TECHNICAL FIELD

This disclosure relates to ophthalmic lenses, and more particularly to designs and/or configurations for ophthalmic lenses, kits and/or series of ophthalmic lenses, and/or methods for correcting, slowing, reducing, and/or controlling the progression of myopia configured for use in conjunction with muscarinic receptor antagonists and/or related compounds.

BACKGROUND

The discussion of the background in this disclosure is included to explain the context of the disclosed embodiments. This is not to be taken as an admission that the material referred to was published, known or part of the common general knowledge at the priority date of the embodiments and claims presented in this disclosure.

Myopia, commonly referred to as shortsightedness, is a disorder of the eye that results in distant objects being focused in front of the retina. Accordingly, the image on the retina is not in focus and results in blurred vision. Optical correction strategies for myopia use ophthalmic lenses to shift the image plane to the retina and thereby provide clear vision. However, these strategies may not slow eye growth and therefore, myopia continues to progress. Used topically, Atropine, a muscarinic receptor antagonist, has demonstrated a level of efficacy in slowing myopia progression. Other myopia control strategies include progressive addition lenses, executive bifocal spectacles, dual focus contact lenses, spectacles with multiple segments, spectacle lenses with scattering features, and orthokeratology.

Although the mechanism of action is still unknown, varying concentrations of Atropine eye drops (0.01% to 1.0%) have been used and there is a concentration dependent response e.g., the higher the concentration, the greater the efficacy. However, the increased side-effects associated with higher doses of Atropine including near blur, photophobia and risk of ultraviolet exposure leading to potential crystalline lens and retinal changes often deter parents and/or caretakers from widely adopting higher concentrations for treatment in the young and therefore limits efficacy. Furthermore, although Atropine may slow the progression of myopia, the efficacy may vary between individuals with some individuals receiving benefit and others not as much.

In addition, due to the loss of accommodative amplitude and resultant near blur induced by certain concentrations of Atropine, they require a concomitant use of an optical aid with near add (relatively more plus power compared to distance power) for near tasks. Another side-effect from Atropine use is photophobia. Research found that myopic children aged 8-10 years receiving atropine 0.5%, 0.1%, and 0.01% request photochromic progressive lenses 70%, 61%, and 6% of the time respectively.

Accordingly, there is a need to provide an ophthalmic lens that can be used in conjunction with a pharmaceutical agent, such as Atropine (or a muscarinic receptor antagonist, or a related compound more generally) that not only corrects the refractive error of the eye, but aids in further slowing the progression of myopia and/or reduces/minimizes visual disturbance(s). The embodiments described herein may solve or address one or more of these and/or other problems disclosed herein. The present disclosure is also directed to pointing out one or more advantages to using exemplary ophthalmic lenses and methods described herein.

SUMMARY

The present disclosure is directed, at least in part, to addressing, overcoming and/or ameliorating one or more of the problems described herein.

The present disclosure is directed, at least in part, to ophthalmic lenses, designs and configurations for ophthalmic lenses and/or methods or systems or series or kits which may be advantageously used in conjunction with one or more pharmaceutical agents to correct, slow, reduce, and/or arrest myopia.

In some embodiments, the pharmaceutical agent may be an agent that can slow, reduce and/or arrest myopia. In some embodiments, the pharmaceutical agent may be an agent that results in a change in one or more of the parameters of the eye including the pupillary diameter, accommodative changes, binocular vision disturbances, visual disturbances and/or any combination thereof. In some embodiments, the pharmaceutical agent may be an agent that results in pupil mydriasis. In some embodiments, the pharmaceutical agent may be an agent that results in accommodative dysfunction.

In some embodiments, the pharmaceutical agent may be a muscarinic receptor antagonist, including, for example, Atropine, pirenzepine, tropine, atropine sulfate, noratropine, atropine-N-oxide, tropine, tropic acid, atropine sulfate, diphenhydramine, dimenhydrinate, dicyclomine, flavoxate, oxybutynin, tiotropium, hyoscine, scopolamine (L-hyoscine), hydroxyzine, ipratropium, tropicamide, cyclopentolate, pirenzepine, homatropine, solifenacin, darifenacin, benzatropine, mebeverine, procyclidine, aclidinium bromide, trihexyphenidylbenzhexol, tolterodine, or a pharmaceutically acceptable salt thereof.

