Classifications

• • G—PHYSICS
  • G02—OPTICS
  • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
  • G02C7/00—Optical parts
  • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
  • G02C7/04—Contact lenses for the eyes
  • G02C7/047—Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
  • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
• • G—PHYSICS
  • G02—OPTICS
  • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
  • G02C7/00—Optical parts
  • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
  • G02C7/04—Contact lenses for the eyes
  • G02C7/041—Contact lenses for the eyes bifocal; multifocal

Definitions

• the present invention relates to contact lenses that are used in treating hyperopia and presbyopia, and more particularly, to contact lenses that are shaped to provide gradual altering of the patient's cornea during continued wear to reshape the cornea to reduce the hyperopic and presbyopic condition.
• myopia is a common condition where an eye cannot focus on far-away objects because the cornea of the eye is curved too steeply (i.e., where the radius of curvature of the cornea is smaller than normal) to provide adequate focusing at the retina of the eye.
• hyperopia is a condition where an eye cannot focus on far-away objects because the cornea of the eye is curved too steeply (i.e., where the radius of curvature of the cornea is smaller than normal) to provide adequate focusing at the retina of the eye.
• hyperopia farsightedness
• Hyperopia is common among young children.
• Severe hyperopia will induce lazy eye or amblyopia in childhood. Mild or moderate hyperopia is tolerable and insidious in young ages but will cause reading problems in older age. Another common problem is astigmatism, where unequal curvature of one or more refractive surfaces of the cornea prevents light rays from focusing clearly at one point on the retina, resulting in blurred vision. Presbyopia is the most common vision problem in adults 40 years and older. It does not matter whether they are emmetropic, myopic or hyperopic in far vision, the middle-aged population over 40 years old will begin to experience difficulty in focusing on close objects, due to the loss of flexibility of the eye's crystalline lens.
• Presbyopia may occur and complicate other refractive problems such as hyperopia, myopia or astigmatism.
• Hyperopia and presbyopia are both conditions for which no entirely suitable permanent treatment has been developed. The conventional way is to wear a pair of heavy convex glasses.
• One approach to correcting hyperopia is through laser surgical reshaping of the cornea. However, such surgical procedures have not been entirely safe and there have been less favorable vision outcome for the hyperopia surgery than that of myopia surgery.
• This reshaped cornea has a lengthened radius of curvature in its central zone, which serves to improve myopia.
• myopia using modem Ortho-K lenses to reshape the cornea
• treating hyperopia or presbyopia using Ortho-K lenses has been met with uncertain outcome and results.
• the first factor is the time needed to achieve a desired visual correction.
• the second factor is the amount of hyperopia that can be corrected using ortho-k.
• Conventional ortho-k techniques and lenses were limited to a reduction of no more than about one diopter of hyperopia.
• the third factor is the amount of time that the correction would "hold” before degrading (known as the "maintenance period").
• Conventional ortho-k techniques and lenses provide variable length for the maintenance period. To prolong this maintenance period, a patient would have to wear a retainer lens.
• the objects of the present invention may be achieved by providing an apparatus and method for correcting a hyperopia and/or presbyopia condition in a patient's eye.
• a contact lens is fitted to a cornea of a patient's eye, the contact lens having a plurality of zones that includes a optical zone, a Plateau zone, a fitting zone, an Alignment zone and the peripheral zone .
• the Plateau zone is carefully created to flatten the mid-peripheral cornea curvature to cause the cornea to have a flattened mid-peripheral portion surrounding the central steeper cornea zone .
• the flatter mid-peripheral plateau zone works together with the steeper optical zone to enhance the steepening of the central cornea to reduce hyperopia.
• a contact lens having a base curve portion of the lens, a plateau curve portion of the lens circumscribing and coupled to the base curve portion, a fitting curve portion of the lens circumscribing and coupled to the plateau curve portion, and an alignment curve portion of the lens circumscribing and coupled to the fitting curve portion, and a peripheral curve portion of the lens circumscribing and coupled to the alignment curve portion.
