Systems and methods of use of a corneal autograft calculator

Abstract

Systems and methods for determining IRA candidacy and optimizing autologous corneal graft location and orientation to standardize and improve IRA procedures. A novel digital virtual model (i.e., a digital twin) of the eye is provided that integrates corneal imaging, pachymetry, topography and limbus / white-to-white measurements, and automates key surgical variables such as trephine size, autologous corneal graft rotations, and curvature and thickness matching, reducing cognitive load on the surgeon and improving accuracy. The embodiments herein provide precise graft placement parameters to maximize the amount of clear cornea in the visual axis. By providing real-time, patient specific guidance, the present embodiments enhance surgical precision and visual outcomes.

Description

SYSTEMS AND METHODS OF USE OF A CORNEALAUTOGRAFT CALCULATORCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to US Provisional Patent Application No. 63 / 575,032, filed on April 5, 2024, titled “Systems and Methods of Use of a Corneal Autograft Calculator,” which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] The present disclosure provides systems and methods for determining and optimizing corneal graft parameters for use in surgery or surgical planning.

[0003] Corneal opacification is a leading cause of vision impairment, particularly when located within the visual or pupillary axis. Blindness from corneal opacification is often the result of full stromal thickness scarring and is commonly treated with rigid contact lenses, topical losartan, and various surgical procedures. Rigid contact lenses improve visual acuity by reducing corneal irregularity, but issues such as inadequate visual rehabilitation, glare, and discomfort limit their effectiveness. Topical losartan has been shown to reduce scarring fibrosis, though it remains an emerging therapy with high costs and mostly anecdotal human evidence.

[0004] Surgical options for corneal opacification include phototherapeutic keratectomy (PTK), penetrating keratoplasty (PKP), deep anterior lamellar keratoplasty (DALK), anterior lamellar keratoplasty (ALK) and ipsilateral rotational autokeratoplasty (IRA). PTK can act as less invasive method to remove superficial opacities using an excimer laser, but has complications including disease recurrence, refractive surprise, post operative pain, delayed epithelial healing, and corneal haze. PKP, one of the most common procedures for opacification, transplants clear donor cornea and is useful in full thickness opacification and endothelial cell disease, but carries risk from graft rejection and subsequent immunosuppression. DALK and ALK, are partial thickness allografts which offer lower risk for intraocular infection, endothelial loss, and rejection, but pose challenges such as host-donor interface irregularity, and the potential need for secondary procedures. Additionally global disparities in availability of donor tissuecreate unpredictable waiting time ranging from a few days in the US, to years in other countries. In some countries, donor corneal tissue, surgical expertise, and facilities are simply not available.

[0005] IRA is an autograft alternative which alleviates the need for donor material, is more affordable, and can be utilized in cases where the risk of graft rejection is high (i.e. in children, deeply vascularized host cornea, trachomatous corneal scarring, large diameter graft, close proximity to recipient limbus). IRA involves trephining and rotating a patient’s own corneal tissue (comeal graft) to reposition an opacity outside the visual axis. IRA is most viable in cases where the opacity is relatively small, and its success depends on precise planning, as multiple variables must be considered which makes manual assessment complex.

[0006] Accordingly, there is need for improved and standardized IRA planning procedures.SUMMARY

[0007] The present embodiments provide systems and methods for determining IRA candidacy and optimizing autologous comeal graft location and orientation to standardize and improve IRA procedures.

[0008] To enhance IRA planning, in certain embodiments, a novel digital virtual model (i.e., a digital twin) is provided that integrates comeal imaging, pachymetry, topography and limbus / white-to-white measurements, and automates key surgical variables such as trephine size and position, autologous comeal graft rotations, and curvature matching, reducing cognitive load on the surgeon and improving accuracy. The embodiments herein provide precise graft placement parameters to maximize the amount of clear cornea in the visual axis. By providing real-time, patient specific guidance, the present embodiments enhance surgical precision and visual outcomes.

[0009] The embodiments advantageously assist surgeons with the time-consuming task of pre-operative planning and performing an IRA and optimize surgical outcomes by utilizing patient specific data. In certain embodiments, the functions of both geometric calculation and digital image manipulation are provided in one place, implemented as an interactive display tool, while also providing additional surgically relevant information. Using corneal topography and pachymetry information, and superimposing three-dimensional data onto the corneal image, the present embodiments advantageously optimize the trephination and placement of the autologous comeal graft for more precise planning. In addition to increased accuracy and enhancedplanning, the embodiments herein enhance efficiency by automating image manipulation and allow for multi-variate customization by the surgeon prior to the operating room.

[0010] In certain aspects, an interactive display tool is provided to enable manipulation of various parameters of the virtual model to determine and calculate corneal graft location, sizing and rotation parameters.

[0011] According to an embodiment, a computer implemented method of determining corneal graft parameters for a subject’s eye is provided. The method may be implemented in a computer system including one or more processors. The computer system may also include a display device, e.g., to display images and elements of an interactive display tool. The method typically includes receiving an image of the eye, the eye having an opacity in a cornea of the eye proximal to a visual axis of the eye, displaying the image of the eye in an interactive display tool, and receiving as user input in the interactive display tool a demarcation of a limbus in the displayed image of the eye, the demarcation indicating a periphery of the limbus along at least a horizontal axis and along a vertical axis and a range or dimension of the limbus (e.g., white-to- white dimension) along the horizontal axis or vertical axis. The method also typically includes determining or calculating a geometric center of the cornea based on the demarcation. The method also typically includes receiving as input an actual measurement of the range or dimension of the limbus along the horizontal axis, and receiving as user input in the interactive display tool an indication of a size of a corneal graft and a location of a center of the corneal graft in the cornea displayed in the interactive display tool. The method may include displaying a circle representing the corneal graft in the interactive display tool, e.g., on the displayed cornea. The method also typically includes determining or calculating an actual size of the corneal graft and the actual center of the corneal graft based on the actual measurement of the range or dimension of the limbus, and determining or calculating coordinates of the corneal graft relative to the center of the cornea, which may include determining coordinates of the corneal graft using the center of the circle representing the corneal graft as displayed by the interactive display tool relative to the center of the cornea. The method also typically includes receiving as user input in the interactive display tool one or multiple indications of an edge or margin of a pupil of the eye displayed in the interactive display tool, or receiving a marking of a margin of the pupil on the image, e.g., to identify or determine the area and location of the pupil to be cleared upon surgical repositioning. The method also typically includes determining or calculating, based on alocation of the opacity in the comeal graft, a degree of rotation of the corneal graft to position a clear area of the comeal graft along the visual axis, e.g., as determined by the marked pupil. The method further typically includes providing as output the coordinates of the comeal graft and / or the actual size of the corneal graft and / or the degree of rotation of the corneal graft, for use in a surgery or surgical planning.

[0012] In certain aspects, the coordinates of the comeal graft relative to the center of the cornea include x and y coordinates of the center of the comeal graft relative to the center of the cornea, wherein x represents the horizontal axis and y represents a vertical axis perpendicular to the horizontal axis, or the coordinates include an amount of decentration of the comeal graft from the center of the cornea and an angle of decentration (e.g., from horizontal) of the corneal graft.

[0013] According to certain aspects, the method further includes receiving one or more of a pachymetry map of the cornea and a topography map of the cornea and a tomography map of the cornea, and the displaying the image of the eye in an interactive display tool includes overlaying the image and one or more of the pachymetry map and the topography map and the tomography map and displaying a combined parameter map of the cornea, the combined parameter map including the image of the eye and visual or numerical indicators identifying one or more parameter values from the pachymetry map and / or the topography map and / or tomography map. Other information useful in certain embodiments includes information from bio-mechanical, wavefront aberration, raytracing, confocal microscopy and vascularization maps and other possible maps or information from corneal imaging in the future.

[0014] According to certain aspects, the method further includes receiving as user input in the interactive display tool an indication of a border of the pachymetry map and / or a border of the topography map and / or a border of the tomography map to enable an accurate overlay with the cornea in the image of the eye.

[0015] According to certain aspects, the method further includes identifying, based on the coordinates of the corneal graft, a trephine position on the cornea of the eye using manual markings directly on the cornea or an augmented reality display device or virtual reality display device or surgical tool, enabling trephination of the corneal graft at the identified trephine position on the cornea of the eye.

[0016] According to certain aspects, the method further includes identifying, based on the drawn or marked pupil, a position which should be cleared of the opacity by rotation of the graft.

[0017] According to certain aspects, the determining a degree of rotation further includes automatically adjusting the degree of rotation based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

[0018] According to certain aspects, the method further includes automatically adjusting one or more of a) the location of the center of the corneal graft, b) the size of the corneal graft, and c) the degree of rotation of the corneal graft, based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

[0019] According to certain aspects, the method further includes receiving as user input in the interactive display tool an adjustment of the location of the center of the corneal graft and / or the size of the corneal graft and / or the degree of rotation of the corneal graft.

