CN111897141B - Peripheral out-of-focus lens and frame glasses - Google Patents
Peripheral out-of-focus lens and frame glasses Download PDFInfo
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Abstract
A peripheral out-of-focus lens and frame glasses, the peripheral out-of-focus lens comprises a central optical area, an annular out-of-focus area is arranged outside the central optical area, and the out-of-focus amount of the out-of-focus area varies in the annular direction. The lens and the glasses can provide larger maximum defocus amount, and a better myopia control effect is achieved.
Description
The application is a divisional application with the application date of 2018, 12 and 25, and the application number of 201811592602.5, and the invention name of the application is 'lens, glasses and a method for acquiring defocus quantity parameters, fitting glasses and evaluating effects'.
Technical Field
The application relates to the field of myopia prevention and control, in particular to a peripheral out-of-focus lens and frame glasses.
Background
Myopia has become a major public health problem, and it also becomes a significant burden to society. The degree of deflection of the light at the interface can be expressed by the refractive power. The optical power depends on the refractive indices of the two media and the radius of curvature of the interface. Myopia is one of the refractive errors. For a normal eyeball, both central and peripheral images are projected on the retina. In a myopic eye, due to the elongation of the eyeball, parallel rays are refracted by a dioptric system of the eye in a relaxed state, and then the focal point falls in front of the retina.
The mechanism of progression of myopia is still under intense discussion and many means of controlling the growth of the ocular axis have been discovered including different concentrations of drugs and different optical designs of lenses. The theory of peripheral defocus is a cause of myopia proposed at the end of the last century by professor Smith of the eye-optics institute of houston, usa. According to the dioptric concept, the focus falling in front of the retina is called myopic defocus and the focus falling behind the retina is called hyperopic defocus. The peripheral defocus theory considers that this hyperopic defocus at the periphery of the retina is the main cause of the increasing number of myopic eyes. The myopic defocus around the retina can slow down the increase of the axis of the eye, and has the effect of inhibiting the development of myopia.
The primary purpose of conventional single vision spectacles is to address the need for the wearer to be blinded and to correct for defocus in the central macular area of the eye. FIG. 1 is a schematic view of an eye corrected with a single vision lens. The object image at the central vision is projected on the retina, and the object image at the peripheral area is projected behind the retina to form hyperopic defocus. The eye adjusts to project an object image of the peripheral region onto the retina, which causes the axis of the eye to stretch slowly. Therefore, after some patients wear ordinary myopia glasses, although the problem of unclear sight is solved, the myopia degree is continuously deepened.
The peripheral out-of-focus lens can reduce the far-vision out-of-focus at the periphery of the retina and even change the retina into near-vision out-of-focus so as to relieve the increase of the eye axis. Such specially designed optical lenses may be lenses of OrthoKeratology lenses (e.g., OK lenses), contact lenses (including soft contact lenses, hard contact lenses such as RGP lenses, etc.), or frame lenses (e.g., prismatic two-frame lenses, progressive addition lenses, etc.). After the myopic eye is corrected by the peripheral defocused lens, the object image at the central vision part is projected onto the retina, and the peripheral object image is projected onto the retina or in front of the retina, so that the myopic defocused effect is formed, as shown in fig. 2. Researches show that the success rate of the peripheral defocused corneal contact lens for controlling myopia (namely inhibiting the growth speed of the axis of the eye) can reach about 30-40%.
The orthokeratology lens adopts an inverse geometric design, achieves the purposes of correcting vision and controlling myopia development by changing the shape of the cornea, and the success rate of controlling the myopia development can reach 32 to 55 percent. Different from frame glasses and corneal contact lenses, the corneal shaping lens only needs to be worn at night, and can reach a normal value without wearing vision in the daytime. The design of the orthokeratology lens is divided into a VCT (vision reshaping treatment) design and a CRT (corneal regenerative thermal corneal refractive correction) design. The orthokeratology mirror designed by VST comprises a basal arc area, a reversal arc area, a positioning arc area and a circumferential arc area.
The central portion of the lenses of contact lenses and frame lenses is typically a central optic zone of constant power, for the peripheral out-of-focus lenses used in this application for myopia control, in which the peripheral area outside the central optic zone has a higher power than the central optic zone, and the difference in power between the two is expressed in degrees of out-of-focus, in D (degrees). For example, if the power of the central optical zone of a lens for near vision is-2.00D (which is typically the power of the lens), and the peripheral position has a defocus amount of 4.5D, then the power of the peripheral position of the lens is 2.5D. If the central optical zone of the lens for near vision has a power of-5.00D and the defocus amount of the peripheral position is still 4.5D, the peripheral position of the lens has a power of-0.50D.
The defocus design of the peripheral defocus lens is related to the effect of myopia control, but which defocus parameters are related to myopia control (meaning control of myopia progression) and the mechanism of the correlation between defocus parameters and myopia control is not clear, so that the design and fitting of the peripheral defocus lens are difficult to perform in a targeted manner, which affects the effect of myopia control that can be achieved by the peripheral defocus lens.
For orthokeratology, there is currently only an estimate of the total amount of defocus that it creates on the cornea. No other defocus parameters associated with myopia control are proposed. Moreover, clinical estimates of the effectiveness of orthokeratology lenses are still lacking in standards, and it takes a long time to be able to determine the effectiveness of myopia control for a particular myope. This affects the application of the corneal mirror shape.
Disclosure of Invention
The following is a summary of the subject matter described in detail herein. This summary is not intended to limit the scope of the claims.
The embodiment of the application provides a peripheral out-of-focus lens, which comprises a central optical area, wherein an annular out-of-focus area is arranged outside the central optical area, and the out-of-focus amount of the out-of-focus area changes in the circumferential direction.
The embodiment of the application provides frame glasses, which comprise a frame and two lenses, and is characterized in that at least one of the two lenses adopts the lens with the out-of-focus periphery as described above.
The lens and the glasses of the embodiment of the application adopt the structure that the defocusing amount changes in the circumferential direction, provide the larger maximum defocusing amount by means of the fluctuation of the defocusing amount, and achieve the better myopia control effect.
Other aspects will be apparent upon reading and understanding the attached drawings and detailed description.
Drawings
FIG. 1 is a schematic illustration of a hyperopic defocus produced when correcting myopia using a single vision lens;
FIG. 2 is a schematic diagram of myopic defocus generated using peripheral defocus lenses;
FIG. 3A is a schematic diagram of defocus as a function of distance for a patient's cornea at the same azimuthal angle;
FIG. 3B is a schematic representation of the change in mRCRP of a patient's cornea over a range of 0 to 360 degrees;
FIG. 4 is a schematic diagram of the components in the built mRCRP model;
FIG. 5 is a schematic diagram of the relationship between the maximum defocus Vmax and the eye axis growth length;
FIG. 6 is a graph showing myopia control success as Vmax varies;
FIGS. 7A-7D are schematic diagrams of several different scenarios for component values in the mRCRP model;
FIGS. 8A and 8B are schematic diagrams of peripheral out-of-focus lenses of two exemplary embodiments of the present application;
FIG. 9 is a schematic view of a orthokeratology lens in accordance with an exemplary embodiment of the present application;
FIG. 10 isbase:Sub>A sectional view taken along line A-A of FIG. 9;
FIG. 11 is a flowchart of a method for obtaining defocus parameters in an exemplary embodiment of the present application;
FIG. 12 is a flowchart of another method for obtaining defocus parameters in an exemplary embodiment of the present application;
FIG. 13 is a flow chart of a method of providing lens fitting according to an exemplary embodiment of the present application;
FIG. 14 is a flow chart of a method of evaluating the effectiveness of myopia control provided by an exemplary embodiment of the present application;
FIG. 15 is a schematic diagram of a computer device of an exemplary embodiment of the present application.
Detailed Description
The description herein describes embodiments, but is intended to be exemplary, rather than limiting and it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of the embodiments described herein. Although many possible combinations of features are shown in the drawings and discussed in the detailed description, many other combinations of the disclosed features are possible. Any feature or element of any embodiment may be used in combination with, or instead of, any other feature or element in any other embodiment, unless expressly limited otherwise.
The present application includes and contemplates combinations of features and elements known to those of ordinary skill in the art. The embodiments, features and elements that have been disclosed in this application may also be combined with any conventional features or elements to form unique aspects as defined by the claims. Any feature or element of any embodiment may also be combined with features or elements from other aspects to form yet another unique aspect as defined by the claims. Thus, it should be understood that any of the features shown and/or discussed in this application may be implemented alone or in any suitable combination. Accordingly, the embodiments are not limited except as by the appended claims and their equivalents. Furthermore, various modifications and changes may be made within the scope of the appended claims.
