WO2017096995A1 - Soft cornea-contacting lens - Google Patents

Soft cornea-contacting lens Download PDF

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Publication number
WO2017096995A1
WO2017096995A1 PCT/CN2016/098790 CN2016098790W WO2017096995A1 WO 2017096995 A1 WO2017096995 A1 WO 2017096995A1 CN 2016098790 W CN2016098790 W CN 2016098790W WO 2017096995 A1 WO2017096995 A1 WO 2017096995A1
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arc
region
contact lens
soft contact
power
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PCT/CN2016/098790
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French (fr)
Chinese (zh)
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齐备
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齐备
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    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • G02C7/041Contact lenses for the eyes bifocal; multifocal
    • G02C7/044Annular configuration, e.g. pupil tuned
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • G02C7/049Contact lenses having special fitting or structural features achieved by special materials or material structures

Definitions

  • the present invention relates to a soft contact lens.
  • a conventional soft contact lens is a soft material lens that is worn on the cornea of a myopic patient to correct vision, and the external object is imaged by the negative power corresponding to the degree of myopia of the wearing eye.
  • the retina on the eye allows the myopic patient to clearly see the external object, thus correcting the myopia of the eye.
  • this traditional soft contact lens does not have the effect of controlling the development of myopia in adolescents.
  • an aspheric soft contact lens has emerged, also known as a high definition SLE.
  • the advent of this aspheric soft contact lens is based on the following recognition: the front surface of the cornea is not a regular spherical surface, but is aspherical curved surface to a certain extent, that is, the central part of the cornea is the most curved, and the peripheral part gradually changes. Therefore, the positive focal force of the center of the cornea is the largest, and the positive focal force is shifted toward the peripheral portion of the cornea.
  • the light emitted by the target is first focused through the center of the cornea, and then focused through the peripheral portion of the cornea, and a corresponding clear image cannot be formed in the fundus. Therefore, the aspherical shape of the cornea affects the visual acuity of the human eye, and the visual sensation of the eye is blurred, which is called the physiological aberration of the eye, as shown in FIG.
  • the design points of the aspheric soft contact lens are as follows.
  • the shape of the optical surface of the front surface of the soft contact lens is designed as a reverse aspherical shape, that is, the central portion of the front surface of the lens has the flatmost curvature and gradually bends toward the periphery.
  • the negative focal force of the center of the lens is the largest, and the negative focal force is gradually decreased toward the peripheral portion of the cornea, thereby canceling the physiological aberration of the cornea, so that the image through which the target light passes is close to the original true state, as shown in FIG. 2 .
  • Aspheric soft contact lens has been marketed for more than ten years. Clinical evaluation has recognized that this lens has the characteristics of clear vision, improved contrast sensitivity and improved color vision. However, clinical investigations have confirmed that this lens does not have the control of myopia development. efficacy.
  • the function of the aspheric soft contact lens is limited to the correction of the physiological aberration caused by the aspherical surface of the cornea, that is, the curvature of the front surface of the lens from the central portion to the peripheral portion.
  • the amount is approximately the same as the curvature of the cornea from the central portion to the peripheral portion. It is known that the physiological aberration of the cornea in the pupil area is only 0.25 to 1.00 D. If the center curvature of the front surface of the lens is 42.00D, the curvature value of the edge of the optical zone is designed to be approximately 42.75D.
  • the Ortho-K CL is made of hard breathable polymer material.
  • the main component is fluorinated silicone polymethyl methacrylate.
  • the water content of the material is ⁇ 1.0% and the deformation strength is >70g.
  • the inner surface is designed with four different curved surfaces, so that the lens plays a role of flattening and shaping the cornea. After the lens is removed, the wearing eye myopia is corrected to some extent within a certain period of time. Lenses are usually worn at night, and the period of use varies depending on the quality of care, usually over one year.
  • Figure 3 shows a coronal view of a Ortho-K CL.
  • Figure 4 shows a sagittal view of a Ortho-K CL.
  • the posterior surface of the Ortho-K CL is sequentially designed from the center to the periphery as four parts: a base arc, a reverse arc, a matching arc and an edge arc.
  • the morphological law is opposite to the flattening of the anterior surface of the cornea from the center to the periphery, that is, the base arc of the central region of the lens is flatter than the central portion of the cornea, and the inversion arc surrounding the base arc is used to eliminate the flatness of the base arc than the cornea of the same region.
  • the matching arc around the inversion arc is the same as the curvature of the same area.
  • the matching arc is the same as the curvature of the cornea, the inner surface of the lens and the front surface of the cornea have a relatively stable adhesion tension under the filling action of the tear liquid.
  • the base arc of the central area of the lens is slightly flatter than the central area of the cornea, the cornea is flattened, thereby achieving the effect of correcting myopia.
  • the accumulation of the flattening effect for a long time will locally maintain the center of the cornea.
  • the morphological "memory" effect of the cornea occurs after the lens is removed. After the center of the cornea is flat, the positive power of the cornea is reduced. If the amount of the flattened shape is equal to the degree of myopia of the wearing eye, the target light can be focused on the retina after entering the eye, thereby making the myopia Get clear vision.
  • the cornea Under the pressure of the lens, the cornea can produce a physical "memory" effect, but still maintain the biological shape of the constant nature, so the shaping effect of the Ortho-K CL is temporary and limited. After stopping wearing the Ortho-K CL, the myopia with the eye within a few days will return to its original extent, so the Ortho-K CL can not cure myopia.
  • the original target of Orthokeratology is to correct myopia.
  • the lens is usually worn at night, and the night lens is centered stably. When the lens is removed during the day, the wearer can wear no corrective glasses for a whole day. Maintain available corrected vision, just as there is no myopia.
  • keratoplasty after several years of keratoplasty, after accumulating a large number of samples of the wearing population, it was gradually found that the degree of myopia in some cases of Ortho-K CL was slowed down. For this unforeseen discovery, there are a large number of follow-up observations on the above clinical phenomena by the fitter.
  • the aspherical shape of the cornea causes the image of the peripheral region of the retina to be imaged behind the retina, so it is in a blurred state and is called peripheral defocus.
  • the negative pressure is formed after the tear liquid is discharged, so that the cornea in the same area is increased in focus, and the physiological aberration of the cornea after shaping is induced. Corrected, the surrounding blurred image is reduced in the field of view of the wearer's eye, which makes the development of myopia in the wearer's eye slow down.
  • Another theory is that after the normal optical glasses correct myopia, there is an abnormal adjustment lag when the eye is gazing near the target, that is, the eye can not be mobilized enough to adjust when the eye is close to the target, and the image of the central region of the retina is blurred. Called the center defocus. In the modern living environment, the use rate of adolescents' near vision has exceeded 90%, making this consistent disease incentives prominent.
  • the keratoplasty mirror refocuses the area of the reversal arc during the wearing process, so that the peripheral part of the retina has a sufficient positive power, which not only effectively controls the peripheral defocus of the retinal image, but also makes the target image appropriate in front of the retina.
  • the focal position of the image is such that when the near target is looked at, the abnormal adjustment lag of the eye is limited.
  • the improvement of image clarity in the center of the retina plays a crucial role in slowing the development of myopia in the wearer's eye.
  • Orthokeratology has the following disadvantages:
  • the posterior surface of the Ortho-K CL is only closely matched with the cornea, and its area is only about 30% of the total area of the lens. Moreover, there are individual differences in the aspherical and ring-surface morphology of the cornea, so that the lens is behind. The contact surface between the surface and the cornea is smaller, so the lens is not stable enough. Accurate quantification of the arc is the key to correcting the success or failure. The arc parameters must be determined by time-consuming repeated trials. This is the Ortho-K CL. The difficulty of fitting is where.
  • the inner surface of the lens and the shape of the cornea are inconsistent, which causes many wearers to wear it for the first time because of the foreign body sensation, even if it is barely wearing the mirror, it will take more than 3 days to adapt.
  • the sensory threshold of wearing the cornea is elevated, so that the cornea is in a state of sensory passivation for a long time, and the blinking is caused by numbness of the cornea, resulting in secondary dry eye symptoms.
  • the wearer often stops or gives up the treatment because of the pain of wearing the mirror. In particular, the children's audience has a bottleneck and fear of keratoplasty.
  • a soft contact lens comprising a posterior surface for covering a layer of tear fluid worn on a surface of a cornea and a front surface opposite the posterior surface, wherein the front surface comprises a circle
  • the central arc zone and the annular arc control zone surrounding the central arc zone, the central arc zone and the rear surface form approximately the same amount of negative power or zero power with the eyesight of the eye, and the arc control zone is composed of
  • the inner and outer positive powers are smoothly increased by the amount, and the total positive value of the positive focus of the arc control zone depends on the myopic power of the wearing eye.
  • the soft contact lens of the invention avoids the shortcomings of the corneal plastic mirror and retains the effect of the corneal plastic mirror to prevent the development of myopia.
