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1.
Does
NearVision
CK have FDA approval?
In March 2004 the US Food and Drug
Administration (FDA) granted approval of the
ViewPoint CK System for performing the
NearVision
CK procedure. It is the first and
only FDA approved vision technology that
improves near vision in the millions of baby
boomers with presbyopia, the age-related eye
condition that sets in after age 40. Since
approval in March thousands of NearVision
CK
procedures have been performed worldwide which
clearly demonstrates the patient demand for a
vision correction procedure to help eliminate
dependence on
reading glasses, and the procedures safety and
effectiveness.
2. How is NearVision
CK performed?
NearVision
CK uses radio waves, instead of a
laser or scalpel, to reshape the cornea and
bring near vision back into focus. NearVision
CK
is performed using a small probe, thinner than a
strand of human hair, that releases radio waves.
The probe is applied in a circular pattern on
the outer cornea to shrink small areas of
collagen. This circular shrinkage pattern
creates a constrictive band (like the tightening
of a belt), increasing the overall curvature of
the cornea. The procedure, which takes less than
three minutes, is done in-office with only
topical anesthesia (eye drops).
3.
Will
you be cutting the cornea?
No. NearVision
CK is performed without the
cutting or removal of tissue. It is a safe,
minimally invasive procedure for baby boomers
who struggle to read a newspaper, menu, alarm
clock or computer.
4.
Is
radiofrequency (RF) energy safe for use on the
eye?
Yes.
The use of RF energy is one of today's most
advanced surgical techniques. In addition to its
use in NearVision
CK, RF technology is being
used in prostate cancer therapy, back surgery,
even cardiovascular procedures.
5.
Will
my vision improve immediately after the
NearVision
CK procedure?
Patients usually notice an immediate improvement
in their near vision after the NearVision
CK
procedure. However, it usually takes several
weeks for the eyes to adjust to the final level
of treatment.
6.
Will
my vision fluctuate after NearVision
CK is
performed?
Most patients will experience mild fluctuations
in their vision after the procedure. This
fluctuation usually subsides within a few
weeks. It is important to understand
that there is a stabilization period following
NearVision
CK. This period influences some
patients' vision more than others. The treated cornea is
reshaping and adjusting itself. Most
fluctuation occurs in
the first two weeks, but the eye will continue to
stabilize beyond that for up to one to three months or more.
This stabilization varies from patient to
patient.
7. Do I need to have one
eye treated or two; and if I have both eyes
treated will they be done on the same day at the
Honolulu Eye Clinic?
NearVision CK is
typically performed on one eye. These patients
usually have the non-dominant (or weaker) eye
enhanced for near vision by CK treatment. About
30 percent of the time, however; both eyes need
to be treated. These patients may have some
distance correction that needs to be treated
also by CK so that the two eyes work will
together comfortably following the procedures.
When both eyes require treatment, the eye that
will have the better distance vision will
generally be treated first. This will lessen any
disturbance to your distance vision as sometimes
happens when both eyes are done at the same
time.
In some cases however, both eyes may be treated
at the same time. If this is done, the patient
may go through a temporary period of blurry
distance vision. This may require temporary
distance glasses to be used until the healing
results in clearer distance vision.
8. NearVision
CK
achieves "Blended Vision". What does that mean?
CK takes advantage of a technique called "Blended
Vision". Unlike monovision, where one eye is
treated for near vision, leaving the untreated
eye for distance vision, "Blended Vision" improves
your ability to focus on near objects without
dramatically affecting distance vision in the
treated eye. Data collected in FDA clinical
trials on the procedure have shown relatively
little effect on depth perception and the
ability to distinguish contrast under day and
night conditions.
9. Can CK be performed on
eyes previously treated by LASIK or after
cataract surgery?
Yes. Performing CK after
cataract or LASIK surgery is an acceptable
“off-label” practice. When a drug or device is
approved for medical use by the U.S. Food and
Drug Administration (FDA), the manufacturer
produces a “label” to explain its use. Once a
device/medication is approved by the FDA,
physicians may use it “off-label” for other
purposes if they are well-informed about the
product, base its use on firm scientific method
and sound medical evidence, and maintain records
of its use and effects.
