BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 depicts an exploded view of the disposable apparatus indicating that the Insertion Tool has a different Proxy Lens that may be placed onto the Insertion Tool to accommodate a wide spectrum of refractive measurements.
FIG. 2 depicts the use of pairs of opposing visual marks on both the proximal and distal surfaces of the Proxy Lens to adjust the Proxy Lens plane perpendicular to the optical axis.
FIG. 3 depicts the use of a set of three points on either the proximal or distal surface of the Proxy Lens. The three points define an equilateral triangular (a=b=c) whose plane is planar with the Proxy Lens plane. The Proxy Lens is adjusted until the tetrahedron created with the apex of the point from the convergence of the two sensors has three isosceles triangles for its faces (a2=b2=c2).
FIG. 4 depicts a strain-gauge transducer attached to the distal end of the Insertion Tool handle. A readout of the transducer reflects the amount of pressure applied to the distal side of the Proxy Lens against the internal surface of the posterior face of the intraocular lens capsular bag.
FIG. 5 depicts flexion in the handle of the Insertion Tool apparatus by either using a soft material on the distal end of the handle, or by using channels or grooves cut into the convex (anterior) side of the distal end of the handle. Flexion is measured and reflects the amount of pressure applied to the distal side of the Proxy Lens against the internal surface of the posterior face of the intraocular lens capsular bag.
FIG. 6 depicts the premise of feature-based passive stereo photogrammetry used to determine depth information along the optical axis. Visual marks are used to determine the location. In this figure one mark (A) creates the conjoined pair for triangulation. Differences in the projected image location of A on the left image—A(xl,yl,zl)—and right image—A(xr,yr,zr)—indicates the real world location A(x,y,z).
FIG. 7 depicts the apparatus used to measure total refraction in the eye (Refractometer), a disposable apparatus that is positioned within the path of the refractive measurement (Proxy Lens), and a carrier and handle on the disposable apparatus used to facilitate insertion and removal (Insertion Tool). A stereoscopic digital imaging system in the refractometer is used to locate the geometric center of the corneal dome, which is used as the reference for the optical axis.
DETAILED DESCRIPTION OF THE INVENTION
Definitions:
Throughout this application various publications are referenced. The disclosures of these publications are hereby incorporated by reference, in their entirety, in this application. Citations of these documents are not intended as an admission that any of them are pertinent prior art. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicant and does not constitute any admission as to the correctness of the dates or contents of these documents.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Generally, the nomenclature used herein and the surgical procedures in opthalmology, materials science, vision science, physics, electronics and computer software described below are well known and commonly employed in the art. Conventional methods are used for these procedures, such as those provided in the art and various general references. As employed throughout the disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings. Where a term is provided in the singular, the inventors also contemplate the plural of that term. The nomenclature used herein and the surgical procedures described below are those well known and commonly employed in the art. Where there are discrepancies in terms and definitions used in references that are incorporated by reference, the terms used in this application shall have the definitions given herein.
Other technical terms used herein have their ordinary meaning in the art that they are used, as exemplified by a variety of technical dictionaries (for example, Chambers Dictionary of Science and Technology, Peter M. B. Walker (editor), Chambers Harrap Publishers, Ltd., Edinburgh, UK, 1999, 1325 pp). The inventors do not intend to be limited to a mechanism or mode of action. Reference thereto is provided for illustrative purposes only.
INTRODUCTION
Throughout this application various publications are referenced. The disclosure of these publications are hereby incorporated by reference, in their entirety, in this application.
The present invention recognizes that it is desirable to have an in situ procedure that can be employed intra-operatively to validate the selection of the IOL that is to be implanted in the intraocular lens capsular bag as a corrective measure for cataracts or other forms of vision loss or impairments. A methodology to perform this validation is presented by several embodiments of the invention that define the apparatus required to measure total refraction in the eye. This methodology of measuring refraction of the entire eye is a more precise way of determining IOL power for the implantable IOL.
