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FEMTOLASIKAGREEMENT & CONSENT FORM

Please take time to read and understand this form thoroughly before signing it.

This form is a legal document that requires your signature before you can be accepted for treatment. It is signed by you and the treating doctor, and is witnessed at the clinic on the day of the procedure. This form gives the doctor the right to treat you and it will cover all subsequent treatments. This form is given to you at least 24 hours prior the treatment so you have ample time to reconsider your procedure.

ALTERNATIVE METHODS OF CORRECTING VISION

Contact lenses and spectacles provide correction for long-sight, short-sight and astigmatism. There are several techniques which can improve vision without spectacles or contact lenses. One technique is FemtoLasik (Femtosecond Laser Assisted in -situ Keratomileusis).

Procedure to be performed under Topical Anesthesia is:

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FEMTOLASIK REFRACTIVE SURGERY

This form lists the alternatives available to you and the known complications. It is given so that you can make an informed decision about having FemtoLasik treatment to correct or modify your short sight, long sight or astigmatism. This information aims to produce a balanced view of FemtoLasik and risks involved.

FemtoLasik

A flap is created using a femtosecond laser device, the flap is lifted by the surgeon, and then excimer laser is performed to reshape the cornea. Anaesthetic eye drops will be instilled in your eyes and you may be offered a sedative tablet. The procedure is completely pain-free however you might feel a slight pressure during the creating of the flap.

For the surgery you are required to lie flat and look into a blinking light. If you accidentally move, the inbuilt tracking device will follow the movement of your eyes and laser will still be done precisely.

Following the surgery, you will be prescribed antibiotic eye drops and anti- inflammatory eye drops and you will be able to go home. Vision is usually restored immediately but in some cases, it might take from 24 to 48 hours. It is important not to rub your eyes and avoid water getting into your eyes. You will be able to resume your work after a couple of days.

The following points are understood:

  • You are fully informed of the advantages and disadvantages and have realistic expectations of the procedure. The doctor decides the treatment protocol, dosage and all aspects of aftercare.
  • The FemtoLasik procedure requires the use of sophisticated electrical equipment and thus as with all electrical instrumentation, it is susceptible to system malfunctions that can be beyond our control, nonetheless, Saint James Hospital - Eye Clinic will be taking all necessary precautions and preparations to ensure patient safety.
  • The FemtoLasik procedure is done to reduce or avoid the wearing of spectacles or contact lenses.
  • FemtoLasik is a surgical procedure and like all surgery it is dependent on the doctor’s skill and is not risk free. The doctor is required to make detailed records of consultation, treatment and any advice given. Medical records are held by Saint James Hospital - Eye Clinic on behalf of the doctor and the patient.
  • The results of FemtoLasik appear to be permanent but owing to natural changes of eyesight with age or illness, the need for spectacles may arise in the long term.
  • Possible complications:
  • Regression of refraction
  • Over or under correction
  • Difficulties relating to fitting of contact lenses if needed
  • Dry Eyes that might take some weeks to resolve, artificial tears will be prescribed
  • Incomplete flap, treatment will be repeated after few weeks
  • Short term complications:
  • Droopy eyelids
  • Double vision
  • Haze
  • Induced astigmatism
  • Glare or haloes
  • Serious complications are rare. Infection, though very uncommon, can occur and fortunately can be treated with antibiotic medications but there may be scarring of the cornea requiring a remedial retreatment or even surgery.
  • Corneal Ectasia is a very rare complication of flap surgeries, however since a high precision thin flap is made with a femtosecond laser, the incidence of ectasia has been completely minimized.
  • Discomfort and imbalance may be felt if only one eye is treated and headaches and dizziness are not uncommon, together with the impairment of judging distances, interference in reading, driving and sports.
  • Should an adverse event occur, such as intense pain, swelling, irritation, infection, it is your responsibility to contact us immediately. Patients should stop taking medication or ointment if an allergic reaction occurs. PATIENT MUST NOT RUB OR TOUCH THEIR EYES after surgery.
  • Visual sharpness is measured by the smallest letter readable on the eye test chart using lenses as necessary. The laser is programmed for very precise degrees of correction, however everybody responds differently to the treatment, which can result in over or under correction or induced astigmatism.
  • Since it is impossible to state every complication which may occur, this list remains incomplete and is adjourned frequently so as to provide the patients with the latest results coming from all over the world.
  • Secondary treatment to the same eye if necessary, may be possible, but it may carry additional risks
  • Although overall results show a very high degree of patients’ satisfaction, it is not possible to predict a result for any single individual.

Patient Declaration

I have been advised that I should take as long as I wish before consenting to the procedure and I am not under any pressure by either the doctors or Saint James Hospital - Eye Clinic to have this treatment. The choice to go ahead is mine based on the benefits and risks, as explained to me both in verbal and written form.

I have also been informed that I can withdraw my consent at any time during the process and that the doctors will act in my best interest.

I understand that a sedative may be given to me before the treatment commences. On signing this form I am not under the influence of any drugs / medication and have not yet had any eye drops administered.

I am satisfied that all of the above has been fully explained and is understood.

Patient’s Signature: / Patient’s Name in Block:
Date: / Time:
Legal Guardian/Representative/Parent Signature: / Legal Guardian/Representative/Parent Name in Block:
Relationship to the Patient: / Date:
Time:
Second Witness Signature: / Second Witness Name in Block:
Relationship to the Patient: / Date:
Time:

Interpreter’s Statement

I have interpreted the information to the best of my ability, and in a way in which I believe the patient can understand:

Interpreter’s Signature: / Interpreter’s Name in Block:
Date: / Time:

Treating Doctor’s Declaration

I have discussed the contents of this form with the patient and I am satisfied that they understand the meaning of the technical terms which it contains, the nature and purpose of the procedure and the side effects and possible complications that are described. I agree to accept this patient on the above terms and provide treatment as set out above.

Treating Doctor’s Signature: / Treating Doctor’s Name in Block:
Date: / Time:

Withdrawal of Patient Consent:

If the patient has withdrawn consent please ask the patient to sign here

Patient’s Signature: / Name of Patient in Block:
Treating Doctor’s Signature: / Name of Doctor in Block:
Date: / Time:

Code: SJH-EC-CL/frm 001 v1.0

Date: May 2016

Saint James Hospital – Eye Clinic