Download artisian phakic intraocular lens

 ARTISIAN PHAKIC INTRAOCULAR LENS
PATIENT INFORMATION SHEET AND CONSENT FORM
FOR CORRECTION OF MYOPIA
Instructions – Please read each page then place your initials in the margin to confirm that
you understand what is written, then sign the consent in the presence of a witness.
INTRODUCTION
This information has been given to me so that I can make an informed decision about having
eye surgery. I may take as much time as I wish to make my decision about signing this
consent form. I have the right to ask questions about any procedure before agreeing to have
an operation. I am aware that I can obtain a second opinion on the proposed surgery.
My Ophthalmologist has informed me that I am myopic (short sighted) and my vision has
stabilised. After discussing my ocular requirements with my Ophthalmologist and based on
the judgement of my medical condition, my Ophthalmologist believes that I am a suitable
candidate for implantation of the Artisan phakic intraocular lens (IOL).
Detailed records of the procedure are kept and the patient/guardian agrees to these records
being included in any future retrospective clinical outcome research study.
DESCRIPTION OF THE DEVICE
I understand that my surgeon has determined that I am a suitable candidate for a phakic
IOL. This new lens is made from perspex with a design similar to existing intraocular lenses
currently used to correct vision after cataract surgery. The phakic IOL is designed to be
placed in the anterior chamber and clip on to the iris. The phakic IOL is designed to improve
my myopic visual condition.
Potential complications associated with the implantation of an Artisan phakic IOL are:

Iris atrophy

Iris pigment precipitates

Lens not centred

Corneal oedema

Endothelial cell loss

Glare
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
Halos / rings

Glaucoma

Intraocular infection
I understand that the phakic IOL may need to be removed from the eye. Potential
complications of surgery to remove the Artisan phakic IOL include premature cataract
formation, corneal damage, inflammation, infection which could lead to loss of the eye,
damage to the iris and other ocular complications.
I understand that the phakic IOL shall be visible to other people who look carefully at my
eye.
Prior to placement of the phakic IOL, it will be necessary for my Ophthalmologist to make
two small holes in the coloured portion of my eye (the iris) to ensure that the intraocular fluid
does not build up behind the phakic IOL resulting in secondary glaucoma. The potential
complications of this procedure, called a YAG laser iridotomy, include damage to the
crystalline lens, inflammation and transient intraocular pressure rises.
Prior to placement of the phakic IOL, it will be necessary for my Ophthalmologist to make
two small holes in the coloured portion of my eye (the iris) to ensure that the intraocular fluid
does not build up behind the phakic IOL resulting in secondary glaucoma. The potential
complications of this procedure, called a YAG laser iridotomy, include damage to the
crystalline lens, inflammation and transient intraocular pressure rises.
If I have surgery to each eye on different days in order to achieve balanced vision, I
understand that I may need to wear a contact lens in the other eye while waiting for this eye
to be treated with a phakic IOL.
If I undergo bilateral simultaneous surgery – Dr Sebban explained thoroughly risks, benefits
and complications.
I understand that the phakic IOL is a new implant in Australia.
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I understand that without surgery to implant the phakic IOL I am able to wear spectacles or
contact lens and there will be little risks to my eyes associated with those spectacles or
contact lenses.
ALTERNATIVE TREATMENTS
I understand I may decide not to have correctable myopic surgery at all, continuing with
spectacles or contact lenses. However, should I decide to have an operation, I understand
there are alternative treatments for myopia such as laser surgery or radial keratotomy. I
understand that my surgeon will provide me additional information on any or all of these
alternative treatments at my request.
METHODS FOR CORRECTING MYOPIA
Spectacles
Spectacles or eyeglasses, generally made of glass or plastic are the most common means
for correcting refractive errors in humans. However, in patients with severe refractive errors,
the lenses of the spectacles may become relatively thick in order to provide adequate
correction. In such cases the spectacles may reduce the apparent size of objects up to 25%
and may be considered unsightly by the patient of uncomfortable to wear for extended
periods and may distort vision, especially peripheral vision. Patients with severe refractive
errors may experience substantial inconvenience in locating their spectacles once they are
removed. Also, spectacles are generally not appropriate for active patients engaged in
vigorous physical activity.
Contact Lenses
Contact lenses made of hard or soft plastic, silicone or other materials (or mixtures) are
frequently prescribed for patients in need of refractive correction. Handling of contact lenses
is difficult for some individuals and not everyone can tolerate them. Complications from
contact lenses include infection, corneal damage and scarring. While these complications
are infrequent with meticulous daily wear of contact lenses, the rate of complications rises
significantly with extended wear usage or poor usage or poor hygiene and cleaning of
contact lenses.
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Intraocular Lenses
Intraocular lenses (IOLs) are made of a variety of plastics and silicone and are intended to
be placed inside the eye as correction for refractive errors.
The commonest form of IOL is used to replace a cataract (the crystalline lens which has
become opaque) during routine cataract surgery. These IOLs have been used extensively
for more than 25 years and more than 1 million IOLs are implanted during cataract surgery
each year. The strength of these IOLs is adjusted to correct any pre-existing refractive error
in addition to replacing the cataract.
Corneal Surgery
Corneal surgery is based on an attempt to alter the shape of the central cornea overlying the
pupil. The alteration in the corneal shape changes the focusing power of the eye thus
correcting the refractive error. All techniques are limited by predictability, range of refractive
errors correctable and continuing alteration in the shape of the cornea resulting in regression
of effect. Distortion of the cornea can result in astigmatism and scarring may cause reduced
vision and other visual symptoms. The techniques are under continual development and
evaluation for safety and efficacy.
Some currently available techniques are:
1. Radial Keratotomy (RK) involves the making of radial, spoke-like, near full thickness
cuts in the cornea to flatten it in order to achieve visual correction. There are several
methods of performing radial keratotomy but all are done with calibrated diamond
blades.
2. Photorefractive Keratectomy (PRK) uses the excimer laser to vaporise the surface of
the cornea so that when healing has occurred the cornea has a new shape.
3. Laser Assisted In Situ Keratomileusis (LASIK) – a thin flap is cut from the front
surface of the cornea leaving the flap attached at one edge. The flap is then reflected
and the deeper layer of the cornea is reshaped using the excimer laser. The flap is
then repositioned so the cornea has a new front shape.
4. Epikeratoplasty wherein a donor corneal button is shaped rather like a small contact
lens then sutured onto the front of the cornea.
5. Intracorneal rings wherein a hard plastic ring is inserted into a pocket in the cornea
created by the surgeon.
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By signing this document in the space provided I indicate that I give my permission for
surgery involving placement of a phakik IOL in my right and/or left eye. PLEASE circle
whether either/or both if consenting for bilateral simultaneous surgery.
Patient’s Name ____________________________________________________________
Patient’s Signature _________________________________________________________
Date _________________________________________ Time _____________________
Place ___________________________________________________________________
Witness Signature ________________ Ophthalmologist’s signature ________________
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