System and method for compensating for tilt of intraocular lens

Abstract

Disclosed herein are systems and methods for compensating for the tilt of an intraocular lens (IOL), and systems and methods for adjusting an IOL. For example, one method may include taking one or more optical coherence tomography (OCT) images of a subject's eye while the IOL is implanted in the subject's eye. The method may also include generating a fixation target so that the fixation target is visible to the subject's eye, and moving the fixation target until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system. The method may also include directing a laser beam generated by the laser of the ophthalmic system onto the IOL.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority of U.S. Patent Application No. 63 / 511306, filed on June 30, 2023, and incorporates by reference in its entirety the content thereof into this application.

[0002] This disclosure generally relates to the field of intraocular lenses, and more specifically, to systems and methods for compensating for the tilt of an intraocular lens (IOL) as part of an adjustment procedure for the IOL.

Background Art

[0003] Cataract is an abnormality of the eye of a subject that involves clouding of the normally clear lens. Cataracts develop as a result of aging, genetic factors, trauma, inflammation, metabolic diseases, or exposure to radiation. Age - related cataracts are the most common type of cataract. In the treatment of cataracts, the surgeon removes the natural lens matrix from the lens capsule of the subject and replaces it with an intraocular lens (IOL). Conventional IOLs provide one or more selected focal lengths that allow the subject to see far away. However, after cataract surgery, subjects with a conventional IOL inserted often need glasses or other corrective eyewear to perform certain activities, because the eye is unable to maintain a sharp image of an object or adjust (i.e., change its refractive power) to focus on an object as the distance changes.

[0004] With newer IOLs such as accommodative IOLs, the eye can regain at least some focusing ability. An accommodative IOL (AIOL) utilizes forces available within the eye to refocus the eye on a distant or near target by changing a portion of the optical system. In addition, it may be necessary to adjust the AIOL and non - adjustable IOLs after surgery or after insertion into the subject's eye. In some examples, the inserted IOL or AIOL can be adjusted using laser treatment.

[0005] However, IOLs or AIOLs may be positioned or oriented within the eye in a way that makes post-implantation adjustment difficult. Therefore, improved solutions that allow clinicians or other medical professionals to safely and accurately adjust AIOLs or IOLs postoperatively may be beneficial. Such solutions should also be designed with clinical considerations in mind. [Overview of the project] [Means for solving the problem]

[0006] Disclosed herein are systems and methods for compensating for the tilt of an intraocular lens (IOL), and systems and methods for adjusting an IOL. In some embodiments, a method for compensating for the tilt of an intraocular lens (IOL) using optical coherence tomography (OCT) guidance includes taking one or more OCT images of a subject's eye using an OCT imaging device such that the IOL can be inserted into the subject's eye; generating a fixation target so that the fixation target is visible to the subject's eye; and moving the fixation target until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system.

[0007] In some embodiments, the OCT imaging device can be communicatively coupled to an electronic display, and moving the fixation target further includes moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0008] In some embodiments, the method may further include determining the degree of tilt of the IOL and moving the fixation target based on the degree of tilt.

[0009] In some embodiments, the inclination angle of the IOL can be approximately 4.0 degrees to approximately 8.0 degrees.

[0010] In some embodiments, moving the fixation target may further include moving the fixation target in at least one of the following directions relative to the subject: inward, laterally, downward, and upward.

[0011] In some embodiments, the optical axis of the ophthalmic system may be the Z-axis of the focusing lens or focusing objective lens of the laser of the ophthalmic system, and moving the fixation target may further include moving the fixation target to a position that is not aligned with the Z-axis and in the axial direction.

[0012] In some embodiments, when the subject is in a supine position, the optical axis can be directed vertically.

[0013] In some embodiments, the fixation target can be the fixation light generated by the fixation light source.

[0014] In some embodiments, the fixation light can be a beam of light having wavelengths in the visible spectrum.

[0015] In some embodiments, the fixation light can be made movable in response to user input from the user of the ophthalmic system.

[0016] In some embodiments, the fixation light source can be configured to be automatically moved by the ophthalmic system.

[0017] In some embodiments, the fixation target can be displayed on a target display visible to the subject.

[0018] In some embodiments, the fixation target can be a computer-generated graphic.

[0019] In some embodiments, the OCT imaging device may be an integrated component of the ophthalmic system.

[0020] In some embodiments, a method of adjusting an intraocular lens (IOL) includes taking one or more OCT images of a subject's eye using an OCT imaging device, where the IOL is inserted into the subject's eye; generating a fixation target such that the fixation target is visible to the subject's eye; moving the fixation target until a cross-section of the IOL as shown in one or more of the OCT images displayed on an electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display; and adjusting the base power of the IOL by directing a laser beam generated by a laser of an ophthalmic system towards the IOL.

[0021] In some embodiments, the OCT imaging device can be communicatively coupled to an electronic display, and moving the fixation target further includes moving the fixation target until a cross-section of the IOL in the state shown in one or more of the OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0022] In some embodiments, the method further includes determining the degree of tilt of the IOL and moving the fixation target based on the degree of tilt.

[0023] In some embodiments, the degree of tilt of the IOL can be from about 4.0 degrees to about 8.0 degrees.

[0024] In some embodiments, moving the fixation target can further include moving the fixation target in at least one of an inward, lateral, downward, and upward direction with respect to the subject.

[0025] In some embodiments, the optical axis of the ophthalmic system can be the Z-axis of a condenser lens or condenser objective lens of a laser of the ophthalmic system, and moving the fixation target further includes moving the fixation target to a position not axially aligned with the Z-axis.

[0026] In some embodiments, when the subject is in a supine position, the optical axis can be directed in the vertical direction.

[0027] In some embodiments, the fixation target can be fixation light generated by a fixation light source.

[0028] In some embodiments, the fixation light can be a beam of light having wavelengths in the visible spectrum.

[0029] In some embodiments, the fixation light can be movable in response to user input by a user of the ophthalmic system.

[0030] In some embodiments, the fixation light source can be configured to be automatically moved by the ophthalmic system.

[0031] In some embodiments, the fixation target can be displayed on a visual target display visible to the subject.

[0032] In some embodiments, the fixation target can be computer-generated graphics.

[0033] In some embodiments, the OCT imaging device can be a built-in component of the ophthalmic system.

[0034] In some embodiments, the laser beam can be generated by a femtosecond laser.

[0035] In some embodiments, directing the laser beam at the IOL can further include directing the laser beam at one or more haptics of the IOL.

[0036] In some embodiments, the IOL can be an adjustable IOL.

[0037] In some embodiments, the IOL can be a non-adjustable fluid-adjustable IOL.

[0038] In certain embodiments, an ophthalmic system is disclosed. The ophthalmic system includes an OCT imaging device configured to generate one or more optical coherence tomography (OCT) images of a patient's eye in which an intraocular lens (IOL) is implanted, and a fixation target generator configured to generate a movable fixation target visible to the subject's eye, the fixation target being configured to move until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system.

[0039] In some embodiments, the OCT imaging device can be communicatively coupled to an electronic display, and moving the fixation target further includes moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0040] In some embodiments, the ophthalmic system further includes a laser configured to generate a laser beam and direct it towards an IOL to adjust the base power of the IOL.

[0041] In some embodiments, the optical axis of the ophthalmic system can be the Z-axis of the focusing lens or focusing objective lens of the laser in the ophthalmic system, and the fixation target is configured to be moved to a position that is not aligned with the Z-axis and axially.

[0042] In some embodiments, when the subject is in a supine position, the optical axis can be directed vertically.

[0043] In some embodiments, the laser beam can be generated by a femtosecond laser.

[0044] In some embodiments, the ophthalmic system may further include a control unit comprising one or more processors coupled to memory, which can be programmed to execute instructions stored in memory to determine the degree of tilt of the IOL, and the fixation target is configured to be moved based on the degree of tilt.

[0045] In some embodiments, the degree of tilt of the IOL can be approximately 4.0 degrees to approximately 8.0 degrees.

[0046] In some embodiments, the fixation target can be made movable in at least one of the following directions with respect to the subject: inward, laterally, downward, and upward.

[0047] In some embodiments, the fixation target can be fixation light generated by a fixation light source that acts as a fixation target light source.

[0048] In some embodiments, the fixation light can be a beam of light having wavelengths in the visible spectrum.

[0049] In some embodiments, the fixation target can be made movable in response to user input from the user of the ophthalmic system.

[0050] In some embodiments, the fixation target can be configured to be automatically moved by an ophthalmic system.

[0051] In some embodiments, the fixation target generation source can be a target display visible to the subject.

[0052] In some embodiments, the fixation target can be a computer-generated graphic.

[0053] In some embodiments, the OCT imaging device can be a built-in component of the ophthalmic system.

[0054] In some embodiments, the IOL can be a controllable IOL.

[0055] In some embodiments, the IOL can be a non-adjustable fluid-adjustable IOL. [Brief explanation of the drawing]

[0056] [Figure 1A] Figure 1A shows a top view of one embodiment of the IOL. [Figure 1B-1C] Figures 1B and 1C show cross-sectional views of the IOL along the cutting line AA in Figure 1A. [Figure 1D-1E] Figure 1D shows a cross-sectional view of another embodiment of the IOL, and Figure 1E shows an exploded view of the IOL. [Figure 2] Figure 2 is a schematic diagram showing a flattened ellipse representing the tilted IOL and an elongated rectangle representing the laser processing zone that can be used to adjust the base degree of the IOL. [Figure 3] Figure 3 shows an ophthalmic system configured to compensate for or adjust the tilt of an IOL. [Figure 4A] Figure 4A shows one embodiment of a fixation target generation source implemented as a fixation light source. [Figure 4B] Figure 4B shows another embodiment of a fixation target generator implemented as a target display. [Figure 4C] Figure 4C shows another embodiment of a fixation target generator implemented as a target display. [Figure 5A-5B] Figure 5A is a schematic cross-sectional view of a tilted IOL inserted into the eye of a subject, and Figure 5B is a schematic cross-sectional view showing a fixation target used to correct the tilt of the inserted IOL in Figure 5A. [Figure 6] Figure 6 is a cross-sectional OCT image showing the tilt of the inserted IOL. [Figure 7] Figure 7 shows several possible directions in which the fixation target can be moved. [Modes for carrying out the invention]

[0057] Figure 1A shows a top view of one embodiment of an adjustable intraocular lens (IOL) 100. For example, the adjustable IOL can be an adjustable accommodative IOL (AIOL). The IOL 100 can be implanted in a patient's eye to correct defocus aberration, corneal astigmatism, spherical aberration, or a combination thereof. The IOL 100 may include an optical portion 102 and one or more haptics 104, including a first haptic 104A and a second haptic 104B coupled to the optical portion 102 and extending periphery therefrom. The IOL 100 can be positioned in the natural lens capsule after the natural lens has been removed.

[0058] In some embodiments, the haptic 104 can be bonded to and adhered to the optical portion 102. For example, the haptic 104 can be bonded to the optical portion 102 after each of them has been formed separately.

[0059] In other embodiments, the IOL 100 can be a one-piece lens, thereby connecting the haptic 104 to the optical portion 102 and extending from there. In these embodiments, the haptic 104 is formed together with the optical portion 102 and is not bonded or otherwise attached to the optical portion 102 in a subsequent process.

[0060] The IOL 100 can be inserted into the subject's natural lens capsule after the patient's natural lens has been removed. The optical portion 102, once inserted into the natural lens capsule, can be configured to refract light entering the eye towards the retina. One or more haptics 104 can be configured to engage with the lens capsule and deform in response to movements of the ciliary muscle associated with deformation of the lens capsule (e.g., muscle relaxation, muscle contraction, or a combination thereof).

