while the present invention will be described more fully hereinafter with reference to the accompanying drawings , in which particular embodiments are shown , it is to be understood at the outset that persons skilled in the art may modify the invention herein described while still achieving the favorable results of this invention . accordingly , the description which follows it to be understood as a broad teaching disclosure directed to persons of skill in the appropriate arts and not as limiting upon the present invention . in a first embodiment best shown in fig1 , 2 and 6 - 8 , referred to herein as the “ full eye illuminator ” the apparatus according to the present invention broadly comprises an illumination means 100 and a means for observing the specularly reflected light 200 . a second embodiment best shown in fig3 a , 3 b , 5 a - 5 c and 9 - 11 , referred to herein as the “ half eye ” illuminator is shown . the mode of operation of the two embodiments is substantially identical and they will therefore be described together using the same reference numerals and where differences between the embodiments occur , they will be discussed . the illumination means 100 for directing light to the lipid layer of the patient &# 39 ; s eye comprises a large area broad spectrum light source covering the visible region and being a lambertian emitter adapted to be positioned in front of the eye on a stand 300 . as employed herein the terms “ lambertion surface ” and “ lambertian emitter ” are defined to be a light emitter having equal intensity in all directions . the light source comprises a large surface area emitter , arranged such that rays emitted from the emitter are specularly reflected from the lipid layer and undergo constructive and destructive interference in the lipid layer . an image of this surface is the backdrop over which the interference image is seen and it should be as spatially uniform as possible . the illumination means 100 illuminates a large area of the face which creates a 2 . 5 mm high by 5 mm long viewable area centered beneath the pupil 310 ( see fig1 ) which is adequate for lipid layer thickness determination and correlation to dry eye . by “ viewable area ” it is meant the active area that satisfies the criteria for viewing interferences fringes ; i . e ., approximately 2 . 5 mm × 7 mm for the half eye illuminator . full - eye illumination , excluding the pupil area , reveals additional information about the whole eye pattern of lipid distribution . the geometry of the illuminator 100 can be most easily understood by starting from the camera lens and proceeding forward to the eye and then to the illuminator . the fundamental equation for tracing ray lines is snell &# 39 ; s law : where n is the refractive index of the medium containing the ray , and θ = the angle of the ray relative to the normal from the surface . for a reflected ray that doesn &# 39 ; t enter the lipid layer , n 1 = n 2 , and under these conditions , snell &# 39 ; s law reduces to the classical “ angle of incidence is equal to the angle of reflectance ” statement . according to the present invention , it is necessary to determine only the extreme rays ( the ones at the outermost boundary of the desired viewing area ) to define the area of the illuminator . since the surface of that portion of the eye to be examined is approximately spherical , a line drawn from the camera lens ( or the observer &# 39 ; s eye ) to the edge of the viewing area on the observed eye will reflect at the same angle on the other side of the line normal to the eye surface at the point of intersection of the line with the eye . when the half eye illuminator used , it may be tilted to better accommodate the nose and illuminate a larger area of the inferior lipid layer . notwithstanding the foregoing , experimentation using the half eye illuminator has shown that a tilt of 10 ° to as much as 30 ° is still functional . returning now to the full eye illuminator , as best shown in fig1 and 2 , it will be seen that facial features block some rays from reaching the surface of the eye . the nose , cheeks , eyebrows , and eyelids block rays , causing shadows on the eye surface . positioning the illuminator for maximum area exposure is unique to each patient &# 39 ; s facial structure . the mechanical dimensions ( height and width ) of the illuminator may be extended to cover the biometric range of facial features of the target population . the illumination means 100 is a broad spectrum light source covering the visible region between about 400 nm to about 700 nm . in the model that was constructed , high efficiency , white light emitting diodes (“ leds ”) 120 were used that have a 50 ° forward projection angle , 2500 mcd typical intensity , and 5 mm diameter ( part number nspw510cs , available from nichia corporation , wixom , mich .). other leds could be added to the present invention to enhance the spectral width in the near uv or near ir regions . the light emitting array platform 130 ( fig6 , 7 ) into which the leds are mounted had a curved surface , subtending an arc of approximately 130 ° from the optical axis of the eye ( see fig5 a ). approximately 96 leds spaced apart in a grid pattern with 6 rows and 16 columns were connected in parallel / series combinations and connected to an appropriate power supply , well known to those skilled in the art and therefore , not shown . a housing is formed around the led array platform 130 by a pair of side panels 135 , bottom and top panels 140 , rear panel 145 and the diffuser means or diffuser 150 . the respective diffuser 150 , led platform 130 , and rear panel 145 are flexible and fit within grooves 147 located in the top and bottom panels 140 and the end pieces 135 . the entire assembly is snapped together and the side panels 135 are then screwed to top and bottom panels 140 . while the illumination means 100 illustrated in the figures is curved or arcuate and has a radius of 7 . 