Ophthalmological devices and methods for treatment of corneal tissue

Abstract

Systems and method for treating corneal ectasias such as keratoconus involve contacting the corneal surface to an aperture-free molding lens under vacuum pressure and cross-linking corneal tissue using UV laser or LED light in the presence of a photosensitive substance such as riboflavin. After release of vacuum, oxygen is applied to the corneal surface to enhance the cross-linking of corneal fibers. Systems may include an imaging system, user interface, vacuum regulator and controller to provide rapid diagnosis and treatment. In some embodiments, the systems may be used to treat glaucoma by applying vacuum without cross-linking of corneal fibers.

Description

OPHTHALMOLOGICAL DEVICES AND METHODS FOR TREATMENT OF CORNEAL TISSUECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority benefit of South African Provisional Application No. 2024 / 03448, filed on May 6, 2024, which is hereby incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] This invention relates to an ophthalmological device and method for treating corneal tissue of a patient having corneal ectasia or glaucoma. The invention relates particularly to an ophthalmological device and method for corneal molding including vacuum molding of the cornea and cross-linking of corneal collagen fibers in the cornea of the patient.BACKGROUND OF THE INVENTION

[0003] Corneal ectasia is a condition characterized by corneal weakness and instability which predisposes the cornea to progressive thinning and steepening with consequent irregular astigmatism, visual loss and eventually perforation. One common form of for corneal ectasia include is keratoconus.

[0004] Keratoconus is a progressive corneal disorder in which the cornea thins and gradually bulges outward into a cone-like shape, causing distorted vision, increased sensitivity to light, irregular astigmatism, and corneal scarring. The corneal thinning results in reduced rigidity and flexibility of corneal tissue. This condition typically begins in adolescence or early adulthood and can vary in severity.

[0005] Glaucoma is a disorder of the eye wherein the optic nerve is damaged causing a loss of visual field. Raised intraocular pressure is a risk factor for developing glaucoma. The treatments for glaucoma include the use of eyedrops for reducing intraocular pressure, the use of shunts for draining aqueous fluid from the eye and both laser and conventional surgery.

[0006] Various methods for treating corneal disease such as keratoconus and glaucoma are known. In many cases, corrective lenses are effective to allow a patient to function normally, but many cases require specialized contact lenses, corneal cross-linking, or, inadvanced cases, corneal transplantation to manage its effects. The bulging of the corneal surface induces ametropia (imperfect refraction causing blurred vision), disrupting the ability of the eye to focus light precisely on the retina.

[0007] Keratoconus disrupts the cornea’s optical uniformity, leading to higher-order aberrations (HOAs) — complex wavefront distortions like coma, trefoil, and spherical aberration that cause glare, halos, and blurred vision, particularly in low light, beyond simple refractive errors. HOAs are challenging to correct with standard lenses and are amplified by the irregular corneal shapes, which can be mapped through corneal topography, a critical diagnostic tool for identifying keratoconus patterns that guide treatment, such as specialized contact lenses, intrastromal corneal ring segments, corneal cross-linking, or corneal transplantation in severe cases.

[0008] It has been found that cross-linking of collagen fibers of the cornea may increase the rigidity of the cornea such that the cornea may better resist intraocular pressure. Cross-linking for the treatment of corneal ectasia after refractive surgery has been approved by the Federal Drug Administration (FDA), with clinical trials confirming its efficacy and safety for treating these pathologies. Cross-linking is considered a minimally invasive technique which seeks to increase corneal stiffness by inducing biochemical cross-linking of adjacent collagen fibers, through the formation of covalent bonds.

[0009] Cross-linking is achieved through the use of a photosensitive substance (typically including 0.1 percent riboflavin without or without 20% dextran as active ingredients) and the stimulation of the photosensitive substance by ultraviolet (UV) light. When riboflavin absorbs ultraviolet light, it reaches a state of excitation that allows it to interact with molecular oxygen, forming reactive species oxygen such as superoxide anion, radial hydroxyl and hydrogen peroxide. The photosensitive substance is thus able to chemically react with corneal tissue upon stimulation by ultraviolet light, the corneal tissue absorbing the photosensitive substance so as to cross-link corneal collagen fibers and thereby increase rigidity of corneal tissue.

[0010] As used herein, a photosensitive substance is a substance that, under the influence of photons, is able to chemically react with corneal tissue which absorbs the photosensitive substance so as to promote cross-linking of corneal collagen fibers and thereby increase the rigidity of corneal tissue. Additional details about corneal cross-linking as a treatment for keratoconus and glaucoma can be found in US 9,802,059, which is hereby incorporated by reference herein in its entirety. The ‘059 patent discloses an apparatus and method for corneal cross-linking in which a lens having a plurality of apertures therein is used to contact and mold a cornea. Prior to the procedure, a photosensitive substance (typically including riboflavin as previously noted) is applied to the cornea. A first side of the lens is brough into contact with the cornea, and a vacuum is applied to the apertures in the lens to molds the corneal surface into a shape that corrects or reduces the abnormal curvature (e.g., in a patient with keratoconus). While the cornea is molded into the corrected shape, a light at a desired wavelength is applied to the cornea through the lens to cross-link and stiffen the corneal tissue so as to retain (at least in part) the corrected shape when the lens is removed.

[0011] While the devices and methods disclosed in the ‘059 patent may be successfully used to treat keratoconus, the changes in refractive index in and adjacent to the apertures in the lens can prevent the cross-linking light from reaching the entire surface of the cornea, resulting in areas or zones that are poorly cross-linked or not cross-lined at all. There is a need for improved apparatus and methods for treating corneal ectasias.

[0012] It is an object of the present invention to treat corneal ectasias in patients using an ophthalmological device and method for molding a cornea of the patient while crosslinking corneal collagen fibers in the cornea of the patient. In particular, it is an object to the invention to provide improved cross-linking that is uniform and without gaps or areas of inconsistent cross-linking and poor shape retention.SUMMARY

[0013] In one embodiment, the invention comprises a system for cross-linking corneal tissue comprising: a) a lens (14, 1802) adapted to transmit light at one or more wavelengths and having a first surface (38) adapted to contact and mold a corneal surface, a lens body (15) having no apertures therein, and a lens periphery (37); b) a lens housing (32, 1820) surrounding the lens periphery and comprising an inner surface (35) adapted to engage at least a portion of the lens periphery, the lens housing having a plurality of passages (34, 1822) therein each comprising a first end having an opening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to 1 ) at least one vacuum source and 2) an oxygen source; and c) a light source (22,1830) adapted to generate and transmit light having one or more desired wavelength through the lens body (15) and into corneal tissue; wherein the lens (14, 1802) is adapted to maintain contact between the first surface and the corneal surface when one or more of the plurality of passages (34, 1822) is fluidly coupled to the at least one vacuum source, and wherein one or more of the plurality of passages (34, 1822) is adapted to provide oxygen to at least a portion of the corneal surface when fluidly coupled to the oxygen source.

[0001] In another embodiment, the invention comprises method of cross-linking corneal tissue using the system of claim 1 , comprising: a) applying a photosensitive substance to the cornea; b) contacting the first surface (38) of the lens (14, 1802) to the corneal surface; c) fluidly coupling each of the plurality of passages (34, 1822) to the at least one vacuum source to induce a vacuum pressure in the passages (34, 1822) to maintain contact between the cornea and the first surface (38); d) using the light source (22, 1830) to generate and transmit light through the lens body (15) into corneal tissue for a first time period to induce cross-linking of corneal tissue; e) terminating the induced vacuum pressure in each of the plurality of passages (34, 1822) by uncoupling the passages (34, 1822) from the at least one vacuum source; f) fluidly coupling each of the plurality of passages (34, 1822) to the oxygen source to provide a flow of oxygen to at least a portion of the corneal surface through at least one of the plurality of passages (34, 1822) for a second time period to promote cross-linking of corneal tissue; and g) uncoupling each of the plurality of passages (34) from the oxygen source.

