Systems and methods for compensating for intraocular lens tilt

Abstract

Systems and methods for compensating for tilt of an intraocular lens (IOL) and systems and methods for adjusting an IOL are disclosed herein. For example, one of the methods may include capturing one or more optical coherence tomography (OCT) images of a subject's eye while implanting the IOL within the subject's eye. The method may further include generating a fixation target such that the fixation target is visible to an eye of the subject; and moving the fixation target until the lateral plane 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 a laser of the ophthalmic system at the IOL.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 63 / 511,306, filed June 30, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure generally pertains to the field of intraocular lenses, and more specifically to systems and methods for compensating for tilt of the intraocular lens (IOL) as part of an IOL adjustment procedure. Background Technology

[0004] Cataracts are a condition involving the clouding of the normally clear lens of a person's eye. Cataracts occur due to aging, genetic factors, trauma, inflammation, metabolic disorders, or exposure to radiation. Age-related cataracts are the most common type. During cataract surgery, doctors remove the original lens matrix from the eye's capsule and replace it with an intraocular lens (IOL). Traditional IOLs provide one or more selected focal lengths that allow the eye to see at a distance. However, after cataract surgery, because the eye can no longer adjust (or change its optical power) to maintain a clear image or focus on objects as their distance changes, people with traditional IOLs often require glasses or other corrective eyewear for certain activities.

[0005] Newer IOLs (such as accommodative IOLs) allow the eye to regain at least some focusing ability. Accommodative IOLs (AIOLs) use available forces in the eye to change a part of the optical system in order to refocus the eye on distant or near targets. Additionally, adjustments to AIOLs and non-accommodative IOLs may be necessary post-operatively or after implantation in the subject's eye. In some cases, laser treatment can be used to adjust the implanted IOL or AIOL.

[0006] However, the way an IOL or AIOL is positioned or oriented within the eye can make post-implantation adjustment difficult. Therefore, improved solutions that allow clinicians or other medical professionals to safely and accurately adjust the AIOL or IOL post-operatively may be beneficial. Such solutions should also be designed with clinical factors in mind. Summary of the Invention

[0007] This document discloses systems and methods for compensating for tilt of an intraocular lens (IOL) and for adjusting an IOL. In some embodiments, a method for compensating for tilt of an intraocular lens (IOL) using optical coherence tomography (OCT) guidance includes: capturing one or more OCT images of a subject's eye using an OCT imaging device, wherein the IOL may be implanted in the subject's eye; generating a fixation target such that the fixation target is visible to the subject's eye; and moving the fixation target until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system.

[0008] In some embodiments, the OCT imaging device may be communicatively coupled to an electronic display, and wherein the motion fixation target further includes moving the fixation target until the lateral plane of the IOL as 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.

[0009] In some embodiments, the method may further include determining the tilt angle of the IOL and moving the fixation target based on the tilt angle.

[0010] In some embodiments, the tilt of the IOL may have a tilt angle between about 4.0 degrees and about 8.0 degrees.

[0011] In some embodiments, the moving fixation target may further include at least one upward moving fixation target relative to the subject in the medial, lateral, downward, and upward directions.

[0012] In some embodiments, the optical axis of the ophthalmic system may be the Z-axis of the focusing lens or focusing objective of the laser of the ophthalmic system, and wherein moving the fixation target may further include moving the fixation target to a position not aligned with the Z-axis axis.

[0013] In some embodiments, the optical axis can be vertically oriented when the subject is lying supine.

[0014] In some embodiments, the fixation target can be a fixation light generated by a fixation light source.

[0015] In some embodiments, the fixed light can be a beam of light with wavelengths in the visible spectrum.

[0016] In some embodiments, the fixation light may be movable in response to user input from the user of the ophthalmic system.

[0017] In some embodiments, the fixation light source can be configured to be moved automatically by the ophthalmic system.

[0018] In some embodiments, the fixation target may be displayed on a target display that is visible to the subject.

[0019] In some embodiments, the fixation target may be a computer-generated graphic.

[0020] In some embodiments, the OCT imaging device may be a component of an ophthalmic system.

[0021] In some embodiments, a method of adjusting an intraocular lens (IOL) includes: using an OCT imaging device to capture one or more OCT images of a subject's eye, wherein the IOL is implanted in 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 the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system; and directing a laser beam generated by a laser of the ophthalmic system to the IOL to adjust the fundamental focal power of the IOL.

[0022] In some embodiments, the OCT imaging device may be communicatively coupled to an electronic display, and wherein the motion fixation target further includes moving the fixation target until the lateral plane of the IOL as 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.

[0023] In some embodiments, the method further includes determining the tilt angle of the IOL and moving the fixation target based on the tilt angle.

[0024] In some embodiments, the tilt angle of the IOL can be between about 4.0 degrees and about 8.0 degrees.

[0025] In some embodiments, the moving fixation target may further include at least one upward moving fixation target relative to the subject in the medial, lateral, downward, and upward directions.

[0026] In some embodiments, the optical axis of the ophthalmic system may be the Z-axis of the focusing lens or focusing objective of the laser of the ophthalmic system, and wherein moving the fixation target further includes moving the fixation target to a position not aligned with the Z-axis axis.

[0027] In some embodiments, the optical axis can be vertically oriented when the subject is lying supine.

[0028] In some embodiments, the fixation target can be a fixation light generated by a fixation light source.

[0029] In some embodiments, the fixed light can be a beam of light with wavelengths in the visible spectrum.

[0030] In some embodiments, the fixation light may be movable in response to user input from the user of the ophthalmic system.

[0031] In some embodiments, the fixation light source can be configured to be moved automatically by the ophthalmic system.

[0032] In some embodiments, the fixation target may be displayed on a target display that is visible to the subject.

[0033] In some embodiments, the fixation target may be a computer-generated graphic.

[0034] In some embodiments, the OCT imaging device may be an integrated component of an ophthalmic system.

[0035] In some embodiments, the laser beam may be generated by a femtosecond laser.

[0036] In some embodiments, directing the laser beam to the IOL may further include directing the laser beam to one or more loops of the IOL.

[0037] In some embodiments, the IOL can be a regulated IOL.

[0038] In some embodiments, the IOL may be a non-adjustable fluid-adjustable IOL.

[0039] In some embodiments, an ophthalmic system is disclosed. The ophthalmic system includes: an optical coherence tomography (OCT) imaging device configured to generate one or more OCT images of an eye having an intraocular lens (IOL) implanted within the eye of a subject; and a fixation target source configured to generate a movable fixation target visible to the subject's eye, wherein the fixation target is configured to move until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system.

[0040] In some embodiments, the OCT imaging device may be communicatively coupled to an electronic display, and wherein the motion fixation target further comprises moving the fixation target until the lateral plane of the IOL as 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.

[0041] In some embodiments, the ophthalmic system further includes a laser configured to generate a laser beam and direct the laser beam to the IOL to adjust the fundamental focal power of the IOL.

[0042] In some embodiments, the optical axis of the ophthalmic system may be the Z-axis of the focusing lens or focusing objective of the laser in the ophthalmic system, and wherein the fixation target is configured to move to a position not aligned with the Z-axis axis.

[0043] In some embodiments, the optical axis can be vertically oriented when the subject is lying supine.

[0044] In some embodiments, the laser beam may be generated by a femtosecond laser.

[0045] In some embodiments, the ophthalmic system may further include a control unit including one or more processors coupled to a memory, wherein the one or more processors may be programmed to execute instructions stored in the memory to determine the tilt of the IOL, and wherein the fixation target is configured to move based on the tilt.

[0046] In some embodiments, the tilt of the IOL can be between about 4.0 degrees and about 8.0 degrees.

[0047] In some embodiments, the fixation target may be movable relative to the subject in at least one of the medial, lateral, downward, and upward directions.

[0048] In some embodiments, the fixation target can be fixation light generated by a fixation light source used as the fixation target source.

[0049] In some embodiments, the fixed light can be a beam of light with wavelengths in the visible spectrum.

[0050] In some embodiments, the fixation target may be movable in response to user input from the user of the ophthalmic system.

[0051] In some embodiments, the fixation target can be configured to be moved automatically by the ophthalmic system.

[0052] In some embodiments, the fixation target source may be a target display that is visible to the subject.

[0053] In some embodiments, the fixation target may be a computer-generated graphic.

[0054] In some embodiments, the OCT imaging device may be an integrated component of an ophthalmic system.

[0055] In some embodiments, the IOL can be a regulated IOL.

[0056] In some embodiments, the IOL may be a non-adjustable fluid-adjustable IOL. Attached Figure Description

[0057] Figure 1A A top plan view of one embodiment of the IOL is shown.

[0058] Figure 1B and Figure 1C It shows the section cut along section AA Figure 1A A cross-sectional view of the IOL.

[0059] Figure 1DA cross-sectional view of another embodiment of the IOL is shown.

[0060] Figure 1E This displays an exploded view of the IOL.

[0061] Figure 2 The diagram shows a flattened ellipse and a slender rectangle. The flattened ellipse represents the tilted IOL, and the slender rectangle represents the treatment area of ​​the laser that can be used to adjust the base focal length of the IOL.

[0062] Figure 3 An ophthalmic system configured to compensate for or adjust the tilt of the IOL was demonstrated.

[0063] Figure 4A An embodiment of a fixed target source implemented as a fixed light source is shown.

[0064] Figure 4B Another embodiment of a fixed target source implemented as a target display is shown.

[0065] Figure 4C Another embodiment of a fixed target source implemented as a target display is shown.

[0066] Figure 5A This is a schematic cross-sectional view of an inclined IOL implanted in the subject's eye.

[0067] Figure 5B This is a schematic cross-sectional view of a fixed target used for correction. Figure 5A The tilt of the implanted IOL.

[0068] Figure 6 This is an oblique cross-sectional OCT image showing the implanted IOL.

[0069] Figure 7 It demonstrates several possible directions in which a fixed target can be moved. Detailed Implementation

[0070] Figure 1A A top plan view of one embodiment of an adjustable intraocular lens (IOL) 100 is shown. For example, the adjustable IOL may be an adjustable accommodative IOL (AIOL). The IOL 100 can be implanted in a subject to correct defocus aberrations, corneal astigmatism, spherical aberrations, or a combination thereof. The IOL 100 may include an optical element portion 102 and one or more loops 104 (including a first loop 104A and a second loop 104B connected to and extending peripherally from the optical element portion 102). The IOL 100 may be positioned within the native capsular bag where the native lens has been removed.

[0071] In some embodiments, the loop 104 may be coupled to and adhered to an optical component.

[0072] Part 102. For example, loops 104 can be adhered to optical part 102 after each loop is formed separately.

[0073] In other embodiments, IOL 100 may be a one-piece lens, such that loop 104 is attached to and extends therefrom the optical portion 102. In these embodiments, loop 104 is formed together with the optical portion 102, rather than being adhered to or otherwise coupled to the optical portion 102 in a subsequent step.

[0074] After the subject's native lens has been removed, the IOL 100 can be implanted into the subject's native capsular bag. When implanted into the native capsular bag, the optic portion 102 can be adapted to refract light entering the eye onto the retina. One or more loops 104 can be configured to engage the capsular bag and adapted to deform in response to ciliary muscle movements (e.g., muscle relaxation, muscle contraction, or a combination thereof) associated with changes in the shape of the capsular bag.

