Ablation systems and methods for treating presbyopia

The ophthalmic surgery system addresses the inadequacies of existing presbyopia treatments by precisely ablating the cornea to create a protrusion for near vision and correct emmetropia, improving visual acuity through a customized ablation profile.

JP7821799B2Active Publication Date: 2026-02-27ALCON INC
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Patent Information

Application Number
JP2023536368
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-12-19
Filing Date
2021-12-13
Publication Date
2026-02-27
Estimated Expiration
2041-12-13

AI Technical Summary

Technical Problem

Current treatments for presbyopia, such as lenses, implants, and multifocal refractive surgery, fail to provide satisfactory results in certain situations.

Method used

An ophthalmic surgery system using a controllable component with a light source and scanner to ablate the cornea based on a designed ablation profile, creating a protrusion in the central region for near vision and correcting emmetropia in the peripheral region.

Benefits of technology

The system effectively provides near vision correction and emmetropia by precisely ablating the cornea according to a customized ablation profile, enhancing visual acuity for individuals with presbyopia.

✦ Generated by Eureka AI based on patent content.

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Abstract

According to certain embodiments, an ophthalmic surgery system for treating presbyopia includes a controllable component and a computer. The controllable component includes a light source that generates a light beam and a scanner that guides the focus of the light beam. The computer identifies an ablation profile to remove tissue from central and peripheral regions of the cornea of ​​a first eye of a pair of eyes. The ablation profile is designed to remove tissue from the central region to create a protrusion and provide near vision, and to remove tissue from the peripheral region to correct emmetropia.
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Description

[Technical Field]

[0001] The present disclosure relates generally to ophthalmic surgical systems and methods, and more particularly to ablation systems and methods for treating presbyopia. [Background technology]

[0002] The eye's lens changes shape to focus light onto the retina so that we can see objects both near and far. In young people, the lens is soft and flexible, easily changing shape. Presbyopia typically occurs after the age of 40, when the lens becomes stiffer and is unable to change shape as easily. This causes the eye to focus light behind the retina when viewing nearby objects, reducing near vision.

[0003] There are approximately 1.7 billion people with presbyopia worldwide, and approximately one-third of the population of the United States is presbyopic. Treatments for presbyopia include lenses (e.g., eyeglasses and contact lenses), implants (e.g., intraocular lenses (IOLs), scleral implants, and corneal inlays), and multifocal refractive surgery. However, current treatments fail to provide satisfactory results in certain situations. Summary of the Invention [Means for solving the problem]

[0004] In one specific embodiment, an ophthalmic surgery system for treating presbyopia includes a controllable component and a computer. The controllable component includes a light source that generates a light beam and a scanner that guides the focus of the light beam. The computer identifies an ablation profile to remove tissue from central and peripheral regions of the cornea of ​​a first eye of a pair of eyes. The ablation profile is designed to remove tissue from the central region to create a protrusion and provide near vision, and to remove tissue from the peripheral region to correct emmetropia. The computer commands one or more of the controllable components to ablate the cornea of ​​the first eye according to the ablation profile.

[0005] Implementations may include none, one, some, or all of the following features.

[0006] The protrusions may have any suitable dimensions, for example, the protrusions may be spherical with a diameter of 0.5 to 4 millimeters and / or a height of 3 to 50 micrometers, such as 20 to 40 micrometers.

[0007] If the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea in the inner portion of the peripheral region than in the outer portion of the peripheral region.

[0008] If the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea in the outer portion of the peripheral region than in the inner portion of the peripheral region.

[0009] If a first eye of the pair is non-dominant and a second eye of the pair is dominant, the computer may identify a second ablation profile designed to correct the second eye to emmetropia and instruct one or more controllable components to ablate the cornea of ​​the second eye according to the second ablation profile.

[0010] The computer may generate a focal spot pattern corresponding to the ablation profile and align the focal spot pattern with the visual axis to ablate the cornea.