• the goal of this type of lenses is to mold the cornea into a shape of central steepemng just like a hummock on top of a plateau.
• the overall diameter of the central optical zone could be varied or divided for different purposes of correcting hyperopia or presbyopia.
• the base curve should preferably be steeper than the central cornea curvature.
• the optical zone should be wide enough for better far vision. It is also preferred to keep the plateau zone as narrow as possible to prevent it from inducing ghost imaging due to the flattened mid-peripheral area.
• the optical zone should be divided into two portions. The central zone should be designed to be very small for the purpose of near vision to prevent it from hindering the far vision. The outer optical zone then should be much wider to mold the juxta-central cornea area into a flatter zone to clear up far vision (reducing myopia, hyperopia, or astigmatism if any).
• FIG. 1 is a side schematic outline view of an ortho-k contact lens according to the present invention in use with a cornea of a patient's eye.
• FIG. 2 is a front planar view of the ortho-k contact lens according to one embodiment of the present invention for hyperopia correction.
• FIG. 3 is a side sectional view of the ortho-k contact lens of FIG. 2.
• FIG. 4 is a front planar view of the ortho-k contact lens according to another embodiment of the present invention for presbyopia correction in a myopic person.
• FIG. 5 is a side sectional view of the ortho-k contact lens of FIG. 4.
• FIG. 6 is a front planar view of the ortho-k contact lens according to one embodiment of the present invention for presbyopia correction in a hyperopic person.
• FIG. 7 is a side sectional view of the ortho-k contact lens of FIG. 6.
• FIGS. 1-3 illustrate an ortho-k contact lens 10 according to one embodiment of the present invention.
• the contact lens 10 is a dual geometric contact lens that is adapted to be worn over the cornea 12 of a patient's eye 14.
• the contact lens 10 has five correction zones, listed from the center of the lens 10 to the outer periphery: an optical zone 20, a plateau zone 22, a fitting zone 24, an alignment zone 26, and a peripheral zone 28.
• the optical zone 20 has a curvature that is defined by the base curve 30.
• the optical zone 20 forms a suitable space for molding tissue to a region substantially centered at the apical center of the cornea 12, and is responsible for the corrective steepening or increasing in the radius of curvature of the central cornea during treatment.
• the radius of curvature of the base curve 30 is smaller than a measured curvature of a central portion of the cornea 12 for treatment of hyperopia, thus creating a central tenting up area 32.
• the tent-up area 32 provides a suitable space for piling the cornea tissue up during vision correction.
• the optical zone in the invention may be divided into two portions for the treatment of presbyopia coupled with hyperopia.
• a tiny inner additive optical curve 30b defined by inner additive optical zone 20b is steeper (shorter radii) than the consecutive outer base curve 3 lb by 1-4 Diopters.
• the outer base curve 3 lb defined by the outer optical zone 21b is steeper (shorter radii) than the central curvature of the cornea 12 by 1-15 diopters.
• the tented-up spacing under the outer optical zone 21b causes the cornea molding to form a steeper juxta-central portion of the cornea 12 for correcting hyperopia, and the even steeper inner optical zone 20b causes the formation of even steeper curvature of the central portion of the cornea 12 for correcting presbyopia.
• the inner optical zone 20b is preferably kept small enough to prevent it from hindering the far vision and the size is usually from 0.5 to 1.5mm.
• the pupil of human eyes will constrict for near reading (so called "near reflex”) and dilate when looking into the distance. Since the tiny central blurred image will be neglected when looking into far distance, we can create a tiny (0.1 - 1.5 mm) steeper inner optical zone 20a, 20b coupled with a wider (1.5 - 4.0 mm) and flatter outer optical zone 21a, 21b to treat the far and near vision simultaneously in one lens.
• the steeper inner optical zone 20a of FIG. 6 can also be incorporated into a single reverse geometric Ortho-K lens to treat coexisting presbyopia and myopia simultaneously.
