Multifunctional ocular biometer and methods of use

Abstract

The present invention is directed to a multifunctional ocular biometer that can have multiple measurement subsystems to obtain various measurements of the eye in both intraoperative and clinical settings. The multifunctional ocular biometer can be used with algorithms to guide surgeons in collecting measurement data. Methods of use of the multifunctional ocular biometer are also disclosed herein.

Description

Multifunctional Ocular Biometer and Methods of Use

[0001] All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art as known to those skilled therein as of the date of the invention described and claimed herein.

[0002] This patent disclosure contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights.GOVERNMENT INTERESTS

[0003] Not applicable.CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims priority to U.S. Provisional Application No. 63 / 670,509, entitled “Multifunctional Ocular Biometer and Methods of Use,” filed on July 12, 2025, the contents of which is incorporated herein by reference in its entirety.TECHNOLOGICAL FIELD

[0005] The present disclosure includes a multifunctional ocular biometer and methods for use thereof. Specifically, the multifunctional ocular biometer disclosed herein combines several measurement subsystems into a single device or system to provide improved measurements of the eye, intraoperatively or clinically. In select embodiments, the systems and methods disclosed herein permit enhanced intraoperative guidance via the collection of data in real-time during a corrective procedure.BACKGROUND

[0006] This section is intended to introduce various aspects of the art, which may be associated with exemplary embodiments of the present disclosure. This discussion is believed to assist in providing a framework to facilitate a better understanding of aspects of the presentdisclosure. Accordingly, it should be understood that this section should be read in this light, and not necessarily as admissions of prior art.

[0007] Ocular biometry is the application of mathematics to measure the anatomical dimensions of the eye. Ocular biometry can be used to obtain preoperative and postoperative measurements of the eye for use in calculations to guide a surgical intervention. Such surgical interventions can include, for example, ocular refractive surgery, corrective surgery, cataract surgery, and other ophthalmic surgeries.

[0008] The patient’s quality of vision depends, at least in part, on how well light is focused by the patient’s eye. Refraction occurs when light bends as it passes through various structures of the eye. The cornea, an outermost clear dome-shaped surface on the front of the eye’s surface, bends or refracts light to help the eye focus. The sclera, a white outer coating of the eye formed by fibrous tissue, connects to muscles that move the eye. Between the cornea and the sclera is the corneal limbus, a dark ring around an iris. The iris is the colored portion of the eye surrounding the pupil, which can adjust the size of the pupil to control the amount of light entering the eye.

[0009] A portion of the light refracted by the cornea travels through the pupil, to the lens. The lens is nearly transparent and generally an ellipsoid, biconvex shape, which can change shape when the eye is focusing on objects at different distances. Light next passes through a vitreous humor, a clear jelly-like substance that fills the center of the eye and keeps the eye’s shape. The cornea and the lens focus light onto the retina of the eye. The retina, a light-sensitive nerve layer of the back of the eye, converts the light into electric signals that are sent to a patient’s brain via an optic nerve. The brain processes the electric signals into images.

[0010] With normal vision, a patient’s eye focuses the light onto the retina. However, a patient can have a refractive error when at least one structure of a patient’s eye is irregular, affecting how well the eye can focus on various objects. Refractive errors of the eye can lead to symptoms in patients including, for example, impaired vision, blurry vision or difficulty focusing, double vision, squinting, eye strain, eye pain, eye fatigue, and headaches. Eye refraction exams can determine whether a patient has any refractive errors, which can indicate the need for refractive corrective measures or corrective procedures, such as prescription glasses or contacts, or surgery. Prescriptions for corrective measures are expressed in the unit of measurement called the diopter; the higher the diopter, the stronger the prescription. Positive diopters represent hyperopia, while negative diopters represent myopia.

[0011] For example, nearsightedness, or myopia, can cause distant objects to appear blurry. This can result when the cornea or lens is overly curved so that light is focused at a point infront of the retina. Another example of a refractive error of the eye includes farsightedness or hyperopia, where a nearby object appears blurry. Farsightedness can occur when the cornea or lens is too flat so that light is focused at a point behind the retina. A further example of a refractive error is astigmatism, where the curve of the lens or cornea is mismatched, so light is focused at multiple points on the retina, resulting in blurred vision from overlapping or combined images on the retina. An age-related example of a refractive error of the eye includes cataracts, where the lens of the eye can become cloudy over time. Another aging-related example of a refractive error of the eye includes presbyopia, where the lens of the eye can become less flexible with age, impairing the ability of the lens to focus on objects.

[0012] Eye aberrometry can be conducted to measure and assess certain aberrations in a patient’s optical system. Eye aberrometry (also referred to as “wavefront aberrometry”) involves measuring the manner in which light travels through the eye by analyzing the wavefront of light as it passes therethrough. To identify potential aberrations in the patient, the obtained measurements from the patient can be compared to values that would be expected in a perfect visual system. However, obtaining the various measurements required to plan for or successfully execute certain ophthalmic procedures requires the use of multiple, separate measurement systems. Using different measurement systems can result in misaligned or inconsistent measurements of a patient’s eye. For instance, there may be differences in calibration between systems. In addition, errors can occur in measurements obtained in switching between the multiple different measurement systems or when the patient is moved from one system to another. For example, if a patient’s head is not straight during a corneal topography measurement, the measurement of an axis of astigmatism will not be accurate.

[0013] Separate systems that can produce unaligned measurements can impact a surgeon’s ability to plan for and subsequently perform corrective procedures. For example, in a corneal transplant, a misaligned measurement can result in a surgeon placing a stitch in a suboptimal position that could ultimately affect optical quality.

[0014] Such errors can compound when unaligned or incorrect preoperative measurements cannot be updated in real time during the surgical procedure, as some of the measurement systems are not adapted for intraoperative use. For example, during an IOL surgery, a surgeon relying on preoperative measurements may not be able to select the appropriate IOL or may implant the IOL with a tilt or into the wrong area. This can result in a poor patient outcome that may need to be postoperatively corrected using a subsequent surgery, increasing risks to the patient and costs to the healthcare system.

[0015] Additionally, using different measurement systems can be costly to providers, and ultimately to patients engaging the services of those providers. For instance, providers may need to purchase multiple, separate systems in order to obtain the measurements to detect and appropriately plan for corrective measures such as surgical interventions.

[0016] Combining different measurement systems presents several issues. For example, some measurement systems work on different optical axes than others, so their combination requires the combination of the components of the measuring systems along a common axis. In addition, combining multiple systems into one requires the simultaneous acquisition of measurement data across multiple different systems. Similarly, as different measurement systems use different lighting and sensors, there are multiple signal paths involving multiple wavelengths that must be properly assembled and combined. Finally, the combination of the systems must preserve proper focus across the eye’s surface, which is spherical, to provide usable measurements for clinical use.SUMMARY OF THE INVENTION

[0017] Disclosed herein is a multifunctional ocular biometer for refractive corrections of the eye that combines several measurement systems into one intraoperative device.

[0018] In one aspect, the present disclosure relates to a multifunctional ocular biometer. In embodiments, the multifunctional ocular biometer comprises a plurality of ophthalmic subsystems. The plurality of ophthalmic subsystems can comprise at least two of: a color imaging subsystem, a subsystem for projection corneal and scleral topography, a keratometry subsystem, an aberrometry subsystem, and a subsystem for optical coherence tomography. The multifunctional ocular biometer can be configured to obtain ophthalmic measurements from a patient’s eye at any one or more of the following timepoints: before the patient undergoes an ocular corrective measure, after the patient undergoes the ocular corrective measure, and during the ocular corrective measure.

[0019] In certain embodiments, the multifunctional ocular biometer is configured for use in a clinical exam setting. The multifunctional biometer can be attached to or otherwise integrated with a surgical microscope.

[0020] In certain embodiments, the ocular corrective measure comprises eyeglasses with corrective lenses, contact lenses, a corrective procedure, or a combination thereof. The corrective procedure comprises ocular refractive surgery.

[0021] In embodiments, the ophthalmic measurements comprise at least three light sources. The at least three light sources can comprise a projection corneal / scleral topography gridprojector (PCT Projector), a keratometer light emitting diode (LED), and one or more super- luminescent diodes (SLDs). The multifunctional ocular biometer can comprise at least three SLDs; or a single source SLD that is split into at least three separate SLDs such that each of the three separate SLDs comprise the same wavelength.

[0022] In embodiments, the multifunctional ocular biometer comprises at least one additional white light-emitting diode light source. The at least one additional white lightemitting diode light source can be placed higher than the eye level of a patient. In embodiments, the at least one additional white light-emitting diode light source is placed lower than the eye level of a patient. In various embodiments, the biometer further includes two additional white light-emitting diode light sources, wherein the first additional white light-emitting diode light source is placed higher than the eye level of a patient, and the second additional white lightemitting diode light source is placed lower than the eye level of a patient.

