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| 1.
What is Paragon CRT®? |
| Paragon
CRT is a specially designed oxygen permeable
therapeutic contact lens used in Corneal Refractive
Therapy. Corneal Refractive Therapy
is a sophisticated, non-surgical process,
which reshapes the cornea while you sleep.
You remove the lenses when you awake and are
able to go through the day without any
other correction. |
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| 2.
How new is Paragon CRT? |
| Contact
lens corneal reshaping is not a new concept.
Previous corneal reshaping designs were only
as successful as technology allowed.
Paragon Vision Sciences has taken the recent
advancements in computerized corneal mapping,
computerized manufacturing, and oxygen permeable
contact lens materials and produced a therapeutic
contact lens design that is like no other.
This has allowed Paragon CRT to become the
one corneal reshaping modality that truly
stands out and the first to earn FDA approval
for nighttime Corneal Refractive Therapy.
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| 3.
Is Corneal Refractive Therapy Permanent? |
| No.
It’s temporary. If you stop wearing
the lenses regularly while you sleep, your
vision will return to its original state in
as little as 72 hours. |
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| 4
.Can everyone wear Paragon CRT? |
| Not
everyone can wear Paragon CRT. This
lens is designed for individuals with low
to moderate myopia (nearsightedness up to
–6.00 diopters) with or without astigmatism
(up to –1.75 diopters). Paragon
CRT therapeutic lenses are not yet available
in bifocal prescriptions for presbyopia (which
requires reading glasses or bifocals).
At your doctor’s discretion you may
be fitted in a monovision mode (one eye corrected
for near vision and one corrected for distance
vision). You might still need reading
glasses. However, since there are variations
in patient physiology and visual needs, the
decision for CRT, at any age, can only
be made after a thorough eye exam and the
recommendations of the eye care professional.
At this time, hyperopia (farsightedness) is
not correctable with CRT. |
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| 5.
How long does it take to reach good vision? |
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Most
patients have rapid improvement in the first
few days of treatment and achieve nearly their
optimum vision in 10 to 14 days. |
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| 6.
What do I do to see adequately in the period
of time between when I start Corneal Refractive
Therapy with Paragon
CRT and when I achieve full treatment? |
| It’s
important to understand that for a time after
you have begun treatment, but before sufficient
treatment is realized, your old glasses or
contacts will no longer be the appropriate
prescription. It may involve insertion
of your Paragon CRT lenses for part of the
day or some use of temporary soft lenses in
different prescriptions as an option. Your
eye care practitioner will discuss your options
for visual correction during that transitional
period of time. |
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| 7.
Are there any risks involved with wearing
Paragon CRT? |
| There
is a small risk involved when any contact
lens is worn. It is not expected that
the Paragon CRT lenses for contact lens Corneal
Refractive Therapy will provide a risk that
is greater than other contact lenses.
There were no serious adverse events reported
in the Paragon CRT FDA clinical study. |
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| 8.
Can I see with my Paragon CRT lenses in? |
| Yes.
One of the great features of the Paragon CRT
lens is that if you have to get up in the
middle of the night, you will be able to see
where you are going. Or, if during the
initial treatment phase, you find you need
some form of vision correction, you can put
in your Paragon CRT lenses and see clearly. |
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| 9.
How often will I have to replace my Paragon
CRT lenses? |
| Generally
speaking the Paragon CRT lenses will have
to be replaced once a year. However,
depending on factors such as protein build-up,
how well the lenses are taken care of, etc.,
the lenses may have to be replaced more frequently. |
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| 10.
How do I care for my Paragon CRT lenses? |
| Your
lenses should be chemically disinfected after
every use (not heat). Your eye care
practitioner will instruct you about which
care system is best for you. |
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| 11.
How much does Corneal Refractive Therapy with
Paragon CRT cost? |
| The
cost for your initial fitting, professional
care, follow-up and Paragon CRT therapeutic
lenses varies. After your first year,
the annual cost of CRT is about the same as
wearing contact lenses or glasses. Many
eye care Practitioners also offer optional
payment plans, which they will be happy to
review with you. You should consult
your Paragon CRT eye care practitioner for
further specific information. |
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12.
Is Corneal Refractive Therapy painful? |
| The
therapy is not painful. Initially, you
may have a slight awareness of the therapeutic
lens. You will not feel the lenses when
you sleep and there is no sense of physical
corneal change…. just visual improvement
when the lenses are removed. |
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13.
Is Corneal Refractive Therapy or Paragon CRT
FDA approved? |
| Paragon
CRT is the first therapeutic lens design approved
by the FDA for overnight contact lens Corneal
Refractive Therapy for the temporary reduction
of myopia. Paragon Vision Sciences,
the manufacturer of Paragon CRT, received
the final written approval on June 13, 2002.
