Evoked Potential Autorefractometry System

This application is related to the following concurrently filed copending U.S. patent applications assigned to the assignee of the present invention: Electroencephalographic (EEG) Cap by Sherwin having U.S. Ser. No. 727,031; Low Noise EEG Probe Wiring System by Sherwin having U.S. Ser. No. 727,060, now allowed Subcaratinaceous EEG Probe by Sherwin and Mohan having U.S. Ser. No. 727,033, U.S. Pat. No. 4,632,120; Shielded, Self-Preparing Electrode Suitable for EEG Mapping by Sherwin having U.S. Ser. No. 727,058, U.S. Pat. No. 4,640,290; Narrow Band EEG Amplifier by Sherwin and Zomp having U.S. Ser. No. 727,056, now allowed; and Phase Lock Stepper Motor Controlled Light Chopper by Sherwin U.S. Ser. No. 727,156 U.S. Pat. Nos. 4,631,466, 52,438.

1. Field of the Invention

The present invention relates to an autorefractometry system suitable for prescribing eyeglass or contact lenses and, more particularly, to an evoked potential autorefractometry system which uses a steady state evoked potential and which is low in cost, does not intimidate patients and provides a highly accurate refractive lens prescription.

2. Description of the Related Art

FIG. 1 illustrates a refractometer typically found in an eye doctor's office. In such a refractometer, lenses of differing refractive power are placed in front of the patient's eyes as the patient indicates whether or not the visual target has improved in focus. Such a system for prescribing eye glass lenses is subjective, requires verbal cooperation from the subject, is not suitable for communication handicapped persons and is very time consuming.

Fig. 1B illustrates a prior art acuity testing system. This movable lens system for generating steady state evoked potential amplitudes has been proposed by Regan in "Rapid Objective Refraction Using Evoked Brain Potentials", Investigative Opthamology, Vol. 12, No. 9, September 1973. In the Regan system, a light projector 20 projects light through a vibrating bar or check transparency 21, through a movable projection focus lens 22 onto a reflecting screen 23 which reflects the alternating stimulus back to the patient 24 through cylindrical lens 28. The evoked potentials are amplified by EEG amplifier 25 and applied to a filtering unit 26 which drives an XY plotter 27. The filter 26 is a synchronous filter that uses the properties of the pythagorean theorem to filter the input signal and produce an amplitude of the evoked potentials. Regan suggested that a digital Fourier transform could be substituted for the filter 26. A cathode ray tube or television has been suggested by Gomer in "Evoked Potential Correlates of Display Image Quality", Human Factors, October 1978, as suitable for an evoked potential stimulus source. Tyler et al in "Rapid Assessment of Visual Function: An Electronic Sweep Technique for the Pattern Visual Evoked Potential" uses a synchronous filter and integrator as a substitute for Regan's filter unit 26 and also used a sine wave grating with a reversal rate of 24 hertz to produce an XY plot of evoked potential amplitude versus spatial frequency for each discrete lens. Such a synchronous filter system requires at least 20 seconds for each sweep of each lens as acuity is being determined.

It is an object of the present invention to provide an evoked potential autorefractometry system suitable for a commercial environment.

It is another object of the present invention to provide a simple, low cost stimulus source in an evoked potential autorefractometry system.

It is a further object of the present invention to provide an evoked potential refractometry system small in size and low in cost that does not require an expensive Fourier Transform unit or synchronous filter.

It is another object of the present invention to provide a system that does not need a cumbersome image screen.

It is an additional object of the present invention to provide a low noise, high reliability shielded visual testing system suitable for a commercial environment.

It is yet another object of the present invention to provide an evoked potential autorefractometry system that does not intimidate the patient.

It is still a further object of the present invention to provide a vision testing system that does not rely on the subjectivity of the subject, but provides an objective measure of a lens which provides the sharpest presentation of a visual object to a patient.

It is another object of the present invention to provide a system that tests vision rapidly and accurately.