Further, in describing representative embodiments, the specification may have presented the method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. Other orders of steps are possible as will be understood by those of ordinary skill in the art. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. Furthermore, the claims directed to the method and/or process should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the embodiments of the present application.
In the present application, both orthokeratology lenses and contact lenses may be made of Gas Permeable Rigid material (RGP) lenses, but these lenses are of two different types. The orthokeratology lens adopts a lens designed by inverse geometrical shape, and the inner surface of the orthokeratology lens consists of a plurality of arc sections. The cornea geometric form is changed through the hydrodynamic effect, the pillow is worn on the front part of the cornea during sleep, the corneal curvature is gradually flattened, the eye axis is shortened, and the pillow does not need to be worn in the daytime. Contact lenses, which are also called contact lenses (contact lenses), are not designed in inverse geometry, and correct vision or protect eyes by optical effects generated by wearing on the cornea of an eyeball, and can include three types of materials, namely hard, semi-hard and soft. The lenses of the frame glasses are arranged on the glasses frame, and the distance exists between the lenses and the eyeballs.
One of the criteria for successful fitting of orthokeratology lenses is to create a centered central location, i.e., a uniform peripheral defocus on the cornea. Research shows that the larger the myopic refractive error is, the larger the formed peripheral defocus amount is, and the myopia control effect is relatively good. However, the specific size is not mentioned as to which parameter the defocus amount is estimated, and the size of the peripheral defocus amount is also limited in various ways, and cannot be made particularly large. The data range of peripheral defocus selected by the research of the conclusion is large and is-1.00 to-6.00D. Meanwhile, the research conclusion is contrary, the magnitude of the peripheral defocus amount and the myopia control effect are not necessarily related, and the peripheral defocus data range generally selected according to the research is small. In addition, in the case of contact lenses and spectacle lenses, if a lens with an excessive peripheral defocus amount is used, the patient feels uncomfortable, the vision and contrast sensitivity are reduced, and the manufacturing is difficult. The existing peripheral defocusing design scheme adopted by lenses of contact lenses and frame glasses has a lower myopia control effect than that of orthokeratology lenses.
If the mechanism of the orthokeratology lens for relieving the eye axis growth can be better explained, the clinical fitting of the orthokeratology lens has great guiding significance, and meanwhile, the mechanism can be popularized to the peripheral defocusing design of contact lens lenses and frame spectacle lenses. Therefore, the inventors of the present application conducted a prospective study to investigate the influence of factors such as the defocus state and degree of the cornea on the growth of the ocular axis of a myopic patient after wearing a keratoplast.
For defocus, only the total amount is estimated or it is assumed that a uniform peripheral defocus condition is formed after the shaping operation. However, the inventor of the present application found that peripheral defocus formed on the cornea after a patient wears a plastic lens is not uniform due to different meridian responses to defocus of the retina caused by corneal astigmatism and aspheric surface of the retina. It is not scientific to use the total or mean value of peripheral defocus to measure the effect of peripheral defocus on myopia control. For myopes of-1.00 to-5.00D, which are frequently seen in clinic, the difference of the total defocus amount of the periphery after the orthokeratology is not large, but the maximum defocus amount on the cornea is caused by the difference of the distribution of the peripheral defocus on the cornea after the orthokeratology (the maximum defocus amount is also called as an extreme value in the application, and the position of the maximum defocus amount on the cornea can be one point or a plurality of points, can be distributed together in a centralized way, and can also be distributed at a plurality of places in a scattered way). The retina is more sensitive to defocus not the total amount, but the extreme value of defocus, i.e. has extreme value sensitivity. The magnitude of the maximum defocus on the cornea is more important than the magnitude of the total defocus amount in terms of the effect of peripheral defocus on myopia control.
The inventor of the application carries out experimental research on the relation between the out-of-focus amount on the cornea and the myopia control effect after the child wears the orthokeratology lens, and the experimental method is as follows:
55 adolescents aged 8-12 years are used as patients, and the patients have no history of using myopia control products, no eye surface diseases and no systemic diseases affecting dioptric systems. The mydriasis optometry of the patient is that SE is more than or equal to-5.50D and less than or equal to-1.00D (SE is equivalent spherical diopter), corneal astigmatism is less than or equal to-1.50D, the refractive error is less than 1.0D, and the optimal correction vision is higher than 20/20. Patients were subjected to a full-scale examination and then were fitted with a corneal plastic lens (euclidd System crop., herndon, VA) produced by euclidean corporation, and all patients were reviewed between 2-5 pm; corneal biomechanics was measured before and one year after wear using an optical correlation biometer (Lenstar LS900, haag-Streit AG, switzerland), respectively. Corneal topography was examined using a corneal topographer (Oculus, wetzlar, germany) before and four months after wear. The right eye data was collected from each patient and normalized by the Charpy-Wilk test. The difference between the ideal and the non-ideal group for myopia control in the model was compared using the rank sum test (Ranksum test) method. And analyzing the relationship between the myopia control success rate and the maximum value of the defocus amount by using a Logistic regression analysis method.
In this experiment, the data obtained from the corneal topography was accurately analyzed to determine the defocus parameter on the cornea using the following method: the positioning of the lens was determined with Matlab software. Equally dividing the cornea into 36 fan-shaped regions by taking the center of the cornea as a circle center, wherein the central angle of each region is 10 degrees, and taking a plurality of sampling points in each region, including a sampling point at the center of the cornea, so as to calculate the defocusing amount of other sampling points. The sampling points can be uniformly distributed in the area, and can also be distributed on 36 direction angles which are sequentially spaced by 10 degrees, and the calculation precision is higher when the sampling points are more. For each area, the defocus of all the sample points in the area can be calculated from the corneal topography, as shown in fig. 3A. The horizontal axis in the figure represents the distance of a point on this region from the center of the cornea (i.e., the radial distance). The vertical axis represents the power of a point on the area. The power at the center of the cornea in the figure is 40 degrees, and the power at other points minus 40 is the defocus at that point. The maximum defocus in the graph represents the defocus of the region and is denoted as mRCRP. mRCRP generally occurs in the corneal region corresponding to the arc of reversal of the orthokeratology mirror.
For each patient, 36 mPCRP and their corresponding angles are available for 36 zones, e.g., the angle for the 0 to 10 zone can be set to 0 ° (or another value of 0-10 °), the angle for the 10 to 20 zone can be set to 10 ° (or another value of 10-20 °), and so on. Curve fitting is performed on the 36 mPCRP curves (i.e., an appropriate curve type is selected to fit the observed data, and the relationship between the two variables is analyzed by using a fitted curve equation), so that a defocus curve, which is called an mPCRP curve, can be obtained, as shown in fig. 3B. The horizontal axis in fig. 3B is the direction angle, the vertical axis is the mPCRP value, and the circle in the graph, i.e. the position of 36 mPCRP in the graph, is the mRCRP curve. The maximum peak of the defocus curve is denoted as Vmax, which is the maximum defocus amount on the cornea after the reshaping, and may be referred to as the maximum defocus amount on the cornea.
For each patient, a model for accurately calculating mPCRP can be established according to the fitted defocus curve: mRCRP = M + F1+ F2. Specifically, a multiple linear regression detection model can be adopted, and relevant factors comprise an equivalent sphere lens, lens positioning, astigmatism, corneal eccentricity and the like. R 2 =0.93 ± 0.06 (mean 0.94). In statistics, where linear regression analysis is performed on variables and least squares is used for parameter estimation, R is 2 The ratio of the regression sum of squares to the total sum of deviations is a ratio that represents the ratio of the total sum of deviations of squares that can be interpreted by the regression sum of squares, and the larger this ratio, the more accurate the model, and the more pronounced the regression effect.
Referring to fig. 4, the model includes three parts: m represents the mean refractive power, this value being related to the initial equivalent spherical lens before the patient wears the orthokeratology lens, represented in the figure as the horizontal dashed line; f1 is a sine curve, which can be expressed as (Mean F1 sin (x + phase 1)), having a peak over 360 degrees of azimuth, F1AmpF2 being the maximum of F1; f2 is a cosine curve, which can be expressed as (Mean F2 sin (2 x + phase2)), having two peaks over 360 degrees of azimuth, and F2Amp is the maximum of F2. Studies have shown that the magnitude of the amplitude F1 of F1 is related to the asymmetry of lens positioning (e.g., wear bias, etc.). While the peak F2 of F2 is associated with corneal astigmatism. The values of the three specific parameters in the model can be obtained by calculation according to the defocus curve. The resulting superposition of the three parts, i.e. the mRCRP curve, is shown by the solid line in the figure. The maximum value is Vmax and the minimum value is Vmin.