[0075] Each loop 104 may include a loop fluid cavity 106 extending through at least a portion of the loop 104. For example, a first loop 104A may include a first loop fluid cavity 106A extending through at least a portion of the first loop 104A, and a second loop 104B may include a second loop fluid cavity 106B extending through at least a portion of the second loop 104B. The loop fluid cavity 106 (e.g., either the first loop fluid cavity 106A or the second loop fluid cavity 106B) may be in fluid communication with or fluidly connected to the optical fluid chamber 108 within the optical component portion 102.

[0076] The optical fluid chamber 108 can be in fluid communication with one or more loop fluid cavities 106 via one or more fluid channels 110. The fluid channel 110 can be a conduit or passageway that fluidly connects the optical fluid chamber 108 to the loop fluid cavity 106. The fluid channels 110 can be spaced apart from each other. For example, a pair of fluid channels 110 can be spaced between about 0.1 mm and about 1.0 mm apart. In some embodiments, each fluid channel 110 can have a diameter between about 0.4 mm and about 0.6 mm.

[0077] The loop 104 can be connected to the optical component portion 102 at the reinforcing portion 112. The reinforcing portion 112 can serve as a loop-optical component interface. A pair of fluid channels 110 can be defined or formed within a portion of the reinforcing portion 112.

[0078] like Figure 1AAs shown, the optical component fluid chamber 108 can be in fluid communication with the first loop fluid cavity 106A through the first pair of fluid channels 110A. The optical component fluid chamber 108 can also be in fluid communication with the second loop fluid cavity 106B through the second pair of fluid channels 110B.

[0079] In some embodiments, a first pair of fluid channels 110A and a second pair of fluid channels 110B may be positioned substantially on opposite sides of the optical component portion 102. The first pair of fluid channels 110A may be positioned substantially diametrically opposed to the second pair of fluid channels 110B. The first pair of fluid channels 110A and the second pair of fluid channels 110B may be defined or extended through a portion of the optical component portion 102. The first pair of fluid channels 110A and the second pair of fluid channels 110B may be defined or extended through the rear element 132 of the optical component portion 102 (see, for example...). Figures 1B to 1E ).

[0080] Figure 1A It is also shown that each loop 104 (e.g., either a first loop 104A or a second loop 104B) can have a proximal attachment end 114 and a distal free end 116. A loop fluid port 152 may be defined at the proximal attachment end 114 of the loop 104 (see, for example...). Figure 1E The loop fluid port 152 can serve as an opening for the loop fluid cavity 106. When the loop 104 is coupled to the optical component portion 102, fluid within the loop fluid cavity 106 can flow out of the loop fluid cavity 106 through the loop fluid port 152 and flow into the optical component fluid chamber 108 via the fluid channel 110. Similarly, fluid within the optical component fluid chamber 108 can flow out of the optical component fluid chamber 108 through a pair of fluid channels 110 and flow into the loop fluid cavity 106 via the loop fluid port 152.

[0081] Each loop 104 may include a radially outer wall 118 and a radially inner wall 120 within the loop lumen. The radially outer wall 118 (also referred to as the radially outer wall of loop 104) may be configured to face and contact the inner surface of the patient's pocket when the IOL 100 is implanted within the pocket. The radially inner wall 120 (also referred to as the radially inner wall of loop 104) may be configured to face the outer peripheral surface 122 of the optical portion 102.

[0082] As previously discussed, after the native lens has been removed from the capsular bag, an IOL 100 can be implanted or introduced into the patient's capsular bag. The patient's capsular bag is connected to suspensory ligament fibers, which in turn connect to the patient's ciliary muscle. The capsular bag is elastic, and ciliary muscle movement can change its shape via the suspensory ligament fibers. For example, when the ciliary muscle relaxes, the suspensory ligaments are stretched. This stretching pulls the capsular bag in a generally radially outward direction due to radially outward forces. This pulling on the capsular bag causes it to elongate, creating space within the bag. When the patient's native lens is present in the capsular bag, the native lens typically becomes flatter (in the anteroposterior direction), which reduces the lens's optical power, thus allowing for distance vision. In this configuration, the patient's native lens is said to be in a state of disaccommodation or undergoing disaccommodation.

[0083] However, when the ciliary muscle contracts, as occurs when the eye attempts to focus on a near object, the radially inward portion of the muscle moves radially inward, causing the suspensory ligaments to relax. This relaxation allows the elastic capsule to contract and exert a radially inward force on the lens within the capsule. When the patient's native lens is present within the capsule, it typically becomes more curved (e.g., the anterior portion of the lens becomes more curved), giving the lens greater optical power, thus allowing the eye to focus on near objects. In this configuration, the patient's native lens is said to be in a state of accommodation or undergoing accommodation.

[0084] In embodiments where IOL 100 is an AIOL, the radial outer wall 118 of the loop lumen of the implanted AIOL can directly engage with or physically contact the portion of the capsule that connects to or is attached to the suspensory ligament or suspensory ligament fibers. Therefore, the radial outer wall 118 of the loop lumen of the AIOL can be configured to respond to capsule shape-changing forces that are radially applied when the suspensory ligament relaxes and stretches due to ciliary muscle movement.

[0085] For example, when the ciliary muscle contracts, the peripheral region of the elastic capsule changes shape and exerts a radially inward force on the radially outer wall 118 of the loop cavity of each loop 104. When the IOL 100 is an AIOL, the radially outer wall 118 of the loop cavity can deform or otherwise change shape, and such deformation or shape change can cause a reduction in the volume of the loop fluid cavity 106. When the volume of the loop fluid cavity 106 decreases, fluid within the loop fluid cavity 106 is moved into or pushed into the optical fluid chamber 108. The optical portion 102 of the AIOL can change shape in response to fluid entering the optical fluid chamber 108 from the loop fluid cavity 106. This can increase the fundamental power or fundamental spherical power of the AIOL and allow patients with AIOLs implanted in their eyes to focus on near objects. In this state, the adjustable AIOL can be considered as having undergone accommodation.

[0086] When the ciliary muscle relaxes, the peripheral region of the elastic capsule stretches radially outward and the capsule elongates, creating more space within it. The radially outer wall 118 of the loop cavity 104 can be configured to respond to this change in capsule shape by returning to its undeformed or unstressed configuration. This causes the volume of the loop fluid cavity 106 to increase or return to its undeformed volume. This increase in the volume of the loop fluid cavity 106 can cause fluid within the optical fluid chamber 108 to be drawn out of or otherwise flow out of the optical fluid chamber 108 and back into the loop fluid cavity 106. Fluid moves from the optical fluid chamber 108 into the loop fluid cavity 106 through the same fluid channel 110 formed within the optical portion 102.

[0087] The optical component 102 of the AIOL can change shape in response to fluid leaving the optical component fluid chamber 108 and entering the loop fluid chamber 106. This reduces the fundamental power or fundamental spherical power of the AIOL and allows patients with AIOLs implanted in their eyes to focus on distant objects or provide distance vision. In this state, the AIOL can be considered to have lost accommodation.

[0088] When IOL 100 is AIOL, the radial outer wall 118 of the loop 104 can be made thinner than the radial inner wall 120 of the loop 104 to allow the loop 104 to maintain a high sensitivity to radial forces applied to the equatorial region of the loop 104 due to changes in the shape of the pouch caused by ciliary muscle movement. Figures 1B to 1D As shown, the radial inner wall 120 of the loop 104 can be designed to be thicker or larger than the radial outer wall 118 of the loop to provide stiffness or elasticity to the loop 104 in the anteroposterior direction. In some embodiments, the shape of the radial inner wall 120 can be tapered when it is closer to the optical component portion 102. When designed in this way, the loop 104 can be less sensitive to bag forces applied in the anteroposterior direction. For example, when bag forces are applied to the loop 104 in the anteroposterior direction, the fluid movement between the loop fluid cavity 106 and the optical component fluid chamber 108 is smaller compared to when forces are applied in the radial direction. Because of the smaller fluid movement, the change in the fundamental focal power of the AIOL is also smaller.

[0089] Although AIOLs are depicted and described in this disclosure, any reference to AIOLs may also refer to one of the AIOLs discussed and depicted in the following U.S. publications: U.S. Patent Publication No. 2021 / 0100652; U.S. Patent Publication No. 2021 / 0100650; U.S. Patent Publication No. 2020 / 0337833; and U.S. Patent Publication No. 2018 / 0153682; and one of the AIOLs discussed and depicted in the following granted 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 contents of which are incorporated herein by reference in their entirety.

[0090] Furthermore, despite Figures 1A to 1E While IOL 100 is presented as AIOL, this disclosure contemplates that IOL 100 could also be a non-adjustable adjustable IOL (also known as a statically adjustable focus IOL). Examples of non-adjustable or statically adjustable focus IOLs are discussed in U.S. Patent No. 11,471,272, the contents of which are incorporated herein by reference in their entirety.

[0091] In some embodiments, the IOL 100 may be designed such that the gap 124 or void spatially separates the radially inner wall 120 of the loop cavity of the loop 104 from the outer peripheral surface 122 of the optical portion 102. This allows a portion of the loop 104 to respond to, for example, a laser 125 directed at the loop 104 (see, for example...). Figures 1B to 1D It changes shape due to external energy such as (e.g., ).

[0092] Figure 1A It was also shown that one or more portions of each loop 104 could be made of a composite material. As will be discussed in more detail in later sections, the composite material may include an energy-absorbing component, multiple expandable or contractile components, and a crosslinked copolymer for making the remainder of the loop 104, or may be made in part from the above. The multiple portions of the loop 104 made of composite material can be configured to respond to a laser 125 directed at the composite material (see, for example...). Figures 1B to 1D It can expand or contract. Depending on the location of the composite material or its integration within each loop 104, the composite material can act as an inner cavity filler 126 to occupy space within the loop fluid inner cavity 106, an inner cavity expander 128 to create more space within the loop fluid inner cavity 106, or act as a retractable part to free up space within the inner cavity or cavity.

[0093] As will be discussed in more detail in later chapters, when laser 125 is applied to the composite material configured as cavity filler 126, the composite material can expand, and in this case, the expansion of the composite material can reduce the volume of the loop fluid cavity 106 and displace the fluid within the loop fluid cavity 106 into the optical fluid chamber 108. This can cause the optical portion 102 to change shape (e.g., make the front or rear element of the optical portion 102 more curved), thereby increasing the fundamental power of the optical portion 102.

[0094] Alternatively, when laser 125 is applied to the composite material configured as an internal cavity expander 128, the composite material can expand, and in this case, the expansion of the composite material can increase the volume of the loop fluid cavity 106 and draw fluid from the optical fluid chamber 108 into the loop fluid cavity 106. This can also change the shape of the optical portion 102 (e.g., making the front or rear element of the optical portion 102 less curved or flatter), thereby reducing the fundamental focal power of the optical portion 102.

[0095] In yet another embodiment, when laser 125 is applied to the composite material configured as a shrinkable portion, the shrinkable portion can shrink or decrease in size, and the shrinkage or reduction of the shrinkable portion can increase the volume of the loop fluid cavity 106 and draw fluid from the optical fluid chamber 108 into the loop fluid cavity 106. This can also change the shape of the optical portion 102 (e.g., making the front or rear element of the optical portion 102 less curved or flatter), thereby reducing the base focal power of the optical portion 102.