[0015] In another embodiment, the invention comprises a system 1800 for cross-linking corneal tissue of a patient comprising: a) a lens (1822) adapted to transmit light at one or more wavelengths and having a first surface (38) adapted to contact and mold a corneal surface, a lens body (15) having no apertures therein, and a lens periphery (37); b) a lens housing (1820) surrounding at least a portion of the lens periphery (37) and comprising: 1 ) an inner surface adapted to contact at least a portion of the lens periphery (37); 2) a plurality of passages (1822), each comprising a first end having an opening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to 1 ) at least one vacuum source and 2) an oxygen source, wherein the lens (1822) is adapted to maintain contact between the first surface (38) of the lens and the corneal surface whenone or more of the plurality of passages (1822) is fluidly coupled to the at least one vacuum source, and wherein one or more of the plurality of passages (1822) is adapted to provide oxygen to at least a portion of the corneal surface when fluidly coupled to the at least one oxygen source; c) a light source (1830) comprising one or more of an incoherent UV light source and a laser light source, the light source (1830) adapted to generate and transmit light having one or more desired wavelength through the lens body (15) and into corneal tissue; d) an imaging system (1850) adapted to capture one or more images of the corneal surface; and e) a controller (1870) adapted to process the one or more images and to perform at least one action selected from: 1 ) identifying the location of one or more aberrations on the corneal surface; 2) classify the one or more aberrations on the corneal surface as a type of corneal aberration; 3) create a corneal map identifying at least one of the location and type of the one or more corneal aberrations; and 4) determine one or more treatment plans for each of the one or more corneal aberrations.

[0016] In a further embodiment, the invention comprises a method of treating glaucoma using a system comprising 1 ) a lens (14, 1802) having (A) a first surface (38) adapted to contact a corneal surface and (B) a lens periphery (37), and 2) a lens housing (32, 1820) surrounding at least a portion of the lens periphery (37) and having a plurality of passages (34, 1822) therein, each having a first end with an opening proximate to the first surface (38) of the lens (14) and a second end adapted to be fluidly coupled to at least one vacuum source, the method comprising: a) contacting the first surface (38) of the lens (14, 1802) to the corneal surface; b) coupling each of the plurality of passages (34, 1822) to the at least one vacuum source to maintain contact between the first surface (38) and the corneal surface for a defined treatment period; c) decoupling each of the plurality of passages (34, 1822) from the at least one vacuum source; and d) removing the first surface (38) of the lens (14, 1802) from contact with the corneal surface.

[0017] According to a first aspect of the invention there is provided hand-held, non- surgical ophthalmological device for use in molding a cornea of an eye of a patient, including: a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being configured to shape corneal tissue of the cornea of the patient when applied to the cornea, at least a portion of the molding lens being transparent in order to permittransmission of ultraviolet (UV) light through the molding lens, the molding head defining fluid flow passages disposed along outer sides of the molding lens; a suction body having a hollow tubular configuration, the suction body being connected to the molding head in an arrangement wherein hollow interiors of the molding head and the suction body define an internal chamber in which a partial vacuum is induced, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head in order to attract the cornea onto the molding surface, the suction body including a suction connector to which a vacuum source is connectable for inducing the partial vacuum, the suction body further including an oxygen feed connector to which a source of oxygen is connectable for permitting oxygen to flow into the internal chamber; a UV light source connected to the suction body for directing a beam of UV light through the internal chamber and through the transparent portion of the molding lens to the cornea, whereby, in use, 1 ) the cornea is irradiated with UV light emitted by the UV light source in order to promote cross-linking of corneal fibers in the corneal tissue when applying the molding lens to the cornea, after application of a photosensitive substance to the cornea; and 2) oxygen provided by the source of oxygen, is applied to the cornea for a predetermined time period in order to promote cross-linking of the corneal tissue.

[0018] In one embodiment of the invention, the molding lens may include a first portion which is transparent to permit the transmission of UV light and a second portion which is opaque so as to prevent the transmission of UV light.

[0019] In an alternative embodiment, an entire light-facing part of the molding lens may be transparent.

[0020] In yet another embodiment, an entire light-facing part of the molding lens may be transparent and the ophthalmological device may include a light-masking device disposed adjacent an inner side of the molding lens, the light-masking device including a first portion configured to permit transmission of UV light therethrough and a second portion which is opaque so as to prevent transmission of UV light, whereby the UV light source is operable to transmit a beam of UV light through the internal chamber and through the first portion of the light-masking device and the molding lens onto the cornea.

[0021] According to a second aspect of the invention there is provided a hand-held, non- surgical ophthalmological device for use in molding a cornea of an eye of a patient, theophthalmological device including: a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being configured to shape corneal tissue of the cornea of the patient when applied to the cornea, a first portion of the molding lens being transparent so as to permit the transmission of ultraviolet (UV) light and a second portion of the molding lens being opaque so as to prevent the transmission of UV light, the molding head defining fluid flow passages disposed along outer sides of the molding lens; a suction body having a hollow tubular configuration, the suction body being connected to the molding head in an arrangement wherein hollow interiors of the molding head and of the suction body define an internal chamber in which a partial vacuum is induced, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head in order to attract the cornea onto the molding surface, the suction body including a suction connector to which a vacuum source is connectable for inducing the partial vacuum; a UV lamp connected to the suction body for transmitting a beam of UV light through the internal chamber and through the first portion of the molding lens to the cornea, whereby, the cornea is irradiated with UV light in order to promote cross-linking of corneal fibers in the corneal tissue after application of a photosensitive substance to the cornea, when applying the molding lens to the cornea.

[0022] The suction body may further include an oxygen feed connector to which a source of oxygen is connectable for permitting oxygen to flow into the internal chamber, whereby oxygen provided by the source of oxygen, is applied to the cornea for a predetermined time period in order to promote cross-linking of the corneal tissue.

[0023] According to a third aspect of the invention there is provided a hand-held, non- surgical ophthalmological device for use in molding a cornea of an eye of a patient, the ophthalmological device including: a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being molded to shape corneal tissue of the cornea when applied to the cornea of the eye of the patient, the molding lens being transparent in order to permit transmission of ultraviolet (UV) light through the molding lens, the molding head defining fluid flow passages disposed along outer sides of the molding lens; a suction body having a hollow tubular configuration, the suction body being connected to the molding head inan arrangement wherein hollow interiors of the molding head and of the suction body define an internal chamber in which a partial vacuum is induced, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head in order to attract the cornea onto the molding surface, the suction body including a suction connector to which a vacuum source is connected for inducing the partial vacuum; a UV lamp connected to the suction body for transmitting a beam of UV light through the internal chamber and through the first portion of the light-masking device and the molding lens onto the cornea, whereby the cornea is irradiated with UV light in order to promote crosslinking of corneal fibers in the corneal tissue after application of a photosensitive substance to the cornea when applying the molding lens to the cornea, the ophthalmological device including a light-masking device which is disposed adjacent an inner side of the molding lens when the suction body is connected to the molding head, the light-masking device including a first portion which is configured to permit transmission of UV light therethrough and a second portion which is opaque so as to prevent transmission of UV light.

[0024] The suction body may further include an oxygen feed connector to which a source of oxygen is connectable for permitting oxygen to flow into the internal chamber, whereby oxygen provided by the source of oxygen, is applied to the cornea for a predetermined time period in order to promote cross-linking of the corneal tissue.

[0025] According to a fourth aspect of the invention there is provided a method for molding a cornea of an eye of a patient, the method including: providing an ophthalmological device including: a) a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being configured to shape corneal tissue of the cornea of the patient when applied to the cornea, at least a portion of the molding lens being transparent so as to permit the transmission of ultraviolet (UV) light, the molding head defining fluid flow passages disposed along outer sides of the molding lens; b) a suction body having a hollow tubular configuration, the suction body being connected to the molding head in an arrangement wherein hollow interiors of the molding head and of the suction body define an internal chamber, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head, the suction bodyincluding a suction connector to which a vacuum source is connectable, the suction body further including an oxygen feed connector to which a source of oxygen is connectable; c) a UV lamp connected to the suction body for directing a beam of UV light through the internal chamber and through the transparent portion of the molding lens to the cornea; applying a photosensitive substance to the cornea; applying the molding surface of the molding lens to the cornea; inducing a partial vacuum in the internal chamber via the vacuum source in order to attract the cornea onto the molding surface of the molding lens; irradiating the cornea with UV light emitted by the UV lamp in order to promote crosslinking of corneal fibers in the corneal tissue; terminating the suction induced in the internal chamber and for a predetermined period of time, permitting a flow of oxygen into the internal chamber via the source of oxygen, in order to promote cross-linking of the corneal tissue; and after elapsing of the period of time, re-commencing suction in the internal chamber.

[0026] In one embodiment of the invention, the molding lens may include a first portion which is transparent so as to permit the transmission of UV light and a second portion of the molding lens which is opaque so as to prevent the transmission of UV light, the method including transmitting UV light from the UV lamp through the first portion of the molding lens so as to promote cross-linking of corneal fibers in the corneal tissue of the eye of the patient, disposed opposite the first portion of the molding lens

[0027] In an alternative embodiment, an entire light facing part of the molding lens may be transparent.