After one year of wear, corneal biomechanics were measured for each patient, with 0.3mm as the ocular axis growth threshold for determining whether myopia control was effective. Results show that 40 out of 55 patients had effective myopia control, the eye axis increased no more than 0.3mm a year, 15 patients had unsatisfactory myopia control, and the eye axis increased more than 0.3mm a year. The results of the success or failure of myopia control are combined with the mRCRP curve of each patient, so that the larger the Vmax on the mRCRP curve of the patient is, the higher the success rate is. As shown in FIG. 5, the horizontal axis represents Vmax, the vertical axis represents the length of the increase of the eye axis, each circle corresponds to one patient, the circles below the 0.3mm line correspond to patients with successful myopia control, and the circles above the 0.3mm line correspond to patients with failed myopia control.
FIG. 6 is a graph of Vmax versus myopia control success rate showing that as Vmax increases, the success rate of myopia control increases (p < 0.05). When Vmax is less than or equal to 1.2D, only 20% of patients succeed; when Vmax is larger than or equal to 3.5D, more than 50% of patients are successful; vmax is more than or equal to 4.5D, and more than 80 percent of patients succeed; when Vmax is more than or equal to 5D, more than 90% of patients are successful. According to the relation, vmax is adopted for evaluation according to the statistical data, and when the Vmax is less than or equal to 1.2D, the probability that the myopia control is effective is 20 percent; when Vmax is larger than or equal to 3.5D, the probability of more than 50% of myopia control is effective; vmax is more than or equal to 4.5D, and the myopia control has more than 80 percent of effective probability; when Vmax is larger than or equal to 5D, the probability of myopia control is more than 90% effective.
The above data are only exemplary, and more and wider (for example, myopic children in different countries) tests can be performed according to the analysis method or similar method provided by the present application, and the data obtained by statistics of the tests do not necessarily have to be the same as the specific data such as the corresponding relation between Vmax and the success rate of myopia control, which is a normal phenomenon.
Taking the threshold value of 4.5D as an example, analyzing the mRCRP curve established for each patient and whether the myopia control is successful or not, it can be found that:
if the value of M is large, although the mRCRP curve does not fluctuate, the defocus amount at each position on the cornea can reach 4.5D, as shown in fig. 7A, and myopia can be effectively controlled.
If the M value is small and the mRCRP curve fluctuates little, the defocus amount of no point on the cornea can reach 4.5D, as shown in FIG. 7B, and there is no control effect.
If the M value is at the mean value, but the mRCRP curve does not fluctuate much, the defocus amount of no point on the cornea exceeds 4.5, as shown in FIG. 7C, and the control effect is not good.
If M is small but mRCRP fluctuates greatly, the defocus amount of a part of points on the cornea exceeds 4.5D, as shown in FIG. 7D, and the control effect is good.
In the model mRCRP = M + F1+ F2 established for the patient, the value of M is related to the degree of myopia. For low to moderate myopia, the value of M will be lower and, according to the model, an increase in F1 and F2 will increase Vmax, improving myopia control. Therefore, the applicant proposes a new theory on the influence of peripheral defocus on myopia control: the retina is sensitive to the extreme value of peripheral defocus, the defocus amount at all positions is not required to be the same, and myopia can be effectively controlled as long as the maximum defocus amount Vmax is large enough. And the larger Vmax is, the higher the success rate of myopia control is, and the myopia control effect can be effectively evaluated by comparing the Vmax of the patient with a set defocus threshold (such as 3.5D and 4.5D). In addition, studies have shown that the success rate of myopia control can be assessed from the defocus threshold as long as a point of the reshaped cornea reaches the defocus threshold. Under the condition of keeping the distance from the threshold value unchanged, if the area (which can be represented by a corresponding central angle) of the cornea with the defocus amount reaching the defocus threshold value is larger, the success rate of the cornea is correspondingly improved.
Although the above studies were conducted with orthokeratology as the source, the established model, and the proposed volatility and threshold of peripheral defocus, are applicable to the design of peripheral defocus lenses. The above theory gives an important hint to lens design: under the condition that the total defocus amount is not changed, vmax can be increased by carrying out uneven design of peripheral defocus, and myopia control is facilitated. This is of great guidance to the lens design of both frame and contact lenses.
In addition, the analysis shows that in the model mRCRP = M + F1+ F2 established for the patient, the amplitudes of F1 and F2 are also relevant to the myopia control effect, and one or both of F1 and F2 is large, so that the success rate of the myopia control is higher. It will be readily appreciated that the large magnitudes of F1 and F2 generally result in a larger maximum peak value Vmax for mRCRP. As can be seen from fig. 4, in the case that the amplitudes of F1 and F2 are not changed, if one peak of F1 and one of the two peaks of F2 are at the same direction angle and the two peaks can be superimposed, the obtained Vmax is the largest, and the myopia control effect is the best. Conversely, the resulting Vmax will decrease and the myopia control will also decrease. As mentioned before, F1 is associated with the lens worn and F2 is associated with corneal astigmatism, this then gives another important hint to lens design and wear: the maximum defocus brought by the lens is aligned with the maximum defocus on the cornea, so that extreme value superposition can be realized, and the myopia control effect can be improved.
To this end, exemplary embodiments of the present application provide a peripheral through-focus lens, which may be, but need not be, circular. As shown in fig. 8A, the lens 1 includes a central optical area 11, an annular out-of-focus area 12 is disposed outside the central optical area, and the out-of-focus amount of the out-of-focus area varies circumferentially. In principle, a large amount of defocus is advantageous for controlling the progression of myopia, but if the amount of defocus is too large, discomfort can be caused to the myope, such as dizziness and the like, and adverse effects such as limited visual field, reduced vision and reduced contrast sensitivity can be caused. Through the change of out of focus volume in the hoop, under the unchangeable condition of the maximum out of focus volume, can reduce the out of focus volume in some separation focus areas to when guaranteeing the myopia control effect, alleviate these adverse effects.
In the exemplary embodiment shown in fig. 8A, the central optical zone 11 of the lens 1 is a circular fixed-focus zone, and the lens 1 includes an annular out-of-focus zone centered at the center of the lens (point "O" in the figure). However, the present application is not limited to this, and the lens may include a plurality of annular defocus regions centered on the center of the lens, and as shown in fig. 8B, the lens 1 includes two annular defocus regions 12a and 12b, and in the figure, the two defocus regions 12a and 12b are exemplarily disposed at an interval therebetween, and the middle may be a fixed focus region with a defocus amount of 0. In other embodiments, more out-of-focus zones may be provided. Among the plurality of defocus regions, only some of the defocus regions may be varied in the circumferential direction, i.e., it falls within the scope of the present application as long as there is one defocus region varied in the circumferential direction.
The shape of the defocusing area in the present application is not necessarily a circular ring, but may also be an elliptical ring or other non-standard ring structure. The position of a point in the out-of-focus zone can be expressed in terms of its orientation angle and radial distance on a coordinate system centered on the lens center. Radial distance refers to the distance of that point from the center of the lens. In fig. 8A, the 0 ° directivity angle is defined to point to the right, and the directivity angle at point P in fig. 8A is denoted as α. The defocus amount of the out-of-focus area varies in the circumferential direction, that is, the defocus amount of the out-of-focus area varies in the range of 360-degree azimuth angles, in other words, when the azimuth angle varies from 0 to 360 °, the defocus amount of the azimuth angle in the out-of-focus area varies. The variation may be a gradual variation, with one or two or more peaks in the 360 range. Mutations such as step-wise transitions may also be present, which the application is not limited to. In a direction angle of the same out-of-focus area, there may be fluctuation in the defocus amount of points with different radial distances, and in this case, the defocus amount of the out-of-focus area in the direction angle may be represented by the maximum defocus amount in the direction angle.
When viewed from the radial direction of the lens, when an out-of-focus area exists, the out-of-focus amount can have an ascending and descending change along with the increase of the radial distance. When a plurality of defocus regions exist, there may be a plurality of ascending and descending processes. The defocus amount of the area outside the out-of-focus area may be smaller than the out-of-focus area or equal to 0, or may be equal to or larger than the out-of-focus area, for example, the defocus amount increases with radial distance. May remain unchanged or continue to increase after the last out-of-focus zone has risen.