[0011] The computer may generate a focal spot pattern corresponding to the ablation profile, and the points of the focal spot pattern may be designated to be aligned with the visual axis of the eye, and the computer may identify the visual axis of the eye and align the points of the focal spot pattern with the visual axis to ablate the cornea.

[0012] In certain embodiments, a method for treating presbyopia includes generating a light beam with a light source of multiple controllable components; directing a focus of the light beam with a scanner of multiple controllable components; identifying, by a computer, an ablation profile to remove tissue from central and peripheral regions of the cornea of ​​a first eye of a pair of eyes, wherein the ablation profile is designed to remove tissue from the central region to create a bulge and provide near vision, and the ablation profile is designed to remove tissue from the peripheral region to correct emmetropia; and instructing, by the computer, one or more of the controllable components to ablate the cornea of ​​the first eye according to the ablation profile.

[0013] Implementations may include none, one, some, or all of the following features.

[0014] The protrusions may have any suitable dimensions, for example, the protrusions may be spherical with a diameter of 0.5 to 4 millimeters and / or a height of 3 to 50 micrometers, such as 20 to 40 micrometers.

[0015] If the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea in the inner portion of the peripheral region than in the outer portion of the peripheral region.

[0016] If the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea in the outer portion of the peripheral region than in the inner portion of the peripheral region.

[0017] If a first eye of the pair is non-dominant and a second eye of the pair is dominant, the method further includes identifying, by the computer, a second ablation profile designed to correct the second eye to emmetropia, and instructing, by the computer, one or more controllable components to ablate the cornea of ​​the second eye according to the second ablation profile.

[0018] The method further includes generating, by the computer, a focal spot pattern corresponding to the ablation profile, and aligning, by the computer, the focal spot pattern with the visual axis to ablate the cornea.

[0019] The method further includes generating, by the computer, a focal spot pattern corresponding to the ablation profile, where points of the focal spot pattern are designated to be aligned with a visual axis of the eye; identifying, by the computer, the visual axis of the eye; and ablating, by the computer, the cornea with the points of the focal spot pattern aligning with the visual axis.

[0020] In certain embodiments, an ophthalmic surgery system for treating presbyopia includes a controllable component and a computer. The controllable component includes a light source that generates a light beam and a scanner that guides the focus of the light beam. The computer identifies an ablation profile to remove tissue from the central and peripheral regions of the cornea of ​​a first eye of a pair of eyes. The first eye of the pair is non-dominant, and the second eye of the pair is dominant. The ablation profile is designed to remove tissue from the central region and create a protrusion to provide near vision. The protrusion is spherical with a diameter of 0.5 to 4 millimeters and a height of 3 to 50 micrometers. The ablation profile is designed to remove tissue from the peripheral region to correct emmetropia. If the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea in the inner peripheral region than in the outer peripheral region. If the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea in the outer peripheral region than in the inner peripheral region. The computer generates a focal spot pattern corresponding to the ablation profile, points of the focal spot pattern are designated to be aligned with the visual axis of the eye, identifies the visual axis of the eye, aligns the points of the focal spot pattern with the visual axis and ablates the cornea, and commands one or more controllable components to ablate the cornea of ​​the first eye according to the ablation profile. The computer identifies a second ablation profile designed to correct the second eye to emmetropia, and commands one or more controllable components to ablate the cornea of ​​the second eye according to the second ablation profile. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 illustrates an example of an ophthalmic laser ablation system for ablating corneal tissue of an eye to treat presbyopia, according to certain embodiments. [Figure 2]FIG. 2 shows an ablation diagram in which the system of FIG. 1 may be used to treat myopic presbyopia. [Figure 3] FIG. 3 shows an ablation diagram in which the system of FIG. 1 may be used to treat hyperopic presbyopia. [Figure 4] FIG. 4 illustrates a method for ablating the cornea of ​​an eye that may be performed by the system of FIG. 1, according to certain embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0022]

[0013] Referring now to the description and drawings, exemplary embodiments of the disclosed apparatus, systems, and methods are shown in detail. The description and drawings are not intended to be exhaustive or to limit the scope of the claims to the specific embodiments shown in the drawings and disclosed in the description. While the drawings represent possible embodiments, the drawings are not necessarily to scale, and certain features may be simplified, exaggerated, omitted, or partially separated to better illustrate the embodiments.

