CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent

Application No. 62/475778, filed March 23, 2017, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] This disclosure relates to method and system for intraocular lens (IOL) image quality, and more particularly to measurement of asymmetrical features.

BACKGROUND

[0003] Ophthalmic lenses, such as spectacles, contact lenses and intraocular lenses, may be configured to provide both spherical and cylindrical power. An intraocular lens (IOL) is a lens implanted in the eye used to treat cataracts or myopia. IOLs may be used for restoring visual performance after a cataract surgery or other ophthalmic procedure in which the natural crystalline lens is replaced with or supplemented by implantation of an IOL. A variety of different types of IOLs are currently available, including monofocal and multifocal IOLs, phakic IOLs and piggyback IOLs (i.e. IOLs implanted in an eye already having an IOL).

[0004] Toric lenses typically have at least one surface that can be described by an asymmetric toric shape having two different primary curvature values in two orthogonal axes, wherein the toric lens is characterized by a "low power meridian" with a constant power equal to the base spherical power and an orthogonal "high power meridian" with a constant power equal to the base spherical power plus the cylinder power of the lens. Intraocular lenses, which are used to replace or supplement the natural lens of an eye, may also be configured to have a cylinder power for reducing or correcting the astigmatic effect of the cornea or eye.

[0005] One significant issue is the cost and/or time needed to develop and evaluate new IOL designs. Current methods and systems for measuring IOL image quality includes modular transfer function (MTF) measurement using an MTF bench for measuring the optical transfer function by its module and phase of an IOL. The MTF is the modulation or contrast of the image formed by the system or IOL for various spatial frequencies or various size targets. Frequently, black and white bars with 100% contrast are used as the targets. As the size of the target decreases, the system's ability to maintain high contrast decreases.

[0006] Such an MTF bench is typically used to measure the image quality with symmetrical features. That is, the modular transfer function is radially symmetrical. For an asymmetrical image quality like a toric lens, the MTF bench measures the X and Y meridians of the lens individually by forcing the image being evaluated be aligned with an X or Y meridian.

[0007] This may not be convenient and accurate enough to reflect the true image quality, especially in asymmetrical lenses, such as an IOL that may provide such as a highly asymmetric IOL or freeform design like the toric IOL with extended tolerance of astigmatic effects.

[0008] Therefore measuring the image quality by the current system design is not enough to capture the best image quality of the system (such an eye). Therefore, a method and system that can measure the meridian dependent image quality is needed to objectively and fully evaluate the image quality of asymmetrical IOLs including asymmetrical toric IOLs like extended tolerance astigmatism ("ETA") IOLs. Examples of such ETA IOLs are described in U.S. Patent Application Nos. 63/312,321 (filed March 23, 2016); 63/312,338 (filed March 23, 2016); and 62/363,428 (filed July 18, 2016), which are each hereby incorporated by reference for all purposes as if fully set forth herein. SUMMARY

[0009] Accordingly, the present invention is directed to a method and system for measuring image quality by spatially varying MTF test that obviates one or more of the problems due to limitations and disadvantages of the related art.

[0010] An advantage of the present invention is to provide a method for evaluating performance of an intraocular lens, comprising: providing an image capture device, such as a charge coupled device (CCD), CMOS, film/light recording material, or any camera, in an initial start position with respect to an ophthalmic device such as an intraocular lens (IOL), toric intraocular lens or the like being measured; capturing a first image; changing a relative angular position of the CCD with respect to the IOL; capturing second image; and determining a measure of intraocular lens performance based upon the captured images. Another aspect of the present invention provides a method for evaluating performance of an intraocular lens, comprising: providing a charge coupled device (CCD) in an initial start position with respect to an intraocular lens (IOL) being measured, wherein the initial start position includes an initial angular position and an initial z-axis position; capturing a first image; repeatedly changing the relative angular position of the CCD with respect to the IOL and capturing images until the relative angular position of the CCD with respect to the IOL reaches a predetermined angular stop position; changing a relative z-axis position of the IOL with respect to the CCD and resetting the relative angular position of the CCD with respect to the IOL to the initial angular start position; repeatedly changing the relative angular position of the CCD with respect to the IOL and capturing images until the relative angular position of the CCD with respect to the IOL reaches the predetermined angular stop position; repeatedly changing the relative z-axis position of the IOL with respect to the CCD and capturing images until the relative z-axis position of the IOL with respect to the CCD reaches a predetermined z-axis stop position; and determining a measure of intraocular lens performance based upon the captured images.