In the exemplary embodiment shown in fig. 8A, the lens includes an indicator 13 for indicating a direction angle at a position where the defocus amount is maximum in the out-of-focus region. The position with the largest defocus amount may be a point or an area including a plurality of points, and if there are a plurality of positions with the largest defocus amounts, one position may be selected to be indicated, or each position may be indicated by using an indicator 13. The indicator may be integrally formed with the lens, or attached to the lens, or embedded within the lens. For example, the indicator may be a protrusion or a groove on the lens, or a marker attached to the corresponding position of the lens, or a marker or even an air bubble in the lens. Although the indicator 13 is an upward arrow in the example in fig. 8A, the indicator may be in the shape of a bar, a dot, or any other symbol. The indication mark may directly indicate a position where the defocus amount is maximum in the out-of-focus area, and an arrow in the figure is used to indicate that the position where the defocus amount is maximum in the out-of-focus area appears at a 90 ° directional angle. When the position with the largest defocus amount in the out-of-focus area is an area, the direction angle of the center position of the area can be generally indicated, but a deviation is allowed, and the use is not affected. The indication mark can also indicate the position with the largest defocus amount in an indirect manner, such as pointing to the opposite direction thereof, and so on. After the indication mark is arranged on the lens, when a myope wears the lens (especially wears a corneal contact lens), the position with the maximum defocus amount of the lens is aligned with the position with the maximum defocus amount of the cornea according to the indication mark, and extreme value superposition is carried out on the defocus amounts of the lens and the cornea, so that the maximum defocus amount of a dioptric system formed by the lens and the cornea is maximized as far as possible, and the myopia control effect is improved. The defocus on the cornea is mainly due to corneal astigmatism, and the position with the largest defocus generally occurs around 90 ° azimuth and 270 ° azimuth. The exact location of which can be determined by detection.
In an exemplary embodiment of the present application, a difference between a maximum value and a minimum value of defocus amounts in the defocus area is not less than 1D, 2D, 3D, 4D, or 5D. This difference reflects the amplitude of defocus fluctuation in the out-of-focus region, and can be selected based on factors such as defocus threshold, lens power, patient tolerance, etc.
In an exemplary embodiment of the present application, the lens is a contact lens, and the out-of-focus area is located in an annular area with a center of the lens as a circle center, an inner diameter of 3mm to 4mm, and an outer diameter of 5 mm to 8 mm. In another exemplary embodiment of the present application, the lens is a lens of a frame glasses, and the out-of-focus area is located in an annular area with an inner diameter of 6mm to 8mm and an outer diameter of 8mm to 12mm, wherein the center of the annular area is the center of the lens. For lenses, the out-of-focus zone is required to exclude the central optical zone on the lens and areas that have little or no effect on myopia control, such as areas where projected light rays do not effectively enter the pupil. Some frame glasses make the defocus at the edge of the lens large, but the defocus in the above-mentioned area is not large, and do not have a good myopia control effect. Therefore, when the defocus amount of the defocus area of the lens is designed and calculated, the defocus amount needs to be designed and calculated according to the set defocus area range, so that an effective myopia control effect is achieved. The annular region may include a central optical region and an outer region of the out-of-focus region in addition to the out-of-focus region.
In an exemplary embodiment of the present application, the lens is a lens of a contact lens, and the defocus area includes a high focus area with a defocus amount no less than 2D, 2.5D, 3D, 3.5D, 4D, 4.5D, 5D, or 5.5D at any position. In another exemplary embodiment of the present application, the lens is a lens of a frame glasses, and the defocus region includes a high focus region having a defocus amount of not less than 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D or 6D at any position.
In the present application, the high-focus area is an area in the defocus area for achieving a desired myopia control effect, and a defocus threshold value may be set, and an area in which the defocus amount at any position in the defocus area is not less than the defocus threshold value is determined as the high-focus area. In this application, a point is also considered to be a special area. The lens of the frame glasses is at a certain distance from the eyeball, the defocusing amount on the lens can play a smaller role than that of the corneal contact lens, and therefore, when the high-focus area is determined, a higher threshold value can be selected when other conditions are the same.
In one example, the defocus threshold used to determine the high focus region may be selected to correspond to a defocus threshold with a myopia control success rate above 50% such as 3.5D, 4D, 4.5D, etc., as described above. After the glasses are worn, the defocus amount of the lenses and the defocus amount of the patient's cornea can be subjected to extreme value superposition, so that the maximum defocus amount of a dioptric system consisting of the lenses and the cornea is larger than the maximum defocus amount of the lenses, and therefore the defocus amount of a designed high-focus area can be smaller than 3.5D when the lenses are designed. The selection of a particular defocus threshold may be based on factors such as the desired success rate of myopia control, corneal astigmatism of the patient, fitting of the patient to the lens, tolerance of the patient to high defocus, size of the clear field of view, and degree of myopia of the patient.
In the case of the embodiment shown in fig. 8A, the high focus area includes one ring segment 121 disposed in the defocus area, but more than two ring segments are also possible. In addition, the shape of the high focal area may be a dot shape or other shapes. This is not a limitation of the present application.
In an exemplary embodiment of the present application, the high focus area falls within one or two or more fan-shaped areas, the fan-shaped areas are centered on the center of the lens, and the sum of central angles is not greater than 30 ° or 60 ° or 90 ° or 120 ° or 150 °. The two edges of the sector area in which the high focus area falls are two connecting lines of the center of the lens and two points with the largest and the smallest direction angles in the high focus area. When there are multiple sector-shaped regions, the multiple sector-shaped regions can be uniformly distributed in the out-of-focus zone, such as centrally symmetric about the center of the lens, or axially symmetric about the diameter of the central optical zone, but are not limited thereto. The smaller the sum of the central angles of the fan-shaped areas in which the high-focus area falls is, the larger the other areas (also called low-focus areas) with smaller defocus amount on the lens is, which is beneficial to improving the wearing comfort, expanding the clear vision and reducing the influence of the high defocus amount on the vision.
In an exemplary embodiment of the present application, the out-of-focus area includes one or two or more than three high-focus areas, and the sum of central angles of the ring segment in which the high-focus areas are located relative to the center of the lens is not less than 5 °, or 15 °, or 30 °, or 45 ° or 60 °. In the example shown in fig. 8A, the lens 1 has a high focus area in a ring segment with a central angle θ with respect to the center of the lens. The larger the sum of the central angles, the larger the proportion of the high focal zone in the visual field, which is beneficial to myopia control, but reduces the clear visual field. The central angle of the high focus area can be expressed as the included angle between two connecting lines from the two points with the maximum and minimum direction angles to the center of the lens in the high focus area.
In the two exemplary embodiments, the maximum value and the minimum value of the central angle corresponding to the high-focus area are limited, and an appropriate value can be selected according to the condition of a patient during actual lens fitting.
In an exemplary embodiment of the present application, the out-of-focus region includes one or any combination of the following structures formed on the outer surface of the lens:
a curved surface with gradually changed defocusing amount;
a fixed focus area; and
and (4) point-shaped bulges.
In one example, the out-of-focus region includes an out-of-focus gradual curved surface formed on an outer surface of the lens. In one example, the out-of-focus area includes a plurality of fixed focus areas (with constant out-of-focus amount in the area) formed on the outer surface of the lens, the out-of-focus areas are different in out-of-focus amount, and step-shaped jumps are formed among the fixed focus areas. In one example, the out-of-focus zone comprises a spot-like protrusion formed in an area of the outer surface portion of the lens (e.g., within a ring segment having a central angle of 90 degrees), the spot-like protrusion constituting an out-of-focus zone in the out-of-focus zone.
The above structures may also be combined, for example, in one example, the out-of-focus area includes one or more fixed focus areas formed on the outer surface of the lens, which may form a part of the high focus area but is not limited thereto, and other areas adopt a curved surface structure with gradually changed out-of-focus amount. In one example, the defocus region comprises a defocus-graded curved surface formed on the outer surface of the lens, including one or more high-focus regions, and one or more point-like protrusions are further provided in at least one of the high-focus regions, and a larger Vmax value can be obtained in the high-focus region by the composite structure. And so on. When the outer surface of the lens is formed with a curved surface with gradually changed defocus, partial astigmatism may be brought, but a certain degree of astigmatism is acceptable, which is beneficial to myopia control.
In an exemplary embodiment of the application, the defocus amount of the defocus region forms a peak value in the direction angle of 0-360 °, and the peak value is not less than 2D, 2.5D, 3D, 3.5D, 4D, 4.5D, 5D, or 5.5D; in another exemplary embodiment of the present application, the defocus amount of the defocus region forms two peaks spaced 120 ° to 240 ° from each other in the 0 ° to 360 ° azimuth, wherein the first peak is not less than 2D or 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D, and the second peak is equal to the first peak or less than the first peak. The case of only one peak corresponds to the case where the lens is designed to generate F1 in the model, and the case of two peaks corresponds to the case where the lens is designed to generate F2 in the model, in which the defocus variation generated by the original corneal astigmatism is applied to the lens design. Because the astigmatism of the cornea of a person mostly appears in the range (about plus or minus 45 degrees) taking the 90-degree direction angle and the 270-degree direction angle as the center, the design of the two peak values and the interval angles thereof is beneficial to realizing the extreme value superposition of the defocus amount of the lens and the cornea, generating a larger Vmax value, expanding the range of a high focus area in the visual field and achieving a better myopia control effect.