[0020] According to certain aspects, the method further includes providing a visual alert based on a periphery of the planned corneal graft being within a threshold distance of a periphery of the limbus.

[0021] According to certain aspects, the receiving the actual measurement includes receiving as input from a user a caliper-based measurement of the eye or receiving as input the actual measurement from an optical biometry instrument. An example of an optical biometry instrument is lOLMaster® by Zeiss®.

[0022] According to certain aspects, one or both of a) the input of the demarcation of the limbus in the displayed image of the eye, and b) the input of an indication of the size of the corneal graft and the location of the center of the corneal graft in the cornea displayed in the display tool are provided by user input via one or more interactive input elements provided in the interactive display tool. The interactive input element(s) may include interactive slider bar(s). Other interactive input elements may include keyboard inputs, e.g., where arrow keys may adjust the position of the x and y coordinates, and the + and - keys may increase or decrease the radius, and mouse clicks to mark the x and y coordinates and drag to adjust the radius, and othergraphical user interface element(s), e.g., where a window pops up with input components such as buttons, sliders or input boxes, or any combination of these.

[0023] According to an embodiment, the method further includes determining an amount of additional corneal tissue to be added in the peripheral region of the graft and / or corneal bed to increase the thickness and reduce thickness mismatch.

[0024] According to an embodiment, the method further includes determining an amount of comeal tissue to be removed near the peripheral region of the graft and / or corneal bed to reduce curvature and / or thickness mismatches.

[0025] According to an embodiment, a computer system is provided that is configured to implement the methods herein, the system comprising a display and one or more hardware processors, and a memory storing instructions, which when executed by the one or more processors, cause the one or more processors to implement the methods and to display images and the interactive display tool and elements thereof on the display.

[0026] In a further embodiment, a non-transitory computer readable medium is provided that stores instructions, which when executed by one or more hardware processors, cause the one or more processors to implement the method methods as described herein.

[0027] Reference to the remaining portions of the specification, including the drawings and claims, will realize other features and advantages of the present invention. Further features and advantages of the present invention, as well as the structure and operation of various embodiments of the present invention, are described in detail below with respect to the accompanying drawings. In the drawings, like reference numbers indicate identical or functionally similar elements.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0028] The detailed description is described with reference to the accompanying figures. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items.

[0029] FIG. 1 shows a method of determining comeal graft parameters for a subject’s eye, according to an embodiment.

[0030] FIG. 2A illustrates an image of an eye and demarcation of the limbus by a user via an interactive display tool interface, according to an embodiment.

[0031] FIG. 2B shows marking the outer border of the mapped area of the cornea, and the outer margin of the pachymetry map, according to an embodiment.

[0032] FIG. 2C shows marking the outer border of the mapped area of the cornea, and the outer margin of the topography map, according to an embodiment.

[0033] FIG. 2D shows Images of the cornea including overlays of pachymetry and topography maps, according to an embodiment.

[0034] FIG. 2E shows an indication of the sizing and placement of a corneal graft (i.e., trephine placement) in the displayed image, according to an embodiment.

[0035] FIG. 3 illustrates an example of sizing and location of the graft or trephine according to an embodiment; the system calculates the size of the trephine based on the range of corneal tissue measurement; demarcation of degrees in relation to the treatment area.

[0036] FIGS. 4 and 5 show examples of how the coordinates may be displayed or output and may include an amount of decentration of the corneal graft from the center of the cornea and an angle of decentration (e.g., from horizontal) of the corneal graft, according to embodiments.

[0037] FIG. 6 illustrates the image of the eye and demarcation of the pupil by a user via an interactive display tool interface, according to an embodiment.

[0038] FIG. 7 and FIG. 8 show visual demonstrations of examples of the clearing of the visual axis and the rotation of the graft needed, according to embodiments.

[0039] FIG. 9A and FIG. 9B show visual demonstrations of information from a pachymetry map and topography map displayed with the graft or trephination, according to embodiments.

[0040] FIG. 10A and FIG. 10B provide examples of visual demonstrations provided to a viewer of pachymetry map information overlay ed with the image of the eye post autokeratopasty, according to embodiments.

[0041] FIG. 11 shows corneal topography and pachymetry information of the right eye of a patient: a) before Ipsilateral Rotational Autokeratoplasty, and b) after Ipsilateral Rotational Autokeratoplasty.

[0042] FIG. 12 shows a progression of Corneal topography and pachymetry of the right eye of a patient following surgical intervention: a) pre-Op Pentacam Images; b) day 1 Post-OpPentacam Images; c) month 4 Post-Op Pentacam Images; and d) month 8 Post-Op Pentacam Images.

[0043] FIG. 13 shows a pachymetry analysis including a progression of corneal thickness throughout the surgical process for a patient: (a) Pre-operative pachymetry; (b) Planned rotation of pachymetry; (c) 4 Months post-operative pachymetry; and (d) 8 Months post-operative pachymetry.

[0044] FIG. 14 shows a topography analysis including a progression of anterior curvature front throughout the surgical process for a patient: (a) Pre-operative topography; (b) Planned rotation of topography; (c) 4 Months post-operative topography; and (d) 8 Months post-operative topography.

[0045] FIG. 15 is a block diagram of example functional components for a computing system or device configured to perform one or more of the processes described herein, according to an embodiment.DETAILED DESCRIPTION

[0046] The following detailed description is exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the following detailed description or the appended drawings.

[0047] Turning to the drawings, and as described in detail herein, embodiments of the disclosure provide methods, devices and systems useful to determine and optimize corneal graft parameters for use in surgical planning and procedures.

[0048] Planning an IRA requires consideration of several factors including the size and shape of the opacity and unique anatomy of the patient’s cornea, including both shape and thickness.One goal is to position clear cornea into the visual axis and place the opacity outside of the visual axis. Secondary goals are to minimize postoperative astigmatism to achieve the best visual acuity, and to avoid mismatching wound edges that are of disparate thickness to avoid wound dehiscence. Aesthetic considerations could also be taken into account by preferentially placing the scar underneath the upper eyelid. Patients are sometimes identified as being eligible for IRAby anecdotal experience of a surgeon experienced with this procedure. Other surgeons will often use geometric formulas and / or manual digital image manipulation in a third-party software to assess candidacy for IRA.

[0049] Currently, there is not one standard technique used for IRA planning, and the manual methods are very subjective and time consuming. There are several guidelines which have been developed to facilitate the process of performing an IRA. While beneficial in nearly all cases, the lack of a standard method inherently leads to more unpredictable and variable outcomes with a frequent need for additional surgery. The present embodiments advantageously provide standardization, and concomitantly more predictable and less variable outcomes. Additionally, these traditional methods also fail to account for the thickness of the corneal graft and bed, and therefore does not minimize graft-bed thickness mismatch which can lead to complications like wound leakage or fistula formation.

[0050] Other common complications that may occur during IRA include improper trephination placement and a potential for induced astigmatism. An important consideration for IRA involves ensuring the trephination is an adequate distance from both the limbus and pupillary axis, as failure to do so results in suboptimal outcomes. Another concern pertains to increased incidence of irregular astigmatism following IRA as compared to PKP. This is likely due to eccentric trephination with variable thickness and shape as the central cornea tends to be thinner and steeper than the peripheral cornea. Other complications with IRA include wound leak, infection, corneal edema, and loss of corneal donor tissue integrity.

[0051] One prior method for IRA planning includes digital image manipulation using Photoshop© (Adobe). This prior method allows for pre-surgical visualization of the proposed rotation; however, this requires learning how to use more complex functions within Photoshop© and can be time consuming to perform. Similar to the geometric calculations, neither the curvature nor the thickness of the cornea are taken into account in these two-dimensional images, which can lead to errors and may not optimize visual acuity. The use of such prior digital manipulation to plan IRA, while somewhat effective, did not provide any advantages over the traditional calculations or guidelines when comparing results. The present embodiments advantageously address deficiencies found in previous computerized methods for planning IRA and offers a novel way to standardize pre-surgical planning while improving efficiency and allowing for a better preoperative assessment of surgical candidacy

[0052] FIG. 1 shows a method 100 of determining corneal graft parameters for a subject’s eye, according to an embodiment. The method may be implemented in a computer system including one or more processors. The computer system may also include a display device, e.g., to display images and elements of an interactive display tool that enables a user to manipulate various display elements. In step 110, an image of the eye is acquired, e.g., using a camera, and received by the computer system. The eye, and image thereof, may include an opacity in a cornea of the eye proximal to a visual axis of the eye. In step 120, the image of the eye is displayed in an interactive display tool. For example, the image may be rendered on a display device as part of an interactive display tool, which includes various interactive display elements that enable a user to mark and adjust various features as will be described herein.