[0023] In certain embodiments, an ophthalmic surgery system ablates a first eye of a pair to treat presbyopia. The system ablates tissue from the central and peripheral regions of the cornea of ​​the eye. The remaining tissue has a protrusion in the central region. The resulting central region of the cornea provides near vision, and the peripheral region provides distance vision. In certain embodiments, the first eye is non-dominant. The system may ablate the second eye to correct emmetropia in the second eye.

[0024] FIG. 1 illustrates an example of an ophthalmic laser ablation system 10 for ablating corneal tissue of an eye 22 to treat presbyopia, according to certain embodiments. In the illustrated example, system 10 includes a laser device 15, a camera 38, and a control computer 30, coupled as shown. Laser device 15 includes controllable components, such as a light source (e.g., laser source 12), a scanner 16, one or more optical elements 17, and / or a focusing objective lens 18, coupled as shown. Computer 30 includes logic 36, a memory 32 (storing a computer program 34), and a display 37, coupled as shown. For ease of explanation, an xyz coordinate system is used as follows: the z direction is defined by the direction of propagation of the laser beam, and the xy plane is perpendicular to the direction of propagation. Other suitable xyz coordinate systems may also be used.

[0025] In overview, laser source 12 generates a laser beam, and scanner 16 directs the focus of the laser beam to ablate tissue from eye 22. Computer 30 identifies an ablation profile to remove tissue from the central and peripheral regions of the cornea. The ablation profile is designed as follows: remove tissue from the central region to create a protrusion to provide near vision, and remove tissue from the peripheral region to correct emmetropia. Computer 30 commands one or more controllable components of system 10 to ablate the cornea according to the ablation profile.

[0026] Looking at the components of the system 10, a light source generates a light beam that ablates tissue in the eye 22 according to a focal spot pattern. The light beam may have a wavelength of, for example, less than 300 nm. In the illustrated embodiment, the light source is a laser source 12 that generates a laser beam that ablates tissue in the eye 22 according to a laser focal spot pattern. The laser source 12 may be an excimer laser, a solid-state laser, or other suitable laser. The focal spot pattern may define x and y coordinates for locations to which pulses of laser radiation should be directed. The focal spot pattern may be determined from an ablation profile, which indicates the volume of tissue to be removed at a specific x, y location on the cornea. Considering the volume of tissue that one pulse ablates, the number of pulses to be directed to a given x, y location can be calculated from the tissue volume defined by the ablation profile.

[0027] The scanner 16 steers the focal point of the laser beam laterally, meaning in the direction perpendicular to the beam propagation direction, i.e., the x and y directions. The scanner 16 may steer the laser beam laterally in any suitable manner. For example, the scanner 16 may include a pair of galvanometrically actuated scanner mirrors that can tilt about mutually perpendicular axes. As another example, the scanner 16 may include an electro-optic crystal that can electro-optically steer the laser beam.

[0028] One (or more) optical elements 17 direct the laser beam towards a focusing objective lens 18. The optical element 17 can act on (e.g., transmit, reflect, refract, diffract, collimate, condition, shape, focus, modulate, and / or act on) the laser beam. Examples of optical elements include lenses, prisms, mirrors, diffractive optical elements (DOEs), holographic optical elements (HOEs), and spatial light modulators (SLMs). In this example, the optical element 17 is a mirror. The focusing objective lens 18 focuses the focus of the laser beam towards a point at the eye 22. In this example, the focusing objective lens 18 is an objective lens, for example an f-theta objective lens.

[0029] The camera 38 records images of the eye 22. Examples of the camera 38 include a video, optical coherence tomography, or eye-tracking camera. The camera 38 outputs image data representing the recorded images of the eye 22 to the computer 30. The computer 30 may perform image processing on the image data to monitor the ablation of the eye 22.