[0061] Each of the haptic 104 may include a haptic fluid internal passage 106 extending over at least a portion of the haptic 104. For example, the first haptic 104A may include a first haptic fluid internal passage 106A extending over at least a portion of the first haptic 104A, and the second haptic 104B may include a second haptic fluid internal passage 106B extending over at least a portion of the second haptic 104B. The haptic fluid internal passage 106 (for example, either the first haptic fluid internal passage 106A or the second haptic fluid internal passage 106B) may be in fluid communication with or fluidly connected to the optical part fluid chamber 108 in the optical part 102.

[0062] The optical partial fluid chamber 108 can communicate fluidly with one or more haptic fluid internal passages 106 through one or more fluid channels 110. The fluid channels 110 can be conduits or passages that fluidly connect the optical partial fluid chamber 108 to the haptic fluid internal passages 106. The fluid channels 110 can be spaced apart from each other. For example, a pair of fluid channels 110 can be spaced apart by about 0.1 mm to about 1.0 mm. In some embodiments, the diameter of each fluid channel 110 can be about 0.4 mm to about 0.6 mm.

[0063] The haptic 104 can be coupled to the optical portion 102 at the reinforcing portion 112. The reinforcing portion 112 can serve as a haptic-optical portion boundary. A pair of fluid channels 110 can be defined or formed within a portion of the reinforcing portion 112.

[0064] As shown in Figure 1A, the optical fluid chamber 108 can communicate fluidly with the first haptic fluid internal passage 106A through the first fluid channel pair 110A. The optical partial fluid chamber 108 can also communicate fluidly with the second haptic fluid internal passage 106B through the second fluid channel pair 110B.

[0065] In some embodiments, the first fluid channel pair 110A and the second fluid channel pair 110B can be positioned substantially opposite each other across the optical portion 102. The first fluid channel pair 110A can be positioned substantially directly opposite the second fluid channel pair 110B. The first fluid channel pair 110A and the second fluid channel pair 110B can be defined or extend through a portion of the optical portion 102. The first fluid channel pair 110A and the second fluid channel pair 110B can be defined or extend through a rear element 132 of the optical portion 102 (see, for example, Figures 1B-1E).

[0066] Figure 1A also shows that each of the haptic 104 (for example, either the first haptic 104A or the second haptic 104B) may have a proximal attachment end 114 and a distal free end 116. A haptic fluid port 152 (see, for example, Figure 1E) may be defined at the proximal attachment end 114 of the haptic 104. The haptic fluid port 152 may serve as an opening for the haptic fluid internal passage 106. When the haptic 104 is coupled to the optical portion 102, the fluid in the haptic fluid internal passage 106 can exit through the haptic fluid port 152 and flow into the optical portion fluid chamber 108 via the fluid channel 110. Similarly, the fluid in the optical partial fluid chamber 108 can exit the optical partial fluid chamber 108 through the fluid channel pair 110 and flow into the haptic fluid internal passage 106 through the haptic fluid port 152.

[0067] Each haptic 104 may include a radially outer haptic internal passage wall 118 and a radially inner haptic internal passage wall 120. The radially outer haptic internal passage wall 118 (also called the radially outer side wall of the haptic 104) may be configured to face and contact the inner surface of the patient's lens capsule when the IOL 100 is inserted into the lens capsule. The radially inner haptic internal passage wall 120 (also called the radially inner side wall of the haptic 104) may be configured to face the outer circumferential surface 122 of the optical portion 102.

[0068] As mentioned above, the IOL 100 can be inserted or introduced into the patient's lens capsule after the natural lens has been removed from that capsule. The patient's lens capsule is connected to zonular fibers that lead to the patient's ciliary muscle. The lens capsule is elastic, and ciliary muscle movement can deform the lens capsule via the zonular fibers. For example, when the ciliary muscle relaxes, the zonule stretches. This stretching causes the lens capsule to generally be pulled radially outward by an outward force. This stretching of the lens capsule lengthens it, creating space within the lens capsule. When the patient's natural lens is in the lens capsule, it usually flattens (in the anterior-posterior direction), thereby reducing its refractive power and enabling distance vision. In this state, the patient's natural lens is said to be in a distance-view accommodative state or to have performed distance-view accommodation.

[0069] However, when the ciliary muscle contracts, as happens when the eye attempts to focus on a nearby object, the radially medial portion of the muscle moves radially inward, causing the zonule to relax. This relaxation of the zonule causes the elastic capsule to contract, applying a radially inward force to the lens within the capsule. When the patient's natural lens is within the capsule, it is usually more curved (for example, the anterior portion of the lens is more curved), thereby giving the lens greater refractive power and enabling the eye to focus on nearby objects. In this state, the patient's natural lens is said to be in a near-view accommodation state, or to have performed near-view accommodation.

[0070] In embodiments where IOL 100 is an AIOL, the radially outer haptic internal passage wall 118 of the inserted AIOL can directly engage with or physically contact with the portion of the lens capsule connected to the zonule or zonule fibers. Thus, the radially outer haptic internal passage wall 118 of the AIOL can be configured to respond to the radially applied capsule deformation force when the zonule relaxes and stretches as a result of ciliary muscle movement.

[0071] For example, when the ciliary muscle contracts, the peripheral region of the elastic lens capsule deforms, applying a radially inward force to the radially outer haptic internal passage walls 118 of the haptic 104. If the IOL 100 is an AIOL, the radially outer haptic internal passage walls 118 can deform or otherwise change shape, and this deformation or change in shape can reduce the volume of the haptic fluid internal passage 106. As the volume of the haptic fluid internal passage 106 decreases, the fluid within the haptic fluid internal passage 106 moves into or is pushed into the optical portion fluid chamber 108. The optical portion 102 of the AIOL can change shape in response to the fluid entering the optical fluid chamber 108 from the haptic fluid internal passage 106. This can increase the base power or base spherical power of the AIOL, thereby allowing the patient with the AIOL implanted in their eye to focus on nearby objects. In this state, the adjustable AIOL can be said to have performed accommodation.

[0072] When the ciliary muscle relaxes, the peripheral region of the elastic lens capsule stretches radially outward, lengthening the lens capsule and creating a larger space within it. The radially outer haptic internal passage wall 118 of the haptic 104 can be configured to respond to this deformation of the lens capsule by returning to its undeformed or unstressed configuration. This increases or decreases the volume of the haptic fluid internal passage 106, or returns it to its undeformed volume. Such an increase in the volume of the haptic fluid internal passage 106 allows the fluid in the optical partial fluid chamber 108 to be drawn out of the optical partial fluid chamber 108 or otherwise drain out and return to the haptic fluid internal passage 106. The fluid exits the optical fluid chamber 108 and moves into the haptic fluid internal passage 106 through the same fluid channel 110 that is formed in the optical portion 102.

[0073] The optical portion 102 of the AIOL can change shape in response to fluid exiting the optical portion fluid chamber 108 and entering the haptic fluid internal passage 106. This reduces the base power or base spherical power of the AIOL, thereby allowing the patient with the AIOL implanted in their eye to focus on distant objects or achieve distance vision. In this state, the AIOL can be considered to have performed accommodative relaxation.

[0074] If IOL 100 is an AIOL, the radially outer haptic internal passage wall 118 of the haptic 104 can be made thinner than the radially inner haptic internal passage wall 120 to allow the haptic 104 to maintain high sensitivity to radial forces applied to the equatorial region of the haptic 104 due to deformation of the lens capsule resulting from ciliary muscle movement. As shown in Figures 1B-1D, the radially inner haptic internal passage wall 120 of the haptic 104 can be designed to be thicker or bulkier than the radially outer haptic internal passage wall 118 to give the haptic 104 rigidity or elasticity in the anterior-posterior direction. In certain embodiments, the radially inner haptic internal passage wall 120 can be made tapered in shape as it approaches the optical portion 102. When designed in this way, the haptic 104 may be less sensitive to forces applied to the lens capsule in the anterior-posterior direction. For example, when a force from the lens capsule is applied to the haptic 104 in the anterior-posterior direction, the fluid movement between the haptic fluid internal passage 106 and the optical partial fluid chamber 108 is less than when the force is applied radially. Because less fluid movement occurs, the change in the base power of the AIOL is also smaller.

[0075] Although AIOLs are illustrated and described in this disclosure, any reference to AIOLs may refer to one of the AIOLs discussed and described in the following U.S. publications, namely U.S. Patent Application Publication No. 2021 / 0100652, U.S. Patent Application Publication No. 2021 / 0100650, U.S. Patent Application Publication No. 2020 / 0337833, U.S. Patent Application Publication No. 2018 / 0153682, and the following issued U.S. patents: U.S. Patent No. 11,426,270, U.S. Patent No. 10,433,949, U.S. Patent No. 10,299,913, U.S. Patent No. 10,195,020, and U.S. Patent No. 8,968,396, the entirety of which is incorporated herein by reference.

[0076] Furthermore, while Figures 1A–1E show IOL 100 as an AIOL, this disclosure also intends for IOL 100 to be a non-adjustable adjustable IOL (also known as a statically adjustable IOL). Examples of non-adjustable or statically adjustable IOLs are discussed in U.S. Patent No. 1,1471,272, the entire contents of which are incorporated herein by reference.

[0077] In some embodiments, the IOL 100 can be designed such that the radially inner haptic internal passage wall 120 of the haptic 104 is radially separated from the outer surface 122 of the optical portion 102 by a gap 124 or void space. This allows a portion of the haptic 104 to change shape in response to external energy (see, for example, laser light 125, see Figures 1B-1D) directed towards the haptic 104.

[0078] Figure 1A also shows that one or more parts of each haptic 104 can be fabricated from a composite material. As will be described in more detail in later sections, the composite material may include, or be partially fabricated from, an energy-absorbing component, multiple expandable components, and a cross-linked copolymer used to fabricate the rest of the haptic 104. The composite material parts of the haptic 104 may be configured to expand or contract in response to laser light 125 (see, for example, Figures 1B-1D) directed at the composite material. Depending on where the composite material is placed or integrated within each of the haptic 104, the composite material may function as an internal passage filler 126 to occupy space within the haptic fluid internal passage 106, or as an internal passage expander 128 to create further space within the haptic fluid internal passage 106, or as a contractible portion to create space within the internal passage or cavity.

[0079] As will be described in more detail in a later section, when the laser beam 125 is irradiated onto the composite material configured as the internal passage filler 126, the composite material can expand, and in this example, the expansion of the composite material reduces the volume of the haptic fluid internal passage 106 and allows the fluid in the haptic fluid internal passage 106 to move into the optical partial fluid chamber 108. This allows the optical part 102 to change shape (for example, the front or rear elements of the optical part 102 can be made more curved), which leads to an increase in the base degree of the optical part 102.

[0080] Alternatively, when the laser beam 125 is irradiated onto the composite material configured as the internal passage expander 128, the composite material can expand, and in this example, the expansion of the composite material can increase the volume of the haptic fluid internal passage 106, causing the fluid in the optical partial fluid chamber 108 to be drawn into the haptic fluid internal passage 106. This can also change the shape of the optical part 102 (for example, making the front or rear element of the optical part 102 less curved, i.e., flattened), resulting in a decrease in the base degree of the optical part 102.

[0081] In another embodiment, when the laser beam 125 is irradiated onto the composite material configured as a contractible portion, the contractible portion can shrink, i.e., its size can be reduced. This reduction or contraction of the contractible portion can increase the volume of the haptic fluid internal passage 106, causing the fluid in the optical portion fluid chamber 108 to be drawn into the haptic fluid internal passage 106. This can also change the shape of the optical portion 102 (for example, by making the front or rear elements of the optical portion 102 less curved, i.e., flattened), resulting in a decrease in the base degree of the optical portion 102.

[0082] One of the technical challenges faced by the applicant is that when IOL 100 is inserted into the patient's lens capsule, the active healing response of the tissue within the lens capsule may compress or contract the optical portion 102 of the lens, resulting in a higher optical refractive power than initially expected. Another technical challenge faced by the applicant is that preoperative biometric measurements performed on the patient's eye may be inaccurate, potentially leading to the prescription and insertion of a lens with the wrong refractive power. Furthermore, yet another technical challenge faced by the applicant is that the cornea or muscles within the patient's eye may change due to injury, disease, or aging. One technical solution discovered and devised by the applicant is to design IOL 100 that can be adjusted postoperatively (i.e., after insertion) to account for such changes or errors.