[0096] One technical problem faced by the applicant is that once the IOL 100 is implanted into the patient's capsular bag, the strong healing response of the tissue within the capsular bag can compress or shrink the optics portion 102 of the lens, resulting in a higher power than initially intended. Another technical problem faced by the applicant is that preoperative biometry of the patient's eye may be incorrect, leading to the creation and implantation of a lens with an incorrect power. Furthermore, yet another technical problem faced by the applicant is that the patient's cornea or intraocular muscles may change due to injury, disease, or aging. One technical solution discovered and developed by the applicant is to design an IOL 100 that can be adjusted post-operatively (i.e., after implantation) to account for such changes or errors.

[0097] Figure 1B and Figure 1C Showing Figure 1A A cross-sectional view taken along section AA from IOL 100. (See attached image.) Figure 1B and Figure 1CAs shown, the optical component 102 may include a front element 130 and a rear element 132. An optical component fluid chamber 108 filled with fluid may be defined between the front element 130 and the rear element 132.

[0098] 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 one or a combination of the front optical surface 134, the rear optical surface 138, or other similar surfaces may be considered and referred to as external optical surfaces. The front inner surface 136 and the rear inner surface 140 may face the optical fluid chamber 108. At least a portion of the front inner surface 136 and at least a portion of the rear inner surface 140 may serve as chamber walls of the optical fluid chamber 108.

[0099] like Figure 1B and Figure 1C As shown, the optical component 102 may have a lens optical axis 142 that extends through the center of the optical component 102 in the front-rear direction. The lens optical axis 142 may extend through the center of both the front element 130 and the rear element 132.

[0100] The thickness of the front element 130 may be greater at or near the lens optical axis 142 than at the periphery of the front element 130. In some embodiments, the thickness of the front element 130 may gradually increase from the periphery of the front element 130 toward the lens optical axis 142.

[0101] In some embodiments, the thickness of the front element 130 at or near the lens optical axis 142 may be between about 0.45 mm and about 0.55 mm. In these and other embodiments, the thickness of the front element 130 near its periphery may be between about 0.20 mm and about 0.40 mm. Furthermore, the front inner surface 136 of the front element 130 may have a smaller curvature or be flatter than the front optical surface 134.

[0102] The thickness of the rear element 132 may be greater at or near the lens optical axis 142 than the portion of the rear element 132 radially outward from the lens optical axis 142 but before reaching the protruding periphery 144 of the rear element 132. The thickness of the rear element 132 may gradually decrease from the lens optical axis 142 to the portion radially outward from the lens optical axis 142 (but before reaching the protruding periphery 144). Figure 1B and Figure 1C As shown, the thickness of the rear element 132 can increase again from the radially inner portion of the protrusion periphery 144 to the radially outer portion of the protrusion periphery 144.

[0103] In some embodiments, the thickness of the rear element 132 at or near the lens optical axis 142 may be between about 0.45 mm and about 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 periphery 144) may be between about 0.20 mm and about 0.40 mm. The thickness of the rear element 132 near the radially outer portion of the raised periphery 144 may be between about 1.00 mm and 1.15 mm. Furthermore, the rear inner surface 140 of the rear element 132 may have a smaller curvature or be flatter than the rear optical surface 138.

[0104] The optical component 102 may have a base focal length or a base spherical focal length. The base focal length of the optical component 102 may be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber 108. The base focal length of the optical component 102 may be configured to increase or decrease as fluid enters or leaves the fluid-filled optical component fluid chamber 108.

[0105] The base focal length of the optical component 102 can be configured to adjust to the fluid flow. Figure 1B The curvature of the optical component fluid chamber 108, as depicted by the curved dashed arrow, increases as fluid enters from the loop fluid cavity 106 into the fluid-filled chamber. For example, the front element 130 of the optical component portion 102 may be configured to increase its curvature in response to fluid entering the optical component fluid chamber 108. Additionally, for example, the rear element 132 of the optical component portion 102 may be configured to increase its curvature in response to fluid entering the optical component fluid chamber 108. In another embodiment, both the front element 130 and the rear element 132 may be configured to increase their curvature in response to fluid entering the optical component fluid chamber 108.

[0106] The base focal length of the optical component 102 can be configured to change with the fluid flow. Figure 1C The curved dashed arrows depict the decrease in curvature as fluid leaves or is drawn out of the fluid-filled optical chamber 108 and enters the loop fluid cavity 106. For example, the front element 130 of the optical portion 102 may be configured to reduce its curvature (or flatten) in response to fluid leaving the optical chamber 108. Similarly, the rear element 132 of the optical portion 102 may be configured to reduce its curvature (or flatten) in response to fluid leaving the optical chamber 108. In another embodiment, both the front element 130 and the rear element 132 may be configured to reduce their curvature in response to fluid leaving the optical chamber 108.

[0107] It should be noted that, although Figure 1B and Figure 1CThe curved dashed arrows illustrate the entry and exit of fluid from the loop fluid cavity 106 into the optical fluid chamber 108, but also the entry and exit of fluid from the optical fluid chamber 108 via fluid channels 110 and orifices 146 defined along the rear element 132. The orifice 146 can be a hole or opening defined along the rear element 132, serving as the end of the fluid channel 110. When the IOL 100 includes a pair of fluid channels 110, the pair of orifices 146 serving as the ends of the fluid channels 110 can be spaced apart from each other between approximately 0.1 mm and approximately 1.0 mm.

[0108] like Figure 1B and Figure 1C As shown, one or more portions of IOL 100 may be made of a composite material designed to respond to external energy (such as laser 125) applied to the composite material. For example, one or more portions of each loop 104 of IOL 100 may be made of a composite material.

[0109] Depending on the location of the composite material or its integration within each loop 104 and the composition of the composite material, the composite material can serve as an inner cavity filler 126, an inner cavity expander 128, or a retractable portion.

[0110] For example, the lumen filler 126 may be part of a loop 104 made of a composite material, designed to reduce the volume of the loop fluid lumen 106 in response to external energy (e.g., laser 125) directed at the lumen filler 126. The lumen expander 128 may be part of a loop 104 made of a composite material, designed to increase the volume of the loop fluid lumen 106 in response to external energy (e.g., laser 125) directed at the lumen expander 128.

[0111] like Figure 1B and Figure 1C As shown, each loop 104 may include a channel 148. The channel 148 may be defined within a portion of the radial inner wall 120 of the loop cavity. For example, the channel 148 may extend partially into the radial inner wall 120 of the loop cavity. The channel 148 may be in fluid communication with the loop fluid cavity 106 or may be considered part of the loop fluid cavity 106.

[0112] In some embodiments, the lumen filler 126 may be positioned at the rear of the channel 148. In these embodiments, the lumen filler 126 may replace or serve as the rear portion of the radial inner wall 120 of the loop lumen. The lumen filler 126 may also be positioned radially inward within the loop fluid lumen 106 that is not a portion of the channel 148.

[0113] At least a portion of the lumen filler 126 may be in fluid communication with the channel 148. For example, at least a portion of the front portion or layer of the lumen filler 126 may be in fluid communication with the channel 148 or otherwise exposed to the channel.

[0114] like Figure 1B and Figure 1C As shown, in some embodiments, the radially outer side of the lumen filler 126 is not in fluid communication with the loop fluid lumen 106. In these embodiments, the radially outer side of the lumen filler 126 is separated from the loop fluid lumen 106 by a portion of the loop 104 that is not made of composite material.

[0115] The lumen expander 128 can be positioned radially inside the channel 148. The lumen expander 128 can also be positioned in front of the lumen filler 126. More specifically, for example, the lumen expander 128 can be positioned in front of the radially inner portion of the lumen filler 126.

[0116] In some embodiments, the lumen expansion 128 may be positioned within the channel 148. In these embodiments, the lumen expansion 128 may be positioned at the radially innermost end of the channel 148. For example, the shape of the inner radial wall 120 of the loop lumen may be tapered when the inner radial wall 120 of the loop lumen is closer to the optical component portion 102. The lumen expansion 128 may be positioned at the radially innermost end of the channel 148, near the tapered end of the inner radial wall 120 of the loop lumen.

[0117] like Figure 1B and Figure 1C As shown, the radially outer side of the lumen expansion 128 may be in fluid communication with the channel 148 and the loop fluid lumen 106. In some embodiments, the lumen expansion 128 does not extend all the way to the radially innermost portion of the radially inner wall 120 of the loop lumen. In these embodiments, a portion of the loop 104 that is not made of composite material may serve as the radially innermost portion of the radially inner wall 120 of the loop lumen and separate the lumen expansion 128 from the outer peripheral surface 122 of the optical component portion 102.

[0118] In some embodiments, the lumen expander 128 may be connected to or otherwise coupled to the lumen filler 126. In these and other embodiments, the lumen expander 128 and the lumen filler 126 may be or refer to different portions of the same composite material. For example, the lumen filler 126 may be substantially shaped as a curved corner, and the lumen expander 128 may be substantially shaped as a rectangular cuboid extending from the front surface of the corner.

[0119] Those skilled in the art will understand that even when different shades are used in the drawings to distinguish between the inner cavity filler 126 and the inner cavity expander 128 (i.e., a darker shaded pattern is used to depict the inner cavity expander 128 and a lighter shaded pattern is used to depict the inner cavity filler 126), both the inner cavity filler 126 and the inner cavity expander 128 may be made of the same composite material or refer to different parts / features of the same composite material.

[0120] In other embodiments, the lumen filler 126 and the lumen expander 128 may be made of different types of composite materials. In these embodiments, the lumen filler 126 may be made of a first type of composite material, and the lumen expander 128 may be made of a second type of composite material. In some embodiments, the lumen filler 126 and the lumen expander 128 may be made of composite materials of different colors. For example, the composite material may contain energy-absorbing components, such as energy-absorbing pigments or dyes.

[0121] As a more specific example, the cavity filler 126 or the cavity expander 128 may be made of a composite material containing a black energy-absorbing pigment (such as graphitized carbon black). In this example, if one of the cavity filler 126 or the cavity expander 128 is made of a composite material containing graphitized carbon black, the other may be made of a different type of composite material containing a red energy-absorbing pigment such as an azo dye (e.g., Disperse Red 1 dye).

[0122] like Figure 1B As shown, external energy (such as laser 125) can be directed at the cavity filler 126 to cause at least a portion of the cavity filler 126 to expand and increase in size. For example, this expansion can manifest itself as a protrusion growing or protruding from the cavity filler 126. For instance, when laser 125 is directed at the front portion or layer of the cavity filler 126 that is in fluid communication with or otherwise exposed to the channel 148, a protrusion can grow from the front portion and into the channel 148. Since the channel 148 is in fluid communication with (or is considered part of) the loop fluid cavity 106, the volume of the loop fluid cavity 106 can decrease in response to the formation of the protrusion. This can allow fluid within the loop fluid cavity 106 to be pushed into or otherwise displaced into the optical fluid chamber 108. As a result, at least one of the front element 130 and the rear element 132 can increase its curvature, and the base focal length of the optical portion 102 can increase in response to laser stimulation directed at the cavity filler 126.