• the inner base curve 30a defining the inner optical zone 20a
• the outer base curve 3 la defining the outer optical zone 21a
• the outer optical zone 21a and outer base curve 31a is determined according to the principle of optical zone / curvature of the reverse geometric ortho-K lenses for proper myopia reduction.
• the incorporated inner optical zone 20a has an inner base curvature 30a that is 1-4 D steeper (shorter radius) than the consecutive outer base curve 3 la of outer optical zone 21a.
• the inner additive base curve 30a is not necessarily steeper (shorter radius), but is preferably flatter (longer radius) than the curvature of the central portion of the cornea 12, except when the myopic power is mild and numerically smaller than that of the presbyopic additive power which in turn could be same as, or slightly steeper (shorter radii) than, the curvature of the central portion of the cornea 12.
• the outer base curve 3 la functioning like the central optical zone / base curve of a reverse geometric Ortho-K lens for myopia reduction, is flatter (larger radius) than the central portion of the cornea 12 by 1 - 30 D, and is designed to compress the juxta-central portion of the cornea 12 for proper myopia reduction.
• the diameter of the optical zone 20 ranges from 3 mm to 8 mm
• the inner optical zone 20a, 20b ranges from 0.5 mm to 1.5 mm
• the outer optical zone 21a, 21b ranges from 1.0 mm to 4.0 mm
• the radii of the curvature for the base curve 30 and the inner base curve 30a, 30b and the outer base curve 31a, 31b ranges from 15.0 mm to 5.0 mm.
• the Plateau zone 22 has a radius of curvature defined by a predefined plateau curve 34, which is longer (i.e., flatter) than the radius of curvature associated with the base curve 30 or outer base curve 30a.
• the flatter plateau zone in lens 10a merges with the flatter outer optical zone 31a and can be looked upon as a continuous and gradual-flattening curve with positive e-value.
• This longer radius of curvature of the plateau zone 22 defines a plateau curvature 34 that is flatter (longer radius) than the measured curvature of the central portion of the cornea 12 and the measured curvature of the portion of the cornea 12 circumscribing the central portion of the cornea 12.
• the plateau zone 22 functions as a primary compression force to the mid-peripheral cornea region substantially surrounding the apical central cornea between the inner and outer optical zones 20, 21a, 21b and the fitting zone 24.
• the plateau zone 22 is preferably kept as narrow as possible, so that it can function as a compression zone for mid-peripheral cornea flattening.
• the flattened mid-peripheral cornea will in turn enhance the central cornea 12 for further steepening.
• the molding technique is named "dual molding” which includes a positive molding for central cornea steepening and a negative molding for mid-peripheral cornea flattening.
• the lens design can also be named a "dual geometric lens” which include a positive geometric zone and a negative geometric zone for the steeper optical zone and flatter plateau zone respectively.
• a narrow flattened mid-peripheral cornea area coupled with a large steepened central and juxta-central cornea area will prevent the person from being bothered by ghost image in far vision.
• the plateau zone 22 performs three primary functions.
• the provision of the plateau zone 22 allows an effective compression on mid-peripheral cornea to push the cornea tissue inward, which in turn steepens the cornea curvature of the central portion of the cornea 12. This represents the positive molding component of the "dual molding".
• the compression force exerted by the flatter plateau zone 22 on mid-peripheral cornea portion will be far more effective for tissue molding than the compression force by traditional method of a series of steeper regular RGP.
• the compression force by a steep fit regular RGP is exerted on more peripheral cornea and is more tangential to the compressed area, so that most of the molded tissue will pile up at mid-peripheral area instead of the central area to cause an adverse effect.
• the plateau zone 22 functions as a compression zone for the effective flattening of the mid-peripheral area surrounding the steepened central cornea area 12. Forming a plateau shape on the mid-peripheral area of the cornea 12 by the compression force of plateau zone 22 will in turn enhance the steepening effect of the central cornea.
• the negative molding component of "dual molding” flattens the mid- peripheral cornea 12 and effectively enhances the positive molding of steepening the central and juxta-central portion of the cornea 12.
