Patent Description:
The human eye provides vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of a crystalline lens onto a retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and the lens.

When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).

In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening is made in the anterior capsule and a thin phacoemulsification cutting tip is inserted into the diseased lens and ultrasonically vibrated. The vibrating cutting tip liquefies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an IOL.

In the natural lens, distance and near vision is provided by a mechanism known as accommodation. The natural lens is contained within the capsular bag and is soft early in life. The bag is suspended from the ciliary muscle by the zonules. Relaxation of the ciliary muscle tightens the zonules, and stretches the capsular bag. As a result, the natural lens tends to flatten. Tightening of the ciliary muscle relaxes the tension on the zonules, allowing the capsular bag and the natural lens to assume a more rounded shape. In this way, the natural lens can focus alternatively on near and far objects.

As the lens ages, it becomes harder and is less able to change its shape in reaction to the tightening of the ciliary muscle. Furthermore, the ciliary muscle loses flexibility and range of motion. This makes it harder for the lens to focus on near objects, a medical condition known as presbyopia. Presbyopia affects nearly all adults upon reaching the age of <NUM> to <NUM>. Additionally, patients may also suffer from other conditions, such as age-related macular degeneration (AMD), which may require an even greater degree of magnification to be able to perform visual functions such as reading.

One approach to providing presbyopia correction is the use of an electro-active optical element in an ophthalmic lens, such as an intraocular lens (IOL) or contact lens. Such an electro-active element may be designed to change optical power (and hence the patient's focal distance) in response to action by the ciliary muscle or detection of associated electrical activity. An exemplary approach is disclosed in <CIT> titled SENSORS FOR TRIGGERING ELECTRO-ACTIVE OPHTHALMIC LENSES.

In advanced presbyopes, age-related degradation of the muscle may inhibit the ciliary muscle's ability to contract, and the electrical signal attendant to ciliary muscle movement may be attenuated or absent. As a result, there is an inherent risk with accommodative IOLs relying on ciliary muscle-driven action that the muscle may not function, and the IOL may not operate properly. Accordingly, there is a need to determine and characterize electrical activity in the ciliary muscle, and pre-screening procedures are needed to determine whether a patient has the requisite ciliary muscle activity to utilize such an electro-active ophthalmic lens.

Reference is made to the documents <CIT> and <CIT> cited in the search report as relating to the state of the art.

It will be appreciated that the scope of the invention is in accordance with the independent claim. Further optional features are provided in the dependent claims. The specification may include further arrangements outside the scope of the present claims provided as background and to assist in understanding the invention.

According to certain embodiments, a computer implemented method for signal processing and analysis includes receiving a plurality of signals generated by a plurality of bipolar electrodes during a ciliary muscle assessment procedure, each of the plurality of signals indicating an electrical field associated with a patient's ciliary muscle and analyzing the signals to evaluate the patient's ciliary muscle accommodative potential. The ciliary muscle assessment procedure may comprise focusing on one or more targets at different distances from the patient. The method may further include providing a contact lens to be applied to a patient's eye, the contact lens comprising the plurality of bipolar electrodes. The at least one of the bipolar electrodes may be aligned with a perimeter of the patient's ciliary muscle when applied to the patient's eye.

In certain examples, analyzing the signals to evaluate the patient's ciliary muscle accommodative potential comprises identifying a subset of the signals corresponding to the at least one of the bipolar electrodes aligned with the perimeter of the patient's ciliary muscle, calculating a value based on the identified subset of signals, and evaluating the patient's ciliary muscle accommodative potential based on the calculated value. Calculating a value based on the identified subset of signals may include calculating a sum of the identified subset of signals. Evaluating the patient's ciliary muscle accommodative potential based on the calculated value may include comparing the calculated sum of the identified subset of signals to a predetermined value.