[0011] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention as claimed.

DESCRIPTION OF DRAWINGS

[0013] The accompanying figures, which are incorporated herein and form part of the specification, illustrate methods and systems for measuring image quality. Together with the description, the figures further serve to explain the principles of the methods and systems for measuring image quality described herein and thereby enable a person skilled in the pertinent art to make and use the methods and systems for measuring asymmetrical image quality.

[0014] FIG. 1 is a (or depicts one embodiment of), for an example using a

ZCT600 toric IOL for correcting a corneal astigmatic power of about 4.2D with 0 degree cylindrical axis, the residual cylinder for -10, 0, and 10 degrees misalignment.

[0015] FIG. 2 illustrates measurement with X or Y only image quality by a current MTF bench with a CAM being zero and not zero for a regular toric IOL with 4.0D cylinder with a null astigmatic lens in an eye model. [0016] FIG. 3 A illustrates Through-Focus and Meridian Response (TFMR) of a toric IOL with 4.0D cylinder in an eye model with a null astigmatic lens when CAM = 0.

[0017] FIG. 3B illustrates Through-Focus and Meridian Response (TFMR) of a toric IOL with 4.0D cylinder in an eye model with a null astigmatic lens when CAM = 10.

[0018] FIG. 4 illustrates a flow diagram according to principles of the present invention for a rotating CCD using a rotational stage.

[0019] FIG. 5 illustrates a flow diagram according to principles of the present invention for modulating the X and Y axis in the image processing software.

[0020] FIG. 6 shows measured MTF values using a known MTF bench for an irregular or asymmetrical-powered toric IOL

[0021] FIGs. 7A and 7B show measured MTF values using the disclosed bench with the TFMR.

DETAILED DESCRIPTION

[0022] Reference will now be made in detail to embodiments of the an improved system and method for measuring meridian-dependent image quality with reference to the accompanying figures, in which like reference numerals indicate like elements.

[0023] It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

[0024] Because the functions of such a toric IOL usually works with a matching null lens to mimic an asymmetric eye model, an MTF bench that measures by alignment with an X or Y meridian will not accurately measure the asymmetric features.

Like MTF that asymmetrical image quality is not only dependent on the best focus

(defocus term), but also on the meridians or symmetry like the astigmatism of the optics under test.

[0025] For example, a regular toric IOL is designed to correct the astigmatic effect caused by the corneal astigmatism or cylindrical power with matching exactly the cylinder axis. If the cylindrical power axis were mismatched by 1 degree, there would be about 3% reduction of the effectiveness of correction. If there were a 10 degrees misalignment, there would be about 35% reduction of such effectiveness of correction.

The residual meridian power can be expressed as:

[0026] OC=2*SIN(Alpha)*C/2*0.7*COS[2*(theta+90+Alpha)/2]

[0027] Where C is the astigmatic power at the IOL plane to be corrected at meridian theta and the Alpha is the misalignment of the cylindrical power axis.

[0028] For an example using a ZCT600 toric IOL for correcting a corneal astigmatic power of about 4.2D with 0 degree cylindrical axis, the residual cylinder for - 10, 0, and 10 degrees misalignment is shown as in FIG. 1. As can be seen, the best image meridian is not along the X or Y axis orientation any longer. For this specific example alone, meridians 45+Alpha/2 and 135 + Alpha/2 respectively. In addition, this also indicates that at alternative 45 and 135 degree meridian angles the Visual Acuity (VA), if the system were used for clinical use, may reflect the optimal than other meridians at best focus, but may not be reflected so if measures the X or Y meridian only. All meridians could be measured by this method. [0029] Referring to FIG. 2, a regular toric IOL with 4.0D cylinder with a null lens in an eye model is used to illustrate the measurement with X or Y only image quality by a current MTF bench with a cylindrical axis misalignment (CAM) being zero and not zero (up to 10 degrees). As it can be seen that the measured MTF values are very low at the given clinically relevant CAM values. It does not reflect the best MTF possible due to the reasons described. In order to improve image quality measurement for asymmetrical lenses, one may consider the following options, but not limited to, to achieve during the test: The object (pinhole, slit, are force target etc.) be angularly modulated or changed; the optic system under test be angularly modulated or changed; the detector (system), image capture device, such as a CCD angularly modulated or changed. Any image capture device, such as CMOS, film/light recording material, any camera, or the like could be used in place of the CCD. The image processing and the image quality calculation algorithm includes the meridian variable, in other words, the X or Y can be angularly modulated or changed.

