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The “Measurement Problem” in Achieving On-target Hydrated Power Hydrophilic IOLs
By Dennis Murphy (amended 19 Jan, 2008) A major problem in hydrophilic IOL manufacture is obtaining very high percentages of on-target hydrated power IOLs that have an acceptable MTF as required by ISO 11979-2. The reasons for this are many but they all have in common the “measurement problem”. This subject generates a lot of debate. In order to explore this and see a way through the forest we need to look at the five main factors that determine the final optical parameters of hydrophilic IOLs. 1. 2. 3. 4. 5. The swell factor of the hydrophilic lens material (SF) The refractive index of the hydrophilic lens material (RI) The thickness of the final lens The radii on the two optic surfaces The sphericity of the two optic surfaces

There is no such thing as a perfect measurement – nor is there any such thing as a perfectly homogenous material that has exactly the same properties throughout its bulk. This is not a reflection on the people taking the measurements, or the people who make a given material. It is simply a fact that is governed by the laws of physics. In reality, any series of measurements of a particular property will be characterized by two parameters – the mean average, and a measure of the variation around the average. The variation is usually stated as the standard deviation. In order to get high yields of good IOLs that we don’t have to sort into their hydrated-power bands as required by ISO 11970-2, we need to know both the average value and the standard deviation of the two important material parameters (SF and RI). A common method of manufacturing IOLs is to wax-mount a blank onto a mandrel, then machine the first surface and cut the haptics. The blank is then transferred directly to a second wax-mounted mandrel and the second side of the lens is machined. The lens is then subjected to further downstream processing. Using this method of manufacture you need to be able to measure the dioptric power of each of the optic surfaces while the lens blank is still wax-mounted on the mandrel by using the equation in ISO 11970-2 that relates the radius (and sphericity) to the dioptric power.

D = DF + DB -[ (

TC ) * DF * DB ] N IOL

Where: D = the dioptric power of the IOL DF = the dioptric power of the front surface of the IOL

DB = the dioptric power of the back surface of the IOL TC = the central thickness, in meters, of the IOL N IOL = the refractive index of the IOL optic material
Where

DF

or

DB

is calculated from the equation

DF or DB =
Where:

(NIOL - NMED ) R

N IOL

= the refractive index of the IOL optic material

2

N MED = the refractive index of the surrounding medium R = the radius, in meters, of the front or back surface of the IOL
The swell factor of the hydrophilic lens material One of the major factors involved in getting good yields is knowing exactly how the material swells during hydration. There are a number of aspects to this question. Most of the swell factor of a particular material is the result of the material type itself and the exact process used to manufacture the blanks. However different induced stress levels during the machining and polishing operations involved in manufacturing the IOL can change the swell factor slightly. For this reason the lens manufacturer needs to conduct their own tests to determine the exact SF value for their particular operation. There are different ideas on how this should be done and we will briefly compare two of these techniques below. A popular method is to simply make a number of IOLs (30 to 50) of a particular nominal dioptric power and then measure the resulting hydrated power and from that work backwards to determine what the assumed swell factor was. At first glance this sounds an easy method. However there are problems hidden in this scheme. Looking at Figures 1 & 2 showing the hydrated power versus the Bi-Convex radius and the variation in the swell factor for a 30 diopter and a 10 diopter lens, it is seen that the as-machined radius tolerance on the 30 diopter lens is only 0.050 mm total in order to keep the hydrated power in the required range of 29.50 to 30.50 diopter. Whereas the 10 diopter lens has a radius tolerance of 0.700 mm before the swell factor variations take its hydrated power outside of its tolerance band of 9.70 to 10.30 diopter (Ref ISO 11979-2).

Hydrated Power versus the Bi-Convex Optic Rad. - RI = 1.462
SF = 1.110 Dioptric Power 31.00 30.50 30.00 29.50 29.00 7.350 7.375 7.400 7.425 7.450 7.475 As-machined Optic radius (mm) SF = 1.125 SF = 1.140

Fig 1 – 30 Diopter lens versus radius and swell factor

Hydrated Power versus the BI-Convex Optic Rad. - RI = 1.462
SF = 1.110 Dioptric Power SF = 1.125 SF = 1.140 10.90 10.60 10.30 10.00 9.70 9.40 21.350 21.700 22.050 22.400 22.750 23.100 As-machined Optic Radius (mm)