The above objects are accomplished by an evoked potential autorefractometry system that includes a computer-driving an alternating checkerboard mirror stimulus to stimulate a patient through a continuously variable focus zoom type lens that is controlled by the computer and maintains a constant image size on the patient's retina. The steady state evoked potentials produced by the patient are amplified, filtered both in an analog and digital fashion to allow peak to peak detection of the evoked potentials to determine amplitude. The peak to peak amplitudes are filtered to produce an average evoked potential amplitude. The lens is first swept rapidly from one extreme of focus to the other extreme in relatively large steps to determine the area in which the peak amplitude occurs. The lens is then subsequently swept in smaller and smaller range sweeps at smaller and smaller steps around the maximum amplitude until the maximum in amplitude is pinpointed at which point the lens position is printed out on the printer as the patient's diopter prescription.

These, together with other objects and advantages which will be subsequently apparent, reside in the details of construction and operation of the system as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof wherein like reference numerals refer to like parts throughout.

FIG. 1A depicts a prior art refractometer requiring subjective analysis of visual function;

FIG. 1B is a prior art evoked potential acuity analysis system requiring no subjective patient response;

FIG. 2 is a block diagram of an evoked potential autorefractometry system according to the present invention;

FIG. 3 is a block diagram illustrating the conceptual operation of the system of FIG. 3;

FIG. 4 is a block diagram of the stimulus motor 60 and control circuit 50 for controlling the stimulus stepper motor 60 of FIG. 2;

FIG. 5 is a block diagram of the checkerboard mirror stimulus generator 70 of FIG. 2;

FIG. 6 is a diagram illustrating the construction of lens 80;

FIG. 7 is a perspective view of an EEG cap 90 including self-preparing electrodes 100 for a patient's head;

FIG. 8 illustrates the details of the selfpreparing electrodes 100 of FIG. 7;

FIGS. 9A and 9B illustrate the construction of the wiring system 110 of the cap in FIG. 7;

FIG. 10 illustrates the details of the high gain, low noise amplifier 120 of FIG. 2;

FIG. 11 illustrates the details of the filter 140 of FIG. 2;

FIG. 12 illustrates the lens stepper motor 180 and control circuit 170 of FIG. 2; and

FIGS. 13A-13C illustrate the flowchart for control of the microcomputer 30 of FIG. 2.

FIG. 2 illustrates in block diagram form the major components of an evoked potential autorefractometry system used to prescribe patients' lenses and print out the prescription. FIG. 3 conceptually illustrates the general operation of the present invention. With respect to both FIG. 2 and FIG. 3, microcomputer 30 activates square wave generator 40 to produce a fixed frequency square wave used by stimulus motor control circuit 50 to control stepper motor 60. The stepper motor 60 controls a checkerboard pattern stimulus generator 70 which projects an alternating checkerboard pattern through continuously variable lens 80 to the patient 24. The amplitude modulated steady state evoked potential produced by the patient includes a very strong fundamental signal at the frequency of the reversal rate of the stimulus, along with undesired harmonics, muscle movement noise and environmental noise. An EEG cap 90 including self-preparing electrodes 100 detects the evoked potentials produced by the patient in response to the alternating changing focus stimulus and transmits the evoked potentials over low noise wiring system 110 to high gain, low noise amplifier 120. The amplifier 120, after boosting the signal level of the evoked potentials, applies the evoked potentials to a very narrow bandpass filter 140 which produces a steady state evoked potential signal free from harmonics and relatively free from noise. The steady state evoked potential signal is applied to an analog-to-digital converter 150 coupled to the microcomputer 30. The microcomputer 30 performs digital filtering followed by peak to peak detection followed by digital filtering which results in average peak to peak amplitude. Essentially the system performs amplitude demodulation of a six hertz signal which was amplitude modulated by varying the focus of the lens. The average peak to peak amplitude or demodulated signal is continually compared to determine the maximum amplitude which coincides with maximum visual acuity. The microcomputer 30 stores the position of the lens 80 associated with the maximum amplitude. The microcomputer 30 also controls the lens 80 through digital input/output unit 160, lens motor control circuit 170 and stepper motor 180 to sweep the lens 80 from one extreme of focus, for example -15 diopter, to the other extreme of focus, for example +15 diopter. During the first sweep, the lens 80 should be moved in increments of 0.08 diopter to provide a relatively continuous change in focus which prevents step or impulse type responses by the eye. During subsequent sweeps, the diopter step can be reduced down to 0.02 diopter if desired. Each sweep should last approximately one minute to prevent fatigue from becoming a problem. After each sweep, the range and lens step size are reduced around the maximum amplitude which was previously detected and another sweep in the opposite direction occurs from the stopping position. The range/step size reduction and sweep process continues until the lens 80 position at which maximum amplitude occurs is determined within desired diopter limits at which point the lens 80 position is printed out by prescription printer 190 as the subject's prescription. Present eyeglass or contact lens making technology requires a precision of one-quarter diopter and the present system can easily provide a prescription within one-quarter diopter.