  • Figure 1 schematically shows the physiological aberration of the cornea
  • Figure 2 is a schematic illustration of an aspheric soft contact lens overcoming the physiological aberrations of the cornea
  • Figure 3 is a schematic illustration of a coronal view of a Ortho-K CL
  • Figure 4 is a schematic illustration of a sagittal view of a Ortho-K CL
  • Figure 5 is a schematic illustration of the morphological changes of the anterior surface of the cornea after Orthokeratology
  • Figure 6 is a schematic illustration of a physiological lens after anatomical shaping using a posterior corneal posterior surface
  • Figure 7 is a schematic illustration of a physiological lens after simulated corneal shaping using a soft contact lens
  • Figure 8 is a schematic illustration of a front surface panorama of a soft contact lens in accordance with an embodiment of the present invention.
  • Figure 9 is a schematic illustration of a frontal major arc subdivided view of a soft contact lens in accordance with an embodiment of the present invention.
  • Figure 10 is a view schematically showing a sagittal arc curvature radius of a main arc region of a soft contact lens according to an embodiment of the present invention
  • Figure 11 is a schematic illustration of a soft contact lens in accordance with an embodiment of the present invention. Arc effect rate analysis chart.
  • the formation of the basic idea of the invention is inspired by a Ortho-K CL.
  • the Ortho-K CL can prevent and control the occurrence and development of myopia to some extent.
  • the present invention intends to extract the effective elements displayed by the corneal morphology of the successful cases of Ortho-K CL, and design it into a soft contact lens.
  • the wearer does not have to modify the corneal morphology to achieve the purpose of preventing and controlling myopia.
  • Learning from the aspheric soft contact lens can not prevent and control the experience of myopia, in the lens surface design to break through the correction of corneal physiological aberrations.
  • the invention adopts a soft contact lens to simulate the corneal morphology of the successful case of the Ortho-K CL, and retains the effective elements of the prevention and control of myopia in the corneal optical interface of the successful case of the Ortho-K CL.
  • the soft contact lens of the present invention can be made, for example, of a soft polymer material, and its main component can be, for example, a hydrogel material such as polyhydroxyethyl methacrylate.
  • the material is soft in texture and has a water content of 38 to 70%.
  • the shape of the inner surface of the lens can be matched to the front surface of the cornea to the maximum extent, so the lens has no shaping effect on the cornea. In the state of wearing the lens, the lens has a corrective effect on myopia. After the lens is removed, the shape of the cornea is unchanged, and the original eye state is restored immediately after wearing the eye.
  • the soft contact lens can be worn on a day-to-day basis, that is, worn during non-sleep periods, without the need for night wear.
  • Myopia is characterized by an abnormal increase in the positive power of the eye.
  • the center of the cornea is flattened, thereby reducing the positive power of the cornea and correcting myopia.
  • Figure 5 shows the morphological changes of the anterior surface of the cornea after Orthokeratology.
  • the anterior surface of the cornea outside the geometric center of the cornea is drawn by the negative pressure of the lens reversal arc to form a focal length of about 2 mm wide. It is believed that the shape and focal metric of the focal zone are myopia prevention and control. A valid element.
  • the corneal tissue between the anterior surface and the posterior surface of the cornea forms a very thin morphological special physiological lens, as shown in FIG.
  • the invention adopts a soft contact lens material to simulate a physiological lens formed by Orthokeratology and advances integrally to the front of the cornea, thereby forming a myopia prevention and control soft contact lens of the present invention, as shown in FIG. Wearing the contact lens, the shape of the cornea is unchanged, and the cornea can be shaped. The purpose of slowing down the development of myopia.
  • FIG. 8 schematically illustrates a front surface panoramic view of a soft contact lens in accordance with an embodiment of the present invention
  • FIG. 9 schematically illustrates The front surface of the soft contact lens of the embodiment of the invention is a main arc subdivided view
  • FIG. 10 is a view schematically showing the main arc sagittal arc radius of the soft contact lens according to an embodiment of the present invention. .
  • a soft contact lens that includes a posterior surface for covering a layer of tear fluid that is worn over the surface of the cornea and opposite the posterior surface a front surface, wherein the front surface includes a circular arc (ie, a circular shape viewed from a front view) and an annular arc surrounding the central arc (ie, a ring viewed from a front view), a central arc region
  • the near-focus power of the wear eye is approximately equal to the negative power or zero power, and the arc control zone is smoothly increased from the inside to the outside, and the positive focus of the arc control zone is always increased.
  • the incremental value depends on the myopic power of the wearing eye.
  • the central arc zone and the arc control zone can be collectively referred to as an effective arc zone.
  • the target correction power specification of the soft contact lens determined by the power between the central arc region and the rear surface can be set, for example, from -1.00 to -9.00 D, and the step weight can be, for example, 0.25 D. .
  • the total positive power increment value of the arc control zone may be 80%-110% of the near vision power of the wear eye.
  • the total positive power increment value of the arc control zone may be approximately equal to the near vision power of the wear eye.
  • the total positive power of the arc control zone can be about 0.75D, which can still prevent the occurrence of myopia.
  • the central arc zone may be a spherical arc and may have a diameter of about 2.0-4.0 mm, and the arc-control zone may have a width of about 2.0-2.4 mm.
  • the central arc zone may have a diameter of about 3 mm and the arc control zone may have a diameter of about 2.1 mm.
  • the arc control zone may further include a proximal ring region surrounding the central arc region and a far loop region surrounding the proximal loop region, and the proximal loop region may have a width of 0.8-1.2 mm, The width of the far loop region is about 1.2 mm, and the amount of focus of the outer edge of the near loop region is 55% to 75% of the total increment of the positive power, and the amount of focus of the outer edge of the far loop region is the positive The total incremental value of the power is 25% to 45%.
  • the proximal loop region may have a width of 1 mm and the focus of the outer edge of the proximal loop region The amount may be 65% of the total increment of the positive power, and the amount of focus of the outer edge of the far loop may be 35% of the total increment of the positive power.
  • the front surface may further comprise an annular release arc region having a width of about 0.8-1.2 mm around the arc control zone, and the release arc region is smoothly decremented from the inner and outer positive power for the prevention and control The amount of focus of the arc, thereby reducing the thickness of the edge of the lens.
  • the width of the release arc can be 0.8 mm.
  • the release of the arc zone can be used without optical effects, and is only used to release the amount of anti-control arc focusing, so as to reduce the thickness of the edge of the lens.
  • the arc area can be decremented by about 75 to 85% of the arc-increasing amount, for example, the arc-increasing amount can be reduced by 80%. Outside the release arc zone, the amount of focus enhancement in the remaining arc control zone can still be appropriately reduced, and the curvature gradient difference between the engagement release arc zone and the front peripheral arc zone as described above is completed.
  • the rear surface may include a base arc region located at a center (ie, a circle in a front view) and a rear peripheral arc region surrounding the base arc (ie, a ring shape in a front view)
  • the base arc region may be a spherical arc surface, and the curvature may be one of several different curvatures selected from the range of about 8.1-8.9 mm according to the curvature of the wearing cornea, and the arc power of the rear peripheral arc region may be more than the base arc.
  • the region is flat 0.75-1.25D, and the front surface may further include a front peripheral arc region surrounding the release arc region, and the arcing power of the front peripheral arc region may be the same as the rear peripheral arc region.
  • the base arc zone can be designed to have two different radii of curvature values depending on the curvature of the cornea worn, 8.6 mm and 8.3 mm, respectively.
  • the radius of curvature of the base arc region can be selected to match the anterior surface of the cornea.
  • the base arc region may have a diameter of 7.0-8.0 mm
  • the rear peripheral arc region may have a width of 3.1-3.3 mm
  • the front peripheral arc region may have a width of 1.7-2.8 mm.
  • the base arc region may have a diameter of 7.5 mm
  • the rear peripheral arc region may have a width of 3.0 mm
  • the front peripheral arc region may have a width of 2.35 mm.
  • the total diameter of the string of the soft antennal lens can be obtained from 13.2-14.6 mm.
  • the lens material main matrix component may be a hydrogel, such as polyhydroxyethyl methacrylate.
  • the lens material may also include sodium hyaluronate and fluorinated silicone as an adjunct to increase the moisturization of the eye and the level of corneal oxygen metabolism.
  • the target correction power and the base arc area of the rear surface of the lens Curvature radius which can calculate the radius of curvature parameter of the central arc area of the front surface of the lens. Calculated as follows.
  • r 1 is the radius of curvature parameter of the central arc of the front surface
  • D is the target corrected power
  • r 2 is the radius of curvature parameter of the base arc region
  • n is the refractive index of the material.
  • the total area of the X-axis prevention and control arc area is increased by the X-axis near-ring area (ie, the percentage of the outer edge of the anti-control arc near the outer ring area is the percentage of the total positive value of the arc-control area. X%), according to the known refractive index of the lens material, the target correction power and the radius of curvature parameter of the central arc region of the front surface, the radius of curvature of the outer edge of the arc control proximal ring region can be calculated. Calculated as follows.
  • r 3 is the radius of curvature of the outer edge of the arc control near ring region.
  • the target correction power and the radius of curvature of the outer edge of the near ring area can be calculated.
  • the radius of curvature of the edge Calculated as follows.
  • r 4 is the radius of curvature of the outer edge of the remote control ring region.
  • the release arc area is decremented by about Z% of the total amount of focus control in the arc control zone, and the radius of curvature of the outer edge of the release arc zone is calculated according to the known refractive index of the lens material, the target correction power and the radius of curvature of the edge of the far loop zone. value. Calculated as follows.
  • r 5 is the radius of curvature value of the outer edge of the release arc zone.