Total refraction of the eye is measured by use of a refractometer. Many refractometers, using conventional optics (as opposed to wave front aberrometers) have already been described in the patent literature and appear below:
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3036568
(May 1962)
Stark
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3536383
(October 1970)
Cornsweet
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3572909
(March 1971)
Van Patten
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3762821
(October 1973)
Bruning
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3930732
(January 1976)
Holly
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4021102
(May 1977)
Iizuka
|
4353625
(October 1982)
Nohda
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4367019
(January 1983)
Kitao
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4372655
(February 1983)
Matsumura
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4390255
(June 1983)
Nohda
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4421391
(December 1983)
Nohda
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4591247
(May 1986)
Matsumura
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4620318
(October 1986)
Kamiya
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4637700
(January 1987)
Krueger
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4678297
(July 1987)
Ishikawa
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4744648
(May 1988)
Kato
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4755041
(July 1988)
Ishikawa
|
4761070
(August 1988)
Fukuma
|
4834528
(May 1989)
Howland
|
4859051
(August 1989)
Fukuma
|
5214456
(May 1993)
Gersten
|
5309186
(May 1994)
Mizumo
|
5500697
(March 1996)
Fujieda
|
5579063
(November 1996)
Magnante
|
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The Invention:
The present invention comprises the methods and apparatus for using a Proxy Lens apparatus (the Proxy Lens) of known refractive power, an Insertion Tool apparatus (the Insertion Tool) for holding and inserting the Proxy Lens in situ intra-operatively, and an intra-operative refractometer apparatus (the Refractometer) or any device that can measure refractive power—sphere, cylinder or other higher order refractive power—of the optical system of the eye. Specifically, it consists of:
- 1. An apparatus (Proxy Lens), which can be a disposable or a reusable item, is held within the optical path of the eye for the purpose of making refractive power measurements of the eye under surgery. The optical path may be external to the intraocular lens capsular bag (i.e., anterior chamber, iris surface, corneal apex) or within the intraocular lens capsular bag after the natural lens has been surgically removed.
- 2. An apparatus (Insertion Tool), which can be a disposable or a reusable item, to both hold and insert (or inject) the Proxy Lens into the optical path of the eye at the appropriate position during surgery for the purpose of making refractive power measurements of the eye.
- 3. An apparatus (Refractometer) to measure the refractive power of the eye during surgery. One described below uses stereoscopic digital imaging system or any other methodology to measure the refractive power of the eye. Other devices, such as optical surgical microscopes and wave front measurement systems, may also be used to measure the refractive power of the eye with the Proxy Lens held in the desired position.
- 4. A method for loading the Insertion Tool with the Proxy Lens.
- 5. A method of introducing the Insertion Tool with the attached Proxy Lens through an opening in the eye and holding the Proxy Lens at the desired position for the purpose of making refractive power measurements of the eye.
- 6. A method of calculating and selecting the refractive power of the IOL for the eye under surgery based on the refractive power measurements made with the Proxy Lens held at the desired position for the purpose of making refractive power measurements of the eye.
- 7. A method for verifying the refractive power of the eye with the Proxy Lens held at the desired position for the purpose of making refractive power measurements of the eye. This can be accomplished with the selection of a Proxy Lens of a calculated power. No refractive error should be present when the Proxy Lens power is same as the calculated power of the IOL. Such measurement will serve as a method of verification.
- 8. A method of correcting the calculated IOL power (as in item 6 above) based on the experience parameters such as healing factors, patient specific anatomy and surgeon related parameters. This will refine the prediction methodology so that the post-operative refractive error is minimized.
The Proxy Lens:
The first unique element of the invention will be the use of an apparatus (Proxy Lens), which will simulate the IOL to be implanted. Measurements provided by the refractometer apparatus will precisely locate the position of the IOL in the post-operative eye. The Proxy Lens is small, disposable and hand held, and easily removable once inserted into the optical path of the eye. The physical characteristics of the Proxy Lens follow.
- 1. One embodiment of the Proxy Lens may be of any shape—plus, minus, cylindrical or multifocal.