In certain examples, the plurality of bipolar electrodes comprises plurality of concentric rings, and each concentric ring comprises a plurality of segments. Identifying the subset of the signals corresponding to the at least one of the bipolar electrodes aligned with the perimeter of the patient's ciliary muscle may include identifying at least one signal from a segment of first ring and identifying at least one signal from a segment of a second ring.

In certain embodiments, an ophthalmic system includes a contact lens configured to contact a surface of a patient's eye. The contact lens may include a plurality of bipolar electrodes, each configured to generate a signal indicating an electrical field associated with a patient's ciliary muscle. The system may further include a diagnostic system that includes a processor and memory configured to receive a plurality of signals generated by the plurality of bipolar electrodes during a ciliary muscle assessment procedure, each of the plurality of signals indicating an electrical field associated with a patient's ciliary muscle. The processor and memory of the diagnostic system may be further configured to analyze the received signals to identify a subset of signals which correspond to a subset of bipolar electrodes aligned with the patient's ciliary body, and calculate a value associated with the identified subset of electrodes. The system may further include a display communicatively coupled to the processor and configured to display the calculated value associated with the identified set of electrodes.

In certain examples, the processor and memory of the diatnostic system are configured to analyze the signals to evaluate the patient's ciliary muscle accommodative potential by identifying a subset of the signals corresponding to the at least one of the bipolar electrodes aligned with a perimeter of the patient's ciliary muscle and calculating a value based on the identified subset of signals.

Calculating a value based on the identified subset of signals may include calculating a sum of the identified subset of signals, and the processor and memory of the diagnostic system may be further configured to compare the calculated sum of the identified subset of signals to a predetermined value stored in the memory.

In certain embodiments, the plurality of bipolar electrodes comprises a plurality of concentric rings, and each concentric ring may include a plurality of segments. Identifying the subset of the signals corresponding to the at least one of the bipolar electrodes aligned with the perimeter of the patient's ciliary muscle may include identifying at least one signal from a segment of first ring and identifying at least one signal from a segment of a second ring.

It is to be understood that both the foregoing general description and the following drawings and detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following.

The accompanying drawings illustrate implementations of the systems, devices, and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure.

These figures will be better understood by reference to the following Detailed Description.

Efforts are ongoing to develop accommodative IOLs designed to change the power of ophthalmic lenses, such an as IOLs, in response to changes in the ciliary muscle. One sensing technique that has been relatively successful for detecting muscle activity is electromyography. Electromyography is a technique in which the electric field pattern surrounding the muscle is measured over time (such as by electric potential measurements) to determine the degree of muscle contraction. As contrasted with methods such as calcium channel ion detection or other direct detection of the neural signal, electromyography focuses on the electrical activity of the muscle itself, and as such, has proved to be a more reliable gauge of muscle activity. Furthermore, it can provide a continuous indication of the degree of muscle activity, and particularly the degree of force exerted by the muscle, rather than binary detection of a neurological signal.

Movement of a muscle fiber is triggered by depolarization of within the muscle fiber, accompanied by movement of ions, which produces a change in electric field. As the depolarization propagates down the muscle fiber, a biphasic electric field signal is produced that switches signs from positive to negative as the depolarization wave moves along the fiber. Electromyography sensors detect this change in electric field, which allows the muscle activity to be measured. Measurements in skeletal muscle have demonstrated that the intensity varies monotonically and generally linearly with the force exerted by the muscle, so that the electric field can be used as an indicator of the amount of force exerted by the muscle.

In application to ophthalmic lenses and in particular IOLs, the correlation between accommodative demand, the degree to which muscle activity is demanded in response to visual stimuli, and the amount of electrical field in the muscles can be observed for purposes of calibrating the lens. Despite the later ineffectiveness of accommodation due to hardening of the lens and aging of the ciliary muscle and surrounding connective tissue, the ciliary muscle continues to contract even in presbyopic eyes. This can provide an indication of accommodative demand that allows more granular detection than previous sensing techniques, such as detection of neural activity or gross detection of electrical activity as a trigger for accommodation. Consequently, rather than detecting a binary transition between near and far vision, such a system could allow a continuous range of adjustment correlated to the electrical activity of the ciliary muscle tissue, which can in turn be calibrated based on the observed accommodation demand. Such calibration could be based on an average response in the population; alternatively, the calibration could be patient-specific.

