是人眼在配戴塑形镜后,角膜形状变为塑形镜基弧区的形状,因此塑形镜基弧区的面形即为角膜实现光学功能的面形。
通过视网膜的弯度计算人眼视网膜需要达到的屈光力分布状态采用本发明的周边离焦可控的非球面视力矫正镜的制备方法,它包括如下步骤:
(1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
(2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
(3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
其他内容同上,在此就不赘述了。
实施例5
在本实施例中,所述视力矫正镜为眼内镜。
眼内镜主要指用于近视屈光的有晶体眼人工晶状体(PIOL),这种PIOL是通过手术的方式,把带有负度数的镜片植入到人眼的角膜与晶状体之间,从而矫正人眼的屈光不正。
眼内镜根据植入位置的不同,分为前房型和后房型,前房型的PIOL一般后表面较为平坦,前表面起主要的屈光作用;而后房型的PIOL一般前表面较为平坦,后表面起主要的屈光作用,也代表着负镜片的两种较为极端和典型的设计方向。
同样,通过本发明的周边离焦可控的非球面视力矫正镜的制备方法,它包括如下步骤:
(1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
(2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
(3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
通过非球面的面形设计,利用非球面控制镜片光学区的面形和曲率半径,使其在不同的孔径下曲率半径呈均匀变化,使其在周边的屈光力比中心屈光力更大,屈光力分布呈现均匀变化的远视性周边离焦的分布状态,控制近视患者的近视度数加深。
镜片本领域人员可以想到,也可以采用非球面公式中的不同非球面系数的组合来达到本发明的目的。
在本发明的设计思路下,本领域人员也可以想到,可以通过与本发明相反的周边离焦控制思路和诊断治疗方法,使人眼达到远视性周边离焦,从而通过主动促进眼轴增长,治疗远视。
如图14所示,根据本发明的一个方面的角膜塑形镜包括镜片100,镜片100的基弧区101(与角膜接触的面的光学区)为非球面,所述非球面为镜片100的基弧区101周边的等效曲率半径的绝对值小于镜片 100的基弧区101中心的曲率半径的绝对值。
如图3所示,镜片100的基弧区101的非球面的表达式为:
Figure PCTCN2016090955-appb-000021
其中,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何一点距横坐标轴(Z)的垂直距离,Q为非球系数,A2i为非球面高次项系数,且所述非球面由所述非球面曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到。
如图4所示,镜片100的基弧区101的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η<1;
比例因子η为镜片不同直径dm、dn下的r之比,m>n,则有:
Figure PCTCN2016090955-appb-000022
对于球面,则η=1;对于周边比中心平坦的非球面,则η>1;对于周边比中心陡峭的非球面,则η<1。
非球面的曲率半径不能用传统球面的曲率半径来表示,而是通过等效曲率半径。镜片100的基弧区101的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000023
其中,其中dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
优选地,所述镜片100的基弧区101的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53<1。
更优选地,所述镜片100的基弧区101的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53≤0.998。
更优选地,所述镜片100的基弧区101的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53≤0.991。
本发明涉及到的具体的实施例参见表3和表4,表中Q、A4、A6、A8为非球面系数;η53为镜片在5mm孔径和3mm孔径下的等效曲率半径的比例因子
表3 角膜塑形镜基弧区面形实施例
曲率半径 Q η53 曲率半径 Q η53
9.643 0.2 0.998 5.000 2.5 0.820
9.643 0.5 0.994 10.000 5.0 0.940
9.643 1.0 0.989 7.000 0.5 0.989
6.136 0.2 0.994 7.000 3.0 0.921
6.136 1.0 0.969 8.000 3.0 0.944
6.136 3.0 0.885 5.000 0.2 0.991
6.136 5.0 0.665 5.000 0.5 0.976