  • Figure 8 is a graph showing the curvature gradient of the effective arc region of the front surface of an exemplary soft lenticular lens according to an embodiment of the present invention, wherein the abscissa indicates each position in the effective arc region of the front surface of the lens.
  • the distance from the geometric center of the cornea, the ordinate indicates the rate of change of curvature at the position relative to the base arc, where the curvature of the base arc is 0, and the rate of change of the center of the effective arc relative to the curvature of the base arc is 100%.
  • the rate of change with respect to the curvature of the base curve gradually decreases, and the rate of change with respect to the curvature of the base curve at a distance of about 3.5 mm from the geometric center of the cornea is zero, that is, equal to the curvature of the base curve.
  • the curve represents only exemplary and illustrative embodiments of the geometric parameters of the soft contact lens of the present invention, and is not intended to limit the invention.
  • the soft contact lens according to an embodiment of the present invention has at least the following advantages.
  • the soft contact lens according to the embodiment of the present invention does not undergo corneal morphology modification after wearing the mirror, and avoids the pathological change of the corneal epithelial cell layer due to the Orthokeratology mirror.
  • the change of the gap between the cornea and the cornea avoids the damage of the corneal epithelial barrier function and the epithelial damage caused by the disorder of the tear layer.
  • the invention can be used for daytime wearing glasses without the accumulation effect of corneal oxygen metabolism disorder induced by keratoplasty at night, resulting in corneal edema and thinning of the stromal layer thickness.
  • the invention successfully avoids the most taboo eye complications of the Orthokeratology wearer's parents and the long-term sequelae that may occur due to wearing glasses.
  • the posterior surface of the lens of the soft contact lens according to the embodiment of the present invention is completely attached to the cornea, so that it is not required to be tried, no need to be reviewed, and the fitting is simple and time-saving, the lens is always stably positioned in the ocular surface, and the coke is corrected.
  • the amount is accurate, and the visual acuity remains unchanged in the morning and afternoon.
  • the correction range can reach 9.00D or more in myopia, and the possibility of correcting the failure is extremely small.
  • the soft contact lens according to the embodiment of the present invention has a soft material, a strong plasticity, a comfortable eye and a non-irritating feeling, and the sensory threshold of wearing the cornea after wearing the lens has no significant change, thereby successfully avoiding the lens.
  • the invention adopts a soft contact lens to simulate the corneal morphology of the successful case of the Orthokeratology mirror, and successfully retains the effective elements of the prevention and control of myopia in the corneal optical interface of the successful case of the Orthokeratology mirror, thereby having myopia prevention. Control function. And because the correction amount is more accurate, the clear vision is more stable and stable, and less wear and tear caused by the complications of wearing glasses, so that the wearing eyes are less susceptible to blurred images, and the effect of myopia prevention and control is more reliable.

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Abstract

A soft cornea-contacting lens comprises a rear surface configured to cover the tear layer on a corneal surface of a lens-wearing eye and a front surface opposite to the rear surface, wherein the front surface comprises a circular central arc region and an annular prevention and control arc region surrounding the central arc region . A negative focal power or zero focal power approximately equal to myopic focal power of the lens-wearing eye is formed between the central arc region and the rear surface, and the positive focal power of the prevention and control arc region is gradually and smoothly increased from inside to outside by an amount depending on the myopic focal power of the lens-wearing eye, thereby controlling myopia can be prevented and controlled.

Description

软性角膜接触镜Soft contact lens 技术领域Technical field
本发明涉及一种软性角膜接触镜。The present invention relates to a soft contact lens.
背景技术Background technique
传统的软性角膜接触镜是一种戴在近视患者的眼球角膜上、用以矫正视力的软性材料镜片,其通过与配戴眼的近视度数对应的负焦度,来使外界物体成像在配戴眼的视网膜上,使近视患者能够清晰地看到外界物体,从而对配戴眼的近视起到了矫正作用。然而,这种传统的软性角膜接触镜并不具有控制青少年近视发展的功效。A conventional soft contact lens is a soft material lens that is worn on the cornea of a myopic patient to correct vision, and the external object is imaged by the negative power corresponding to the degree of myopia of the wearing eye. The retina on the eye allows the myopic patient to clearly see the external object, thus correcting the myopia of the eye. However, this traditional soft contact lens does not have the effect of controlling the development of myopia in adolescents.
近年来,出现了一种非球面软性角膜接触镜,又称为高解像软性角膜接触镜(high definition SCL)。这种非球面软性角膜接触镜的问世是基于以下认识:角膜的前表面并非规则的圆球面,而是在一定程度上呈非球面弧面,即角膜的中心部最弯,周边部逐渐变平,因此角膜中心部正焦力最大,向角膜周边部移位正焦力递减。目标物发出的光线,通过角膜中心部先聚焦,通过角膜周边部后聚焦,不能在眼底同步形成对应的清晰影像。因此角膜的非球面形态影响了人眼的视觉敏锐度,使眼睛的视觉微感模糊,称为眼的生理性像差,如图1所示。In recent years, an aspheric soft contact lens has emerged, also known as a high definition SLE. The advent of this aspheric soft contact lens is based on the following recognition: the front surface of the cornea is not a regular spherical surface, but is aspherical curved surface to a certain extent, that is, the central part of the cornea is the most curved, and the peripheral part gradually changes. Therefore, the positive focal force of the center of the cornea is the largest, and the positive focal force is shifted toward the peripheral portion of the cornea. The light emitted by the target is first focused through the center of the cornea, and then focused through the peripheral portion of the cornea, and a corresponding clear image cannot be formed in the fundus. Therefore, the aspherical shape of the cornea affects the visual acuity of the human eye, and the visual sensation of the eye is blurred, which is called the physiological aberration of the eye, as shown in FIG.
非球面软性角膜接触镜的设计要点如下,将软性角膜接触镜的前表面光学区的形态设计为逆向非球面形态,即镜片前表面的中心部曲率最平,向周边逐渐变弯,使镜片中心部负焦力最大,向角膜周边部移位负焦力逐渐递减,从而抵消角膜的生理像差,使目标光线通过的影像接近于的原始真态,如图2中所示。非球面软性角膜接触镜已经市场化十余年,临床评价公认该种镜片具有视觉清晰、对比敏感度提高和色视觉改善等特点,但临床调查证实该种镜片也不具有控制青少年近视发展的功效。The design points of the aspheric soft contact lens are as follows. The shape of the optical surface of the front surface of the soft contact lens is designed as a reverse aspherical shape, that is, the central portion of the front surface of the lens has the flatmost curvature and gradually bends toward the periphery. The negative focal force of the center of the lens is the largest, and the negative focal force is gradually decreased toward the peripheral portion of the cornea, thereby canceling the physiological aberration of the cornea, so that the image through which the target light passes is close to the original true state, as shown in FIG. 2 . Aspheric soft contact lens has been marketed for more than ten years. Clinical evaluation has recognized that this lens has the characteristics of clear vision, improved contrast sensitivity and improved color vision. However, clinical investigations have confirmed that this lens does not have the control of myopia development. efficacy.
这是由于这种非球面软性角膜接触镜的功能仅限于矫正角膜非球面弧面带来的生理性像差,即镜片前表面自中心部向周边部曲率逐渐变弯的递 量与角膜自中心部向周边部曲率逐渐变平递量大致相同。已知瞳孔区角膜的生理性像差仅为0.25~1.00D。设镜片前表面的中心曲率为42.00D,则光学区边缘曲率值约设计为42.75D。This is because the function of the aspheric soft contact lens is limited to the correction of the physiological aberration caused by the aspherical surface of the cornea, that is, the curvature of the front surface of the lens from the central portion to the peripheral portion. The amount is approximately the same as the curvature of the cornea from the central portion to the peripheral portion. It is known that the physiological aberration of the cornea in the pupil area is only 0.25 to 1.00 D. If the center curvature of the front surface of the lens is 42.00D, the curvature value of the edge of the optical zone is designed to be approximately 42.75D.
与软性角膜接触镜相对的另一种角膜接触镜为角膜塑形镜,又称为角膜塑形用硬性透气接触镜(Ortho-k lens)。角膜塑形镜采用硬质透气高分子聚合物材料制作,主要成分为氟化硅氧烷聚甲基丙烯酸甲酯,该种材料含水量<1.0%,变形强度>70g。内表面设计为四种不同的弧面,使镜片对角膜起到了压平塑形的作用,摘下镜片以后,在一定时间内一定程度上使配戴眼近视获得矫正。镜片通常在夜间配戴,使用周期视保养质量有一定差异,通常在一年以上。Another type of contact lens that is opposite to a soft contact lens is a Ortho-K lens, also known as a Ortho-k lens for Orthokeratology. The Ortho-K CL is made of hard breathable polymer material. The main component is fluorinated silicone polymethyl methacrylate. The water content of the material is <1.0% and the deformation strength is >70g. The inner surface is designed with four different curved surfaces, so that the lens plays a role of flattening and shaping the cornea. After the lens is removed, the wearing eye myopia is corrected to some extent within a certain period of time. Lenses are usually worn at night, and the period of use varies depending on the quality of care, usually over one year.