620 inches from the center of the eye under examination , it could be flat as long as it subtends 130 ° around the eye . a curved surface is more efficient in doing this , as the geometry yields a smaller device which is easier for the practitioner to use in a clinical setting . the total power radiated from the illuminator 100 must be kept to a minimum to prevent accelerated tear evaporation . in addition , air currents generated by heating or cooling systems can also cause excess evaporation and must be minimized ( preferably eliminated ) to maintain measurement accuracy . the brightness , or intensity , measured in μw / mm 2 , entering the pupil can cause reflex tearing , squinting , and other visual discomforts , all of which affect measurement accuracy . for a full - eye illuminator , the curved lambertian emitter includes a centrally positioned hole defining an opening 160 through which the means for collecting and focusing the specularly reflected light , i . e ., a camera , eye , or other lens 200 , is positioned . the opening 160 in the center substantially prevents direct illumination from entering the pupil of the test eye . while less than optimal , the opening 160 could be located in other parts of the illuminator . the other eye , however , has the full light intensity entering the pupil . if the illumination intensity is low enough , the exposed eye does not react . the exposed eye may also be occluded with a mask , or the illuminator may be segmented so that parts of the surface are not illuminated . the half - eye illuminator stops below the centerline of the eye and does not directly illuminate either pupil or stated otherwise , light rays can only enter the pupil obliquely and do not impinge on the retina . the current full - eye illuminator has a brightness or illumination intensity of between about 3 μw / mm 2 and 15 μw / mm 2 with about 4 . 5 μw / mm 2 at the surface of the illuminator being preferred , which is held 1 - 2 inches from the eye . the total radiated power is less than 1 w and preferably no more than 400 mw . brightness above about 6 μw / mm 2 becomes uncomfortable to the second eye if it enters the pupil so as to impinge directly on the retina . the front surface of the illuminator is the lambertian emitter , i . e ., all points on the extended illuminator surface are lambertian emitters , and comprises a flexible white translucent acrylic plastic sheet 150 approximately 1 / 16 inch thick that serves the function of diffusing the light emitted from a plurality of led point sources and transforming them into the uniform lambertian emitter in order to prevent alteration of the proprioceptive senses and reduce heating of the tear film , it is important to minimize the incident power and intensity on the eye and thus , the means for collecting and for focusing the specularly reflected light such as a high sensitivity color camera 200 should be employed . the video camera , slit lamp or other observation apparatus 200 is positioned in opening 160 and is also mounted on stand 300 as shown in fig2 or in the case of the half eye illuminator positioned above the emitter as per fig3 a and 3 b . detailed visualization of the image patterns requires a means for collecting the specularly reflected light and for focusing the specularly reflected light such that the interference patterns from the lipid layer are observable . good digital imaging requires a ccd video camera having a resolution of up to 1280 × 1024 pixels and at least 15 hz frame rate to show the progression of lipid interference patterns as they spread across the eye . the avt dolphin 145c , ⅔ inch , ccd camera with 6 . 45 μm 2 pixels meets the requirements and outputs a signal representative thereof which may serve as the input signal to any one of a number of devices such as a video monitor ( preferably high resolution ) or a computer for analysis and / or archiving purposes . the lens system employed in the instant tear film analyzer images a 15 - 40 mm dimension in the sample plane ( the eye ) onto the active area of the ccd detector ( e . g . about . 