<CIT> discloses exemplary electro-active ophthalmic lenses that include electromyography sensors configured to detect an electric field of a ciliary muscle, generate a signal indicative of the electric field, and adjust optical power for an electro-active optical element based on the signal. In particular embodiments, the sensor provides for automatic control of an electro-active lens. In other embodiments, the sensor provides a user-controlled interface for operating the electro-active lens.

Most accommodative IOLs are designed to change optical power (and hence the patient's focal distance) in response to action by the ciliary muscle. In some cases, performance of such ophthalmic products can be limited due to physiological constraints within the eye, including residual ciliary muscle force. For example, in advanced presbyopes age-related degradation of the ciliary muscle may reduce or possibly eliminate its ability to contract. Without adequate screening, such a patient runs a higher risk of surgically receiving an advanced accommodative IOL which may not work properly after implantation. Accordingly, accommodating IOLs or other ophthalmic devices which work by detecting ciliary muscle electrical activity as an indicator to change optical power may not work effectively if the electrical signal obtained from a patient's ciliary muscle activity is substantially attenuated or absent.

There are currently no techniques available for assing ciliary muscle accommodative potential in phakic eyes (e.g., prior to removal of the crystalline lens for IOL implantation). Accordingly, embodiments of the present disclosure provide a non-invasive screening technique and tool to preoperatively assess a patient's ciliary electrical activity and evaluate his or her potential to accommodate. This may be accomplished, for example, via sensing of ciliary muscle electrical activity prior to implanting an accommodative IOL or application of custom ciliary muscle-driven accommodating contact lenses, as described herein. Some embodiments may identify eyes in which a ciliary muscle-driven accommodative ophthalmic device would not function as intended, prior to surgery or purchase, to guide the decision on whether such devices are appropriate for a particular individual. While the following description focuses primarily on IOLs, the described techniques could also be used in contact lenses or spectacles driven by ciliary muscle activity.

<FIG> is a high-level overview demonstrating a method <NUM> of screening a patient for a ciliary-driven ophthalmic device, according to certain embodiments. At step <NUM>, a measuring device is applied to a patient's eye. In certain examples, the measuring device comprises an electrode contact lens as described below. The lens may be positioned on the eye such that one or more electrodes in or on the contact lens is adjacent to, on, around, and/or within the ciliary muscle (or a perimeter/circumference thereof) to acquire electrical signal data based on ciliary muscle movement.

At step <NUM>, ciliary function screening is performed. In one example, a care provider may perform a preoperative exam to determine and characterize a patient's ciliary muscle activity. For example, once the electrode contact lens is placed on the eye, the patient may follow instructions to look at objects at varying distances, such as near (e.g., within <NUM>) and far (e.g., beyond <NUM>), under an established procedure. As the patient changes focus (or attempts to change focus, as the case may be) to different target distances, the ciliary muscle attempts to change the focusing power of the natural lens accordingly. This causes a change in the electrical field of the patient's ciliary muscle(s) which can be detected and signaled b the electrode(s) on the contact lens.

Accordingly, at step <NUM>, an electrical signal generated by the electrode(s) in response to the electrical field of the ciliary muscle at each distance may be set to and received, processed, and/or recorded by a computer <NUM> for subsequent presentation and evaluation. In some instances, the electrical signals are transmitted via wired or wireless communication from the electrodes of the lens to the computer <NUM>. As noted below, a plurality of signals may be received from various electrodes on the lens during the screening procedure, and the received signals may be evaluated by the computer <NUM> (e.g., using summing, averaging, comparing, and/or statistical processing algorithms, etc.) in order to select those which provide the most accurate and/or reliable indication of ciliary muscle activity. The particular electrode signals selected may depend on the position of the contact lens on the patient's eye, as well as the characteristics of the patient's eye itself. The computer <NUM> may also process the signals and convert them to numerical values or other measurements which characterize ciliary muscle activity, responsiveness, strength, and/or accommodative capacity. Raw or processed signal data may be output by the computer and shown on a display <NUM>.