[0123] External energy, such as laser 125 (e.g., a laser pulse), can be directed at the cavity expander 128 to cause at least a portion of the cavity expander 128 to expand and increase in size. This expansion can itself manifest as an expansion of the channel 148, as will be discussed in more detail in later sections. For example, when laser 125 is directed at the cavity expander 128, the cavity expander 128 can increase in size and enlarge the channel 148. Since the channel 148 is in fluid communication with (or is considered part of) the loop fluid cavity 106, the volume of the loop fluid cavity 106 can increase in response to the increase in the cavity expander 128. This allows fluid within the loop fluid cavity 106 to be drawn from the optical fluid chamber 108 and into the loop fluid cavity 106. As a result, at least one of the front element 130 and the rear element 132 can reduce its curvature, and the base focal length of the optical portion 102 can be reduced in response to a laser 125 (e.g., a laser pulse) directed at the cavity expander 128.

[0124] Figure 1D A cross-sectional view of another embodiment of the IOL 100 is shown, which includes a retractable portion 160 made of a different type of composite material. In some embodiments, the retractable portion 160 may be adhered to or otherwise coupled to a portion of the radial inner wall 120 of the loop cavity of each loop 104. Figure 1D As shown, the retractable portion 160 may be adhered to or otherwise attached to a portion of the rear portion of the radial inner wall 120 of the loop cavity. In other embodiments not shown in the figures, the retractable portion 160 may be adhered to or otherwise attached to a portion of the front portion of the radial inner wall 120 of the loop cavity.

[0125] The retractable portion 160 may be partially located within a channel 148 formed along the radial inner wall 120 of the loop cavity of each loop 104. The retractable portion 160 may occupy the space within the channel 148 before being exposed to external energy.

[0126] In other embodiments, at least a portion of the radial inner wall 120 of the loop cavity may be made of a composite material. For example, at least a portion of the rear or front portion of the radial inner wall 120 of the loop cavity may be made of a composite material.

[0127] The retractable portion 160 can shrink or decrease in size in response to a laser 125 (e.g., a laser pulse) directed at it. Since the retractable portion 160 previously occupied space within the channel 148, reducing its size increases the available space within the channel 148. Furthermore, since the channel 148 is in fluid communication with the loop fluid cavity 106, the volume of the loop fluid cavity 106 can increase when the retractable portion 160 shrinks. This allows fluid within the optical fluid chamber 108 to be drawn into the loop fluid cavity 106. As a result, at least one of the front element 130 and the rear element 132 can reduce its curvature, and the base focal length of the optical portion 102 can decrease in response to a laser 125 directed at the retractable portion 160 made of composite material.

[0128] The retractable portion 160 may initially be a block extending into the channel 148. The volume of the block may decrease in response to external energy directed at the retractable portion 160. As the volume of the block decreases, the available space volume within the channel 148 and the volume of the loop fluid cavity 106 may increase, thereby drawing fluid from the optical fluid chamber 108 and into the loop fluid cavity 106.

[0129] The base focal length of the optical component 102 can be configured to decrease as fluid leaves or is extracted from the fluid-filled optical component fluid chamber 108 and enters the loop fluid cavity 106, such as... Figure 1D As depicted in [the text]. For example, the front element 130 of the optical component 102 may be configured to reduce its curvature (or flatten) in response to fluid exiting the optical component fluid chamber 108. Additionally, for example, the rear element 132 of the optical component 102 may be configured to reduce its curvature (or flatten) in response to fluid exiting the optical component fluid chamber 108. In another embodiment, both the front element 130 and the rear element 132 may be configured to reduce their curvature in response to fluid exiting the optical component fluid chamber 108.

[0130] In some embodiments, the fluid within the optical component fluid chamber 108 and the loop fluid cavity 106 may be oil. More specifically, in some embodiments, the fluid within the optical component fluid chamber 108 and the loop fluid cavity 106 may be silicone oil or a fluid. For example, the fluid may be silicone oil partially composed of diphenylsiloxane. In other embodiments, the fluid may be silicone oil partially composed of a ratio of two dimethylsiloxane units to one diphenylsiloxane unit. More specifically, in some embodiments, the fluid may be silicone oil partially composed of diphenyltetramethylcyclotrisiloxane or a copolymer of diphenylsiloxane and dimethylsiloxane. In further embodiments, the fluid may be silicone oil comprising a branched polymer.

[0131] A fluid (e.g., silicone oil) may be refractively matched to the lens body material used to fabricate the optical component portion 102. When the fluid is refractively matched to the lens body material, the entire optical component portion 102 containing the fluid can function as a single lens. For example, the fluid may be selected such that it has a refractive index between about 1.48 and 1.53 (or between about 1.50 and 1.53). In some embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.2 and 1.3. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.3 and 1.5. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.1 and 1.2. Other exemplary fluids are described in U.S. Patent Publication No. 2018 / 0153682, which is incorporated herein by reference in its entirety.

[0132] The optical component portion 102 may be partially made of a deformable or flexible material. In some embodiments, the optical component portion 102 may be partially made of a deformable or flexible polymeric material. For example, the front element 130, the rear element 132, or a combination thereof may be partially made of a deformable or flexible polymeric material. The one or more loops 104 (e.g., the first loop 104A, the second loop 104B, or a combination thereof) may be partially made of the same deformable or flexible material as the optical component portion 102. In other embodiments, the one or more loops 104 may be partially made of a material different from that of the optical component portion 102.

[0133] In some embodiments, the optical component 102 may include or be partially made of a lens body material. The lens body material may be partially made of a crosslinked copolymer comprising copolymer blends. The copolymer blends may include alkyl acrylates or alkyl methacrylates, fluoroalkyl (meth)acrylates, and phenylalkyl acrylates. This disclosure contemplates, and will be understood by those skilled in the art, that these types of acrylic crosslinked copolymers may generally be copolymers of various acrylates, methacrylates, or combinations thereof, and unless otherwise specified, the term "acrylate" as used herein may be understood to interchangeably refer to acrylates, methacrylates, or combinations thereof. The crosslinked copolymer used to make the lens body material may include about 3% to 20% (by weight) of alkyl acrylates, about 10% to 35% (by weight) of fluoroalkyl acrylates, and about 50% to 80% (by weight) of phenylalkyl acrylates. In some embodiments, the crosslinked copolymer may include, or be partially composed of, each of the following: n-butyl acrylate as an alkyl acrylate, trifluoroethyl methacrylate as a fluoroalkyl acrylate, and styrene acrylate as a phenylalkyl acrylate. More specifically, the crosslinked copolymer used to make the lens body material may include about 3% to 20% (by weight) (e.g., between about 12% and 16%) of n-butyl acrylate, about 10% to 35% (by weight) (e.g., between about 17% and 21%) of trifluoroethyl methacrylate, and about 50% to 80% (by weight) (e.g., between about 64% and 67%) of styrene acrylate.

[0134] The final composition of the crosslinked copolymer used to make the lens body material may also include a crosslinker or crosslinking agent, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer used to make the lens body material may also include about 1.0% of a crosslinker or crosslinking agent (e.g., EGDMA). The final composition of the crosslinked copolymer used to make the lens body material may also include an initiator or initiator (e.g., Perkadox 16) and a UV absorber.

[0135] One or more loops 104 may include or be partially made of loop material. The loop material may include or be partially made of crosslinked copolymers, which include copolymer blends. Copolymer blends may include alkyl acrylates, fluoroalkyl acrylates, and phenylalkyl acrylates. For example, the crosslinked copolymer used to make the loop material may include about 10% to 25% (by weight) of alkyl acrylates, about 10% to 35% (by weight) of fluoroalkyl acrylates, and about 50% to 80% (by weight) of phenylalkyl acrylates. In some embodiments, the crosslinked copolymer used to make the loop material may include about 10% to 25% (by weight) (e.g., between about 19% and about 23%) of n-butyl acrylate, about 10% to 35% (by weight) (e.g., between about 14% and about 18%) of trifluoroethyl methacrylate, and about 50% to 80% (by weight) (e.g., between about 58% and about 62%) of styrene acrylate. The final composition of the crosslinked copolymer used to make the loop material may also include about 1.0% of a crosslinker or crosslinking agent, such as EGDMA. The final composition of the crosslinked copolymer used to make the loop material may also include several photoinitiators or photoinitiators (e.g., camphorquinone, 1-phenyl-1,2-propanedione and 2-ethylhexyl-4-(dimethylamino)benzoate).

[0136] In some embodiments, the refractive index of the lens body material may be between about 1.48 and about 1.53. In some embodiments, the refractive index of the lens body material may be between about 1.50 and about 1.53 (e.g., about 1.5178).

[0137] The front element 130 may be attached to or otherwise adhered to the rear element 132 via adhesive 150 or an adhesive layer. The adhesive layer may be substantially annular. The adhesive 150 or adhesive layer may be positioned at the peripheral edge of the optical component portion 102, between the front element 130 and the rear element 132. For example, the adhesive 150 may be positioned on top of the raised periphery 144 of the rear element 132.

[0138] Adhesive 150 or the adhesive layer may include or be made in part of a biocompatible adhesive. Adhesive 150 or the adhesive layer may include or be made in part of a biocompatible polymer adhesive.

[0139] Adhesive 150 or the adhesive layer may include or be partially made of a crosslinkable polymer precursor formulation. The crosslinkable polymer precursor formulation may include or be partially made of: copolymer blends, hydroxy-functional acrylic monomers, and photoinitiators.

[0140] The copolymer blend may include alkyl acrylates (e.g., about 41% to about 45% by weight of n-butyl acrylate), fluoroalkyl acrylates (e.g., about 20% to about 24% by weight of trifluoroethyl methacrylate), and phenylalkyl acrylates (about 28% to about 32% by weight of styrene acrylate). The hydroxyl-functionalized acrylic monomer may be 2-hydroxyethyl acrylate (HEA). A photoinitiator may be used to promote 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-methylphenylacetone).

[0141] In some embodiments, the same adhesive 150 used to bond the front element 130 to the rear element 132 may also be used to bond or attach one or more loops 104 to the optical portion 102.

[0142] Figure 1E It is also shown that each loop 104 (e.g., either a first loop 104A or a second loop 104B) may have a proximal attachment end 114 and a closed distal free end 116. A loop fluid port 152 may be defined at the proximal attachment end 114 of the loop 104. The loop fluid port 152 may serve as a chamber opening for the loop fluid cavity 106. When the loop 104 is coupled to the optical component portion 102, fluid within the loop fluid cavity 106 may flow out of the loop fluid cavity 106 through the loop fluid port 152 and flow into the optical component fluid chamber 108 via a pair of fluid channels 110. Similarly, fluid within the optical component fluid chamber 108 may flow out of the optical component fluid chamber 108 through the pair of fluid channels 110 and flow into the loop fluid cavity 106 via the loop fluid port 152. A pair of outer orifices 156 and an inner orifice 146 can be used as the ends of the fluid channel 110.

[0143] like Figure 1A and Figure 1E As shown, each loop 104 can be coupled to the optical component portion 102 at the reinforcing portion 112. For example, the first loop 104A can be coupled or attached to the optical component portion 102 at the first reinforcing portion 112A, and the second loop 104B can be coupled or attached to the optical component portion 102 at the second reinforcing portion 112B.