A microcomputer, such as a Commodore 64, is particularly suitable as the microcomputer 30 since it includes a square wave generator 40, commonly called a tone generator, which operates independently of the microcomputer 30. During initialization and start-up of the autorefractometry system, the microcomputer 30 loads into the square wave generator 40 a control word which causes the generator 40 to produce a square wave at a frequency of 2.4 kilohertz. The analog-to-digital converter 150 and digital input/output unit 160 are available as a single plug compatible board designated an MW 611 available from Micro West Electronics and purchasable from Micro World Electronix, Inc. located in Lakewood, Colorado.

The 2.4 kilohertz signal generated by square wave generator 40 is applied to the stimulus motor control circuit 50 illustrated in FIG. 4 to control stepper motor 60. The 2.4 kilohertz square wave is applied to a four bit binary up counter 51 which generates a 1.2 kilohertz signal applied as a clock signal to filter 140 through line driver 52. The four bit binary up counter 51 can be a 74LS193 available from Texas Instruments. Three bits B.sub.1 -B.sub.3 of the output of the binary counter 51 are applied to an 8-step sequence 4-phase stepper drive circuit 53 which can be a ROM designated DM87S188 manufactured by National Semiconductor. A ROM map in accordance with Table 1 below is suitable for converting the binary count into 4-drive signals for the stepper motor 60.

The stepper motor 60 spins a chopper wheel 71 in the stimulus generator 70 as illustrated in FIG. 5. The chopper wheel 71, spinning at three cycles per second, alternately interrupts light sources A and B designated as 72 and 73 which can be ordinary 75 watt incandescent bulbs. The three hertz chopper wheel 71 spin rate produces a pattern reversal rate of six hertz which is in the frequency range where patients produce the maximum amplitude steady state evoked potentials. The light from light source A is transmitted through matte filter 74 and reflected off beam splitter 75. Beam splitter 75 reflects the light through checkerboard mirror 76 which is positioned approximately 32 inches in light path length from the lens 80. The checkerboard mirror 76 should have a check spacial frequency of 8 cycles per inch (16 inch checks) to obtain maximum evoked potentials from the subject with the lens 80, described hereafter with respect to FIG. 6, positioned at a distance of 32 inches from the mirror 76. The checks should provide an alternating achromatic black and white pattern, which provides the largest evoked potential as compared to other colors, and should have a contrast ratio of at least 60 percent for the best evoked potential. The light from light source B transmitted through matte filter 77, is reflected off beam splitter 78. The checkerboard mirror 76 reflects the light back to beam splitter 78 which transmits the light from the front of checkerboard mirror 76 toward the patient 24. The light can optionally be reflected off of a mirror 79. The mirror 79 allows the stimulus generator and lens combination to be arranged in a more compact space. The light from light sources A 72 and B 73 must travel approximately equal length paths to the subject to maintain the proper contrast ratio, so care must be taken in producing the stimulus generator 70. In addition, a beam splitter 75 must be used which matches beam splitter 78, rather than a 100 percent mirror so that the proper contrast ratio is maintained. The various mirrors, matte filters and beam splitters are commonly available from an optical supply house.

When the alternating checkerboard stimulus pattern leaves the stimulus generator 70, it passes through lens 80 which is positioned against the eye of subject 24. Lens 80 is a continuously variable focus lens that includes a geared focus. The lens 80 must provide a constant image size to the subject's retina so that variations in stimulus pattern size on the retina do not cause variations in the amplitude of the evoked potential produced by the subject. The design of such a continuously variable focus lens 80 with a geared focus that produces a constant image size is available from Optical Research Associates of Pasadena, California at a relatively high cost.

