Facts You Need to Know About LASIK (Laser Assisted In-Situ Keratomileusis) Laser Treatment

 

Patient Information Booklet

Information for patients considering
LASIK surgery for INDICATION

 

 

 

 

Device Name

 

Company, etc.

 

 

 


Table of Contents

 

Section 1 – Introduction

Indications for use

Introduction

 

Section 2 - How your eye works; how the Device works

 

Section 3 – What are the Benefits

Clinical Study to Evaluate Benefits

Patient Demographics

VA without glasses after treatment

VA without glasses after treatment compared with glasses before treatment (Required for wavefront-guided; optional for others)

 

Section 4 – What are the Risks (see page 4 for a typical section)

Contraindications – when can’t you have LASIK

What warnings and other information do you need to know about

Warnings

Precautions

Clinical Study to evaluate risks

VA with glasses after treatment

Change in VA with glasses after treatment

Adverse events and complications

Patient symptoms after treatment (worse and significantly worse)

 

Section 5 - What to expect from the surgery

 

Section 6 - Questions to ask your Doctor

 

Section 7 – Patient Questionnaire

 

Section 8 - Self Test

 

Section 9 - Summary of Important Information

 

Section 10 - Glossary

 

 

 


General Notes on Patient Labeling

 

1.      The above outline is not prescriptive and may be adapted for the individual device and indications and to the sponsor’s ideas of the best ways to do things as long as it is as clear as possible for the patient to understand how the procedure/device works, what are the benefits and risks, and what to expect during and after the surgery.

 

2.      Labeling generally includes a Table of Contents at the beginning and a Glossary at the end.  An index at the end is optional.    It is recommended that different major sections be identified and numbered (Section 1 – Introduction, Section 2 – How the Eye Works, etc.)

 

3.      It is recommended that the Patient Labeling be written as close to 6th grade level as possible.  Ophthalmic terms are defined in the Glossary, or if difficult to define in simple terms are avoided where possible.

 

4.      Words or phrases that are explained in the Glossary are generally identified at each occurrence in the text by highlighting with italics, or bolding, or etc., where possible.

 

5.      Tables are made as “readable” to the uninformed patient as possible.

 

6.      In all tables, or at the beginning of each clinical section, it is explained that “n” is the number of patients treated in each category. 

 

7.      When tables show “lines” lost or gained, it is explained that “a gain of lines” means that patients could read 1 or more rows of letters on the eye chart (visual acuity chart) after surgery that they could not read before surgery.”

 

8.      Contraindications and warnings are the same for physician and patient labeling.  Most of the precautions are the same as those in the physician labeling, although there may be some minor differences and additions.  Contraindications, warnings and precautions in the patient labeling are explained to the patient regarding “why” they may result in a problem.

 

9.      Subjective Patient Complications (questionnaire ratings of symptoms such as glare, halos, ghost images, driving problems, ocular dryness, etc.) are reported in the Risks section with ONLY the columns for “worse” and “significantly worse.” If the sponsor wishes, toward the end of the booklet (perhaps in a section entitled patient questionnaire) they may report the full table of subjective symptoms, including those that improved.

 

10.  The Benefits section includes the results of the clinical trial showing benefits.  The Risks section includes the results of the trial regarding risks, adverse events and complications.


Section 4 – What are the Risks

 

Contraindications—When Can’t You Have LASIK?

 

If you have any of the following situations or conditions you should not have LASIK because the risk is greater than the benefit:

 

    You are pregnant or nursing, because these conditions may cause temporary and unpredictable changes in your cornea and a LASIK treatment may improperly change the shape of your cornea.

 

    You have collagen vascular (e.g., rheumatoid arthritis), autoimmune (e.g., lupus), or immunodeficiency diseases (e.g., AIDS), because these conditions affect the body’s ability to heal.

 

    You show signs of keratoconus or any other condition that causes a thinning of your cornea. This condition can lead to serious corneal problems during and after LASIK surgery.  It may result in need for additional surgery and may result in poor vision after LASIK.

 

    You are taking medications with ocular side effects, e.g. Isotretinoin (Accutane®[1]) for acne treatment or Amiodarone hydrochloride (Cordarone®[2]) for normalizing heart rhythm, because they may affect the accuracy of the LASIK treatment or the way your cornea heals after LASIK. This may result in poor vision after LASIK.

 

What Warnings and Other Information Do You Need to Know About?

 

Warnings

If you have any of the following conditions, you may have LASIK if your doctor evaluates the seriousness of your condition and believes the benefit of having LASIK is greater than the risk.