[0023] The multifunctional biometer can comprise a cold mirror, wherein the cold mirror is configured to create at least two analysis paths comprising a visible light path and a nearinfrared (NIR) light path. The visible light path can provide light for the color imaging subsystem, the subsystem for projection corneal and scleral topography, the keratometry subsystem, or a combination thereof. In embodiments, the NIR light path provides light for the aberrometry subsystem, the subsystem for optical coherence tomography, or a combination thereof.

[0024] In certain embodiments, the color imaging subsystem comprises a white flood LED, an imaging lens, a front-view color camera or a combination thereof, wherein the white flood LED is configured to illuminate the patient’s eye, the lens is configured to image the light from the white flood LED onto the front-view camera, and the front-view camera is configured to obtain one or more images of the patient’s eye. The color imaging subsystem further can comprise a doubly telecentric lens. In embodiments, the color imaging subsystem further comprises a second front-view camera that is configured to operate within the NIR range.

[0025] In various embodiments, the subsystem for projection corneal and scleral topography comprises a projection arm and an imaging arm; the projection arm comprising an LED, at least two processing lenses, a projection lens, a grid target, or a combination thereof; and the imaging arm comprising a camera, an imaging lens, a bandpass filter, or a combination thereof. The subsystem for keratometry can comprise a plurality of source LEDs, an imaging camera lens, a bandpass filter, and an imaging camera sensor. In embodiments, the at least one source LED can be configured to emit a perpendicular light array and a chief principal light ray; the perpendicular light ray being configured to intersect a virtual image of the source LED that isreflected by a cornea of the patient’s eye; and the chief principal light ray being configured to reflect off the cornea, through the imaging camera lens and the bandpass filter, and to the imaging camera sensor. The keratometry subsystem can comprise up to 12 source LEDs.

[0026] In certain embodiments, the aberrometry subsystem comprises: a super luminescent diode (SLD) configured to provide a beacon light source; a focusing lens; a beam splitter; a beam trap configured to prevent stray light contamination; a wavefront sensor; a wavefront camera; a first relay lens group that comprises at least two relay lenses; a second relay lens group that comprises at least two relay lenses; or a combination thereof. The SLD can be configured to provide a light source with a wavelength of about 830 nm.

[0027] In embodiments, the subsystem for optical coherence tomography comprises a dualbeam time domain low-coherence interferometer (“Dual Beam TD-LCI”), a standard-time domain low-coherence interferometer (“Standard TD-LCI”), or a combination thereof.

[0028] In various embodiments, the multifunctional ocular biometer comprises: a manipulator; a support base, the support base having a first end and a second end, the second end connected to a first end of the biometer at about a ninety-degree angle; a patient support system, comprising at least one rest for the patient’s head, the patient support system configured to align the patient’s eye level with the second end of the biometer.

[0029] In another aspect, a method of measuring a patient’s eye using any of the various multifunctional ocular biometers is disclosed herein. In certain embodiments the method comprises obtaining a multifunctional ocular biometer as disclosed herein; obtaining a first ophthalmic measurement from a first ophthalmic subsystem; obtaining a second ophthalmic measurement from a second ophthalmic subsystem, wherein the second ophthalmic subsystem is different from the first ophthalmic subsystem; and calculating one or more ophthalmic values from the first and second ophthalmic measurements. The method can further comprise displaying the one or more ophthalmic values to a user.

[0030] Other objects and advantages of this invention will become readily apparent from the ensuing description.BRIEF DESCRIPTION OF THE FIGURES

[0031] Certain illustrations, charts, or flow charts are provided to allow for a better understanding of the present invention. It is to be noted, however, that the drawings illustrate only selected embodiments of the inventions and are therefore not to be considered limiting ofscope. Additional and equally effective embodiments and applications of the present invention exist.

[0032] Figure 1 shows a side view of a multifunctional ocular biometer under one exemplary embodiment, configured to be used intraoperatively.

[0033] Figure 2 shows a side view of a multifunctional ocular biometer under one exemplary embodiment, configured to be used for standard clinical use in an examination room.

[0034] Figure 3 shows a schematic of certain subsystems of the multifunctional ocular biometer (MOB) under various exemplary embodiments.

[0035] Figure 4 shows a simplified schematic view of an exemplary subsystem of the MOB that permits color imaging of the front of the eye under one embodiment.

[0036] Figure 5 provides a simplified schematic view of an exemplary subsystem that permits collection of data related to projection topography of the cornea and sclera.

[0037] Figure 6 shows an exemplary grid pattern that can be collected from the imaging camera of the Figure 5 embodiment.

[0038] Figure 7 provides unaligned and aligned grid patterns that can be obtained from the subsystem of Figure 5.

[0039] Figure 8 provides a graphical single-arc approximation to mean cornea and sclera arcs under one embodiment of the present disclosure.

[0040] Figure 9 shows a graphical estimation of the required depth of field for the grid projection arm under one embodiment of the Figure 5 subsystem.

[0041] Figure 10 provides a graphical estimation of the required horizontal field of view for grid projection under one embodiment of the Figure 5 subsystem.

[0042] Figure 11 shows a simplified schematic view of an exemplary LED keratometry subsystem of the MOB under one embodiment.

[0043] Figure 12 shows a simplified schematic view of an exemplary aberrometry subsystem of the MOB under one embodiment.

[0044] Figure 13 illustrates the spots image obtained with a wavefront camera from the Figure 12 embodiment. The exemplary captured wavefront spots image includes that for a reference plane wave (left) and that for a diverging wavefront (right).

[0045] Figure 14 provides a schematic summary of an exemplary calculation flow for processing wavefront spots images such as those collected from the subsystem embodiment of Figure 12.

[0046] Figure 15 shows a simplified schematic view of an exemplary optical coherence tomography subsystem of the MOB under one embodiment.

[0047] Figure 16 provides a simplified schematic view of an exemplary voice-controlled MOB system under one embodiment.DETAILED DESCRIPTION OF THE INVENTION

[0048] Detailed descriptions of one or more embodiments are provided herein. It is to be understood, however, that the present invention can be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in any appropriate manner.

[0049] The singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification can mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”

[0050] Wherever any of the phrases “for example,” “such as,” “including” and the like are used herein, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. Similarly, “an example,” “exemplary” and the like are understood to be nonlimiting.

[0051] The term “substantially” allows for deviations from the descriptor that do not negatively impact the intended purpose. Descriptive terms are understood to be modified by the term “substantially” even if the word “substantially” is not explicitly recited. Therefore, for example, the phrase “wherein the lever extends vertically” means “wherein the lever extends substantially vertically” so long as a precise vertical arrangement is not necessary for the lever to perform its function.

[0052] The terms “comprising” and “including” and “having” and “involving” (and similarly “comprises,” “includes,” “has,” and “involves”) and the like are used interchangeably and have the same meaning. Specifically, each of the terms is defined consistent with the common United States patent law definition of “comprising” and is therefore interpreted to be an open term meaning “at least the following,” and is also interpreted not to exclude additional features, limitations, aspects, etc. Thus, for example, “a process involving steps a, b, and c” means that the process includes at least steps a, b, and c. Wherever the terms “a” or “an” are used, “one or more” is understood, unless such interpretation is nonsensical in context.

[0053] The term “about” is used herein to mean approximately, roughly, around, or in the region of. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. Ingeneral, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20 percent up or down (higher or lower).

[0054] For purposes of the present disclosure, it is noted that spatially relative terms, such as “up,” “down,” “right,” “left,” “beneath,” “below,” “lower,” “above,” “upper” and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over or rotated, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0055] As used herein, the term “subject,” or “patient,” can include humans and mammals (e.g., mice, rats, pigs, cats, dogs, and horses), and non-mammals (e.g., Aves such as chickens, etc.). Typical subjects to which the methods described herein can be applied include mammals, particularly primates, especially humans. For veterinary applications, a wide variety of subjects will be suitable, non-limiting examples of which comprise livestock such as cattle, sheep, goats, cows, swine; poultry such as chickens, ducks, geese, turkeys; and domesticated animals particularly pets such as dogs and cats. For diagnostic or research applications, a wide variety of mammals can be suitable subjects, non-limiting examples of which comprise rodents (e.g., mice, rats, hamsters), rabbits, primates, and swine such as inbred pigs and the like. The term “living subject” can refer to a subject noted above or another organism that is alive.