6.136 4.0 0.818 5.000 0.7 0.966
5.000 1.0 0.949 5.000 2.0 0.876
5.000 1.2 0.937 5.000 2.5 0.820
5.000 1.5 0.917 5.000 2.9 0.741
表4 角膜塑形镜基弧区面形实施例
曲率半径 Q A4 A6 A8 η53
5.946 9.400E-02 1.604E-04 1.695E-06 2.829E-07 0.990
4.935 1.385E-01 4.806E-04 4.146E-06 9.006E-07 0.978
4.934 1.385E-01 4.702E-04 4.087E-06 8.892E-07 0.978
4.939 1.618E-01 6.567E-04 1.322E-05 8.648E-07 0.970
5.068 8.048E-03 6.610E-05 6.408E-07 2.590E-09 0.997
本领域的技术人员很容易想到,可以采用不同的非球面系数组合来实现与本发明相同的非球面结构。
在本发明近视性周边离焦控制近视增长以及镜片的非球面设计思路下,本领域人员也可以想到,可以通过镜片基弧区与本发明相反的变形控制,来使镜片在大孔径下的等效曲率半径绝对值大于小孔径下的等效曲率半径绝对值,使人眼达到远视性周边离焦,从而通过主动促进眼轴增长,治疗远视。
结合图15、图16、图17和图18所示,根据本发明的一个方面的眼内镜包括镜片的光学区100和支撑襻110,镜片的光学区100的前表面101或者后表面102至少一个为非球面,所述非球面为镜片的光学区100周边的等效曲率半径的绝对值大于镜片的光学区100中心的曲率半径的绝对值。
结合图2和图19所示,所述镜片在孔径方向按所设定的屈光力周边离焦量均匀变化,所述镜片的屈光力随孔径增大而增大,屈光力的绝对值随孔径增大而减小,所述镜片在房水中的屈光力为≤0D。
在图19中,A为球面镜片的屈光力分布曲线,B为现有的非球面镜片的屈光力分布曲线,C为本发明眼内镜的镜片的屈光力分布曲线。
结合图3和图20所示,镜片的光学区100的非球面的表达式为:
Figure PCTCN2016090955-appb-000024
其中,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何 一点距横坐标轴(Z)的垂直距离,Q为非球系数,A2i为非球面高次项系数,且所述非球面由所述非球面曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到。
在图20中,A’为球面基础曲线,B’为现有非球面基础曲线,C’为本发明的非球面基础曲线。
如图4所示,镜片的光学区100的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η>1;
比例因子η为镜片不同直径dm、dn下的r之比,m>n,则有:
Figure PCTCN2016090955-appb-000025
对于球面,则η=1;对于周边比中心平坦的非球面,则η>1;对于周边比中心陡峭的非球面,则η<1。
镜片的光学区100的等效曲率半径的计算方法如下:
Figure PCTCN2016090955-appb-000026
其中,其中dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为η43≥1.005。
优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为1.002≤η43≤1.09。
优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为1.01≤η43≤1.09。
本发明的若干实施例参见表5,表中涉及到Rp、Qp、A4、A6、A8这些参数的实施例为非球面位于镜片后表面,Rp为后表面基础球面曲率半径,Qp、A4、A6、A8为非球面系数。涉及到Ra、Qa、A4、A6、A8这些参数的实施例为非球面位于镜片前表面,Ra为后表面基 础球面曲率半径,Qa、A4、A6、A8为非球面系数。η43为镜片在4mm孔径和3mm孔径下的等效曲率半径的比例因子。
表5 实施例
折射率 Rp Qp A4 A6 A8 η43
1.45 5.516 -0.218 -6.089E-04 -4.574E-04 3.574E-05 1.048
1.48 6.838 -3.263 -5.330E-04 -1.525E-06 6.005E-08 1.041
1.50 7.811 -3.176 -5.774E-04 1.016E-06 -1.214E-08 1.038
1.55 10.700 -3.263 -5.330E-04 -1.525E-06 6.005E-08 1.034
1.60 13.200 -3.263 -5.330E-04 -1.525E-06 6.005E-08 1.035
1.70 18.200 -3.263 -5.330E-04 -1.525E-06 6.005E-08 1.042
1.45 5.700 -5.000 0 0 0 1.053
1.45 5.700 -10.000 0 0 0 1.086