At step <NUM>, results of step <NUM> are evaluated. Signal values or measurements generated and/or displayed at step <NUM> may be reviewed and evaluated by computer <NUM> and/or a care provider to make a surgical recommendation or choice for the patient (e.g., whether or not to recommend or provide a ciliary-driven accommodative device). Step <NUM> may be performed manually by a care provider, or automatically by computer <NUM>. For example, the care provider may view and evaluate measurements of ciliary muscle activity generated at step <NUM> to determine whether they are above or below predetermined threshold(s), or within a predetermined range or target result deemed suitable for utilization of ciliary-driven ophthalmic devices. In other examples, a computer <NUM> may execute instructions stored in memory to automatically analyze measurements of ciliary muscle activity generated at step <NUM> and automatically perform such an evaluation. Applicable threshold values, ranges, or targets for comparison may be stored in memory of the computer <NUM> and may be configured by a user.

If measured ciliary muscle activity generated at step <NUM> is satisfactory and passes the evaluation at step <NUM> (e.g., the muscle activity is above a threshold, at a target, or within a predetermined range), the care provider may proceed to step <NUM>. In such cases, ciliary muscle activity may be sufficient to support proper functioning of ciliary-driven ophthalmic devices, such as electro-active accommodative IOLs. The care provider may consider and evaluate ciliary-driven ophthalmic devices when choosing or formulating recommendations for the patient.

If measured ciliary muscle activity generated at step <NUM> is unsatisfactory and does not pass the evaluation at step <NUM> (e.g., the muscle activity is below a threshold, far from a target, or outside a predetermined range), the care provider may proceed to step <NUM>. In such cases, ciliary muscle activity may be insufficient to support proper functioning of ciliary-driven ophthalmic devices, such as electro-active accommodative IOLs, and the care provider may consider and evaluate alternatives to ciliary-driven ophthalmic devices when choosing or formulating recommendations for the patient.

Accordingly, certain embodiments of the disclosure provide a technique for non-invasive screening for a ciliary-driven ophthalmic device, including implantable IOLs.

The designs and functionality of the ophthalmic system and electrode contact lens will now be described in additional detail. Various electrode designs for characterizing and measuring ciliary-muscle activity may be developed and used. For example, electrodes for measuring ciliary muscle electrical signals may comprise metal or wire adhered or embedded in a contact lens. Such lenses may be placed on the eye to measure ciliary electrical signals.

In general, the location and spacing of the electrodes relative to the position of the ciliary muscle can have an impact on the ability to detect the electrical signal. For instance, in the case of a continuous electrode (e.g., <NUM> degrees around an optical axis of a contact lens), as the electrode position is decentered (e.g., misaligned superiorly, as shown in <FIG> and <FIG>) or moves on the eye (potentially due to gravity, eye movement, or blinking), the signal may be degraded or potentially inverted as the electrode moves off the muscle position. One approach to minimizing the effect of lens movement is to suction the lens onto the corneal surface. However, this can be uncomfortable and may not be entirely effective. Further, such an approach may not address potential signal changes related to ciliary muscle movement.

Another factor which can impact the ability to measure ciliary electrical signal changes is a potential mismatch between the diameter of the ciliary muscle and the diameter(s) of the electrode(s). Indeed, even inter-patient variations in ciliary muscle diameter can be present. Moreover, this can be a static problem or could vary as a function of accommodation if the ciliary muscle contracts appreciably.