 

   Diabetes.  If you have diabetes and depend on insulin, LASIK may be risky for you because your diabetes may interfere with the healing of you eyes.

 

   History of herpes simplex or herpes zoster infection that has affected your eyes.  If you have had a Herpes simplex or a Herpes zoster infection that affected your eyes, and have an infection now, LASIK is more risky for you

 

   Symptoms of significant dry eye.  If you have severely dry eyes, LASIK may increase the dryness.  This may or may not go away.  This dryness may delay healing of the flap or interfere with the surface of the eye after surgery.

 

   Severe allergies.  If you have severe allergies and take medicines for them, LASIK is more risky for you.

 

   History of blepharitis (redness along the eyelash line with crusting of the lashes often accompanied by burning, itching and irritation of the eyes).  Blepharitis can increase the risk of  infection or inflammation of the corneal flap after surgery.

 

 

Precautions

It is unknown whether LASIK is safe and effective for the following conditions.  You should discuss these conditions with your doctor.

 

    Unstable eyes that have changed in their visual acuity more than 0.5 diopters in nearsightedness or astigmatism in the last 12 months, and your nearsightedness or astigmatism is getting worse.  If your eyes are unstable, the right amount of treatment cannot be determined. This may result in poor vision after LASIK.

 

    Corneal disease or abnormality (e.g., scar, infection, etc.).  If you have an abnormal corneal condition, such as corneal scars, it may affect the accuracy of the LASIK treatment or the way your cornea heals after LASIK.  This may result in poor vision after LASIK.  If your eyes have an active disease, it is unknown whether LASIK is safe and effective for you.

 

    History of uveitis/iritis of the eye.  The safety and effectiveness of LASIK in patients with a history of inflammation inside the eye has not been established.  Such conditions are often treated with steroids, which can affect wound healing.  Active or resolving disease could affect the measurements upon which the LASIK treatment is based and could affect the healing process.

 

    History of injury or surgery to the center of the cornea (for example, surgery to correct vision such as RK, PRK, LASIK), or other surgery on the eye.  If your eyes are injured or you have had surgery, it is unknown whether LASIK will weaken the cornea too much. This may result in poor vision after LASIK.

 

    Corneas are too thin.  If your corneas are too thin to allow your doctor to cut a proper flap in the LASIK procedure, you can’t have LASIK because it is necessary to have a flap. 

 

    History of glaucoma or have had pressure greater than 23 mmHg inside your eyes, because it is unknown whether LASIK is safe and effective for you.

 

    Take medicines that might make it harder for wounds to heal, such as sumatriptan succinate (Imitrex[3]) used for migraine headaches, because it is unknown whether LASIK is safe and effective for you.

 

    Younger than XX years of age or over 65 years of age, because it is unknown whether LASIK is safe and effective for you.

 

    Nearsightedness is worse than XX Diopters or astigmatism is worse than XX Diopters, because it is unknown whether LASIK is safe and effective for you.

 

    Over the long term (more than X months), because it is unknown whether LASIK is safe and effective for periods longer than X months.

 

    For retreatment with this laser for LASIK, because it is unknown whether LASIK is safe and effective for repeating the LASIK procedure on the same eye.

 

    Undiagnosed dry eyes.  Your doctor should also evaluate you for dry eyes before surgery. You may have dry eyes after LASIK surgery even if you did not have dry eyes before surgery.

 

    Large pupils.  Before surgery, your doctor should measure your pupil size under dim lighting conditions. If your pupils in dim light are ³ XX mm, consult with your doctor about the risk that the surgery may cause negative effects on your vision, such as glare, halos, and night driving difficulty.

 

    Dim lighting, rain, snow, fog, or bright glare.  You might have difficulty seeing in dim lighting, rain, snow, fog, or bright glare.  Whether you may have poor vision under these conditions is hard to predict because it has been studied so little. 

 

    For treatment of more than XX D of nearsightedness or more than XX D of astigmatism. There were not enough patients in the clinical study with more than XX D of nearsightedness or more than XX D of astigmatism to determine the effectiveness and complication rates of this laser with the same reliability as for eyes with less than XX D of nearsightedness or less than XX D of astigmatism.

 

    Any other medications you are taking.  Let you doctor know if you are taking any prescription medicines or any medications you bought without a prescription.

 

 

 



[1] Accutane® is a registered trademark of Hoffmann-La Roche Inc.

[2] Cordarone® is a registered trademark of Sanofi-Synthelabo Inc.

[3] Imitrex Reg TM of Glaxo Group Limited