[0053] In step 130, a demarcation of a limbus in the displayed image of the eye is received as user input in the interactive display tool. FIG. 2A shows an example of a rendered image of an eye and a demarcation of the limbus according to an embodiment. As shown in FIG. 2A horizontal and vertical bars or display elements may be provided as part of the interactive display tool. Interactive display tools or elements may be provided to demark a periphery of the displayed limbus along at least a horizontal axis and along a vertical axis. For example, the user may position or adjust the vertical bar to identify or demark the boundary of the limbus in the displayed image, and the user may position or adjust the horizontal bar to demark the white-to- white diameter of the limbus at its widest point. The demarcation also includes a range or dimension of the limbus (e.g., white-to-white dimension or diameter) along the horizontal axis or vertical axis.

[0054] The method also typically includes determining or calculating a geometric center of the cornea based on the demarcation. As shown in FIG. 2A, for example, the horizontal line diameter (white-to-white measurement of the limbus) has a length of 823 pixels and the vertical bar has a dimension of 754 pixels. From this information the system may calculate the geometric center of the cornea in the image. In this example, the geometric center is determined to be at x, y coordinates of 576.5 and 486.0 (pixels) from the bottom left comer of the displayed image.

[0055] In step 140, an actual measurement of the range or dimension of the limbus (white-to- white measurement) along the horizontal axis is received. The actual measurement may be entered as input by a user, e.g., after taking a caliper-based measurement of the eye.Alternatively, the actual measurement may be provided as input from an optical biometry instrument, such as lOLMaster, or other optical biometry system or device, either directly over a network connection, or as input by a user.

[0056] In some embodiments, where a pachymetry map is used, an indication of the size / diameter of the Pachymetry map (i.e., 9.0mm) may be displayed and marked. For example, the method may include displaying a circle (See FIG. 2B) representing the outer margin of the map. In some embodiments, where a topography map is used, an indication of size / diameter of the topography map (9.00mm) may be displayed and marked. For example the method may include displaying a circle (see FIG. 2C) representing the outer margin of the map. As an additional step, overlays of one or both of the pachymetry map and the topography map may be displayed on the cornea in the image as shown in FIG. 2D.

[0057] In step 150, an indication of a size of a corneal graft and a location of a center of the comeal graft is entered or received, for example, as user input in the interactive display tool. FIG. 2E shows an indication of the sizing and placement of a corneal graft (i.e., trephine placement) in the displayed image, according to an embodiment. The method may include displaying a circle 205 representing the corneal graft in the interactive display tool, e g., on the displayed cornea. As shown in FIG 2E, in an embodiment, the interactive tool may include interactive display elements such as sliders to enable then user to display and adjust the placement and location of the graft or trephine. For example, adjusting the x and y-coordinate sliders will adjust the center location of the trephine or graft and adjusting the radius slider will adjust the diameter of the displayed circle 205 representing the trephine or graft. In an embodiment, an alert, e.g., a visual alert, may be provided based on a periphery of the planned comeal graft being within a threshold distance of a periphery of the limbus. FIG. 2D shows an example of a displayed alert. The alert advantageously enables the user to adjust, using the interactive display tool, the location of the center of the comeal graft and / or the size of the comeal graft.

[0058] In step 160, the actual size of the corneal graft or trephine is calculated or determined and the actual center of the corneal graft is calculated or determined based on the actual measurement of the range or dimension of the limbus. FIG 3 shows an example of sizing and location of the graft or trephine according to an embodiment. In step 170, in an embodiment, the coordinates of the corneal graft are determined or calculated relative to the center of the cornea,which may include determining coordinates of the corneal graft using the center of the circle 205 representing the comeal graft as displayed by the interactive display tool relative to the center of the cornea. In certain aspects, the coordinates of the corneal graft relative to the center of the cornea include x and y coordinates of the center of the comeal graft relative to the center of the cornea, wherein x represents the horizontal axis and y represents a vertical axis perpendicular to the horizontal axis. In an embodiment, as shown in FIG. 4 and FIG. 5, the coordinates may be displayed or output and may include an amount of decentration of the corneal graft from the center of the cornea and an angle of decentration (e.g., from horizontal) of the corneal graft.

[0059] In step 180, the pupil is demarked to identify or determine the area and location of the pupil to be cleared upon surgical repositioning as shown in FIG. 6. For example, in an embodiment, one or multiple indications of an edge or margin of a pupil of the eye displayed in the interactive display tool are received as user input using interactive elements of the interactive display tool, or a marking of a margin of the pupil on the image is received, e.g., to identify or determine the area and location of the pupil to be cleared upon surgical repositioning. In an embodiment, based on the drawn or marked pupil, a position which should be cleared of the opacity by rotation of the graft is identified by the system.

[0060] In step 190, the system determines or calculates, based on a location of the opacity in the corneal graft, a degree of rotation of the comeal graft to position a clear area of the comeal graft along the visual axis, e.g., as determined by the marked pupil. FIG. 7 and FIG. 8 show a visual demonstration of example of the clearing of the visual axis and the rotation of the graft needed.

[0061] In step 195, the system provides as output the coordinates of the corneal graft and / or the actual size of the corneal graft and / or the degree of rotation of the corneal graft, for use in a surgery or surgical planning. For example, based on the coordinates of the comeal graft, a trephine position on the cornea of the eye may be manual marked directly on the cornea by a surgeon, or using an augmented reality display device or virtual reality device or surgical tool, enabling trephination of the corneal graft at the identified trephine position on the cornea of the eye. Information about the size of the graft and rotation needed may be used by the surgeon to adjust instrument parameters for enabling surgery.

[0062] In an embodiment, additional information about the subjects eye may be used to improve surgical outcomes. For example, in an embodiments, the method further includesreceiving one or more of a pachymetry map of the cornea and a topography map of the cornea and a tomography map of the cornea. The system uses this information and may display the information. For example, displaying the image of the eye in the interactive display tool may include overlaying the image and one or more of the pachymetry map and the topography map and the tomography map and displaying a combined parameter map of the cornea, where the combined parameter map includes the image of the eye and visual or numerical indicators identifying one or more parameter values from the pachymetry map and / or the topography map and / or tomography map. For example, FIG. 9A and FIG. 9B show visual demonstrations of information from a pachymetry map and topography map displayed with the graft or trephination. In an embodiment, the method further includes receiving as user input in the interactive display tool an indication of a border of the pachymetry map and / or a border of the topography map and / or a border of the tomography map to enable an accurate overlay of the map(s) and / or information (parameters) from the map(s) with the cornea in the displayed image of the eye, both before surgery and after a prospective surgery. FIG. 10A and FIG. 10B provide examples of visual demonstrations provided to a viewer of such information overlayed with the image of the eye post autokeratopasty.

[0063] In some embodiments, the determined degree of rotation may be automatically adjusted based on one or more parameters such as corneal thickness and corneal curvature or other information from the pachymetry map of the cornea and / or the topography map of the cornea and / or the tomography map of the cornea. Additionally or alternatively, one or more of a) the location of the center of the corneal graft, b) the size of the corneal graft, and c) the degree of rotation of the corneal graft may be automatically adjusted based on one or more parameters such as corneal thickness and corneal curvature or other information from the pachymetry map of the cornea and / or the topography map of the cornea and / or the tomography map of the cornea.

[0064] According to certain embodiments, various user input such as a) the input of the demarcation of the limbus in the displayed image of the eye, and b) the input of an indication of the size of the corneal graft and the location of the center of the corneal graft in the cornea as displayed in the display tool may provided or adjusted by the user input via one or more interactive input elements provided in the interactive display tool. The interactive input element(s) may include interactive slider bar(s). Other interactive input elements may include keyboard inputs, e.g., where arrow keys may adjust the position of the x and y coordinates, andthe + and - keys may increase or decrease the radius, and mouse clicks to mark the x and y coordinates and drag to adjust the radius, and other graphical user interface element(s), e.g., where a window pops up with input components such as buttons, sliders or input boxes, or any combination of these.

[0065] Additional features, aspects, enhancements and advantages are provided below.

[0066] Image Acquisition

[0067] Images of the anterior segment of the eye were captured, e.g., using a slit lamp or other imaging modality to obtain a diffuse photo of the whole eye. Other viable options include modem cell-phone photos, or a fundus camera pulled back to image the external eye. Pachymetry and topography maps of the eye were obtained from Pentacam® (OCULUS).

[0068] Digital Twin Creation

[0069] In an embodiment, the system creates and stores a digital model of the eye, e.g., a digital twin of the cornea is created by overlaying the comeal pachymetry and topography and / or tomography maps onto the comeal image. The digital twin includes relevant information and parameters from the pachymetry and topography and tomography maps and the comeal image as well as additional information and parameters that may be input and adjusted using the interactive display tool. Geometric calculations are performed to obtain the coordinates for trephine placement and graft position, the size of the trephine, and the angle of rotation of the graft, for obtaining maximum comeal clarity in the pupillary zone. Jupyter notebooks like Google Colab and Python may be used. For example, Python libraries like OpenCV© and PIL©, may be used for image processing, manipulation, and overlaying. NumPy© may be used for numerical operations and Math (docs.python.org / 3 / library / math) for geometric calculations to obtain the coordinates and trephine size.