The present disclosure is directed, at least in part, to an ophthalmic lens that may be provided and/or may be used in conjunction with a muscarinic receptor antagonist (e.g., Atropine or Atropine based compounds) for slowing myopia. The ophthalmic lens may comprise a feature configured, at least in part, based on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine based compounds) in use. The ophthalmic lens may have features for correcting the refractive error of the eye and features to slow, reduce, and/or arrest the progression of myopia.

In some embodiments, an ophthalmic lens is provided and/or may be used in conjunction with a muscarinic receptor antagonist (e.g., Atropine or Atropine based compounds) for slowing the progression of myopia. The ophthalmic lens may comprise a feature configured, at least in part, based on the concentration of for example, Atropine or Atropine based compounds in use. The ophthalmic lens may have one or more features for correcting the refractive error of the eye, one or more features to slow, reduce, and/or arrest myopia, and/or one or more features to minimize or reduce visual disturbances at all (or substantially all) viewing distances.

In some embodiments, the ophthalmic lens to be used in conjunction with a muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) may comprise a base lens with a front and back surface. In some embodiments, the ophthalmic lens may further comprise one or more myopia control elements to slow myopia that may be incorporated in and/or on the base lens and/or interspersed or disposed across the lens. In some embodiments, the one or more myopia control elements may be disposed across the entire lens or may be disposed in one or more regions of the lens. In some embodiments, the one or more myopia control elements of the ophthalmic lens may be refractive, diffractive, contrast modulating, phase-modulating, meta-surfaces, light scattering, light-deviating, amplitude modulating, aberrated, holographic, light-diffusing elements, or a combination of one or more elements thereof. In some embodiments, the one or more myopia control elements may be discrete elements or may be continuous elements. In some embodiments, the one or more discrete myopia control elements may be positioned apart from the other myopia control elements. In some embodiments, the one or more discrete myopia control elements may be positioned in contact with or conjoined with or fused with one or more of other myopia control elements or a combination thereof. In some embodiments, the refractive elements may be shaped as a circular element, ring, arc, triangular, spiral or any other shape or a combination thereof or shaped as a continuous refractive power profile. In some embodiments, the refractive elements may be designed to provide no defocus, hyperopic defocus, myopic defocus, extended depth of focus or a combination thereof compared to refractive power profile in one or more first viewing regions designed to correct for the distance refractive error of the eye. In some embodiments, the one or more myopia control elements may be present across one or both surfaces or in between the surfaces or incorporated into the bulk of the ophthalmic lenses and may be present across the entire surface or limited to one or more regions of the lens

In some embodiments, an ophthalmic lens is provided and/or may be used in conjunction with a muscarinic receptor antagonist, for example, Atropine or Atropine based compounds for slowing the progression of myopia. The ophthalmic lens may have one or more myopia control elements to slow, reduce, and/or arrest myopia. In some embodiments, the ophthalmic lens has one or more first viewing regions that incorporate a power profile that substantially corrects for the distance refractive error of the eye. In some embodiments, at least one of the one or more first viewing regions has a feature that is selected at least in part, to minimize, reduce or eliminate visual disturbances for the user when used in conjunction with Atropine. In some embodiments, at least one of the one or more first viewing regions may be sized based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) in use. In some embodiments, at least one of the one or more first viewing regions may correct for one or more of higher order aberrations induced, at least in part, by an increase in pupillary diameter. The ophthalmic lens may have one or more first viewing regions that incorporate a power profile that substantially corrects for the distance refractive error of the eye and at least one of the first viewing regions has one or more features selected to minimize or reduce visual disturbances at all (or substantially all) viewing distances and is based at least in part on the concentration of Atropine or Atropine related compounds.