10 mm horizontal dimension for a ⅔ in . ccd ). the lens f - number should be as low as practical to capture maximum light and minimize the illumination power needed for a good image . the lens chosen for the half - eye and full - eye systems is the navitar zoom 7000 close focus zoom lens for ⅔ in . format ccds . at lower magnification ( 25 - 40 mm field of view ), the eye and lids can be examined to observe the relationship of the blink to the lipid layer thickness . a more detailed analysis of the lipid layer can be obtained with a slightly higher magnification showing a 15 - 25 mm field of view . the lipid layer thickness is not uniform and is classified on the basis of the most dominant color present in the interference pattern . it is believed that the lipid layer for most individuals cannot exceed 180 nm , and since thicker lipid layers provide better protection from evaporation than thinner lipid layers , thicker lipid layers provide greater protection against the development of dry eye states . thinner lipid layers are associated with dry eye states and dry eye symptoms , particularly if the lipid layer thickness is less than 75 nm . the present system displays the interference patterns from white light incident on the lipid layer film . the relation between the colors of the interference pattern and the lipid layer thickness ( llt ) are shown in table 1 . extensive research has established that thicker films are indicated by a blue and brown color , mid - thickness films are indicated by a yellow color , thinner films are indicated by a grey - yellow color , and very thin films exhibit a gray scale of different densities with white representing the thinnest . it is believed in color photometry , brown can be obtained in an additive process by mixing small intensities of red and green , or orange and blue , basically the opposite ends of the visible light spectrum . alternatively , brown can be obtained in a subtractive process by filtering out the central yellow - green colors from the white spectrum , leaving a blue - orange mix . it has not been verified why the wavelengths of light observed in the interference film are inverse to the film thickness , but extensive clinical testing has led the inventors to the belief and the theory that destructive interference is the dominant process . the closer the wavelength is to the film thickness , the greater the interference , so yellow - red interference will have the strongest effect in a thicker film . however , thicker films appear blue , so it is postulated that red wavelengths are removed from the incident light spectrum by destructive interference and the reflected light appears blue . for a thinner film , blue will have a stronger interference . since the thinner films appear reddish , it is assumed that the blue is removed by destructive interference . from this , we assume that the color seen is the broadband surface reflection with the dominant interference color band removed . that is , interference subtracts the portion of the spectrum indicative of the film thickness from the reflected light , leaving the complementary colors . this is the best explanation known to the inventors of how brown is obtained from a system of this type . table 1 lists the colors of the visible spectrum and their respective wavelengths . it must be noted that the thickness of the lipid layer on the eye is much smaller than all the wavelengths of visible light . therefore , full wavelength interference patterns are believed not to be possible . for fractional wavelengths , ( λ / 2n , n = 1 , 2 . . . ) the intensity in the interference pattern decreases rapidly as n increases and the ability to differentiate weak interference patterns from the background decreases accordingly . when the lipid film thickness falls below about 90 nm , no color is seen in the image generated by the present apparatus ( employing the current led light source ), only gray of varying density . it is presumed that violet and ultraviolet interference effects predominate at this thickness , but since they are absent from the incident spectrum , no color can be seen . any interference remaining over the visible light spectrum is so weak due to the very small fraction ( λ / 2n , n & gt ; 5 ) that full - spectrum reflection and absorption effects dominate and no particular color can be seen . broadband destructive interference in the 60 - 75 nm layers gives way to broadband constructive interference at the thinnest layer (& lt ;= 30 nm ). in summary , it is believed that the present invention demonstrates the results of subtractive colors , where subtracting the blue end from white light leaves a reddish tint , subtracting the center ( yellow - green ) from the spectrum leaves a brownish tint , and subtracting orange - red leaves a blue tint . because all the interference patterns are fractional wavelengths , and therefore relatively weak in intensity , the images are not strongly saturated . image enhancement techniques therefore assume a higher importance for good visibility . film thickness below about 90 nm can be determined by gray scale analysis . should the use of real time or high speed data transfer and large storage volumes be required for a given application , the use of a means for recording the output signal representative of the specularly reflected light ( video output signal ) such as a high performance computer system would be needed . as employed herein , the term “ real time ” is defined as data transfer , storage and retrieval at a rate required for image generation that the observer requires for a subjectively satisfactory viewing experience . for viewing the motion of the lipid layer interference pattern after blinking a minimum of about 15 frames per second is satisfactory for seamless motion perception . depending upon settings , the camera can create 1 . 