[0028] In yet a further embodiment, an entire light facing part of the molding lens may be transparent and the ophthalmological device head may include a light-masking device which is disposed adjacent an inner side of the molding lens, the light-masking device including a first portion is configured to allow transmission of UV light therethrough and a second portion which is opaque so as to prevent transmission of UV light, the method including transmitting a beam of UV light through the internal chamber and through the first portion of the light-masking device and the molding lens onto the cornea in order to promote cross-linking of corneal fibers in the corneal tissue of the eye of the patient, opposite the first portion of the light-masking device.

[0029] According to a fifth aspect of the invention there is provided a method for molding a cornea of an eye of a patient, the method including: providing an ophthalmological device including: a) a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being configured to shape corneal tissue of the cornea of the patient when applied to the cornea, a first portion of the molding lens being transparent so as to permit transmission of ultraviolet (UV) light and a second portion of the molding lens being opaque so as to prevent transmission of UV light through the molding lens, the molding head defining fluid flow passages disposed along outer sides of the molding lens; b) a suction body having a hollow tubular configuration, the suction body being connected to the molding head in an arrangement wherein hollow interiors of the molding head and of the suction body define an internal chamber, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head, the suction body including a suction connector to which a vacuum source is connectable; c) a UV lamp connected to the suction body for directing a beam of UV light through the internal chamber and through the first portion of the molding lens to the cornea; applying a photosensitive substance to the cornea; applying the molding surface of the molding lens to the cornea; inducing a partial vacuum in the internal chamber via the vacuum source in order to attract the cornea onto the molding surface of the molding lens; and transmitting a beam of UV light through the internal chamber and through the first portion of the molding lens to the cornea, in order to irradiate a portion of the cornea disposed opposite the first portion of the molding lens with UV light in order to promote cross-linking of corneal fibers in the corneal tissue thereby to promote cross-linking of corneal fibers in the corneal tissue

[0030] According to a sixth aspect of the invention, there is provided a method for molding a cornea of an eye of a patient, the method including: providing an ophthalmological device including: a) a molding head having a hollow, tubular molding body and a molding lens having a curved molding surface having a predetermined curvature, the molding surface being configured to shape corneal tissue of the cornea of the patient when applied to the cornea, the molding lens being transparent in order to permit transmission of ultraviolet (UV) light through the molding lens, the molding headdefining fluid flow passages disposed along outer sides of the molding lens; b) a suction body having a hollow tubular configuration, the suction body being connected to the molding head in an arrangement wherein hollow interiors of the molding head and of the suction body define an internal chamber, the internal chamber being in fluid flow communication with the fluid flow passages of the molding head, the suction body including a suction connector to which a vacuum source is connectable; c) a UV lamp connected to the suction body for directing a beam of UV light through the internal chamber and through the transparent portion of the molding lens to the cornea; and d) a light-masking device which is disposed adjacent an inner side of the molding lens, the light-masking device including a first portion which is configured to permit transmission of UV light therethrough and a second portion which is opaque so as to prevent transmission of UV light, applying a photosensitive substance to the cornea; applying the molding surface of the molding lens to the cornea; inducing a partial vacuum in the internal chamber via the vacuum source in order to attract the cornea onto the molding surface of the molding lens; and transmitting a beam of UV light through the internal chamber and through the first portion of the light-masking device and the molding lens onto the cornea, in order to irradiate the cornea with UV light thereby to promote cross-linking of corneal fibers in the corneal tissue.BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 is a three-dimensional view of an ophthalmological device for use in molding a cornea of an eye of a patient, in accordance with the invention.

[0032] Figure 2 is an exploded three-dimensional view of the ophthalmological device of Figure 1 .

[0033] Figure 3 shows an exploded sectional side view of the ophthalmological device of Figure 1 .

[0034] Figure 4 shows a sectional side view of the ophthalmological device of Figure 1 , in an assembled condition.

[0035] Figure 5 shows a side view of the molding head of the ophthalmological device of Figure 1 .

[0036] Figure 6 shows a sectional side view of the molding head of Figure 5.

[0037] Figure 7 shows an end view of the molding head of Figure 5 as seen from the front end thereof.

[0038] Figure 8 shows an end view of the suction body of the ophthalmological device of Figure 1 , as seen from the front end thereof.

[0039] Figure 9 shows a side view of the suction body of Figure 8.

[0040] Figure 10 shows a sectional side view of the suction body of Figure 8.

[0041] Figure 11 shows a side view of the ophthalmological device of Figure 1 , illustrating the operation and the connection thereof to a vacuum source, a source of oxygen and an electrical power pack.

[0042] Figure 12 shows a three-dimensional view of an alternative embodiment of an ophthalmological device for use in molding a cornea of an eye of a patient, in accordance with the invention.

[0043] Figure 13 shows an exploded three-dimensional view of the ophthalmological device of Figure 12.

[0044] Figure 14 shows an exploded sectional side view of the ophthalmological device of Figure 12.

[0045] Figure 15 shows a sectional side view of the ophthalmological device of Figure 12, in an assembled condition.

[0046] Figure 16 shows a side view of the ophthalmological device of Figure 12, illustrating the operation and connection thereof to a vacuum source, a source of oxygen and an electrical power pack.

[0047] Figure 17 shows a side view of the ophthalmological device of Figure 12, illustrating the operation and the connection thereof to a vacuum source, a source of oxygen and an electrical power pack.

[0048] Figure 18 is a block diagram of an ophthalmological system for treating corneal disorders, according to one embodiment.

[0049] Figure 19 is a block diagram of another ophthalmological system for treating corneal disorders, according to one embodiment.

[0050] Figure 20 shows exemplary corneal topographical maps of characteristic patterns of keratoconus.

[0051] Figure 21 is a graph of intraocular pressure for keratoconus treated with crosslinking through a vacuum-assisted lens.DESCRIPTION

[0052] Exemplary embodiments are illustrated in referenced figures of the drawings. The embodiments disclosed herein are illustrative rather than restrictive, and the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of this disclosure. Examples are all intended to be non-limiting, and the particular embodiments disclosed may be altered or modified and all such variations are considered within the scope and spirit of the invention, which are limited only by the scope of the claims.

[0053] Corneal topography, a key diagnostic tool for keratoconus, is used to noninvasively map the curvature of the cornea. It involves scanning the cornea to identify its curvature and shape, and reveals characteristic abnormal patterns that are used in planning appropriate treatments, including cross-linking. Topography maps typically involve calculation of quantitative measurements such as the Kmax value of the maximal corneal curvature or steepness, which indicates the severity of the condition.

[0054] Figure 20 illustrates a number of known patterns of abnormal curvature from corneal topography of keratoconus patients. Round (2010) and oval (2015) topographies are common early indicators of keratoconus, where the steepest corneal area forms a roughly circular or elongated oval shape, respectively, reflecting centralized or slightly extended conical protrusion. The symmetrical protrusion induces moderate HOAs, primarily coma and spherical aberration, due to slight wavefront warping while maintaining relative uniformity.

[0055] Superior (2020) and inferior steepening (2025) patterns, where curvature localizes above or below the corneal center, are more common, with inferior steepening dominating due to typical cone displacement downward in keratoconus. These generate pronounced vertical coma, especially in inferior cases, as the asymmetric steepening tilts the optical axis, scattering light unevenly and worsening visual distortions like halos.

[0056] Irregular topography (2030), prevalent in advanced or unstable keratoconus, lacks defined curvature, producing severe HOAs, including coma, trefoil, and higher-degree aberrations, as the chaotic surface curvature drastically distorts the wavefront, leading to significant visual impairment.

[0057] Symmetrical bowtie topography (2040), showing a balanced hourglass shape with evenly distributed steepening above and below the corneal center, indicating a balanced astigmatic pattern. This creates moderate HOAs, mainly trefoil and astigmatic aberrations, from symmetric but complex wavefront errors. Symmetrical bowtie with skewed radial axes (2045), in contrast, retains the hourglass shape but exhibits a slight tilt in one or more of the axes, suggesting early asymmetry in corneal steepening. It introduces slight coma due to the tilted axes, adding a directional bias to light scattering that subtly increasing distortion.