[0083] Figures 1B and 1C show cross-sectional views of IOL 100 along the cutting line AA in Figure 1A. As shown in Figures 1B and 1C, the optical portion 102 may include a front element 130 and a rear element 132. The fluid chamber 108 of the fluid-filled optical portion can be defined between the front element 130 and the rear element 132.

[0084] The front element 130 may include a front optical surface 134 and a front inner surface 136 opposite to the front optical surface 134. The rear element 132 may include a rear optical surface 138 and a rear inner surface 140 opposite to the rear optical surface 138. Any of the front optical surface 134, the rear optical surface 138, or any combination thereof can be considered and referred to as an outer optical surface. The front inner surface 136 and the rear inner surface 140 can face the optical partial fluid chamber 108. At least a portion of the front inner surface 136 and at least a portion of the rear inner surface 140 can serve as the chamber wall of the optical partial fluid chamber 108.

[0085] As shown in Figures 1B and 1C, the optical portion 102 may have a lens optical axis 142 extending in the front-to-back direction through the center of the optical portion 102. The lens optical axis 142 may extend through the centers of both the front element 130 and the rear element 132.

[0086] The thickness of the front element 130 can be made thicker at or near the lens optical axis 142 than at its periphery. In some embodiments, the thickness of the front element 130 can be gradually increased from the periphery toward the lens optical axis 142.

[0087] In certain embodiments, the thickness of the front element 130 at or near the lens optical axis 142 can be about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the front element 130 near the periphery can be about 0.20 mm to about 0.40 mm. Furthermore, the front inner surface 136 of the front element 130 can have a smaller curvature than the front optical surface 134, i.e., it can be flatter.

[0088] The thickness of the rear element 132 can be greater than the portion of the rear element 132 radially outward from the lens optical axis 142, but before reaching the raised peripheral portion 144, at or near the lens optical axis 142. The thickness of the rear element 132 can be gradually reduced radially outward from the lens optical axis 142 (but before reaching the raised peripheral portion 144). As shown in Figures 1B and 1C, the thickness of the rear element 132 can again increase from the radially inner portion of the raised peripheral portion 144 to the radially outer portion of the raised peripheral portion 144.

[0089] In certain embodiments, the thickness of the rear element 132 at or near the lens optical axis 142 can be approximately 0.45 mm to approximately 0.55 mm. In these and other embodiments, the thickness of the rear element 132 radially outward from the lens optical axis 142 (but before reaching the raised peripheral portion 144) can be approximately 0.20 mm to approximately 0.40 mm. The thickness of the rear element 132 near the radially outward portion of the raised peripheral portion 144 can be approximately 1.00 mm to approximately 1.15 mm. Furthermore, the rear inner surface 140 of the rear element 132 can have a smaller curvature than the rear optical surface 138, i.e., it can be flattened.

[0090] The optical portion 102 may have a base degree or a base spherical degree. The base degree of the optical portion 102 may be configured to change based on the internal fluid pressure in the fluid chamber 108 of the fluid-filled optical portion. The base degree of the optical portion 102 may be configured to increase or decrease as the fluid enters or exits the fluid chamber 108 of the fluid-filled optical portion.

[0091] The base degree of the optical portion 102 can be configured to increase as the fluid enters the fluid-filled optical portion fluid chamber 108 from the haptic fluid internal passage 106, as shown by the curved dashed arrow in Figure 1B. For example, the front element 130 of the optical portion 102 can be configured to increase its curvature in response to the fluid entering the optical portion fluid chamber 108. Alternatively, for example, the rear element 132 of the optical portion 102 can be configured to increase its curvature in response to the fluid entering the optical portion fluid chamber 108. In another embodiment, both the front element 130 and the rear element 132 can be configured to increase their curvature in response to the fluid entering the optical portion fluid chamber 108.

[0092] The base degree of the optical portion 102 can be configured to decrease as the fluid exits the fluid-filled optical portion fluid chamber 108 or is drawn out and enters the haptic fluid internal passage 106, as shown by the curved dashed arrow in Figure 1C. For example, the front element 130 of the optical portion 102 can be configured to decrease its curvature (i.e., flatten) in response to the fluid exiting the optical portion fluid chamber 108. Similarly, the rear element 132 of the optical portion 102 can be configured to decrease its curvature (i.e., flatten) in response to the fluid exiting the optical portion fluid chamber 108. In another embodiment, both the front element 130 and the rear element 132 can be configured to decrease their curvature in response to the fluid exiting the optical portion fluid chamber 108.

[0093] Figures 1B and 1C show the fluid entering the optical partial fluid chamber 108 from the haptic fluid internal passage 106 with curved dashed arrows, but it should be noted that the fluid enters and exits the optical partial fluid chamber 108 through the fluid channel 110 and the opening 146 defined along the rear element 132. The opening 146 can be a hole or opening defined along the rear element 132 that serves as the end of the fluid channel 110. If the IOL 100 includes a pair of fluid channels 110, the pair of openings 146 that serve as the ends of the fluid channels 110 can be spaced about 0.1 mm to about 1.0 mm apart from each other.

[0094] As shown in Figures 1B and 1C, one or more parts of the IOL 100 can be fabricated from composite materials, which are designed to respond to external energy such as laser light 125. For example, one or more parts of each of the haptic 104 of the IOL 100 can be fabricated from composite materials.

[0095] Depending on where the composite material is positioned or incorporated within each of the haptics 104, and depending on the composition of the composite material, the composite material can function as an internal passage filler 126, an internal passage expander 128, or a shrinkable portion.

[0096] For example, the internal passage filler 126 can be a portion of the haptic 104 made of a composite material, and the composite material is designed to decrease the volume of the haptic fluid internal passage 106 in response to external energy (e.g., laser light 125) directed towards the internal passage filler 126. The internal passage expander 128 can be a portion of the haptic 104 made of a composite material, and the composite material is designed to increase the volume of the haptic fluid internal passage 106 in response to external energy (e.g., laser light 125) directed towards the internal passage expander 128.

[0097] As shown in Figures 1B and 1C, each of the haptic 104 may include a channel 148. The channel 148 may be defined within a portion of the radially inward haptic internal passage wall 120. For example, the channel 148 may partially extend within the radially inward haptic internal passage wall 120. The channel 148 may be in fluid communication with the haptic fluid internal passage 106, or may be considered as part of the haptic fluid internal passage 106.

[0098] In some embodiments, the internal passage filler 126 can be positioned behind the channel 148. In these embodiments, the internal passage filler 126 can function as a replacement for, or as part of, the rear portion of the radially inward haptic internal passage wall 120. The internal passage filler 126 can also be positioned radially inward of the portion of the haptic fluid internal passage 106 that is not the channel 148.

[0099] At least a portion of the internal passage filler 126 can be in fluid communication with the channel 148. For example, at least a portion of the front part or layer of the internal passage filler 126 can be in fluid communication with the channel 148, or otherwise exposed thereto.

[0100] As shown in Figures 1B and 1C, in some embodiments, the radially outer side of the internal passage filler 126 is not in fluid communication with the haptic fluid internal passage 106. In these embodiments, the radially outer side of the internal passage filler 126 is separated from the haptic fluid internal passage 106 by the portion of the haptic 104 that is not made of composite material.

[0101] The internal passage expansion member 128 can be positioned radially inward of the channel 148. The internal passage expansion member 128 can also be positioned in front of the internal passage filler 126. More specifically, for example, the internal passage expansion member 128 can be positioned in front of the radially inward portion of the internal passage filler 126.

[0102] In some embodiments, the internal passage extension member 128 can be positioned within the channel 148. In these embodiments, the internal passage extension member 128 can be positioned at the innermost radial end of the channel 148. For example, the radially inward haptic internal passage wall 120 can be made to taper as it approaches the optical portion 102. The internal passage extension member 128 can be positioned at the innermost radial end of the channel 148 near the tapered end of the radially inward haptic internal passage wall 120.

[0103] As shown in Figures 1B and 1C, the radially outer side of the internal passage extension 128 can be in fluid communication with the channel 148 and the haptic fluid internal passage 106. In some embodiments, the internal passage extension 128 does not extend completely to the radially innermost portion of the radially inner haptic internal passage wall 120. In these embodiments, the portion of the haptic 104 that is not made of composite material acts as the radially innermost portion of the radially inner haptic internal passage wall 120, allowing the internal passage extension 128 to be separated from the outer circumferential surface 122 of the optical portion 102.

[0104] In some embodiments, the internal passage expansion member 128 can be connected to or otherwise joined to the internal passage filler member 126. In these and other embodiments, the internal passage expansion member 128 and the internal passage filler member 126 can be different parts of the same composite material or refer to each other. For example, the internal passage filler member 126 may be in the shape of a substantially curved cornice, and the internal passage expansion member 128 may be in the shape of a rectangular parallelepiped extending substantially from the front of this cornice.

[0105] Those skilled in the art will understand that, although different colored shading is used in the figure to distinguish the internal passage filler 126 and the internal passage expander 128 (i.e., a darker shaded pattern is used to show the internal passage expander 128 and a lighter shaded pattern is used to show the internal passage filler 126), both the internal passage filler 126 and the internal passage expander 128 can be made from the same composite material, or refer to different parts / features of the same composite material block.

[0106] In other embodiments, the internal passage filler 126 and the internal passage expander 128 can be made from different types of composite materials. In these embodiments, the internal passage filler 126 can be made from a first type of composite material, and the internal passage expander 128 can be made from a second type of composite material. In certain embodiments, the internal passage filler 126 and the internal passage expander 128 can be made from composite materials of different colors. For example, the composite material may contain energy-absorbing components such as energy-absorbing pigments or dyes.

[0107] As a more specific example, either the internal passage filler 126 or the internal passage expander 128 can be made from a composite material containing a black energy-absorbing pigment, such as graphitized carbon black. In this example, if one of the internal passage filler 126 or the internal passage expander 128 is made from a composite material containing graphitized carbon black, the other can be made from another type of composite material containing a red energy-absorbing pigment, such as an azo dye (e.g., Disperse Red 1 dye).

[0108] As shown in Figure 1B, external energy such as laser light 125 can be directed towards the internal passage filler 126 to cause at least a portion of the internal passage filler 126 to expand and increase in size. For example, this expansion may manifest as a bulge extending from or protruding from the internal passage filler 126. For example, if the laser light 125 is directed towards a front portion or layer of the internal passage filler 126 that is in fluid communication with the channel 148 or otherwise exposed to the channel, the bulge can extend from the front portion into the channel 148. Since the channel 148 is in fluid communication with (or considered to be part of) the haptic fluid internal passage 106, the volume of the haptic fluid internal passage 106 may decrease in accordance with the formation of the bulge. This allows the fluid in the haptic fluid internal passage 106 to be pushed into the optical partial fluid chamber 108 or otherwise displaced. As a result, in response to the laser stimulation being directed towards the internal passage filler 126, at least one of the forward element 130 and the rear element 132 can increase its curvature, and the base degree of the optical portion 102 can increase.

[0109] External energy, such as laser light 125 (e.g., a laser pulse), can be directed towards the internal passage expander 128 to expand at least a portion of it, increasing its size. As will be described in more detail in a later section, this expansion can manifest as an expansion of the channel 148. For example, when laser light 125 is directed towards the internal passage expander 128, the internal passage expander 128 can increase in size and expand the channel 148. Since the channel 148 is in fluid communication with (or can be considered part of) the haptic fluid internal passage 106, the volume of the haptic fluid internal passage 106 can increase in proportion to the increase in the internal passage expander 128. This allows the fluid in the haptic fluid internal passage 106 to be drawn from the optical partial fluid chamber 108 into the haptic fluid internal passage 106. As a result, in response to the laser beam 125 (e.g., a laser pulse) being directed towards the internal passage expansion material 128, at least one of the forward element 130 and the rear element 132 can reduce its curvature, and the base degree of the optical portion 102 can be reduced.