[0056] Eye aberrometry can be conducted in a clinical setting or intraoperatively, offering an assessment of retinal image quality for a patient. In embodiments, eye aberrometry comprises measuring a patient’s retinal image quality such as via detection of topical monochromatic aberrations of the eye. Aberration, as used herein, can refer to any deviation from a perfect optical system. In embodiments, aberrations result in visual imperfections or distortions. By way of example, under perfect conditions, an eye converges wavefronts of light onto a retina in a predictable manner. Thus, measurements from a patient’s eye can be compared to the predicted or expected measurements to determine if the patient’s eye has any observable aberrations. Such aberrations can indicate certain refractive errors, such as those related to pupil size or other ocular conditions. Examples of low-order ocular aberrations include myopia, hyperopia, and astigmatism, while high-order aberrations can include spherical aberrations(causing night myopias, which can be exacerbated following LASIK or ablation of the surface of the eye), coma (common following corneal transplantation, a thinned cornea, or decentered ablations) and trefoil (common following refractive surgery).

[0057] In embodiments, eye aberrometry can quantify and describe the specific aberrations present in a patient’s eyes, providing a more detailed assessment of visual quality as compared to traditional measurements. Information obtained from eye aberrometry can be used to customize vision correction procedures to permit a more personalized treatment based on the unique optical characteristics of a patient’s eyes. Data obtained from eye aberrometry can be used to design and refine contact lenses or eyeglass lenses to efficiently address an individual's unique visual aberrations. Further, eye aberrometry can be used following certain corrective procedures to evaluate the outcomes and identify any residual aberrations that may impact visual quality.

[0058] In addition to vision correction, data obtained from eye aberrometry can be used in research and clinical settings to understand and diagnose various optical abnormalities and irregularities in the eye.

[0059] Corrective measures for refractive errors can include eyeglasses with corrective lenses, contact lenses, corrective procedures, or a combination thereof. In embodiments, corrective procedures include ocular refractive surgery. Non-limiting examples of corrective procedures include corneal laser surgery (e.g., laser-assisted in situ keratomileusis (“LASIK”)), phakic intraocular lenses (“IOLS”), and aphakic IOLS following cataract extraction. Such procedures can change the refractive quality of the eye while ideally not diminishing the overall refractive quality of the eye.

[0060] LASIK can refer to a refractive surgery that can change the shape of a patient’s cornea, usually by cutting a hinged flap in the cornea, using an excimer laser beam to reshape the cornea, and then repositioning the flap. LASIK can correct refractive errors like myopia, hyperopia, and astigmatism.

[0061] An IOL can be an artificial lens that can be implanted either with a patient’s natural lens still in the eye (“aphakic IOL”) or after removing an eye’s natural lens (“phakic IOL”), usually due to a cataract. Toric IOLs can be used in a patient with astigmatism to correct the refractive error created by the uneven curve in the patient’s cornea or lens.

[0062] A corneal transplantation can be performed on a patient that has a damaged cornea, replacing it with donor corneal tissue. A damaged cornea may be less transparent or may change in shape as compared to a normal eye; in both cases, the ability of the cornea to focus light on the retina is impaired.

[0063] Measurements of the eye’s structures can be obtained and used for calculations in various phases of ophthalmic corrective procedures. Preoperative measurements in a clinical setting can be used diagnostically or to optimize planning of the procedure. Intraoperative measurements can inform a surgeon’s actions during the procedure. Postoperative measurements can be used to detect an improper surgical result and plan for any corrective measures. Postoperative measurements can also be used to confirm the success of a surgical procedure. For example, measurements taken in a preoperative assessment of the eye before cataract surgery can be used to calculate the appropriate IOL for that patient. The measurements taken of a patient’s eye depend on the method of vision correction and can include one or more of the following: refraction, ocular aberrations, corneal power measurements, corneal shape, sclera shape, horizontal visible iris diameter, and axial distances within the eye.

[0064] Color imaging of the front of an eye can use a camera to capture images of various structures of the eye, including the iris, pupil, limbus, sclera, and eyelids. Analysis of these images can provide an ophthalmologist with important measurements and other information relating to a patient’s eye. For example, such imaging can elucidate the orientation or rotation of the eye within the socket, pupil contour, limbus contour, diameter of the pupil, diameter of the limbus (also called horizontal visible iris diameter), distance between eyelids, shape of eyelids, and sclera veins and other features.

[0065] Projection topography of the cornea and sclera can be used to measure the shape and curvature of the front surface of the cornea. The measurements from such topography can be used to calculate the power of the cornea. Also, measurement of the sclera provides valuable elevation information for accurate scleral contact lens fitting.

[0066] Keratometry can measure the power of the cornea, which is based on the curvature of the cornea and is expressed in diopters. Corneal power can be used to calculate the power of any IOL that may be implanted using formulas known to those skilled in the art. The accuracy with which corneal power is measured using standard keratometry methods can change after refractive surgeries like LASIK. Keratometry can also be used to assess the extent of various refractive errors like astigmatism or to fit contact lenses. Keratometry can be done manually or automatically.

[0067] Whole-eye optical coherence tomography (OCT) can refer to using light waves to take cross-sectional images of a patient’s retina. OCT can provide measurements that can be used to diagnose various eye conditions including axial length OCT, axial position OCT, element shape OCT. For example, abnormal axial length can be indicative of myopia. In embodiments, OCT also provides shape elevation measurements for eye components. Non-limiting examples of such eye components include such as the surfaces of the cornea, the sclera, the iris, the surfaces of the crystalline lens, and the surfaces of an IOL.

[0068] Real-time eye tracking and registration can be used in conjunction with other measurement systems, like OCT, to reduce artifacts due to movement. In addition, when placing IOLS, eye tracking can be used to guide the intraoperative placement of IOLS. For example, intraoperative imaging systems can find eye marks and IOL marks to place the IOL in the appropriate axis.

[0069] Disclosed in various embodiments herein is a multifunctional ocular biometer (also referred to as “MOB” or “biometer”) that comprises a plurality of subsystems with a single system or instrument. In various embodiments, the MOB disclosed herein can be used in an intraoperative setting. In other embodiments, the biometer can be used in a clinical setting.

[0070] In certain embodiments, the MOB comprises one or more of: a color imaging subsystem, a subsystem for projection corneal and scleral topography, a keratometry subsystem, an aberrometry subsystem, and a subsystem for optical coherence tomography. One embodiment includes at least of the above-referenced subsystems. Certain embodiments can comprise all the above-referenced subsystems. Embodiments can include 2, 3, 4, or 5 of the subsystems referenced above. In a particular embodiment, the MOB comprises a color imaging subsystem, a subsystem for projection topography, a keratometry subsystem, an aberrometry subsystem, and a subsystem for optical coherence tomography. Exemplary embodiments of these subsystems are described in more detail below. Without being bound by theory, the multifunctional ocular biometer as disclosed herein enables a user (such as an ophthalmologist or surgeon) to quickly and efficiently collect clinical measurements from a patient’s eye, wherein such measurements are calibrated across such subsystems. Embodiments permit simultaneous acquisition and alignment of a plurality of measurements from a patient’s eye.

[0071] Various embodiments permit a user to combine certain measurements obtained from a plurality of subsystems to permit an understanding of certain features or structures of the eye and their relative measurements to one another. Without being bound by theory, such information improves the ability of the user to detect refractive errors in patients, plan for corrective refractive procedures, implement certain corrective procedures more accurately, monitor patients after corrective procedures for improved patient outcomes, or a combination thereof. In embodiments, aligning preoperative and postoperative measurements can optimize an assessment of the degree of success of the surgical procedure. Such alignment can also instruct a plan for any corrective measures that may be beneficial following a correctiveprocedure. This may be particularly useful when a given corrective procedure was performed with an unsuccessful result.

[0072] Additional improvements in patient outcomes can occur when preoperative measurements are compared to measurements taken during a given corrective procedure. Without being bound by theory, such “real-time” measurements obtained while performing a corrective procedure will both improve patient outcomes and save time for the user or medical professional, ultimately reducing overall eye healthcare costs.Description of Selected Embodiments

[0073] Before explaining at least one embodiment of the disclosure in detail, it is to be understood that the disclosure is not necessarily limited in its application to the details set forth in the following description or exemplified by the examples. The disclosure is capable of other embodiments or of being practiced or carried out in numerous ways. Other compositions, compounds, methods, features, and advantages of the present disclosure will be or become apparent to one having ordinary skill in the art upon examination of the following drawings, detailed description, and examples. It is intended that all such additional compositions, compounds, methods, features, and advantages be included within this description, and be within the scope of the present disclosure.

[0074] In the various embodiments, the present disclosure relates generally to ophthalmic equipment and systems and associated procedures, methods of use, and methods of treatment. By way of examples, the present disclosure can relate to equipment and procedures for performing a corrective procedure on a patient’s eye (e.g., cataract surgery or any other procedure described herein).

