Affix Patient Label

Date:

Phakic Lens Implant 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. [Please note that in case of invasive procedures (i.e. surgery), the consent of the patient who is unable to read or write shall be witnessed by two persons (Act CLIV of 1997 on Health Care)] 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.

I declare that I am fully informed about the procedure and its risks and complications.

Procedure to be performed under Local / Topical Anesthesia is:

[insert name of procedure and laterality]

______

My doctor informed me about the procedure, the risks and complications and the expected outcomes. Also I was informed about the post -operative management.

The doctor replied to all of my questions fully and properly. I have had enough time to decide which treatment options to choose and lens I would like to choose.

I could ask all my questions and understood all the information and replies I was given. I also know that the exact results cannot be guaranteed.

I am also aware that during and after the surgery, very rarely, complications may occur where my eyesight can deteriorate. Very rarely, there may be other complications that might require another surgery.

In extremely rare cases, the planned procedure has to be modified and very rarely the planned lens implant cannot be carried out.

Surgery risks include reactions to medicines and vision changes. Common side effects include:

  • Redness
  • Scratchiness of the eye
  • Sensitivity to light

These risks are rare and may be outweighed by the potential benefits of restoring your vision.

Other risks:

  • Infection
  • Retinal detachment
  • Increase in eye pressure (glaucoma)
  • Corneal haze
  • Synechiae
  • Cataract formation
  • Surgical re-intervention
  • Loss of 2 or more lines of best corrected visual acuity
  • Loss of endothelial cell density

The phacik lens implant is a method to remove the glasses however it can happen, that the implant has to be removed in the extreme case of a complication directly related to the lens. You may need reading glasses when you reach presbyopic age.

Even after the most accurate intra ocular lens planning is done, it may be possible that you will need glasses to achieve perfect vision.

I understand that even after accurate biometry is done, the final outcome may not be perfect.

I understand that in some very rare cases it may be needed to remove the lens or replace it.

I was informed that my surgeon will update me continuously about my status before, during and after the surgery.

I have the right to refuse any of the treatment offered to me, however I understand that in this case my surgeon will not take any responsibility of the consequence that this might cause.

I am signing this consent form after fully understanding it, free of will and fully aware of my responsibility. Based on this, I give permission to the surgeon to carry out the procedure.

I declare that I am aware of all the conditions and price of the operation.

I understand that the phakic lens implantation will be done under local anesthesia which risks were explained to me fully and properly.

Patient’s 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 nor Saint James Hospital - Eye Clinic to have this procedure. The choice to go ahead is mine based on the benefits and drawbacks, 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 procedure 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 have informed my doctor about all my illnesses that I am aware of, the medications that I currently take, including herbal supplements and also of any allergies that I have.

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/frm009 v1.0

Date: May 2016

Saint James Hospital – Eye Clinic