图3示出了角膜塑形镜的冠状面图。图4示出了角膜塑形镜的矢状面图。如图3、4中所示,角膜塑形镜的后表面由中心向周边依次设计为基弧、反转弧、配适弧和边缘弧等四个部分。与角膜前表面从中心向周边越来越平坦的形态规律相反,即镜片中心区的基弧比角膜中心部平坦,围绕在基弧以外的反转弧为了消解基弧的平坦度比同区角膜弯曲,围绕在反转弧以外的配适弧与同区角膜曲率相同。Figure 3 shows a coronal view of a Ortho-K CL. Figure 4 shows a sagittal view of a Ortho-K CL. As shown in FIGS. 3 and 4, the posterior surface of the Ortho-K CL is sequentially designed from the center to the periphery as four parts: a base arc, a reverse arc, a matching arc and an edge arc. The morphological law is opposite to the flattening of the anterior surface of the cornea from the center to the periphery, that is, the base arc of the central region of the lens is flatter than the central portion of the cornea, and the inversion arc surrounding the base arc is used to eliminate the flatness of the base arc than the cornea of the same region. Bending, the matching arc around the inversion arc is the same as the curvature of the same area.
当镜片附着角膜时,由于配适弧与角膜同区弧度相同,在泪液的充填作用下,镜片内表面与角膜前表面产生较为稳定的附着张力。与此同时由于镜片中心区的基弧比角膜中心区稍平坦,则对角膜起到了压平的作用,从而达到矫正近视的效果,长时间的压平效应的积累就会将角膜中心局部维持在变平的“塑形”状态,在摘下镜片以后角膜就会发生物理学上的形态性“记忆”效果。角膜中心部平坦以后使角膜的正焦力减量,若压平塑形的量值与配戴眼的近视程度等量,则可使目标光线进入眼睛以后在视网膜上聚焦,因而可以使近视眼获得清晰视力。When the lens is attached to the cornea, since the matching arc is the same as the curvature of the cornea, the inner surface of the lens and the front surface of the cornea have a relatively stable adhesion tension under the filling action of the tear liquid. At the same time, since the base arc of the central area of the lens is slightly flatter than the central area of the cornea, the cornea is flattened, thereby achieving the effect of correcting myopia. The accumulation of the flattening effect for a long time will locally maintain the center of the cornea. In the flattened "shaping" state, the morphological "memory" effect of the cornea occurs after the lens is removed. After the center of the cornea is flat, the positive power of the cornea is reduced. If the amount of the flattened shape is equal to the degree of myopia of the wearing eye, the target light can be focused on the retina after entering the eye, thereby making the myopia Get clear vision.
角膜在镜片的压平作用下,可以产生物理学上的形态“记忆”效果,但仍然保持生物学的形态恒常性质,因此角膜塑形镜的塑形作用是暂时的、有限度的。在停止配戴角膜塑形镜以后,数天之内配戴眼的近视就会恢复原来的程度,故角膜塑形镜并不能治愈近视。 Under the pressure of the lens, the cornea can produce a physical "memory" effect, but still maintain the biological shape of the constant nature, so the shaping effect of the Ortho-K CL is temporary and limited. After stopping wearing the Ortho-K CL, the myopia with the eye within a few days will return to its original extent, so the Ortho-K CL can not cure myopia.
角膜塑形镜最初的矫治目标定位在矫正近视,镜片通常在夜间配戴,取夜间镜片居中稳定定位,而白天摘下镜片后,配戴者可以在一整天时间内不用戴任何矫正眼镜,维持可用的矫正视力,与没有近视眼一样。然而角膜塑形镜流行数年以后,在积累了大量配戴人群样本后,逐渐发现部分配戴角膜塑形镜案例的近视程度发展趋缓。对于这一始料未及的发现,有验配师对上述临床现象做了大量随访观察,有文献对于配戴角膜塑形镜与配戴普通软性角膜接触镜数年间近视发展程度进行比较分析,结果证实配戴角膜塑形镜以后配戴眼的近视程度的发展趋缓有显著性差异。又有文献对配戴角膜塑形镜与配戴普通软性角膜接触镜数年间眼轴长延长程度进行比较分析,结果证实配戴角膜塑形镜以后配戴眼的眼轴长延长程度的发展趋缓有显著性差异。The original target of Orthokeratology is to correct myopia. The lens is usually worn at night, and the night lens is centered stably. When the lens is removed during the day, the wearer can wear no corrective glasses for a whole day. Maintain available corrected vision, just as there is no myopia. However, after several years of keratoplasty, after accumulating a large number of samples of the wearing population, it was gradually found that the degree of myopia in some cases of Ortho-K CL was slowed down. For this unforeseen discovery, there are a large number of follow-up observations on the above clinical phenomena by the fitter. There are literatures comparing the development of myopia with keratoplasty and wearing ordinary soft contact lenses for several years. The results confirmed that there was a significant difference in the development of the degree of myopia after wearing the Ortho-K CL. In addition, the literature compares the length of the axial length of the keratoplasty with the ordinary soft contact lens for several years. The results confirm the development of the length of the axial length of the eye after wearing the Ortho-K CL. There is a significant difference in slowing down.
配戴角膜塑形镜以后配戴眼的近视程度的发展趋缓已成为不争的事实。对于其成因,近年来的研究认为近视的发生发展与视网膜的模糊影像相关,当视网膜出现模糊影像就会影响视网膜神经递质的水平,继而影响眼球轴长的生长发育。由于眼轴异常延长,则外界目标物的影像就会聚焦于视网膜前方,从而形成近视。It has become an indisputable fact that the development of myopia with the eye after wearing a Ortho-K CL has become slower. For its causes, recent studies have suggested that the occurrence and development of myopia is related to the blurred image of the retina. When the retina appears blurred, it will affect the level of retinal neurotransmitters, which in turn affects the growth and development of the axial length of the eye. As the axial length is abnormally extended, the image of the external target will be focused on the front of the retina to form myopia.
有学说认为在通常的光学眼镜矫正近视以后,角膜的非球面形态使得视网膜周边区域的影像在视网膜后方结像,故呈模糊状态,被称为周边离焦。而在角膜塑形镜在配戴过程中,由于反转弧区域不与角膜接触,其间收纳的泪液排出后形成负压,使得同区角膜增焦,诱使塑形后的角膜生理性像差被修正,周边模糊影像在戴镜眼的视野中减少,从而使戴镜眼近视发展趋缓。另一种学说则认为在通常的光学眼镜矫正近视以后,配戴眼注视近目标时存在着异常调节滞后,即在注视近目标时配戴眼不能动员足够的调节,视网膜中心区影像模糊,被称为中心离焦。而在现代生存环境中,青少年近用视力的使用率已经超过90%,使得这一致病诱因被凸显。而角膜塑形镜在配戴过程中反转弧区域的增焦,使得视网膜周边部具有足量的正焦力,不仅有效地控制了视网膜影像的周边离焦,且使目标影像在视网膜前方适当的焦位结像,因此在注视近目标时,限制了眼的异常调节滞后。 视网膜中心影像清晰度的提高,对于使戴镜眼近视发展趋缓起到至关重要的作用。It is said that after the normal optical glasses correct myopia, the aspherical shape of the cornea causes the image of the peripheral region of the retina to be imaged behind the retina, so it is in a blurred state and is called peripheral defocus. In the process of wearing the Orthokeratology mirror, since the area of the inverted arc is not in contact with the cornea, the negative pressure is formed after the tear liquid is discharged, so that the cornea in the same area is increased in focus, and the physiological aberration of the cornea after shaping is induced. Corrected, the surrounding blurred image is reduced in the field of view of the wearer's eye, which makes the development of myopia in the wearer's eye slow down. Another theory is that after the normal optical glasses correct myopia, there is an abnormal adjustment lag when the eye is gazing near the target, that is, the eye can not be mobilized enough to adjust when the eye is close to the target, and the image of the central region of the retina is blurred. Called the center defocus. In the modern living environment, the use rate of adolescents' near vision has exceeded 90%, making this consistent disease incentives prominent. The keratoplasty mirror refocuses the area of the reversal arc during the wearing process, so that the peripheral part of the retina has a sufficient positive power, which not only effectively controls the peripheral defocus of the retinal image, but also makes the target image appropriate in front of the retina. The focal position of the image is such that when the near target is looked at, the abnormal adjustment lag of the eye is limited. The improvement of image clarity in the center of the retina plays a crucial role in slowing the development of myopia in the wearer's eye.
但角膜塑形镜存在着以下缺点:However, Orthokeratology has the following disadvantages:
(1)配戴角膜塑形镜会使角膜中心区域受压,带来角膜上皮细胞层的病理性改变和角膜各层次间隙的改变,可能引发角膜上皮屏障功能破坏和泪液层的紊乱而带来上皮损伤,并可能因戴镜而产生眼并发症和远期后遗症。(1) Wearing a Ortho-K CL will pressure the central area of the cornea, causing pathological changes in the corneal epithelial cell layer and changes in the cornea at various levels, which may lead to the destruction of the corneal epithelial barrier function and the disorder of the tear layer. Epithelial damage, and may cause eye complications and long-term sequelae due to wearing glasses.