A more cost effective version of the lens 80 can be constructed from commercially available parts as illustrated in FIG. 6. Light from stimulus generator 70 enters a +1 diopter close-up lens 81 available from Tiffen of Hauppauge, New York. The close-up lens 81 includes a screw thread adapter which mates with a 17.times.60 telescope 82 available from any optical supply house. A suitable telescope 82 can be obtained from a K-Mart Department Store and is designated a Focal Telepscope having Model No. 20-20-63. The telescope 82 should have focus control rod 83 which can be fitted with a chain sprocket 84. The telescope 82 focus is adjusted through chain 85 by sprocket 86 attached to lens stepper motor 180. A step down ratio between sprockets 84 and 86 should be 1.5. A suitable chain and sprocket set is available from Boston Gear. The lens stepper motor 180 and lens stepper motor control circuit 170 are discussed later.

When the patient produces evoked potentials in response to the alternating stimulus, the potentials are picked up by self-preparing electrodes 100 mounted in an EEG cap 90 at positions to confront the patients occipital lobes, as illustrated in FIG. 7. In an adult, the first or lowest electrode should be mounted just above the inion, the second electrode should be positioned approximately one hundred millimeters above the first electrode and the third electrode should be behind the ear. The EEG cap 90 includes a band adjustor 91 mounted on the front of a flexible plastic headband such as can be found in chemical face shields or hardhats. The cap includes a 5 cc syringe pump 92 for applying an electrolyte solution through Teflon surgical tubes 93 to the electrodes 100 and scalp after the cap 90 is placed on the head. Various clamps 94 hold the tubes 93, pump 92 and low noise line cable 110 connected to the electrodes 100 in place. Additional details concerning the construction and use of the EEG cap 90 of FIG. 7 can be found in the copending and concurrently filed application entitled Electroencephalographic Cap mentioned in the cross-references to related applications section and which is incorporated herein by reference.

Each self-preparing electrode 100 includes a tulip probe 101, as illustrated in FIG. 8, which penetrates a keratinous layer of dead skin without penetrating the epidermis beneath and without causing bleeding. The tulip probe 101 is forced through the caratinaceous layer by spring 102 and held in place by probe cartridge 103. The probe cartridge 103 frictionally fits into a probe cartridge holder 104 which snaps into the cap 90. The probe cartridge holder 104 is soldered to the wire cable 110 by electronic solder. Heat shrink tubing 105 surrounds the probe cartridge 104 and is covered by a shield braid 106. The shield braid 106 is connected to a shield of the wiring cable 110, extends down to headband 90 and is surrounded by a second layer of heat shrink tubing 107. The electrolyte is supplied by electrolyte tube 93 which is held in proximity to the tulip probe 101 by tube clamp 108. The tulip probe 101, spring 102 and probe cartridge 103 can be obtained from Ostby-Barton of Warwick, Rhode Island, and are commonly used as probes for electronic circuits. The heat shrink tubing 105 and 107 and the shield braid 106 can be obtained from any electrical supply house. Additional details concerning the construction of self-preparing electrodes can be found in the copending concurrently filed applications mentioned in the crossreferences to related applications section and entitled Subcaratinaceous Electroencephalographic Probe and Shielded Self-preparing Electrode Suitable For Electro-encephalographic Mapping which are both incorporated by reference herein.

The evoked potentials, produced by the patient 24 and picked up by self-preparing electrodes 100 are conducted over an optimized shielded cable wiring system 110 as depicted in FIGS. 9A and 9B. A conductor 111 is surrounded by polyethylene insulation 112 which is surrounded by a shield layer 113. Between the shield layer 113 and polyethylene insulation 111 is a graphite layer 114 which reduces triboelectric and microphonic-type electrical noise. The shield 113 is surrounded by a Teflon insulation layer 115. A shield braid 116 surrounds the Teflon layer 115 and is covered by heat shrink tubing 117. As can be seen in FIG. 9B, a cable bundle is completely surrounded by the shield braid 116 which extends all the way from amplifier 120 over the electrode 100 completely shielding the signal path from the patient's head to the amplifier 120. The cable interior to the shield braid 116 is a microdot shield cable available from Microtech of Boothwyn, Pennsylvania designated LN1. Of course, the shield braid 116 and heat shrink tubing 117 can be obtained from any electrical supply house. The cap wiring system 110 should be arranged to have as small a loop capture area as possible to reduce unwanted noise. Additional details concerning the construction and use of the low noise wiring system of FIG. 9 can be found in the copending concurrently filed application entitled Low Noise Electroencephalographic Probe Wiring System mentioned in the cross-references to related applications section and which is incorporated herein by reference.