4 - 3 . 9 mb images at 15 per second , or 21 - 57 mb / sec which must be processed by the computer for storage , display , or computation . at this rate , one minute of recording requires 1 . 26 - 3 . 42 gb of storage . given the presently available technology , it is not reasonable to store recording sessions in ram , so the data from the camera must be streamed directly to a storage system sized to meet the anticipated volume of data . for example , 500 gb of storage could record 147 - 397 tests of one minute duration . various forms of data management could be applied to reduce the storage requirements , including image size , compression , and minimizing recording time adequate to good diagnostics . the software to operate the camera , capture the images , store and retrieve image files , and execute chosen calculations on the data is critical to the success of the system . relevant specifications are : the mechanical system consists of components to position the patient &# 39 ; s head , position the illuminator and camera , focus the camera , and switch position between eyes . current ophthalmic chin rests are adequate for positioning and restraining the head . they include vertical ( z axis ) adjustment . a movable frame positions the camera and illuminator opposite the patient &# 39 ; s face . the illuminator and camera move together in a gross manner , but the illuminator has an independent x and rotational motions for accommodating different facial geometries . switching from eye to eye requires moving the whole camera / illuminator frame away from the patients face ( x motion ) and horizontally to line up with the second eye ( y motion ). focusing the camera requires fine control of x motion , and vertical z motion is required to accommodate differences in patient eye positions . a classical slit lamp biomicroscope stand incorporates most of these motions , and have added angular motions not needed in the present system . fig1 , 2 , 3 a - 3 c illustrate the full - eye system . a typical examination session proceeds as follows : presets : the vertical relationship between the camera and the illuminator is set . for a half - eye illuminator , the camera position is just enough higher than the illuminator top edge that the image contains no edge effects . when using the full - eye illuminator , the camera is positioned coaxially with the hole through the illuminator . the camera / illuminator position should not need adjusting thereafter . 1 . the patient is seated and asked to place their chin on the chin rest . the chin rest is adjusted ( z axis ) for the comfort of the patient . the patient is asked to hold their forehead against the forehead rest . 2 . the frame holding the camera & amp ; illumination is positioned on the axis of the first eye and brought close enough for rough focus on the skin . 3 . the frame is adjusted for vertical and horizontal centering , and then moved forward for fine focusing . 4 . the illuminator is adjusted forward and back , and rotated for best illumination of the eye . repeat fine focus as necessary . the patient is asked to look directly at the center or top center of the camera lens . instructions are given to the patient for blinking regimens by the diagnostician . 6 . the frame may be pulled away from the patient ( to clear the nose ) and moved horizontally to the next eye . steps 2 - 5 are repeated . the system could be fully motorized and operated in manual , semi - autonomous , or autonomous modes , depending upon the sophistication of the control software . a fully automatic system would adjust the mechanical stand , focus the camera , record the motion of the lipid film , calculate various measurements of the film structure , report an assessment of the quality of the lipid film , and record the data in the patient &# 39 ; s record file . the invention having been thus disclosed , diverse changes and variation in the apparatus and method will occur to those skilled in the art , and all such changes and modifications are intended to be within the scope of the invention , as set forth in the following claims :
the invention comprises an apparatus for measuring the relative thickness of the lipid layer component of the precorneal tear film on the surface of an eye after distribution of the lipid layer subsequent to blinking is disclosed . an illuminator directs light to the lipid layer of a patient &# 39 ; s eye . the illuminator is a broad spectrum light source covering the visible region and is a lambertion light emitter such that the light source is specularly reflected from the lipid layer and undergoes constructive and destructive interference in the lipid layer . a collector collects and focuses the specularly reflected light such that the interference patterns on the tear film lipid layer are observable . the collector also produces an output signal representative of the specularly reflected light which is suitable for further analysis , such as projection on to a high resolution video monitor or analysis by or storage in a computer . in order to facilitate ease of measurement , the patient &# 39 ; s head may be positioned on an observation platform when the illuminator directs light to the lipid layer of the patient &# 39 ; s eye .