[0070] The horizontal corneal white-to-white measurement may be taken by a user or doctor from the patient’s eye using calipers and entered into the digital twin. Alternatively, an optical biometry device, such as the lOLMaster® produced by Zeiss, may be used to obtain the actual white-to-white dimension and other information. The image(s) of the cornea and the pachymetry and topography maps are uploaded into the digital twin and the comeal periphery is marked all around using a drawing tool provided as part of the interactive display tool. Care should be taken to accurately mark the horizontal white-to-white in the displayed image, as it will be registered with the manual (actual) white-to-white measurement taken of the patient’s eye from the opticalbiometry instrument or calipers. Next the outer border of the pachymetry and / or topography maps are marked to obtain an accurate overlay of the pachymetry and topography images, e.g., which are 9 mm in diameter, on the cornea, which is approximately 11-12 mm in diameter. For example, the optimal position and size of the trephine is visually marked using the interactive display tool. Simultaneously, the trephine marking may be displayed on the pachymetry and topography of the overlaid cornea. The digital twin provides the size of the trephine to be used and the coordinates in relation to the center of the cornea. The coordinates define the center of the trephine and hence the corneal graft and may include the x and y coordinates relative to the center of the cornea or the amount of decentration from the center of the cornea and the angle of decentration, e.g., from horizontal. These coordinates can be used for manually marking the patient’s cornea during surgery or with a computer-assisted digital guidance system integrated into a surgical operating microscope or similar device. In an embodiment, if the size of the trephine may be too large, e.g., an edge or periphery of the trephine falls within a certain range, e.g., 1 mm, of the adjacent limbus, an alert is provided. FIG. 2D show an example alert display The size and placement of the trephine may then be re-adjusted accordingly.

[0071] The pupil or the approximate anticipated position of the pupil post pupilloplasty is marked and the autologous corneal graft is rotated to obtain a clear cornea in the marked pupillary zone; the position of the graft may be fine-tuned to reduce the mismatch in thickness between the edge of the graft and the corneal bed. The match of topography of the bed and the graft all around is noted. The position of the opacity may be adjusted so that it is maximally covered by the upper lid of the eye. In some embodiments, an amount of additional corneal tissue to be added in the peripheral region of the graft and / or bed to increase the thickness and reduce thickness mismatch is determined. In some embodiments, an amount of comeal tissue removal, e g., by laser ablation to flatten the cornea, near the peripheral region of the graft and or corneal bed to reduce curvature or thickness mismatch is determined. Such determinations may be based on various additional information such as may be included or derived from a pachymetry map, a topography map and / or a tomography map of the cornea.

[0072] There are several benefits to the use of the present embodiments including simplified and standardized planning, improved workflow efficiency, enhanced surgical decision making, and three dimensional consideration. Existing IRA planning methods are non-standardized, time consuming, and require multiple difficult to obtain measurements. The present embodimentsstreamline the process by automatically integrating imaging data, and only requires a single (actual) white-to-white measurement to perform the various calculations and register the image to ensure calculations are scaled to the actual physiological dimensions of the eye and cornea. In an embodiment, adjustments are easily visualized and modified using sliding inputs provided in the interactive display tool, which allows the surgeon to virtually trial a number of different graft positions.

[0073] Traditional digital planning of IRA relies on Photoshop©, which has a steep learning curve and lacks the flexibility to model different iterations of potential graft size and placement easily. The present embodiments automate planning and advantageously allow for multiple potential iterations with fine-tuning of trephine size, location and rotation using simple interactive functions such as sliding functions. The entire planning process, which typically can take over an hour, can be completed in under five minutes, and potential revisions could be done while the patient is being prepared on the operating table with only a cell phone and the patient’s measured white-to-white. If the information entered provides a result that does not provide enough clear cornea in the visual axis, does not provide good thickness matching, or if any other issue presents, an easy revision is quickly possible through adjustment of trephine size, position, or rotation.

[0074] The present embodiments facilitate the immediate visualization of potential surgical outcomes, which enables the surgeon to identify suitable candidates for IRA in real time. This real time assessment benefits patient counseling and decision making, reducing any unnecessary consultations and optimizing clinical workflow. The prior methods would require an hour-long process to determine if the patient is a good candidate for IRA, while the present embodiments avoid such delay and allow for the patient information to be entered with the patient in the exam chair, and the patient can be shown what the end result of surgery would look like. This efficiency is particularly valuable in busy clinical settings where time constraints can be a significant concern for overscheduled physicians.

[0075] Previous concerns with digital models stemmed from the fact that a two dimensional image was used to plan a three-dimensional procedure, leading to potential thickness mismatch and subsequent complications such as wound leaks, fistula formation, and corneal edema. Certain embodiments include displaying overlays of pachymetry and topography data onto the image, providing a more accurate representation of the autologous corneal graft structure inrelation to the corneal bed. The use of pachymetry and topography information allows for better alignment of the graft, potentially reducing post-operative astigmatism and improving visual outcomes.

[0076] The cornea has a thickness gradient from the center of the cornea to the periphery; the peripheral cornea is thicker than the central cornea. There is usually tissue loss in the region of a comeal scar. Thus, due to the offset of the center of the trephination / graft relative to the center of the cornea, rotating the comeal graft could create comeal thickness mismatches that are difficult to predict. These areas of mismatch require additional sutures to reduce risk of wound dehiscence, or fistula formation. The present embodiments advantageously provide a visual representation of these mismatches, allowing surgeons to plan their suture placement accordingly to prevent complications.

[0077] Although it is possible to manually superimpose pachymetryic and topographic data in Photoshop©, this is a labor-intensive and error prone process due to scaling issues.Standardizing the smaller area of the cornea (diameter 9mm) mapped from a tomography device must be exactly overlaid on to the image of a larger diameter (10-12 mm) cornea. The number of pixels in both images must be considered, and it is essential to create a standard key to relate pixels to mm. The present embodiments advantageously automate this process, preventing any distortion in the thickness or curvature, and ensure precise overlay and standardization.

[0078] An embodiment was tested in two cases (see, Examples / Results below) and demonstrated accuracy of the embodiment (“tool” in the Examples / Results) comparable to traditional methods while significantly reducing planning time. The first case confirmed an accurate and reliable result, consistent with traditional planning methods. The second case highlighted that planning a procedure with the tool results in good patient outcomes with fewer complication risks. The streamlined approach allows surgeons to feel more confident in the data and its manipulations, knowing that they have the information they need, and allows them to focus on the meticulous task of placing corneal sutures rather than extensive preoperative calculations, enhancing efficiency and precision.

[0079] The present embodiments have the ability to increase IRA accessibility, particularly in resource-limited settings. IRA eliminates the reliance on donor tissue which reduces wait times and subsequently reduces the risk for development of derivational amblyopia in children. IRA minimizes graft rejection to a theoretical impossibility and it also has less endothelial cellloss when compared to ALK, DALK, and PKP. Ultimately this leads to reduced steroid dependence and the associated complications such as cataracts and glaucoma are also reduced. It also eliminates viral and prion disease transmission risk inherent from allografts as well as the lifelong risk of delayed rejection. While the patient population eligible for IRA does not always directly align with those eligible for DALK and other procedures, this tool helps identify more quickly those that do qualify for IRA and does make IRA much more feasible for those that do qualify. All these factors make the IRA significantly beneficial to those with reduced access to follow-up visits in resource deficient regions or with increased risk of corneal graft rejection.The efficiency of the present embodiments enables more procedures in high-demand settings like medical mission trips, potentially restoring sight for individuals who would have otherwise been blind for life.

[0080] While corneal imaging is widely available, topography and / or pachymetry information may not always be available, which would limit the full capabilities of the present embodiments. In an embodiment, surgery can still be planned and implemented without use of the topography and / or pachymetry information, however the advantageous consideration of thickness and mismatch may not be included.

[0081] In an embodiment, the use of Al-driven corneal scar and limbal mapping may be used to further automate the calculations and display functions of the digital twin and interactive display tool and remove the need for manual white-to-white measurements. Current Al models exist today which can accurately identify corneal scars and outline the limbus; however, they are sensitive to image quality and may require refinement before they can reliably perform limbus and pupil identification and corneal scar segmentation.

[0082] In an embodiment, IRA consistency can be enhanced by guiding a femtosecond laser for more precise trephination, reducing variation between planned and actual trephine size. The present embodiments provide accuracy up to 2 decimal places for trephine size and location, so it can minimize the current 0.25mm variability and irregular trephination, both of which are a common cause of IRA complications.

[0083] In some embodiments, predictive modeling for post-IRA astigmatism may be implemented to further improve visual outcomes; with sufficient patient data, a predictive model or tool (e.g., software algorithm) can forecast procedure outcomes. This data collection can be both prospective and retrospective; input data may include historical data from existing patientswho have already undergone IRA and a comparison can be made of projected versus actual IRA outcomes to further refine the predictive accuracy. Users, e.g., surgeons, can input patient data into the predictive model to refine graft placement, size, and rotation to reduce the amount of predicted post operative astigmatism. This model may also recommend strategic suture placement to further minimize astigmatism after healing.