- 2. Another embodiment of the Proxy Lens—of known power—is manufactured from a rigid or a soft (and thus foldable) transparent material.
- 3. Another embodiment of the Proxy Lens may also be inflatable with a gas or a liquid to make the refractive power adjustable. This also allows the Proxy Lens to be positioned against the internal surface of the posterior face of the intraocular lens capsular bag.
- 4. Another embodiment of the Proxy Lens has higher order aberration information manufactured within it to facilitate measurement and/or verification of higher orders of refraction.
Following the removal of the cataract or clear lens, the surgeon positions the Proxy Lens into the optical path for the refraction measurement. In one embodiment of the method, the Proxy Lens is positioned external to the intraocular lens capsular bag (i.e., anterior chamber, iris surface, corneal apex). In another embodiment of the method, the Proxy Lens in inserted through the initial incision used for the natural lens extraction and places it within the intraocular lens capsular bag. With the Proxy Lens held in position, a measurement of the refractive power of the intra-operative eye is made. The refractive measurement and the power of the Proxy Lens are then used to calculate the precise power of the intended IOL in order to give the patient maximal vision post-operatively.
The Proxy Lens inserted in the intraocular lens capsular bag has certain distinct advantages that are claimed.
- 1. The Proxy Lens approximates the in situ position of the natural lens and where the IOL will be implanted, reducing errors introduced during assumptions made with pre-operative predictive formulae. These errors include:
- a. anterior Chamber Depth and the final resting position of the IOL on the optical axis.
- b. decentration that may occurs as a result of implantation, and
- c. tilting of the IOL with respect to the lens plane perpendicularity relative to the optical axis.
- 2. If the position and orientation of the post-operative IOL can be more accurately assessed in longitudinal studies, these parameters can be used to position the Proxy Lens to approximate those parameters. This can then be used to more accurately adjust the selection of the correct power of the permanent IOL intra-operatively as addition measures of validation against the pre-operative predictive calculation of the refractive power.
- 3. The patient is conscious and is asked to fixate on a visual target in the optical field that represents the optical axis of the refractometer. An aphakic eye is unable to focus precisely on this visual target and lessens the accuracy of the visual field approximating the optical field. Inserting a Proxy Lens to increase visual acuity improves the patient's ability to assist with position the eye on the optical axis and making refractive measurements more accurate.
The Insertion Tool:
The second unique element of the invention will be the use of an apparatus (Insertion Tool) to facilitate the insertion and removal of the Proxy Lens onto a position located on the optical axis so that a refractive measurement can be made. The physical characteristics of the Insertion Tool follow:
- 1. The Insertion Tool may have a permanent or a temporary Proxy Lens. If the Proxy Lens is permanent, the Proxy Lens and the Insertion Tool are manufactured as one unit and selection of the correct power Proxy Lens includes the attached Insertion Tool. If the Proxy Lens is temporary, the Insertion Tool will have on it a holding mechanism that positions the Proxy Lens in place for the insertion of the Proxy Lens onto the optical axis. The Insertion Tool in this case is a universal apparatus that may be used with Proxy Lens of different refractive powers.
- 2. In one embodiment of the Insertion Tool, a Light Emitting Diode (LED) or a fiber optic bundle is attached to the distal end of the handle on the distal side of the Proxy Lens landing to illuminate the posterior lens capsular bag, thus making it visible. This allows the position of internal surface of the position face of the intraocular capsular bag to be measured relative to the Proxy Lens.
- 3. In another embodiment of the Insertion Tool, an orifice manufactured in the distal end of the handle allows negative pressure to be introduced in the intraocular capsular bag. This negative pressure will force a constriction of the capsular bag and introduce surface based wrinkles that are visible on the internal surface of the position face of the intraocular capsular bag. These surface deformations will scatter and deflect light in patterns that yield more contrast and features. These features can then be detected in an area-based active stereo photogrammetry analysis to determine both shape and position of the posterior capsule.
- 4. In another embodiment of the Insertion Tool, the Proxy Lens is soft, thus allowing it to be folded. The Insertion Tool then is used as a holding device for the folded Proxy Lens and utilizes pneumatic pressure to inject the folded lens into the intraocular capsular bag where it is unfolded and placed into position.
