Looking Beyond Laser Eye Surgery

Informed consent for the Lentis Comfort Lens

INTRODUCTION

This information is being provided to you so that you can make an informed decision on choosing the Lentis Comfort 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 ageing 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 Multifocal Lens Surgery? A 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 MONOVISION.

 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. Patient initials ……………….. With a traditional ‘fixed focus’ artificial lens you will still need glasses to change your distance of object viewing. The Lentis Comfort lens is a type of lens, designed to produce good distance, intermediate and near vision. Unlike the Accommodating lenses available the Lentis Comfort lens has near, intermediate 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 a lot of good near, intermediate and far vision again without glasses or contact lenses.

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. 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 week after the first eye. You will have the best results if both eyes have this special type of lens. Vision can be strange for the first few days and there may be a flickering light sensation and a crescent shadow on the outer part of the visual field. This begins to settle and vision 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 and we want a slightly different outcome between the eyes as this increases the overall range of vision. We do not expect that you will be completely glasses free but you should be for about 95% of general daily activity. As multifocal lenses split the light, contrast can be reduced a little, so more light is needed when reading especially inside. The light from energy saving bulbs is not that bright. Very small print / embroidery and any prolonged reading will be easier with a little reading glasses addition. The distance of reading is likely to be different from what you are used to so adjustments to your reading distance and work desk are advised. Typically patients use the ‘ready readers +1.5’ for those occasions such as wanting to read very small print, dim light conditions or wanting to hold text closer to them. While there are other stronger multifocal lenses to give you smaller text, they can produce waxy distance vision and troublesome halos and glare and in my opinion the overall satisfaction results from the Comfort lens are superior. In other words all lens results have an area of compromise that has to be accepted but the Comfort lens has an excellent track record from results I have as well as patient and Optician feedback.

It is normal to experience some glare / halos around lights at night and especially with supermarket / artificial lighting but the special smooth design of the Lentis Comfort allows this to be minimal and the degree they are noticed reduces over the first few months while the brain adjusts to this new lens - a concept called neuroadaption. Occasional glasses for night driving may be of help to reduce this further.

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 Lentis Comfort lens do not need glasses for most of their daily activity. The Comfort lens produces a very good result but perfection is just not possible and for this reason these lenses are not for patients who expect perfection. As said above we would expect you to be free of glasses for about 95% of general daily activity.

I have read and understood this page. Patient initials ……………….. PATIENT CONSENT

In giving my permission for use of the Lentis Comfort 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 or refraction outcome differs from predicted. Other refractive surgical procedures such as laser may be able to further correct any astigmatism or refractive error should this be needed.

PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING

The details of the expected outcome of using the Lentis Comfort lens has 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 a Lentis Comfort 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 Multifocal 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 centre where a Multifocal 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 signature …………………………………………………………………

Date ……………………………….

Witness signature …………………………………………………………………

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 lens. I am neither a stockholder in nor paid consultant to any of the companies who produce these Multifocal lenses.

Oliver Backhouse – Consultant Eye Surgeon. Website: www.cataract.org.uk