Download 7.2.8 Patient Information - Saint James Hospital Eye Clinic

SMILE procedure
SMILE is the only technique available in the world, wherein the laser surgery is performed without using
any blade and without lifting any flap. In other words, your fear of cutting the cornea with a blade is
absolutely removed by this procedure and at the same time unlike most of the FEMTOSECOND lasers in
the market; we do-not make and lift a corneal flap. Thus the whole integrity of the cornea is preserved and
there are minimal risks involved in this surgery compared to the conventional LASIK or FEMTO LASIK.
What is the SMILE Procedure?
The combination of precise refractive femtosecond laser technology and lenticule extraction marks the start
of a new era in refractive surgery.
Tissue removal instead of ablation
The SMILE procedure bears a great number of advantages compared to conventional refractive correction
methods due to its unique features:
Flapless – creating a small incision rather than a full flap
All-Femto – FS lenticule cutting substitutes excimer tissue ablation
Single step – on laser device, one integrated procedure
Advantages of the SMILE procedure:
• Minimally invasive surgery
• Preserves integrity of upper corneal layers
• Ensures preservation of corneal biomechanical stability
• Less nerves damaged and therefore, less varying severity of dry eye syndrome
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Date: August 2016
Saint James Hospital – Eye Clinic
• Absence of flap eliminates the risk for flap complications such as epithelium in-growth, flap dislocation,
infections and striae.
• Faster healing of epithelium
Eligibility
To be eligible for the SMILE procedure, you must be over 18 years of age and not have had a significant
change in your glasses or contact lens prescription for the preceding twelve months. Other factors, such as
the general health of your eye, will be examined at the preoperative assessment.
Contraindications
• Recurrent eye inflammations or infections
• Excessive corneal disease or scarring
• Degenerative disease of cornea
• Use of certain drugs
• Pregnancy and nursing
• Certain rheumatological conditions (Lupus, Rheumatoid arthritis, Sjogrens etc)
• Severe dry eyes
• Inadequate corneal tissue
• Uncontrolled diabetes
• Pacemaker
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Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
Enhancements
An overwhelming success rate with SMILE achieved in most cases after the initial procedure. However,
due to an individual’s prescription level and unique physiology, an additional treatment or enhancement
procedure may sometimes be required. If this is the case, you would need to return to your original surgeon,
for re -evaluation and if possible for retreatment.
In general, patients must wait at least three months after the first procedure, and complete all mandatory
post-operative appointments, before requesting an enhancement. In majority of cases, the decision about
any need for enhancement can be made at the three- month post-operative visit. You may also be required
to complete an annual eye examination prior to requesting a re-treatment. Whether or not you experience
the need for an enhancement, keep in mind that all patients will eventually require reading glasses as part
of the unrelated and natural aging process of the eye
SMILE – The procedure
Topical Anesthesia
What are the advantages of topical anesthesia?
A topical anesthetic generally works well at preventing you feeling any pain during the operation. It also
gives you pain relief after the operation. It usually has few risks and side effects. This is because it doesn’t
affect any other part of your body, such as your breathing or your heart. People recover more quickly
following surgery under topical anesthetic and can go home on the same day. You can continue to take
any prescribed medicine you are on and may be able to eat and drink as normal.
Who administers the topical anesthetic and how is it given?
Eye surgeons and nurses are trained to administer topical anesthetic using numbing eye drops.
Before the Operation Day
Health Check: The Initial Patient Assessment
You will be asked about:
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General health and fitness
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Medical problems
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Chronic conditions
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Ocular problems
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Diabetes
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Your current medication
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Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
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If you are pregnant
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Allergies
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Smoking
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Alcohol intake
The Day of the Operation
You will receive clear instructions about if you should stop eating or drinking.
You can continue to take most prescribed medication as normal, including up to and on the day of your
operation. If you are taking blood thinning agents, please inform your surgeon. If you have a cough or
heavy cold on the day of the surgery, your operation might need to be postponed.

Please bring any medication you are taking with you to the clinic on the day of your operation so
that the surgeon and nurses can check them out.