[0110] Figure 1D shows a cross-sectional view of another embodiment of the IOL 100, including a retractable portion 160 made of a different type of composite material. In some embodiments, the retractable portion 160 can be bonded to or otherwise connected to a portion of the inner haptic internal passage wall 120 in each radial direction of the haptic 104. As shown in Figure 1D, the retractable portion 160 can be bonded to or otherwise connected to a portion of the rear portion of the inner haptic internal passage wall 120 in the radial direction. In other embodiments not shown, the retractable portion 160 can be bonded to or otherwise connected to a portion of the front portion of the inner haptic internal passage wall 120 in the radial direction.

[0111] The retractable portion 160 can be partially positioned within channels 148 formed along the inner haptic internal passage walls 120 in each radial direction of the haptic 104. The retractable portion 160 can occupy space within the channels 148 until exposed to external energy.

[0112] In another embodiment, at least a portion of the radially inward haptic internal passage wall 120 can be made of composite material. For example, at least a portion of the rear or front portion of the radially inward haptic internal passage wall 120 can be made of composite material.

[0113] The retractable portion 160 can shrink, i.e., decrease in size, in response to the laser beam 125 (e.g., a laser pulse) being directed towards it. Since the retractable portion 160 previously occupies space within the channel 148, reducing the size of the retractable portion 160 increases the available space within the channel 148. Furthermore, since the channel 148 is in fluid communication with the haptic fluid internal passage 106, reducing the size of the retractable portion 160 can increase the volume of the haptic fluid internal passage 106. This allows the fluid in the optical partial fluid chamber 108 to be drawn into the haptic fluid internal passage 106. As a result, at least one of the forward element 130 and the rear element 132 can reduce its curvature in response to the laser beam 125 being directed towards the retractable portion 160 made of composite material, which can reduce the base degree of the optical portion 102.

[0114] The contractible portion 160 can initially be a bulky portion extending into the channel 148. The volume of the bulky portion can shrink in response to external energy being directed towards the contractible portion 160. As the volume of the bulky portion decreases, the volume of the available space in the channel 148 and the volume of the haptic fluid internal passage 106 may increase, thereby drawing the fluid from the optical partial fluid chamber 108 into the haptic fluid internal passage 106.

[0115] The base degree of the optical portion 102 can be configured to decrease as the fluid exits the fluid-filled optical portion fluid chamber 108 or is drawn out and enters the haptic fluid internal passage 106, as shown in Figure 1D. For example, the front element 130 of the optical portion 102 can be configured to decrease its curvature (i.e., flatten) in response to the fluid exiting the optical portion fluid chamber 108. Similarly, the rear element 132 of the optical portion 102 can also be configured to decrease its curvature (i.e., flatten) in response to the fluid exiting the optical portion fluid chamber 108. In another embodiment, both the front element 130 and the rear element 132 can be configured to decrease their curvature in response to the fluid exiting the optical portion fluid chamber 108.

[0116] In some embodiments, the fluid in the optical partial fluid chamber 108 and the haptic fluid internal passage 106 can be an oil. More specifically, in certain embodiments, the fluid in the optical partial fluid chamber 108 and the haptic fluid internal passage 106 can be a silicone oil or fluid. For example, the fluid can be a silicone oil made partially of diphenylsiloxane. In other embodiments, the fluid can be a silicone oil made partially of a ratio of 2 units of dimethylsiloxane to 1 unit of diphenylsiloxane. More specifically, in some embodiments, the fluid can be a silicone oil made partially of diphenyltetramethylcyclotrisiloxane or a copolymer of diphenylsiloxane and dimethylsiloxane. In yet another embodiment, the fluid can be a silicone oil containing a branched polymer.

[0117] The fluid (e.g., silicone oil) may be refractive index-matched with the lens body material used to fabricate the optical portion 102. When the fluid is refractive index-matched with the lens body material, the entire optical portion 102 containing the fluid can function as a single lens. For example, the fluid may be selected to have a refractive index of about 1.48 to 1.53 (or about 1.50 to 1.53). In some embodiments, the polydispersity index of the fluid (e.g., silicone oil) may be about 1.2 to 1.3. In other embodiments, the polydispersity index of the fluid (e.g., silicone oil) may be about 1.3 to 1.5. In other embodiments, the polydispersity index of the fluid (e.g., silicone oil) may be about 1.1 to 1.2. Other exemplary fluids are described in U.S. Patent Application Publication No. 2018 / 0153682, which is incorporated herein by reference in its entirety.

[0118] The optical portion 102 can be partially fabricated from a deformable or flexible material. In some embodiments, the optical portion 102 can be partially fabricated from a deformable or flexible polymer material. For example, the front element 130, the rear element 132, or a combination thereof can be partially fabricated from a deformable or flexible polymer material. One or more haptics 104 (e.g., a first haptic 104A, a second haptic 104B, or a combination thereof) can be partially fabricated from the same deformable or flexible material as the optical portion 102. In other embodiments, one or more haptics 104 can be partially fabricated from a material different from that of the optical portion 102.

[0119] In some embodiments, the optical portion 102 may be partially comprised of or fabricated with lens body material. The lens body portion may be partially fabricated with a crosslinked copolymer comprising a copolymer blend. The copolymer blend may include alkyl acrylates or methacrylates, fluoroalkyl (meth)acrylates, and phenyl-alkyl acrylates. It is intended by this disclosure, and it should be understood as such, that these types of acrylic crosslinked copolymers may generally be copolymers of multiple acrylates, methacrylates, or combinations thereof, and the term “acrylate” as used herein should be understood to mean acrylates, methacrylates, or combinations thereof interchangeably unless otherwise specified. The crosslinked copolymer used in fabricating the lens body material may contain about 3% to 20% (wt%) of alkyl acrylates, about 10% to 35% (wt%) of fluoroalkyl acrylates, and about 50% to 80% (wt%) of phenyl-alkyl acrylates. In some embodiments, the crosslinked copolymer may contain, or be partially made from, n-butyl acrylate as an alkyl acrylate, trifluoroethyl methacrylate as a fluoroalkyl acrylate, and phenylethyl acrylate as a phenylalkyl acrylate. More specifically, the crosslinked copolymer used in the manufacture of the lens body material may contain n-butyl acrylate in an amount of about 3% to 20% (wt%) (e.g., about 12% to 16%), trifluoroethyl methacrylate in an amount of about 10% to 35% (wt%) (e.g., about 17% to 21%), and phenylethyl acrylate in an amount of about 50% to 80% (wt%) (e.g., about 64% to 67%).

[0120] The final composition of the crosslinked copolymer used in the manufacture of the lens body material may also include a crosslinker, i.e., a crosslinking agent, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer used in the manufacture of the lens body material may also include a crosslinker, i.e., a crosslinking agent (e.g., EGDMA) in an amount of about 1.0%. The final composition of the crosslinked copolymer used in the manufacture of the lens body material may also include an initiator, i.e., a starter (e.g., Percadox 16) and a UV absorber.

[0121] One or more haptic 104 may contain or be partially made from haptic material. The haptic material may contain or be partially made from a crosslinked copolymer containing a copolymer blend. The copolymer blend may contain alkyl acrylates, fluoroalkyl acrylates, and phenyl-alkyl acrylates. For example, the crosslinked copolymer used in the production of the haptic material may contain alkyl acrylates in an amount of about 10% to 25% (wt%), fluoroalkyl acrylates in an amount of about 10% to 35% (wt%), and phenyl-alkyl acrylates in an amount of about 50% to 80% (wt%). In some embodiments, the crosslinked copolymer used in the production of haptic materials may contain about 10% to 25% (wt%) (e.g., about 19% to 23%) of n-butyl acrylate, about 10% to 35% (wt%) (e.g., about 14% to 18%) of trifluoroethyl methacrylate, and about 50% to 80% (wt%) (e.g., about 58% to 62%) of phenylethyl acrylate. The final composition of the crosslinked copolymer used in the production of haptic materials may also contain about 1.0% of a crosslinker, i.e., a crosslinking agent, such as EGDMA. The final composition of the crosslinked copolymer used in the production of haptic materials may also contain several photoinitiators, i.e., photoinitiators (e.g., camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-(dimethylamino)benzoic acid).

[0122] In some embodiments, the refractive index of the lens body material can be approximately 1.48 to approximately 1.53. In certain embodiments, the refractive index of the lens body material can be approximately 1.50 to approximately 1.53 (for example, approximately 1.5178).

[0123] The front element 130 can be attached to the rear element 132 via adhesive 150 or an adhesive layer, or otherwise bonded. The adhesive layer can be substantially annular in shape. The adhesive 150 or adhesive layer can be positioned at the peripheral edge of the optical portion 102 between the front element 130 and the rear element 132. For example, the adhesive 150 can be positioned on the raised peripheral portion 144 of the rear element 132.

[0124] The adhesive 150 or adhesive layer may contain or be partially made from a biocompatible adhesive. The adhesive 150 or adhesive layer may contain or be partially made from a biocompatible polymer adhesive.

[0125] The adhesive 150 or adhesive layer may contain or be partially prepared from a crosslinked polymer precursor formulation. The crosslinked polymer precursor formulation may contain or be partially prepared from a copolymer blend, a hydroxyl-functionalized acrylic monomer, and a photoinitiator.

[0126] The copolymer blend may include alkyl acrylates (e.g., about 41% to about 45% (wt%) of n-butyl acrylate), fluoroalkyl acrylates (e.g., about 20% to about 24% (wt%) of trifluoroethyl methacrylate), and phenylalkyl acrylates (about 28% to about 32% (wt%) of phenylethyl acrylate). The hydroxyl-functionalized acrylic monomer may be 2-hydroxyethyl acrylate (HEA). Photoinitiators can be used to accelerate the curing of the adhesive. For example, the photoinitiator may be Darocur 4265 (a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide and 2-hydroxy-2-methylpropiophenone).

[0127] In some embodiments, the same adhesive 150 used to bond the front element 130 to the rear element 132 can also be used to bond or fix one or more haptics 104 to the optical portion 102.

[0128] Figure 1E also shows that each of the haptic 104 (for example, either the first haptic 104A or the second haptic 104B) may have a proximal attachment end 114 and a closed distal free end 116. A haptic fluid port 152 can be defined at the proximal attachment end 114 of the haptic 104. The haptic fluid port 152 can serve as a chamber opening for the haptic fluid internal passage 106. When the haptic 104 is coupled to the optical portion 102, the fluid in the haptic fluid internal passage 106 can flow out of the haptic fluid internal passage 106, through the haptic fluid port 152, and into the optical portion fluid chamber 108 via the fluid channel pair 110. Similarly, the fluid in the optical portion fluid chamber 108 can flow out of the optical portion fluid chamber 108, through the fluid channel pair 110, and into the haptic fluid internal passage 106 via the haptic fluid port 152. The pair of outer opening 156 and inner opening 146 can serve as the ends of the fluid channel 110.

[0129] As shown in Figures 1A and 1E, each of the haptic 104 can be coupled to the optical portion 102 at the reinforcing portion 112. For example, the first haptic 104A can be coupled to or attached to the optical portion 102 at the first reinforcing portion 112A, and the second haptic 104B can be coupled to or attached to the optical portion 102 at the second reinforcing portion 112B.

[0130] More specifically, the proximal mounting end 114 can be coupled to a protruding outer surface 154 of the rear element 132. The protruding outer surface 154 can also be called the "receptacle" or "haptic mounting receptacle." The protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 of the optical portion 102. For example, the protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 of the rear element 132 of the optical portion 102. The protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 by only about 10 micrometers to 1.0 mm, or about 10 micrometers to 500 micrometers.