To address these and other potential difficulties with accurately measuring and characterizing ciliary muscle activity, certain embodiments of the employ specialized electrode designs. For example, multiple bipolar electrodes may be used. Such electrodes can be segmented or multi-faceted, and may include, for example, one side of an electrode ring located outside a perimeter or circumference of the ciliary muscle and the opposite side electrode inside the perimeter or circumference of the ciliary muscle. This configuration may be used to cancel signals and/or reduce the overall signal magnitude.

In addition, certain embodiments may divide the electrode into segments or individual components in order to generate a more comprehensive map of the ciliary electrical activity. In such examples, different areas can be selected or disregarded (either manually by a care provider or automatically by a computer <NUM>) as appropriate (e.g., based on alignment and position with respect to the perimeter or circumference of the ciliary muscle) to better characterize the true electrical signal (i.e., to obtain an accurate measurement of the electrical activity resulting from ciliary muscle movement).

For instance, each individual electrode segment of an electrode contact lens may be connected to an ophthalmic diagnostic system (e.g., computer <NUM>) that includes a processor and memory configured to receive, process, and display (e.g., via display <NUM>) a measure of detected ciliary muscle activity. A care provider may inspect an alignment of various electrode segments with the patient's ciliary muscle to identify and select the appropriate segments (e.g., those which are best aligned with the ciliary muscle) on which to base an evaluation, as described by step <NUM>. In other examples, the diagnostic system automatically select the appropriate segments on which to base the evaluation. In different implementations, each segment may be continuously sampled or intermittently samples using a time-based multiplexing technique. One or more of these features may be used to optimize signal characterization and account for variables such as external lens movement, ciliary muscle movement with accommodation, and differences in ocular anatomy where otherwise the misaligned signal from one side could degrade the opposite side as the electrode position changes.

<FIG>and <FIG> illustrate an example of a contact lens with two embedded circular electrodes for measuring ciliary muscle activity and illustrating principles of the present disclosure. Eye <NUM> comprises a ciliary muscle <NUM> indicated by a circle around the iris (not labeled). A transparent contact lens placed on the cornea of eye <NUM> comprises a reference electrode <NUM> and a measurement electrode <NUM>. Measurement electrode <NUM> sized to overlay the perimeter of ciliary muscle <NUM>, while reference electrode <NUM> is larger and lies further away from ciliary muscle <NUM>, outside the circumference. (In alternative embodiments, reference electrode <NUM> could be smaller than measurement electrode <NUM>, lying further away from ciliary body <NUM> but closer to the pupil of eye <NUM>. ) The difference in an electrical signal received from reference electrode <NUM> and measurement electrode <NUM> can be used to measure the magnitude of electrical signal in ciliary body <NUM>. In a well-aligned example, as shown in <FIG>, the difference in signal strength between reference electrode <NUM> and measurement electrode <NUM> will be the same or similar at any angle. For example, the signal difference left of the pupil of eye <NUM> would be the same as the signal difference to the right of the pupil, or above or below it as well. In certain examples, the measured signal (over <NUM> degrees) may be determined by summing these differences across all angles.

<FIG> illustrates the same features of <FIG>, but with reference electrode <NUM> and measurement electrode <NUM> misaligned superiorly with respect to ciliary muscle <NUM>. In this example, reference electrode <NUM> is positioned over ciliary muscle <NUM>, inferiorly and the difference signal (between reference electrode <NUM> and measurement electrode <NUM>) in this position could dramatically depart from the analogous difference signal in the position showing in <FIG>. In some cases, the inferior signal measured in <FIG> (near the bottom of electrodes <NUM>, <NUM>) may be the inverse of that in <FIG>.

Superiorly, neither reference electrode <NUM> nor measurement electrode <NUM> is well-aligned to ciliary muscle <NUM>, and the measured superior difference signal measured in <FIG>(near the top of electrodes <NUM>, <NUM>) may be very small. As a result, the measured signal over <NUM> degrees may differ significantly in <FIG>, compared with the measurement taken in the arrangement show in <FIG>. Although superior displacement is shown in this example, relative displacement between electrodes <NUM>, <NUM> and ciliary body <NUM> could occur in any direction.