The peripheral out of focus lens of the above-mentioned embodiment of this application has adopted out of focus volume in the structure of annular change and be favorable to new structural design such as lens, the superimposed structure of cornea out of focus volume extreme value, can reach better near-sighted control effect.
In an exemplary embodiment of the present application, there is also provided a pair of frame glasses, comprising a frame and two lenses, wherein at least one of the two lenses adopts any one of the above-mentioned lenses with out-of-focus peripheral edges. In one example, the out-of-focus zone in the lens comprises a high focus zone, which is located above or below the center of the lens. In another example, the out-of-focus zone in the lens comprises two in-focus zones, one above and the other below the center of the lens; wherein, the high focus area refers to an area in which the defocus amount at any position in the defocus area is not less than 2.5D, 3D, 3.5D, 4D, 4.5D, 5D, 5.5D, or 6D. In this application, a high focus zone is considered to be above the center of the lens if an upward vertical line through the center of the lens passes through the high focus zone, and below the center of the lens if a downward vertical line through the center of the lens passes through the high focus zone. The arrangement of the high focal zone above and/or below the center of the lens also helps to achieve extreme superimposition of defocus amounts of the lens and cornea, considering that corneal astigmatism of a person mostly occurs in a range (around plus or minus 45 °) centered at 90 ° azimuth and 270 ° azimuth. For a small portion of the population where corneal astigmatism occurs at other angles, the need for that portion can be met by manufacturing, selecting lenses with the high focal zone designed at other angles.
The above is for the design of peripheral out-of-focus lenses, and the present application also applies the above theory to the design of orthokeratology lens, thereby providing orthokeratology lens 2, as shown in fig. 9 and 10, which comprises a base arc zone (i.e. central optical zone) 21, a reversal arc zone 22, a positioning arc zone 23 and a peripheral arc zone 24, wherein at least one of the base arc zone 21 and the reversal arc zone 22 has a structural variation in the circumferential direction. The circumferential variation here means that there is structural variation within a range of 0 to 360 degrees of the direction angle with the center of the lens as the center. Orthokeratology lenses do not directly correct vision themselves, but indirectly correct vision by reshaping the cornea and inhibit the progression of myopia. The traditional design is based on deforming the cornea into the shape of a basal arc surface to achieve the aim of defocusing. In the embodiment, the special design of the base arc area or the reversal arc area promotes the fluctuation of the shaped cornea in the circumferential direction, so that the expected maximum defocus amount can be reached.
In an exemplary embodiment of the present application, the reversal arc zone includes at least two ring segments, two are shown, wherein one ring segment 221 hasbase:Sub>A height greater than the other ring segment 222, see the sectionbase:Sub>A-base:Sub>A of the lens of fig. 9 shown in fig. 10, the corneal shaping is locked on the cornea 3, and the height of the reversal arc zone at the first ring segment 221 is greater than the height of the other ring segment 222. The space of the deformation of the cornea at the position can be improved by increasing the height of the arc section, and the defocusing amount of the corresponding position on the cornea after the shaping is favorably improved. In another exemplary embodiment of the present application, the reversal arc area may also be set to be an aspheric shape with a gradient in height in the circumferential direction, so that the position on the cornea corresponding to the reversal arc area is changed in the circumferential direction by the defocus amount after the shaping, resulting in a better myopia control effect. In addition, the reversal arc area can also be designed to be widened, for example, the width of the reversal arc area is increased from 1 mm-2 mm to 1.2 mm-2.2 mm or more under the condition of ensuring stable positioning. The width of the reversal arc area is increased, which is helpful for improving the defocusing amount of the position of the reversal arc area corresponding to the cornea. For the base arc area, under the condition of ensuring that the vision correction meets the requirements, an asymmetric structural design can be adopted to achieve the effect of changing the defocusing amount of the shaped cornea in the circumferential direction.
Since the correlation of defocus to myopia control is not clear, in previous practice, only the amount of defocus taken over the cornea was considered. According to the new theory of out-of-focus and myopia control provided by the application, the embodiment of the application provides the following method for acquiring out-of-focus parameters so as to acquire out-of-focus parameters related to myopia control for occasions such as lens fitting.
As shown in fig. 11, an exemplary embodiment of the present application provides a method for obtaining a defocus amount parameter, including:
step 110, collecting defocus amounts of a plurality of sampling points on a cornea of a user in a naked eye state of the user, wherein the sampling points are distributed on a plurality of direction angles in a coordinate system taking the center of the cornea as an origin;
the collection of defocus on the cornea can be realized by using a cornea map instrument, and the cornea map instrument is a novel device which is assisted by a computer and can present a cornea surface curvature image, and can generate a cornea map. The defocus of the sample points selected on the cornea can be calculated from the corneal topography.
And 120, obtaining a defocus parameter according to the defocus of the plurality of sample points on the cornea.
In an exemplary embodiment of the present application, in the naked eye state of the user, the defocus amount parameter obtained in the naked eye state before fitting of glasses for the myope is used for fitting glasses for the myope; in another exemplary embodiment of the application, in the naked eye state of the user, the defocus parameter obtained in the naked eye state after a myope has cornea shaped by a keratoplast is used to evaluate the myopia control effect of the myope after wearing the keratoplast. The orthokeratology lens worn by the myope in this embodiment may be the orthokeratology lens in the embodiment of this application, or may be other orthokeratology lenses such as a conventional orthokeratology lens.
In an exemplary embodiment of the present application, the defocus parameter includes one or any combination of the following parameters:
defocus amounts of a plurality of sample points on the cornea;
a maximum defocus on the cornea;
position information of a maximum defocus amount on the cornea;
the maximum defocus amount on the cornea and one or more set defocus threshold values;
one or more of the presence, number, size and position of the effective defocus area;
the maximum defocus on the cornea is determined according to the defocus of the plurality of sample points on the cornea, the effective defocus area refers to an area where the defocus at any position on the cornea is not less than a corresponding defocus threshold, and the defocus threshold is not less than 3.5D, 4D, 4.5D, 5D, or 5.5D.
In one example, determining a maximum defocus on the cornea from the defocuses of the plurality of sample points on the cornea includes:
and taking the maximum value of the defocusing amount of the plurality of sample points on the cornea as the maximum defocusing amount on the cornea. This also provides a higher accuracy if there are a large number of spots. The position information of the maximum defocus on the cornea is the position information of the sample point with the maximum defocus; or
Determining the maximum value of the defocusing amount on each direction angle according to the defocusing amount of the sample point on each direction angle in the plurality of direction angles; performing curve fitting according to the defocusing amount on each direction angle to obtain a defocusing amount curve on the direction angle of 0-360 degrees; and determining the maximum peak value of the defocus curve as the maximum defocus on the cornea.
In addition to the above method, in an example, the plurality of sampling points on the cornea are uniformly distributed on the peripheral membrane, or a curved surface fitting may be performed according to the plurality of sampling points, and a maximum peak value of a curved surface obtained by fitting may be used as the maximum defocus amount on the cornea. The present application is not limited to a particular calculation.
There are different ways to select the spots on the cornea. For example, samples may be selected at least 18 equally spaced azimuth angles, each azimuth angle collecting defocus for at least 3 samples. As another example, the defocus amount of at least 50 samples can be collected at 360 equally spaced azimuth angles. The specific setting can be according to actual need such as the requirement of measurement accuracy.
An exemplary embodiment of the present application further provides a method for obtaining a defocus amount parameter, as shown in fig. 12, including:
step 210, when a myope wears a corneal contact lens, acquiring defocusing amounts of a plurality of sample points on a dioptric system consisting of a cornea and a lens of the myope, wherein the sample points are distributed on a plurality of direction angles in a coordinate system taking the center of the cornea as an origin;
the defocus values of the various spots on the dioptric system can also be detected using a corneal mapper or similar detection device. The defocus amounts of the plurality of samples on the dioptric system in this embodiment are defocus amounts of the plurality of samples on the front surface of the dioptric system.
And step 220, obtaining a defocus parameter according to the defocus amounts of a plurality of sample points on the dioptric system.
The defocus parameter obtained in this step is the defocus parameter on the dioptric system.
The contact lenses in this embodiment may or may not use the peripheral defocus lenses of the present application.