[0131] The proximal mounting end 114 has a substantially flat surface and can be bonded or otherwise attached to the substantially flat surface of the protruding outer surface 154. When the proximal mounting end 114 is bonded to the protruding outer surface 154, the haptic fluid port 152 can surround the outer opening 156 of the fluid channel 110. The haptic 104 can be bonded or attached to the optical portion 102 by a biocompatible adhesive 150. In some embodiments, the adhesive 150 can be the same adhesive used to bond or attach the front element 130 to the rear element 132.

[0132] In some embodiments, the composite material may include a composite substrate, an energy-absorbing component, and a plurality of expandable or contractible components. As described above, one or more parts of each haptic 104 can be made from the composite material.

[0133] The composite substrate can be made of hydrophobic acrylic material. For example, the composite substrate can be made of phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), or a combination thereof.

[0134] In one exemplary embodiment, the composite substrate may include a methacrylate-functional or methacrylic-functional crosslinked polymer and a reactive acrylic monomer diluent such as lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controlling the amount of lauryl methacrylate (SR313) relative to ADMA, the overall corresponding hardness (i.e., more ADMA) or softness (i.e., more SR313) of the cured composite material can be controlled. The methacrylate-functional or methacrylic-functional crosslinked polymer can be prepared using a crosslinked polymer precursor formulation.

[0135] The crosslinked polymer precursor formulation may include the same copolymer blend used to produce the optical portion and haptic. The copolymer blend may include alkyl acrylates or methacrylates (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylates (e.g., trifluoroethyl methacrylate), and phenyl-alkyl acrylates (e.g., phenylethyl acrylate). For example, the copolymer blend may contain about 41% to about 45% (wt%) of n-butyl acrylate, about 20% to about 24% (wt%) of trifluoroethyl methacrylate, and about 28% to about 32% (wt%) of phenylethyl acrylate. The crosslinked polymer precursor formulation may include, or be partially made from, a copolymer blend, a hydroxyl-functionalized acrylic monomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265 or a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and 2-hydroxy-2-methylpropiophenone).

[0136] The composite substrate may contain approximately 50% to 65% (e.g., approximately 55% to 60%) (wt%) of a methacrylate-functional or methacrylic-functional crosslinked polymer (as described above), approximately 32% to 38% (e.g., approximately 32.70%) (wt%) of a reactive acrylic monomer diluent lauryl methacrylate (SR313), and approximately 5% to 9% (e.g., approximately 7.30%) (wt%) of a reactive acrylic monomer diluent adamantyl methacrylate (ADMA).

[0137] The composite material can be fabricated in several operations. The first operation may include preparing an uncolored composite substrate. The second operation may include mixing the composite substrate with an energy-absorbing component, an expansive component or a shrinkable / burstable element, and one or more initiators such as a photoinitiator, a thermal initiator, or a combination thereof. The third operation may include placing the uncured composite material at a desired location within the haptic 104 (for example, near the channel 148) and curing the composite material in situ.

[0138] For example, an uncolored composite substrate can be mixed with an energy-absorbing component such as a dye (e.g., Disperse Red 1 dye) or a pigment (graphitized carbon black). Energy-absorbing components will be discussed in more detail later.

[0139] In some embodiments, the expandable component may constitute about 5.0% to about 15.0% by weight of the final composition of the composite material. More specifically, the expandable component may constitute about 8.0% to about 12.0% by weight (e.g., about 10.0%) of the final composition of the composite material. In these and other embodiments, the energy-absorbing component may constitute about 0.044% to about 0.44% by weight (or about 0.55%) of the final composition of the composite material.

[0140] The photoinitiator may be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-phosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propan-1-one). The photoinitiator may constitute about 1.30% by weight of the final composition of the composite material. In addition, the composite material may also contain a thermal initiator. The thermal initiator may constitute about 1.00% by weight of the final composition of the composite material. In some embodiments, the thermal initiator may be a dialkyl peroxide such as Luperox® peroxide. In other embodiments, the thermal initiator may be Perkadox.

[0141] In some embodiments, the energy-absorbing component absorbs external energy (e.g., laser energy), converts this energy into heat, and conducts this energy to the composite substrate, causing it to expand.

[0142] In some embodiments, the expandable component may be an expandable microsphere comprising an expandable thermoplastic shell and a foaming agent contained within the expandable thermoplastic shell. The microsphere may be configured to expand such that the diameter of at least one of the microspheres can increase to about 2 × of its original diameter. In other embodiments, the microsphere may be configured to expand such that the diameter of at least one of the microspheres can increase to about 4 × of its original diameter, i.e., four times its original diameter. In yet another embodiment, the microsphere may be configured to expand such that the diameter of at least one of the microspheres can increase to about 2 × to about 4 × (or about 3.5 ×) of its original diameter. For example, the initial diameter of the microsphere may be about 12 μm. In response to external energy being applied to or directed at the composite material, or in response to energy being transferred to or transmitted to the microsphere, the diameter of the microsphere may increase to about 40 μm.

[0143] The volume of at least one of the microspheres can be configured to expand by about 10 × to about 50 × in response to external energy being applied to or directed to the composite material, or in response to energy being transferred to or transmitted to the microsphere.

[0144] In some embodiments, the blowing agent can be an expandable fluid such as an expandable gas. More specifically, the blowing agent can be a branched-chain hydrocarbon. For example, the blowing agent can be isopentane. In other embodiments, the blowing agent may be cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane, or may include such mixture.

[0145] Each of the expandable components may include a thermoplastic shell. The thickness of the thermoplastic shell may change as the size of the expandable component increases. More specifically, the thickness of the thermoplastic shell may decrease as the size of the expandable component increases. For example, if the expandable component is an expandable microsphere, the thickness of the thermoplastic shell (i.e., its thickness in the radial direction) may decrease as the diameter of the expandable microsphere increases.

[0146] In some embodiments, the thermoplastic shell can be fabricated in part from a nitrile or acrylonitrile copolymer. For example, the thermoplastic shell can be fabricated in part from acrylonitrile, styrene, butadiene, methyl acrylate, or a combination thereof.

[0147] As mentioned above, the expandable component can constitute approximately 8.0% to 12% by weight of the final composition of the composite material. The expandable component can constitute approximately 10% by weight of the final composition of the composite material.

[0148] The expandable component can be dispersed in the composite substrate that constitutes the bulk of the composite material, or distributed by other means. The composite substrate can act as a matrix for holding or supporting the expandable component. The composite material can expand in response to the expansion of the expandable component (e.g., thermoplastic microspheres). For example, the volume of the composite material can increase in response to the expansion of the expandable component.

[0149] The composite material also includes an energy-absorbing component. In some embodiments, the energy-absorbing component can be an energy-absorbing dye.

[0150] In certain embodiments, the energy-absorbing dye can be an energy-absorbing dye. For example, the energy-absorbing dye can be an azo dye. In some embodiments, the azo dye can be a red azo dye, such as Disperse Red 1 dye. In other embodiments, the azo dye can be an orange azo dye such as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dye such as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dye such as Disperse Blue dye (e.g., Disperse Blue 1), or a combination thereof.

[0151] In additional embodiments, the energy-absorbing dye may be a pigment or may include one. For example, the energy-absorbing dye may be graphitized carbon black as a pigment or may include one.

[0152] Similar to the expansion component, the energy-absorbing component can be dispersed within the composite substrate that constitutes the bulk of the composite material, or distributed in other ways. The composite substrate can serve as a matrix for holding or supporting the expansion component and the energy-absorbing component.

[0153] As mentioned above, the energy-absorbing component can constitute approximately 0.025% to 1.0% by weight (or more specifically, approximately 0.045% to 0.45%) of the final composition of the composite material.

[0154] Energy-absorbing components (e.g., azo dyes, graphitized carbon black, or combinations thereof) can absorb or capture external energy (e.g., light energy, or more specifically, laser light) applied to or directed at the composite material. The energy-absorbing components can absorb or capture external energy and convert this energy into thermal energy or heat, or transfer it to the expandable component.

[0155] The thermoplastic outer shell can soften and begin to flow when thermal energy is transferred to or transmitted to the expandable component. The thermoplastic outer shell of the expandable component can then begin to thin, i.e., decrease in thickness, in response to the transfer or transmission of thermal energy to the expandable component. As the thermoplastic outer shell softens and begins to decrease in thickness, the blowing agent in the expandable component can expand. The blowing agent can also expand in response to the transfer or transmission of thermal energy or heat to the expandable component. The expansion of the blowing agent can cause the expandable component (e.g., thermoplastic microspheres) to expand, i.e., increase in volume. This ultimately causes the composite material to expand, i.e., increase in volume.

[0156] As described above, the external energy can be laser light 125, and the energy-absorbing component can absorb or capture the laser light 125 directed at the composite material, convert the light energy into thermal energy or heat, or transfer it to the expandable component. The foaming agent in the expandable component can expand or be activated in response to the thermal energy or heat. The expandable component and ultimately the composite material can expand, i.e., increase in volume, in response to this light energy being directed at the composite material.

[0157] As described above, in some embodiments, the composite material may include a composite substrate, an energy-absorbing component, and a plurality of shrinkable components (e.g., shrinkable and / or burstable microspheres). The shrinkable and / or burstable microspheres may be dispersed together with the energy-absorbing component within the composite substrate, or otherwise distributed. The composite substrate can serve as a matrix for holding or supporting the shrinkable and / or burstable microspheres and the energy-absorbing component.

[0158] Shrinkable or burstable microspheres may include an internal phase and one or more vacuum voids housed within a thermoplastic outer shell. Shrinkable microspheres can be configured to shrink, i.e., decrease in size, so that the diameter of at least one of the microspheres is reduced by about half of its original diameter.

[0159] For example, a contractible microsphere can initially be fabricated with a diameter of approximately 50 μm to 100 μm. In response to external energy being applied to or directed at the first composite material, or in response to energy being transferred to or transmitted to the contractible microsphere, the diameter of the contractible microsphere can be reduced to approximately 25 μm to 50 μm.

[0160] The internal phase can be a fluid capable of undergoing one or more phase transitions. In some embodiments, the internal phase can be configured to undergo a phase transition from gas to liquid at a temperature lower than the internal phase's boiling point. If the internal phase is encapsulated in a thermoplastic shell, one or more vacuum voids can be formed when the internal phase condenses into a liquid phase within the thermoplastic shell.

[0161] In one embodiment, the internal phase may be water or may contain water. In this embodiment, vacuum voids can be formed when water vapor in the thermoplastic outer shell condenses into liquid water.

[0162] In other embodiments, the internal phase may be or may contain ethylene glycol (which has a higher boiling point than water). In yet another embodiment, the internal phase may be or may contain a silicone-based fluid such as a specific cyclic siloxane (e.g., hexamethylcyclotrisiloxane). In an additional embodiment, the internal phase may be or may contain a polydiethylsiloxane (PDMS) oligomer or a specific type of hydrofluoroether.

[0163] The thermoplastic outer shell can soften and begin to flow when thermal energy is transferred or transmitted from the energy-absorbing component to the contractile microspheres. If the external energy is laser light 125, the energy-absorbing component can absorb or capture the laser light 125 directed at the composite material, converting the light energy into thermal energy or heat.

[0164] The thermoplastic outer shell of a contractile microsphere has a glass transition temperature (Tg) of the thermoplastic outer shell. shell The thermoplastic shell can be configured to soften or begin to flow at temperatures higher than its glass transition temperature. The thermoplastic shell may also begin to thin at temperatures higher than its glass transition temperature. When the thermoplastic shell softens or thins, it may collapse and decrease in size due to the vacuum within the thermoplastic shell, in addition to the external pressure around it.

[0165] In some embodiments, at least some of these microspheres can also be configured to rupture when their thermoplastic outer shell decomposes or breaks in response to external energy directed at the first composite material. In these embodiments, the internal phase of the ruptureable microsphere is soluble in the surrounding haptic material or silicone oil.