[0030] The computer 30 controls the components of the system 10 according to a computer program 34. For example, the computer 30 controls the components (e.g., the laser source 12, the scanner 16, the optical element 17, and / or the focusing objective lens 18) to focus the laser beam of the laser device 15 on the eye 22 to ablate at least a portion of the eye 22 according to the ablation profile. In certain embodiments, the computer 30 generates a focal spot pattern corresponding to the ablation profile. The computer 30 may generate the focal spot pattern by identifying focal points corresponding to the tissue to be ablated according to the ablation profile. The ablation profile indicates the volume of tissue to be ablated at a specific x, y location on the cornea. Considering the volume of tissue that one pulse ablates, the number of pulses to be directed to a certain x, y location can be calculated from the tissue volume defined by the ablation profile.

[0031] In one specific embodiment, computer 30 identifies an ablation profile to remove tissue from the central and peripheral regions of the cornea. The ablation profile is designed as follows: In another embodiment, where tissue is removed from the central region to create a protrusion to provide near vision and tissue is removed from the peripheral region to correct emmetropia, computer 30 may identify the ablation profile by retrieving the profile from memory 32, where the ablation profile has been identified as described above.

[0032] In certain embodiments, computer 30 aligns the focal spot pattern with an axis of the eye (e.g., the optical axis or visual axis) to ablate the cornea. In certain cases, a particular point of the focal spot pattern is designated to be aligned with the axis. Computer 30 may receive measurements or coordinates (e.g., x- and y-coordinates) identifying the location of the axis and then align the point with the axis by aligning the point on the axis. In certain embodiments, computer 30 may identify the x- and y-coordinates of the visual axis according to the methods described in U.S. Patent Application Nos. 63 / 010293 (filed April 15, 2020) and 63 / 033327 (filed June 2, 2020). Computer 30 may then align the particular point with the x- and y-position of the visual axis.

[0033] In certain embodiments, computer 30 treats a pair of eyes. A first eye (e.g., a non-dominant eye) is treated according to an ablation profile having a protrusion for near vision correction, and a second eye (e.g., a dominant eye) is treated with a profile that corrects emmetropia. In embodiments, the dominant eye or the non-dominant eye may be the first eye or the second eye.

[0034] 2 and 3 show examples of ablation figures 50 (50a, 50b) that may be used by the system 10 of FIG. 1 to treat myopic presbyopia and hyperopic presbyopia, respectively. The ablation figures 50 may be used for any suitable refractive procedure that reshapes the cornea, such as laser in situ keratomileusis (LASIK) or excimer laser photorefractive keratomileusis (PRK). In the example, the ablation figures 50 (50a, 50b) are used for LASIK. In the example, the ablation figures 50 show the epithelium 51 and the cornea 52. The cornea 52 has a central region 55 and a peripheral region 57. The central region 55 is generally centered on the axis of the eye (e.g., the visual axis or optical axis), and the peripheral region 57 extends from the central region 55 toward the edge of the cornea.

[0035] Flap incision 53 represents the incision made to create the LASIK flap. Removed tissue 62 (62a, 62b) represents the tissue ablated according to the ablation profile, and remaining tissue 64 (64a, 64b) represents the tissue remaining after ablation. Ablation surface 60 (60a, 60b) represents the stromal surface remaining after tissue has been ablated according to the ablation profile.

[0036] Ablation surfaces 60 in central region 55 and peripheral region 57 may have any suitable size and / or shape, and computer 30 may determine the dimensions of ablation surfaces 60 in any suitable manner. In certain embodiments, computer 30 may receive information describing the refractive correction and determine the dimensions from the information.

