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					                         Informed consent for the AcriLISA
                                   Bifocal Lens

This information is being provided to you so that you can make an informed decision on
choosing the AcriLISA Bifocal lens.

Around about the age of 45, the changes in your eyes usually follows a predictable course ……
you will develop Presbyopia where you lose your „accommodation‟ - the ability to rapidly and
smoothly focus on far, mid and near-range objects. As the natural “crystalline” lens of your eye
experiences a decline in its flexibility, so you experience a gradual loss of the ability to focus on
near objects. This is because the increasingly rigid lens can no longer focus light rays coming from
close objects (such as letters on a page) to fall on to the retina, so the image sent to your brain is
fuzzy. This is why you need reading glasses or bifocals. Later on, often from your late 50‟s
onwards the effect of cataracts may become noticeable.

What are Cataracts?
Cataracts are a progressive condition where your natural lens becomes cloudy and eventually
opaque. Various conditions may cause cataracts but the most common cause is simply the aging
process: the lens slowly loses its water content and so increases in density. Cataracts become
noticeable in almost everyone over the age of 70. Cataracts develop slowly in most people, and the
gradual deterioration in your vision becomes more noticeable over time. You may notice:
             Cloudy or fuzzy vision.
             Changes in the way you see colours.
             Headlights seem too bright when driving at night.
             Glare from lamps or the sun.
             Double vision.

For patients suffering from Presbyopia and/or Cataract there are now some options that may help
reduce the need for both distance AND reading glasses, possibly on a permanent basis.

Why choose Bifocal Lens Surgery?
A Bifocal / Multifocal lens can be used in any Lens Refractive Surgery including PRELEX
(Presbyopia Lens Exchange) and for Cataract Surgery. The ultimate aim is to give you clear vision
for far, mid and near-range objects without the need for glasses. This type of surgery has
significant advantages over other types of refractive surgery including LASER and
            Removal of your natural lens means you will not develop cataracts as you get older
              – with other types of refractive surgery such as laser you can still develop cataracts
              and/or have a continuing change in your prescription.
            Magnification is at a natural level.
            Full peripheral (side to side) vision.
            Permanent solution to a focusing problem.
            No age limit.
            Use in short-sighted and long-sighted eyes.

                                        I have read and understood this page. Patients initials -----------------

       O.Backhouse                       Page 1                                      08/04/2009
With a traditional „fixed focus‟ artificial lens you will still need glasses to change your distance of
object viewing. The AcriLISA Bifocal lens is a new type of lens, designed to produce good
distance and near vision. Unlike the Accommodating lenses available the AcriLISA bifocal lens
has near and far focus built into the lens design rather than relying on the slightly unpredictable
movement of an Accommodating lens to produce near vision. You are likely to enjoy useful near
and far vision again without glasses or contact lenses. The AcriLISA Bifocal lens has potential
advantages over other Multifocal lenses currently available as it gives good near and far vision in
differing lighting conditions independent of the pupil size as well as reduced glare / halos.

What Results to Expect.
Once the decision that lens surgery will be beneficial to you, your eyes will be measured to
calculate the power of the artificial lens that will give you improved vision. The Yorkshire Eye
Hospital has some of the most advanced technology to allow the highest degree of accuracy when
it comes to measuring your eyes. The microsurgery is performed under local anaesthesia as a day
case procedure through a 2.75mm wound that usually requires no stitches. This allows a rapid
ability to return to work after a few days. The operation risks are the same as for cataract surgery.
The second eye can be done a few weeks after the first eye. You are likely to have the best results
if both eyes have this special type of lens.

The improvement in vision occurs over the first few days and continues to improve over the weeks
and months ahead. Your vision should be clearer and colours brighter.

Not everyone will gain the same result with this lens. There is therefore no guarantee that you will
be completely glasses free. You will experience some halos around lights especially at night but
the special refractive / diffractive smooth edge design of the AcriLISA allows this to me minimal
and the degree they are noticed reduces over the first few months. While this lens has been
designed to see 6/6 (20/20 USA) vision at all distances this can not be guaranteed. Remember,
most people do not have 6/6 vision at all distances yet function quite comfortably. It has been
found that the majority of people who have the AcriLISA bifocal lens do not need glasses for most
of their daily activity.

                                       PATIENT CONSENT

In giving my permission for use of the AcriLISA Bifocal lens, I understand the following:

      I have received no guarantee as to the success of my particular case.
      Risks of the surgical procedure are similar to those of a standard cataract operation.
      Glasses may still be needed afterwards to achieve sharper vision if:
           o I have significant astigmatism.
           o Refraction outcome differs from that predicted.

Other refractive surgical procedures such as laser may be able to further correct any astigmatism or
refractive error should this be needed.

                                        I have read and understood this page. Patients initials -----------------

       O.Backhouse                        Page 2                                     08/04/2009

The details of the expected outcome of using the AcriLISA Bifocal lens have been presented to me
in detail in this document and explained to me by my Ophthalmologist. My Ophthalmologist has
answered all my questions to my satisfaction. I therefore consent to having an AcriLISA Bifocal
lens used on my:

Right / Left Eye

I give permission to my Ophthalmologist to use the data about my procedure and any subsequent
treatment to further understand accommodating lenses and for audit purposes. I understand that my
name will remain confidential, unless I give subsequent written permission for it to be disclosed
outside my Ophthalmologist‟s office or the centre where an accommodating lens was implanted. I
understand that, since it is impossible to state every complication that can occur, the list of
complications explained to me regarding the use of this lens may not be complete.

Patients Name -----------------------------------------------------------------

Date -------------------------------------

Witness Name -----------------------------------------------------------------

Date ------------------------------------

                             I have been offered a copy of this consent form (please initial) ---------

NOTE: Some of this information is taken from company marketing brochures for the
AcriLISA lenses. I am neither a stockholder in nor paid consultant to any of the companies
who produce Bifocal / Multifocal lenses.

        O.Backhouse                           Page 3                           08/04/2009