[0166] In some embodiments, the thermoplastic shell may be made of polyacrylonitrile or partially made of it. In some embodiments, the thermoplastic shell may be made of polystyrene or partially made of it. In yet another embodiment, the thermoplastic shell may be made of poly(methyl methacrylate) or partially made of it. The thermoplastic shell may also include a photoinitiator (e.g., a UV initiator). For example, the photoinitiator may be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-phosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propane-1-one). The thermoplastic shell can be formed when the monomer of the outer shell material is curved via UV curing together with the photoinitiator.

[0167] The thermoplastic shell can be reformed in its hardened state or become glassy again when the temperature is below the glass transition temperature of the thermoplastic shell (i.e., when external energy is no longer directed towards the composite material). The diameter of the shrinkable microspheres may decrease as the thermoplastic shell reforms around the liquid inner phase, displacing the space previously occupied by one or more vacuum voids.

[0168] Figure 2 is a schematic diagram showing a flat ellipse representing a portion of the tilted IOL 100 and an elongated rectangle representing a laser processing zone 200 that may be used to adjust the base power of the IOL 100. In some embodiments, the IOL 100 may be tilted by an angle of inclination of 4.0 to 8.0 degrees. For example, when the IOL 100 is implanted in a subject's eye, the IOL 100 may be tilted with respect to the subject's line of sight.

[0169] As shown in Figure 2, if IOL 100 is tilted, it may become difficult to adjust the base power of IOL 100 postoperatively by directing laser light 125 (e.g., laser pulses) at the tilted IOL 100.

[0170] For example, the adjustment protocol or processing protocol may require that multiple laser pulses be directed to multiple locations along one haptic 104A of the IOL 100, and then additional laser pulses be directed to multiple locations along other haptic 104B of the IOL 100 (see, for example, Figure 1A), in a rapid and continuous manner.

[0171] Depending on the adjustment or processing protocol, the subject may often be required to be in a supine position. In this case, the laser's optical axis can be in the longitudinal direction, i.e., the Z direction. The laser beam of a laser (e.g., a femtosecond laser) can typically be scanned in a horizontal XY plane with a pair of orthogonal galvanometric scanners. This scan can be performed in a few milliseconds. However, the longitudinal position (or Z position) of the processing area is typically adjusted by an adjustable, nearly confocal lens pair. Z positioning or scanning is slower than X / Y scanning and cannot keep up with the round-trip scan time of X / Y scanning. Therefore, the optimal or preferred processing zone of the laser is a substantially planar processing zone 200, or a processing zone 200 perpendicular (or substantially perpendicular) to the laser's optical axis.

[0172] As shown in Figure 2, when the IOL 100 is tilted, the substantially planar processing zone 200 extends beyond the boundary of the IOL 100. This means that if the IOL 100 is tilted, the laser may unintentionally damage the patient's eye by exposure to laser energy. Furthermore, if the IOL 100 is tilted, the substantially planar processing zone 200 means that the laser contacts the IOL 100 at different depths, which may result in unevenness in any desired shape changes of the IOL 100. Therefore, it is necessary to correct such tilts to address the aforementioned drawbacks caused by the tilt of the IOL 100.

[0173] Figure 3 shows an ophthalmic system 300 configured to compensate for and adjust the tilt of the IOL 100 postoperatively. For example, the system 300 can be used to perform an IOL adjustment procedure after the IOL 100 has been inserted into the patient's eye. In some embodiments, the IOL adjustment procedure may require compensating for or correcting the tilt of the inserted IOL to position the IOL 100 in place for the remainder of the adjustment procedure.

[0174] The system 300 may include an OCT imaging device 302 configured to generate one or more optical coherence tomography (OCT) images of the eye of a subject or patient in which an IOL 100 has been implanted.

[0175] The system 300 may also include one or more electronic displays 304 and a control unit 306. The control unit 306 and the one or more electronic displays 304 can be coupled to each other and to the OCT imaging device 302 in a communicative manner.

[0176] At least one of the electronic displays 304 can display one or more OCT images captured by the OCT imaging device 302. The OCT images can be displayed in real time on the electronic display 304 while a user (e.g., a clinician, surgeon, or other ophthalmologist) operates the system 300.

[0177] The OCT imaging device 302 can generate an imaging beam used to scan the subject's eye. The imaging beam can be directed into the eye by a beam splitter. Light scattered from the anatomical structures of the eye and implanted structures (e.g., IOL 100) within the eye is reflected back and used by the OCT imaging device 302 to form cross-sectional images of the eye and any implants within it. For example, the OCT imaging device 302 can generate cross-sectional images by measuring the echo time delay and intensity of backscattered or backreflected light. The OCT measurement of echo time delay is based on a correlation method that compares the backscattered or backreflected light signal with a reference light signal traveling a known path length.

[0178] The OCT imaging apparatus 302 may include an OCT light source that generates low-power visible wavelength light. In other embodiments, the OCT light source can generate light in the near-infrared (NIR) range (i.e., wavelengths from about 900 nm to about 1,400 nm).

[0179] For example, the OCT light source of the OCT imaging device 302 can be a superpalminescent diode. The OCT imaging device 302 may also include an interferometer such as a Michelson interferometer, a reference mirror, a Garbo scanner used to scan the eye with the imaging beam, and a spectrometer.

[0180] In some embodiments, the OCT imaging device 302 can be communicatively coupled to a control unit 306, and one or more processors in the control unit 306 can be programmed to process imaging signals and control various hardware components of the OCT imaging device 302.

[0181] In one embodiment, the OCT imaging device 302 can be a spectral domain OCT (SD-OCT). In other embodiments, the OCT imaging device 302 can be a wavelength-swept light source OCT (SS-OCT), frequency domain OCT, Fourier domain OCT, or composite Fourier OCT.

[0182] The OCT imaging device 302 can also generate a three-dimensional (3D) composite OCT image by combining two-dimensional (2D) cross-sectional OCT images.

[0183] Referring here to Figures 4A-4C and 5A-5B, the system 300 may include a fixation target generator 400 configured to generate a movable fixation target 404 (see Figures 4A-4C) visible to the subject's eye. As will be discussed in more detail in the following sections, the fixation target 404 may be configured to be moved until the cross section 502 of the IOL 100 (see Figures 5A and 5B) is perpendicular or substantially perpendicular to the optical axis 506 of the ophthalmic system 300 (see Figures 5A and 5B). For example, the fixation target 404 may be moved until the cross section 502 of the IOL 100 in the state shown in one or more OCT images displayed on the electronic display 304 is perpendicular or orthogonal (or substantially perpendicular or orthogonal) to the optical axis 506 displayed on the electronic display 304.

[0184] The system 300 may also include an ophthalmic laser 308 configured to generate pulses of laser light and direct them towards the IOL 100 to adjust the base power or power of the IOL 100. A control unit 306 may be configured to control the ophthalmic laser 308. In some embodiments, the laser 308 may be a femtosecond laser.

[0185] In some embodiments, the optical axis 506 of the system 300 may refer to the optical axis or Z-axis of the focusing lens or focusing objective lens of the laser 308. In certain embodiments, moving the fixation target 404 may further include moving the fixation target 404 to a position that is not axially aligned with the optical axis 506 of the laser.

[0186] As shown in Figure 3, the subject or patient can assume a supine position during the IOL adjustment procedure. In these embodiments, the optical axis 506 can be oriented vertically.

[0187] In some embodiments, the fixation target generation source 400 may be a fixation light source (e.g., a low-power laser or laser pointer). In these embodiments, the fixation target 404 may be a fixation light source such as a beam of light having a wavelength in the visible spectrum (e.g., about 350 nm to 750 nm).

[0188] In certain embodiments, the fixation target generator 400 can be moved by a user or operator of the system 300. In other embodiments, the fixation target generator 400 can be moved automatically by the ophthalmic system 300.

[0189] In some embodiments, the fixation target 404 can be moved in response to user input applied by the user or operator of the system 300 (for example, via an input device such as a mouse, keyboard, or buttons or touchpad on a component of the system 300). In other embodiments, the fixation target 404 can be moved automatically by the system 300.

[0190] In other embodiments, the fixation target generation source 400 can be a target display 408 visible to the subject or patient. In these embodiments, the fixation target 404 can be a computer-generated graphic 410 (see Figures 4B and 4C) generated on the target display 408.

[0191] In some embodiments, the OCT imaging device 302 and the laser 308 can be integrated with the ophthalmic system 300.

[0192] As described above, the OCT images acquired by the OCT imaging device 302 can be displayed on the electronic display 304 of the system 300. The OCT images can guide the operator / user of the system 300 (e.g., a clinician, surgeon, or other ophthalmologist) when performing IOL adjustment procedures. In IOL adjustment procedures, it may be necessary for the cross-section 502 of the IOL 100 to be perpendicular to, or orthogonal to (or substantially perpendicular to) the optical axis 506 of the laser 308 of the system 300.

[0193] In some embodiments, the OCT image displayed on the electronic display 304 allows the operator / user to determine in real time whether the cross-section 502 of the IOL 100 is perpendicular to, or orthogonal to (or substantially perpendicular to, or orthogonal to) the optical axis 506 of the laser 308. In these embodiments, the optical axis 506 can be displayed on the electronic display 304 alongside the cross-sectional OCT image of the IOL 100 showing the cross-section 502 of the IOL 100.

[0194] In some embodiments, the ophthalmic system 300 may include a laser module, a laser controller, multiple beam splitters, a focusing objective lens, and a patient interface. The laser module can generate a beam of laser pulses and emit it to a point or focused spot within the inserted IOL 100, as directed by the laser controller. The laser controller can also adjust specific beam parameters of the laser beam and control where the beam is directed within the eye. The laser controller can perform these functions by transmitting one or more power control signals and scanning control signals to the laser module.

[0195] The laser beam generated by laser 125 or laser 308 can be guided into the eye by one or more beam splitters. Focusing objective lenses can focus the laser beam using one or more objective lenses, while the patient interface can stabilize the patient's eyeball during laser treatment.

[0196] In some embodiments, laser 308 can be an ultrafast pulsed diode pump solid-state femtosecond laser. Laser 308 is a nanosecond (10⁻¹⁶) laser. -9 (seconds), picoseconds (10 -12 (seconds), or femtoseconds (10⁻¹⁰ seconds) -15 Laser pulses can be generated with a duration of (seconds). Laser pulses can be generated with a pulse repetition rate of 1 kHz to a maximum of 500 kHz. More specifically, laser pulses can be generated with a pulse repetition rate of approximately 10 kHz to approximately 100 kHz. In other embodiments, laser pulses can be generated with a pulse repetition rate of 0.1 kHz to 1,000 kHz.

[0197] In some embodiments, the laser beam generated by laser 308 can have a wavelength of approximately 900 nm to approximately 1100 nm (i.e., the near-infrared (NIR) range). For example, the laser beam generated by laser 308 can have a wavelength of approximately 1030 nm.

[0198] In alternative embodiments, the laser beam generated by laser 308 can be a green laser light having a wavelength of approximately 480 nm to 650 nm (e.g., 532 nm). In these embodiments, laser 308 can be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser.

[0199] Figure 4A shows that the fixation target generation source 400 may be a fixation light source 402. In some embodiments, the fixation light source 402 may be a low-power laser or laser pointer. In these embodiments, the fixation target 404 may be a fixation light 406, such as a beam of visible light having a wavelength in the visible spectrum (e.g., about 350 nm to 750 nm). The fixation light 406 may be visible to the subject or patient undergoing IOL adjustment treatment.

[0200] In certain embodiments, the fixation light 406 can be moved in response to user input provided by a user or operator of the ophthalmic system 300. For example, the fixation light 406 can be moved in response to user input provided by a user or operator to an input device such as a mouse or keyboard communicatively coupled to the system 300, or a button or touchpad on a component of the system 300. In other embodiments, the fixation light 406 can be moved automatically by the system 300 based on calculations performed by one or more processors of the control unit 306.