In some embodiments, an ophthalmic lens is provided and/or may be used in conjunction with Atropine or Atropine based compounds for slowing the progression of myopia. The ophthalmic lens may have one or more myopia control elements to slow, reduce, and/or arrest myopia. The ophthalmic lens may have one or more first viewing regions that corrects for the distance refractive error of the eye and at least one of the first viewing regions has one or more features selected to minimize or reduce visual disturbances at all (or substantially all) viewing distances and is selected based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the ophthalmic lens may have one or more second viewing regions designed to provide acceptable vision for intermediate and/or near viewing distances and/or positioned elsewhere on the ophthalmic lens relative to at least one of one or more of the first viewing regions (e.g., the one or more of the first viewing regions selected to minimize or reduce visual disturbances). In some embodiments, the one or more second viewing regions having one or more features selected to provide acceptable vision for intermediate and/or near viewing distances may incorporate a power profile that is relatively more positive compared to the power profile of one or more first viewing regions. The relatively more positive power (or add power) of one of the second viewing regions is based at least in part on the concentration of Atropine or Atropine related compounds and designed to provide acceptable vision for intermediate and/or near distances. In some embodiments, the size and/or the relatively more positive power of the second viewing region may be selected based, at least in part, on the concentration of Atropine or Atropine related compounds in use. In some embodiments, the ophthalmic lens may have one or more second viewing regions designed to provide acceptable vision for intermediate and/or near viewing distances and selected to minimize or reduce visual disturbances. In some embodiments, at least one of the one or more second viewing regions may correct for one or more of higher order aberrations induced, at least in part, by an increase in pupillary diameter. In some embodiments, the type, size, arrangement, position, power profile, fill factor of one or more myopia control elements in one or more of the second viewing regions may be selected based, at least in part, on the concentration of pharmaceutical agent in use to minimize or reduce visual disturbances. In some embodiments, the one or more second viewing regions may be positioned at any combination of one or more of inferior, superior, temporal, nasal, oblique, concentric co-axial, concentric non co-axial, eccentric, non-concentric, inferonasal, inferotemporal, or any other position or combination thereof relative to at least one of the one or more first viewing regions.

In some embodiments, the ophthalmic lens has a second viewing region positioned inferiorly relative to the first viewing region for distance and has a power profile that is relatively more positive than the power profile of the first viewing region that is based at least in part on the concentration of concentration of Atropine or Atropine related compounds in use and provides acceptable vision for near distances. In some embodiments, the relatively more positive power profile of one or more second viewing regions may be relatively uniform or may be relatively non-uniform across the viewing region. In some embodiments, the relatively more positive power profile of the one or more second viewing regions may be progressive across the viewing region with the least amount of relatively more positive power positioned at the boundary between the first viewing region and the second viewing region and the most amount of relatively more positive power positioned towards the periphery further away from the boundary between the first viewing region and the second viewing region.

In some embodiments, the ophthalmic lens may further comprise one or more of a light absorbing filter or a light absorbing element or a photochromic filter or a photomask or a phase-shift mask to further reduce, minimize or eliminate visual disturbance for the eye. In some embodiments, the ophthalmic lens may further comprise a light absorbing filter or a photo mask or a phase shift mask in one or more first viewing regions and/or second viewing regions. In some embodiments, the ophthalmic lens may further comprise a light absorbing filter and/or an element that may range in density across one or more of the viewing regions. In some embodiments, the color and/or intensity of the light absorbing element, light absorbing filter or a photochromic filter may be based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) in use. In some embodiments, the color/wavelength of light absorption and/or intensity of the light absorbing element, or a photochromic filter may be based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) and the color of the iris of the eye.

The present disclosure is directed, at least in part, to a method for improving the rate for slowing of myopia. The method comprises providing an ophthalmic lens in conjunction with a muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) for use in an eye with myopia. In some embodiments, the ophthalmic lens may comprise one or more myopia control elements to slow the progression of myopia. In some embodiments, the one or more myopia control elements may be disposed across the entire lens or may be disposed in one or more regions of the lens. The ophthalmic lens may have one or more first viewing regions that substantially corrects for the distance refractive error of the eye and at least one of the first viewing regions has one or more features selected to minimize or reduce visual disturbances at all (or substantially all) viewing distances and based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the ophthalmic lens may further comprise one or more second viewing regions, positioned on the ophthalmic lens relative to the first second viewing regions and may incorporate a power profile that is relatively more positive compared to the power profile of one or more first viewing regions (e.g., the at least one of the first viewing regions having one or more features selected to minimize or reduce visual disturbances). The relatively more positive power (or add power) of one of the second viewing regions is based at least in part on the concentration of Atropine or Atropine related compounds and designed to provide acceptable vision for intermediate and/or near distances. In some embodiments, the one or more second viewing regions may be positioned inferior, superior, temporal, nasal, oblique, concentric co-axial, concentric non co-axial, eccentric, non-concentric, inferonasal, inferotemporal, or any other position or combination of one or more thereof. In some embodiments, the ophthalmic lens may further comprise a light absorbing filter or a light absorbing element or a photochromic filter or a photo mask or a phase shift mask to reduce, minimize and/or eliminate visual disturbance for the eye. In some embodiments, the light absorbing filter or the light absorbing element or the photochromic filter or the photo mask or the phase shift mask may be present in one or more of the first and/or second viewing regions and based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the color, wavelength of absorption, location/distribution and/or intensity of the light absorbing element, or a photochromic filter may be selected based, at least in part, on the muscarinic receptor antagonist (e.g., concentration of Atropine or Atropine related compounds) in use. In some embodiments, the pitch structure, depth, type, intensity and absorber of the photo mask and/or phase shift mask may be selected based, at last in part, on the muscarinic receptor antagonist in use.