In an exemplary embodiment of the present application, the obtained defocus parameter includes one or any combination of the following parameters:
a maximum defocus amount on the dioptric system;
comparing the maximum defocus amount on the dioptric system with one or more set defocus thresholds;
wherein the maximum defocus amount of the dioptric system is determined according to defocus amounts of a plurality of sample points on the dioptric system, and the defocus threshold value is not less than 3.5D, 4D, 4.5D, 5D, or 5.5D. The method for determining the maximum defocus amount of the dioptric system can refer to the above method for determining the maximum defocus amount of the cornea, and is not described here.
In one example, one defocus threshold is set, for example, a threshold for determining whether the myopia control is successful, such as 4.5D, and in another example, a plurality of defocus thresholds, such as 3.5D and 4.5D or more, are set, and the maximum defocus amount is compared with the plurality of defocus thresholds, so that the section in which the maximum defocus amount is located can be represented more accurately, and the effectiveness of the myopia control can be quantitatively evaluated.
In an exemplary embodiment of the present application, the defocus parameter obtained according to the defocus amounts of the plurality of sample points on the dioptric system includes: and determining the existence, quantity, size and position of an effective defocus area according to the defocus amounts of the plurality of sample points, wherein the effective defocus area refers to an area where the defocus amount at any position on the dioptric system is not less than a corresponding defocus threshold value, and the defocus threshold value is not less than 3.5D, 4D, 4.5D, 5D or 5.5D.
In this embodiment, according to the difference of the corresponding out-of-focus threshold, there may be one or more effective out-of-focus areas, and different effective out-of-focus areas are obtained by adopting different out-of-focus threshold determinations. For example, there may be an effective defocus area corresponding to a defocus threshold of 3.5D, an effective defocus area corresponding to a defocus threshold of 4.5D, and so on. There may be one or more of the same number of effective defocus regions. If an effective defocus area exists, the maximum defocus amount on the dioptric system is larger than the defocus threshold corresponding to the effective defocus area, and the myopia control effectiveness can be evaluated more finely by combining the size information of the effective defocus area. The size information of the effective defocus area can be represented by the size of the central angle corresponding to the effective defocus area, the area of the effective defocus area, or the like. Besides the size information, the relevance of the position information obtained by the statistical analysis and the effectiveness of myopia control can be combined with other information of the effective defocus area, such as specific position information, for fine evaluation.
In an exemplary embodiment of the present application, the spectacles worn by the myope are contact lenses, the contact lenses use any one of the lenses described in the embodiments of the present application, and the lenses comprise an indicator mark for indicating a position in an out-of-focus area of the lenses where the defocus amount is maximum; before acquiring defocus amounts of a plurality of samples on the dioptric system, the method further comprises: and calibrating the wearing angle of the lens according to the indication mark of the lens, so that the position with the maximum defocus amount in the out-of-focus area of the lens is aligned with the position with the maximum defocus amount on the cornea of the myope. Because the myope should be calibrated to obtain a good myopia control effect when wearing the device, the calibration needs to be carried out before the defocus parameter is measured, and more accurate data can be obtained. The position can be calibrated by rotating the lens by an angle around the line connecting the lens center and the cornea center after the lens center is aligned with the cornea center.
After obtaining above-mentioned defocus parameter, obtain defocus parameter be used for assessing myopia control effect that myope worn corneal contact lens, for example, assess the effect of patient wearing traditional peripheral out of focus corneal contact lens to myopia control, if the effect is not good can in time change other lenses like this application peripheral out of focus lens.
In an exemplary embodiment of the present application, the defocus parameter includes a maximum defocus amount on the cornea, or a comparison result between the maximum defocus amount on the cornea and a defocus threshold value; the method for determining the myopia control effect according to the defocus quantity parameter comprises the following steps: judging whether the maximum defocus amount on the cornea is not smaller than the defocus threshold value or not according to the defocus amount parameter, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective; or alternatively
The defocus parameter comprises the maximum defocus on the cornea or the comparison result of the maximum defocus on the cornea and a plurality of set defocus threshold values; the determining of the myopia control effect according to the defocus quantity parameter comprises the following steps: and judging whether the maximum defocus amount on the cornea is not less than one or more defocus threshold values according to the defocus amount parameter, if so, searching for a corresponding myopia control success rate according to the maximum defocus threshold value in the one or more defocus threshold values, and determining a myopia control effect according to the myopia control success rate.
In an exemplary embodiment of the present application, the defocus amount parameter at least includes information on presence or absence and size of an effective defocus area; the determining of the myopia control effect according to the defocus quantity parameter comprises the following steps: if the cornea has an effective out-of-focus area, searching a corresponding myopia control success rate according to an out-of-focus threshold corresponding to the effective out-of-focus area and the size information of the effective out-of-focus area, and determining a myopia control effect according to the myopia control success rate.
In the above embodiment, the determining the myopia control effect according to the myopia control success rate includes: directly using the myopia control success rate to represent a myopia control effect; or judging whether the myopia control success rate is not less than the expected success rate, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective.
An exemplary embodiment of the present application further provides a fitting method, as shown in fig. 13, including:
step 310, acquiring a defocus parameter of a myope in an naked eye state before fitting a spectacle according to any method in the embodiment of the application;
and 320, fitting glasses for the myope according to the defocus quantity parameter.
The glasses fitting can be selected from the manufactured glasses to a proper pair of glasses, and can also be a new personalized glasses designed for the myopes. The glasses can use the peripheral out-of-focus lenses of the application and can also use the traditional peripheral out-of-focus lenses.
In an exemplary embodiment of the present application, the defocus parameter includes a maximum defocus on the cornea and position information of the maximum defocus; fitting a pair of glasses for the myope according to the defocus quantity parameter, comprising: and selecting a peripheral defocused contact lens or a lens of frame glasses for the myope, so that after the maximum defocused amount on the cornea of the myope is superposed with the defocused amount of the corresponding position of the lens in an alignment manner, the obtained sum is not less than a set defocused threshold value, wherein the defocused threshold value is not less than 3.5D or 4D or 4.5D or 5D or 5.5D, and the defocused threshold value can be specifically selected according to a desired myopia inhibition effect, tolerance of the patient and the like. The lens of the contact lens is directly attached to the cornea, and the center of the lens needs to be aligned with the center of the cornea before alignment. For the frame glasses, the lens and the cornea have a certain distance, the center of the lens can be aligned with the cornea before alignment, and the corresponding relation of other positions can refer to the original rule.
In an exemplary embodiment of the present application, the defocus parameter includes defocus information of a plurality of sample points on the cornea; fitting a pair of glasses for the myope according to the defocus quantity parameter, comprising: and selecting a peripheral out-of-focus lens of a contact lens or a frame glasses for the myope, so that when the myope wears the lens, after the out-of-focus amount on the cornea is superposed with the out-of-focus amount at the corresponding position of the lens in an alignment manner, at least an effective out-of-focus area exists and the size of the effective out-of-focus area meets the requirement, wherein the effective out-of-focus area refers to an area with an out-of-focus amount at any position not less than a corresponding out-of-focus threshold value, the out-of-focus threshold value is not less than 3.5D or 4.5D or 5D or 5.5D, and one out-of-focus threshold value can be specifically selected according to the desired myopia inhibition effect, tolerance of the myope and the like.
In one example, the size of the effective defocus area satisfies the requirement, including: the effective defocus area satisfies one or more of the following conditions:
the central angle of the ring section where the effective defocusing area is located relative to the center of the lens is not less than an angle threshold value, and the angle threshold value is a set value which is not less than 5 degrees, 15 degrees, 30 degrees, 45 degrees or 60 degrees;
the sum of the areas of the effective defocusing areas is not less than a set area threshold.
In an exemplary embodiment of the present application, the lens is any one of the lenses described in the embodiments of the present application; before the performing the overlay, the method further includes: the fitting angle of the lens is calibrated (which can be done in software) so that the position where the defocus amount is maximum in the out-of-focus zone of the lens is aligned with the position where the defocus amount is maximum on the cornea of the myope. And the alignment is carried out before the superposition, so that more accurate defocusing data can be obtained, and the required value of the maximum defocusing amount is reduced.