[0201] In some embodiments, the fixation beam 406 can be moved by one or more beam splitters. In other embodiments, the fixation beam 406 can be moved by physically moving the fixation light source 402.

[0202] Figure 4B shows that the fixation target generator 400 may be a target display 408. The target display 408 can be positioned so that it is visible to the subject or patient during the IOL adjustment procedure. For example, when the subject is in a supine position, the target display 408 can be positioned above the subject in the vertical direction.

[0203] In some embodiments, the target display 408 can be an electronic flat panel display. For example, the target display 408 can be a liquid crystal display (LCD) screen. In other embodiments, the target display 408 can be a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or an active-matrix OLED (AMOLED) display. In additional embodiments, the target display 408 can be projected onto a beam splitter that can be viewed by the subject or patient.

[0204] In these embodiments, the fixation target 404 can be a computer-generated graphic 410 generated on the target display 408. For example, the computer-generated graphic 410 can be a graphic of light.

[0205] In some embodiments, the computer-generated graphic 410, which serves as a fixation target 404, can be moved in response to user input provided by the user or operator of the ophthalmic system 300. For example, the computer-generated graphic 410 can be moved in response to user input provided by the user or operator to an input device such as a mouse or keyboard communicatively coupled to the system 300, or a button or touchpad on a component of the system 300. In other embodiments, the computer-generated graphic 410 can be moved automatically by the system 300 based on calculations performed by one or more processors of the control unit 306.

[0206] Figure 4C shows that the computer-generated graphics 410 can also be in the form of computer-generated characters, icons, or symbols. Furthermore, the computer-generated graphics 410 can be high-contrast characters, icons, or symbols.

[0207] Figures 4B and 4C show the fixation target 404 as a light-colored graphic displayed on a dark-colored background. The present disclosure intends that the fixation target 404 may also be a dark-colored graphic displayed on a light-colored background.

[0208] Figure 5A is a schematic cross-sectional view of an IOL 100 that has been inserted into the eye of a subject and is tilted. For example, the degree of tilt of IOL 100 may range from approximately 4.0 degrees to approximately 8.0 degrees. More specifically, for example, the degree of tilt of IOL 100 may be approximately 5.5 degrees.

[0209] In some embodiments, the inclination may be nasal (see also Figure 7). The inclination may also be lateral, upward, and / or downward (see also Figure 7).

[0210] The inserted IOL 100 can also be tilted with respect to the subject's line of sight 500. For example, the IOL 100 can be tilted by an angle kappa (κ) with respect to the line of sight 500.

[0211] In some embodiments, the angle kappa can be an angle defined by the line of sight 500 and the pupillary axis. In other embodiments, the angle kappa can be defined by the cross section 502 of the inserted IOL 100 and a plane 504 that is perpendicular to or perpendicular (or substantially perpendicular or perpendicular) the optical axis 506 of the ophthalmic system 300.

[0212] For example, the optical axis 506 can be the Z-axis of the focusing lens or focusing objective lens of the laser 308 of the ophthalmic system 300. The optical axis 506 can be directed vertically or substantially oppositely when the subject is in a supine position (see, for example, Figure 3).

[0213] In some embodiments, the degree of tilt of the IOL 100 can be calculated or determined based on the OCT image captured by the OCT imaging device 302 and displayed on the electronic display 302. In these embodiments, the plane 504 that is perpendicular to or perpendicular to (or substantially perpendicular to or perpendicular to) the optical axis 506 can be predetermined or determined based on the orientation of the laser 308 or the focusing lens or focusing objective lens of the laser 308. The cross-section 502 of the inserted IOL 100 can be determined by the user or operator of the system 300 (e.g., a clinician, surgeon, or other ophthalmologist) based on the OCT image captured by the OCT imaging device 302 and displayed on the electronic display 304.

[0214] In other embodiments, the degree of tilt of the IOL 100 can be automatically calculated or determined by one or more processors in the control unit 306 of the system 300. For example, one or more processors in the control unit 306 can automatically analyze the OCT image captured by the OCT imaging device 302 and determine or calculate the degree of tilt of the IOL 100 without requiring any or any substantial input from the user.

[0215] Figure 5B is a schematic cross-sectional view showing a fixation target 404 used to correct the tilt of the implanted IOL 100. While the fixation target 404 is moved to a new location or position, the subject may be instructed to focus on the fixation target 404.

[0216] In another embodiment, after the fixation target 404 has been moved to a new location or position, the subject may be instructed to focus on the fixation target 404.

[0217] As shown in Figure 5B, the fixation target 404 can be moved to a location or position that is not aligned axially with the optical axis 506 or Z-axis of the ophthalmic system 300 (when the subject is in a supine position).

[0218] The fixation target 404 can be moved in at least one of the following directions relative to the subject: medial / nasal, lateral / temporal, downward, upward, or a combination thereof.

[0219] The fixation target 404 can be moved until the cross section 502 of the inserted IOL 100 is perpendicular or substantially perpendicular to the optical axis 506 of the ophthalmic system 300 (e.g., the optical axis of the laser 308 of the ophthalmic system). In some embodiments, moving the fixation target 404 may include moving the fixation target 404 until the cross section 502 of the IOL in the state shown in the OCT image displayed on the electronic display 304 is perpendicular or substantially perpendicular to the optical axis 506 of the ophthalmic system 300 displayed on the electronic display 304 (see also Figure 6).

[0220] In some embodiments, the fixation target 404 can be moved based on the degree of tilt of the IOL 100. For example, the degree of tilt of the IOL 100 can be an angular kappa. In this example, the fixation target 404 can be moved until the angle formed by the new line of sight 500 and the optical axis 506 is equal to or substantially equal to the angular kappa.

[0221] The fixation target 404 can be moved in response to user input applied by the user or operator of the system 300 (for example, via an input device such as a mouse, keyboard, or buttons or touchpad on a component of the system 300). In another embodiment, the fixation target 404 can be moved automatically by the control unit 306 of the system 300.

[0222] In some embodiments, the fixation target 404 can be held in this new location / position while the laser beam 125 (e.g., a laser pulse) generated by the laser 308 is directed towards the IOL 100. The laser beam 125 can be used to adjust the base power of the IOL 100.

[0223] Figure 6 is a cross-sectional OCT image showing the tilt of IOL 100 when it is implanted in the eye of a subject / patient. The cross-sectional OCT image can be displayed on the electronic display 304 of the system 300. As shown in Figure 6, when IOL 100 is tilted, the optical axis 506 of the ophthalmic system 300 is not perpendicular to or orthogonal to the cross-section 502 of the implanted IOL 100.

[0224] As mentioned above, due to certain limitations on the laser 308, the processing zone or processing area of ​​the laser 308 may be substantially planar. Thus, one technical problem faced by the applicant is how to apply laser processing to all necessary processing areas on the tilted IOL 100 without putting the patient's eyes at risk due to unintended exposure to laser energy. This risk is heightened when such laser energy must be directed to one or more haptics 104 located around the central optical portion 102. Another technical problem faced by the applicant is that when the IOL 100 is tilted, a substantially planar processing zone 200 means that the laser contacts the IOL 100 at different depths, which may result in non-uniform changes in any desired shape of the IOL 100.

[0225] The technical solution discovered and devised by the applicant is the system and method disclosed herein, in which a fixation target 404 (see Figures 4A-4C and 5A-5B) is used to adjust or correct the tilt of the IOL 100. The fixation target 404 can be displayed or otherwise presented to a subject or patient so that the subject or patient can follow the fixation target 404 with their eyes without moving their head. The fixation target 404 can be moved to a new location or position until the cross section 502 of the IOL 100 (e.g., as shown in a cross-sectional OCT image) is perpendicular or substantially perpendicular to the optical axis 506 of the laser 308 (therefore, the angle kappa becomes zero).

[0226] While the laser beam 125 (e.g., a laser pulse) generated by the laser 308 is directed towards the IOL 100, the fixation target 404 can be held in this new location / position.

[0227] Figure 7 shows several possible directions in which the fixation target 404 can be moved. As shown in Figure 7, the fixation target 404 (any of the exemplary fixation targets shown in Figures 4A-4C) can be moved inward 700, laterally 702, upward 704, downward 706, or any combination thereof.

[0228] Regarding the subject / patient's eye, the medial direction 700 can also be called the nasal direction. Similarly, the transverse direction 702 can also be called the temple direction.

[0229] This disclosure can also be described by the following sections.

[0230] Section 1. A method for compensating for the tilt of an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: taking one or more OCT images of a subject's eye using an OCT imaging device, wherein the IOL is implanted in the subject's eye; generating a fixation target so that the fixation target is visible to the subject's eye; and moving the fixation target until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system.

[0231] The method of paragraph 1, wherein the OCT imaging device is communicably coupled to an electronic display, and moving the fixation target further comprises moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0232] The method of paragraph 1, further comprising: determining the degree of tilt of the IOL and moving the fixation target based on the degree of tilt.

[0233] Section 4. The inclination angle of the IOL is approximately 4.0 degrees to approximately 8.0 degrees, according to the method in Section 1.

[0234] Paragraph 5. The method of paragraph 1, further comprising moving the fixation target in at least one of the following directions with respect to the subject: medial, lateral, downward, and upward.

[0235] Section 6. The method of Section 1, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective lens of the laser of the ophthalmic system, and moving the fixation target further includes moving the fixation target to a position not aligned with the Z-axis and in the axial direction.

[0236] Paragraph 7. When the subject is in a supine position, the optical axis is directed vertically, as in Paragraph 6.

[0237] Section 8. The method of Section 1, wherein the fixation target is the fixation light generated by the fixation light source.

[0238] Section 9. The method of Section 8, wherein the fixation light is a beam of light having wavelengths in the visible spectrum.

[0239] Paragraph 10. The method of Paragraph 8, wherein the fixation light is movable in response to user input by the user of the ophthalmic system.

[0240] Section 11. The method of Section 8, wherein the fixation light source is configured to be automatically moved by an ophthalmic system.

[0241] Section 12. The fixation target is displayed on a target display visible to the subject, using the method described in Section 1.

[0242] Section 13. The fixation target is a computer-generated graphic, using the method of Section 12.

[0243] Section 14. The method of Section 1, wherein the OCT imaging device is a built-in component of the ophthalmic system.

[0244] Section 15. A method for adjusting an intraocular lens (IOL), comprising: taking one or more OCT images of a subject's eye using an OCT imaging device, wherein the IOL is inserted into the subject's eye; generating a fixation target so that the fixation target is visible to the subject's eye; moving the fixation target until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of an ophthalmic system; and adjusting the base power of the IOL by directing a laser beam generated by a laser of an ophthalmic system towards the IOL.

[0245] Paragraph 16. The method of paragraph 15, wherein the OCT imaging device is communicably coupled to an electronic display, and moving the fixation target further includes moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0246] The method of paragraph 15, further comprising determining the degree of tilt of the IOL and moving the fixation target based on the degree of tilt.

[0247] Item 18. The degree of inclination of the IOL is approximately 4.0 degrees to approximately 8.0 degrees, according to the method of Item 17.

[0248] Paragraph 19. The method of paragraph 15, wherein moving the fixation target further includes moving the fixation target in at least one of the following directions with respect to the subject: inward, laterally, downward, and upward.

[0249] Paragraph 20. The method of paragraph 15, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective lens of the laser of the ophthalmic system, and moving the fixation target further includes moving the fixation target to a position not aligned with the Z-axis and in the axial direction.

[0250] Item 21. When the subject is in a supine position, the optical axis is directed vertically, as in the method of Item 20.

[0251] Section 22. The fixation target is the fixation light generated by the fixation light source, as in the method of Section 15.

[0252] Section 23. The method of Section 22, wherein the fixation light is a beam of light having wavelengths in the visible spectrum.

[0253] Paragraph 24. The method of Paragraph 22, wherein the fixation light is movable in response to user input by the user of the ophthalmic system.