[0058] Asymmetric bowtie patterns (2050, 2055, 2060) reflect greater irregularity and HOA severity. Asymmetric bowtie with inferior steepening (2050) shows a bowtie shape in which the lower half is significantly steeper than the upper half, aligning with common inferior cone placement. It significantly elevates vertical coma and trefoil, as the steep lower corneal gradient disrupts the wavefront asymmetrically, intensifying symptoms like glare. Asymmetric bowtie with superior steepening (2055), in which the upper half is steeper than the lower half, is less frequent than inferior steepening but similarly increases coma with an upward tilt, altering light paths oppositely. Asymmetric bowtie with skewed radial axes (2060) combines the bowtie shape with tilted axes and uneven steepening, producing high coma and trefoil levels, compounding optical irregularities. Across these patterns, keratoconus amplifies HOAs by distorting corneal shape, with each topography type contributing distinct aberration profiles that complicate vision and inform tailored management strategies.

[0059] In one aspect, the present invention provides improved devices and methods for cross-linking corneal tissue that allows the healthcare provided to vary the forces applied to the corneal at different radial positions. At present, vacuum-assisted corneal crosslinking does not allow a practitioner to vary the strength of the vacuum pressure applied at different radial locations of the corneal periphery. It could be helpful, for example, to provide relatively stronger vacuum pressure at the upper and / or lower central part of the corneal periphery when treating a patient with superior steeping or inferior corneal steeping relative to lateral locations with lesser steepening. In cases with skewed axes,such as symmetric or asymmetric bowties with skewed radial axes, it could be advantageous to provide greater levels of vacuum at radial locations corresponding with the axis of greatest steepening.

[0060] In one aspect, the present disclosure provides improved systems and methods for treating ectasia by providing more consistent cross-linking across the entire corneal surface. The systems and methods provide improved cross-linking that is uniform with reduced or no corneal areas with poor or no cross-linking, yielding improved shape retention after the procedure.

[0061] In one aspect, the present disclosure provides systems to allow a user to provide different levels of vacuum at different radial positions of the eye corresponding to the need for flattening at a given location. Without being bound by theory, it is believed that improved flattening of the cornea may be achieved by providing a stronger vacuum near the periphery with the highest abnormal curvature, which may orient the corneal fibers in a more uniform direction and allow improved rigidity following the procedure.

[0062] In one embodiment, described with reference to Figures 1 - 11 , a hand-held, non-surgical ophthalmological device for use in molding a cornea 4 of an eye 2 of a patient is designated by the reference numeral 10. In one embodiment, the device 10 may be used to treat keratoconus. In another embodiment, the device 10 may be used to treat glaucoma.

[0063] The ophthalmological device 10 comprises a molding lens 14 and a housing body 17 for the molding lens. Molding lens 14 includes a lens body 15 having a first surface 38 adapted to mold a cornea to a desired shape, a second side 39 opposite to the first surface, and a lens periphery 37. The curved, outwardly-facing molding surface 38 has a predetermined concave curvature configured to shape corneal tissue. Housing body 17 includes a molding head 12 and a suction body 16 that may be joined together, e.g., by screw threads 45 on the suction body and screw threads 33 on the molding head. In alternative embodiments (not shown), quick-release couplings may be used instead of threaded connectors, or housing body 17 may comprise a unitary structure. Suction body 16 has a hollow interior and includes a suction port 18 for connecting the ophthalmological device 10 to one or more vacuum sources, an oxygen port 20 for connecting to an oxygen source 60, and a light source 22 which may comprise a light-emitting diode (LED) UVlamp, a laser, or other light source type emitting light at one or more defined wavelengths for cross-linking cornea tissue. In one embodiment, the light source may be a LED UV lamp having a wavelength of about 370 nm and an irradiance of about 9 mW / cm2

[0064] Molding head 12 comprises a hollow, cylindrical molding body 24 with a front end 26 and a rear end 28. The molding body 24 has a relatively larger diameter cylindrical rear section 30 and a smaller diameter cylindrical front section 32. The smaller diameter cylindrical front section 32 provides a housing for the molding lens 14, and includes an inner surface 31 that contacts the lens periphery 37. In one embodiment, described in connection with Figure 19, the housing body 17 may comprise a simplified structure adapted to maintain the lens 14 and light source 22 in a fixed position relative to one another, such as a lens housing comprising a small ring couplable to the one or more vacuum sources and the oxygen source 60, and a spacing member 1927 adapted to hold the light source in a fixed position relative to the lens. In the embodiment of Figures 1 -11 , rear section 30 of molding head 12 includes an internal screw thread 33 to engage external screw thread 45 on suction body 16.

[0065] To enable the vacuum to be delivered to the eye 4 to retain it in contact with molding lens 14, front section 32 includes a number of circumferentially-spaced passages or passages 34 extending longitudinally along inner surface 31 . A ridge formation 36 extends circumferentially along an inner side of the front section 32 near, but spaced apart from, the front end 26 of the molding head 12. The channels or passages 34 extend through the ridge formation 36 which provides a seat against which a front side of the molding lens is seated and retained within the molding head 12 and housing body 17. Passages 34 include a first end having an opening proximate to the first surface of the lens and a second end adapted to be fluid coupled to at least one vacuum source and the oxygen source 60 to facility cross-linking of corneal tissue.

[0066] When suction body 16 is joined to molding head 12, housing body 17 defines an internal chamber 40. In the embodiment of Figure 11 , the second end of each passage 34 is fluidly coupled to internal chamber 40, which in turn may be fluidly coupled to the at least one vacuum source and the oxygen source 60. In alternative embodiments, the passages may be directly coupled to the vacuum and oxygen source 60. Suction body 16 has a front end 42 and a rear end 43. Front end 42 of suction body 16, which engagesrear end 28 of molding head 12 via to complete the housing body 17, includes a plurality of castellations 44 each having an undercut slot 44.1 at a base thereof. The purpose of the castellations 44 and the undercut slots 44.1 will be explained in more detail in connection with Figures 12-15.

[0067] When threads 45 on suction body 16 are screwed into threads 33 of molding head 12, the front end 42 of the suction body abuts against a peripheral outer rear edge of the molding lens 14, securely retaining the molding lens between ridge formation 36 and the suction body front end. A rubber O-ring seal 46, located in a groove 47 on the outer surface of suction body 16, provides an air-tight seal between suction body 16 and molding head 12 to ensure that internal chamber 40 of housing body 17 will not leak under vacuum conditions or when supplying oxygen to the eye 4 via passages 34.

[0068] Internal chamber 40 is in fluid communication with the channels or passages 34 of the molding head via suction port 18 and oxygen port 20. A pipe or conduit 54, shown in Figure 11 , may connect suction port 18 to one or more vacuum sources, such as a syringe 56 which may be operated by a medical practitioner for inducing a partial vacuum in internal chamber 40 in order to attract the cornea 4 onto the molding surface 38 of the molding lens 14.

[0069] In alternative embodiments, suction port 18 may provide an inlet for a plurality of hoses or other conduits, each coupled to at least two of the passages 34 to allow different vacuum pressures to be applied at different radial positions around the periphery of the cornea. As described more fully in connection with Figures 18 and 19, a vacuum regulator 1840 may also be provided to control the vacuum pressure of each passage 34 to provide a desired vacuum pressure profile around a periphery of the cornea. In one embodiment, the vacuum regulator may individually control the vacuum pressure of each passage 34 to a user-selected vacuum pressure.

[0070] Referring again to Figures 1-11 , an oxygen source 60 (Figure 11 ) may be connected to oxygen port 20 via a pipe or conduit 58 to permit oxygen to flow into the internal chamber 40. Applicant has discovered that the cross-linking process may be enhanced (e.g., performed faster or more completely) by delivering oxygen to the cornea after one or more cross-linking time periods in which the cornea is vacuum-molded to the first surface 38 of the lens and subjected to light from the light source 22. After a cross-linking treatment period, which may range from 5 seconds to 30 minutes, preferably 30 seconds to 10 minutes, and more preferably from 2-5 minutes, the vacuum may be released to separate the cornea from at least a portion of the first surface 38, and oxygen may be applied to the cornea from oxygen source 60 via conduit 58, internal chamber 40, and passages 34. Oxygen is applied to the cornea 4 for a predetermined time period ranging from 3 second to 5 minutes, preferably 15 seconds to 2 minutes, and promotes cross-linking of corneal fibers of the corneal tissue. After the oxygen treatment period, the oxygen delivery may be terminated and a partial vacuum is again induced in the internal chamber. The cross-linking and oxygen delivery processes may be repeated one or more times to improve the degree of cross-linking. In contrast to prior art designs, molding lens 14 does not have apertures in the lens body 15. Because there are no perturbations or discontinuities in the refractive index traveled by the light across the lens body 15, embodiments of the present invention enable more consistent cross-linking throughout the corneal surface, and there are no areas where cross-linking is absent because of inadvertent masking caused by apertures over the corneal surface.