Fig 2 – 10 Diopter lens versus radius and swell factor

3 The two graphs take into account the variations in the material swell factor but are based on the average value of the refractive index. As will be seen later, even small changes in the value of the RI can move the hydrated power out of the tolerance band. You then have to sort these IOLs and hope you have customers for them before their shelf-life expires. Because higher dioptric powers are much more sensitive to optic radius variations than lower powers, then the sort of swell factor test that we are talking about here needs to be done at the highest dioptric power in your range to give “reliable” results. Doing this sort of test, at say 15 diopter, where the radius tolerance is much greater, will almost certainly lead to significant hydrated power errors at higher diopters. However even doing this type of test on a 30 diopter lens will give very ambiguous results for the actual swell factor. There are still four separate variables involved here – SF, RI, radius value and sphericity. This method does not separate out the dioptric contribution from each of these four factors – and these factors can be significant as we will see. There is a further complication in performing a test such as this. The hydrophilic blank must expand equally in all directions (X, Y & Z) if the expanded hydrated lens form is to remain correct relative to the as-machined lens form (be it spheric – or aspheric). One possible problem that can occur is for the expansion characteristics of the blank material to vary across the thickness of the blank. If one side of the blank expands slightly more than the other side, then the hydrated blank will take on a spherical curve as shown by the yellow cross-sectional view in Figure 3 – instead of the top and bottom surfaces remaining flat. This occurs because of the same mechanism used in a bi-metallic thermostat strip where the material with the greater expansion lies on the outside of the curve and which forces the bi-metal strip to bend due to its greater expansion than the metal on the inside of the curve. The end result of a hydration problem such as this is that the curvature on the outside of the hydrated lens will become steeper, and the curvature on the inside of the bend will flatten out. The effect of these curvature changes will be to influence the actual “effective” hydrated power and MTF of the lens (refer to the section on sphericity)

Fig 3 –Possible differential expansion problem through the blank In order to separate out the effects on the hydrated power from the four parameters that are involved here (SF, RI, radius value and sphericity) two separate tests are needed. First, a few blanks should be fully hydrated to see if they bend. Failure at this initial stage indicates almost certain problems in obtaining the targeted hydrated-power, particularly at higher diopters. The second test should measure the actual physical radial (X &Y) and the axial (Z) expansion of a “suitable number” of IOLs using a non-contact measuring instrument such as a 3-axis measuring microscope. These measurements should be carried out on the as-machined IOLs and then again on the same IOLs after hydration. The differences in size of each lens are then a true measure of the actual expansion. It does not matter what dioptric power the tests are done on as you are taking a direct measurement of the material expansion – not indirectly inferring it from the combined result of four separate factors. This figure can then be used as the scaling factor on the Lathe with absolute confidence that it represents the actual true SF.

4 The thickness of the final lens The thickness of a lens is a part of the thick lens formula. But it has only a minimal effect on the final hydrated power of the lens. As an example, on a 30 diopter lens with a nominal edge thickness of 0.275 mm, a change of plus or minus 0.10mm on the edge thickness only produces a change in the dioptric power of less than plus and minus 0.02 diopters. The as-machined radii on the two optic surfaces The radii on the lens surfaces has a very large effect on the dioptric power of high powered IOLs, but does not have a huge effect at lower powers. As was shown in Figure 1, a change in the asmachined bi-convex radius of only 0.050 mm – in conjunction with the swell factor range of 1.110 to 1.140 – was sufficient to produce a swing in the hydrated power across the full allowed range of 29.50 to 30.50 diopters. To take an accurate radius measurement of 0.050 mm can certainly be done – but it is “not easy”. One of the problems in accurate measurements is being able to trust the figures. As an example, an instrument gives a certain figure of, say, 7.42400 mm for a particular lens radius. Assuming that the instrument has been calibrated, how do we know that is correct as the reference lens used in calibration can be affected by the “lens location” issue covered next. To check the accuracy and precision (repeatability) of the instrument you need to completely remove the reference lens from the measuring instrument – then replace it and take a new measurement – then complete this procedure, say thirty times on the same lens. By doing this you check not only the spread of the measurements inherent in the instrument design – but you also check any errors that arise from any “lens location” errors associated with the work holding fixture. There can be some significant errors associated with the work holding fixture. Unless each separate measurement is slightly different to the previous one – then it can be absolutely stated that “something” is wrong with the setup. You should get a series of measurements that are normally distributed (Figure 4). It is not unknown that the spread of the measurements will approach (or sometimes even exceed) the required total tolerance that you need to measure. In a case such as this, how can you be certain at the end when you go to measure the hydrated power that you will find that all the lenses will fall within the targeted hydrated-power? There can be a number of reasons for these variations. However they are real variations and will be reflected in the final hydrated power of each lens.