[0075] Ocular refractive surgery and other corrective procedures can be performed on the human eye. During a refractive surgical procedure, the refractive quality of the eye is altered. The goal of refractive surgery typically is to correct a defective refractive condition of the eye, while not diminishing the overall refractive quality of the eye. In some cases, the goal is to improve the overall refractive quality of the eye.

[0076] Non-limiting examples of corrective efforts include a wide range of methods such as spectacle lenses, contact lenses, corneal laser surgery, phakic intraocular lenses (IOL), and aphakic IOLS following cataract extraction.

[0077] The planning of the visual interventions can require various measurements of the eye to be corrected. Depending upon the vision correction method, these measurements can include one or more of the following: refraction, ocular aberrations, corneal powermeasurements, corneal shape, sclera shape, horizontal visible iris diameter, pupil diameter and axial distances within the eye.

[0078] Pre-treatment measurements, post-treatment measurements, or both can be required for each of these corrective methods so that the pre-treatment plans can be optimized to yield the best outcome for future interventions and to correct an unacceptable post-treatment result. The ability to align eye measurements from pre- to post-treatment exams represents one element in performing this algorithm optimization and correction of post-treatments.

[0079] For certain interventions, it can be preferrable to update these measurements in realtime during surgery. Such real-time updates in these measurements can be particularly useful for surgical interventions, such as corneal transplantation and IOL implantation. By way of example, in the case of corneal transplantation, the ability to see how to control peripheral stitches during surgery to yield the best optical quality for the cornea is crucial. In the case of IOL surgery, the ability to measure the state of the eye prior to cataract surgery can allow the surgeon to measure an eye’s optical components, select the appropriate IOL, and implant the IOL all at one time while the patient is lying beneath the surgical microscope. This can be applicable to either phakic IOLS (where the IOL is like an implantable contact lens) and aphakic IOLS (where the IOL is implanted following removal of a cataractous crystalline lens). Without being bound by theory, the intraoperative methods disclosed herein will save time for the surgeon and patient and hence, drastically reduce overall eye healthcare costs.

[0080] In various embodiments, a multifunctional ocular biometer (MOB) is disclosed herein. The MOB can comprise any one or more of: color imaging of the front of the eye, projection comeal / scleral topography, keratometry, aberrometry, and whole-eye optical coherence tomography (OCT). In certain embodiments, these procedures can be integrated into a single system. The disclosed technology can be provided in at least two forms. One form can be for standard clinical use as in an examination room, and the other form can be attached to a surgical microscope for intraoperative use.

[0081] Top-level description of intraoperative system under one embodiment

[0082] Figure 1 shows a top-level layout of the intraoperative system 100 under one embodiment. In this figure a patient 110 is lying below a surgical microscope 130 while the surgeon 120 looks through the surgical microscope and the primary beam splitter of the biometer 140.

[0083] Top-level description of clinical system under an embodiment

[0084] Figure 2 shows a top-level layout of the clinical system 200 under an embodiment. In this figure a patient 210 is sitting up with an eye under test looking into the biometer 240while being supported by a chin and headrest 270. The chin and headrest are affixed to a support base 250. The biometer 240 is attached to a manipulator 260 which sits on a support base 250. The operator 220 uses the joystick of the manipulator 260 to position the biometer 240 relative to the patient 210 and performs an exam. In embodiments, the operator 220 uses the joystick of the manipulator 260 to perform coarse positioning of the biometer 240 in one or more of the horizontal direction (along the “x” axis), the vertical direction (along the “y” axis), and depth direction (along the “z” axis). After the initial coarse positioning, the clinical system 200 can be configured to automatically fine tune the biometer to capture or process the eye features under examination.

[0085] Top level layout of subsystems under certain embodiments

[0086] Figure 3 shows a top-level schematic of certain subsystems of the MOB under various embodiments. As shown in Figure 3, one embodiment can comprise three light sources: (1) a projection corneal / scleral topography grid projector (PCT Projector), which uses light in the blue region, (2) keratometer LEDs which use white light, and super-luminescent diodes (SLDs) that are distributed as SLD1, SLD2, and SLD3. In embodiments one or more of SLD1, SLD2, and SLD3 can be split from a single primary SLD such that one or more of SLD1, SLD2, and SLD3 share the same wavelength. Additionally, two vertically oriented white LEDs can be illuminated to direct the patient’s gaze upward or downward to allow additional eye coverage for the projection corneal topography subsystem. In embodiments, the two vertically oriented white LEDs are disposed near the primary fixation source to generate the two additional fixation points discussed below.

[0087] Starting from the eye, there are two main analysis paths which are separated by a cold mirror (CM). Reflected from the cold mirror is the visible light path which supports the subsystems for viewing the front of the eye, measuring keratometry, and measuring the projection corneal / scleral topography data. The projection corneal / scleral topography data further limits the visible light to the green region. Transmitting through the cold mirror is the NIR light path which supports the subsystems for wavefront measurement, axial length measurement, anterior chamber OCT, and other axial position measurements and eye surface scans.

[0088] Details of exemplary subsystems are further described below.

[0089] Subsystem for color imaging of the front of the eye

[0090] Figure 4 shows a simplified view of the subsystem 300 for color imaging of the front of the eye under one embodiment. In this subsystem the light from a white flood LED 304 (such as the keratometer / Flood LEDS of Figure 3) illuminates an eye 303 and is imagedby a lens 302 onto a front-view color camera 301. In embodiments, the color camera 301 is capable of being communicatively coupled with one or more computer networks, computing devices, mobile devices, or combinations thereof. The color camera can comprise a camera that includes a USB connection port for communicating with a computer network, a computer device, a mobile device, or a combination thereof. The horizontal field of view at the front of the eye is about 20 mm. The front-view camera 301 captures images of the iris, pupil, limbus, sclera, and the eyelids. Analysis provided by these images include any one or more of eye rotation and orientation, pupil contour, pupil diameter, limbus contour, limbus diameter (also called horizontal visible iris diameter), scleral veins and other features, and distance between and shape of the eyelids. To reduce the effect of distance-based magnification on image measurements, a doubly telecentric lens can be used for the front-view camera.

[0091] Not shown in the system layout, a separate and second front-view camera that operates in the NIR range can also be employed along with an additional NIR light source to capture the same data as the color front-view camera. In embodiments, the second front-view camera can also capture a retro-illuminated view of the lens. This allows robust detection of iris features and the pupil contour which can be difficult to resolve in dark iris eyes illuminated only by visible light.

[0092] Subsystem for projection corneal / scleral topography

[0093] Figure 5 shows a simplified view of an exemplary subsystem 400 for projection topography of the anterior cornea and sclera under one embodiment. In this subsystem, light from an LED 401 can be processed by lenses 402 and 403 to fully illuminate the grid target 404. In embodiments, the LED 410 is a cobalt blue LED. The grid target can be projected onto the anterior cornea and sclera of the eye 406 by the projection lens 405. This projection arm (401 to 405) can be positioned to make an angle 410 with respect to the imaging arm (407 to 409) which is aligned to the eye’ s optical axis. In embodiments the angle 410 comprises a value that optimizes both the depth of field of the imaging camera 407 and the resolution and accuracy of the elevation measurements. The angle 410 can be about 17°. In this embodiment, the imaging arm comprises the imaging lens 409, a band-pass filter (BPF) 408, a camera 407, or a combination thereof.

[0094] Figure 6 shows the projected grid pattern obtained from the systems of Figure 5 400 as viewed from the imaging camera 407. In embodiments, the grid projection pattern is created by placing a pattern of chrome on BK7 optical glass. In this embodiment, the grid pattern is pre-warped so that the imaged grid appears “regularized” as shown in Figure 6 on a sphere with a radius of about 10.12 mm. In embodiments, this pre-warping simplifies the imageprocessing of the captured image and allows the coordinates to represent the deviation from the average eye shape. In addition, the overall performance of the grid projection topography is made more robust. The diameter for the entire imaged grid pattern is about 20 mm. The spacing for the grid lines is about 0.1 mm. The thickness for the grid lines is about 0.01 mm. The center, darkened squares are 0.5 x 0.5 mm each. As can be seen, in this embodiment, the bottom right corner of the top square and the top left corner of the bottom square (also referred to as the “centering point”) meet at the center of the grid pattern. This figure is not to scale.