[0071] Light source 22 is connected to rear end 43 of suction body 16 through a lamp mounting aperture 48 (Figure 3), for directing light (e.g., laser pulses are a beam of UV light) through internal chamber 40 and lens body 15 to the cornea 4 of the patient’s eye 2 to cross-link corneal fibers in the corneal tissue while applying the molding lens to the cornea, after application of a photosensitive substance to the cornea. A portable electrical power source 62 is provided for energizing the UV lamp. In alternative embodiments, the light source 22 may be powered by other power sources such as a wire coupled to a standard power outlet.

[0072] In one embodiment, the entire molding lens 14 is transparent and allows the cross-linking light through the entirety of the lens body 15. In other embodiments, shown in Figure 2 with the reference numerals 14.1 , 14.2 and 14.3, a portion of the lens body 15 is transparent, while another portion of the lens body is masked so as to render the masked portion opaque, thereby preventing the transmission of UV light therethrough. Masking of the molding lens 14 permits specific areas of the cornea disposed opposite the transparent portion of the lens body 15 to be targeted for area-specific cross-linkingof corneal fibers, while those areas of the cornea opposite the masked portions remain unaffected by the cross-linking treatment.

[0073] With reference to Figures 12 - 15, a second embodiment of an ophthalmological device 100 is depicted, with like numbers referring to like structures of Figures 1 -11. Ophthalmological device 100 is similar to ophthalmological device 10 in that the lens body 15 of molding lens 14 is entirely transparent and free of apertures, as is the case with the molding lens 14 of the ophthalmological device 10, so as to allow transmission of UV light uniformly therethrough and the ophthalmological device 100. However, in contrast to the embodiment of Figures 1 -11 , ophthalmological device 100 includes a light mask 64 which is releasably mounted to the suction body 16 at a front end 42 thereof. In the embodiment of Figures 12-15, the light mask 64 comprises a disc form of metal or other material opaque to light from the light source. More specifically, the light masking 64 includes a number of circumferentially-spaced, radially-projecting locating tabs 66 which are received in undercut slots 44.1 at the bases of castellations 44 in a press and twist action. The light mask 64 is cut so as to define an opening 68 allowing light (and air or oxygen for purposes of creating a vacuum or delivering oxygen via chamber 40) to pass therethrough, and a masking portion 70 preventing the passage of light therethrough.

[0074] When the molding head 12 and the suction body 16 are assembled to form housing body 17, the light mask 64 is located adjacent to a second side 39 of molding lens 14 that is on the opposite side of lens body 15 from first surface 38. In contrast to lenses 14.1 , 14.2 and 14.3 of device 10 that provide opaque portions of the lens body 15 of molding lens 14, mask 64 includes a first portion (opening 68) permitting transmission of light from the light source to the cornea, and a masking portion 70 that is opaque to light from the light source. Light mask 64 may be cut from a metal according to a particular pattern in order to achieve masking of the cornea as required.

[0075] Use of the light-masking disc 64 in device 100 permits specific areas of the cornea not masked by portion 70 to be targeted for area-specific cross-linking of corneal fibers, while those areas of the cornea opposite the masked portion(s) remain unaffected by the cross-linking treatment. To minimize bending and reflecting of UV light after it passes through the light-masking disc 64, in device 100 a laser would be preferred as the light source 22.

[0076] At present, corneal topography and corneal cross-linking involve separate systems that must be manually reconciled together to effectively treat the patient. In one aspect, the present disclosure provides systems and methods for corneal mapping that allow a user to plan, either manually or in response to a system -generated proposed treatment, how and where a cross-linking light source such as a laser will be applied to corneal tissue. The system includes an imaging system for capturing images of the corneal surface and a controller or processor to process the images and provide information to a system user about the patient’s corneal surface and / or treatment. A user interface allows the user to receive and provide information to the system to direct or control a treatment of the patient with a light source. In some embodiments, the treatment plan may be automatically implemented by the system to provide cross-linking light to user-selected areas of the cornea at specified treatment parameters (e g., light wavelength, application time for UV light to be applied, number of laser pulses at specific corneal locations, laser pulse width, fluence, pulse energy, pulse frequency, etc.).

[0077] The system may include a vacuum regulator to enable a user to control vacuum pressures to provide different vacuum pressures at different radial positions along the corneal periphery corresponding to the need for flattening at a given location. In some embodiments, the treatment plan may be automatically implemented by the system to provide cross-linking light to user-selected areas of the cornea at specified treatment parameters (e.g., light wavelength, application time for UV light to be applied, number of laser pulses at specific corneal locations, laser pulse width, fluence, pulse energy, etc.).

[0078] Figure 18 is a block diagram of an ophthalmological system 1800 for treating corneal ectasia according to one aspect of the present invention. System 1800 includes some components that are similar to those describe in connection with Figures 1 -17, but includes additional components adapted to allow a user to provide improved treatments for corneal ectasia. The system includes a molding lens 1802, a lens housing 1820 adapted to at least partially surround the molding lens, and a light source 1830 for crosslinking corneal tissue. A spacing element or spacer 1826 couples the lens housing 1820 and the light source 1830 together as a functional unit. A vacuum regulator 1840 allows the user to control vacuum pressures at different radial positions on the corneal periphery and to regulate the delivery of oxygen to the cornea. An imaging system 1850 capturesimages of the patient’s cornea for use by the system in providing treatment to the patient. A user interface 1860 allows the user to interact with the system, and may provide and receive data from the user. A controller 1870 comprising one or more processors is provided to control the operations of the system, including the operation of the light source 1830, vacuum regulator 1840, imaging system 1850, and user interface 1860.

[0079] Although not shown explicitly in Figure 18, it will be understood that the system 1800 also includes a power supply providing power to electrically active system components. The power supply may comprise a power supply coupled to a standard A / C power outlet to convert AC to DC power at one or more voltages, and may include a battery. The power supply provides power to controller 1870, which may in turn provide power and instructions to the other electrically active system components.

[0080] Molding lens 1802, similar to molding lens 14 of figures 1 -17, is adapted to mold a cornea 4 of an eye 2 of a patient to a desired shape during cross-linking of corneal tissue. Although depicted schematically and not functionally in Figures 18 and 19, lens 1802 includes structures described in connection with Figures 1 -17, including a lens body 15, a first surface 38 adapted to mold the cornea, a second side 39 opposite to the first surface, and a lens periphery 37. First surface 38 has a predetermined concave curvature configured to shape corneal tissue, and lens body 15 comprises a solid structure with no apertures therein to facilitate uniform cross-linking of corneal tissue.

[0081] Lens housing 1820 surrounds and contacts at least a portion of the lens 1802, and is couplable to the vacuum regulator 1840, which allows a system user to control vacuum pressures and oxygen delivery to the cornea. Lensing housing 1820 includes a plurality of passages 1822 (represented by a single passage 1822 schematically and not structurally in Figures 18-19), similar to passages 34 described in connection with Figures 17. Each passage 1822 in lens housing 1820 is circumferentially disposed around the lens periphery, and has a first end with an opening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to the vacuum regulator 1840.

[0082] Passages 1822 are used to regulate the application of vacuum and delivery of oxygen to corneal tissue at different corneal radial locations proximate to the periphery 37 of the lens 1802. In the embodiment of Figure 18, passages 1822 are coupled to vacuum regulator 1840 via the spacing element 1826 (e.g., via ports / conduits asdescribed in connection with ports 18 and 20 in Figures 1 -17). In an alternative embodiment (not shown), vacuum regulator 1840 may be omitted, and passages 1822 may be directly coupled to a vacuum source or to an oxygen source via one or more connectors and / or conduits (not shown) on the lens housing 1820, which may be a complete or partial ring structure.

[0083] Spacing element 1826 is provided to maintain lens 1802 and lens housing 1820 in a desired position relative to light source 1830 and imaging system 1850. In the embodiment shown in Figure 18, spacer 1826 is coupled to lens housing 1820 at a first end and to light source 1830 and imaging system 1850 at a second end, and comprises a tubular structure having a chamber 1828 similar to housing body 17 described in connection with Figures 1-17. In an alternative embodiment, shown in Figure 19, a simplified spacer 1927 comprises a member that does not have a chamber for guiding delivery of light from the light source 1830 to the cornea, and is simply coupled to lens housing 1820 at a first end and to light source 1830 and imaging system 1850 at a second end. In some embodiments, the spacing element 1826, 1927 is adjustable in length to vary the distance between one or both of the light source 1830 and the imaging system 1850 from the lens 1802. The adjustment (e.g., via telescoping sections or worm / gear driven rack) may allow the distances of the lens from the light source 1830 and the imaging system 1850 to be independently adjusted.