[0084] In some embodiments, corneal biomechanics may be used to enhance the predictive capacity of the predictive model. Corneal biomechanics influence surgical outcomes, as stiffer corneas exhibit less motion than more elastic ones. Corneal hysteresis, the primary measure of biomechanical strength, varies from person to person and can also change as the result of disease processes like corneal scarring, glaucoma, and keratoconus. Incorporating stiffness data into the predictive model would advantageously enhance the predictive accuracy even further.

[0085] In an embodiment, output data (e.g., trephine / graft coordinates) may be provided to and used in a virtual / augmented reality system to help improve patient outcomes. For example, the computer-assisted digital guidance system (e.g. Callisto®) allows surgeons to overlay the mapped trephine position onto the physical cornea during surgery. Expanding into virtual reality and a holographic model enables intuitive interaction with a virtual eye model, enhancing the visualization and assessment of graft thickness matching and corneal curvature assessment. This virtual reality tool could also serve as a training platform for surgeons to practice on realistic eye models, optimizing outcomes for their future patients.

[0086] While the primary focus of the present embodiments may be for IRA, the digital twin model tool disclosed herein could have far-reaching applications within ophthalmology as well as into other fields. In ophthalmology, the tool can aid corneal crosslinking (CXL) for keratoconus, corneal allografts, LASIK, and other similar procedures. In CXL, the tool could help optimize the distribution of UV light and riboflavin application to maximize treatment efficacy while minimizing tissue damage. In corneal allografts, it could help match a donor cornea that would best fit the recipient. For LASIK and PRK, the tool could personalize treatment plans by analyzing corneal topography and thickness, optimizing the ablation pattern to better optimize visual outcomes by reducing irregular astigmatism. Through these applications and others, the tool can significantly enhance precision, personalization, and safety across various corneal procedures.

[0087] Outside ophthalmology, the tool could enhance procedures involving grafts where thickness and appearance of grafts have important roles, such as plastic surgery, orthopedic surgery, and cardiology. In facial grafting, the tool could be used to predict skin graft outcomes by measuring skin thickness and optimizing placement. In cases where rotational skin grafting is necessary, a digital twin model could be used to measure skin thickness and predict the visual outcome of the grafting procedure and estimate optimal placement. In rhinoplasty, the tool could aid in shaping septal extension grafts which are important to control the projection, rotation, and shape of the nose. Anterior cruciate ligament reconstruction in knee surgery is another area where graft length and diameter are important considerations. In aortic grafts, the tool could improve planning by optimizing blood flow projections, and predicting thickness match to prevent turbulent flow. The predictive capability of the present embodiments, coupled with the ability to update the model in real time as the patient heals, could improve treatment planning and post-operative care.

[0088] The integration of the digital twin tool embodiments in IRA planning offers a significant step forward in the treatment of corneal scarring. By enabling precise, patient specific surgical plans, this comprehensive tool can reduce the complexity, variability, and subjectivity often involved in the traditional planning of IRA. Its capability for manual adjustment of surgical variables in real-time allows for surgeons to explore multiple surgical plans, thereby helping to identify the most appropriate approach to optimize patient outcomes. The tool’s automation combined with opportunities for physician input, seeks to minimize the potential for errors and promote a more standardized approach, potentially leading to improved surgical results. The tool also holds the potential to be scaled up to assist in planning other corneal procedures and procedures in other domains of medicine, for example as discussed above. By utilizing patient specific data and incorporating with surgeon expertise, the digital twin tool enhances the ease and efficiency of surgical planning, while improving both patient safety and the overall effectiveness of the IRA procedure.

[0089] Examples / Results

[0090] Retrospective use on a past IRA case confirmed the accuracy of the digital twin tool and significantly reduced planning time. A patient undergoing IRA with this tool achieved successful graft placement, improved visual function, and no post-operative complication orrejection. By reducing cognitive load and standardizing planning, this tool enhances IRA procedures, making them more efficient and standardized.

[0091] Patient case #1 - Post-Surgical Validation

[0092] A 13-year-old patient presented with corneal opacity causing significant vision loss down to 20 / 150 located in the visual axis secondary to trauma from a thrown pencil five years ago. The patient underwent primary suture repair of corneal laceration, suture removal, as well as cataract extraction & intraocular lens implantation following the trauma which resulted in significant corneal opacification. A 6.5mm full thickness central corneal scar was noted and diagnostic rigid contact lens fitting revealed a best corrected vision of 20 / 60. Unfortunately, the patient was unable to tolerate rigid contact lens wear and elected to continue with glasses. Five years later the patient returned, interested in corneal transplantation and it was ultimately determined IRA was the best option. Pre-operative assessment included slit lamp photos and Pentacam® imaging for tomographic data, including pachymetry and topography. Topography showed highly irregular astigmatism of up to 6.4D at 108 degrees (See, FIG. 11). Surgical planning was performed by the surgeon using traditional methods of geometric calculations as well as Photoshop© to determine position. A trephination size of 7.5mm with a ,75mm eccentric trephination towards one ‘clock and a corneal rotation angle of 180 degrees was performed with 21 10-0 Nylon sutures. Following surgery, corneal photos and imaging scans were inputted into a system embodiment as described herein which determined the same trephination size and rotation angle as was calculated and performed during the surgery.

[0093] Patient case #2 - Pre-Surgical Planning

[0094] A 33-year-old patient presented with corneal opacity located in the visual axis secondary to globe trauma and traumatic aphakia causing significant vision loss down to 20 / 500. Pre-operative evaluation with the patient included discussion of other therapies including hard contact lens use and standard penetrating keratoplasty. The patient was determined to have sufficient clear cornea adjacent to the opacity and they elected to proceed with IRA, in addition to pupilloplasty and secondary intraocular lens placement. Pre-operative assessment included pachymetry, topography, and slit lamp photos which were used to create the digital twin. The system herein simulated a trephination size of 8.25mm, coordinates of 0.14mm on the x axis towards 9 o’clock, and 0.16 on the y axis toward 12 o’clock, and a rotation angle of 180 degrees. The information provided was used to guide the actual IRA procedure and the Callisto Eye (CarlZeiss Meditec, Jena, Germany) computer-assisted digital guidance system was utilized to show the surgical variables.

[0095] The autologous comeal graft was successfully trephined and rotated to maximize clear cornea in the visual axis while also optimizing corneal thickness and topography difference (See FIGS. 12, 13 and 14) between the graft and comeal bed and the surgery was completed without complications.

[0096] Post Operative Results

[0097] Visual acuity at post-op month eight improved to 20 / 150. No signs of graft rejection or other complications have been observed during the follow-up period. The patient has reported significant improvement in visual function. And 10 sutures remain along the comeal graft interface. There is residual irregular astigmatism, largely because of the remaining sutures and scar tissue causing the graft to lie very flat. The current comeal shape at post-op month eight is similar to that predicted by the tool. This is anticipated to improve upon complete suture removal and the final post-op astigmatism is yet to be determined

[0098] FIG. 15 is a block diagram of example functional components for a computing system or device 1502 configured to perform one or more of the processes described herein above and / or below, according to an embodiment. One particular example of computing system or device 1502 is illustrated. Many other embodiments of the computing device 1502 may be used. In the illustrated embodiment of FIG. 15, the computing device 1502 includes one or more processor(s) 1511, memory 1512, a network interface 1513, one or more storage devices 1514, a power source 1515, output device(s) 1560, and input device(s) 1580. The computing device 1502 also includes an operating system 1518 and a communications client 1540 that are executable by the computing device 1502. Each of components 1511, 1512, 1513, 1514, 1515, 1560, 1580, 1518, and 1540 is interconnected physically, communicatively, and / or operatively for inter-component communications in any operative manner.

[0099] As illustrated, processor(s) 1511 are configured to implement functionality and / or process instructions for execution within computing device 1502. For example, processor(s) 1511 execute instructions stored in memory 1512 or instructions stored on storage devices 1514. The processor may be implemented as an ASIC including an integrated instruction set. Memory 1512, which may be a non-transient computer-readable storage medium, is configured to storeinformation within computing device 1502 during operation. In some embodiments, memory 1512 includes a temporary memory, area for information not to be maintained when the computing device 1502 is turned OFF. Examples of such temporary memory include volatile memories such as random access memories (RAM), dynamic random access memories (DRAM), and static random access memories (SRAM). Memory 1512 maintains program instructions for execution by the processor(s) 1511.

[0100] Storage devices 1514 also include one or more non-transient computer-readable storage media. Storage devices 1514 are generally configured to store larger amounts of information than memory 1512. Storage devices 1514 may further be configured for long-term storage of information. In some examples, storage devices 1514 include non-volatile storage elements. Non-limiting examples of non-volatile storage elements include magnetic hard disks, optical discs, floppy discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.