<FIG> illustrates an electrode arrangement for a ciliary-activity detecting contact lens which can help overcome difficulties caused by displacement, according to certain embodiments. In particular, lens <NUM> comprises four concentric electrode rings <NUM>-<NUM>, each divided into four segments shown as groups <NUM>, <NUM>, <NUM>, and <NUM>. Outer ring electrode <NUM> and each smaller ring <NUM>, <NUM>, and <NUM> can each measure electrical activity in each segment <NUM>, <NUM>, <NUM>, and <NUM>, providing a reading at sixteen separate segments or channels. Although a total of sixteen segments or channels is shown in <FIG>, the number of rings and their division may be varied as appropriate to optimize performance while managing complexity, as an increasing number of channels requires increasing complexity in electrical design and processing requirements. For example, certain embodiments may include between two and six concentric electrode rings divided into between two and six groups, thereby providing anywhere between <NUM> and <NUM> segments or channels. Other variations are contemplated within the scope of the present disclosure.

Notably, the present disclosure is not limited to an electrode configuration of segmented annuli as shown in <FIG>. Other embodiments may include a lens having differently shaped, sized, or arranged electrodes. <FIG>, for example, illustrates an embodiment of a lens <NUM> which includes an outer ring of electrodes <NUM> and an inner ring of electrodes <NUM>, each including sixteen electrode segments. Accordingly, the embodiment of <FIG> may support up to <NUM> channels. Again, although a total of <NUM> channels are shown in <FIG>, the number of electrodes and rings may vary as appropriate to optimize performance while managing complexity, as an increasing number of channels requires increasing complexity in electrical design and processing requirements. For example, certain embodiments may include between two and six concentric electrode rings, each including between three and <NUM> electrodes, thereby providing anywhere between <NUM> and <NUM> channels. Other variations are contemplated within the scope of the present disclosure.

<FIG> illustrates possible scenarios resulting from application of a contact lens comprising electrode rings (identical to lens <NUM> shown in <FIG>) to a patient. In <FIG>, lens <NUM> is centered on eye <NUM> and all four segments of the third ring from the center (corresponding to ring <NUM> of <FIG>) are well-aligned with the perimeter or circumference of ciliary muscle <NUM>. Summing the signals generated by each of the four segments of ring <NUM> yields a signal comparable to that obtained from measurement electrode <NUM> shown in <FIG> - a result that may be considered accurate and reliable.

In contrast, lens <NUM> of <FIG> is decentered (misaligned superiorly, analogous to <FIG>) on eye <NUM>. As a result, the segments of ring <NUM> are not well-aligned to ciliary body <NUM> in <FIG>, and summing the signals generated by each of the four segments of ring <NUM> would yield a signal comparable to that obtained from measurement electrode <NUM> shown in <FIG> - likely an unreliable and inaccurate result.

However, in<FIG>, the lower electrodes of ring <NUM> (toward the bottom of <FIG>, corresponding to segments <NUM> and <NUM> shown in <FIG>) are well-aligned to ciliary body <NUM>. Similarly, the upper electrodes of ring <NUM> (toward the top of<FIG>, corresponding to segments <NUM> and <NUM> shown in <FIG>) are suitably aligned to ciliary body <NUM>. As a result, summing the signals generated by the two lower electrodes of ring <NUM> and two upper electrodes of ring <NUM> yields a result comparable to that obtained from measurement electrode <NUM> shown in <FIG> - again, a result that may be considered accurate and reliable.

In this manner, a lens according to the invention comprising a plurality of electrode segments configured to independently generate and transmit signals may be used to accurately evaluate ciliary muscle activity in accordance with the method of <FIG>, even if the lens is misaligned with respect to the ciliary body. This can be achieved by selecting signals from electrodes which are well-aligned with the ciliary muscle. Such a selection may be peformed manually by a care provider, or automatically by a computer <NUM>, as discussed below.