• the flatter plateau zone will also prevent the cornea tissue, which is squeezed inward by the alignment zone 26 (described later), from piling up at the mid-peripheral area.
• the flat plateau curve 34 of the plateau zone 22 reserves more room for the vertical height of the fitting zone 24 so that the fitting curve 36 can be fitted much steeper than the plateau curve 34. This allows the fitting curve 36 to form a space for proper tear circulation and a room for tissue molding before connecting to the alignment zone 26 (described later).
• the diameter of the plateau zone 22 ranges from 0.1 mm to 2.0 mm.
• the radius of curvature for the plateau curve 34 is flatter (longer radius) than the central base curve 30 or outer base curve 3 lb by 3 - 30 diopters, and is usually between 8 - 25 diopters.
• the plateau zone 22 and plateau curve 34 merges with the outer optical zone 21a and outer base curve 31a, respectively.
• the contact lens 10 with two or more plateau zones and curves as well as substitute the zone with an aspheric curve of a positive e value, or even merge with zone 21a or zone 21b to form a continuously flatter curvature next to the inner optical zone 20a or 20b.
• the fitting zone 24 of lens 10 has a radius of curvature defined by a fitting curve 36 with the radius of curvature being less than ⁇ i.e., shorter than) the radius of curvature associated with the plateau curves 34. Since the plateau zone and curve in lens 10a (shown in FIGS. 4 and 5) merge with the outer optical zone 21a and outer base curve 31a, the plateau curve 34 in lens 10a can then be looked upon as having the same definition of outer optical zone 21a and outer base curve 31a for lens 10a shown in FIGS. 4 and 5. This shorter radius of curvature of the fitting zone 24 yields a fitting curvature 36 that is much steeper than the plateau curve 34.
• the fitting zone 24 acts as a transition region between the plateau zone(s)
• the fitting zone 24 brings the posterior surface of the contact lens 10 to a bearing relationship on the mid- ⁇ eripheral portion of the cornea 12 under the plateau zone 22, and provides compression force on the plateau zone 22, thereby compressing the mid-peripheral portion of the cornea 12, for dual molding of the cornea 12.
• the width of the fitting zone 24 ranges from 0.1 mm to 2.0 mm
• the radius of curvature for the fitting curve 36 is 5-30 diopters steeper than the plateau curve 34, and is 15 diopters flatter to 15 diopters steeper than the base curve.
• a lens can be calculated from the view point of saggital depth.
• a saggital depth calculation translates the component curvatures and each width for a lens into a simple factor known as the saggital depth.
• a saggital depth will be measured from the center of a lens to the denoted width, and will also define the slope of an area on a lens.
• the angles Al, A2, A3 and A4 illustrated in FIG. 3 can be calculated as the "saggital depth/zone width" and can be considered to be a slope ratio, which can be defined as the vertical height/zone width. Since a dual geometric lens has multiple curvatures, we have to calculate the vertical height of each zone and add them up.
• the summation of (i) vertical height of the optical zone 20, (ii) the vertical height of the plateau zone 22 , and (iii) the vertical height of the fitting zone 24 should be equal to the height of the original cornea with the same zone width (i.e., the 3 total zones) plus 10 microns (this additional 10 microns is an allowance made to prevent the lens 10 from bearing on the cornea 12).
• This is the underlying principle of saggital depth calculation.
• a more detailed explanation of saggital depth calculation is provided in ADVANCED CL FITTING, PART SEVEN, TRENDS IN MODERN ORTHOKERATOLOGY, Optician, No. 5645, Vol. 215, April 3, 1996, pages 20-24, whose entire disclosure is incorporated by this reference as though fully set forth herein.
• the alignment zone 26 is designed to provide and maintain centration of the lens 10 by having a radius of curvature that is either the same as, or slightly longer than the central curvature of the cornea 12 (i.e., to match the peripheral cornea).