[0084] Light source 1830 is coupled to the second end of spacing element 1826 to facilitate application of light at one or more selected wavelengths to corneal tissue through lens 1802. The light source 1826 may comprise a light-emitting diode (LED) UV lamp, a laser, or other light source type emitting light at one or more defined wavelengths (e.g. about 370 nm) for cross-linking cornea tissue. In a preferred embodiment, the light source 1826 comprises a laser adapted to generate and apply laser pulses having a specified beam shape (e.g., circular or square), area (e.g., 0.5 - 3.0 mm in length or diameter), and pulse parameters (e.g., laser pulse width, fluence, pulse energy, wavelength, frequency, etc.). In one embodiment, one or more aspects of the light applied to the cornea may be user-selected, as discussed more fully in connection with the user interface.

[0085] Providing light at precisely defined parameters is important to ensure safe and reliable treatment as described herein. However, manufacturing variability can sometimesresult in parameters of the light source (e.g., wavelength) being outside of design specifications. Accordingly, in one embodiment (not shown) a spectrometer may be provided to measure the wavelength of light during the cross-linking procedure, and alert a user if the wavelength is outside of a desired cross-linking wavelength or wavelength range. In a further embodiment, the system may adjust the light source (e.g., the electrical current and / or voltage, or using heating or cooling) to restore the wavelength to a desired value.

[0086] A vacuum regulator 1840 allows the user to control vacuum pressures at different radial positions on the corneal periphery and to regulate the delivery of oxygen to the cornea. In one embodiment, the vacuum regulator 1840 is connected to one or more vacuum sources (not shown), and comprises a series of valves and / or switches and conduits that are electronically controllable to couple one or more of the plurality of passages 1822 to the vacuum source(s). In one embodiment, the vacuum regulator 1840 may comprise one or more actuatable elements (e.g., an air reservoir in a syringe or other pump) that may be coupled via valves or switches to directly regulate the vacuum pressure in at least one (e.g., one, two, three, or all) of the passages 1822. In another embodiment, the vacuum regulator 1840 may comprise a network of switches to couple one or more of the passages 1822 to one a set of discrete vacuum sources having known vacuum pressures. In one embodiment, the vacuum regulator 1840 may be adapted to couple a first subset of the plurality of the passages 1822 to a first vacuum source having a first vacuum pressure, and couple a second subset of the plurality of the passages to a second vacuum source different from the first vacuum pressure. In one embodiment, the vacuum regulator 1840 is adapted to allow a user to control the vacuum pressure in each passage 1822 to two of more different vacuum pressures. In one embodiment, the vacuum regulator is adapted to individually couple each of the passages 1822 to a user- defined or selected vacuum pressure to provide a user-defined vacuum pressure profile around a periphery of the cornea to facility patient-specific cross-linking.

[0087] In addition to controlling the vacuum pressure in each of the passages 1822, the vacuum regulator 1840 is adapted to disconnect or terminate the coupling of the plurality of passages to a vacuum source and to connect or couple each of the passages to theoxygen source, and vice versa in treatments involving repeated application of vacuum, light application, and oxygen application to the cornea to treat the patient.

[0088] An imaging system 1850 captures images of the patient’s cornea and / or corneal surface for use by the system in providing treatment to the patient. In one embodiment, the imaging system comprises a camera to capture images of the cornea of the patient. The camera may comprise any known still or video cameras used in capturing still or video images of the cornea. As described more fully below, the system also includes a controller 1870 to process the images. In one embodiment, the system 1800 may allow the lens housing 1820 and lens 1802 to be removed from the light path between the camera and the patient’s cornea (e.g., by a pivotable connection of the lens housing to the spacing element 1826 or 1927), so that the user may capture images before or after treatment for creating a corneal map. The lens may again be placed in the image path, and additional images may be captured with the cornea in contact with the molding lens 1802 either before or during treatment. Additional images may be captured after treatment by moving the lens out of the imaging path.

[0089] The camera may comprise any known cameras for imaging corneas and / or generating corneal maps, and may include CCD imaging devices. In one embodiment, a light source different from the treatment light source 1830 may be provided to capture images of the eye at one or more desired lighting conditions to obtain diagnostic or treatment-specific information about the patient’s conditions or treatment results.

[0090] A controller 1870 is provided to control the operations previously described in connection with the light source 1830, vacuum regulator 1840, and imaging system 1850, as well as those of the user interface described hereafter. Controller 1870 may comprise any of one or more computing or data processing elements known in the art to control the operations imaging and laser treatment systems such as microprocessors, microcontrollers, field programmable gate arrays (FPGAs), memory elements, software, firmware, executable code, logic elements, and other forms of circuitry. More generally, the controller 1870 is adapted to control the operations of substantially all of the electronic components of the system 1800, including the light source 1830 (e.g., initiating or terminating light delivery to the cornea, or causing the light source to operate at user- defined parameters of laser pulse width, beam shape, and fluence), the vacuum regulator1840 (e g., connecting or disconnecting one or more passages 1822 to or from a vacuum source or oxygen source, starting or terminating vacuum or oxygen flow, or regulating the vacuum pressure or level of oxygen flow to the cornea), and imaging system 1850 (e.g., initiating image capture and controlling the electronic components of the camera), and the user interface 1860, described more fully below.

[0091] The controller 1870 is also adapted to process image data from the imaging system 1850 to identify the location of one or more aberrations on the corneal surface and to classify the aberration(s) (e.g., as an aberration type described in connection with Figure 20). In one embodiment, the controller 1870 may create a corneal map identifying the location(s) on the cornea and / or type of the aberration(s) identified from image data received from the imaging system 1850. In one embodiment, the controller includes software and / or firmware to calculate or determine one or more treatment plans for the patient, based upon the location, type(s), and / or severity of aberrations identified during the image processing. This may include, e.g., identifying on a treatment map areas to receive specified laser pulses to cross-link corneal tissue to correct the abnormal curvature, and the parameters defining such laser pulses. In one embodiment, as part of the treatment plan, the controller 1870 may indicate vacuum pressures to be provided at different radial positions around the corneal periphery during cross-linking to optimally flatten the cornea.

[0092] In one embodiment, the controller 1870 may analyze images prior to applying light from the light source 1820 to the cornea to confirm that the lens 1802 has been properly placed on the cornea. In particular, the camera may be used to capture images after a vacuum has been induced in one or more of passages 1822 and the images processed to determine whether or not an air bubble exists between the cornea and the lens 1802. The image processor may provide a signal to the user (e.g., via the user interface 1860), to indicate whether an air bubble or other indication of improper lens placement exists that the user should correct before delivering light to the cornea.

[0093] Although the embodiments of Figures 18 and 19 depict one controller 1870 comprising a separate element from the vacuum regulator 1840, imaging system 1850, light source 1830, and user interface 1860, it will be apparent to persons of skill in the art having the benefit of this disclosure that the functions described herein for controller 1870could be implemented as part of one or more of the electrically active components of the system, or comprising multiple processing or electronic units or subunits. For example, separate processors may be provided in each of vacuum regulator 1840, imaging system 1850, light source 1830, and user interface 1860, and functions described herein as performed by the controller may be performed by one or more processing elements located in various components of the system, and each such embodiment is expressly intended as within the scope of the present disclosure. Electronic elements differing solely in structure but performing the same function or functions noted in connection with controller 1870 are likewise within the scope of this disclosure.

[0094] A user interface 1860 allows a user to interact with the system 1800 to receive or input data to examine, diagnose, and treat a patient having corneal ectasia. The user interface 1860 allows a user to direct system 1800 to perform actions such as capture and process images via the imaging system 1850 and controller 1870, display the images on a screen or other display apparatus, and receive user inputs to direct actions and / or select parameters for performing a treatment. The user interface 1860 may display a variety of data to a user including: images of the patient’s cornea showing the location of corneal aberrations and their classification type prior to treatment; a corneal map identifying the location and type of corneal aberrations; one or more treatment plans determined from analysis of corneal images and / or the corneal map (e.g., cross-linking parameters for the light source 1830 to provide laser pulses for cross-linking corneal tissue).