The present disclosure is directed, at least in part, to a kit or set or series of ophthalmic lenses to be used in conjunction with a muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds) for slowing the progression of myopia. The kit comprises a plurality of ophthalmic lenses that comprise one or more features configured or selected to be used based on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compounds). The one or more ophthalmic lenses in the kit or set or series comprises a base lens with a front and back surface. In some embodiments, the ophthalmic lens in the kit or set or series may comprise one or more myopia control elements to slow myopia. In some embodiments, the one or more myopia control elements of the ophthalmic lens may be refractive, diffractive, contrast modulating, phase-modulating, meta-surfaces, light scattering, light-deviating, amplitude modulating, aberrated, holographic, light-diffusing elements, or a combination of one or more elements thereof. The ophthalmic lens may have one or more first viewing regions that substantially corrects for the distance refractive error of the eye and at least one of the first viewing regions has one or more features selected to minimize or reduce visual disturbances at all (or substantially all) viewing distances and based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the kit or series comprises ophthalmic lenses with varying dimensions for at least one of one or more of the first viewing regions designed to minimize visual disturbances and are selected based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) in use. In some embodiments, the size of the one or more of the first viewing regions designed to minimize visual disturbances may vary between the ophthalmic lenses in the series or set or kit and is selected to be used in conjunction with a particular concentration of atropine. In some embodiments, the one or more first viewing regions may control, reduce and/or minimize one or more of higher order aberrations to minimize visual disturbances and the aberration control may vary between the ophthalmic lenses in the series or set or kit. In some embodiments, the size and/or aberration control of the one or more of the first viewing regions may be designed to minimize visual disturbances and may vary between the ophthalmic lenses in the series or set or kit and is selected to be used in conjunction with a particular concentration of atropine In some embodiments, the size of the one or more first viewing regions designed to minimize visual disturbances for the eye may be relatively smaller in size when used in conjunction with lower concentrations of atropine compared to the size of the first viewing region used in conjunction with higher concentrations of atropine.

In some embodiments, the ophthalmic lenses in the set or kit or series may further comprise one or more second viewing regions, positioned on the ophthalmic lens relative to the first viewing regions and may incorporate a power profile that is relatively more positive compared to the power profile of one or more first viewing regions. The relatively more positive power (or add power) and/or size of one of the second viewing regions is based at least in part on the concentration of Atropine or Atropine related compounds and designed to provide acceptable vision for intermediate and/or near distances. In some embodiments, the one or more second viewing regions may be positioned inferior, superior, temporal, nasal, oblique, concentric co-axial, concentric non co-axial, eccentric, non-concentric, inferonasal, inferotemporal, or any other position or combination of one or more thereof on the ophthalmic lens relative to at least one of the one or more first viewing regions. In some embodiments, the kit comprises ophthalmic lenses with varying degrees of relatively more positive power profile in one or more second viewing regions that are selected for use based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) in use. In some embodiments, the ophthalmic lens may further comprise a light absorbing filter or a light absorbing element or a photochromic filter or a photo mask or a phase shift mask or any other optical mask to further reduce, minimize or eliminate visual disturbance for the eye. In some embodiments, the light absorbing filter or the light absorbing element or the photochromic filter or the photo mask or the phase shift mask may be present in one or more of the first and/or second viewing regions and based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the color, wavelength of absorption, location/distribution and/or intensity of the light absorbing element or a photochromic filter may be selected based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) in use. In some embodiments, the pitch structure, depth, type, intensity and absorber of the photo mask and/or phase shift mask may be selected based, at last in part, on the muscarinic receptor antagonist in use.