LASIK or cataract surgery patients often develop
the need for reading glasses following those
procedures. Many doctors throughout the US and
abroad are already using CK for patients
following LASIK and cataract surgery.
10.
Will
I have to wear a patch over my eye after the
NearVision
CK procedure?
No, you will not have to wear patches or
bandages.
11.
How
soon can I return to work?
With NearVision
CK, the majority of patients are
able to return to work and other normal
activities the day after their procedure.
Although recovery is fairly quick, it is
advisable to be careful with your eyes and to
avoid any strain. Those whose jobs demand
intense clarity of vision (such as dentistry,
surgery or computer work) may want to give their
eyes some extra rest for several days following
the procedure before going back to work.
12.
What
will I feel during the NearVision
CK procedure?
The NearVision
CK procedure is considered
painless. You will be aware of an eyelid support which
helps to hold your eye open (lid speculum). The most
common sensation that patients experience is a
feeling of pressure on the eye. After the
procedure, there may be some mild discomfort. Many patients experience a foreign-object
sensation or "scratchiness" in the
eye. This usually subsides within 24 - 48 hours
of the procedure.
13.
What
type of anesthesia is used during the NearVision
CK procedure?
A local anesthetic in the form of eye drops is
used to numb the eye.
14. Why doesn't NearVision
CK use a laser?
NearVision
CK is a non-laser procedure that uses
controlled radio waves to improve near vision.
Rather than removing tissue with a laser,
NearVision
CK reshapes the cornea using an
entirely different method: the application of
low-level, radiofrequency (RF) energy applied in
a circular pattern on the outer cornea, to
shrink small areas of corneal tissue. This
circular pattern acts like a belt tightening
around the cornea to increase its overall
curvature and temporarily improve near vision.
The procedure, which takes less than three
minutes, is done in-office with only topical
anesthesia (eye drops).
15.
Will
the instrument used in the
NearVision
CK
procedure penetrate my cornea?
NearVision
CK is performed using a probe (Keratoplast™
Tip) that is as thin as a strand of human hair.
The probe, introduced into the cornea, applies
controlled radiofrequency (RF) energy,
stabilizes the CK procedure and guarantees the
precise depth of treatment.
16.
What
are the risks and side effects of NearVision
CK?
Because NearVision
CK is minimally invasive, the
procedure has exhibited very minimal risk and
almost no side effects. During the first 24 to
48 hours after NearVision
CK, you may experience
tearing and some discomfort, including a
foreign-object sensation in the eyes. You may
also experience initial slight over-correction
of your vision, which stabilizes during the
following weeks. However, because NearVision
CK
doesn't cut or remove tissue, many of the side
effects associated with other vision treatment
procedures have not been observed with
NearVision
CK.
17.
Are
there restrictions after having NearVision
CK?
As with any vision treatment procedure where the
cornea is altered, certain precautions should be
taken. After the NearVision
CK procedure,
patients should avoid getting contaminated water
in their eyes for at least one week. This
includes water from swimming pools, spas, lakes
and the ocean. When showering or taking baths,
patients should keep their eyes closed in order
to avoid getting soap and dirty water into their
eyes. When exercising, sweat should be kept out
of the eyes for at least a week after the
procedure. Also, patients should avoid rubbing
their eyes vigorously for two weeks following
the procedure. Patients should avoid
applying eye makeup for three days after the
procedure.
18.
Am
I guaranteed 20/20 vision following NearVision
CK?
No doctor can absolutely
guarantee a certain result from any vision
treatment procedure. However, in the FDA
clinical study, nearly 87% of patients had 20/20
vision while looking at objects in the distance
and were able to read phonebook-size print (J3)
after having NearVision
CK (12-month follow-up
data).
19.
How
long will the improvements from NearVision
CK last?
Currently, no one knows exactly how long the
treatment will last. It varies from
patient to patient because of eye anatomy
differences. CK patients are encouraged to think
of their treatment much like one considers
cosmetic and other age-defying procedures. CK
may last from 3 to 5 years, occasionally less,
occasionally more. After this period the patient
can go back to glasses or contacts or one or
more retreatments with CK may be possible. The
years of relief from dependence on reading glasses are
most often seen as a compelling reason to have
the procedure.