(2)角膜塑形镜的后表面只有配适弧区域与角膜紧密配合,其面积仅约占镜片总面积的30%,更由于角膜的非球面和环曲面形态存在个体差异,使镜片的后表面与角膜的接触面更小,因此镜片的配适不够稳定,配适弧的精确定量成为矫正成败的关键,配适弧参数必须通过耗时的反复试戴才能确定,这是角膜塑形镜验配的难点所在。常诱发近视矫正不足、不规则散光、偏位棱镜,故角膜塑形镜的矫正焦量仅为近似值,有一定比率的配戴者无论怎样修改矫正方案均不能成功,近视超过5.00D的案例矫正失败率则更高。即使低度近视矫正成功后,也不能避免由于角膜塑形量的弹复导致的上午与下午矫正量的变化,晚间因瞳径扩大,入眼光线景深缩短,矫正视力尤为模糊。角膜塑形镜验配技术的繁复耗时,以及不能克服的矫正误差和矫正失败,饱受验配师诟病。(2) The posterior surface of the Ortho-K CL is only closely matched with the cornea, and its area is only about 30% of the total area of the lens. Moreover, there are individual differences in the aspherical and ring-surface morphology of the cornea, so that the lens is behind. The contact surface between the surface and the cornea is smaller, so the lens is not stable enough. Accurate quantification of the arc is the key to correcting the success or failure. The arc parameters must be determined by time-consuming repeated trials. This is the Ortho-K CL. The difficulty of fitting is where. Often induced by myopia correction, irregular astigmatism, offset prism, so the corrected focal length of the Ortho-K CL is only an approximation, a certain ratio of wearers can not be modified anyway, no matter how to correct the correction of myopia more than 5.00D The failure rate is even higher. Even if the low myopia correction is successful, the morning and afternoon corrections caused by the resilience of the corneal shaping can not be avoided. In the evening, due to the enlargement of the diameter, the depth of field of the eye is shortened, and the corrected visual acuity is particularly blurred. The cumbersome and time-consuming techniques of keratoplasty, as well as the inability to overcome correction errors and corrections, have been criticized by the fitter.
(3)角膜塑形镜因镜片硬度大,镜片内表面与角膜形态不一致,导致很多配戴者首次配戴即因异物感不能接受,即使勉强戴镜也要渡过3天以上的适应期,配戴眼角膜的感觉阈值升高,使角膜长期处于感觉钝化状态,由于角膜感觉麻木导致瞬目减少,导致继发眼干症状。配戴者常因不堪忍受戴镜痛苦发生停戴或放弃矫治。尤其儿童受众人群对角膜塑形镜存在接受瓶颈和恐惧心理。(3) Because of the high hardness of the lens, the inner surface of the lens and the shape of the cornea are inconsistent, which causes many wearers to wear it for the first time because of the foreign body sensation, even if it is barely wearing the mirror, it will take more than 3 days to adapt. The sensory threshold of wearing the cornea is elevated, so that the cornea is in a state of sensory passivation for a long time, and the blinking is caused by numbness of the cornea, resulting in secondary dry eye symptoms. The wearer often stops or gives up the treatment because of the pain of wearing the mirror. In particular, the children's audience has a bottleneck and fear of keratoplasty.
可见,本领域中需要一种改进的能够防控近视发展且克服了角膜塑形镜缺点的技术方案。It can be seen that there is a need in the art for an improved technical solution that can prevent the development of myopia and overcome the shortcomings of Ortho-K CL.
发明内容 Summary of the invention
为解决上述技术问题,提出了本发明的技术方案。In order to solve the above technical problems, the technical solution of the present invention has been proposed.
在本发明的一个方面,提供了一种软性角膜接触镜,包括用于覆盖于配戴眼角膜表面的泪液层上的后表面以及与后表面相对的前表面,其中,前表面包括圆形的中心弧区与围绕中心弧区的环形防控弧区,中心弧区与后表面之间形成与配戴眼的近视焦度大约等量的负焦度或零焦度,防控弧区由内向外正焦度逐量平滑递增,防控弧区的正焦度总增量值取决于配戴眼的近视焦度。In one aspect of the invention, a soft contact lens is provided comprising a posterior surface for covering a layer of tear fluid worn on a surface of a cornea and a front surface opposite the posterior surface, wherein the front surface comprises a circle The central arc zone and the annular arc control zone surrounding the central arc zone, the central arc zone and the rear surface form approximately the same amount of negative power or zero power with the eyesight of the eye, and the arc control zone is composed of The inner and outer positive powers are smoothly increased by the amount, and the total positive value of the positive focus of the arc control zone depends on the myopic power of the wearing eye.
本发明的软性角膜接触镜避免了角膜塑性镜的各项缺点,保留了角膜塑性镜预防近视发展的功效。The soft contact lens of the invention avoids the shortcomings of the corneal plastic mirror and retains the effect of the corneal plastic mirror to prevent the development of myopia.
附图说明DRAWINGS
图1示意性地示出了角膜的生理性像差;Figure 1 schematically shows the physiological aberration of the cornea;
图2示意性地示出了非球面软性角膜接触镜克服了角膜的生理性像差;Figure 2 is a schematic illustration of an aspheric soft contact lens overcoming the physiological aberrations of the cornea;
图3示意性地示出了角膜塑形镜的冠状面图;Figure 3 is a schematic illustration of a coronal view of a Ortho-K CL;
图4示意性地示出了角膜塑形镜的矢状面图;Figure 4 is a schematic illustration of a sagittal view of a Ortho-K CL;
图5示意性地示出了角膜塑形后角膜前表面的形态变化;Figure 5 is a schematic illustration of the morphological changes of the anterior surface of the cornea after Orthokeratology;
图6示意性地示出了采用角膜后表面平行前移分析角膜塑形后的生理透镜;Figure 6 is a schematic illustration of a physiological lens after anatomical shaping using a posterior corneal posterior surface;
图7示意性地示出了采用软性角膜接触镜模拟角膜塑形后的生理透镜;Figure 7 is a schematic illustration of a physiological lens after simulated corneal shaping using a soft contact lens;
图8示意性地示出了根据本发明的实施例的软性角膜接触镜的前表面全景图;Figure 8 is a schematic illustration of a front surface panorama of a soft contact lens in accordance with an embodiment of the present invention;
图9示意性地示出了根据本发明的实施例的软性角膜接触镜的前表面主要弧区细分图;Figure 9 is a schematic illustration of a frontal major arc subdivided view of a soft contact lens in accordance with an embodiment of the present invention;
图10示意性地示出了根据本发明的实施例的软性角膜接触镜的主要弧区矢状各弧曲率半径图;Figure 10 is a view schematically showing a sagittal arc curvature radius of a main arc region of a soft contact lens according to an embodiment of the present invention;
图11示意性地示出了根据本发明的实施例的软性角膜接触镜的前有 效弧递变率分析图。Figure 11 is a schematic illustration of a soft contact lens in accordance with an embodiment of the present invention. Arc effect rate analysis chart.
具体实施方式detailed description
本发明的基本思想的形成受到角膜塑形镜的启示。鉴于大量临床实验证实角膜塑形镜可以在一定程度上防控近视的发生与发展,本发明拟将角膜塑形镜成功案例的角膜形态所显示的有效元素提取,设计成软性角膜接触镜,使配戴者不必修改角膜形态同样达到防控近视的目的。借鉴非球面软性角膜接触镜并不能防控近视的经验,在进行镜片面形设计时突破矫正角膜生理性像差的限制。也就是说,本发明采用软性角膜接触镜模拟了角膜塑形镜成功案例的角膜形态,保留了角膜塑形镜成功案例的角膜光学界面中近视防控的有效元素。The formation of the basic idea of the invention is inspired by a Ortho-K CL. In view of a large number of clinical experiments, it can be confirmed that the Ortho-K CL can prevent and control the occurrence and development of myopia to some extent. The present invention intends to extract the effective elements displayed by the corneal morphology of the successful cases of Ortho-K CL, and design it into a soft contact lens. The wearer does not have to modify the corneal morphology to achieve the purpose of preventing and controlling myopia. Learning from the aspheric soft contact lens can not prevent and control the experience of myopia, in the lens surface design to break through the correction of corneal physiological aberrations. That is to say, the invention adopts a soft contact lens to simulate the corneal morphology of the successful case of the Ortho-K CL, and retains the effective elements of the prevention and control of myopia in the corneal optical interface of the successful case of the Ortho-K CL.
本发明的软性角膜接触镜例如可以采用软质高分子聚合物材料制作,其主要成分例如可以为诸如聚甲基丙烯酸羟乙酯的水凝胶材料。该种材料质地柔软,含水量可为38~70%。镜片内表面形态设计可以与角膜前表面最大限度吻合,故镜片对于角膜并无塑形作用。在戴镜状态下,镜片对于近视起到矫正作用,在摘下镜片以后,角膜形态不变,配戴眼立即恢复原有的近视状态。该软性角膜接触镜的配戴方式可以为日戴,即在非睡眠时间配戴,而无需夜间配戴。The soft contact lens of the present invention can be made, for example, of a soft polymer material, and its main component can be, for example, a hydrogel material such as polyhydroxyethyl methacrylate. The material is soft in texture and has a water content of 38 to 70%. The shape of the inner surface of the lens can be matched to the front surface of the cornea to the maximum extent, so the lens has no shaping effect on the cornea. In the state of wearing the lens, the lens has a corrective effect on myopia. After the lens is removed, the shape of the cornea is unchanged, and the original eye state is restored immediately after wearing the eye. The soft contact lens can be worn on a day-to-day basis, that is, worn during non-sleep periods, without the need for night wear.