[0030] A solution according to principles of the present invention measures the modular transfer function through-focus and meridian (Through-Focus and Meridian Response) to evaluate image quality in the lens. Measuring the MTF through focus gives the best focus position and measuring the MRF through meridian gives the optimal meridian angle that reflects the best image quality, here the MTF values. [0031] According to principles of the present invention, the image capture device or CCD used to measure IOL performance can be rotated to evaluate the IOL at predetermined CAM angles such that the various meridian responses can be measured, whereas conventional measurements are conducted only at a single meridian (or CCD position), typically 0 degrees. Such comparison is illustrated in FIG. 3Aa and 3B. FIGs. 3A and B illustrate Through Focus and Meridian Response (MTF) of a toric IOL with 4.0D cylinder in an eye model with a null astigmatic lens when (a) CAM = 0 degrees and (b) CAM = 10 degrees. For the same case of using the IOL with 4.0D cylinder with a null lens in an eye model, FIGs. 3 A and 3B illustrates the measured 3D image quality or MTF values in a contour format.

[0032] FIG. 3A illustrates measurement of the axis focal plane only at 0 degrees. The best MTF values illustrated in FIG. 3 A center on the 0mm depth. However, once the CCD is rotated, it can be shown that the best MTF performance of the sample IOL is not at 0 degrees, but instead at roughly -45 degrees and roughly +45 degrees.

[0033] As it can be seen that for any given CAM value, the measured 3D

MTF value accurately reflects the optimal image quality of the toric IOL under test, although the best MTF values was not captured alone X or Y orientation. In addition, the measured TFMR also, if validated, can give the residual astigmatic and sphere equivalent powers simultaneously. If the Null lens is free of any power or non-existed, the measured would be the astigmatism power and spherical equivalent powers of the IOL.

[0034] Rotating the CCD as described above does not provide information as to the best focal plane of the IOL. Thus, additional focal plane information should be determined. That is, focal plane can be varied and tested by moving the location of the CCD with respect to the lens such that the lens is measured in both CAM and meridian response.

[0035] In an embodiment of the present system and method, an initial start focal plane position of the IOL is determined and an end focal plane position is determined. An initial CCD rotation angle is determined and an end CCD rotation angle is determined. The CCD and the IOL are placed in proper relative position. Measurements are taken at the initial rotation angle and initial focal plane position of the CCD. After initial measurement, the rotation angle or the focal plane position are incremented and additional measurements taken. The rotation angle may be incremented by rotating the physical CCD, rotating a stage hosting the CCD, or rotating the IOL or a stage or holder hosting the IOL to change the relative angular position of the CCD with respect to the IOL. According the principles of the present embodiment, the relative rotation angle is incremented by 1 degree, but may be incremented at 0.5 degrees or as the resolution of the CCD will allow. The focal plane position may be incremented by moving the physical CCD or a stage hosting the CCD, or moving the IOL or the stage or holder hosting the IOL to change the relative focal plane depth of the IOL with respect to the CCD. According the principles of the present embodiment, the relative focal plane position is incremented by .02mm (20 microns), but may be incremented at 0.01mm (10 microns) or as the resolution of the CCD will allow. That is, the following is measured or tracked: 1) movement of the CCD in Z; 2) rotation of IOL or detector (CCD); 3) rotation of the sample window; 4) rotation of patterned /featured object / etc.