The evoked potentials, having a magnitude of 1 to 10 microvolts, are transmitted to a low noise, high gain shielded amplifier 120 having a connector 121, as illustrated in FIG. 10. The connector 121 is connected to a shield case which completely surrounds the amplifier 120. The amplifier 120 is a differential type amplifier providing a gain of approximately 10.sup.6 and a common mode rejection of 85 dB. The shielded amplifier 120 includes a battery power supply (not shown) inside the shield 120. The evoked potential signals from the subject 24 are applied to a clipping circuit 122 which prevents large amplitude signals from being applied to the amplifying circuits of the amplifier 120. The evoked potential signals are applied to a high impedance element 123 provided to match high impedance electrodes. The input signals are then applied to differential amplifier 124. The differential amplifier is connected to a bandpass filter 125 via an isolating capacitor 126. The bandpass filter 125 transmits the band-limited evoked potential signals through isolating capacitor 127 to a second bandpass filter 128. The second bandpass filter 128 applies the band limited evoked potentials to a lowpass filter 129 which has a bandpass range which overlaps the bandpass range of highpass filter 130. The highly amplified band-limited evoked potential signals exit the shielded amplifier 120 through connector 131. Additional details concerning the construction and operation of the high gain EEG amplifier of FIG. 10 can be found in the copending concurrently filed application entitled Narrow Band Electroencephalographic Amplifier mentioned in the cross-references to related applications section and incorporated by reference herein.

The evoked potential signals from amplifier 120 are applied to the filter 140 illustrated in FIG. 11. The filter circuit 141 is a commonly available very narrow bandpass capacitor switched filter in which the bandpass center frequency is controlled by an external 1.2 kilohertz clock signal produced by stimulus motor control circuit 50. The external clock signal is supplied by motor control circuit 50; however, it can be supplied from another source since it does not have to be synchronous with the signals in the control circuit 50. If a 2.4 kilohertz signal is used as the clock signal for filter circuit 141, a 12 hertz center frequency results. The filter circuit 141 can be a hybrid analog/digital filter Model R5620 available from EEG Reticon. The Q inputs of the filter are connected to switches 142 which control the bandwidth of the filter. The switch configuration shown provides a bandpass around six hertz of approximately one hertz when driven by the 1.2 kilohertz clock. A capacitor 143 of 0.01 microfarads is connected across the power supply terminals of the filter chip 141 to suppress power supply noise. The relatively clean six hertz output of the filter chip 141 is applied to the A/D converter 150. The A/D converter samples the six hertz evoked potential output signal produced by the filter 140 every 100 microseconds. As mentioned previously, the analog-to-digital converter is a commercially available unit which also includes a digital input/output unit 160.

The microcomputer 30 produces a running sum of 255 samples from the analog-to-digital converter 150 which helps remove high frequency converter 150 and filter 140 artifacts and acts as a lowpass filter. That is, as each new sample is produced by analog-to-digital converter 150, the microcomputer 30 subtracts the older sample from the sum and adds the newest sample to the sum thereby providing a running sum of 255 samples. The sum is continuously compared to detect the lowest value or valley in a curve produced by the running sum and the highest value or peak. The peak to peak or peak to valley difference is the amplitude of the evoked potential produced by the patient. This evoked potential amplitude is then lowpass filtered using a 16 point running sum to remove additional noise therein. The 16 point running sum, which is produced every 1/12 seconds, is the average peak to peak amplitude of the evoked potential produced by the patient. The current value of the average peak to peak amplitude is continuously compared to previous peak amplitudes to determine the maximum value. At each new maximum value, the lens position of the continuously variable lens 80 is stored. After each comparison operation, an up or down lens movement pulse is produced by the microcomputer 30 and transmitted to the lens motor control circuit 170 through digital input/output interface 160.