20.
Will I ever need glasses or contacts immediately
after NearVision CK, or again in
the future?
The vast majority of patients do not have to use
corrective lenses after the CK
procedure to do functional reading tasks.
Glasses may be needed for more demanding visual
tasks such as driving at night and perhaps
prolonged computer use. However, depending on your age and
the type of refractive disorder you have, you
may need additional vision treatment at some
point (CK or other surgery, reading glasses or
contacts).
This is because your eyes continue to change as
you age, and no one can avoid presbyopia, which is the natural
result of aging that occurs as the lens in
your eye loses flexibility.
21.
Can
NearVision
CK treat myopia (nearsightedness)?
No, because NearVision
CK was designed for baby boomers who
struggle to read menus, price tags or see their
computers — symptoms of fading near vision
which require a steepening of the cornea.
NearVision
CK is not designed to flatten the central
cornea, the effect required for the treatment of
myopia.
22.
Is
NearVision
CK reversible?
No, because, as with most vision improvement procedures,
NearVision
CK is not reversible. Once the
procedure has been performed, it is not possible
to "remove" its effects. This is an
important factor for anyone thinking about
undergoing a vision procedure to carefully
consider. To make sure NearVision
CK is right
for you, seek the advice of your doctor.
23. Will my health insurance cover the cost of
the NearVision
CK procedure?
Because NearVision
CK is considered "elective
surgery", most health insurance plans
do not cover it. There are a few plans that
offer some benefits. Employers' flexible spending
plans may offer tax advantages for the
procedure. Please consult your employer's plan
administrator if you have questions about this.
24. Who is the ideal candidate for NearVision
CK?
You're likely a good candidate for NearVision CK
if you:
- Are over age 40
- Had great vision your whole life
- Require reading glasses to compensate for
fading near vision
-
Have had no drastic changes in vision or eyeglass
prescription within the past year
-
Have no eye conditions such as glaucoma, severe
dryness, keratoconus, herpes of the eye,
aggressive keloid formation or corneal dystrophy
-
Have no physical conditions such as diabetes,
pregnancy or nursing, and vascular or autoimmune
diseases
This is not a complete list of indications and
contraindications. To determine if you are a candidate for CK,
obtain a thorough examination from your eye
surgeon, and seek his or her recommendations.
25. How is a precise amount of radiofrequency (RF)
energy and depth of treatment ensured during the
NearVision
CK procedure?
The technology used during the procedure was
engineered and designed specifically for
performing NearVision
CK. This means that the
precise amount of RF energy needed to affect the
corneal tissue, at the precise tissue
temperature and depth of treatment, were
meticulously investigated and defined. The
Keratoplast™ Tip penetrates the cornea to a
depth of 450 µm and utilizes a plastic stop at
the very distal portion to assure precise depth.
26. Can NearVision
CK be performed on patients
who have a pacemaker?
No. The NearVision
CK equipment can produce
interference that may adversely influence the
operation of other electronic equipment.
Therefore, NearVision
CK is contraindicated for
patients who are wearing a pacemaker.
27. What enables NearVision
CK to be performed
in-office?
NearVision
CK is a minimally invasive procedure
that does not require cutting of the cornea, and
therefore does not carry the associated risks or
surgical complications. The procedure is
relatively quick and easy to perform — taking
an average of just 3 minutes.
28. What does the cost of NearVision
CK include?
The cost of your treatment varies from patient
to patient. The cost is
comprehensive and includes a thorough
pre-treatment refractive
eye exam, the procedure itself, and post-procedure exams as determined by the doctor.
There is no doctor or clinic charge for
enhancements, if required,
during the first year (only the treatment tip
(device) fee charged by the manufacturer of the
CK system). After one year, should the patient be
a candidate for and desire a re-treatment or
booster treatment, the Honolulu Eye Clinic will perform
this at 50% of the then current fee. To
determine your costs, please telephone our
clinic and ask to speak with our CK Patient
Coordinator.
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