1.45 5.583 -0.302 -6.258E-04 -5.129E-06 -1.221E-07 1.016
1.50 8.116 -0.525 -1.65E-04 -9.82E-07 1.96E-08 1.008
1.55 10.634 -0.530 -7.84E-05 -6.75E-07 1.93E-08 1.005
1.70 18.170 -0.739 -7.92E-06 -4.60E-07 1.44E-08 1.002
折射率 Ra Qa A4 A6 A8 η43
1.45 -5.670 2.891 -4.209E-05 1.460E-03 -1.193E-04 1.037
在本发明的目的下,镜片的光学区100的非球面在大孔径下的等效曲率半径的绝对值大于小孔径下的等效曲率半径的绝对值,非球面可以位于前表面和后表面的任意一面,或两面均为非球面。
本领域的技术人员可以想到,也可以采用非球面公式中的不同非球面系数的组合来达到本发明的目的;镜片的支撑襻110的形状也可以是起到相同作用的任何攀形。
在本发明近视性周边离焦控制近视增长以及镜片的非球面设计思路下,本领域人员也可以想到,可以通过镜片相反的变形控制来使镜片在大孔径下的屈光力绝对值大于小孔径下的屈光力绝对值,使人眼达到远视性周边离焦,从而通过主动促进眼轴增长,治疗远视。
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内,本发明要求保护范围由所附的权利要求书及其等效物界定。

Claims (16)

  1. 一种周边离焦可控的非球面视力矫正镜的制备方法,其特征在于,包括如下步骤:
    (1)通过对人眼视网膜形状或人眼裸眼周边离焦量或人眼戴镜周边离焦量的检查,计算并判断人眼形成近视化离焦所需的条件;
    (2)根据近视化离焦得到的条件,形成视力矫正镜片的屈光力随孔径变化的分布方案;
    (3)根据上述得到视力矫正镜片的屈光力分布方案,制作成视力矫正镜,使视力矫正镜屈光力附加至人眼后,整眼屈光力在视网膜上形成的屈光力分布在周边区域大于中心区域,且落于视网膜之前,形成近视性离焦。
  2. 如权利要求1所述的非球面视力矫正镜的制备方法,其特征在于,在上述步骤(1)中,人眼视网膜形状通过眼科检测设备测量,如果眼科检测设备将视网膜视为球面,则以视网膜的曲率半径衡量视网膜的形状;如果眼科检测设备将视网膜视为非球面,则以非球面的等效曲率半径衡量视网膜的形状;非球面的等效曲率半径的计算方法如下:
    Figure PCTCN2016090955-appb-100001
    其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
  3. 如权利要求1或2所述的非球面视力矫正镜的制备方法,其特征在于,在上述步骤(2)中,视力矫正镜片与人眼形成的整眼屈光力(D′t)的分布状态相对于视网膜的形状为近视性离焦,满足:
    Figure PCTCN2016090955-appb-100002
    其中,Dr为整眼在半径为r时的屈光力,D0为整眼在小孔径时(傍轴)的屈光力,即整眼屈光力的标称值,r为视网膜平面的半径,R为视网膜的曲率半径或者等效曲率半径。
  4. 如权利要求1或2所述的非球面视力矫正镜的制备方法,其特征在于,视网膜的形状通过光学相干断层成像仪OCT或类似眼科检测设备测量。
  5. 如权利要求1所述的非球面视力矫正镜的制备方法,其特征在于,在上述步骤(1)中,人眼裸眼周边离焦量(ΔD1)与戴镜状态下的周边离焦量(ΔD3)均通过眼科检测设备测量,所述非球面视力矫正镜的离焦量(ΔD2)已知,在视力矫正镜片提供的周边离焦量(ΔD2)+人眼裸眼周边离焦量(ΔD1)≥0,人眼形成近视化周边离焦;当人眼戴镜周边离焦量(ΔD3)>0时,表明试戴片镜片的离焦量已满足使人眼达到近视化周边离焦的条件。
  6. 如权利要求1所述的非球面视力矫正镜的制备方法,其特征在于,当人眼戴镜周边离焦量(ΔD3)≤0时,表明镜片的离焦量仍然使人眼处于远视化周边离焦的状态,需要加大镜片的离焦量,使人眼达到近视化周边离焦。
  7. 如权利要求1至6任一项所述的非球面视力矫正镜的制备方法,其特征在于,可以根据患者自身的生理条件及对近视控制程度的要求,进行镜片周边离焦量的增大或减小,达到个性化的视力矫正。
  8. 如权利要求1所述的非球面视力矫正镜的制备方法,其特征在于,在上述步骤(3)中,根据步骤(2)得到的屈光力分布方案,通过非球面设计方法制作成视力矫正镜,所述非球面的表达式:
    Figure PCTCN2016090955-appb-100003
    其中,Z(y)为视力矫正镜镜片的非球面在YZ平面上的曲线的表达式,c为光学部基础球面表面曲率半径的倒数,y为所述曲线上任何一点距横坐标轴(Z)的垂直距离,Q为非球面系数,A2i为非球面高次项系数,所述非球面面形上的各点由所述曲线通过围绕横坐标轴(Z)进行旋转对称变化而得到;
    通过调整视力矫正镜镜片的Q值、各非球面系数,使视力矫正镜镜片的面形在径向不同部位表现为不同的等效曲率,在整个光学区实现等效曲率均匀、连续的变化,从而使视力矫正镜镜片在不同的孔径下具备与近视性离焦屈光力分布状态相适应的屈光力,周边区域屈光力大于中心区域屈光力;