[0101] The computing device 1502 uses network interface 1513 to communicate with external devices (e.g., biometry instruments) via one or more networks. Network interface 1513 may be a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other non-limiting examples of network interfaces include wireless network interface, Bluetooth®, 9G and WiFi® radios in mobile computing devices, and USB (Universal Serial Bus). In some embodiments, the computing device 1502 uses network interface 1513 to wirelessly communicate with an external device or other networked computing device.

[0102] The computing device 1502 includes one or more separate or integrated input devices 1580. Some input devices 1580 are configured to sense the environment and capture images or other signals. Some input devices 1580 are configured to receive input from a user through tactile, audio, video, or other sensing feedback. Non-limiting examples of input devices 1580 include a presence-sensitive screen, a mouse, a keyboard, a voice responsive system, camera 1503, a video recorder 1504, a microphone 1506, a GPS module 1508, or any other type of device for detecting a command from a user or for sensing the environment. In some examples, a presence-sensitive screen includes a touch-sensitive screen.

[0103] One or more output devices 1560 are also included in computing device 1502.Output devices 1560 are configured to provide output to another system or device or to a userusing tactile, audio, and / or video stimuli. Output devices 1560 may include a display device or display screen (e.g., a separate screen or part of the presence-sensitive screen), a sound card, a video graphics adapter card, or any other type of device for converting a signal into an appropriate form understandable to humans or machines. Additional examples of output device 1560 include a speaker, a cathode ray tube (CRT) monitor, a liquid crystal display (LCD), or any other type of device that can generate intelligible output to a user. In some embodiments, a device may act as both an input device and an output device.

[0104] The computing device 1502 includes one or more power sources 1515 to provide power to the computing device 1502. Non-limiting examples of power source 1515 include single-use power sources, rechargeable power sources, and / or power sources developed from nickel-cadmium, lithium-ion, or other suitable material.

[0105] The computing device 1502 includes an operating system 1518. The operating system 1518 controls operations of the components of the computing device 1502. For example, the operating system 1518 facilitates the interaction of communications client 1540 with processors 1511, memory 1512, network interface 1513, storage device(s) 1514, input device 1580, output device 1560, and power source 1515.

[0106] As also illustrated in FIG. 15, the computing device 1502 includes communications client 1540. Communications client 1540 includes communications module 1545. Each of communications client 1540 and communications module 1545 includes program instructions and / or data that are executable by the computing device 1502. For example, in one embodiment, communications module 1545 includes instructions causing the communications client 1540 executing on the computing device 1502 to perform one or more of the operations and actions described in the present disclosure. In some embodiments, communications client 1540 and / or communications module 1545 form a part of operating system 1518 executing on the computing device 1502.

[0107] According to various embodiments, one or more of the components shown in FIG. 15 may be omitted from the computing device 1502.

[0108] Appendix A

[0109] Embodiments of the present invention may comprise a system and methods of use that may determine and demarcate the position and the location of various parameters of thetreatment area, the position and location of a graft or excised tissue, and a degree of rotation thereof. The invention may yield the coordinates to position or rotate the graft or excised tissue within the treatment area of the subject. The invention may position the graft or excised tissue within in the treatment area (ex. to clear the visual axis) of the subject. The invention may be used to treat indications or conditions, that include but are not limited to ophthalmic conditions or indications. The invention may be used to create a surgical procedure plan or strategy for surgical procedures or interventions, such as a corneal autograft procedure. The invention may be a system for calculating and demarcating the coordinates to position and rotate a graft for surgical procedures, comprising: a system, parameters of a subject, treatment area, a graft, coordinates, a degree of rotation, and a surgical plan or strategy. The invention may be a method for calculating and demarcating the coordinates to position and rotate a graft for surgical procedures, comprising: a system, parameters of a subject, treatment area, a graft, coordinates, a degree of rotation, and a surgical plan or strategy.

[0110] Corneal scarring is a common problem, and if the scar is in the visual or pupillary axis, it can cause decreased vision. A corneal autograft procedure may be performed in the event of sufficiently clear cornea is adjacent to an opacity that can be rotated and brought into the visual axis front of the pupil as a means to improve vision. The procedure entails eccentric round trephination of the subject’s corneal tissue (i.e. autograft) and its rotation to position the clear, unobscured cornea within the visual axis, in front of the pupil of the subject. With the visual axis cleared and unobstructed by an opacity, the subject’s vision improves. With a graft as the subject’s own corneal tissue (i.e. an autograft), the probability of host rejection of the graft is little to none. Autograft procedures may obviate the need for more invasive procedures, including but not limited to allogenic corneal transplantations, which pose the risk of corneal graft rejection for the duration of the subject’s life.

[0111] Efforts to optimize the positioning and rotation of subject’s corneal tissue for the autograft procedure have been considered. The use of computer software to determine the size and rotation of the graft based on images of the subject’s eye has been explored. Many of these methods require manual manipulation of the images to scale, overlay and rotate the images to find the ‘best’ position. Such practices, however, are time consuming and can only provide a qualitative, visual idea of the approaches to place and rotate the autograft. Other methods may use mathematical calculations to demonstrate how a graft with a decentration and a formula forthe rotation angle of the graft are sufficient to perform the autograft procedure. Although this method may serve as a general approach for any subject undergoing a rotation autograft procedure, many of these calculated approaches fail to implement various eye parameters into its formulation, including but not limited to the pachymetry (i.e. the measurement of comeal thickness), topography, corneal curvature, pupil diameter, and other like parameters not listed herein.

[0112] The proper alignment of the thickness, curvature and other parameters of the graft or excised tissue with the subject’s treatment area (ex. comeal bed) are important for optimal surgical performance and outcome. The present invention may implement the various parameters and characteristics of the eye, which may better address the individual parameters specific to the subject. Using the specific parameters of the subject may enable the treatment of indications or conditions of the subject. Using the specific parameters of the subject may enable the proper positioning and rotation of the graft that may yield an optimal surgical procedure plan or strategy for the surgeon and surgical outcome for the subject. The invention may aid in preventing complications of surgical procedures or intervention, that include but are not limited to comeal autograft surgery. Such complications from comeal autograft surgical procedures may include but are not limited to wound leakage, development of a fistula, high astigmatism, and other like complications.

[0113] Example Embodiments:

[0114] In one embodiment, the invention may receive the input of subject parameters or data. The input may be an image file. The image file may be in a format as jpeg, jpg, png, or other like image file formats. The input may be maps, including but not limited to pachymetry maps, topography maps, curvature maps, heat maps, or other like data maps. In another embodiment, the invention overlays or stacks the subject’s input data. The overlay of the input data may allow the alignment of subject’s parameters or characteristics, such as the thickness of the potential graft and the treatment area (ex. subject corneal bed).

[0115] In one embodiment, the invention may demarcate the potential position or the treatment area for the graft or excised tissue (ex. trephine). In another embodiment, the user of the invention may demarcate the potential position for the graft or excised tissue of the treatment area (ex. trephine). The position of the treatment area may depend on the location and the size ofthe indication or condition, such as but not limited to a scar, opacities of the cornea, irregular astigmatism, or like indications or conditions, within the treatment area. The position of the treatment area may depend upon the location and the size of the various parameters of the eye, including but not limited to the opacity, the thickness of the cornea, the curvature of the cornea, the pupillary size or diameter, the pupillary shape, or other like parameters.

[0116] In one embodiment, the invention may demarcate the limbus and the range of the corneal tissue (ex. white to white) in the input image of the subject. The demarcation of the limbus and the range of the corneal tissue may be completed manually by user. The demarcation of the limbus and the range of the corneal tissue may be completed automatically using the invention’s computing systems, processor, software or other like systems.

[0117] In one embodiment, the invention may determine and demarcate the position and the location of various parameters of the treatment area. In one embodiment, the invention may determine and demarcate the location of the center of cornea. In one embodiment, the invention may determine and demarcate the position of the center of graft. In one embodiment, the invention may determine and demarcate the amount of decentration of the graft from the center of the cornea. In one embodiment, the invention may determine and demarcate the angle of decentration from the center of the cornea In one embodiment, the invention may provide coordinates to demarcate the subject’s treatment area (i.e. the cornea) in consideration of the position and the location of parameters of the subject’s eye. The coordinates may be demarcated manually by the user of the invention. The coordinates may be demarcated by the invention via augmented reality displays. The augmented reality may project the coordinates directly onto the subject’s treatment area (i.e. the cornea). The coordinates may be demarcated by the invention via virtual reality displays. In another embodiment, the coordinates may serve as a guide for the user to excising the tissue or the graft (i.e. trephine) within the treatment area based on positioning and location.