<FIG> illustrates an ophthalmic system <NUM> which may be used to perform method <NUM>, according to certain embodiments. The system includes one or more electrode contact lenses <NUM> are designed for placement on the surface of the cornea of a patient's eye for a ciliary muscle evaluation procedure. Lens <NUM> may comprise multiple electrodes and segments as shown in <FIG> and <FIG>, but is not limited to the arrangement shown in those embodiments.

Once lens <NUM> is placed on a patient's eye, a care provider may perform the steps illustrated and described above with respect to step <NUM> of <FIG>. In some instances, as the patient looks at objects at varying distances, the ciliary muscle attempts to change the focusing power of the natural lens accordingly. This causes a change in the electrical field of the patient's ciliary muscle(s). At each distance, electrical signals <NUM> generated by each electrode or channel of lens <NUM> may be transmitted to and received by a computer <NUM> which includes a processor and memory configured to execute instructions for processing the signals <NUM>. Signals <NUM> may be transmitted to computer <NUM> via wired or wireless communication. In certan embodiments, particular segments or channels of the multi-electrode lens <NUM> aligned with the patient's ciliary body may be identified and selected by computer <NUM>, as discussed above with respect to the example of <FIG>.

Computer <NUM> comprises one or more processors <NUM> and memory <NUM>. Memory <NUM> may include persistent and volatile media, fixed and removable media, and magnetic and semiconductor media. Memory <NUM> is operable to store programs, codes, scripts, instructions, data, and the like. Memory <NUM> as shown includes sets or sequences of instructions, namely, an operating system, and an ophthalmic diagnostic program. The operating system may be a UNIX or UNIX-like operating system, a Windows® family operating system, an Apple® family operating system (e.g., macOS, iOS), or another suitable operating system. Instructions and data stored in memory <NUM> are accessible to processor <NUM> and are executable by the processor <NUM> to perform the steps discussed herein. The processor <NUM> may be or include a general purpose microprocessor, as well as a specialized co-processor or another type of data processing apparatus. In some cases, the processor <NUM> performs high level operation of the ciliary function diagnostic evaluation discussed herein. The processor <NUM> may be configured to execute or interpret software, scripts, programs, functions, executables, or other instructions stored in the memory <NUM> to receive, interpret, process, and evaluate signals generated by electrodes during ciliary muscle screening (e.g., as described in the process <NUM> of <FIG>). Accordingly, computer <NUM> is specially adapted to perform ophthalmic-specific processes related to ciliary muscle function, as described herein.

For example, a processor of computer <NUM> may execute instructions to compare and evaluate signals <NUM> received from each electrode or channel of lens <NUM> to determine and select the best signals for further processing and/or evaluation. In certain examples, the processor of computer <NUM> may execute summing, averaging, comparing, and/or statistical processing algorithms using the received signals to identify and select a subset of signals which which provide the most accurate and/or reliable indication of ciliary muscle activity. In some examples, this may include identifying and selecting signals which, based on the algoritm performed by the processor, are best situated within and aligned to the perimeter or circumference of the ciliary muscle. Algorithms executed by the processor may include also comparing each received signal with upper and lower thresholds, mean or median values (which may be calculated based on received signals), or other indicia useful for evaluating the quality and/or reliability of the received signal. As noted above, the subset of electrode signals selected may depend on the position of the contact lens on the patient's eye, as well as the characteristics of the patient's eye itself.

Additionally or alternatively, the instructions can be encoded as preprogrammed or re-programmable logic circuits, logic gates, or other types of hardware or firmware components.

In some examples, a user may use an input device <NUM> (e.g., keyboard, mouse, touch screen, voice recognition, etc.) to assist with the identification and selection of particular segments or channels of the multi-electrode lens <NUM> for the evaluation step. Additionally or alternatively, computer <NUM> may identify and select particular segments or channels of the multi-electrode lens <NUM> for the evaluation step automatically, based on algorithms noted above.