Fig 4 – Accuracy versus precision of a measurement The sphericity of the two optic surfaces Unless the polished and hydrated shape of the lens is exactly as specified (spheric or a specific asphere) then two things automatically follow. First the resolving power of the lens will be seriously degraded as parallel incoming light rays will not all focus at a single point. Perhaps less obvious is the fact that the center of the focal range (e.g. point of best focus) of a lens that is not the specified shape will change as Figure 5 shows. This FL change occurs simply because

5 of the relationship known as Snell's Law that describes refraction and involves the angles of incidence on the optic surfaces and the indices of refraction of the two mediums. If the lens shape is not correct, then the “effective power” of a lens with a given optic radius – but whose geometry is not spherical – will be different to the same lens if you adjusted the X-axis offset in order to make it spherical.

Fig 5 – Variations in “effective power” from sphericity errors The “measurement problem” in this case is compounded because you have two surfaces on a lens. Even if the radius is correct on both surfaces, then any small sphericity errors on either or both surfaces will expand during hydration and change the measured power. The question then becomes how reliably and accurately you can measure sphericity. The refractive index of the hydrophilic lens material Like any parameter, RI is characterized by an average value and a standard deviation. These RI variations are on top of the swell factor variations. As can be seen in Figure 6 we show the hydrated power variations for the same 30 diopter lens as in Figure 1, but in this graph we keep the asmachined bi-convex lens radius constant at 7.425 mm and vary the RI.

Hydrated Power versus the Refractive Index - optic rad.= 7.425
SF = 1.110 Dioptric Power 31.00 30.50 30.00 29.50 29.00 28.50 1.459 SF = 1.125 SF = 1.140

1.460

1.461 1.462 1.463 Refractive Index

1.464

1.465

Fig 6 – 30 Diopter lens versus RI and swell factor Actual calculations show that by holding the two optic radii at exactly 7.425 mm and with each of the optic radii exactly spherical (e.g. zero tolerances) we only need a change of 0.001 in the RI to take the hydrated power of the IOL to its lower and upper limits of 29.50 and 30.50 diopters. For the 10 diopter lens in Figure 2 the RI situation is a little better. If we keep to a zero tolerance on the radius (22.400 mm) and exact sphericity, we need an RI change of 0.0042 to swing between the hydrated power limits of 9.70 and 10.30 diopters. It is true that Statistical variations in both the SF and the RI can combine to relieve the situation somewhat where you will get a low value of SF that combines with a high value of RI etc. However anyone who has ever had much experience with “statistical tolerancing” will be well aware of the batches of product that you have to quarantine and make a “matching batch of parts” for because

6 the “The tolerances didn’t all “statistically combine” quite as we expected them to.” Statistical tolerancing is not a reliable production technique and can give some “nasty surprises”. The SF range of the material batch is known but it is not possible to know the exact value for any individual blank unless you hydrate it first. This means that the as-machined optic radius tolerance range must be set to suit the batch SF range – taking into account the RI range. Given this situation, it is desirable to eliminate RI as a variable in the machining and polishing process. This can be done by the addition of an appropriately configured Brewster angle microscope to the lathe for the second-cut surface. The Brewster angle is read by the lathe software and the RI for that blank automatically calculated. This RI value is then used in conjunction with the already known exact radius value of the first-cut surface to calculate the matching radius for the second-cut surface – hence eliminating RI variations from the variable mix. Summary In order to get high yields of on-target hydrated-power hydrophilic IOLs that all meet the minimum acceptable MTF values we need several things. • Material manufacturers should quote the average value and the standard deviation of both the material swell factor and refractive index. • The IOL manufacturer should directly measure the actual physical expansion of the material and not rely on an indirect measurement via the hydrated power of the test batch as that has four separate parameters included in it (e.g. SF, RI, radius value and sphericity) • Measuring instruments should be calibrated and their true accuracy and precision (repeatability) under actual working conditions known and tabulated. • The radius on the second-cut surface of the IOL should be calculated as a function of both the actual polished radius value on the first-cut surface (which is based on the nominal RI) and also as a function of the actual as-measured RI of the particular blank. This enables the optic radii tolerance to be as large as the SF will allow as you have now effectively eliminated the RI as one of the uncontrolled variables in the machining process. Some more to explore Design Issues in Mechanical Tolerance Analysis - ADCATS Report No. 87-5 October 26, 1987 K. W. Chase, W. H. Greenwood Available at: http://adcats.et.byu.edu/Publication/87-5/WAM2.html Polarized Light Microscopy - Brewster's Angle Contributing Authors Mortimer Abramowitz - Olympus America, Inc., John C. Long, Matthew J. Parry-Hill, and Michael W. Davidson - National High Magnetic Field Laboratory Available at: http://www.olympusmicro.com/primer/java/polarizedlight/brewster/index.html +++++++++++++++++++++++++++++++++ END ++++++++++++++++++++++++++++++++++++++++++++