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.