近视表现为眼的正焦力异常增高。配戴角膜塑形镜以后,将角膜中心部压平塑形,从而消减角膜的正焦力,达到矫正近视的目的。图5示出了角膜塑形后角膜前表面的形态变化。从图中可以看到,距离角膜几何中心以外的角膜前表面受镜片反转弧的负压牵引形成大约2mm宽的增焦区,据信增焦区的形态和焦度量值为近视防控的有效元素。Myopia is characterized by an abnormal increase in the positive power of the eye. After wearing the Ortho-K CL, the center of the cornea is flattened, thereby reducing the positive power of the cornea and correcting myopia. Figure 5 shows the morphological changes of the anterior surface of the cornea after Orthokeratology. As can be seen from the figure, the anterior surface of the cornea outside the geometric center of the cornea is drawn by the negative pressure of the lens reversal arc to form a focal length of about 2 mm wide. It is believed that the shape and focal metric of the focal zone are myopia prevention and control. A valid element.
如果将角膜后表面向前平行推移,可以看到角膜前表面与后表面之间的角膜组织形成了极薄的形态特殊的生理性透镜,如图6中所示。If the posterior surface of the cornea is moved forward in parallel, it can be seen that the corneal tissue between the anterior surface and the posterior surface of the cornea forms a very thin morphological special physiological lens, as shown in FIG.
本发明采用软性角膜接触镜材料模拟角膜塑形所形成的生理性透镜,并整体前移到角膜前方,从而形成本发明的近视防控软性角膜接触镜,如图7中所示。配戴该角膜接触镜,角膜的形态不变,同样可达到角膜塑形后 近视发展趋缓的目的。The invention adopts a soft contact lens material to simulate a physiological lens formed by Orthokeratology and advances integrally to the front of the cornea, thereby forming a myopia prevention and control soft contact lens of the present invention, as shown in FIG. Wearing the contact lens, the shape of the cornea is unchanged, and the cornea can be shaped. The purpose of slowing down the development of myopia.
现参照8-10描述本发明的实施例,其中,图8示意性地示出了根据本发明的实施例的软性角膜接触镜的前表面全景图;图9示意性地示出了根据本发明的实施例的软性角膜接触镜的前表面主要弧区细分图;图10示意性地示出了根据本发明的实施例的软性角膜接触镜的主要弧区矢状各弧半径图。Embodiments of the present invention will now be described with reference to 8-10, wherein FIG. 8 schematically illustrates a front surface panoramic view of a soft contact lens in accordance with an embodiment of the present invention; FIG. 9 schematically illustrates The front surface of the soft contact lens of the embodiment of the invention is a main arc subdivided view; FIG. 10 is a view schematically showing the main arc sagittal arc radius of the soft contact lens according to an embodiment of the present invention. .
如图8-10中所示,根据本发明的实施例,提供了一种软性角膜接触镜,其包括用于覆盖于配戴眼角膜表面的泪液层上的后表面以及与后表面相对的前表面,其中,前表面包括圆形(即从正面视图中观察为圆形)的中心弧区与围绕中心弧区的环形(即从正面视图中观察为环形)防控弧区,中心弧区与后表面之间形成与配戴眼的近视焦度大约等量的负焦度或零焦度,防控弧区由内向外正焦度逐量平滑递增,防控弧区的正焦度总增量值取决于配戴眼的近视焦度。中心弧区和防控弧区可以统称为有效弧区。As shown in Figures 8-10, in accordance with an embodiment of the present invention, a soft contact lens is provided that includes a posterior surface for covering a layer of tear fluid that is worn over the surface of the cornea and opposite the posterior surface a front surface, wherein the front surface includes a circular arc (ie, a circular shape viewed from a front view) and an annular arc surrounding the central arc (ie, a ring viewed from a front view), a central arc region The near-focus power of the wear eye is approximately equal to the negative power or zero power, and the arc control zone is smoothly increased from the inside to the outside, and the positive focus of the arc control zone is always increased. The incremental value depends on the myopic power of the wearing eye. The central arc zone and the arc control zone can be collectively referred to as an effective arc zone.
由所述中心弧区与后表面之间的焦度所决定的该软性角膜接触镜的目标矫正焦度规格例如可以设置为-1.00~-9.00D,且步距递量例如可以为0.25D。The target correction power specification of the soft contact lens determined by the power between the central arc region and the rear surface can be set, for example, from -1.00 to -9.00 D, and the step weight can be, for example, 0.25 D. .
根据本发明的实施例,所述防控弧区的正焦度总增量值可以为配戴眼的近视焦度的80%-110%。例如,所述防控弧区的正焦度总增量值可以与配戴眼的近视焦度大约等量。对于还没有近视的配戴眼,可以使防控弧区的正焦度总增量值约为0.75D,这样仍可以防治近视的发生。According to an embodiment of the invention, the total positive power increment value of the arc control zone may be 80%-110% of the near vision power of the wear eye. For example, the total positive power increment value of the arc control zone may be approximately equal to the near vision power of the wear eye. For the wearing eye without myopia, the total positive power of the arc control zone can be about 0.75D, which can still prevent the occurrence of myopia.
根据本发明的实施例,所述中心弧区可以为球面弧,且其直径可以约为2.0-4.0mm,所述防控弧区的宽度可以约为2.0-2.4mm。例如,所述中心弧区的直径可以约为3mm,所述防控弧区的直径可以约为2.1mm。According to an embodiment of the invention, the central arc zone may be a spherical arc and may have a diameter of about 2.0-4.0 mm, and the arc-control zone may have a width of about 2.0-2.4 mm. For example, the central arc zone may have a diameter of about 3 mm and the arc control zone may have a diameter of about 2.1 mm.
根据本发明的实施例,所述防控弧区进一步可以包括围绕中心弧区的近环区和围绕近环区的远环区,所述近环区的宽度可以为0.8-1.2mm,所述远环区的宽度为约1.2mm,且近环区外缘的增焦量为所述正焦度总增量值的55%~75%,远环区外缘的增焦量为所述正焦度总增量值的25%~45%。例如,所述近环区的宽度可以为1mm,且近环区外缘的增焦 量可以为所述正焦度总增量值的65%,远环区外缘的增焦量可以为所述正焦度总增量值的35%。According to an embodiment of the present invention, the arc control zone may further include a proximal ring region surrounding the central arc region and a far loop region surrounding the proximal loop region, and the proximal loop region may have a width of 0.8-1.2 mm, The width of the far loop region is about 1.2 mm, and the amount of focus of the outer edge of the near loop region is 55% to 75% of the total increment of the positive power, and the amount of focus of the outer edge of the far loop region is the positive The total incremental value of the power is 25% to 45%. For example, the proximal loop region may have a width of 1 mm and the focus of the outer edge of the proximal loop region The amount may be 65% of the total increment of the positive power, and the amount of focus of the outer edge of the far loop may be 35% of the total increment of the positive power.
根据本发明的实施例,前表面还可以包括围绕所述防控弧区的宽度约为0.8-1.2mm的环形释放弧区,释放弧区由内向外正焦度平滑递减,用于消解防控弧的增焦量,从而消减镜片边缘的厚度。例如,释放弧区的宽度可以为0.8mm。According to an embodiment of the invention, the front surface may further comprise an annular release arc region having a width of about 0.8-1.2 mm around the arc control zone, and the release arc region is smoothly decremented from the inner and outer positive power for the prevention and control The amount of focus of the arc, thereby reducing the thickness of the edge of the lens. For example, the width of the release arc can be 0.8 mm.
释放弧区可以无光学功效,仅用于释放防控弧增焦量,达到消减镜片边缘厚度的目的。释放弧区可递减约75~85%防控弧增焦量,例如可递减80%的防控弧增焦量。释放弧区以外可以仍适当递减余下防控弧区增焦量,完成衔接释放弧区与如上所述的前周边弧区之间的曲率梯度差。The release of the arc zone can be used without optical effects, and is only used to release the amount of anti-control arc focusing, so as to reduce the thickness of the edge of the lens. The arc area can be decremented by about 75 to 85% of the arc-increasing amount, for example, the arc-increasing amount can be reduced by 80%. Outside the release arc zone, the amount of focus enhancement in the remaining arc control zone can still be appropriately reduced, and the curvature gradient difference between the engagement release arc zone and the front peripheral arc zone as described above is completed.