    等效曲率半径通过:
    Figure PCTCN2016090955-appb-100004
    描述,
    其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
  9. 一种根据权利要求1的制备方法制备的非球面视力矫正镜,所述视力矫正镜是眼外佩戴的矫正镜,其特征在于,所述镜片光学区的凸面或者凹面至少一个为非球面,当所述镜片光学区的凸面为非球面时,镜片光学区周边的等效曲率半径的绝对值小于镜片光学区中心的曲率半径的绝对值;当所述镜片光学区的凹面为非球面时,镜片光学区周边的等效曲率半径的绝对值大于镜片光学区中心的曲率半径的绝对值。
  10. 如权利要求9所述的视力矫正镜,其特征在于,所述镜片光学区的非球面的面形通过等效曲率半径的比例因子η限定,η为不同孔径dm、dn下的r之比,其中,m>n:
    Figure PCTCN2016090955-appb-100005
    所述镜片光学区的等效曲率半径的计算方法如下:
    Figure PCTCN2016090955-appb-100006
    其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径;
    当所述镜片光学区的凹面为非球面时,则非球面的等效曲率半径比例因子η>1,优选的,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为1.002≤η53≤1.086;当所述镜片光学区的凸面为非球面时,则非球面的等效曲率半径比例因子η<1,优选的,非球面在5mm孔径和3mm孔径下的等效曲率半径比例因子η53为0.682≤η53≤0.986;
  11. 如权利要求9所述的视力矫正镜,,其特征在于,所述镜片在空气中的屈光力≤0D,所述镜片屈光力在径向随孔径增大而增大,所述镜片屈光力绝对值随孔径增大而减小。
  12. 如权利要求11所述的视力矫正镜,其特征在于,所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为ΔD53≥0.005D;优选地,所述镜片的屈光力在5mm和3mm孔径下的屈光力之差为0.005D≤ΔD53≤8.849D。
  13. 一种根据权利要求1的制备方法制备的非球面视力矫正镜,所述视力矫正镜是角膜塑形镜,其特征在于,所述镜片基弧区的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η<1;优选的所述镜片基弧区的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53<1;更优选的,所述镜片基弧区的非球面在5mm孔径和3mm孔径下的面形的等效曲率半径的比例因子η为0.67≤η53≤0.998;
    比例因子η为镜片不同直径dm、dn下的r之比,m>n:
    Figure PCTCN2016090955-appb-100007
    所述镜片基弧区的等效曲率半径的计算方法如下:
    Figure PCTCN2016090955-appb-100008
    其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非 球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
  14. 一种根据权利要求1的制备方法制备的非球面视力矫正镜,所述视力矫正镜是眼内镜,其特征在于,所述镜片光学区的前表面或者后表面至少一个为非球面,镜片在孔径方向按所设定的屈光力周边离焦量均匀变化,所述镜片的屈光力随孔径增大而增大,屈光力的绝对值随孔径增大而减小,所述镜片在房水中的屈光力为≤0D。
  15. 如权利要求14所述的非球面视力矫正镜,其特征在于,所述镜片光学区的非球面的面形通过等效曲率半径的比例因子η限定,所述非球面的等效曲率半径的比例因子η>1;优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为η43≥1.005;更优选地,所述镜片光学区的非球面在4mm孔径和3mm孔径下的等效曲率半径的比例因子η为1.002≤η43≤1.09;
    比例因子η为镜片不同直径dm、dn下的r之比,m>n,则有:
    Figure PCTCN2016090955-appb-100009
    所述镜片光学区的等效曲率半径的计算方法如下:
    Figure PCTCN2016090955-appb-100010
    其中,dm为测量孔径,M为孔径dm处的点,hm为M点的矢高,即非球面在M点与顶点之间的高度差,rm为M点的等效曲率半径。
  16. 一种利用近视性周边离焦来控制和延缓近视增长的诊断治疗方法,其特征在于,所述诊断治疗方法通过使用根据权利要求1所述的非球面视力矫正镜的制备方法中制备的非球面视力矫正镜来实现。
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