[0254] Section 25. The method of Section 22, wherein the fixation light source is configured to be automatically moved by an ophthalmic system.

[0255] Section 26. The fixation target is displayed on a target display visible to the subject, using the method described in Section 15.

[0256] Section 27. The fixation target is a computer-generated graphic, according to the method of Section 26.

[0257] Section 28. The method of Section 15, wherein the OCT imaging device is a built-in component of the ophthalmic system.

[0258] Section 29. The laser beam is generated by a femtosecond laser, as in Section 15.

[0259] Paragraph 30. Directing a laser beam to an IOL, the method of paragraph 15, further comprising directing a laser beam to one or more haptics of the IOL.

[0260] Paragraph 31. The IOL is a controlled IOL, according to the method of paragraph 15.

[0261] Paragraph 32. The IOL is a non-adjustable fluid-adjustable IOL, according to the method of paragraph 15.

[0262] Paragraph 33. An ophthalmic system comprising: an OCT imaging device configured to generate one or more optical coherence tomography (OCT) images of a subject's eye in which an intraocular lens (IOL) is implanted; and a fixation target generator configured to generate a movable fixation target visible to the subject's eye, wherein the fixation target is moved until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system.

[0263] Paragraph 34. The ophthalmic system of paragraph 33, wherein the OCT imaging device is communicably coupled to an electronic display, and moving the fixation target further includes moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0264] Section 35. An ophthalmic system of Section 33, further comprising a laser configured to generate and direct a laser beam onto an IOL in order to adjust the base power of the IOL.

[0265] Paragraph 36. The ophthalmic system of paragraph 35, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective lens of the laser of the ophthalmic system, and the fixation target is configured to be moved to a position not aligned with the Z-axis and axially.

[0266] Paragraph 37. The ophthalmic system described in Paragraph 36, in which the optical axis is directed vertically when the subject is in a supine position.

[0267] Section 38. The ophthalmic system described in Section 35, in which the laser beam is generated by a femtosecond laser.

[0268] Paragraph 39. The ophthalmic system of paragraph 33, further comprising a control unit including one or more processors coupled to memory, the one or more processors being programmed to execute instructions stored in memory to determine the degree of tilt of an IOL, and a fixation target being configured to be moved based on the degree of tilt.

[0269] Section 40. The degree of tilt of the IOL is approximately 4.0 degrees to approximately 8.0 degrees, as described in Section 39 of the ophthalmic system.

[0270] Paragraph 41. The ophthalmic system of paragraph 33, wherein the fixation target is movable in at least one of the following directions with respect to the object: medial, lateral, downward, and upward.

[0271] Section 42. The fixation target is the fixation light generated by the fixation light source, which serves as the fixation target generating source, as defined in Section 33 of the ophthalmic system.

[0272] Section 43. Fixation light is a beam of light having wavelengths within the visible spectrum, as defined in Section 42 of the ophthalmic system.

[0273] Paragraph 44. The ophthalmic system of Paragraph 33, wherein the fixation target is movable in response to user input by the user of the ophthalmic system.

[0274] Section 45. The ophthalmic system of Section 33, configured such that the fixation target can be automatically moved by the ophthalmic system.

[0275] Section 46. The fixation target generation source is a target display visible to the subject, as defined in Section 33 of the ophthalmic system.

[0276] Section 47. Fixation targets are computer-generated graphics, as in Section 46 of the ophthalmic system.

[0277] Section 48. An ophthalmic system as described in Section 33, in which an OCT imaging device is an integrated component of the ophthalmic system.

[0278] Section 49. IOLs are accommodative IOLs, as defined in Section 33 of the ophthalmic system.

[0279] Section 50. IOL is a non-adjustable fluid-adjustable IOL, an ophthalmic system as defined in Section 33.

[0280] Several embodiments have been described. Nevertheless, those skilled in the art will understand that various modifications and improvements to the disclosure can be made without departing from the spirit and scope of the embodiments. Elements of systems, devices, apparatus and methods shown in any embodiment are illustrative for that particular embodiment and can be used in combination or otherwise in other embodiments within the disclosure. For example, the steps of any method depicted in the figures or described in the disclosure do not require a specific sequence or sequence shown or described in order to achieve the desired result. In addition, other step operations may be provided to achieve the desired result, or steps or operations may be excluded or omitted from the described method or process. Furthermore, any component or part of any apparatus or system described in the disclosure or depicted in the figures may be removed, excluded or omitted to achieve the desired result. In addition, certain components or parts of systems, devices or apparatus shown or described herein have been omitted for brevity and clarity.

[0281] Therefore, other embodiments are included within the scope of the claims set forth below, and this specification and / or drawings may be considered illustrative rather than restrictive.

[0282] Each of the individual variations or embodiments described and illustrated herein has individual components and features that can be readily separated from or combined with any features of other variations or embodiments. Modifications can be made to adapt specific situations, materials, substance compositions, processes, process actions, or steps to the object, spirit, or scope of the invention.

[0283] The methods described herein may be performed in any logically possible order of the events described, or in the order in which the events are described. Furthermore, additional steps or operations may be provided or omitted to achieve the desired result.

[0284] Furthermore, if a range of values ​​is provided, all values ​​between the upper and lower limits of that range, as well as any other specified values ​​within that specified range or values ​​contained therein, are also included in the present invention. Any optional feature of the described variant of the present invention may be expressed and claimed, either independently or in combination with any one or more of the features described herein. For example, a statement of a range of 1 to 5 should be considered to disclose partial ranges such as 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, and individual numerical values ​​within those ranges, such as 1.5, 2.5, etc., and any whole or partial increments between them.

[0285] All existing subject matter referenced herein (e.g., publications, patents, patent applications) is incorporated herein by reference in its entirety, except where such subject matter may conflict with the subject matter of the present invention (in which case the material present herein shall prevail). References are provided only with respect to disclosures prior to the filing date of this application. Nothing in this specification should be construed as acknowledging that the present invention is not entitled to a prior date by prior art.

[0286] References to singular items include the possibility of multiple identical items existing. More specifically, where used herein and in the accompanying claims, the singular forms “a,” “an,” “the said,” and “the” include the plural form unless the context clearly requires a different interpretation. Furthermore, it should be noted that claims may be drafted to exclude optional elements. Therefore, this statement is intended to serve as a prior basis for using exclusive terms such as “alone,” “only,” or for using “negative” limitations in connection with specifying claim elements. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the invention pertains.

[0287] A reference to the phrase "at least one of" means any combination of one or more of the respective items or components (or list of items or components) when such phrase modifies a plurality of items or components. For example, the phrase "at least one of A, B, and C" means (i) A, (ii) B, (iii) C, (iv) A, B, and C, (v) A and B, (vi) B and C, or (vii) A and C.

[0288] In understanding the scope of the present disclosure, the term "comprising" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of the recited features, elements, components, groups, integers, and / or steps, but do not preclude the presence of other unrecited features, elements, components, groups, integers, and / or steps. The above applies also to words having similar meanings, such as "including", "having", and their derivatives. The terms "portion", "section", "a part", "member", "element", or "component", when used in the singular, may have a dual meaning of a single part or multiple parts. As used herein, the terms indicating directions such as "front, rear, above, below, vertical, horizontal, downward, transverse, lateral, and perpendicular" and other similar terms indicating directions refer to those positions of the device or apparatus or those directions of the device or apparatus being translated or moved.

[0289] Finally, terms of degree such as "substantially", "about", and "approximately", as used herein, mean an appropriate amount of deviation from the explicitly stated value, or from the explicitly stated value plus or minus a reasonable amount such that the end result does not vary significantly or substantially (e.g., such variation is appropriate, a deviation of up to ±0.1%, ±1%, ±5%, or ±10%). For example, "about 1.0 cm" can be interpreted to mean "1.0 cm" or "0.9 cm to 1.1 cm". When a term of degree such as "about" or "approximately" is used to refer to a number or value that is part of a range, the term can be used to modify both the minimum and maximum numbers or values.

[0290] Those skilled in the art will understand that the various methods disclosed herein can be embodied in a non - transitory readable medium, a machine - readable medium, and / or a machine - accessible medium containing instructions that are compatible with, readable by, and / or executable by a processor of a machine, device, or computing device or a server processor. The instructions can be stored in one or more computer - readable memories or storage devices that execute tasks specified to be executed on a processor (e.g., a CPU, a GPU, or a processor core).

[0291] The present disclosure is not intended to be limited to the scope of the specific forms described, but is intended to include alternative, improved, and equivalent forms of the variations or embodiments described herein. Further, the scope of the present disclosure includes all other variations or embodiments that may be apparent to those skilled in the art in view of the present disclosure.

Claims

1. In ophthalmic systems, An OCT imaging device configured to generate one or more optical coherence tomography (OCT) images of a subject's eye in which an intraocular lens (IOL) is implanted inside the eye, A fixation target generator configured to generate a movable fixation target visible to the eye of the subject, wherein the fixation target is configured to move until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system, An ophthalmic system including

2. The ophthalmic system according to claim 1, wherein the OCT imaging device is communicably coupled to an electronic display, and moving the fixation target further includes moving the fixation target until the cross-section of the IOL in the state shown in one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

3. The ophthalmic system according to claim 1, further comprising a laser configured to generate a laser beam and adjust the base power of the IOL toward the IOL.

4. The ophthalmic system according to claim 3, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective lens of the laser of the ophthalmic system, and the fixation target is configured to be moved to a position not aligned axially with the Z-axis.

5. The ophthalmic system according to claim 4, wherein when the subject is in a supine position, the optical axis is directed in the vertical direction.

6. The ophthalmic system according to claim 3, wherein the laser beam is generated by a femtosecond laser.

7. The ophthalmic system according to claim 1, further comprising a control unit including one or more processors coupled to memory, the one or more processors being programmed to execute instructions stored in memory to determine the degree of tilt of the IOL, and the fixation target being configured to be moved based on the degree of tilt.

8. The ophthalmic system according to claim 7, wherein the degree of inclination of the IOL is approximately 4.0 degrees to approximately 8.0 degrees.

9. The ophthalmic system according to claim 1, wherein the fixation target is movable in at least one of the following directions with respect to the subject: inward, laterally, downward, and upward.

10. The ophthalmic system according to claim 1, wherein the fixation target is fixation light generated by a fixation light source that serves as the fixation target generation source.

11. The ophthalmic system according to claim 10, wherein the fixation light is a beam of light having wavelengths in the visible spectrum.

12. The ophthalmic system according to claim 1, wherein the fixation target is movable in response to user input by the user of the ophthalmic system.

13. The ophthalmic system according to claim 1, wherein the fixation target is configured to be automatically moved by the ophthalmic system.

14. The ophthalmic system according to claim 1, wherein the fixation target generation source is a target display visible to the subject.

15. The ophthalmic system according to claim 14, wherein the fixation target is a computer-generated graphic.

16. The ophthalmic system according to claim 1, wherein the OCT imaging device is a built-in component of the ophthalmic system.

17. The ophthalmic system according to claim 1, wherein the IOL is an accommodative IOL.

18. The ophthalmic system according to claim 1, wherein the IOL is a non-adjustable fluid-adjustable IOL.

19. In a method for adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, The process involves taking one or more OCT images of a subject's eye using an OCT imaging device, wherein the IOL is inserted into the subject's eye, and the image is taken accordingly. The fixation target is generated such that the fixation target is visible to the eye of the subject, The fixation target is moved until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system. A method that includes this.

20. In the method of adjusting intraocular lenses (IOLs), The process involves taking one or more OCT images of a subject's eye using an OCT imaging device, wherein the IOL is inserted into the subject's eye, and the image is taken accordingly. The fixation target is generated such that the fixation target is visible to the eye of the subject, The fixation target is moved until the cross-section of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system, The laser beam generated by the laser of the ophthalmic system is directed towards the IOL to adjust the base power of the IOL, A method that includes this.

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