根据本发明的实施例,后表面可以包括位于中心的圆形(即在正面视图中为圆形)的基弧区以及围绕基弧的环形(即在正面视图中为环形)的后周边弧区,基弧区可以为球形弧面,其曲率可以为根据配戴眼角膜的曲率选自约8.1-8.9mm范围内的若干不同曲率之一,后周边弧区的弧面焦度可以较基弧区平坦0.75-1.25D,并且前表面还可以包括围绕所述释放弧区的前周边弧区,前周边弧区的弧面焦度可以与后周边弧区相同。例如,基弧区可以根据配戴眼角膜的曲率设计为两种不同的曲率半径量值,分别为8.6mm和8.3mm。基弧区的曲率半径的选择可以与配戴眼角膜前表面相吻合。According to an embodiment of the present invention, the rear surface may include a base arc region located at a center (ie, a circle in a front view) and a rear peripheral arc region surrounding the base arc (ie, a ring shape in a front view) The base arc region may be a spherical arc surface, and the curvature may be one of several different curvatures selected from the range of about 8.1-8.9 mm according to the curvature of the wearing cornea, and the arc power of the rear peripheral arc region may be more than the base arc. The region is flat 0.75-1.25D, and the front surface may further include a front peripheral arc region surrounding the release arc region, and the arcing power of the front peripheral arc region may be the same as the rear peripheral arc region. For example, the base arc zone can be designed to have two different radii of curvature values depending on the curvature of the cornea worn, 8.6 mm and 8.3 mm, respectively. The radius of curvature of the base arc region can be selected to match the anterior surface of the cornea.
根据本发明的实施例,所述基弧区的直径可以为7.0-8.0mm,所述后周边弧区的宽度可以为3.1-3.3mm,所述前周边弧区的宽度可以为1.7-2.8mm。例如,所述基弧区的直径可以为7.5mm,所述后周边弧区的宽度可以为3.0mm,所述前周边弧区的宽度可以为2.35mm。According to an embodiment of the present invention, the base arc region may have a diameter of 7.0-8.0 mm, the rear peripheral arc region may have a width of 3.1-3.3 mm, and the front peripheral arc region may have a width of 1.7-2.8 mm. . For example, the base arc region may have a diameter of 7.5 mm, the rear peripheral arc region may have a width of 3.0 mm, and the front peripheral arc region may have a width of 2.35 mm.
由此,可获得该软性触角接触镜镜片的弦线总直径为13.2-14.6mm。Thereby, the total diameter of the string of the soft antennal lens can be obtained from 13.2-14.6 mm.
根据本发明的实施例,镜片材料主基质成分可以为水凝胶,例如可以为聚甲基丙稀酸羟乙酯。镜片材料还可以包括作为辅助成分的玻璃酸钠和氟化硅氧烷,其功效为增加配戴眼的湿润度和角膜氧代谢水平。According to an embodiment of the invention, the lens material main matrix component may be a hydrogel, such as polyhydroxyethyl methacrylate. The lens material may also include sodium hyaluronate and fluorinated silicone as an adjunct to increase the moisturization of the eye and the level of corneal oxygen metabolism.
根据已知的镜片材料的折射率、目标矫正焦度和镜片后表面基弧区的 曲率半径,可以计算镜片前表面中心弧区的曲率半径参数。计算公式如下。According to the known refractive index of the lens material, the target correction power and the base arc area of the rear surface of the lens Curvature radius, which can calculate the radius of curvature parameter of the central arc area of the front surface of the lens. Calculated as follows.
Figure PCTCN2016098790-appb-000001
Figure PCTCN2016098790-appb-000001
式中r1为前表面中心弧区的曲率半径参数,D为目标矫正焦度,r2为基弧区的曲率半径参数,n为材料的折射率。Where r 1 is the radius of curvature parameter of the central arc of the front surface, D is the target corrected power, r 2 is the radius of curvature parameter of the base arc region, and n is the refractive index of the material.
此外,假设防控弧近环区完成X%的防控弧区增焦总量(即防控弧近环区外缘增焦量占防控弧区的正焦度总增量值的百分比为X%),根据已知的镜片材料的折射率、目标矫正焦度和前表面中心弧区的曲率半径参数可以计算防控弧近环区外缘的曲率半径值。计算公式如下。In addition, it is assumed that the total area of the X-axis prevention and control arc area is increased by the X-axis near-ring area (ie, the percentage of the outer edge of the anti-control arc near the outer ring area is the percentage of the total positive value of the arc-control area. X%), according to the known refractive index of the lens material, the target correction power and the radius of curvature parameter of the central arc region of the front surface, the radius of curvature of the outer edge of the arc control proximal ring region can be calculated. Calculated as follows.
Figure PCTCN2016098790-appb-000002
Figure PCTCN2016098790-appb-000002
式中r3为防控弧近环区外缘的曲率半径。Where r 3 is the radius of curvature of the outer edge of the arc control near ring region.
假设防控弧远环区完成Y%的防控弧区增焦总量,根据已知的镜片材料的折射率、目标矫正焦度和近环区外缘的曲率半径参数可以计算远环区外缘的曲率半径值。计算公式如下。Assume that the total area of the YV prevention and control arc area is increased by the anti-control arc far loop area. According to the known refractive index of the lens material, the target correction power and the radius of curvature of the outer edge of the near ring area, the far loop area can be calculated. The radius of curvature of the edge. Calculated as follows.
Figure PCTCN2016098790-appb-000003
Figure PCTCN2016098790-appb-000003
式中r4为防控弧远环区外缘的曲率半径。Where r 4 is the radius of curvature of the outer edge of the remote control ring region.
假设释放弧区递减约Z%的防控弧区增焦总量,根据已知的镜片材料的折射率、目标矫正焦度和远环区边缘的曲率半径值计算释放弧区外缘的曲率半径值。计算公式如下。Assume that the release arc area is decremented by about Z% of the total amount of focus control in the arc control zone, and the radius of curvature of the outer edge of the release arc zone is calculated according to the known refractive index of the lens material, the target correction power and the radius of curvature of the edge of the far loop zone. value. Calculated as follows.
Figure PCTCN2016098790-appb-000004
Figure PCTCN2016098790-appb-000004
式中r5为释放弧区外缘的曲率半径值。Where r 5 is the radius of curvature value of the outer edge of the release arc zone.
图8示出了根据以上设计的根据本发明的实施例的示例性的软性角膜镜镜片前表面有效弧区的曲率递变曲线,其中横坐标表示镜片前表面的有效弧区中的各位置距角膜几何中心的距离,纵坐标表示该位置处相对于基弧的曲率的变化率,其中以基弧的曲率为基准0位,以有效弧区的中心相对于基弧的曲率的变化率为100%。由图中可见,随着与角膜几何中心的 距离增大,相对于的基弧曲率的变化率逐渐减小,并在距角膜几何中心约3.5mm处相对于基弧曲率的变化率为0,即与基弧曲率相等。当然,如本领域的技术人员可理解的,该曲线仅表示本发明的软性角膜接触镜镜片的几何参数的示例性和说明性实施方式,而不是对本发明的限制。Figure 8 is a graph showing the curvature gradient of the effective arc region of the front surface of an exemplary soft lenticular lens according to an embodiment of the present invention, wherein the abscissa indicates each position in the effective arc region of the front surface of the lens. The distance from the geometric center of the cornea, the ordinate indicates the rate of change of curvature at the position relative to the base arc, where the curvature of the base arc is 0, and the rate of change of the center of the effective arc relative to the curvature of the base arc is 100%. As can be seen from the figure, along with the geometric center of the cornea As the distance increases, the rate of change with respect to the curvature of the base curve gradually decreases, and the rate of change with respect to the curvature of the base curve at a distance of about 3.5 mm from the geometric center of the cornea is zero, that is, equal to the curvature of the base curve. Of course, as will be appreciated by those skilled in the art, the curve represents only exemplary and illustrative embodiments of the geometric parameters of the soft contact lens of the present invention, and is not intended to limit the invention.
根据本发明的实施例的软性角膜接触镜至少有以下优点。The soft contact lens according to an embodiment of the present invention has at least the following advantages.
(1)根据本发明的实施例的软性角膜接触镜与角膜塑形镜比较,戴镜后不发生角膜形态的修改,避免了由于角膜塑形镜带来的角膜上皮细胞层的病理性改变和角膜各层次间隙的改变,避免了角膜上皮屏障功能破坏和泪液层的紊乱带来的上皮损伤。本发明可为日间戴镜,不发生角膜塑形镜夜间戴镜诱发的角膜氧代谢障碍的积累效应,导致角膜水肿和基质层厚度薄化。本发明成功地回避了角膜塑形镜配戴者家长最为忌讳的眼并发症和因戴镜可能产生的远期后遗症。(1) Compared with the Orthokeratology mirror, the soft contact lens according to the embodiment of the present invention does not undergo corneal morphology modification after wearing the mirror, and avoids the pathological change of the corneal epithelial cell layer due to the Orthokeratology mirror. The change of the gap between the cornea and the cornea avoids the damage of the corneal epithelial barrier function and the epithelial damage caused by the disorder of the tear layer. The invention can be used for daytime wearing glasses without the accumulation effect of corneal oxygen metabolism disorder induced by keratoplasty at night, resulting in corneal edema and thinning of the stromal layer thickness. The invention successfully avoids the most taboo eye complications of the Orthokeratology wearer's parents and the long-term sequelae that may occur due to wearing glasses.
(2)根据本发明的实施例的软性角膜接触镜的镜片后表面与角膜全面附着,因此无须试戴,无需复查,验配简单省时,镜片在眼表始终稳定居定位中,矫正焦量精确,上午与下午比较视力清晰度持续不变,矫正范围可达近视9.00D或更大,矫正失败的可能性极小。(2) The posterior surface of the lens of the soft contact lens according to the embodiment of the present invention is completely attached to the cornea, so that it is not required to be tried, no need to be reviewed, and the fitting is simple and time-saving, the lens is always stably positioned in the ocular surface, and the coke is corrected. The amount is accurate, and the visual acuity remains unchanged in the morning and afternoon. The correction range can reach 9.00D or more in myopia, and the possibility of correcting the failure is extremely small.