[0144] More specifically, the proximal attachment end 114 can be coupled to the protruding outer surface 154 of the rear element 132. The protruding outer surface 154 may also be referred to as a "landing" or a "loop attachment platform". The protruding outer surface 154 can extend radially outward from the outer peripheral surface 122 of the optical component portion 102. For example, the protruding outer surface 154 can extend radially outward from the outer peripheral surface 122 of the rear element 132 of the optical component portion 102. The protruding outer surface 154 can extend radially outward from the outer peripheral surface 122 by approximately 10 micrometers to 1.0 mm or by approximately 10 micrometers to 500 micrometers.

[0145] The proximal attachment end 114 may have a substantially flat surface for adhesion or other attachment to a substantially flat surface of the protruding outer surface 154. When the proximal attachment end 114 is attached to the protruding outer surface 154, the loop fluid port 152 may surround the outer aperture 156 of the fluid channel 110. The loop 104 may be attached or adhered to the optical component portion 102 via a biocompatible adhesive 150. In some embodiments, the adhesive 150 may be the same adhesive used for attaching or adhering the front element 130 to the rear element 132.

[0146] In some embodiments, the composite material may include a composite substrate, an energy-absorbing component, and a plurality of expandable or shrinkable components (e.g., shrinkable and / or burstable microspheres). As previously discussed, one or more portions of each loop 104 may be made of the composite material.

[0147] The composite substrate can be composed of hydrophobic acrylic materials. For example, the composite substrate can be composed of styrene acrylate (PEA), styrene methacrylate (PEMA), or a combination thereof.

[0148] In one example embodiment, the composite substrate may include a methacrylate-functionalized or methacrylate-functionalized crosslinkable polymer and a reactive acrylic monomer diluent, which includes 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-functionalized or methacrylate-functionalized crosslinkable polymer can be prepared using a crosslinkable polymer precursor formulation.

[0149] Crosslinkable polymer precursor formulations may include the same copolymer blends used for making optical components and loops. The copolymer blends may include alkyl acrylates or alkyl methacrylates (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylates (e.g., trifluoroethyl methacrylate), and phenylalkyl acrylates (e.g., ethyl phenyl acrylate). For example, the copolymer blend may include about 41% to about 45% (by weight) of n-butyl acrylate, about 20% to about 24% (by weight) of trifluoroethyl methacrylate, and about 28% to about 32% (by weight) of ethyl phenyl acrylate. Crosslinkable polymer precursor formulations may include copolymer blends, hydroxy-functionalized acrylic monomers (e.g., HEA), and photoinitiators (e.g., Darocur 4265 or a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and 2-hydroxy-2-methylphenylacetone) or partially thereof.

[0150] The composite substrate may include about 50% to about 65% (e.g., about 55% to about 60%) (by weight) of methacrylate functional groups or methacrylate functional group crosslinkable polymers (as discussed above), about 32% to about 38% (e.g., about 32.70%) (by weight) of reactive acrylic monomer diluent lauryl methacrylate (SR313), and about 5% to about 9% (e.g., about 7.30%) (by weight) of reactive acrylic monomer diluent adamantyl methacrylate (ADMA).

[0151] The composite material can be produced in several operations. A first operation may include preparing an uncolored composite substrate. A second operation may include mixing the composite substrate with an energy-absorbing component, an expandable or contractile and / or burstable element, and an initiator such as one or more photoinitiators, thermal initiators, or combinations thereof. A third operation may include placing the uncured composite material into a desired location within loop 104 (e.g., near channel 148) and curing the composite material into place.

[0152] For example, uncolored composite substrates can be mixed with energy-absorbing components such as dyes (e.g., Disperse Red 1 dye) or pigments (graphitized carbon black). Energy-absorbing components will be discussed in more detail below.

[0153] In some embodiments, the expandable component may comprise about 5.0% to about 15.0% by weight of the final composite formulation. More specifically, the expandable component may comprise about 8.0% to about 12.0% (e.g., about 10.0%) by weight of the final composite formulation. In these and other embodiments, the energy-absorbing component may comprise about 0.044% to about 0.44% (or about 0.55%) by weight of the final composite formulation.

[0154] The photoinitiator may be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenylphosphine oxide / 2-hydroxy-2-methyl-1-phenyl-1-propanone). The photoinitiator may comprise approximately 1.30% by weight of the final formulation of the composite material. Additionally, the composite material may also include a thermal initiator. The thermal initiator may comprise approximately 1.00% by weight of the final formulation 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.

[0155] In some embodiments, the energy-absorbing component can absorb external energy (e.g., laser energy), convert the energy into heat, and conduct the energy to the composite substrate to cause the composite substrate to expand.

[0156] In some embodiments, the expandable component may be expandable microspheres comprising an expandable thermoplastic shell and a foaming agent contained within the expandable thermoplastic shell. The microspheres may be configured to expand such that the diameter of at least one of the microspheres can increase by about 2 times the original diameter. In other embodiments, the microspheres may be configured to expand such that the diameter of at least one of the microspheres can increase by about 4 times or four times the original diameter. In still other embodiments, the microspheres may be configured to expand such that the diameter of at least one of the microspheres can increase by between about 2 times and about 4 times (or about 3.5 times) the original diameter. For example, the microspheres may initially have a diameter of about 12 µm. In response to external energy applied to or directed at the composite material, or in response to energy transferred or transmitted to the microspheres, the diameter of the microspheres may increase to about 40 µm.

[0157] The volume of at least one of the microspheres can be configured to expand by about ten times (10X) to about 50 times (50X) in response to external energy applied to or directed to the composite material or in response to energy transferred or transmitted to the microspheres.

[0158] 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 hydrocarbon. For example, the blowing agent can be isopentane. In other embodiments, the blowing agent can be or include cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.

[0159] Each expandable component may include a thermoplastic shell. The thickness of the thermoplastic shell may vary 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, when 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.

[0160] In some embodiments, the thermoplastic shell may be made in part from a nitrile or an acrylonitrile copolymer. For example, the thermoplastic shell may be made in part from acrylonitrile, styrene, butadiene, methyl acrylate, or a combination thereof.

[0161] As previously discussed, expandable components can comprise between approximately 8.0% and approximately 12% by weight of the final composite formulation. Expandable components can comprise approximately 10% by weight of the final composite formulation.

[0162] Expandable components may be dispersed or otherwise distributed within the composite matrix that constitutes the bulk of the composite material. The composite matrix may serve as a matrix for holding or supporting the expandable components. The composite material may expand in response to the expansion of the expandable components (e.g., thermoplastic microspheres). For example, the volume of the composite material may increase in response to the expansion of the expandable components.

[0163] The composite material also includes an energy-absorbing component. In some embodiments, the energy-absorbing component may be an energy-absorbing colorant.

[0164] In some embodiments, the energy-absorbing colorant may be an energy-absorbing dye. For example, the energy-absorbing dye may be an azo dye. In some embodiments, the azo dye may be a red azo dye, such as Disperse Red 1. In other embodiments, the azo dye may be an orange azo dye, such as Disperse Orange (e.g., Disperse Orange 1); a yellow azo dye, such as Disperse Yellow (e.g., Disperse Yellow 1); a blue azo dye, such as Disperse Blue (e.g., Disperse Blue 1); or a combination thereof.

[0165] In an additional embodiment, the energy-absorbing colorant may be or may include a pigment. For example, the energy-absorbing colorant may be or may include graphitized carbon black as a pigment.

[0166] Similar to expandable components, energy-absorbing components can be dispersed or otherwise distributed within the composite substrate that constitutes the main body of the composite material. The composite substrate can serve as a matrix for retaining or supporting both the expandable components and the energy-absorbing components.

[0167] As previously discussed, the energy-absorbing component may comprise between about 0.025% and about 1.0% (or more specifically, about 0.045% and about 0.45%) by weight of the final formulation of the composite material.

[0168] 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 energy) applied to or directed at the composite material. The energy-absorbing components can absorb or capture external energy and then convert or transfer the energy into heat or heat to the expandable component.

[0169] When heat is transferred or transported to the expandable component, the thermoplastic shell can soften and begin to flow. The thermoplastic shell of the expandable component can then begin to thin or decrease in thickness in response to the heat transferred or transported to it. As the thermoplastic shell begins to soften and decrease in thickness, the foaming agent within the expandable component can expand. The foaming agent can also expand in response to the heat transferred or transported to the expandable component. This expansion of the foaming agent can cause the expandable component (e.g., thermoplastic microspheres) to expand or increase in volume. This ultimately causes the composite material to expand or increase in volume.

[0170] As previously discussed, the external energy can be laser 125, and the energy-absorbing component can absorb or capture the laser 125 directed at the composite material, converting or transferring the light energy into heat energy or heating the expandable component. The foaming agent within the expandable component can expand or be excited in response to the heat energy or heat. The expandable component, and the final composite material, can expand or increase in volume in response to this light energy directed at the composite material.

[0171] As previously discussed, 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 or otherwise distributed within the composite substrate. The composite substrate may serve as a matrix for retaining or supporting the shrinkable and / or burstable microspheres and the energy-absorbing component.

[0172] Shrinkable or burstable microspheres may include an inner phase and one or more vacuum voids contained within a thermoplastic shell. Shrinkable microspheres may be configured to shrink or shrink in size such that the diameter of at least one microsphere can be reduced by approximately half of its original diameter.

[0173] For example, shrinkable microspheres can initially be fabricated to have a diameter between about 50 µm and 100 µm. In response to external energy applied to or directed at the composite material, or in response to energy transferred or transmitted to the shrinkable microspheres, the diameter of the shrinkable microspheres can be reduced to between about 25 µm and 50 µm.

[0174] The inner phase can be a fluid capable of undergoing one or more phase changes. In some embodiments, the inner phase can be configured to undergo a phase change from vapor to liquid at a temperature below the boiling point of the inner phase. When the inner phase is encapsulated within a thermoplastic housing, one or more vacuum voids can be formed as the inner phase condenses into a liquid phase within the thermoplastic housing.

[0175] In one embodiment, the internal phase may be or include water. In this embodiment, a vacuum void can be formed when water vapor within the thermoplastic shell condenses into liquid water.

[0176] In other embodiments, the internal phase may be or include ethylene glycol (which has a higher boiling point than water). In further embodiments, the internal phase may be or include a silicon-based fluid, such as certain cyclosiloxanes (e.g., hexamethylcyclotrisiloxane). In additional embodiments, the internal phase may be or include polydimethylsiloxane (PDMS) oligomers or certain types of hydrofluoroethers.

[0177] When heat energy is transferred or transported from the energy-absorbing component to the shrinkable microspheres, the thermoplastic shell can begin to soften and flow. When the external energy is laser 125, the energy-absorbing component can absorb or capture the laser 125 directed at the composite material and convert the light energy into heat energy.

[0178] The thermoplastic shell of the shrinkable microspheres can be configured to operate at a temperature higher than the glass transition temperature (Tg) of the thermoplastic shell. 壳体 The thermoplastic shell softens or begins to flow at temperatures above its glass transition temperature. It can also begin to thin at temperatures above its glass transition temperature. As the thermoplastic shell softens or thins, it may collapse and decrease in size due to external pressure around it and the vacuum inside.

