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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. The swell factor of the hydrophilic lens material (SF)

2. The refractive index of the hydrophilic lens material (RI)
3. The thickness of the final lens
4. The radii on the two optic surfaces
5. 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.
TC
D = DF + DB -[ ( ) * 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

(NIOL - NMED )
DF or DB =
R
Where:
N IOL = the refractive index of the IOL optic material
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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 SF = 1.125 SF = 1.140
31.00
Dioptric Power

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)

Fig 1 – 30 Diopter lens versus radius and swell factor

Hydrated Power versus the

BI-Convex Optic Rad. - RI = 1.462
SF = 1.110 SF = 1.125 SF = 1.140
10.90
Dioptric Power

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
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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.
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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 as-
machined 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
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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 as-
machined 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 SF = 1.125 SF = 1.140
Dioptric Power

31.00
30.50
30.00
29.50
29.00
28.50
1.459 1.460 1.461 1.462 1.463 1.464 1.465
Refractive Index
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
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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

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