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Do not wear any make up, eye creams or face creams
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Do not wear any perfume or after shave
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Wear comfortable loose clothing
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Have someone to accompany you after the surgery
In the clinic
You will be seen by your eye surgeon. Your eye surgeon will check and mark the eye/s that is being
operated on and discuss the operation with you. You will be asked to sign a consent form and your forehead
may be marked on the side of the eye to be operated on.
What happens next?

You may be asked to put on a cap and plastic over shoes. You will keep your own clothes on and
you should wear comfortable clothing that is loose around the neck.

Depending on the type of operation you are having the nurses may give you some eye drops. It is
sensible to use the toilet before you go to the laser suite, so that you can lie still comfortably
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The recovery area nurse will accompany you to the laser suite.
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Safety Checks – Nurses will ask you some questions to check who you are, and what
operation you are having. They will check again with you which eye is being operated on
and check your consent form. This is done to be in line with the latest guidelines issued by
the World Health Organization – Safe Surgery Checklist
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Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
Can I have something to calm me down?
Our doctors and nurses are very used to helping people relax. Sedatives can sometimes make you very
sleepy and slow your breathing during the operation. Please discuss your wishes with your eye surgeon.
What happens in the Laser Suite?
You will be made comfortable on the operating table and the eye surgeon will then give you the eye drops
which numb the eye.
After the local anesthetic is given, your eye will be kept closed to prevent from anything touching and
damaging the surface of the eye.
The Operation
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The nurse will check that you are lying comfortably on the laser table and that your head is
supported.
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Your eye will be cleansed with a disinfectant solution.
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You will be swiveled underneath the Femtosecond laser, you will feel some pressure from the
device and in a few seconds, a lenticule is created, and then removed by the surgeon.
Can I speak during the operation?
It is best not to speak during the laser procedure, however if you want to say something, you will be asked
to move your hand gently and the eye surgeon will stop operating so that you can speak.
Will I see anything?
You will usually be able to see bright lights and you may see some movements during the operation. This
varies from person to person. You will not be able to see any detail.
What if I blink or move?
A small clip keeps your eyelids open so you do not need to worry about blinking. The laser has a tracking
device that allows the laser to follow the movements of the eye with precision.
After the Operation
A nurse will escort you back to the recovery area. Your eye may be covered with a transparent eye shield
until the following day to protect it and stop you from rubbing it whilst asleep. You will be discharged home
after some time. Before you go, the recovery nurse will give you written instructions about recovering from
your surgery, for example what activities to avoid. The nurse will tell you about any medication you need
to take and will show you how to put the eye drops if you are unsure. You will be asked to come back to
the clinic for further follow up appointments.
Will I be in pain?
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Date: August 2016
Saint James Hospital – Eye Clinic
There will be no pain after SMILE, however a sensation of foreign body or excess tears can occur during
the first few hours.
When can I drive?
You will need to ask your surgeon how long you should wait before driving, as it varies from person to
person, however in most cases driving can be resumed after 2 days.
Do I need to take special care?
You will receive individual instructions about the care of your eye, but you should think about the following:
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Avoid rubbing the eye for 4 weeks
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Do no use make up for 1 week
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Do not swim for 4 weeks
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After 1 week you are allowed to run, ride a bike, do aerobics, but wear sunglasses when outdoors
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Avoid strenuous contact sports for 3 months
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Wear sunglasses when in the sun for 2-3 months
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If you are a restless sleeper, wear an eye shield so you can’t rub your eye without knowing when
asleep
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Contact us if you notice worsening of your symptoms, for example if your vision gets worse, if you
develop new symptoms or if the eye becomes painful.
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Avoid very heavy lifting, strenuous exercise and swimming until you get the all clear from your
doctor.
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Take care in windy weather in case you get something in your eye. Sunglasses can give some
extra protection form dust and grit.
Potential Complications
Like any surgical procedure, SMILE involves risk of unsuccessful results, complications or serious injury,
from unknown and unforeseen causes.
Although the vast majority of our patients experience a significant improvement in their vision, neither your
surgeon, nor your optometrist, not the eye clinic nor its staff, can promise or guarantee that the procedure
will be 100% effective or make your vision better than it was before the procedure. During your pre-operative
examination, the likely surgical efficacy outcome (e.g. the chances of you seeing well without glasses or
SJH-EC-PI/frm 007 v1.0
Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
contact lenses after one surgery) will be conveyed to you based on the level of your particular refractive
error.