• a predefined alignment curve 38 defines the curvature of the alignment zone 26, which is almost the same as the measured curvature of the portion of the cornea 12 circumscribing the central portion of the cornea 12.
• the alignment zone 26 creates a large bearing area 40 in a region corresponding with the portion of the cornea 12 where a centering force is created that maintains the optical zone 20 substantially at the apical center of the cornea 12.
• the alignment zone 26 further produces a secondary compressive force in the large bearing area 40 that cooperates with the primary compressive force from the plateau curve to flatten the mid-peripheral portion of the cornea 12 contributes to the negative molding component of the dual molding for hyperopia and / or presbyopia reduction during vision correction.
• the alignment curve 38 is determined by mean K (also known as KM). In other words: a. (Vertical KM + Horizontal KM)/2.
• the central mean K in turn will be recalculated to estimate the mid-peripheral radius of curvature according to the eccentricity (e-value) of a cornea to match the point that the alignment zone 26 contacts the cornea 12.
• This calculation method enjoys two benefits over known methods. First, this calculation method can be used for both toric (astigmatic) or non-toric corneas. Corneas with the same horizontal central KM do not mean they should be fitted with the same ortho-k lens.
• the vertical curvature could be different (astigmatic or toric cornea), the e-value could also be different, and they should be considered as different corneas.
• the peripheral attachment of the alignment zone 26 will be improved.
• the associated alignment curve 38 creates a bearing zone over a large surface area of the cornea 12, which is helpful in aligning the lens 10 at the apex of the cornea 12.
• the width of the alignment zone 26 ranges from 0.1 mm to 5.0 mm (depending on the fitting characteristics desired and the particular shape factors of the cornea 12), the radius of curvature for the alignment curve 38 is 1-30 diopters steeper than the plateau curve 34, and the alignment curve 38 is also about 1-25 diopters less steep (i.e., flatter) than the fitting curve 36.
• the alignment zone 26 can be segmented into multiple curves and any combination of any shapes or curves, as long as sufficient bearing area is maintained.
• the peripheral zone 28 is designed with a radius of curvature longer than that of the cornea 12, yielding a curvature less than a measured curvature of a portion of the cornea 12 circumscribing the central portion of the cornea 12 that corresponds to the alignment zone 26.
• the peripheral zone 28 has its surface contour defined by a predefined peripheral curve 42 which has a curvature that nearly parallels the portion of the cornea 12 underneath it, but is flatter than the cornea 12.
• the peripheral zone 28 promotes tear flow under the contact lens 10 by taking advantage of a tear pumping action created when the individual blinks the eyelid. This tear flow allows constant lubrication and oxygenation of the lens-cornea interface and results in a more comfortable and wearable lens 10.
• the peripheral zone 28 is designed to create a slight edge lift which allows easy contact lens removal from the cornea 12.
• the width of the peripheral zone28 ranges from 0.1 mm to 2.0 mm
• the radius of curvature for the peripheral curve 42 is 0-15 diopters greater (flatter) than the plateau curve 34, and is also about 1-35 diopters greater(longer radii) than the fitting curve 36, or the alignment curve 38.
• the peripheral curvature should be carefully calculated according to the aforementioned saggital theory to achieve an edge lift of 100-120 microns.
• An overly-large edge lift may induce a reverse suction force to create air bubbles under the lens 10, while an overly-small edge lift may reduce tear circulation and cause lens seal-off.
• the different radii used to define the base curve 30, the plateau curve 34, the fitting curve 36, the alignment curve 38 and the peripheral curve 42 are calculated after careful examination of the patient's eye and the associated ocular tissue.
• the corneal curvature must be measured, the proper contact lens power defined, and the anticipated physiological response to the contact lens 10 must be determined.
• An individual skilled in the examination techniques of the ocular system is typically capable of performing these tasks.
• the provision of one or more plateau zones 22 offers dual molding force to facilitate the steepening of the central portion of the cornea 12 for hyperopia and / or presbyopia correction.