[0095] Figure 7 shows unaligned (A) and aligned (B) grid patterns with respect to the frontview camera (such as camera 301 identified in Figure 3). In embodiments, the crosshair pattern is located on an operator-perceivable display, and the crosshair pattern is configured to assist the operator with properly centering the grid for optimal data acquisition. In this embodiment, a properly centered grid is achieved when the intersection of the two crosshairs in the crosshair pattern is aligned with the centering point of the grid pattern. As can be seen in Figure 7(A), in the unaligned case, the centering point of the darkened squares does not meet at the center of the large graphically generated cross pattern. Namely, the centering point is positioned above and to the left of the crosshair intersection. By contrast, as shown in Figure 7(B), when aligned, the centering point meets at the center of the large graphically generated cross pattern.

[0096] Figure 8 shows a single arc approximation to mean cornea and sclera arcs under one embodiment of the present disclosure. As shown, the cornea has a mean radius of about 8.0 mm (7.8 mm) and the sclera has a mean radius of about 12.0 mm. The location where the cornea and sclera meet is called the limbus. The limbus has a diameter of about 12.0 mm. The single arc approximation has a radius of about 10.12 mm. Also, we can see that the depth of field for the imaging arm is about 5 mm, and the horizontal field of view is about 20 mm.

[0097] Figure 9 shows an estimation of the required depth of field for the grid projection arm of Figure 5. The depth of field for the grid projection arm is about 7.03 mm.

[0098] Figure 10 shows an estimation of the required field of view for the grid projection arm of Figure 5. The horizontal field of view for the grid projection is about 19.03 mm.

[0099] From the projection comeal / scleral topography, we calculate raw elevation data of the cornea and about 2.5 mm onto the sclera. We also fit the elevation data of the cornea with a Zernike polynomial expansion. In embodiments, the polynomial expansion permits calculation of power values, corneal aberrations, and the generation of power color maps. In certain embodiments, the power values can be used to calculate simulated keratometry values at the 3 -mm (or other) zone.

[0100] The primary fixation source for the comeal / scleral data can be the wavefront NIRbeacon, and the primary fixation point can be along the path of the wavefront beacon. This can be the primary alignment method for the other measurement subsystems of the MOB. The comeal / scleral subsystem can comprise two additional fixations: one requiring the eye to gaze upward about 30 degrees as compared to the primary fixation point, and one requiring the eye to gaze downward about 30 degrees from the primary fixation point. In embodiments, the additional two gaze directions allow additional data to be gathered which are algorithmically combined into one single eye model. These additional fixation points also allow the wavefront and the axial length to be calculated in the periphery of the retina.

[0101] Subsystem for keratometry

[0102] Two methods are provided for calculating keratometry. As mentioned above, one embodiment includes calculation of keratometry values from the projection corneal / scleral topography subsystem. To provide a secondary and potentially more robust / accurate method of calculating keratometry, the present disclosure provides a source LED (see 501 of Figure 11) that is configured to provide light to be reflected off a patient’s anterior cornea. The source LED can be employed by an operator to assess the principal powers of the anterior cornea. In embodiments, the source LED comprises a reflection ring, wherein the reflection ring comprises a plurality of LEDs arranged in a ring pattern. In embodiments, the reflection ring comprises up to 50 LEDs. The reflection ring can comprise as few as two LEDS. In embodiments, the reflection ring comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 LEDs. The reflection ring can comprise of up to 12 LEDs.

[0103] Figure 11 shows a simplified view of such an LED keratometry subsystem under one embodiment 500 for one of the source LEDs. In this figure, a source LED 501 emits a plurality of light rays, two of which are shown. One light ray (the perpendicular ray) is perpendicular to the cornea 502 and so intersects the center of rotation of the cornea 503. This ray intersects the virtual image 504 of the source LED reflected by the cornea. In embodiments, when an operator views the light from the source LED reflecting off the cornea, the source LED (such as a reflection ring as described above) appears to be located at the virtual image 504 plane of the cornea. The radius of the cornea is about 8.0 mm, and the virtual image can be located about halfway between the cornea vertex and the center of curvature. A second ray (the chief or principal ray) reflects off the cornea at a reflection point 505 about its surface normal 506. This reflected ray then passes through the center of the imaging camera lens 507, the band-pass filter 508, and intersects the image camera sensor 509.

[0104] Given the location of the virtual image in the image camera, the geometry illustrated in this figure can be solved to find the radius of curvature at the reflection point. The image ofthe reflected source LEDs can be fitted with an ellipse to find the principal radii and angles. The corresponding principal radii of curvatures can be determined and converted to steep and flat power values using the below equation:337.5whereR = one of the principal radii in mmP = power in diopters corresponding to radius R

[0105] During calculation of the keratometry values, multiple results can be averaged using the following algorithm. For this algorithm, the power and axis keratometry values can first be converted to their corresponding astigmatic decomposition values. After averaging the astigmatic decomposition values, we can convert back to the power and axis form for the final values.

[0106] Keratometry averaging algorithm under the present embodiment:1. Acquire N individual measurements.2. Convert the power and axis measurements to astigmatic decomposition values.3. Find the best fit centroid for N-k of the measurements.4. Average the closest N-k measurements.5. Convert the astigmatic decomposition values to the final power and axis values.

[0107] In one embodiment, to convert the power and axis values+ P2@ -42, > P2), to equivalent astigmatic decomposition values M, cO, and c45, the following set of equations can be used.

[0108] To convert the astigmatic decomposition values back to power and axis values we use the following set of equations.A = mod (Axis + 90, 180)

[0109] Subsystem for aberrometry

[0110] Figure 12 shows a simplified view of the aberrometry subsystem 600 under one exemplary embodiment. In this embodiment, an SLD provides a beacon light source of a wavelength of about 830 nm. This beacon can be focused by lens L3 and reflected off the beam splitter (BS) and enters the eye where it makes a diffuse spot on the retina. In one embodiment, at least a portion of the beacon that is transmitted by the beam splitter is absorbed by the beam trap (BT) to prevent stray light contamination at the wavefront camera (WF camera). The diffuse beacon reflection from the retina can exit the eye and form a wavefront at the exit pupil Pl of the eye. As shown in this embodiment, the first relay lens group LI to L2 along the optical axis relays the wavefront at Pl to a conjugate plane P2. The distance from the exit pupil Pl to the first relay lens LI is equal to the focal length Fl of LI. The distance between the two relay lenses LI and L2 is equal to the sum of the focal lengths of LI and L2. The distance between L2 and the conjugate plane to Pl at P2 is FL The second relay lens group is L4 to L5. The distance from the conjugate plane P2 to lens L4 is F2, the focal length of L4. The distance between the lenses L4 to L5 is given by the variable D which is adjusted by the position of the defocus stage. In embodiments, one purpose of the defocus stage is to allow the automatic (or optionally interactive) focusing of the spots image. This increases the range and reliability of the aberrometry measurements by removing a significant component of the wavefront aberrations. The distance between L5 and the wavefront sensor (WFS) is F2, the focal length of L5. The distance between the wavefront sensor and the WF Camera is F3, the focal length of the micro-lens array (MLA) of the wavefront sensor. The system matrix from the eye’s exit pupil at Pl to the conjugate plane P3 can be given by:

[0111] For F2 = 25 mm and the eye’s refraction Rx=-20 diopters, the proper focusing distance D = 37.5 mm. For F2 = 25 mm and Rx=30 diopters, the proper focusing distance D = 68.75 mm.

[0112] Figure 13 illustrates the spots image on the WF camera of Figure 12 for a reference plane wave (left) and a diverging wavefront (right). Note that the spot locations on the WF camera change due to the local derivative of the incident wavefront.

[0113] Figure 14 provides a schematic summary of certain steps that can be used in reconstructing the wavefront due to a change in the location of the spots in one embodiment of the present disclosure. In this embodiment, the first step comprises determining the location of spots for a reference plane wave and recording the location as part of the system calibration. When presented with an unknown wavefront, the presently disclosed systems permit determination of the unknown spots and calculation of the difference between their locations and the reference spot locations. The differences in the spot locations allow estimation of the local derivatives of the incident wavefront using the following equations. dW (x, y) Ax dW (x, y) Ay - = - and - = - dx f dy f

[0114] These wavefront derivatives can then be used to construct a set of equations which calculate the Zernike coefficients ctof the unknown wavefront. In one embodiment, this system of equations has the following form and can be solved by numerical linear algebra methods. Note that the exemplary system of equations can be solved for rectangular coordinate Zernike

[0115] From the Zernike coefficients, various attributes of the wavefront can be computed, such as refraction in the form of sphere + cylinder x axis values. In one embodiment, the refraction in plus cylinder notation can be calculated using the following equation.

[0116] In these equations, R is the radius of the Zernike region of support in mm, and the coefficients are in microns.

[0117] As with the keratometry averaging, the following averaging algorithm can be directly applied to a set of N individual measurements.