Additionally, the processor of computer <NUM> may execute instructions to process raw signal data and convert them to numerical values or other measurements which characterize ciliary muscle activity, responsiveness, strength, and/or accommodative capacity. Raw or processed signal data may be output by the computer and shown on a display <NUM> (e.g., a monitor, screen, heads-up display, tablet device, etc.). Based on the displayed data and information, the care provider may then proceed to step <NUM> and evaluate the results and data obtained from multi-electrode lens <NUM>. Additionaly or alternatively, the processor of computer <NUM> may compare the sleected measurement values and data to predetermined thresholds, targets, and ranges to provide a notification, recommendation, or alert to the care provider via display <NUM>.

It is noted that the processor of computer <NUM> may include one or more CPUs, microprocessors, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), digital-signal processors (DSPs), system-on-chip (SoC) processors, or analogous components. The memory of computer <NUM> may include volatile or non-volatile memory including, magnetic media, optical media, random access memory (RAM), read-only memory (ROM), removable media, or analogous components. The memory of computer <NUM> may store instructions for software programs and algorithms that, when executed by the processor, analyze signals received from lens <NUM> as discussed above. As used in the claims, the terms "processor," "memory," "instructions," and the like refer to classes of structures that are well-known to those skilled in the art. As such, these terms are to be understood as denoting structural rather than functional elements of the disclosed system.

Accordingly, embodiments of the present disclosure provide novel and useful systems and methods for preoperatively assessing a patient's ciliary electrical activity. Using the disclosed systems and methods, a care provider may identify eyes in which a ciliary muscle-driven accommodative ophthalmic device would not function as intended, prior to surgery or purchase, to guide the decision on whether such devices are appropriate for a particular individual. Conversely, using the disclosed systems and methods, a care provider may identify eyes in which a ciliary muscle-driven accommodative ophthalmic device would likely function well, prior to surgery or purchase, to guide the decision on whether such devices are appropriate for a particular individual.

Claim 1:
An ophthalmic system (<NUM>), comprising:
a contact lens (<NUM>) configured to contact a surface of a patient's eye, wherein the contact lens comprises a plurality of bipolar electrodes comprising a plurality of concentric rings (<NUM>-<NUM>), wherein each concentric ring comprises a plurality of segments (<NUM>, <NUM>, <NUM>, <NUM>), each of the plurality of segments (<NUM>, <NUM>, <NUM>, <NUM>)configured to generate a signal indicating an electrical field associated with a patient's ciliary muscle; and
a diagnostic system (<NUM>) comprising one or more processors (<NUM>) and a memory (<NUM>) comprising instructions for evaluating the patient's ciliary muscle accommodative potential;
wherein the diagnostic system (<NUM>) is configured to:
receive a plurality of signals (<NUM>) generated by the plurality of segments (<NUM>, <NUM>, <NUM>, <NUM>) of the concentric rings (<NUM>-<NUM>) during a ciliary muscle assessment procedure, each of the plurality of signals indicating an electrical field associated with a patient's ciliary muscle;
analyze the received signals including comparing the received signals to evaluate differences in quality and accuracy of the plurality of signals received from the plurality of segments;
identify a subset of signals that provide accurate measurement of the electrical activity from the ciliary muscle for use in evaluating the patient's ciliary muscle, wherein the subset of signals identified by the analysis are received from a subset of the plurality of segments of the concentric rings aligned with the patient's ciliary body, wherein evaluating the plurality of signals received from the plurality of segments (<NUM>, <NUM>, <NUM>, <NUM>) further comprises comparing the signals with a threshold, mean or median value; and
calculate a value associated with the identified subset of the plurality of segments (<NUM>, <NUM>, <NUM>, <NUM>), wherein calculating the value comprises summing the signals of the subset of signals generated by the segments (<NUM>, <NUM>, <NUM>, <NUM>) that are aligned with the patient's ciliary body
and a display (<NUM>) communicatively coupled to the processor and configured to display the calculated value associated with the identified subset of the plurality of segments.