FIG. 1 shows the Insertion Tool and Proxy Lens. A handle is attached to the landing where the Proxy Lens is positioned. The surgeon uses the handle to manipulate Proxy Lens onto the optical axis.
Several factors must be considered to mitigate factors that may lower the power and precision of the refractive measurement using the Proxy Lens and the Insertion Tool apparatus:
- 1. The plane of the Proxy Lens should be positioned perpendicular to the optical axis. If the Proxy Lens is not positioned in this manner, off-axis errors will be introduced during refractive measurements made with the refractometer. The orientation of the plane of the Proxy Lens can be adjusted with the implementation two methods that are claimed in this invention. Both methods assume that the fixation point is directly on the optical axis.
- A. Visual punctate marks are manufactured on the proximal and distal surface of the Proxy Lens as a set of pairs, and where the members of each pair of marks are directly in line with the optical axis of the Proxy Lens. The Proxy Lens is then held in place with the Insertion Tool apparatus and adjusted until each pair of opposing marks appear as one because they are directly on top of each other when viewed from a fixation point in the optical axis at infinity (FIG. 2). When this occurs visually, the Proxy Lens plane is considered to be perpendicular to the optical axis. Infinity is used for this theoretical argument because the refractometer apparatus of this invention uses non-orthogonal images for the stereo pair imaging. Because measurement at infinity is practically not possible, the alignment of the marks must be visualized from a fixation point that is off-axis by a distance from the center as determined by the location of the marks themselves.
- B. Visual punctate marks are manufactured on the proximal or distal surface of the Proxy Lens in a minimum set of three points near the peripheral edge of the surface. The location of the set of three points must define an equilateral triangle and the plane represented by these three points must be parallel to the plane of the Proxy Lens. The location of the set of three points will be measured by using the refractometer apparatus of this invention. One embodiment of this apparatus contains a stereoscopic digital imaging system. A distance measurement method, such as feature-based passive stereo photogrammetry, can then be used to calculate the location of each of the three points. This convergence of the two stereo cameras represents the apex of a tetrahedron. The planar equilateral triangle forms the base of the tetrahedron and the three triangular faces are formed by the two points of each segment of the planar equilateral triangle with the apex as the third point. The Proxy Lens is adjusted until each of the three faces of the tetrahedron is isosceles, indicating that the three points of the planar equilateral triangle are equidistance from the apex, and thus, the Proxy Lens plane is perpendicular to the optical axis (FIG. 3).
- 2. The position of the Proxy Lens relative to the posterior capsule should be controlled. Posterior capsule opacification (PCO) remains the most common long-term complication of cataract surgery (Apple et al, 1992; Kappelhof and Vrensen, 1992). In the most common forms of PCO, lens epithelial cells (LEC) migrate and proliferate between the posterior capsule and the IOL, forming monolayers and Elschnig pearls, leading to a decrease in visual acuity and loss of contrast sensitivity. The most common management option is capsulotomy using the neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The rate of incidence of PCO is declining due to new surgical tools and modern IOL design (Apple et al, 2001). Six factors were isolated leading to improved outcomes—three were surgery related and three were IOL related. Of the surgery related factors, depth fixation of the IOL intra-operatively is a critical factor where contact with the posterior side of the capsule decreases LEC migration and thus the incidence and severity of PCO. The contact of the two surfaces blocks migration of LEC from the equatorial side of the lens capsule (Peng et al, 2000). There are also reported adverse effects of YAG treatment for PCO (Billotte and Berdeaux, 2004). In this case, longitudinal studies of elderly patients with IOL implants and incidence of YAG capsulotomy at 5% rate vs. 20% rate decreases the incidence of intraocular pressure, glaucoma, macular edema and retinal detachment.
For these reasons, the depth fixation of the Proxy Lens relative to the internal surface of the posterior face of the intraocular lens capsular bag should be measured and controlled. The depth fixation of the Proxy Lens is critical to achieving the correct refraction measurement that reflects the optimal and desired position of the IOL.