The up and down pulses are applied to the respective inputs of a 4-bit binary up/down counter 171, as illustrated in FIG. 12, which can be a 74LS193 available from Texas Instruments. The output of the up/down counter is applied to an 8-step sequence 4-phase stepper drive circuit which can be a ROM designated DM87S188 manufactured by National Semiconductor. The ROM includes a ROM map as illustrated in Table 1 previously which converts the count in the up/down counter 171 into control signals for lens stepper motor 140. A buffer 173 and Darlington power transistors 174 convert the output of ROM 172 into power signals for the 400 half step per revolution lens stepper motor 180. The buffer 173 can be a CD4050 obtainable from RCA, and the motor 12 can be a Model M03 by SLOSYN of Superior Electric of Bristol, Connecticut and transistors 12 can be MC1411 from Motorola. Additional details concerning the construction and operation of the stepper motor control circuit 170 can be found in the copending concurrently filed application entitled Phase Locked Stepper Motor Controlled Light Chopper mentioned in the cross-references to related applications section and which is incorporated by reference herein.

As previously discussed, the microcomputer 30 not only controls the focus of lens 80, but also initiates square wave generator 40 and provides digital filtering of the evoked potentials produced by the patient 24. The operation of the microcomputer is illustrated in detail in the flowcharts of FIGS. 13A-13C. When the system is started, waveform parameters of the system tone generator are set 200. Once the parameters are set, the outputs from the MW611 board are initialized 210. Next, the chopper wheel 71 is started to spin 220 by incrementing until the speed reaches the desired frequency. Next, the lens 80 is set to its minus limit 230 by driving the lens 80 as far as it will go in one direction with the maximum number of steps being 1800. Next, the filter array values are set 240 to appropriate values. A sample from the analog-to-digital converter 150 is obtained and applied 250 to digital filter 1 which produces the 256 point running sum. Next, the resulting sum is applied to a 6 hertz amplitude detector 260 after which the resulting amplitude is applied to the second digital filter 290 which produces the 16 point running sum. Once the amplitude is filtered by the second digital filter 290, the amplitude is compared to the last maximum and the lens 80 position is stored if appropriate. After the prescription is determined 300, lens control 320 is executed in dependence upon the number of the pass of the continuously variable focus lens 80 across the peak amplitude point. In the first pass lens steps are approximately 0.08 diopter, in the second pass lens steps are approximately 0.04 diopter and in the third pass steps are approximately 0.02 diopter. At the end of the third pass, the prescription is printed directly from the lens position if the lens position can be converted directly into diopter measurements or a simple look-up table can be provided in the computer 30 to convert lens position into diopter measurements.

In alternate configurations, the stepper motor control circuit 50 for the stimulus stepper motor 60 could be decoupled from the computer 30. If the stimulus stepper motor control circuit 50 is decoupled, a phase locked stepper motor control circuit such as described in the related application entitled Phase Locked Stepper Motor Controlled Light Chopper could be driven synchronously with a 60 hertz signal available from a wall socket. A different sampling rate for the A/D converter 150 could also be used. Interchangeable colored filters could be provided for light sources 72 and 73 so that color blindness could be tested. A liquid crystal display could also be substituted for the checkerboard mirror stimulus generator as long as a contrast ratio of at least 60 percent is provided. A faster convergence to the patient's prescription can be obtained by allowing the patient to provide a crude subjective focus via adjusting the focus of the telescope 82; however, it would be necessary to communicate the lens 80 position at the crude focus to the lens control program of FIG. 13. In addition, it is also possible to substitute commercially available light gates or shutters for the stepper motor 180 and chopper wheel 171.

The many features and advantages of the invention are apparent from the detailed specification and, thus, it is intended by the appended claims to cover all such features and advantages of the system which fall within the true spirit and scope of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, as discussed above, it is not desired to limit the invention to the exact construction and operation illustrated and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.