In an exemplary embodiment of the present application, the method further includes: acquiring the diameter of the pupil of the myope; selecting a lens of a frame glasses or a cornea contact lens for the myope, wherein the diameter of the central optical area of the lens is determined according to the diameter of the pupil, and the larger the diameter of the pupil is, the larger the diameter of the determined central optical area of the lens is. Here a personalized design according to the size of the patient's pupil. For example, the diameter of the pupil can be graded into 5 different sizes, while the diameter of the central optical zone of the lens can also be graded into 5 different sizes. If the diameter of the pupil is the smallest order, then the lens with the smallest diameter of the central optical zone is selected, and if the diameter of the pupil is the largest order, then the lens with the largest diameter of the central optical zone is selected. And so on. In other examples, the diameter of the pupil and the number of lens gradations need not be equal. The diameter of the pupil may not be graded, but the pupil diameter may be directly divided into a plurality of zones, each zone corresponding to the diameter of one of the central optical zones of the lens.
At present, whether a keratoplasty mirror is effective for myopia control of a patient needs to measure the change of an axis of an eye after wearing the keratoplasty mirror for one year, and evaluation mainly aims at positioning and vision of the keratoplasty mirror. This requires a significant amount of time and can delay the opportunity for effective treatment by other methods for patients who have ineffective control.
To this end, an exemplary embodiment of the present application provides a method for evaluating the effect of myopia control using defocus, as shown in fig. 14, including:
step 410, acquiring defocus parameters obtained by a myope in an naked eye state after the cornea is shaped by a cornea shaping mirror according to any method described in the embodiments of the present application;
and step 420, determining the myopia control effect of the cornea shaping mirror on the myope according to the defocus quantity parameter.
In an exemplary embodiment of the present application, the defocus parameter includes a maximum defocus on the cornea, or a comparison result between the maximum defocus on the cornea and a defocus threshold; the determining of the myopia control effect according to the defocus quantity parameter comprises the following steps: judging whether the maximum defocus amount on the cornea is not smaller than the defocus threshold value or not according to the defocus amount parameter, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective; or
The defocus parameter comprises the maximum defocus on the cornea or the comparison result of the maximum defocus on the cornea and a plurality of set defocus threshold values; the method for determining the myopia control effect according to the defocus quantity parameter comprises the following steps: and judging whether the maximum defocus amount on the cornea is not less than one or more defocus threshold values according to the defocus amount parameter, if so, searching for a corresponding myopia control success rate according to the maximum defocus threshold value in the one or more defocus threshold values, and determining a myopia control effect according to the myopia control success rate. The myopia control success rate corresponding to the defocus threshold can be obtained and stored according to corresponding experimental data statistics.
In an exemplary embodiment of the present application, the defocus amount parameter at least includes presence/absence of an effective defocus area and size information (when there is no effective defocus area, the size information and the like are null information); the determining of the myopia control effect according to the defocus quantity parameter comprises the following steps: if the cornea has the effective out-of-focus area, searching the corresponding myopia control success rate according to the out-of-focus threshold corresponding to the effective out-of-focus area and the size information of the effective out-of-focus area, and determining the myopia control effect according to the myopia control success rate. The myopia control success rate corresponding to the defocus threshold and the size information of the effective defocus area can be obtained and stored according to corresponding experimental data statistics. If the defocus quantity parameter comprises a plurality of effective defocus areas corresponding to different defocus thresholds, a plurality of myopia control success rates can be found, and one effective defocus area is selected to determine the myopia control effect. For example, the myopia control success rate is found according to the effective defocus area corresponding to the maximum defocus threshold and the size information thereof, and the myopia control effect is determined using the found myopia control success rate, but the present application is not limited thereto. The myopia control success rate found according to the plurality of effective defocus areas and the size information thereof can also be comprehensively considered, for example, the maximum value, the average value or the minimum value is taken to determine the myopia control effect, and the application does not limit the effect.
In the above exemplary embodiments of the present application, the determining the myopia control effect according to the myopia control success rate includes: directly using the myopia control success rate to represent a myopia control effect; or judging whether the myopia control success rate is not less than the expected success rate, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective.
In an exemplary embodiment of the application, the myopia control effect is evaluated within 2 weeks or within 1 month or within 3 months or within 6 months after the myopic patient wears the keratoplasty mirror.
Unlike previous evaluation methods, the above embodiments of the present application provide a method for evaluating the effectiveness of myopia control using defocus parameters. And whether the orthokeratology mirror is effective for the patient can be judged in a short time, so that the clinical efficiency is improved, and the condition of the patient is prevented from being delayed and other means for controlling myopia are avoided. The application provides a new evaluation standard of the orthokeratology lens, and has important significance.
The method for acquiring the defocus amount parameter, the method for fitting the glasses and the method for evaluating the myopia control effect of the embodiments can be realized by using computer equipment. As shown in fig. 15, the computer device includes a processor 50, a memory 60, and a computer program stored on the memory 60 and operable on the processor 50, and the processor 50 executes the computer program to implement the processing of any one of the methods according to the above-mentioned embodiments of the present application.
An exemplary embodiment of the present application also provides a computer-readable storage medium, on which a computer program is stored, which, when executed by a processor, implements the processing of any one of the methods described in the above-mentioned embodiments of the present application.
It will be understood by those of ordinary skill in the art that all or some of the steps of the methods, systems, functional modules/units in the devices disclosed above may be implemented as software, firmware, hardware, or suitable combinations thereof. In a hardware implementation, the division between functional modules/units mentioned in the above description does not necessarily correspond to the division of physical components; for example, one physical component may have multiple functions, or one function or step may be performed by several physical components in cooperation. Some or all of the physical components may be implemented as software executed by a processor, such as a central processing unit, digital signal processor, or microprocessor, or as hardware, or as an integrated circuit, such as an application specific integrated circuit. Such software may be distributed on computer readable media, which may include computer storage media (or non-transitory media) and communication media (or transitory media). The term computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data, as is well known to those of ordinary skill in the art. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital Versatile Disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can accessed by a computer. In addition, communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media as is well known to those skilled in the art.
Claims (44)
1. A peripheral out-of-focus lens, the lens comprising a central optical zone, wherein an annular out-of-focus zone is provided outside the central optical zone, the out-of-focus amount of the out-of-focus zone varying circumferentially; the lens comprises an indicating mark, and the indicating mark is used for indicating the direction angle of the position with the maximum defocus amount in the defocus area, so that the position with the maximum defocus amount of the lens is aligned with the position with the maximum defocus amount on the cornea when a myope wears the lens, and extreme value superposition of the defocus amounts on the lens and the cornea is realized.
2. The lens of claim 1,
the difference between the maximum value and the minimum value of the defocusing amount in the defocusing area is not less than 1D.
3. The lens according to claim 1,
the difference between the maximum value and the minimum value of the defocusing amount in the defocusing area is not less than 2D.
4. The lens according to claim 1,
and the difference between the maximum value and the minimum value of the defocusing amount in the defocusing area is not less than 3D.
5. The lens of claim 1,
the difference between the maximum value and the minimum value of the defocusing amount in the defocusing area is not less than 4D.
6. The lens according to claim 1,
the difference between the maximum value and the minimum value of the defocusing amount in the defocusing area is not less than 5D.
7. The lens according to claim 1,
the lens is a contact lens of a cornea, and the out-of-focus area is positioned in an annular area which takes the center of the lens as the circle center, has the inner diameter of 3 mm-4 mm and the outer diameter of 5 mm-8 mm; or
The lens is a lens of frame glasses, and the out-of-focus area is positioned in an annular area which takes the center of the lens as the center of a circle, has an inner diameter of 6-8 mm and an outer diameter of 8-12 mm.
8. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 2D at any position; or alternatively
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 2.5D at any position.
9. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 2.5D at any position; or alternatively
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 3D at any position.
10. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 3D at any position; or
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 3.5D at any position.
11. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 3.5D at any position; or
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 4D at any position.
12. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 4D at any position; or
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 4.5D at any position.
13. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 4.5D at any position; or
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 5D at any position.
14. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 5D at any position; or alternatively
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 5.5D at any position.
15. The lens according to one of claims 1 to 7,
the lens is a lens of a corneal contact lens, and the defocusing area comprises a high-focus area with the defocusing amount not less than 5.5D at any position; or
The lens is a lens of frame glasses, and the out-of-focus area comprises a high-focus area with out-of-focus amount not less than 6D at any position.
16. The lens of claim 8,
the high focal area falls into one or two or more than three sector areas, the sector areas take the center of the lens as the circle center, and the sum of the central angles is not more than 30 degrees.
17. The lens of claim 8,
the high focal area falls into one or two or more than three sector areas, the sector areas take the center of the lens as the circle center, and the sum of the central angles is not more than 60 degrees.
18. The lens according to claim 8,
the high focal area falls into one or two or more than three sector areas, the sector areas take the center of the lens as the circle center, and the sum of the central angles is not more than 90 degrees.