[0179] In some embodiments, at least some of these microspheres may also be configured to burst upon disintegration or rupture of the thermoplastic shell in response to external energy directed at the first composite material. In these embodiments, the internal phase of the burstable microspheres may dissolve into the surrounding loop material or silicone oil.

[0180] In some embodiments, the thermoplastic shell may be polyacrylonitrile or made in part thereto. In some embodiments, the thermoplastic shell may be polystyrene or made in part thereto. In other embodiments, the thermoplastic shell may be poly(methyl methacrylate) or made in part thereto. 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)phenylphosphine oxide / 2-hydroxy-2-methyl-1-phenyl-1-propanone). A thermoplastic shell can be formed when the monomers of the shell material are bent together with the photoinitiator via UV curing.

[0181] When the temperature is below the glass transition temperature of the thermoplastic shell (i.e., when external energy is no longer directly directed at the composite material), the thermoplastic shell can reform in its hardened state or become glassy again. The diameter of the shrinkable microspheres can decrease as the thermoplastic shell reforms around the inner phase below the liquid phase and the space previously occupied by one or more vacuum voids is displaced.

[0182] Figure 2This is a schematic diagram showing a flattened ellipse and an elongated rectangle. The flattened ellipse represents a portion of the tilted IOL 100, and the elongated rectangle represents the treatment area 200 of the laser that can be used to adjust the base focal power of the IOL 100. In some embodiments, the IOL 100 may be tilted at a tilt angle between 4.0 degrees and 8.0 degrees. For example, when the IOL 100 is implanted in a subject's eye, the IOL 100 may be tilted relative to the subject's line of sight.

[0183] like Figure 2 As shown, the tilt of IOL 100 may make it challenging to adjust the baseline focal length of IOL 100 postoperatively by guiding laser 125 (e.g., laser pulses) to the tilted IOL 100.

[0184] For example, adjusting a treatment protocol might require directing multiple laser pulses to multiple locations along one loop 104A of IOL 100, followed by rapidly and sequentially directing additional laser pulses to multiple locations along another loop 104B of IOL 100 (see example...). Figure 1A ).

[0185] Adjusting or treating the procedure may often require the subject to lie supine. In this case, the laser's optical axis can be vertical or in the Z-direction. The laser beam of a laser (e.g., a femtosecond laser) is typically scanned in a horizontal XY plane using a pair of orthogonal galvanometer scanners. This scan can be completed in milliseconds. However, the vertical position (or Z-position) of the treatment site is typically adjusted using a pair of adjustable near-confocal lenses. Z-positioning or scanning is slower than X / Y scanning and cannot keep up with the round-trip time of X / Y scanning. Therefore, the optimal or preferred treatment area for the laser is a substantially planar treatment area 200 or a treatment area 200 perpendicular to (or substantially perpendicular to) the laser's optical axis.

[0186] like Figure 2 As shown, when the IOL 100 is tilted, the essentially planar treatment area 200 extends beyond the boundaries of the IOL 100. This means that when the IOL 100 is tilted, the laser may unintentionally damage the patient's eye by being exposed to laser energy. Furthermore, the essentially planar treatment area 200 when the IOL 100 is tilted 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 address the aforementioned drawbacks caused by the tilt of the IOL 100 to correct this tilt.

[0187] Figure 3An ophthalmic system 300 is shown, configured to compensate for tilt of the IOL 100 and adjust the IOL 100 postoperatively. For example, once the IOL 100 has been implanted in a subject's eye, the system 300 can be used to perform an IOL adjustment procedure. In some embodiments, the IOL adjustment procedure may require compensating for or correcting the tilt of the implanted IOL so that the IOL 100 is placed in the proper position for the remainder of the adjustment procedure.

[0188] System 300 may include an optical coherence tomography (OCT) imaging device 302 configured to generate one or more OCT images of the eye of a subject or patient with an IOL 100 implanted in the eye.

[0189] 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 may be communicatively connected to each other and communicatively connected to the OCT imaging device 302.

[0190] 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 on the electronic displays 304 in real time as a user (e.g., a clinician, surgeon, or other ophthalmology professional) operates the system 300.

[0191] OCT imaging device 302 can generate an imaging beam for scanning a subject's eye. The imaging beam can be directed into the eye via a beam splitter. Light scattered from ocular anatomy and implanted structures (e.g., IOL 100) within the eye can be reflected back and used by OCT imaging device 302 to form cross-sectional images of the eye and any implants therein. For example, OCT imaging device 302 can generate cross-sectional OCT images by measuring the echo time delay and the intensity of the backscattered or reflected light. OCT measurements of the echo time delay are based on correlation techniques that compare the backscattered or reflected light signal with a reference light signal traveling along a known path length.

[0192] OCT imaging device 302 may include an OCT light source that generates light in the low-power visible wavelength range. In other embodiments, the OCT light source may generate light in the near-infrared (NIR) range (i.e., wavelengths between about 900 nm and about 1,400 nm).

[0193] For example, the OCT light source of the OCT imaging device 302 may be a superluminescent diode. The OCT imaging device 302 may also include an interferometer (such as a Michelson interferometer), a reference mirror, a galvanometer scanner for scanning the imaging beam on the eye, and a spectrometer.

[0194] In some embodiments, the OCT imaging device 302 may be communicatively connected to the control unit 306, and one or more processors of the control unit 306 may be programmed to process imaging signals and control various hardware components of the OCT imaging device 302.

[0195] In one embodiment, the OCT imaging device 302 may be spectral domain OCT (SD-OCT). In other embodiments, the OCT imaging device 302 may be swept-source OCT (SS-OCT), frequency domain OCT, Fourier domain OCT, or complex Fourier OCT.

[0196] OCT imaging device 302 can also generate three-dimensional (3D) composite OCT images by combining two-dimensional (2D) cross-sectional OCT images.

[0197] Still referencing Figures 4A to 4C and Figures 5A to 5B The system 300 may include a fixation target source 400 configured to generate a movable fixation target 404 visible to the subject's eye (see [link]). Figures 4A to 4C As will be discussed in more detail in the following sections, the fixed target 404 can be configured to move until it reaches the transverse plane 502 of IOL 100 (see [link to relevant section]). Figure 5A and Figure 5B ) perpendicular or substantially perpendicular to the optical axis 506 of the ophthalmic system 300 (see Figure 5A and Figure 5B For example, the fixation target 404 can be moved until the lateral plane 502 of the IOL 100, as shown in one or more OCT images displayed on the electronic display 304, is perpendicular or orthogonal to (or substantially perpendicular or orthogonal to) the optical axis 506 displayed on the electronic display 304.

[0198] System 300 may also include an ophthalmic laser 308 configured to generate laser pulses and direct them to the IOL 100 to adjust the fundamental focal power or refractive power of the IOL 100. Control unit 306 may be configured to control the ophthalmic laser 308. In some embodiments, laser 308 may be a femtosecond laser.

[0199] 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 of the laser 308. In some embodiments, moving the fixed target 404 may further include moving the fixed target 404 to a position that is not axially aligned with the optical axis 506 of the laser.

[0200] like Figure 3As shown, the subject or patient can lie in a supine position during the IOL adjustment procedure. In these embodiments, the optical axis 506 can be vertically oriented.

[0201] In some embodiments, the fixed target source 400 may be a fixed light source (e.g., a low-power laser or a laser pointer). In these embodiments, the fixed target 404 may be a fixed light, such as a beam of light with a wavelength in the visible spectrum (e.g., between about 350 nm and 750 nm).

[0202] In some embodiments, the fixation target source 400 may be moved by a user or operator of the system 300. In other embodiments, the fixation target source 400 may be moved automatically by the ophthalmic system 300.

[0203] In some embodiments, the fixed target 404 may move in response to user input exerted by a user or operator of the system 300 (e.g., applied to an input device such as a mouse or keyboard, or a button or touchpad on a component of the system 300). In other embodiments, the fixed target 404 may be moved automatically by the system 300.

[0204] In other embodiments, the fixation target source 400 may be a target display 408 visible to the subject or patient. In these embodiments, the fixation target 404 may be a computer-generated graphic 410 generated on the target display 408 (see [link to documentation]). Figure 4B and Figure 4C ).

[0205] In some embodiments, the OCT imaging device 302 and the laser 308 may be integrated with the ophthalmic system 300.

[0206] As previously discussed, OCT images captured by OCT imaging device 302 can be displayed on electronic display 304 of system 300. OCT images can guide the operator / user (e.g., clinician, surgeon, or other ophthalmology professional) of system 300 during IOL adjustment procedures. IOL adjustment procedures may require the lateral plane 502 of IOL 100 to be perpendicular or orthogonal to (or substantially perpendicular or orthogonal to) the optical axis 506 of laser 308 of system 300.

[0207] In some embodiments, the OCT image displayed on the electronic display 304 can allow an operator / user to determine in real time whether the lateral plane 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 may be displayed on the electronic display 304 together with a cross-sectional OCT image of the IOL 100 showing the lateral plane 502 of the IOL 100.

[0208] In some embodiments, the ophthalmic system 300 may include a laser module, a laser controller, multiple beam splitters, focusing objectives, and a patient interface. The laser module can generate a laser pulse beam and, as instructed by the laser controller, emit it to a point or focal spot within the implanted IOL 100. The laser controller can also adjust certain beam parameters of the laser beam and control the position of the beam within the eye. The laser controller can perform these functions by sending one or more power control signals and scan control signals to the laser module.

[0209] The laser beam 125, or the laser beam generated by laser 308, can be guided into the eye by one or more beam splitters. A focusing objective lens can be used to focus the laser beam, while a patient interface can stabilize the patient's eye during laser treatment.

[0210] In some embodiments, laser 308 may be an ultrafast pulsed diode-pumped solid-state femtosecond laser. Laser 308 can generate pulses with durations of nanoseconds (10⁻⁶). -9 picosecond (10) -12 (seconds) or femtoseconds (10) -15 A laser pulse (seconds). The laser pulse can be generated at a pulse repetition rate between 1 kHz and up to 500 kHz. More specifically, the laser pulse can be generated at a pulse repetition rate between about 10 kHz and about 100 kHz. In other embodiments, the laser pulse can be generated at a pulse repetition rate between 0.1 kHz and 1000 kHz.

[0211] In some embodiments, the laser beam generated by laser 308 may have a wavelength between about 900 nm and 1100 nm (i.e., in the near-infrared (NIR) range). For example, the laser beam generated by laser 308 may have a wavelength of about 1030 nm.

[0212] In alternative embodiments, the laser beam generated by laser 308 may be a green laser with a wavelength between about 480 nm and 650 nm (e.g., 532 nm). In these embodiments, laser 308 may be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser.

[0213] Figure 4A The fixation target source 400 is shown to be a fixation light source 402. In some embodiments, the fixation light source 402 may be a low-power laser or a laser pointer. In these embodiments, the fixation target 404 may be a fixation light 406, such as a visible light beam with a wavelength in the visible spectrum (e.g., between about 350 nm and 750 nm). The fixation light 406 may be visible to a subject or patient undergoing an IOL adjustment procedure.

[0214] In some embodiments, the fixed-beam 406 may move in response to user input applied by a user or operator of the ophthalmic system 300. For example, the fixed-beam 406 may move in response to user input applied by a user or operator to an input device, such as a mouse or keyboard communicatively connected to the system 300, or a button or touchpad on a component of the system 300. In other embodiments, the fixed-beam 406 may be moved automatically by the system 300 based on calculations performed by one or more processors of the control unit 306.