[0036] A method and system for rotating the CCD using a rotational stage over 180 degrees in 1 degree increments/resolution is illustrated in the flow chart of FIG. 4. A system for implementing the method includes, e.g., a typical bench illustration: light source, target, (optional) collimator, (optional) null lens, eye model (ACE/ISO), relay system, detector (microscope + CCD system or S-H system. As illustrated in the flow chart, z start, z end and z step are provided, where z start is the initial focal plane measurement position of the IOL relative to the CCD, z end is the end focal plane measurement position of the IOL relative to the CCD, and z step is the increment between focal plane measurement positions of the IOL relative to the CCD. As illustrated in the flow chart, G start, 0_end and G step are provided, where G start is the initial relative rotation angle of the CCD relative to the IOL, 0_end is the end relative rotation angle of the CCD relative to the IOL, and G step is the increment between measurement positions of the rotation angle of the CCD relative to the IOL. As long as the focal plane position is less than z end, an image is captured by the CCD and, e.g., line spread function (LSF) /point spread function (PSF) and modular transfer function at the X/Y location and the point transfer function at the X/Y location are measured, plotted, recorded and/or the like for the particular location (rotation angle, X, Y). The value of the next measurement angle location Θ is calculated. As long as the value of the next measurement angle location is less than 0_end, the CCD (or its stage) is rotated by the appropriate increment G step. If the value of the next measurement angle location Θ is larger than G step, then the next measurement angle returns to G start by rotating the CCD (or its stage), and the relative position of the CCD and IOL is incremented to the next focal plane position by incrementing focal plane measurement position z by z step. If the value of the focal plane measurement position z, having been incremented, is greater than z end, then the measurement of the IOL by the CCD is concluded. Exemplary values for z start, z end and z_step are -2mm, +2mm and .02mm, respectively. Exemplary values for 0_start, 0_end and 0_step are -90degrees, +90 degrees, and 1 degree, respectively. These values cover IOL cylindrical powers of about 22D.

[0037] Alternatively, as illustrated in FIG. 5, the X and Y axis in the image processing software without significantly changing any other hardware. E.g., rather than rotating the CCD itself or its stage to change the relative angular position of the CCD with respect to the IOL, an image capture window may be rotated appropriately according to the steps described above. As illustrated in the flow chart, z start, z end and z step are provided, where z start is the initial focal plane measurement position of the IOL relative to the CCD, z end is the end focal plane measurement position of the IOL relative to the CCD, and z step is the increment between focal plane measurement positions of the IOL relative to the CCD. As illustrated in the flow chart, G start, 0_end and G step are provided, where G start is the initial relative rotation angle of the CCD relative to the IOL, 0_end is the end relative rotation angle of the CCD relative to the IOL, and G step is the increment between measurement positions of the rotation angle of the CCD relative to the IOL. As long as the focal plane position is less than z end, an image is captured by the CCD and, e.g., line spread function (LSF) /point spread function (PSF) and modular transfer function at the X/Y location and the point transfer function at the X/Y location are measured, plotted, recorded and/or the like for the particular location (rotation angle, X, Y). The value of the next measurement angle location Θ is calculated. As long as the value of the next measurement angle location is less than 0_end, the image capture window is rotated by the appropriate increment G step. If the value of the next measurement angle location Θ is larger than G step, then the next measurement angle returns to G start by rotating the image capture window relative to the IOL, and the relative position of the CCD and IOL is incremented to the next focal plane position by incrementing focal plane measurement position z by z step. If the value of the focal plane measurement position z, having been incremented, is greater than z end, then the measurement of the IOL by the CCD is concluded.

[0038] For another example, for an irregular or asymmetrical powered toric

IOL, as shown in Figure 6, the measured MTF values using a current MTF bench and the disclosed bench with the TFMR are shown in Figure 7 a and b.

[0039] As it can be seen that the TFMR is obvious reflects the optimal image quality more in full of the irregular IOL. [0040] The methods and system for measuring asymmetrical image quality is helpful measuring lens designs that can operate over a range of misalignments (e.g., +/- 10 degrees of misalignment) as compared to conventional tone IOLs, which would work up to only +/- 3 degrees. That is, aspects and embodiments described herein address the issue that prior art measurement devices cannot effectively measure performance of lens designs that operate over a range of misalignment, because prior art measurement devices do not take into account misalignment and point of focus of such an "ETA" lens, e.g. a lens with extended band operation (e.g., can work up to +/- 10 degree of rotational error whereas current lens will not work if there is a +/- 3 degree offset, for example). In addition, it can be appreciated the disclosed system and methods can be used to measure any type of lens, and is not limited to those that operate over a range of misalignments.

[0041] While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the present invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.