Some embodiments described herein may provide for a set or series of ophthalmic lenses to be used in conjunction with the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) for slowing myopia. The set or series of lens designs for ophthalmic lenses may comprise one or more lens designs with one or more features configured or selected to be used based, at least in part, on the concentration of the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) in use. The one or more ophthalmic lenses in the set or series comprises a base lens with a front and back surface. In some embodiments, the ophthalmic lens may comprise one or more myopia control elements may be disposed across the entire lens or may be disposed in one or more regions. The ophthalmic lens may have one or more first viewing regions that substantially corrects for the distance refractive error of the eye and at least one of the first viewing regions has one or more features selected to minimize or reduce visual disturbances at all (or substantially all) viewing distances and based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the size of the one or more first viewing regions designed to minimize or reduce visual disturbances for the eye may be relatively smaller in size when used in conjunction with lower concentrations of Atropine compared to the size of the first viewing region used in conjunction with higher concentrations of Atropine. In some embodiments, the one or more first viewing regions may further incorporate a power profile to control, minimize and/or reduce one or more of higher order aberrations to minimize visual disturbances and the type, magnitude of control or minimization of one or more of higher order aberrations may vary between the ophthalmic lenses depending on the concentration of Atropine. In some embodiments, the size of the one of one or more first viewing regions may be combined with a photo mask or a phase shift mask and/or controlled for aberrations to minimize or reduce visual disturbances for the eye and based at least in part of the concentration of Atropine or Atropine related compounds.

In some embodiments, the ophthalmic lens may further comprise one or more second viewing regions, positioned on the ophthalmic lens relative to at least one of the first viewing regions and may incorporate a power profile that is relatively more positive compared to the power profile of the at least one of the first viewing regions. The relatively more positive power (or add power) and/or size of one of the second viewing regions is based at least in part on the concentration of Atropine or Atropine related compounds and designed to provide acceptable vision for intermediate and/or near distances. In some embodiments, the location/position, strength/intensity, and the size of the myopia control elements across one or more of the first viewing regions and/or across one or more of the second viewing zones may be chosen to minimize or reduce visual disturbances to the eye and selected based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, the relation between the type, location, strength, size, and the area occupied by one or more of the myopia control elements and the size of at least one of one or more first viewing regions may be designed to minimize or reduce visual disturbances to the eye and selected, based at least in part on the concentration of Atropine or Atropine related compounds. In some embodiments, when used in conjunction with lower concentrations of ≤0.01% atropine compared to >0.01% atropine, the size of at least one of the one or more first viewing regions that incorporates the distance refractive error and designed to minimize visual disturbances for the eye of the wearer may be relatively smaller in size whereas the strength and/or size and/or area occupied by one or more myopia control elements may be relatively higher.

In some embodiments, at least one of the one or more first viewing regions and one of one or more of the second viewing regions may be completely free or substantially free of the myopia control elements to reduce, minimize or eliminate visual disturbances for the user. In some embodiments, the one or more myopia control elements may be present in one of one or more first viewing regions and one of one or more of second viewing regions and the type, size, arrangement and fill factor of the myopia control elements may vary between the regions. In some embodiments, the arrangement, size, magnitude and/or strength of the one or more of myopia control elements comprising one or more of refractive, diffractive, prismatic, contrast modulating, phase-modulating, meta-surfaces, light scattering, light-deviating, amplitude modulating, aberrated, holographic, light-diffusing elements, or a combination of one or more elements thereof to be used in conjunction with the muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) may be varied across the regions of the ophthalmic lens based on the rate of myopia progression of the eye.

In some embodiments, the ophthalmic lens to be used in conjunction with muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) may comprise a light absorbing filter or a light absorbing element or a photochromic filter or a photo mask or a phase shift mask to further reduce, minimize and/or eliminate visual disturbance for the eye. In some embodiments, the ophthalmic lens to be used in conjunction with muscarinic receptor antagonist (e.g., Atropine or Atropine related compound) may comprise a prism or prism component across one or more of the first viewing regions and/or one of the second viewing regions to further reduce, minimize, and/or eliminate visual disturbance for the eye.

In some embodiments, the ophthalmic lens may be a spectacle lens comprising a feature configured based at least in part on a concentration of and for use in conjunction with one or more pharmaceutical agents for slowing the progression of myopia. In some embodiments, the ophthalmic lens may be a contact lens.

Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims provided herein.