[0118] Zernike aberrations averaging algorithm1. Acquire N individual measurements.2. Find the best fit centroid for N-k of the measurements.3. Average the closest N-k measurements.

[0119] Not shown in the aberrometry subsystem is an electroactive lens that can be used to adjust the wavefront beacon focus. Since the aberrometer can measure a range of ametropia from -20D to +30D, the ability to adjust the beacon focus can be necessary to permit the eye to clearly see the beacon over the full range and allow the wavefront sensor to generate a good representation of the aberrations of the eye with respect to the fovea.

[0120] Also not shown in the aberrometry subsystem is an aperture that can be present in the second focusing relay lens. In embodiments, this aperture keeps the spots image of high quality and relatively free of spurious light artifacts.

[0121] Subsystem for OCT

[0122] Figure 15 shows a simplified view of an OCT subsystem 700 under one embodiment of the present disclosure. There can be two different interferometer methods employed for OCT measurements. In certain embodiments, the measurements provided include corneal thickness, anterior chamber depth, lens thickness, axial length, or a combination thereof. In one embodiment, a dual-beam time-domain low-coherence interferometer (Dual Beam TD-LCI) measures the axial length and is shown in the top part of the figure, and a standard time-domain low-coherence interferometer (TD-LCI) measures the other distances about the anterior portion of the eye and is shown in the bottom part of the figure.

[0123] For one embodiment of the Dual Beam TD-LCI, the input light source SLD1 is input to fiber coupler FC1. The two beams provided by fixed mirror Ml and linearly scanned (LS) mirror M2 are presented to the eye via beam splitters BS2 and BS4. When the optical pathdifference between the two beams is equal to the optical path of the length of the eye, a strong correlation is presented to photo detector PD 1. This analog signal can be converted into a digital signal using analog-to-digital converter ADC1 and communicated to a microprocessor on the PCB. This digital signal can be processed to locate the peak correlation and can be simultaneously associated with the location of the linear scanner LS which provides the distance between the mirrors Ml and M2. From this distance the axial length can be computed for the current measurement. In embodiments, several such measurements are computed to help produce a more accurate axial length measurement via a robust averaging algorithm described below.

[0124] Axial length averaging algorithm1. Acquire N individual measurements.2. Find the best fit value for N-k of the measurements.3. Average the closest N-k measurements.

[0125] Under one embodiment of the standard TD-LCI used to measure the anterior portion of the eye, the input light source SLD2 is input to fiber coupler FC2. The comparison legs of the Michelson interferometer include a reference path formed by mirror M3 being controlled by linear scanner LS and a measurement path that is scanned using scanner XYS in the XY plane which is orthogonal to the optical axis of the eye and presented to the eye via beam splitter BS1. When the reference and measurement paths are optically equal, a strong correlation is presented to photo detector PD2. This analog signal can be converted into a digital signal using analog-to-digital converter ADC2 and communicated to a microprocessor on the PCB. This digital signal can be processed to locate a sequence of correlation peaks and can simultaneously be associated with the location of the linear scanner LS which provides a measure of the reference distance at these peaks. From these reference distances, any one or more of the corneal surface, corneal thickness, corneal back surface axial length, anterior chamber distance, and lens thickness can be computed. In embodiments, the XY scanner allows these measurements to be computed along various scans such as circles around the geometric center of the eye or various meridians of the eye. Several such measurements can be computed to help produce a more accurate set of axial locations using the averaging algorithm described below. In addition to measuring the distance between optical surfaces, the XYS scanner can be used to trace out the surface elevations of the optical surfaces.

[0126] Axial locations averaging algorithm under one embodiment1. Acquire N individual sets of measurements.2. Find the best fit value for N-k of the sets of measurements.3. Average the closest N-k sets of measurements.

[0127] System process and analysis details for exemplary embodiments

[0128] Exam alignment embodiments

[0129] The data reported by the MOB for a given exam can be subject to an eye’s alignment. In embodiments, part of the alignment is achieved by using a consistent fixation source. For the MOB, this fixation can comprise the NIR wavefront beacon.

[0130] Also, between the various data types, such as cornea / scleral topography, OCT data, front-view images and exams taken at different times, the eye can cyclo-rotate (rotation about the optical axis) so that the data is no longer properly aligned for making angular measurements, such as corneal power meridian. In embodiments, to keep the data aligned, the front-view cameras provide iris and scleral data that allow features to be found and used to rotate the data appropriately. In rare cases where these features cannot be found automatically, the user can interactively select features for this registration.

[0131] Exam storage embodiments

[0132] With permission from the user, the data collected during an exam can be uploaded to a secure central repository on the web. This data can then be used to optimize processing and analysis algorithms based on artificial intelligence (Al) and machine learning. Updates are then provided to the MOBs in the field. This continual optimization can be carried out over the life of the MOB.

[0133] Exam quality check embodiments

[0134] During processing of the various individual subsystem images and data analysis, various quality checks can be performed. In such embodiments, images are processed using Al algorithms to detect eye events. Exemplary eye events include blinks, dry eye, non-fixation, objects in the field of view (e.g., surgical instruments), artifacts (e.g., extraneous light glare, poor focus, frame-to-frame motion, poor image contrast, saturated images, or a combination thereof), and others that may be known in the art. In certain embodiments, these algorithms include convolutional neural networks (CNNs), deep neural networks (DNNs), and other machine learning regression and classification algorithms.

[0135] By way of non-limiting example, in one embodiment, dry eye is detected by analyzing the wavefront spots image for spots drop out using a CNN trained for this purpose. In addition, CNNs looking at the visible and NIR keratometer LED images can also detect dry eye. When dry eye over an area is detected, the surgeon is notified that additional wetting onthe eye is warranted.

[0136] In various embodiments, when any one or more of these adverse quality events occur, the user can be notified of the issue. The user can further be informed of any action the user should take to increase the quality of the acquisitions (e.g., removal of a surgical instrument from the field of view). In embodiments wherein the exam quality is below one or more pre-defined thresholds, exam data is not provided to the user and the user is notified of this. The pre-defined thresholds can depend on the type of data being generated or measured (e.g., ocular aberrations). In embodiments, the pre-defined thresholds are based on analysis of eye model data and apparent measurement accuracy. The pre-defined thresholds can be updated based on empirical / clinical results. In embodiments that employ artificial intelligence, associated models can be continually updated based on exam results obtained by surgeons in the field.

[0137] In certain embodiments, these quality checks are part of the data saved with exams.

[0138] Exam auto-acquisition embodiments

[0139] For each data subsystem, an auto-acquisition function can be in operation alongside the quality check. In embodiments, when the exam is properly aligned and of sufficient quality, the exam is automatically acquired and processed. As used herein, the phrase “sufficient quality” for an exam refers to conditions that are likely to produce measurements that meet a given system’s specifications. In certain embodiments, “sufficient quality” refers to exams with conditions that meet or exceed the pre-defined thresholds referenced above. By way of nonlimiting example, a pre-defined threshold can be reporting corneal power to within a 0.25 D of the true value. If the exam is not properly aligned, the user can be notified of this event. The user can further be notified of appliable procedures or steps to correct or alleviate the misalignment. For example, in one embodiment, during acquisition a mark can be made on the screen to show the user where the image should be centered. In one embodiment, when the image is too far away from the centration mark, exam acquisition is prohibited. In rare occasions where it is not possible to auto-acquire an exam, certain embodiments can permit the user to override this function and manually acquire an exam. A manual override flag can be captured in the exam and can be included in the exam’s display.

[0140] User specific profiles

[0141] In embodiments, a user may set and select a profile set of options for the MOB acquisition, analysis, display software, or a combination thereof. This can include determining which displays are automatically shown for a given exam and what analysis and other data appear on the displays. In addition, it can include reports that are designed to contain specificdata and information that can be selected for distribution such as via printing, faxing, or sending to an email address.

[0142] Binocular analysis

[0143] In certain embodiments, binocular displays and reports showing both left and right eye can be provided. For data that evaluates visual acuity, individual eye acuity, as well as a combination binocular acuity, can be provided. In embodiments, this combination acuity is processed by finding the MTF of the right and left eye and then finding a combined MTF by selecting the maximum contrast from each individual eye’s MTF for each frequency sample. Various methods of predicting acuity from the MTF can then be used to quantify the acuity. By way of example, these methods can include comparison to a human contrast threshold function and calculation of the MTFa value as explained in the ANSI EDOF IOL standard (see, ANSI Z80.35-2018: Ophthalmics - Extended Depth of Focus Intraocular Lenses).

[0144] Advanced graphics displays

[0145] Various graphical and data displays are generated for the user. In addition to the typical graphs, color maps, bar graphs, data tables, surface representations, and interactive 3D eye models can be presented to the user. The eye models can be generated by the available data collected by the exams and both eyes can be presented at one time.