(3)根据本发明的实施例的软性角膜接触镜由于镜片材质柔软,可塑性强,配戴眼舒适无刺激感,戴镜后配戴眼角膜的感觉阈值无显著变化,从而成功地回避了角膜塑形镜儿童受众人群的接受瓶颈和恐惧心理。(3) The soft contact lens according to the embodiment of the present invention has a soft material, a strong plasticity, a comfortable eye and a non-irritating feeling, and the sensory threshold of wearing the cornea after wearing the lens has no significant change, thereby successfully avoiding the lens. The bottleneck and fear of the audience of the Orthokeratology children's audience.
(4)本发明采用软性角膜接触镜模拟了角膜塑形镜成功案例的角膜形态,成功地保留了角膜塑形镜成功案例的角膜光学界面中近视防控的有效元素,从而具有了近视防控的功能。且因矫正量更精确,清晰视力更持续稳定,更少因戴镜并发症引起的停戴,使配戴眼更少感受模糊影像,近视防控的效果更为确实可靠。(4) The invention adopts a soft contact lens to simulate the corneal morphology of the successful case of the Orthokeratology mirror, and successfully retains the effective elements of the prevention and control of myopia in the corneal optical interface of the successful case of the Orthokeratology mirror, thereby having myopia prevention. Control function. And because the correction amount is more accurate, the clear vision is more stable and stable, and less wear and tear caused by the complications of wearing glasses, so that the wearing eyes are less susceptible to blurred images, and the effect of myopia prevention and control is more reliable.
以上参照附图描述了本发明的实施例,应指出的是,以上描述仅为示例性和说明性的,而不是对本发明的限制。例如,附图及描述中示出的形状、尺寸、曲线等仅是示例性和说明性的,可以有各种变化和修改。再例如,说明书和权利要求书中的术语,例如中心弧区、防控弧区、近环区、 远环区、释放弧区、前周边弧区、基弧区、后周边弧区等等,仅仅是为了叙述方便而指定的,并不构成对本发明的限制。这些术语所表达的概念完全可以使用其他术语来表达。本发明的保护范围仅由所附权利要求书的文字表述及其等价物来限定。 The embodiments of the present invention have been described above with reference to the accompanying drawings, and the description of the present invention is intended to be illustrative and not restrictive. For example, the shapes, dimensions, curves, and the like shown in the drawings and the description are merely exemplary and illustrative, and various changes and modifications are possible. For example, the terms in the specification and claims, such as the central arc zone, the arc control zone, the near ring zone, The far loop region, the release arc region, the front peripheral arc region, the base arc region, the rear peripheral arc region, and the like are specified only for convenience of description, and do not constitute a limitation of the present invention. The concepts expressed by these terms can be fully expressed using other terms. The scope of the invention is to be limited only by the description of the appended claims and their equivalents.

Claims (13)

  1. 一种软性角膜接触镜,包括用于覆盖于配戴眼角膜表面的泪液层上的后表面以及与后表面相对的前表面,其中,前表面包括圆形的中心弧区与围绕中心弧区的环形防控弧区,中心弧区与后表面之间形成与配戴眼的近视焦度大约等量的负焦度或零焦度,防控弧区由内向外正焦度逐量平滑递增,防控弧区的正焦度总增量值取决于配戴眼的近视焦度。A soft contact lens comprising a posterior surface for covering a layer of tears worn on a surface of a cornea and a front surface opposite the posterior surface, wherein the front surface comprises a circular central arc region and a central arc region The circular arc control zone forms a negative power or zero power of the near vision power with the eye worn by the central arc area and the rear surface, and the arc control zone is smoothly increased from the inside to the outside. The total positive value of the positive focus of the arc control zone depends on the myopic power of the wearing eye.
  2. 根据权利要求1的软性角膜接触镜,其中,所述防控弧区的正焦度总增量值为配戴眼的近视焦度的80%-110%。The soft contact lens of claim 1, wherein the total positive power of the arc control zone is from 80% to 110% of the nearsighted power of the wear eye.
  3. 根据权利要求2的软性角膜接触镜,其中,所述防控弧区的正焦度总增量值与配戴眼的近视焦度大约等量。A soft contact lens according to claim 2, wherein the total positive power increment value of said arc control zone is approximately equal to the near vision power of the wear eye.
  4. 根据权利要求1的软性角膜接触镜,其中,当配戴眼的近视焦度为0焦度时,所述防控弧区的正焦度总增量值为约0.75D。The soft contact lens according to claim 1, wherein when the nearsighted power of the wearing eye is 0 degrees, the total positive power of the arc control zone is about 0.75D.
  5. 根据权利要求1的软性角膜接触镜,其中,所述中心弧区的直径约为2.0-4.0mm,所述防控弧区的宽度约为2.0-2.4mm。A soft contact lens according to claim 1, wherein said central arc region has a diameter of about 2.0 to 4.0 mm, and said arc control region has a width of about 2.0 to 2.4 mm.
  6. 根据权利要求5的软性角膜接触镜,其中,所述中心弧区的直径约为3mm。A soft contact lens according to claim 5, wherein said central arc region has a diameter of about 3 mm.
  7. 根据权利要求5的软性角膜接触镜,其中,所述防控弧区的宽度约为2.1mm。A soft contact lens according to claim 5, wherein said arc-deflecting zone has a width of about 2.1 mm.
  8. 根据权利要求1的软性角膜接触镜,其中,所述防控弧区包括围绕中心弧区的近环区和围绕近环区的远环区,所述近环区的宽度为0.8-1.2mm,所述远环区的宽度为约1.2mm,且近环区外缘的增焦量为所述正焦度总增量值的55%~75%,远环区外缘的增焦量为所述正焦度总增量值的25%~45%。The soft contact lens of claim 1 wherein said arc control zone comprises a proximal zone surrounding the central arc zone and a distal zone surrounding the proximal zone, said proximal zone having a width of 0.8-1.2 mm The width of the far loop region is about 1.2 mm, and the amount of focus of the outer edge of the near loop region is 55% to 75% of the total increment of the positive power, and the amount of focus of the outer edge of the far loop region is The total positive power increment value is 25% to 45%.
  9. 根据权利要求8的软性角膜接触镜,其中,所述近环区的宽度为1mm,且近环区外缘的增焦量为所述正焦度总增量值的65%,远环区外缘的增焦量为所述正焦度总增量值的35%。 The soft contact lens according to claim 8, wherein said proximal ring region has a width of 1 mm, and said outer ring edge has a focus amount of 65% of said positive power total incremental value, and said distal ring region The amount of focus of the outer edge is 35% of the total increment of the positive power.
  10. 根据权利要求1的软性角膜接触镜,其中,前表面还包括围绕所述防控弧区的宽度约为0.8-1.2mm的环形释放弧区,释放弧区由内向外正焦度平滑递减,用于消解防控弧的增焦量,从而消减镜片边缘的厚度。A soft contact lens according to claim 1, wherein the front surface further comprises an annular release arc region having a width of about 0.8-1.2 mm around said arc control zone, the release arc region being smoothly diminished from the inner and outer positive powers, It is used to eliminate the amount of focus of the arc control, thereby reducing the thickness of the edge of the lens.
  11. 根据权利要求5的软性角膜接触镜,其中,后表面包括位于中心的圆形的基弧区以及围绕基弧的环形的后周边弧区,基弧区为球形弧面,其曲率为根据配戴眼角膜的曲率选自约8.1-8.9mm范围内的若干不同曲率之一,后周边弧区的弧面焦度较基弧区平坦0.75-1.25D,并且前表面还包括围绕所述释放弧区的前周边弧区,前周边弧区的弧面焦度与后周边弧区相同。A soft contact lens according to claim 5, wherein the rear surface comprises a circular base arc region at the center and a circular rear peripheral arc region surrounding the base arc, the base arc region being a spherical arc surface having a curvature according to The curvature of the cornea of the eye is selected from one of several different curvatures in the range of about 8.1-8.9 mm, the arc of the posterior peripheral arc is 0.75-1.25 D flat compared to the base arc, and the front surface further includes the release arc. In the front peripheral arc area of the area, the arcing power of the front peripheral arc area is the same as that of the rear surrounding arc area.
  12. 根据权利要求11的软性角膜接触镜,其中,所述基弧区的直径为7.0-8.0mm,所述后周边弧区的宽度为3.1-3.3mm,所述前周边弧区的宽度为1.7-2.8mm。The soft contact lens according to claim 11, wherein said base arc region has a diameter of 7.0 to 8.0 mm, said rear peripheral arc region has a width of 3.1 to 3.3 mm, and said front peripheral arc region has a width of 1.7. -2.8mm.
  13. 根据权利要求1的软性角膜接触镜,其中,镜片材料主基质成分为水凝胶,辅助成分为玻璃酸钠和氟化硅氧烷。 A soft contact lens according to claim 1, wherein the main matrix component of the lens material is a hydrogel, and the auxiliary components are sodium hyaluronate and fluorinated silicone.
PCT/CN2016/098790 2015-12-07 2016-09-13 Soft cornea-contacting lens WO2017096995A1 (en)

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