There is a small possibility that the procedure or a complication arising from the procedure could cause
your vision to be blurred either temporarily or permanently, doubled, distorted, or have halos or other
disturbances, and that these would NOT be correctable with glasses or contact lenses. In the event this
should occur, your surgeon will discuss and offer you advise on further treatment, which may involve
medications and/ or more surgery. If the outcome cannot be corrected by medications or external surface
corneal surgery, the only way of restoring the vision may be a corneal transplant.
However, it is believed that with current techniques and technology, the combined risk of all causes of a
corneal transplant being necessary is approximately one in 20,000 or less.
Halos and Starburst
The SMILE technique is well designed to reduce the incidence of halos and star bursts. However, some
patients do not see clearly at night or dim light and may notice glare and star burst around the lights and
illuminated objects after the procedure.
This may be a temporary phenomenon or rarely a permanent problem. This is more commonly seen in
patients with high levels of short sightedness or long-sightedness and for patients with larger than average
pupil size.
Equipment Malfunction
Rarely the equipment can fail to operate and can produce undesirable result. However our maintenance
standards are equivalent to the best in the world and tested by German technology from Carl Zeiss. The
instrument goes through a testing protocol before each surgery.
Under-or Over Correction
The SMILE surgery corrects precise amount of tissue to correct the desired refractive power. However
rarely under and over correction of results is possible and it may require retreatment or use of glasses or
contact lens.
Light Sensitivity and Fluctuating Vision
The smile technique reduces the chance of light sensitivity and fluctuation of vision in most cases by precise
correction and removal of tissue. But rarely light sensitivity and fluctuation of vision is possible, which will
stabilize in most cases by 1 to 4 weeks. In 1% of cases it may be permanent.
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Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
Dry Eyes
SMILE technique reduces the chance of dry eyes due to less chance of cutting the corneal nerve, since the
corneal flap is not developed in this form of treatment.
However, in some cases dry eyes is possible and it can be treated with eye lubricants or punctual occlusion.
Optical Imbalance
If the surgeon performs the procedure on each eye on different days, in the interim period the eyes may
not be able to balance and focus properly until the procedure is performed on both eyes because there will
be a power difference between the two eyes.
Regression
The cornea is a living tissue and once any part of it is removed to reshape the cornea and correct the
refractive error, it can re-grow and thicken to compensate for the changes in the shape. Therefore some
effect of the correction may decrease over time and patient may require either further treatment or
correction using glasses or contact lens.
Corneal Ectasia
A certain amount of corneal tissue must remain after SMILE procedure. This is believed to relate to the long
term stability of the cornea. In rare instances, less tissue is left and this may lead to bulging of the cornea
thus reversing the intended flattening effect of the treatment, or it can lead to progressive corneal deformity
with thinning and increasing curvature changes, and the cornea can develop an irregular shape. The
progressive corneal deformation is called ectasia, sometime requiring collagen cross linkage or corneal
transplant.
This complication may occur in 1 out of 10,000 cases.
Diffuse Lamellar Keratitis (DLK)
1 in 500 patients experience a temporary inflammatory reaction beneath the corneal surface. This condition
has been called “Sands of Sahara” or diffuse lamellar keratitis also known as “DLK”. The exact cause of
this complication has not been identified, and is likely due to many different factors. Patients with DLK may
not show any symptoms at all or may experience blurred vision and tearing, which can last from several
days, up to several weeks, and which can delay the healing process.
DLK generally can be treated with topical and/or oral steroids, occasionally with possible need for surgical
intervention (the surgeon irrigates beneath the corneal surface).
SJH-EC-PI/frm 007 v1.0
Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic
Some Rare Side Effects
Epithelial in-growth, vascular occlusion, Microscopic corneal surface irregularity, infection, haemorrhage,
blockage and other unforeseen complications which may or may not be directly related to the surgical
procedure, can occur rarely.
Patient Safety:
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Certified laser machine operator will assist surgeon during the procedure
Patient identity checks according to WHO Safe Surgery Checklists
Professional and well trained team with longstanding experience in refractive surgery
SJH-EC-PI/frm 007 v1.0
Authors: Tanya Costa
Date: August 2016
Saint James Hospital – Eye Clinic