[0095] In addition to providing information to the user as an output, the user interface 1860 is adapted to allow a user to input information to direct operations of the system, and may include one or more of a keyboard input, a voice-activated input, and inputs via a touch-screen, among other known input / output modalities. In response to corneal images, maps, and / or potential treatments displayed on the user interface 1860, the user may respond with an input accepting or rejecting the location of a corneal aberration identified by the imaging system 1850 and displayed on a cornea map on a screen. The system 1800 thus allows the healthcare provider to exercise professional discretion to disregard areas that the user does not believe comprise a treatable aberration. Similarly, the user may provide an input accepting or rejecting the type or classification of a cornealaberration identified by the controller 1870 from processed images, or the user may provide an input correcting or changing the type of aberration identified by the processor 1870, allowing the user to remain in full control of the patient’s diagnosis and treatment. In embodiments that provide treatment plans to the user, the user may provide an input accepting a proposed treatment option, or directing the controller to perform a treatment plan for one or more corneal aberrations presented to the user.

[0096] The user interface 1860 may also allow the user to specify, independently of any analysis or plan determined by the controller 1870, a treatment to be provided by the system 1800 to one or more corneal aberrations. This may include inputs from the user defining the treatment, such as one or more corneal locations or areas to receive laser light, the vacuum pressure for each of the one or more passages 1822 to be developed by the vacuum regulator 1840, one or more laser light parameters such as beam shape, pulse width, pulse frequency, pulse energy, pulse fluence, laser wavelength, etc.), or an input directing the controller 1870 to initiate a treatment plan input by the user for treating one or more corneal aberrations. User interface 1860 also displays various status indicators and data to the user associated with the system and / or a treatment session, such as the vacuum pressure actually present in each passage, flow rate of oxygen, pulse treatment parameters, and power supply status.

[0097] In one aspect, the invention comprises a method of treating glaucoma using a system such as ophthalmological system 10, 100, or 1800 as described above. The system may in some embodiments comprise a simplified system without an oxygen source or light source, and comprising 1 ) a molding lens such as lens 14 or lens 1802 having a first surface such as surface 38, adapted to contact a corneal surface, and a lens periphery, and 2) a lens housing such as lensing housing 1802 surrounding at least a portion of the lens periphery, and having a plurality of passages such as passages 1822 with a first end opening proximate to the first surface of the lens and a second end adapted to be coupled to at least one vacuum source.

[0098] The glaucoma treatment method includes contacting the first surface of the lens to the corneal surface, and coupling the passages of the lens housing to at least one vacuum source to maintain contact between the first surface and the corneal surface for a treatment period, decoupling the passages / channels from the at least one vacuumsource, and removing the first surface from contact with the corneal surface. The treatment period may comprise a period within a of range one minute to one hour, and more preferably within a range of 1 -30 minutes.

[0099] In one embodiment a total treatment time within a range of 5-20 minutes may be provided in 2-5 treatment cycles ranging from 1-10 minutes of treatment time followed by 15 seconds - 2 minutes of time in which no vacuum is applied to the corneal surface. In one embodiment, the vacuum pressure may comprise a pressure within the range of 5- 500 torr, more preferably a pressure within the range of 25-100 torr.

[0100] Figure 21 shows changes in intraoperative pressure (IOP) following treatment for keratoconus using vacuum-assisted cross-linking from the time of treatment. The data summarizes, with mean and standard error bars, the intraoperative pressure for twenty- one patients treated by aspirating the cornea into a molding lens having six passages using a vacuum pressure of about 43.5 torr in each passage, with exposure to UV light at 370 nm with a fluence of about 9mW / cm2 for 3 minutes. The vacuum was released and oxygen was provided to the corneal surface for 30 seconds. The process was repeated once, followed by a final UV exposure for 4 minutes, with 30 seconds oxygen exposure, totaling ten (10) minutes of cross-linking exposure.

[0101] As shown in Figure 21 , the mean IOP at the time of treatment was 10.62 D, which declined to a low of 8.76 D at three months post-treatment. At six months post-treatment, the mean IOP rose to 11 .90, but fell again to 10.00 at 12 months post-treatment. Without being bound by theory, it is believed that the increase in IOP between 3 and 6 months is related to the healing of the cornea following the cross-linking procedure. The data in Figure 21 demonstrate that an unexpected side effect of vacuum -assisted cross-linking therapy is reduced IOP for at least three months. Without being bound by theory, it is believed that suction of the cornea into the lens mold increases the eye volume, facilitating the movement of plaque out of the Schlemm Canal and at least temporarily restoring its ability to regulate IOP.

[0102] In one embodiment, the invention is a method of treating glaucoma using a system comprising 1 ) a lens having (A) a first surface adapted to contact a corneal surface and (B) a lens periphery, and 2) a lens housing surrounding at least a portion of the lens periphery and having a plurality of passages therein, each having a first end with anopening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to at least one vacuum source, the method comprising: a) contacting the first surface of the lens to the corneal surface; b) coupling each of the plurality of passages to the at least one vacuum source to maintain contact between the first surface and the corneal surface for a defined treatment period; c) decoupling each of the plurality of passages from the at least one vacuum source; and d) removing the first surface of the lens from contact with the corneal surface.

[0103] The defined treatment period of the method of treating glaucoma comprises a treatment period within a range of 1 minute to 1 hour, or a period with a range of 1 minute to 30 minutes.

[0104] In one embodiment, the defined treatment period of the glaucoma treatment method is a time period within a range of 1 -5 minutes, and the steps of decoupling the changes from the vacuum source and removing the first surface of the lens from contact with the corneal surface comprise a time period ranging from 15 sec to 5 minutes, followed by repeating steps (a) - (d) from 1 -5 times.

[0105] In one embodiment, the method of treating glaucoma further comprises: e) repeating steps (a)-(d) one or more times after a time period ranging from 2 months to 6 months.

[0106] In one embodiment, the system described above for use in the method of treating glaucoma further comprises 3) a vacuum regulator adapted to allow a user to individually control the vacuum pressure in each of the plurality of passages.

[0107] In one embodiment, coupling each of the plurality of passages to the at least one vacuum source comprises individually controlling the vacuum pressure in each of the plurality of passages to a user-selected vacuum pressure to provide a user-defined vacuum pressure profile around a periphery of the cornea.

[0108] The particular embodiments disclosed above are illustrative only, as the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Embodiments of the present invention disclosed and claimed herein may be made and executed withoutundue experimentation with the benefit of the present disclosure. While the invention has been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to systems, apparatus, and methods described herein without departing from the concept, spirit, and scope of the invention. Examples are all intended to be non-limiting. It is therefore evident that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention, which are limited only by the scope of the claims.

Claims

CLAIMSWhat is claimed is:1 . A system for cross-linking corneal tissue comprising: a) a lens (14, 1802) adapted to transmit light at one or more wavelengths and having a first surface (38) adapted to contact and mold a corneal surface, a lens body (15) having no apertures therein, and a lens periphery (37); b) a lens housing (32, 1820) surrounding the lens periphery and comprising an inner surface (35) adapted to engage at least a portion of the lens periphery, the lens housing having a plurality of passages (34, 1822) therein each comprising a first end having an opening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to 1 ) at least one vacuum source and 2) an oxygen source; and c) a light source (22, 1830) adapted to generate and transmit light having one or more desired wavelength through the lens body (15) and into corneal tissue; wherein the lens (14, 1802) is adapted to maintain contact between the first surface and the corneal surface when one or more of the plurality of passages (34, 1822) is fluidly coupled to the at least one vacuum source, and wherein one or more of the plurality of passages (34, 1822) is adapted to provide oxygen to at least a portion of the corneal surface when fluidly coupled to the oxygen source.

2. The system of claim 1 , wherein the lens housing (32, 1820) comprises a portion of a housing body (17, 1826) for housing the lens and the light source, the housing body comprising an internal chamber (40, 1828) adapted to allow light to pass from the light source through the internal chamber (40, 1826) and lens body (15) into corneal tissue, and wherein the second end of each of the plurality of passages (34, 1822) comprises an opening in fluid communication with the internal chamber, the housing body further comprising at least one connector adapted for coupling the internal chamber and the plurality of passages (34, 1822) to the at least one vacuum source and the oxygen source.

3. The system of claim 1 , further comprising a mask adapted to prevent light from the light source from reaching at least a portion of the cornea, wherein the mask comprisesone of a portion of the lens (14.1 , 14.2, 14.3) and a mask element (64) adapted to be positioned between the light source (22, 1830) and the lens (14, 1802).