[0118] In one embodiment, the invention may determine and demarcate the degree of rotation of the graft or excised tissue in the treatment area (ex. the cornea). In one embodiment, the invention may provide coordinates to demarcate the subject’s treatment area (i.e. the cornea) in consideration of the degree of rotation of the parameters of the subject’s eye. In another embodiment, the degree of rotation demarcated by the invention or user may position graft or excised tissue to create the clearest area of visual axis. In another embodiment, the coordinatesmay serve as a guide for the user to excise tissue or the graft (i.e. trephine) within the treatment area based on the degree of rotation.

[0119] In one embodiment, the invention may tune, modify or adjust the overlay of data or input for optimized alignment. In another embodiment, the invention may tune, modify or adjust the demarcations or coordinates for optimal alignment of the removed graft or excised tissue within the treatment area (i.e. the subject’s corneal bed). In another embodiment, the invention may tune, modify or adjust the demarcations or coordinates for optimal alignment of the parameters of the removed graft or excised tissue with the parameters of the treatment area (i.e. the subject’s corneal bed). The parameters of the eye may include but are not limited to the thickness, the curvature, the degree of rotation of the graft or excised tissue, or other like parameters. In one embodiment, the tuning, modifying or adjusting the demarcations or coordinates for optimal alignment and positioning and the degree of rotation of the graft or excised tissue may achieve optimal vision for the subject. In another embodiment, the tuning, modifying or adjusting the demarcations or coordinates for optimal alignment and positioning and the degree of rotation of the graft or excised tissue may reduce the risk of surgical complications.

[0120] In one embodiment, the present invention may aid in the determination of the size of the graft or excised tissue. The graft or excised tissue may be autograft, allograft, xenograft, manufactured tissue, other like or a combination thereof. The graft or excised tissue may be round, circular, elliptical or other like shapes. The graft or excised tissue may comprise a portion of tissue unaffected by an indication or condition (ex. clear cornea). The device used to excise tissue or create a graft may be a trephine or like device. The tissue or graft that may be excised may be a portion of the cornea or the cornea. In another embodiment, the invention may yield the coordinates to position the device to excise tissue or a graft. In another embodiment, the invention may yield the coordinates to position the graft or excised tissue on the treatment area of the subject. The treatment area of the subject may be the eye. The treatment area of the subject’s eye may be the or a portion of the cornea. In one embodiment, the invention may provide a degree of rotation of the graft or excised tissue. The invention may provide a degree of rotation of the graft or excised tissue to clear the visual axis of the treatment area. In another embodiment, the invention may detect the proximity of the peripheral edge of the graft. The invention may detect the proximity of the peripheral edge of the graft is from the limbus of theeye. In one embodiment, the invention may give an alert. The invention may give an alert when the proximity of the peripheral edge of the graft is within a distance of the limbus. The invention may give an alert when the proximity of the peripheral edge of the graft is within a distance at or below 1 mm from the limbus. In another embodiment, the present invention may provide the amount of decentration of the graft from the center of the treatment area. The present invention may provide the amount of decentration of the graft from the corneal center or pupillary center.

[0121] In one embodiment, the present invention may provide coordinates. The invention may provide coordinates based on the parameters of the subject’s treatment area. The treatment area may be the eye, such as but not limited to the cornea or like areas of the eye. The invention may provide coordinates based on the parameters of the subject’s cornea. In another embodiment, the coordinates provided by the invention may be in millimeters, pixels or other like units of measure. In one embodiment, the invention may mark the coordinates on the treatment area manually by user. In another embodiment, the invention may mark the coordinates on the treatment area with a heads-up display, augmented reality, virtual reality or other like technologies. In another embodiment, the invention may mark the coordinates on the treatment area with artificial intelligence models. The artificial intelligence model may mark coordinates by in-painting of the images of the subject’s treatment area.

[0122] In one embodiment, the present invention may be used to treat indications or conditions. The indications or conditions treated by the invention may include but not limited to ophthalmic conditions or indications. The ophthalmic conditions or indications may include opacities of the cornea, irregular astigmatism, scarring or other like indications.

[0123] In one embodiment, a user of the invention may be a physician or surgeon. A physician or surgeon may use the invention to create a surgical procedure plan or strategy. The invention may be used to create a surgical procedure plan or strategy for corneal autograft procedures. The surgical procedure plan or strategy using the invention may occur prior to surgical procedure. The surgical procedure plan or strategy may include the size of the graft or excised tissue. The surgical procedure plan or strategy may include the position or location of the graft or excised tissue. The surgical procedure plan or strategy may include the position or location of the graft or excised tissue prior to or after excision. The surgical procedure plan or strategy may include the degree of rotation of the graft or excised tissue. The surgical procedureplan or strategy may include the degree of rotation of the graft or excised tissue prior to or after excision.

[0124] In one embodiment, the invention may be implemented with various devices. The invention may be implemented with various surgical devices. The surgical devices include but are not limited to femtosecond laser, and like surgical devices. In another embodiment, the invention may be implemented with various imaging devices. Imaging devices that may implement the invention may include but are not limited to microscopes, holograms or other like devices. The microscope devices may implement an augmented reality display or a heads-up display. The hologram devices may implement virtual reality images. The virtual reality images may be used for surgical planning, training, and education.

[0125] In one embodiment, the invention may be automated or implement an automated process. In another embodiment, the invention may implement artificial intelligence models. The artificial intelligence models may recommend coordinates with the input of subject’s data or eye parameters. Subject data and parameters may include images, pachymetry maps, topography maps, pupillary diameter, and other like data not included herein. In another embodiment, the invention may comprise of a system, computer processing units, processors, hardware or software.

[0126] Additional description of an example embodiment:

[0127] Step 1. An image of the patient’s eye which has an opacity is uploaded and displayed.Pachymetry and topography maps are also uploaded.

[0128] Step 2. Using a marking tool, the exact placement of the trephine is decided. This depends upon the location and size of the opacity the thickness and curvature of the cornea, and the pupillary size and shape.

[0129] Step 3. The user marks the limbus and the corneal white to white in the image. This may be done automatically using software tools also. The patient’s white to white measurement taken manually or from machines like IOL master are also given to the calculator as input.

[0130] Step 4. The location of the center of cornea, the position of the center of graft, the amount of decentration of graft from the center of the cornea and the angle of decentration fromthe horizontal are all obtained from the autograft calculator. The coordinates are used for marking the patient’s cornea manually or to fed into augmented reality displays for projection onto the cornea, or to virtual reality displays for teaching purpose. These guide the surgeon to trephine the graft at the exact desired position for getting optimal results.

[0131] Step 5. The degree of rotation of the graft is determined. The calculator enables positioning of the clearest area of the graft into the visual axis.

[0132] Step 6. Fine tuning with matching the thickness and curvature of the rotated corneal graft to the host bed is also performed. This helps in both deciding the position of the graft and the degree of rotation to achieve optimal vision and reduce the risk of surgical complications. Adjusting the proximity of the graft to be more than 1 mm from the limbus and positioning the opacity or maximum opacity under the upper lid for cosmetic reasons, may also be included as fine tuning.

[0133] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0134] The use of the terms “a” and “an” and “the” and “at least one” and similar referents in the context of describing the disclosed subject matter (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term “at least one” followed by a list of one or more items (for example, “at least one of A and B”) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separatevalue is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or example language (e.g., “such as”) provided herein, is intended merely to better illuminate the disclosed subject matter and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0135] Certain embodiments are described herein. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the embodiments to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A computer-implemented method of determining corneal graft parameters for a subject’s eye implemented by a computer system having one or more processors, the method comprising: receiving an image of the eye, the eye having an opacity in a cornea of the eye proximal to a visual axis; displaying the image in an interactive display tool; receiving, as user input, a demarcation of a limbus in the displayed image of the eye, the demarcation indicating a periphery of the limbus along at least a horizontal axis and a vertical axis and a white-to-white diameter along the horizontal axis; determining a geometric center of the cornea based on the demarcation; receiving as input an actual measurement of the white-to-white diameter of the limbus along the horizontal axis; receiving as user input a size of a corneal graft and a location of a center of the corneal graft in the cornea displayed in the interactive display tool; determining an actual size of the corneal graft and the center of the corneal graft based on the actual measurement of the white-to-white diameter of the limbus determining coordinates of the corneal graft relative to the center of the cornea; receiving as user input one or multiple marking indications of an edge or margin of a pupil of the eye displayed in the interactive display tool, or a marking of the margin of the pupil on the image by the interactive tool; determining, based on a location of the opacity in the corneal graft, a degree of rotation of the corneal graft to position a clear area of the corneal graft along the visual axis, as determined by the marked pupil; and providing as output the coordinates of the corneal graft, the actual size of the corneal graft and the degree of rotation of the corneal graft for use in a surgery or surgical planning.

2. The method of claim 1, further including displaying a circle representing the comeal graft and receiving as user input an adjustment of the size or diameter of the circle adjusting the interactive tool;wherein the determining coordinates includes determining coordinates of the corneal graft using the center of the circle as displayed by the interactive display tool relative to the center of the cornea.