[0146] Advanced analysis

[0147] Since the MOB can acquire various types of eye data during an examination, the ability to combine the data to make advanced inferences about the state of the eye is presented. For example, in one embodiment, using the corneal wavefront from the comea / scleral topographer and the wavefront aberrations, we can generate and display the internal aberrations of the eye. Using the OCT profiles and the wavefront aberrations data we can determine if the current IOL is tilted or decentered. This tilt and decentration detection ability applies to either a phakic or aphakic IOL. Another example is the ability to discern the expected lens position (ELP) for an IOL based on intraoperative analysis of the aphakic deflated crystalline bag which remains after the cataractous crystalline lens has been removed. In embodiments, this will help the surgeon make a last-minute decision on the correct IOL lens power for a patient. Another example is the ability to detect out-of-range intraocular pressure (IOP). In embodiments, the projection comeal / scleral topography subsystem provides grid images that, when trained on a large number of exam images, can provide classifications such as IOP too low, IOP in normal range, IOP too high, or a combination thereof. This IOP classification information can be used to alert the surgeon during intraoperative procedures to make a compensatory change that increases or decreases the IOP and can allow the analysis software to reject exam analysis dueto poor examination conditions. Another example includes the ability to have a supervisor algorithm monitor the results of each of the subsystems and determine the conditions for acquiring all data under optimal conditions. This can occur, for example, when the eye is not blinking, the cornea is not exhibiting dry eye areas, optical glint or other image / data artifacts are not present in any of the subsystem sensor data, or a combination thereof.

[0148] Voice control

[0149] Program control can be difficult for a user while performing certain procedures. For example, during surgery it is often difficult to permit program control as both of the surgeon’s hands are occupied. To facilitate program control under such conditions, as shown in Figure 16, a voice control mode can be provided that allows a user to direct the MOB what to do on a given display. This includes all functions that are normally performed by an interactive user interface. As shown in the exemplary embodiment of Figure 16, an operator can control the system using one or more voice commands. In such embodiments, the operator can issue an attention or “wake” word that is configured to alert the voice input processor that the operator is preparing to issue a voice command. As shown in the Figure 16 example, this attention word can be the word “Attention,” however, it will be understood that any word in the English language can be utilized as the attention word. Following activation of the voice input processor, the operator issues the voice command, which the voice input processor converts into a text command and communicates the command to the processor. The text command is then sent to the appropriate coupled electronic device to complete the desired action. In various embodiments the voice command can be selected from a plurality of pre-established phrases or commands that instruct the MOB system to operate in a given way or produce a given output. By way of example, these voice commands can correspond to options that may be otherwise (or additionally) accessible to select via a mouse or other pointer device from a pre-selected menu of options. Such voice commands can be used to direct the MOB to display certain images or user interfaces to the operator. With reference to Figure 16, when the voice command comprises the phrase “display color map,” the voice input processor converts the audio input to a text command and then passes the text command (either directly or through one or more intermediary processors) to the display class waiting for the next command. The display class then generates the appropriate display and presents the color map to the operator.

[0150] It should be understood that, while the various subsystems are individually described above, in embodiments, these described subsystems will be incorporated into a single MOB to permit simultaneous data acquisition across all subsystems by a user.

[0151] In various embodiments, the subsystems described herein are physically combinedin a manner that ensures the same optical axis across all measurements and subsystems. In certain embodiments, subsystems can be arranged within the MOB according to the particular wavelength of light being emitted or detected. In one embodiment, a single, primary SLD source is distributed or split into individual SLD sources (such as via fiber optics) to different subsystems. Such distribution of the source SLD can provide a cost-saving feature. The subsystems can be controlled via real-time algorithms to provide measurements in rapid and deterministic time intervals to permit conveyance of results and information to the operator directly or after being combined with data from other subsystems.

[0152] In embodiments, the systems and methods disclosed herein can be communicatively coupled with computer networks, computing devices, mobile devices, or combinations thereof. Under certain embodiments, the systems and methods disclosed herein may utilize the communicative coupling to relay data from each subsystem to other subsystems or aggregate the data into a central repository of such information.

[0153] In embodiments, the systems and methods disclosed herein can present collected data directly to a user through a display that is associated with one or more computing devices or mobile devices. The computing devices or mobile devices can be communicatively coupled to one or more applications running on at least one processor of a remote server. The systems and methods disclosed herein can transmit data or results of data analysis (as described below) to the remote server. Third party clients such as health care professionals or researchers may (with appropriate consents and compliance with HIPAA and other federal and state privacy legislation) receive application data through requests to remote server applications. In embodiments, such third-party health care providers can then recommend or prescribe a therapeutic agent or other treatment option (such as a corrective procedure) as appropriate according to the data received.

[0154] As indicated above, data may be communicated to a computing application which may then be presented to a user, a health professional, a researcher, or a combination thereof. However, the computing application may initially analyze and interpret raw data to determine the patient’s likelihood of having a particular condition, disease, or disorder. The application may then send analytical results to remote server applications for third party access. Under an embodiment, data analytics may be performed by the application, remote server applications, or a combination thereof.

[0155] The communicative coupling can be accomplished through one or more wireless communications protocols. The communicative coupling may comprise a wireless local area network (WLAN). A WLAN connection may implement WiFi™ communications protocols.Alternatively, the communicative coupling comprises a wireless personal area network WP AN. A WPAN connection may implement Bluetooth™ communications protocols.

[0156] Embodiments can comprise a data port for relaying data to the mobile device or other computing device. The data port may be a USB connection or any other type of data port. The data port allows for a wired communication between any one or more of the subsystems described herein and separate computing devices. The data port may be used alone or in combination with the wireless communications protocols of the subsystems described above.

[0157] In one embodiment, the computing application compares the data received to historical patient data. The historical patient data can include data reported through prior scientific publications, data compiled from the health professional’s own patient records, data from EMR systems that represent diverse patient populations, or any other source of patient data or combinations thereof. Of course, all such data comply with HIPAA and state / federal data privacy legislation.

[0158] Using such information, the application can detect similarities and differences in the patient’s data with historical patient data and uses statistical methods to calculate the probability that the user is suffering from a particular condition, disease, or disorder. Using this probability data, a health care professional can make certain recommendations or prescriptions to treat or otherwise alleviate the condition, disease, or disorder or any symptoms associated therewith.

[0159] Data can be reported to users via a dashboard type view for the user to see results and receive recommendations. These results are under an embodiment viewable through an application interface. As indicated above, data and data analysis can additionally reside on a remote server. A user may access such data and analysis through a desktop client.

[0160] Computer networks suitable for use with the embodiments described herein include local area networks (LAN), wide area networks (WAN), Internet, or other connection services and network variations such as the world wide web, the public internet, a private internet, a private computer network, a public network, a mobile network, a cellular network, a value- added network, and the like. Computing devices coupled or connected to the network may be any microprocessor-controlled device that permits access to the network, including terminal devices, such as personal computers, workstations, servers, mini computers, main-frame computers, laptop computers, mobile computers, palm top computers, hand held computers, mobile phones, TV set-top boxes, or combinations thereof. The computer network may include one or more LANs, WANs, Internets, and computers. The computers may serve as servers, clients, or a combination thereof.

[0161] The systems and methods disclosed herein can be a component of a single system, multiple systems, and / or geographically separate systems. The presently disclosed systems and methods can also be a subcomponent or subsystem of a single system, multiple systems, and / or geographically separate systems. The components of systems and methods disclosed herein can be coupled to one or more other components (not shown) of a host system or a system coupled to the host system.

[0162] One or more components of the systems and methods described herein and / or a corresponding interface, system, or application to which the systems and methods described herein are coupled or connected includes and / or runs under and / or in association with a processing system. The processing system includes any collection of processor-based devices or computing devices operating together, or components of processing systems or devices, as is known in the art. For example, the processing system can include one or more of a portable computer, portable communication device operating in a communication network, a network server, or a combination thereof. The portable computer can be any of a number and / or combination of devices selected from among personal computers, personal digital assistants, portable computing devices, and portable communication devices, but is not so limited. The processing system can include components within a larger computer system.

[0163] The processing system of an embodiment includes at least one processor. The term “processor” as generally used herein refers to any logic processing unit, such as one or more central processing units (CPUs), digital signal processors (DSPs), application-specific integrated circuits (ASIC), etc. The processor can be disposed within or upon a single chip. The processing system can further include at least one memory device or subsystem. The processing system can also include or be coupled to at least one database. The processor and memory can be monolithically integrated onto a single chip, distributed among a number of chips or components, and / or provided by some combination of algorithms. The systems and methods described herein can be implemented in one or more of software algorithm(s), programs, firmware, hardware, components, circuitry, in any combination.