Furthermore, the centration of the natural lens should also be considered. Studies have reported that the natural lens deviate 0.25 mm superiorly with a tilt of 6 degrees in the inferotemporal direction (Tscherning, 1898). Other studies report that IOLs are decentered about 0.64 mm superotemporally with a tilt of 6.75 degrees with the superonasal edges tipped forward after extracapsular cataract extraction (Auran et al, 1990). However, more recently, IOL decentration after phacoemulsification has improved to 0.14 to 0.34 mm with 2.06 to 4.88 degrees of tilt (Hayashi et al, 1997; Wang et al, 1998; Jung et al, 2000; Hayashi et al, 2001; Taketani et al, 2004).
For these reasons, the precise centration and tilt of the Proxy Lens relative to the optical axis should be measured and controlled. The centration of the Proxy Lens is critical to achieving the correct refraction measurement that reflects the optimal and desired position of the IOL. The tilt is any deviation from the planarity of the Proxy lens focal plane as measured perpendicular to the optical axis. This planarity is measured and enforced by the use of methods in this invention. Another embodiment of this invention introduces tilt as measured in post-operative conditions of implanted IOLs to simulate the final resting position and orientation of the IOL. This approximation of their final resting position and orientation will then give a more accurate intra-operative measure of refraction and allow for any changes in the selection of the permanent IOL intra-operatively.
Current techniques and modern design of IOLs reduce errors with IOL fixation. However, depth fixation, centration and tilt of the Proxy Lens relative to the posterior surface of the intraocular lens capsular bag and the optical axis remain critical as a means to reduce post-operative complications and concomitant management. With the trend towards elective implantation of IOL, the use of the Proxy Lens and the intra-operative measurement of the refractive power will significant reduce post-operative complication. This is an important benefit of this invention. To facilitate the fixation of the Proxy Lens relative to the internal surface of the posterior face of the intraocular lens capsular bag, both A) physical and B) optical methods are claimed in this invention.
- A. Physical methods encompass the measurement of proximity. Proximity measurements claimed in this invention utilize 1) strain-gauge transducers to measure pressure changes, and 2) flexion in the neck of the Insertion Tool apparatus handle.
- 1. The Insertion Tool apparatus has a strain-gauge transducer at the distal end of the handle, just before the circular landing that holds the Proxy Lens (FIG. 4). As the landing that holds the Proxy Lens, or the Proxy Lens surface itself, contacts the internal surface of the posterior face of the intraocular lens capsular bag, the pressure increases as measured on an external readout. The pressure will reach an optimal zenith, which is determined empirically. The movement of the Insertion Tool apparatus is then halted for refractive measurement.
- 2. The Insertion Tool apparatus has flexion engineered into the distal end of the handle, just before the circular landing that holds the Proxy Lens (FIG. 5). Flexion is introduced by two methods claimed in this for this apparatus:
- a. A different material at the distal end of the Insertion Tool handle that is softer and thus more pliable then the proximal end of the Insertion Tool handle,
- b. Channels or grooves cut onto the convex (anterior) side of the distal end of the Insertion Tool handle.
- As pressure increases in both cases, a distinct and measurable change in the angle is noted from the proximal end to the point of angle change, and from that point to the distal. The angle may be read by visualizing the components and geometry with the digital imaging system as one of the embodiments of the Refractometer apparatus. It may also be read by using a material that changes color when bent under pressure. The angle will reach an optimal zenith, which is determined empirically. The movement of the Insertion Tool apparatus is then halted for refractive measurement.
- B. Optical methods encompass the measurement of 1) feature-based passive stereo photogrammetry and 2) area-based active stereo photogrammetry.