[0037] In certain embodiments, computer 30 may calculate the dimensions of peripheral region 57 from information describing the distance vision correction. In certain examples, removal of 14 to 18 micrometers of thickness corresponds to approximately 1 diopter of correction. The location of the thickness (e.g., central or peripheral) depends on whether the correction is for myopia or hyperopia. Generally, myopia treatments remove thicker portions of the cornea in the inner portion than in the outer portion of the peripheral region (e.g., ablation diagram 50a in FIG. 2 ), and hyperopia treatments remove thicker portions of the cornea in the outer portion than in the inner portion of the peripheral region (e.g., ablation diagram 50b in FIG. 3 ). In certain embodiments, ablation of peripheral region 57 may be designed to correct myopia or hyperopia to emmetropia. Emmetropia is a vision condition in which distant objects at infinity are sharply focused by the eye's lens in a neutral or relaxed position. Emmetropia may range from +1 to −1 diopters.

[0038] In embodiments, computer 30 may calculate the dimensions of protrusions 58 in central region 55 from information describing the near vision correction. In certain examples, protrusions 58 have a diameter of 0.5 to 4 millimeters (e.g., 0.5 to 1, 1 to 2, 2 to 3, and / or 3 to 4 millimeters) and a center of protrusion 58 has a thickness of 3 to 50 micrometers (e.g., 3 to 10, 10 to 20, 20 to 25, 25 to 30, 30 to 35, 35 to 40, and / or 40 to 50 micrometers). Generally, protrusions 58 with a greater central thickness provide greater presbyopia correction. In one example, protrusions 58 with a spherical shape, a 2 millimeter diameter, and a 30 micrometer central thickness add 2.5 to 4.0 diopters of power.

[0039]

[0023] Figure 4 illustrates a method for ablating the cornea of ​​an eye that may be performed by system 10 of Figure 1, according to certain embodiments. The method begins at step 110, where computer 30 receives surgical input describing a surgical procedure. The surgical input may include information that computer 30 can use to look up or calculate an ablation profile describing the tissue to be removed. The surgical input may describe the x, y location of the patient's eye, for example, the spherical error, cylindrical error, axis of the cylindrical error, addition power (spherical error for reading distance correction), and / or visual axis.

[0040] Computer 30 identifies an ablation profile from the surgical input in step 112. The ablation profile may be stored or may need to be calculated in step 113. If an ablation profile is stored in step 113, the method proceeds to step 114, where computer 30 searches for and retrieves the stored ablation profile. The method then proceeds to step 126, where computer 30 begins ablation of the cornea.

[0041] If there is no ablation profile stored in step 113, the method proceeds to steps 116-122, where computer 30 calculates an ablation profile. Computer 30 identifies an ablation profile for the peripheral region in step 116. In certain cases, the peripheral region may be designed to treat myopia, and the ablation profile may remove thicker portions of material in the peripheral region toward the center. In other cases, the peripheral region may be designed to treat hyperopia, and the ablation profile may remove thicker portions of material in the peripheral region toward the periphery. Computer 30 identifies an ablation profile for the central region in step 122. The protrusions in the central region may have any suitable shape and / or size. In certain embodiments, the diameter of the protrusions is 0.5 to 4 millimeters, and the centers of the protrusions have a thickness of 3 to 50 micrometers.

[0042] In step 126, computer 30 aligns the focal spot pattern corresponding to the ablation profile with an axis of the eye (e.g., the visual axis or optical axis). In certain embodiments, computer 30 may identify the focal spot pattern corresponding to the ablation profile. Computer 30 may receive measurements or coordinates identifying the location of the axis and then align the focal spot pattern with the axis. In step 128, computer 30 instructs the controllable components to ablate the cornea according to the ablation profile. The method then ends.

[0043] Components (such as a control computer) of the systems and devices disclosed herein may include interfaces, logic, and / or memory, any of which may include computer hardware and / or software. An interface can receive input to and / or send output from a component and is typically used to exchange information between, for example, software, hardware, peripherals, a user, and combinations thereof. A user interface (e.g., a graphical user interface (GUI)) is one type of interface that may be used by a user to interact with a computer. Examples of user interfaces include a display, a touchscreen, a keyboard, a mouse, a gesture sensor, a microphone, and a speaker.