[0215] In some embodiments, the fixed beam 406 may be moved by one or more beam splitters. In other embodiments, the fixed beam 406 may be moved by physically moving the fixed light source 402.

[0216] Figure 4B The fixation target source 400 is shown to be a target display 408. The target display 408 can be positioned such that it is visible to the subject or patient during IOL adjustment procedures. For example, when the subject is lying supine, the target display 408 can be positioned vertically above the subject.

[0217] In some embodiments, the target display 408 may be an electronic flat panel display. For example, the target display 408 may be a liquid crystal display (LCD) screen. In other embodiments, the target display 408 may be a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or an active-matrix OLED (AMOLED) display. In yet another embodiment, the target display 408 may be projected onto a beamsplitter that can be viewed by a subject or patient.

[0218] In these embodiments, the fixation target 404 may be a computer-generated graphic 410 generated on the target display 408. For example, the computer-generated graphic 410 may be a flashing graphic.

[0219] In some embodiments, the computer-generated graphic 410 serving as the fixation target 404 may move in response to user input applied by a user or operator of the ophthalmology system 300. For example, the computer-generated graphic 410 may move in response to user input applied by a user or operator to an input device, such as a mouse or keyboard communicatively connected to the system 300, or a button or touchpad on a component of the system 300. In other embodiments, the computer-generated graphic 410 may be moved automatically by the system 300 based on calculations performed by one or more processors of the control unit 306.

[0220] Figure 4CThe computer-generated graphic 410 can also be in the form of computer-generated letters, icons, or symbols. Furthermore, the computer-generated graphic 410 can be high-contrast letters, icons, or symbols.

[0221] although Figure 4B and Figure 4C The fixed target 404 is displayed as a light-colored graphic on a dark background. This disclosure contemplates that the fixed target 404 could also be a dark-colored graphic displayed on a light-colored background.

[0222] Figure 5A This is a schematic cross-sectional view of an IOL 100 implanted in the subject's eye with the tilt angle between approximately 4.0 degrees and approximately 8.0 degrees. More specifically, for example, the tilt angle of the IOL 100 can be approximately 5.5 degrees.

[0223] In some embodiments, the tilt can be in the nasal direction (see also) Figure 7 This tilt can also be in the temporal direction, upward direction, and / or downward direction (see also: Figure 7 ).

[0224] The implanted IOL 100 can also be tilted relative to the subject's line of sight 500. For example, the IOL 100 can be tilted relative to the line of sight 500 by an angle of kappa (κ).

[0225] In some embodiments, angle κ may be an angle defined by line of sight 500 and pupil axis. In other embodiments, angle κ may be defined by a lateral plane 502 of the implanted IOL 100 and a plane 504 that is perpendicular to or orthogonal to (or substantially perpendicular to or orthogonal to) the optical axis 506 of the ophthalmic system 300.

[0226] For example, optical axis 506 can be the Z-axis of the focusing lens or focusing objective of the laser 308 of the ophthalmic system 300. When the subject is lying supine, optical axis 506 can be oriented vertically or substantially vertically (see example...). Figure 3 ).

[0227] In some embodiments, the tilt of the IOL 100 can be calculated or determined based on OCT images captured by the OCT imaging device 302 and displayed on the electronic display 304. In these embodiments, the plane 504 perpendicular to or orthogonal to (or substantially perpendicular to or orthogonal to) the optical axis 506 can be predetermined or determined based on the orientation of the laser 308 or the orientation of the focusing lens or focusing objective of the laser 308. The lateral plane 502 of the implanted IOL 100 can be determined by the user or operator of the system 300 (e.g., a clinician, surgeon, or other ophthalmologist) based on OCT images captured by the OCT imaging device 302 and displayed on the electronic display 304.

[0228] In other embodiments, the tilt of IOL 100 may be automatically calculated or determined by one or more processors of control unit 306 of system 300. For example, one or more processors of control unit 306 may analyze OCT images captured by OCT imaging device 302 and automatically determine or calculate the tilt of IOL 100 without any input from the user or any substantial input.

[0229] Figure 5B This is a schematic cross-sectional view of fixation target 404, which is used to correct the tilt of the implanted IOL 100. When fixation target 404 is moved to a new location or position, the subject can be instructed to focus on fixation target 404.

[0230] In other embodiments, 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.

[0231] like Figure 5B As shown, fixation target 404 can be moved to a location or position that is not aligned with the optical axis 506 or Z-axis of ophthalmic system 300 (if the subject is lying supine).

[0232] The fixation target 404 can be moved upward relative to the subject in at least one of the medial / nasal direction, lateral / temporal direction, downward direction, upward direction, or a combination thereof.

[0233] The fixation target 404 can be moved until the lateral plane 502 of the implanted 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 lateral plane 502 of the IOL (as 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).

[0234] In some embodiments, the fixed target 404 may be moved based on the tilt of the IOL 100. For example, the tilt of the IOL 100 may be angle κ. In this example, the fixed target 404 may 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 angle κ.

[0235] The fixed target 404 can move in response to user input exerted by a user or operator of the system 300 (e.g., applied to an input device such as a mouse or keyboard, or a button or touchpad on a component of the system 300). In other embodiments, the fixed target 404 can be moved automatically by the control unit 306 of the system 300.

[0236] In some embodiments, when a laser 125 (e.g., a laser pulse) generated by laser 308 is directed to IOL 100, the fixation target 404 can be maintained at this new location / position. Laser 125 can be used to adjust the base focal length of IOL 100.

[0237] Figure 6 This shows a tilted cross-sectional OCT image of the 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...) Figure 6 As shown, when the IOL 100 is tilted, the optical axis 506 of the ophthalmic system 300 is not perpendicular to or orthogonal to the transverse plane 502 of the implanted IOL 100.

[0238] As previously discussed, due to certain limitations on the laser 308, the treatment area or region of the laser 308 can be substantially planar. Therefore, one technical problem faced by the applicant is how to apply laser treatment to all necessary treatment sites on a tilted IOL 100 without putting the patient's eyes at risk due to accidental exposure to laser energy. This risk is amplified when such laser energy must be directed to one or more loops 104 located around the central optic portion 102. Another technical problem faced by the applicant is that when the IOL 100 is tilted, the substantially planar treatment area 200 means that the laser contacts the IOL 100 at different depths, which may result in non-uniformity for any desired shape changes of the IOL 100.

[0239] The technical solutions discovered and developed by the applicant are the systems and methods disclosed herein, wherein fixed-view target 404 (see Figures 4A to 4C and Figures 5A to 5BThis is used to adjust or correct the tilt of the IOL 100. The fixation target 404 can be displayed or otherwise presented to the subject or patient, and the subject or patient can track the fixation target 404 with their eyes without moving their head. The fixation target 404 can be moved to a new position or orientation until the lateral plane 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 (thus eliminating angle κ).

[0240] When the laser 125 (e.g., a laser pulse) generated by the laser 308 is directed to the IOL 100, the fixed target 404 can be maintained at this new location.

[0241] Figure 7 Several possible directions in which the fixed target 404 can be moved are shown. For example... Figure 7 As shown, fixed target 404 ( Figures 4A to 4C Any example fixed target shown can move in the inward direction 700, the outward direction 702, the upward direction 704, the downward direction 706, or any combination thereof.

[0242] Regarding the subject's / patient's eyes, the medial direction 700 can also be referred to as the nasal direction. Similarly, the lateral direction 702 can also be referred to as the temporal direction.

[0243] This disclosure may also be described in accordance with the following terms:

[0244] Clause 1. A method for compensating for tilt of an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, the method comprising: capturing 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 such that the fixation target is visible to the subject's eye; and moving the fixation target until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system.

[0245] Clause 2. The method as described in Clause 1, wherein the OCT imaging device is communicatively coupled to an electronic display, and wherein moving the fixation target further comprises moving the fixation target until the lateral plane of the IOL as shown in the 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] Clause 3. The method as described in Clause 1 further includes: determining the tilt of the IOL and moving the fixation target based on the tilt.

[0247] Clause 4. The method as described in Clause 1, wherein the tilt of the IOL has a tilt angle between about 4.0 degrees and about 8.0 degrees.

[0248] Clause 5. The method as described in Clause 1, wherein moving the fixation target further comprises moving the fixation target upward relative to the subject in at least one of the medial, lateral, downward, and upward directions.

[0249] Clause 6. The method as described in Clause 1, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective of the laser of the ophthalmic system, and wherein moving the fixation target further comprises moving the fixation target to a position not aligned with the Z-axis axis.

[0250] Clause 7. The method as described in Clause 6, wherein the optical axis is oriented vertically when the subject is lying in a supine position.

[0251] Clause 8. The method as described in Clause 1, wherein the fixation target is a fixation light generated by a fixation source.

[0252] Clause 9. The method as described in Clause 8, wherein the fixed beam is a beam of light with a wavelength in the visible spectrum.

[0253] Clause 10. The method as described in Clause 8, wherein the fixation light is movable in response to user input from the user of the ophthalmic system.

[0254] Clause 11. The method as described in Clause 8, wherein the fixation light source is configured to be moved automatically by the ophthalmic system.

[0255] Clause 12. The method as described in Clause 1, wherein the fixation target is displayed on a target display visible to the subject.

[0256] Clause 13. The method as described in Clause 12, wherein the fixed target is a computer-generated graphic.

[0257] Clause 14. The method as described in Clause 1, wherein the OCT imaging device is a component of the ophthalmic system.

[0258] Clause 15. A method for adjusting an intraocular lens (IOL), the method comprising: capturing 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 such that the fixation target is visible to the subject's eye; moving the fixation target until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system; and directing a laser beam generated by a laser of the ophthalmic system to the IOL to adjust the fundamental power of the IOL.

[0259] Clause 16. The method of Clause 15, wherein the OCT imaging device is communicatively coupled to an electronic display, and wherein moving the fixation target further comprises moving the fixation target until the lateral plane of the IOL as shown in the one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0260] Clause 17. The method of Clause 15 further includes: determining the tilt of the IOL and moving the fixation target based on the tilt.

[0261] Clause 18. The method as described in Clause 17, wherein the tilt of the IOL is between approximately 4.0 degrees and approximately 8.0 degrees.

[0262] Clause 19. The method of Clause 15, wherein moving the fixation target further comprises moving the fixation target relative to the subject in at least one of the medial, lateral, inferior, and superior directions.

[0263] Clause 20. The method as described in Clause 15, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective of the laser of the ophthalmic system, and wherein moving the fixation target further comprises moving the fixation target to a position not aligned with the Z-axis axis.

[0264] Clause 21. The method as described in Clause 20, wherein the optical axis is oriented vertically when the subject is lying in a supine position.

[0265] Clause 22. The method as described in Clause 15, wherein the fixation target is a fixation light generated by a fixation source.

[0266] Clause 23. The method as described in Clause 22, wherein the fixed beam is a beam of light with a wavelength in the visible spectrum.

[0267] Clause 24. The method as described in Clause 22, wherein the fixation light is movable in response to user input from the user of the ophthalmic system.

[0268] Clause 25. The method as described in Clause 22, wherein the fixation light source is configured to be moved automatically by the ophthalmic system.