4. The system of claim 1 , further comprising: d) a vacuum regulator (1840) adapted to control the vacuum pressure in at least one of the plurality of passages (1822) to a vacuum pressure different from the vacuum pressure in at least one other of the plurality of passages (1822).

5. The system of claim 4, wherein the vacuum regulator (1840) is adapted to allow the user to control the vacuum pressure in each of the plurality of passages (1822) to two or more different vacuum pressures.

6. The system of claim 4, wherein the vacuum regulator (1840) is further adapted to couple each passage of the plurality of passages (1822) to a user-selected one of the at least one vacuum source and the oxygen source.

7. The system of claim 4, further comprising: e) an imaging system (1850) adapted to capture one or more images of the corneal surface; and f) a controller (1870) comprising one or more processors to process the one or more images and to perform at least one action selected from:1 ) identifying the location of one or more aberrations on the corneal surface;2) classify the one or more aberrations on the corneal surface as a type of corneal aberration;3) create a corneal map identifying at least one of the location and type of the one or more corneal aberrations; and4) determine one or more treatment plan for each of the one or more corneal aberrations.

8. The system of claim 7, further comprising:g) a user interface (1860) adapted to present to a user an image of the cornea and at least one of:1 ) the location of each of the one or more corneal aberrations;2) the type of corneal aberration for each of the one or more corneal aberrations; and3) one or more treatment plan for each of the one or more corneal aberrations.

9. The system of claim 8, wherein the user interface (1860) is further adapted to receive one or more user inputs selected from:1 ) an input accepting the location of one or more corneal aberrations presented to the user;2) an input rejecting the location of one or more corneal aberrations presented to the user;3) an input accepting the type of corneal aberration of one or more corneal aberrations presented to the user;4) an input rejecting the type of corneal aberration of one or more corneal aberrations presented to the user;5) an input of a correction of the type of corneal aberration of one or more corneal aberrations presented to the user;6) an input accepting a treating plan for one or more corneal aberrations presented to the user;7) an input directing the controller to perform a treatment plan of one or more corneal aberrations presented to the user;8) an input specifying a treatment to be provided for one or more corneal aberrations presented to the user; and9) an input directing the controller to initiate a treatment plan input by the user for one or more corneal aberrations presented to the user.

10. The system of claim 9, wherein the light source (1830) comprises one or more of an incoherent UV light source and a laser light source, and wherein the controller (1870) is adapted to control the light output of the one or more of an incoherent UV light source and a laser light source.11 . A method of cross-linking corneal tissue using the system of claim 1 , comprising: a) applying a photosensitive substance to the cornea; b) contacting the first surface (38) of the lens (14, 1802) to the corneal surface; c) fluidly coupling each of the plurality of passages (34, 1822) to the at least one vacuum source to induce a vacuum pressure in the passages (34, 1822) to maintain contact between the cornea and the first surface (38); d) using the light source (22, 1830) to generate and transmit light through the lens body (15) into corneal tissue for a first time period to induce cross-linking of corneal tissue; e) terminating the induced vacuum pressure in each of the plurality of passages (34, 1822) by uncoupling the passages (34, 1822) from the at least one vacuum source; f) fluidly coupling each of the plurality of passages (34, 1822) to the oxygen source to provide a flow of oxygen to at least a portion of the corneal surface through at least one of the plurality of passages (34, 1822) for a second time period to promote cross-linking of corneal tissue; and g) uncoupling each of the plurality of passages (34) from the oxygen source.

12. The method of claim 11 , further comprising: h) repeating steps (b) - (g) one or more times.

13. The method of claim 12, wherein the photosensitive agent is riboflavin.

14. The method of claim 11 , wherein the first time period is a time period ranging from 30 seconds to 10 minutes, and the second time period is a time period ranging from 3 seconds to 5 minutes.

15. A system 1800 for cross-linking corneal tissue of a patient comprising: a) a lens (1822) adapted to transmit light at one or more wavelengths and having a first surface (38) adapted to contact and mold a corneal surface, a lens body (15) having no apertures therein, and a lens periphery (37);b) a lens housing (1820) surrounding at least a portion of the lens periphery (37) and comprising:1 ) an inner surface adapted to contact at least a portion of the lens periphery (37);2) a plurality of passages (1822), each comprising a first end having an opening proximate to the first surface of the lens and a second end adapted to be fluidly coupled to 1 ) at least one vacuum source and 2) an oxygen source, wherein the lens (1822) is adapted to maintain contact between the first surface (38) of the lens and the corneal surface when one or more of the plurality of passages (1822) is fluidly coupled to the at least one vacuum source, and wherein one or more of the plurality of passages (1822) is adapted to provide oxygen to at least a portion of the corneal surface when fluidly coupled to the at least one oxygen source; c) a light source (1830) comprising one or more of an incoherent UV light source and a laser light source, the light source (1830) adapted to generate and transmit light having one or more desired wavelength through the lens body (15) and into corneal tissue; d) an imaging system (1850) adapted to capture one or more images of the corneal surface; and e) a controller (1870) adapted to process the one or more images and to perform at least one action selected from:1 ) identifying the location of one or more aberrations on the corneal surface;2) classify the one or more aberrations on the corneal surface as a type of corneal aberration;3) create a corneal map identifying at least one of the location and type of the one or more corneal aberrations; and4) determine one or more treatment plans for each of the one or more corneal aberrations.

16. The system of claim 15, wherein: the lens housing (32, 1820) comprises a portion of a housing body (17, 1826) for housing the lens (14, 1802) and the light source (22, 1830), the housing body (17, 1826) comprising an internal chamber (40, 1828) adapted to allowing light to pass from the light source (1830) to the chamber (40, 1828), andthe second end of each of the plurality of passages comprises an opening in fluid communication with the internal chamber (40, 1828), the housing body (17, 1826) further comprising at least one connector adapted for coupling the internal chamber (40, 1828) and the plurality of passages (34, 1822) to the at least one vacuum source and the oxygen source.

17. The system of claim 15, further comprising: f) a vacuum regulator (1840) adapted to regulate the vacuum pressure in one or more of the plurality of passages (1822) to a user-selected pressure different from the vacuum pressure in at least one other of plurality of passages (1822).

18. The system of claim 17, wherein the vacuum regulator (1840) is adapted to allow the user to individually control the vacuum pressure in each of the plurality of passages (1822) to a user-selected vacuum pressure.

19. The system of claim 15, further comprising: f) a user interface (1860) adapted to present to a user an image of the cornea and at least one of:1 ) the location of one or more corneal aberrations;2) the type of corneal aberration for each of the one or more corneal aberrations;3) one or more treatment plans for each of the one or more corneal aberrations.

20. The system of claim 19, wherein the user interface (1860) is further adapted to receive one or more user inputs selected from:1 ) an input accepting the location of one or more corneal aberrations presented to the user;2) an input rejecting the location of one or more corneal aberrations presented to the user;3) an input accepting the type of corneal aberration of one or more corneal aberrations presented to the user;4) an input rejecting the type of corneal aberration of one or more corneal aberrations presented to the user;5) an input of a correction of the type of corneal aberration of one or more corneal aberrations presented to the user;6) an input accepting a treating plan for one or more corneal aberrations presented to the user;7) an input directing the controller to perform a treatment plan for one or more corneal aberrations presented to the user;8) an input specifying a treatment to be provided for one or more corneal aberrations presented to the user; and9) an input directing the controller to initiate a treatment plan input by the user for one or more corneal aberrations presented to the user.

21. The system of claim 15, wherein the light source (1830) is a laser light source, the system further comprising: f) a user interface (1860) adapted to receive a user input defining a treatment to be provided to the corneal surface, user input comprising at least one of:1 ) one or more locations on the corneal surface to receive laser light;2) one or more laser light parameters selected from a beam shape, a pulse width, a pulse frequency, a pulse energy, a pulse fluence, and a laser wavelength for laser light pulses to be delivered to corneal tissue.

22. The system of claim 15, wherein the imaging system (1850) comprises a video camera to capture a video image of the cornea during at least one of the treatment process and a pretreatment period of contact between the first surface and the corneal surface; and wherein the controller (1870) is further adapted to process at least one of still image and a video during a period of contact between the first surface (38) of the lens and the corneal surface, to determine whether or not an air bubble is present between the first surface (38) and the corneal surface, and to provide an indication to a user of the presence or absence of an air bubble.

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