[0044] Logic can perform the operations of a component. Logic may include one or more electronic devices that process data, e.g., execute instructions to generate output from input. Examples of such electronic devices include computers, processors, microprocessors (e.g., central processing units (CPUs)), and computer chips. Logic may include computer software that encodes instructions that can be executed by the electronic device to perform operations. Examples of computer software include computer programs, applications, and operating systems.

[0045] A memory may store information and may comprise a tangible, computer-readable, and / or computer-executable storage medium. Examples of memory include computer memory (e.g., random access memory (RAM) or read-only memory (ROM)), mass storage media (e.g., hard disks), removable storage media (e.g., compact discs (CDs) or digital video or versatile discs (DVDs)), databases, network storage (e.g., servers), and / or other computer-readable media. Certain embodiments may be directed to memory encoded with computer software.

[0046] While the present disclosure has been described with respect to particular embodiments, modifications of the embodiments (e.g., alterations, substitutions, additions, omissions, and / or other modifications) will be apparent to those skilled in the art. Accordingly, modifications may be made to the embodiments without departing from the scope of the invention. For example, modifications may be made to the systems and devices disclosed herein. As will be apparent to those skilled in the art, components of the systems and devices may be integrated or separated, or operations of the systems and devices may be performed by more, fewer, or other components. As another example, modifications may be made to the methods disclosed herein. As will be apparent to those skilled in the art, the methods may include more, fewer, or other steps, and the steps may be performed in any suitable order.

[0047] To assist the Patent Office and readers in interpreting the claims, applicants note that no claim or claim element is intended to invoke 35 U.S.C. §112(f) unless the words "means for" or "step for" are expressly used in a particular claim. The use of other terms in the claims (e.g., "mechanism," "module," "device," "unit," "component," "element," "member," "apparatus," "machine," "system," "processor," or "controller") is understood by applicants to refer to structures known to those of ordinary skill in the relevant art and is not intended to be subject to 35 U.S.C. §112(f).

Claims

1. 1. An ophthalmic surgical system for treating presbyopia, comprising: A plurality of controllable components, a light source configured to generate a light beam; a scanner configured to direct a focus of the light beam; a controllable component comprising: A computer, identifying an ablation profile to remove tissue from central and peripheral regions of the cornea of ​​a first eye of the pair, the ablation profile designed to remove tissue from the central region and create a protrusion to provide near vision, the protrusion in the central region of the cornea having a diameter of 0.5 to 4 millimeters and a height of 3 to 50 micrometers, and the ablation profile designed to remove tissue from the peripheral region to correct emmetropia; instructing one or more of the controllable components to ablate the cornea of ​​the first eye according to the ablation profile; identifying a second ablation profile designed to correct emmetropia in a second eye of the pair; commanding one or more of the controllable components to ablate a second central region and a second peripheral region of the cornea of ​​the second eye according to the second ablation profile to correct emmetropia in the second eye; a computer configured to: An ophthalmic surgery system comprising:

2. The ophthalmic surgical system of claim 1 , wherein the protrusion is spherical.

3. The ophthalmic surgical system of claim 1 , wherein the protrusions have a height of 20 to 40 micrometers.

4. 10. The ophthalmic surgical system of claim 1, wherein when the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea in an inner portion of the peripheral region than in an outer portion of the peripheral region.

5. 10. The ophthalmic surgical system of claim 1, wherein when the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea in an outer portion of the peripheral region than in an inner portion of the peripheral region.

6. The computer further comprises: generating a focal spot pattern corresponding to the ablation profile; ablating the cornea with the focal spot pattern aligned with the visual axis; The ophthalmic surgical system of claim 1 , configured to:

7. The computer further comprises: generating a focal spot pattern corresponding to the ablation profile, wherein points of the focal spot pattern are designated to be aligned with the visual axis of the eye; Identifying the visual axis of the eye; ablating the cornea by aligning the points of the focal spot pattern with the visual axis; The ophthalmic surgical system of claim 1 , configured to:

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