- 1. In feature-based passive stereo photogrammetry, passive stereo vision (stereo photogrammetry) is used to calculate the 3-space position (depth) of the Proxy Lens by using corresponding 2-D points between the left and right images that are projections of the same physical point in the 3-D scene (stereo matching). By using the Refractometer apparatus in this invention that implements stereo vision, the geometric relationship between the two cameras and their intrinsic parameters is known from a calibration process. The 3-space coordinates of a point can be determined from the 2-D coordinates using epipolar geometry (Eric and Grimson, 1985; Chai, 1998). In these machine vision problems, the corresponding point in the first image of a conjoined pair for stereo matching is identified by searching along an epipolar line in the second image. These are computationally intense image processing tasks (Han et al, 2001; Deriche and Faugeras, 1990; Marapane and Trived, 1989; Weng et al, 1989; Eric and Grimson, 1985).
- With the Proxy Lens apparatus, the identification of the conjoined pair may be reduced to a much simpler computational task by manufacturing easily visualized discrete objects on the Proxy Lens itself and making highly confident assumptions of their locations on each of the stereo images (FIG. 6). The use of three locations will define the Proxy Lens focal plane, as is needed to determine the planarity of the lens in the optical path.
- 2. When features are less distinct, such as on biological membranes, area-based active stereo photogrammetry can be used to determine position. The known position of the inner surface of the posterior side of the lens capsular bag will aid in approximating the position of the final resting position of the permanent IOL. This information would be used for the critical placement of the Proxy Lens for the measure of refraction. To enable visualization of the posterior surface for active stereo photogrammetry, several methods are claimed:
- a. Reflect a light from the posterior surface. As described earlier, this method is enabled with the use of the LED or the fiber optic bundle attached to the distal end of the handle on the Insertion Tool apparatus. The pattern of the reflected light can be a discrete point in which case conventional triangulation as in feature-based methods can be utilized. The pattern can also be a line or circle, so that additional information on the surface topography can be calculated by measuring deformations along the line scan axis.
- b. Use of a water soluble dye such as gentian violet or trypan blue ophthalmic solution to increase visibility of the posterior capsule.
- c. Improve visibility of the posterior surface by using negative pressure to introduce surface based wrinkles that are visible on the internal surface of the position face of the intraocular capsular bag. These surface deformations will scatter and deflect light in patterns that yield more contrast and features. These features can then be detected in an area-based active stereo photogrammetry analysis to determine both shape and position of the posterior capsule. As described earlier, this method is enabled with the use of an orifice manufactured in the distal end of the handle of the Insertion Tool apparatus.
A piano contact lens may also be used to neutralize any irregularity on the corneal surface (i.e., scratches or wrinkles). This will both help get an accurate refraction and allow better fixation on the part of the patient. The plano contact lens will also have marks on it in the same manner as the Proxy Lens to help visualize and determine its location on the optical axis with the same methodology mentioned above for the Proxy Lens.
The Refractometer:
The third unique element of the invention will be use of an apparatus (Refractometer), which will perform the measure of refraction. The Refractometer will use a digital imaging system and an illuminated target. This is an architecture similar to many of the patents listed above in the Introduction. If the Proxy Lens is utilized to only get spherical and cylindrical first order numbers of aberration, the embodiment of the Refractometer need not be much different than what is in the prior art.
However, if accuracy of the placement of the Proxy Lens in 3-space is required, for example, to get higher order aberration parameters, or to more closely approximate the in situ position and orientation of the implanted IOL post-operatively, another embodiment of the Refractometer will require a stereoscopic digital imaging system to obtain three-dimensional information. This embodiment is unique compared to the above patents. The stereoscopic digital imaging system is used to locate the center (either the apex or the visual axis) of the “cornea dome” (i.e., geometric center of the cornea) and thus better relate the optical axis of the ocular optical system (the essential axis for a precise measurement) to a real anatomic reference point (FIG. 7). This is important in order to be able to reproduce and verify initial measurements. The stereoscopic digital imaging system will also be used for the various methods of this invention to locate position of objects, such as the Proxy Lens in 3-space.
The stereoscopic digital imaging system is referenced in another patent application (US 2005/0117118 A1, Jun. 2, 2005; PCT WO 03/030763 A1, Apr. 17, 2003).
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Patent Application
20080004610