The issuance of this approval is the culmination
of the most extensive clinical study to date
to establish the safety and efficacy of contact
lens corneal reshaping in overnight use. |
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14.
What is the difference between Corneal Refractive
Therapy and Paragon CRT? |
| Corneal
Refractive Therapy is the process of
using a therapeutic contact lens to reduce
myopia by reshaping the corneal surface while
you sleep. Paragon CRT is the product
for this therapy. |
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15.
Are there age restrictions for Corneal Refractive
Therapy with Paragon CRT? |
| No.
The FDA placed no age restrictions on candidates
for Corneal Refractive Therapy with Paragon
CRT. CRT is being successfully
performed on children 12 years old and younger.
It can be a great option for children and
teens that are active in sports activities
or any other extra curricular activities.
Those who are older and presbyopic (requiring
reading glasses or bifocals) may still be
candidates for CRT. They may correct
their distance vision with CRT and wear near-vision
reading glasses for close work. At the
doctor’s discretion you may be fitted
in a monovision mode (one eye corrected for
near vision and one corrected for distance
vision).
Visual
requirements due to age or activities can
only be assessed after a thorough eye exam.
Your Paragon CRT certified eye care professional
will recommend what is best for you. |
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16.
Are the Paragon CRT lenses difficult to insert
or remove? |
| These
lenses are generally no more difficult to
insert or remove than any other similar contact
lens. You may want to instill comfort
or rewetting drops prior to insertion of the
lenses and immediately upon waking.
The lenses must move freely prior to removal.
If you have difficulty removing the Paragon
CRT lens, there are lens removal aids available
to assist this process. |
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17.
If I discontinue CRT, will my vision to return
to normal? |
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There
are no recorded permanent corneal changes
post-treatment. Generally, the more
myopia being reduced, the longer it will take
for the corneal curvature to return to normal.
For instance, if your pretreated correction
was - 4.50D, it would take a few days longer
to return to normal than if the pretreated
correction was -1.50D. |
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18.
My driver’s license is marked that I
need corrective lenses to operate a motor
vehicle. What do I do about that? |
| Your
eye care professional will supply you with
a document that states you are participating
in a visual therapy program that eliminates
the need for corrective lenses during working
hours. The document should have an expiration
date and you should have your driver’s
license updated with a new vision screening
through your local DMV office to reflect this
change, before the expiration date. |
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19.
What happens if I lose or damage a lens? |
| Corneal
Refractive Therapy is different than wearing
regular contact lenses. If you discontinue
wear for one night, your vision may be impaired
the next day. Previously worn glasses
or contact lenses may not help. Immediate
replacement is necessary! Having
a spare pair of lenses is strongly recommended. |
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20.
Do benefit programs cover Corneal Refractive
Therapy? |
| This
is an elective procedure, and to the best
of our knowledge is not usually covered by
benefit programs. If regular contact
lenses are covered under your vision care
plan, Corneal Refractive Therapy may be partially
covered. You should check with your
benefits plan administrator. |
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21.
I suffer from “dry” eyes, am I
a candidate for Corneal Refractive Therapy? |
| Only
your eye care professional can determine if
you are a CRT candidate. Many patients
with slightly dry eyes do well with CRT.
Since you are wearing the lenses only while
sleeping, the closed eye state minimizes evaporative
loss of tears and can give dry-eye patients
suitable vision without compromising the ocular
surface. |
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22.
I used to wear contact lenses, but stopped
due to discomfort. Am I a candidate
for Corneal Refractive Therapy? |
| Paragon
CRT lenses are worn at night while you are
sleeping. This greatly reduces any discomfort
normally experienced while wearing contact
lenses during the day. |
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23.
I have astigmatism. Am I a candidate
for Corneal Refractive Therapy? |
| Paragon
CRT is designed to correct myopia with to
1.75 diopters of astigmatism. Each individual
should be evaluated by a certified eye care
professional to determine if CRT is right
for your visual requirements. |
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24.
I wear glasses. Am I a candidate for
Corneal Refractive Therapy? |
| The
transition from wearing only glasses to Paragon
CRT should not be a concern. About 18%
of the patients in the FDA study were non-contact
lens wearers. The dropout rate
related to discomfort was only 3.9%. |
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25.
How can I tell if I have the original Paragon
CRT lenses? |
| Each
lens is laser marked to assure you and your
eye care practitioner that you have the original
Paragon CRT therapeutic contact lens.
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Comprehensive
eye exams