3. The method of claim 1, wherein the coordinates of the corneal graft relative to the center of the cornea include x and y coordinates of the center of the corneal graft relative to the center of the cornea, wherein x represents the horizontal axis and y represents a vertical axis perpendicular to the horizontal axis, or an amount of decentration of the corneal graft from the center of the cornea and an angle of decentration (from horizontal) of the corneal graft.

4. The method of claim 1, further including: receiving one or more of a pachymetry map of the cornea, a tomography map of the cornea and a topography map of the cornea; wherein the displaying the image of the eye in an interactive display tool includes overlaying the image and one or more of the pachymetry map and the topography map and the tomography map and displaying a combined parameter map of the cornea, the combined parameter map including the image of the eye and visual or numerical indicators identifying one or more parameter values from the pachymetry map and / or the topography map and / or the tomography map.

5. The method of claim 4, further including receiving as user input an indication of a border of the pachymetry map and / or a border of the topography map and / or a border of the tomography map to enable an accurate overlay with the cornea in the image of the eye.

6. The method of claim 1, further including: identifying, based on the coordinates of the corneal graft, a trephine position on the cornea of the eye using manual markings directly on the cornea or an augmented reality display device or virtual reality display device or surgical tool, enabling trephination of the corneal graft at the identified trephine position on the cornea of the eye.

7. The method of claim 1, further including identifying, based on the marked pupil, a position which should be cleared of the opacity by rotation of the corneal graft.

8. The method of claim 1, wherein the determining a degree of rotation further includes automatically adjusting the degree of rotation based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

9. The method of claim 1, further includes automatically adjusting one or more of a) the location of the center of the corneal graft, b) the size of the corneal graft, and c) the degree of rotation of the corneal graft, based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

10. The method of claim 1, further includes receiving as user input an adjustment of the location of the center of the corneal graft and / or the size of the corneal graft and / or the degree of rotation of the corneal graft.

11. The method of claim 1, further comprising providing a visual alert based on a periphery of the corneal graft being within a threshold distance of a periphery of the limbus.

12. The method of claim 1, wherein the receiving the actual measurement includes receiving as input from a user a caliper-based measurement of the eye or receiving as input the actual measurement from an optical biometry instrument.

13. The method of claim 1, wherein one or both of a) the input of the demarcation of the limbus in the displayed image of the eye, and b) the input of an indication of the size of the comeal graft and the location of the center of the corneal graft in the cornea displayed in the display tool are provided via one or more interactive elements provided in the interactive display tool.

14. The method of claim 1, further including determining an amount of additional comeal tissue to be added in the peripheral region of the graft and / or comeal bed to increase the thickness and reduce thickness mismatch.

15. The method of claim 1, further including determining an amount of corneal tissue to be removed near the peripheral region of the graft and / or comeal bed to reduce curvature and / or thickness mismatches.

16. A computer system including a display, one or more hardware processors and a memory storing instructions ad which, when executed by the one or more processors cause the computer system to implement a method of determining corneal graft parameters for a subject’s eye, by implementing steps of: receiving an image of the eye, the eye having an opacity in a cornea of the eye proximal to a visual axis; displaying on the display the image; receiving, as user input in an interactive display tool, a demarcation of a limbus in the displayed image of the eye, the demarcation indicating a periphery of the limbus along at least a horizontal axis and a vertical axis and a white-to-white diameter along the horizontal axis; determining a geometric center of the cornea based on the demarcation; receiving as input an actual measurement of the white-to-white diameter of the limbus along the horizontal axis; receiving as user input in the interactive display tool a size of a comeal graft and a location of a center of the corneal graft in the cornea displayed in the interactive display tool; determining an actual size of the corneal graft and the center of the corneal graft based on the actual measurement of the white-to-white diameter of the limbus determining coordinates of the corneal graft relative to the center of the cornea; receiving as user input in the interactive display tool one or multiple marking indications of an edge or margin of a pupil of the eye displayed in the interactive display tool, or a marking of the margin of the pupil on the image by the interactive tool; determining, based on a location of the opacity in the comeal graft, a degree of rotation of the corneal graft to position a clear area of the corneal graft along the visual axis, as determined by the marked pupil; and providing as output the coordinates of the corneal graft, the actual size of the corneal graft and the degree of rotation of the corneal graft for use in a surgery or surgical planning.

17. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement displaying a circle representing the corneal graft and receiving as user input an adjustment of the size or diameter of the circle adjusting the interactive tool; wherein the determining coordinates includes determining coordinates of the corneal graft using the center of the circle as displayed by the interactive display tool relative to the center of the cornea.

18. The computer system of claim 16, wherein the coordinates of the corneal graft relative to the center of the cornea include x and y coordinates of the center of the corneal graft relative to the center of the cornea, wherein x represents the horizontal axis and y represents a vertical axis perpendicular to the horizontal axis, or an amount of decentration of the corneal graft from the center of the cornea and an angle of decentration (from horizontal) of the corneal graft.

19. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement: receiving one or more of a pachymetry map of the cornea, a tomography map of the cornea and a topography map of the cornea; wherein the displaying the image of the eye in an interactive display tool includes overlaying the image and one or more of the pachymetry map and the topography map and the tomography map and displaying a combined parameter map of the cornea, the combined parameter map including the image of the eye and visual or numerical indicators identifying one or more parameter values from the pachymetry map and / or the topography map and / or the tomography map.

20. The computer system of claim 19, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement receiving as user input an indication of a border of the pachymetry map and / or a border of the topography map and / or a border of the tomography map to enable an accurate overlay with the cornea in the image of the eye.

21. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement: identifying, based on the coordinates of the corneal graft, a trephine position on the cornea of the eye using manual markings directly on the cornea or an augmented reality display device or virtual reality display device or surgical tool, enabling trephination of the corneal graft at the identified trephine position on the cornea of the eye.

22. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement identifying, based on the marked pupil, a position which should be cleared of the opacity by rotation of the corneal graft.

23. The computer system of claim 16, wherein the determining a degree of rotation further includes automatically adjusting the degree of rotation based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

24. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement automatically adjusting one or more of a) the location of the center of the corneal graft, b) the size of the corneal graft, and c) the degree of rotation of the corneal graft, based on one or more parameters from a pachymetry map of the cornea and / or a topography map of the cornea and / or a tomography map of the cornea, wherein the one or more parameters include a corneal thickness parameter and a corneal curvature parameter.

25. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement receiving as user input an adjustment of the location of the center of the corneal graft and / or the size of the corneal graft and / or the degree of rotation of the corneal graft.

26. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement providing avisual alert based on a periphery of the corneal graft being within a threshold distance of a periphery of the limbus.

27. The computer system of claim 16, wherein the receiving the actual measurement includes receiving as input from a user a caliper-based measurement of the eye or receiving as input the actual measurement from an optical biometry instrument.

28. The computer system of claim 16, wherein one or both of a) the input of the demarcation of the limbus in the displayed image of the eye, and b) the input of an indication of the size of the corneal graft and the location of the center of the comeal graft in the cornea displayed in the display tool are provided via one or more interactive elements provided in the interactive display tool.

29. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement determining an amount of additional corneal tissue to be added in the peripheral region of the graft and / or comeal bed to increase the thickness and reduce thickness mismatch.

30. The computer system of claim 16, wherein the instructions, which when executed by the one or more processors, further cause the computer system to implement determining an amount of corneal tissue to be removed near the peripheral region of the graft and / or corneal bed to reduce curvature and / or thickness mismatches.

31. A tangible, non-transitory computer-readable medium having instructions thereon which, when executed by one or more processors, provide for determining corneal graft parameters for a subject’s eye, by executing the following steps: receiving an image of the eye, the eye having an opacity in a cornea of the eye proximal to a visual axis; displaying the image in an interactive display tool; receiving, as user input, a demarcation of a limbus in the displayed image of the eye, the demarcation indicating a periphery of the limbus along at least a horizontal axis and a vertical axis and a white-to-white diameter along the horizontal axis; determining a geometric center of the cornea based on the demarcation;receiving as input an actual measurement of the white-to-white diameter of the limbus along the horizontal axis; receiving as user input a size of a corneal graft and a location of a center of the corneal graft in the cornea displayed in the interactive display tool; determining an actual size of the corneal graft and the center of the corneal graft based on the actual measurement of the white-to-white diameter of the limbus determining coordinates of the corneal graft relative to the center of the cornea; receiving as user input one or multiple marking indications of an edge or margin of a pupil of the eye displayed in the interactive display tool, or a marking of the margin of the pupil on the image by the interactive tool; determining, based on a location of the opacity in the corneal graft, a degree of rotation of the corneal graft to position a clear area of the corneal graft along the visual axis, as determined by the marked pupil; and providing as output the coordinates of the corneal graft, the actual size of the corneal graft and the degree of rotation of the corneal graft for use in a surgery or surgical planning.

Images