[0269] Clause 26. The method as described in Clause 15, wherein the fixation target is displayed on a target display visible to the subject.

[0270] Clause 27. The method as described in Clause 26, wherein the fixed target is a computer-generated graphic.

[0271] Clause 28. The method as described in Clause 15, wherein the OCT imaging device is a component of the ophthalmic system.

[0272] Clause 29. The method as described in Clause 15, wherein the laser beam is generated by a femtosecond laser.

[0273] Clause 30. The method as described in Clause 15, wherein directing the laser beam to the IOL further includes directing the laser beam to one or more loops of the IOL.

[0274] Clause 31. The method as described in Clause 15, wherein the IOL is a regulatory IOL.

[0275] Clause 32. The method as described in Clause 15, wherein the IOL is a non-adjustable fluid adjustable IOL.

[0276] Clause 33. An ophthalmic system comprising: an optical coherence tomography (OCT) imaging device configured to generate one or more OCT images of an eye having an intraocular lens (IOL) implanted within the eye of a subject; and a fixation target source configured to generate a movable fixation target visible to the subject's eye, wherein the fixation target is configured to move until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system.

[0277] Clause 34. An ophthalmic system as described in Clause 33, wherein the OCT imaging device is communicatively coupled to an electronic display, and wherein moving the fixation target further comprises moving the fixation target until the lateral plane of the IOL as shown in the one or more OCT images displayed on the electronic display is perpendicular or substantially perpendicular to the optical axis displayed on the electronic display.

[0278] Clause 35. The ophthalmic system as described in Clause 33 further includes: a laser configured to generate a laser beam and direct the laser beam to the IOL to adjust the fundamental focal power of the IOL.

[0279] Clause 36. An ophthalmic system as described in Clause 35, wherein the optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective of the laser of the ophthalmic system, and wherein the fixation target is configured to move to a position not aligned with the Z-axis axis.

[0280] Clause 37. An ophthalmic system as described in Clause 36, wherein the optical axis is vertically oriented when the subject is lying in a supine position.

[0281] Clause 38. An ophthalmic system as described in Clause 35, wherein the laser beam is generated by a femtosecond laser.

[0282] Clause 39. An ophthalmic system as described in Clause 33, wherein the ophthalmic system further includes a control unit comprising one or more processors coupled to a memory, wherein the one or more processors are programmed to execute instructions stored in the memory to determine the tilt of the IOL, and wherein the fixation target is configured to move based on the tilt.

[0283] Clause 40. An ophthalmic system as described in Clause 39, wherein the inclination of the IOL is between about 4.0 degrees and about 8.0 degrees.

[0284] Clause 41. An ophthalmic system as described in Clause 33, wherein the fixation target is movable relative to the subject in at least one of the medial, lateral, downward, and upward directions.

[0285] Clause 42. An ophthalmic system as described in Clause 33, wherein the fixation target is a fixation light generated by a fixation light source used as the fixation target source.

[0286] Clause 43. An ophthalmic system as described in Clause 42, wherein the fixation beam is a beam of light with a wavelength in the visible spectrum.

[0287] Clause 44. An ophthalmic system as described in Clause 33, wherein the fixation target is movable in response to user input from a user of the ophthalmic system.

[0288] Clause 45. An ophthalmic system as described in Clause 33, wherein the fixation target is configured to be moved automatically by the ophthalmic system.

[0289] Clause 46. An ophthalmic system as described in Clause 33, wherein the fixation target source is a target display visible to the subject.

[0290] Clause 47. An ophthalmic system as described in Clause 46, wherein the fixation target is a computer-generated graphic.

[0291] Clause 48. An ophthalmic system as described in Clause 33, wherein the OCT imaging device is a component of the ophthalmic system.

[0292] Clause 49. An ophthalmic system as described in Clause 33, wherein the IOL is an accommodative IOL.

[0293] Clause 50. An ophthalmic system as described in Clause 33, wherein the IOL is a non-adjustable fluid-adjustable IOL.

[0294] Several embodiments have been described. However, those skilled in the art will understand that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Elements of the systems, apparatuses, devices, and methods shown with any embodiments are exemplary for particular embodiments and can be used in combination or otherwise in other embodiments within this disclosure. For example, steps of any method depicted in the figures or described in this disclosure do not require the specific order or sequence shown or described to achieve the desired result. Alternatively, other steps may be provided, or steps or operations may be eliminated or omitted from the described methods or processes to achieve the desired result. Furthermore, any component or portion of any device or system described in this disclosure or depicted in the figures may be removed, eliminated, or omitted to achieve the desired result. Additionally, for brevity and clarity, certain components or portions of the systems, apparatuses, or devices shown or described herein have been omitted.

[0295] Accordingly, other embodiments are within the scope of the following claims, and the description and / or drawings may be considered illustrative rather than restrictive.

[0296] Each of the individual variations or embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other variations or embodiments. Modifications may be made to suit particular circumstances, materials, composition, processes, process actions, or steps to the objectives, spirit, or scope of the invention.

[0297] The methods described herein can be performed in any logically possible order of the events described, as well as in the order of the events themselves. Furthermore, additional steps or operations may be provided, or steps or operations may be eliminated to achieve the desired result.

[0298] Furthermore, where a range of values ​​is provided, every intermediate value between the upper and lower limits of that range, as well as any other statement or intermediate value within that range, is covered within the scope of this invention. Moreover, any optional features of the described inventive variations may be set forth and claimed independently or in combination with any one or more features described herein. For example, the description of ranges 1 to 5 should be considered as having disclosed subranges (e.g., 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, etc.) as well as individual numbers within that range (e.g., 1.5, 2.5, etc.) and any overall or partial increments therebetween.

[0299] All existing subjects mentioned herein (e.g., publications, patents, patent applications) are incorporated herein by reference in their entirety, except where such subject matter might conflict with the subject matter of this invention (in which case the content herein shall prevail). Items cited are provided only because they were disclosed prior to the filing date of this application. Nothing herein should be construed as an admission that this invention is not entitled to precedence over such material by virtue of a prior invention.

[0300] References to singular items include the possibility that multiple identical items exist. More specifically, as used herein and in the appended claims, the singular forms “a / an,” “the,” and “the” include the plural referents unless the context clearly indicates otherwise. It should be further noted that claims may be drafted to exclude any optional elements. Thus, this statement is intended to serve as a prior basis for the use of exclusive terms such as “only,” “merely,” etc., when referencing claim elements or using the “negative” limitation. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0301] The phrase “at least one of…” refers to any combination of one or more of those items or components when such a phrase modifies multiple items or components (or an enumerated list 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.

[0302] In understanding the scope of this disclosure, the term "comprising" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers, and / or steps. The foregoing also applies to words with similar meanings, such as the terms "comprising," "having," and their derivatives. Furthermore, the terms "section," "section," "part," "component," "element," or "part" when used in the singular can have a dual meaning of a single part or multiple parts. As used herein, the following directional terms "forward, backward, above, downward, vertical, horizontal, below, lateral, sideways, and vertical," and any other similar directional terms, refer to those positions of the device or equipment or those directions in which the device or equipment is translated or moved.

[0303] Finally, degree terms as used herein (such as “basically,” “about,” and “approximately”) refer to a specified value or a specified value plus a reasonable amount of deviation from the specified value (e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10%, as such variation is appropriate) such that the final result is not significantly or substantially altered. For example, “about 1.0 cm” could be interpreted as meaning “1.0 cm” or between “0.9 cm and 1.1 cm.” When degree terms (such as “about” or “approximately”) are used to refer to numbers or values ​​that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.

[0304] Those skilled in the art will understand that the various methods disclosed herein can be implemented as non-transitory readable media, machine-readable media, and / or machine-accessible media, including instructions compatible with, readable, and / or executable by a processor or server of a machine, apparatus, or computing device. The instructions may be stored in one or more computer-readable memories or storage devices, and when executed on a processor (e.g., a CPU, GPU, or a processor core therein), these instructions perform a specified task.

[0305] This disclosure is not intended to be limited to the specific forms set forth herein, but rather to cover alternatives, modifications, and equivalents to the variations or embodiments described herein. Furthermore, the scope of this disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art in light of this disclosure.

Claims

1. An ophthalmic system comprising: An optical coherence tomography (OCT) imaging apparatus, the OCT imaging apparatus being configured to generate one or more OCT images of the eye having an intraocular lens (IOL) implanted within the eye of a subject; and A fixation target source is configured to generate a movable fixation target visible to the subject's eye, wherein the fixation target is configured to move until the lateral plane of the IOL is perpendicular to or substantially perpendicular to the optical axis of the ophthalmic system.

2. The ophthalmic system as claimed in claim 1, wherein, The OCT imaging device is communicatively connected to an electronic display, and wherein moving the fixation target further comprises moving the fixation target until the lateral plane of the IOL, as shown in the 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 of claim 1, further comprising a laser configured to generate a laser beam and direct the laser beam to the IOL to adjust the fundamental power of the IOL.

4. The ophthalmic system as described in claim 3, wherein, The optical axis of the ophthalmic system is the Z-axis of the focusing lens or focusing objective of the laser in the ophthalmic system, and the fixation target is configured to move to a position not aligned with the Z-axis axis.

5. The ophthalmic system as described in claim 4, wherein, When the subject is lying supine, the optical axis is vertically oriented.

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

7. The ophthalmic system of claim 1, wherein, The ophthalmic system further includes a control unit, the control unit including one or more processors coupled to a memory, wherein the one or more processors are programmed to execute instructions stored in the memory to determine the tilt of the IOL, and wherein the fixation target is configured to move based on the tilt.

8. The ophthalmic system of claim 7, wherein, The tilt angle of the IOL is between approximately 4.0 degrees and approximately 8.0 degrees.

9. The ophthalmic system of claim 1, wherein, The fixation target is movable relative to the subject in at least one of the medial, lateral, downward, and upward directions.

10. The ophthalmic system of claim 1, wherein, The fixation target is the fixation light generated by the fixation light source used as the fixation target source.

11. The ophthalmic system of claim 10, wherein, The fixed-view light is a beam of light with a wavelength in the visible spectrum.

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

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

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

15. The ophthalmic system of claim 14, wherein, The fixed target is a computer-generated graphic.

16. The ophthalmic system of claim 1, wherein, The OCT imaging device is a component of the ophthalmic system.

17. The ophthalmic system of claim 1, wherein, The IOL mentioned is a regulatory IOL.

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

19. A method for compensating for tilt of the intraocular lens (IOL) using optical coherence tomography (OCT), the method comprising: One or more OCT images of a subject's eye are captured using an OCT imaging device, wherein the IOL is implanted inside the subject's eye; Generate a fixation target such that the fixation target is visible to the subject's eyes; and Move the fixation target until the lateral plane of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system.

20. A method for adjusting an intraocular lens (IOL), the method comprising: One or more OCT images of a subject's eye are captured using an OCT imaging device, wherein the IOL is implanted inside the subject's eye; Generate a fixation target such that the fixation target is visible to the subject's eyes; Move the fixation target until the lateral plane of the IOL is perpendicular or substantially perpendicular to the optical axis of the ophthalmic system; and The laser beam generated by the laser of the ophthalmic system is directed to the IOL to adjust the base power of the IOL.

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