[0164] The components of any system that include the systems and methods described herein can be located together or in separate locations. Communication paths couple the components and include any medium for communicating or transferring files among the components. The communication paths include wireless connections, wired connections, and hybrid wireless / wired connections. The communication paths also include couplings or connections to networks including local area networks (LANs), metropolitan area networks (MANs), wide area networks (WANs), wireless personal area networks (WPANs), proprietarynetworks, interoffice or backend networks, and the Internet. Furthermore, the communication paths include removable fixed mediums like floppy disks, hard disk drives, and CD-ROM disks, as well as flash RAM, Universal Serial Bus (USB) connections, RS-232 connections, telephone lines, buses, and electronic mail messages.

[0165] Aspects of the systems and methods described herein may be implemented as functionality programmed into any of a variety of circuitry, including programmable logic devices (PLDs), such as field programmable gate arrays (FPGAs), programmable array logic (PAL) devices, electrically programmable logic and memory devices and standard cell-based devices, as well as application specific integrated circuits (ASICs). Some other possibilities for implementing aspects of the systems and methods described herein include: microcontrollers with memory (such as electronically erasable programmable read only memory (EEPROM)) or without memory, embedded microprocessors, firmware, software, etc. Furthermore, aspects of the systems and methods described herein may be embodied in microprocessors having software-based circuit emulation, discrete logic (sequential and combinatorial), custom devices, fuzzy (neural) logic, quantum devices, and hybrids of any of the above device types. Of course, the underlying device technologies may be provided in a variety of component types, e.g., metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like emitter- coupled logic (ECL), polymer technologies (e.g., silicon-conjugated polymer and metal- conjugated polymer-metal structures), mixed analog and digital, etc.

[0166] It should be noted that any system, method, and / or other components disclosed herein may be described using computer aided design tools and expressed (or represented), as data and / or instructions embodied in various computer-readable media, in terms of their behavioral, register transfer, logic component, transistor, layout geometries, and / or other characteristics. Computer-readable media in which such formatted data and / or instructions may be embodied include, but are not limited to, non-volatile storage media in various forms (e.g., optical, magnetic or semiconductor storage media) and carrier waves that may be used to transfer such formatted data and / or instructions through wireless, optical, or wired signaling media or any combination thereof. Examples of transfers of such formatted data and / or instructions by carrier waves include, but are not limited to, transfers (uploads, downloads, e- mail, etc.) over the Internet and / or other computer networks via one or more data transfer protocols (e.g., HTTP, FTP, SMTP, etc.). When received within a computer system via one or more computer-readable media, such data and / or instruction-based expressions of the abovedescribed components may be processed by a processing entity (e.g., one or more processors)within the computer system in conjunction with execution of one or more other computer programs.EQUIVALENTS

[0167] Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein. Such equivalents are considered to be within the scope of this invention and are covered by the following claims.

Claims

What is claimed:

1. A multifunctional ocular biometer comprising: a plurality of ophthalmic subsystems, the plurality of ophthalmic subsystems comprising at least two of: a color imaging subsystem, a subsystem for projection corneal and scleral topography, a keratometry subsystem, an aberrometry subsystem, and a subsystem for optical coherence tomography (“OCT”); wherein the multifunctional ocular biometer is configured to obtain ophthalmic measurements from a patient’s eye at any one or more of the following timepoints: before the patient undergoes an ocular corrective measure, after the patient undergoes the ocular corrective measure, and during the ocular corrective measure.

2. The multifunctional ocular biometer of claim 1, wherein the multifunctional ocular biometer is configured for use in a clinical exam setting.

3. The multifunctional biometer of claim 1, wherein the multifunctional ocular biometer is attached or otherwise integrated with a surgical microscope.

4. The multifunctional biometer of claim 1, wherein the ocular corrective measure comprises eyeglasses with corrective lenses, contact lenses, a corrective procedure, or a combination thereof.

5. The multifunctional biometer of claim 4, wherein the corrective procedure comprises ocular refractive surgery.

6. The multifunctional biometer of claim 1, wherein the ophthalmic measurements comprising at least three light sources, the at least three light sources comprising aproj ection comeal / scleral topography grid projector (PCT Projector), a keratometer light emitting diode (LED), and one or more super-luminescent diodes (SLDs).

7. The multifunctional ocular biometer of claim 6, comprising at least three at least three SLDs; or a single source SLD that is split into at least three separate SLDs such that each of the three separate SLDs comprise the same wavelength.

8. The multifunctional ocular biometer of claim 6, further comprising at least one additional white light-emitting diode light source.

9. The multifunctional ocular biometer of claim 8, wherein the at least one additional white light-emitting diode light source is placed higher than the eyelevel of a patient.

10. The multifunctional ocular biometer of claim 8, wherein the at least one additional white light-emitting diode light source is placed lower than the eyelevel of a patient.

11. The multifunctional ocular biometer of claim 8, wherein the biometer further includes two additional white light-emitting diode light sources, wherein the first additional white lightemitting diode light source is placed higher than the eyelevel of a patient, and the second additional white light-emitting diode light source is placed lower than the eyelevel of a patient.

12. The multifunctional biometer of claim 1, the multifunctional biometer further comprising a cold mirror, wherein the cold mirror is configured to create at least two analysis paths comprising a visible light path and a near-infrared (NIR) light path;the visible light path providing light for the color imaging subsystem, the subsystem for projection corneal and scleral topography the keratometry subsystem, or a combination thereof; and the NIR light path providing light for the aberrometry subsystem, the subsystem for optical coherence tomography, or a combination thereof.

13. The multifunctional biometer of claim 1, wherein the color imaging subsystem comprises a white flood LED, an imaging lens, a front view color camera or a combination thereof, wherein the white flood LED is configured to illuminate the patient’s eye, the lens is configured to image the light from the white flood LED onto the front-view camera, and the front view camera is configured to obtain one or more images of the patient’s eye.

14. The multifunctional biometer of claim 13, wherein the color imaging subsystem further comprises a doubly telecentric lens.

15. The multifunctional biometer of claim 13, wherein the color imaging subsystem further comprises a second front-view camera that is configured to operate within the NIR range.

16. The multifunctional biometer of claim 1, wherein the subsystem for projection corneal and scleral topography comprises a projection arm and an imaging arm; the projection arm comprising an LED; at least two processing lenses, a projection lens, a grid target, or a combination thereof; and the imaging arm comprising a camera, an imaging lens, a bandpass filter, or a combination thereof.

17. The multifunctional biometer of claim 1, wherein the subsystem for keratometry comprises a plurality of source LEDs, an imaging camera lens, a bandpass filter, and an imaging camera sensor.

18. The multifunctional biometer of claim 17, wherein at least one source LED is configured to emit a perpendicular light array and a chief principal light ray; the perpendicular light ray being configured to intersect a virtual image of the source LED that is reflected by a cornea of the patient’s eye; and the chief principal light ray being configured to reflect off the cornea, through the imaging camera lens and the bandpass filter, and to the imaging camera sensor.

19. The multifunctional biometer of claim 17, wherein the keratometry subsystem comprises up to 12 source LEDs.

20. The multifunctional biometer of claim 1, wherein the aberrometry subsystem comprises: a super luminescent diode (SLD) configured to provide a beacon light source; a focusing lens; a beam splitter; a beam trap configured to prevent stray light contamination; a wave front sensor; a wavefront camera; a first relay lens group that comprises at least two relay lenses; a second relay lens group that comprises at least two relay lenses; and a combination thereof.

21. The multifunctional biometer of claim 20, wherein the SLD is configured to provide a light source with a wavelength of about 830 nm.

22. The multifunctional biometer of claim 1, wherein the subsystem for OCT comprises a dual- beam time domain low-coherence interferometer (“Dual Beam TD-LCI”), a standard-time domain low-coherence interferometer (“Standard TD-LCI”) or a combination thereof.

23. The multifunctional ocular biometer of claim 2, comprising: a manipulator; a support base, the support base having a first end and a second end, the second end connected to a first end of the biometer at about a ninety-degree angle; a patient support system, comprising at least one rest for the patient’s head, the patient support system configured to align the patient’s eye level with the second end of the biometer.

24. A method of measuring a patient’s eye, the method comprising: obtaining the multifunctional ocular biometer of any one of claims 1-23; obtaining a first ophthalmic measurement from a first ophthalmic subsystem; obtaining a second ophthalmic measurement from a second ophthalmic subsystem, wherein the second ophthalmic subsystem is different from the first ophthalmic subsystem; and calculating one or more ophthalmic values from the first and second ophthalmic measurements; and displaying the one or more ophthalmic values to a user.

Images