• the invention of a tiny and steeper inner optical zone 30a,30b open up a new era of correcting dual refraction errors of presbyopia coupled with hyperopia, or presbyopia coupled with myopia simultaneously in one lens.
• the present invention enables treatment of dual refractive problems in one lens by dual molding force from a dual geometric lens.
• a typical dual geometric lens will have consecutive curvatures featuring interlaced steep-flat-steep-flat curvatures from the central portion outward.
• the contact lens 10 of the present invention can achieve a reduction of hyperopia up to 2.0-10.0 diopters with a shorter wearing time (e.g., 6-10 hours a day for initial wearing, and 4-8 hours a day to maintain) and longer maintenance period (e.g., 1-7 days after the lens 10 is removed).
• a shorter wearing time e.g., 6-10 hours a day for initial wearing, and 4-8 hours a day to maintain
• longer maintenance period e.g., 1-7 days after the lens 10 is removed.
• a contact lens having the following dimensions was provided for a AA0786 patient:
• optical zone 20 width 4.0 mm, radius of curvature 7.25 mm
• plateau zone 22 width 1.1 mm, radius of curvature 9.79mm
• fitting zone 24 width 0.5 mm, radius of curvature 6.57 mm
• alignment zone 26 width 1.2 mm, radius of curvature 7.85 mm
• peripheral zone 28 width 0.4 mm, radius of curvature 11.30 mm
• optical zone 20 width 4.0 mm, radius of curvature 7.16 mm
• plateau zone 22 width 1.1 mm, radius of curvature 9.85 mm
• fitting zone 24 width 0.5 mm, radius of curvature 6.59 mm
• alignment zone 26 width 1.2 mm, radius of curvature 7.85 mm
• peripheral zone 28 width 0.4 mm, radius of curvature 11.30 mm
• the contact lenses were worn by the patient for 7 day, at 7-8 hours a day.
• the maintenance period (of nearly zero power) lasted for all awakening hours with a 5-7 hour maintenance night wearing.
• the topography of the cornea is well-centered and has a definite boundary of a hummock-on-plateau shape to support an efficient reduction in hyperopia. This case has been followed for 3 months with no side effects.
• a contact lens having the following dimensions was provided for a AA0751 patient:
• optical zone width 5.6 mm, radius of curvature 8.89 mm
• fitting zone width 0.8 mm, radius of curvature 7.04 mm
• alignment zone width 1.5 mm, radius of curvature 8.03 mm
• peripheral zone width 0.4 mm, radius of curvature 11.80 mm
• inner optical zone 20a width 1.0 mm, radius of curvature 8.50 mm
• outer optical zone 21a width 2.50 mm, radius of curvature 8.83 mm
• plateau zone 22 none (merged with outer optical zone 2 la)
• fitting zone 24 width 0.6 mm, radius of curvature 6.85 mm
• alignment zone 26 width 1.5 mm, radius of curvature 8.07 mm
• peripheral zone 28 width 0.4 mm, radius of curvature 11.90 mm
• the contact lenses were worn by the patient for 7 day, at 7-8 hours a day.
• the patient experienced a myopia and astigmatism reduction to zero power for both eyes.
• the far vision was 20/20 on right eye and 20/25+ on left eye.
• the near vision was 20/40 on right eye but was 20/20 on left eye.
• the patient enjoyed the simultaneous improvement of far and near visions.
• the quality of the near vision will be much improved (from 20/40 on right to 20/20 on left eye) by the incorporation of inner optical zone 21a.
• inner optical zone 21a There should have been no problem fitting both eyes with dual geometric lenses if the requirement for far vision was not so critical. Otherwise we should correct the non dominant eye(left eye in this case) for reading and maintain a better far vision for the dominant sighing eye (right eye in this case).
• the maintenance period (of nearly zero power) lasted for all awakening hours with a 5-7 hour maintenance night wearing.
• the topography of the cornea is well-centered and has a definite tiny central steeper island to support an efficient reduction in myopia and presbyopia. This case has also been followed for 3 months with no side effects.

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