19. The lens of claim 8,
the high focus area falls into one or two or more than three fan-shaped areas, the fan-shaped areas take the center of the lens as the center of a circle, and the sum of central angles is not more than 120 degrees.
20. The lens of claim 8,
the high focus area falls into one or two or more than three fan-shaped areas, the fan-shaped areas take the center of the lens as the center of a circle, and the sum of central angles is not more than 150 degrees.
21. The lens of claim 8,
the defocusing area comprises one or two or more than three high-focus areas, and the sum of central angles of the ring sections where the high-focus areas are located relative to the center of the lens is not less than 5 degrees.
22. The lens of claim 8,
the defocusing area comprises one or two or more than three high-focus areas, and the sum of central angles of ring sections where the high-focus areas are located relative to the center of the lens is not less than 15 degrees.
23. The lens of claim 8,
the out-of-focus area comprises one or two or more than three high-focus areas, and the sum of the central angles of the ring sections where the high-focus areas are located relative to the center of the lens is not less than 30 degrees.
24. The lens of claim 8,
the defocusing area comprises one or two or more than three high-focus areas, and the sum of central angles of the ring sections where the high-focus areas are located relative to the center of the lens is not less than 45 degrees.
25. The lens of claim 8,
the defocusing area comprises one or two or more than three high-focus areas, and the sum of central angles of the ring sections where the high-focus areas are located relative to the center of the lens is not less than 60 degrees.
26. The lens of claim 8,
the central optical area is a circular fixed focus area, the lens comprises an annular out-of-focus area or a plurality of annular out-of-focus areas, the annular out-of-focus areas take the center of the lens as the center of a circle, and the high focus area is one or more ring sections arranged in the out-of-focus area.
27. The lens according to one of claims 1 to 7,
the out-of-focus zone comprises one or any combination of the following structures formed on the outer surface of the lens:
a curved surface with gradually changed defocusing amount;
a fixed focus area;
and (4) point-shaped bulges.
28. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 2D; or alternatively
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 2D, and the second peak value is equal to the first peak value or less than the first peak value.
29. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 2.5D; or alternatively
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 2.5D, and the second peak value is equal to the first peak value or less than the first peak value.
30. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 3D; or
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 3D, and the second peak value is equal to the first peak value or less than the first peak value.
31. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 3.5D; or
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 3.5D, and the second peak value is equal to the first peak value or less than the first peak value.
32. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 4D; or alternatively
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 4D, and the second peak value is equal to the first peak value or less than the first peak value.
33. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 4.5D; or alternatively
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 4.5D, and the second peak value is equal to or less than the first peak value.
34. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 5D; or
Two peak values with the interval of 120-240 degrees are formed on the direction angle of 0-360 degrees by the defocusing amount of the defocusing area, wherein the first peak value is not less than 5D, and the second peak value is equal to or less than the first peak value.
35. The lens according to one of claims 1 to 7,
the defocusing amount of the defocusing area forms a peak value in a direction angle of 0-360 degrees, and the peak value is not less than 5.5D; or
The defocusing amount of the defocusing area forms two peak values with the interval of 120-240 degrees on the direction angle of 0-360 degrees, wherein the first peak value is not less than 5.5D, and the second peak value is equal to or less than the first peak value.
36. A framed spectacle comprising a frame and two lenses, wherein at least one of said two lenses is a lens according to any one of claims 1 to 35.
37. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two in-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 2.5D at any position in the defocus area.
38. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two out-of-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area in which the defocus amount at any position in the out-of-focus area is not less than 3D.
39. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two in-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 3.5D at any position in the out-of-focus area.
40. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two in-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 4D at any position in the defocus area.
41. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two in-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 4.5D at any position in the out-of-focus area.
42. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two out-of-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 5D at any position in the out-of-focus area.
43. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two in-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 5.5D at any position in the out-of-focus area.
44. The framed eyewear of claim 36,
the out-of-focus area comprises a high-focus area, and the high-focus area is positioned above or below the center of the lens; or, the out-of-focus area comprises two out-of-focus areas, one of which is located above the center of the lens and the other of which is located below the center of the lens;
wherein the high focus area refers to an area with a defocus amount not less than 6D at any position in the defocus area.
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| CN202010535487.9A CN111897141B (en) | 2018-12-25 | 2018-12-25 | Peripheral out-of-focus lens and frame glasses |
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| CN201811592602.5A CN109581690B (en) | 2018-12-25 | 2018-12-25 | Lens, glasses and method for acquiring defocus parameter, fitting and evaluating effect |
| CN202010535487.9A CN111897141B (en) | 2018-12-25 | 2018-12-25 | Peripheral out-of-focus lens and frame glasses |
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| CN202010535489.8A Active CN111708183B (en) | 2018-12-25 | 2018-12-25 | Lens of cornea shaping mirror |
| CN201811592602.5A Active CN109581690B (en) | 2018-12-25 | 2018-12-25 | Lens, glasses and method for acquiring defocus parameter, fitting and evaluating effect |
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| CN109946849A (en) * | 2019-04-25 | 2019-06-28 | 齐备 | Optical frame glasses |
| EP3736617A1 (en) * | 2019-05-10 | 2020-11-11 | Carl Zeiss Vision International GmbH | Method of forming an optical correction means |
| CN110515218A (en) * | 2019-09-10 | 2019-11-29 | 欧普康视科技股份有限公司 | A kind of Ortho-K |
| CN111000525B (en) * | 2019-11-21 | 2022-02-15 | 明灏科技（北京）有限公司 | Corneal plastic lens fitting method and system based on big data |
| CN113359320A (en) * | 2020-03-04 | 2021-09-07 | 亨泰光学股份有限公司 | Aspheric lens for controlling growth speed of eye axis by retina competition |
| CN113806908A (en) * | 2021-08-04 | 2021-12-17 | 美视(杭州)人工智能科技有限公司 | Parameter processing method based on cornea shaping lens fitting and related equipment |
| CN116125679B (en) * | 2023-01-19 | 2023-10-10 | 天津松润医疗器械有限公司 | Personalized defocus parameter determining method, lens matching method and effect evaluation equipment |
| CN117309334A (en) * | 2023-10-31 | 2023-12-29 | 上海婷伊美科技有限公司 | Cornea shaping mirror performance test method with Tesla valve-shaped round hole unit |
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| TWI410696B (en) * | 2005-02-15 | 2013-10-01 | Univ Queensland | Lens control of myopla |
| US8388130B2 (en) * | 2008-11-03 | 2013-03-05 | Vicoh, Llc | Non-deforming contact lens |
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| CN102129132B (en) * | 2011-03-29 | 2012-05-30 | 南开大学 | Design method for cornea contact lens based on wave front technology |
| CN102508944B (en) * | 2011-10-10 | 2014-09-10 | 沈阳理工大学 | Corneal surface shape fitting method |
| TWI516830B (en) * | 2012-05-07 | 2016-01-11 | 星歐光學股份有限公司 | Contact lens for myopia control |
| SG10201400920RA (en) * | 2014-03-24 | 2015-10-29 | Menicon Singapore Pte Ltd | Apparatus and methods for controlling axial growth with an ocular lens |
| CN203930241U (en) * | 2014-06-11 | 2014-11-05 | 上海鹤影光学技术有限公司 | A kind of Ortho-K |
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| CN105974605A (en) * | 2016-05-10 | 2016-09-28 | 段亚东 | Four-quadrant area ambitus out-of-focus corneal contact lens |
| CN105785589A (en) * | 2016-05-10 | 2016-07-20 | 段亚东 | Four-quadrant-region peripheral out-of-focus frame glasses lens |
| TWI595286B (en) * | 2016-06-07 | 2017-08-11 | Continuous zoom contact lenses | |
| US10001660B1 (en) * | 2017-02-24 | 2018-06-19 | Edward Chow | Methods of designing reverse geometry lenses for myopia control |
| CN107861262B (en) * | 2017-12-10 | 2024-04-09 | 段亚东 | Fan-shaped concentric circle peripheral defocus spectacle lens |
| TWI640307B (en) * | 2017-12-27 | 2018-11-11 | 優你康光學股份有限公司 | Dual defocus lens |
-
2018
- 2018-12-25 CN CN202010535487.9A patent/CN111897141B/en active Active
- 2018-12-25 CN CN202010535489.8A patent/CN111708183B/en active Active
- 2018-12-25 CN CN201811592602.5A patent/CN109581690B/en active Active
Also Published As
| Publication number | Publication date |
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| CN111708183B (en) | 2023-03-24 |
| CN111897141A (en) | 2020-11-06 |
| CN109581690B (en) | 2020-07-03 |
| CN109581690A (en) | 2019-04-05 |
| CN111708183A (en) | 2020-09-25 |
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