Corneal Refractive
Therapy with Paragon CRT®
Now you can be free of
daytime contact lenses and glasses during your daily
activities without undergoing surgery, and enjoy great vision! Recent clinical
research combined with the latest corneal surface mapping technology,
computerized manufacturing and space age oxygen-breathing materials have brought
new science to corneal reshaping.
Corneal Refractive Therapy
is a non-surgical process clinically developed
to reshape the cornea while you sleep the result is the temporary correction of
myopia (nearsightedness) with or without moderate astigmatism (irregular
surface of the cornea).
Similar in appearance to
standard contact lenses Paragon CRT therapeutic
lenses gently reshape the corneal surface during sleep and provide clear,
natural
vision when the lenses are removed upon waking.
Because Paragon CRT offers
freedom from glasses and the hassle of wearing
contact lenses during the day, this leading-edge technology can enhance the
lifestyle of those requiring vision correction. Active individuals can freely
participate in sports without the interference of glasses or bother of contacts.
Eye irritation or dryness sometimes associated with contact lens wear due to
outside dust and pollutants is eliminated.
1. What is Paragon CRT®?
Paragon CRT is a unique rigid gas
permeable contact lens design temporarily correct myopia (nearsightedness) by
gently and reversibly reshaping your cornea while you sleep. You may then be
able to go throughout the day without any lenses. Paragon CRT lenses are made
from an overnight contact lens material in a special design intended for this
purpose.
2. Can everyone wear Paragon
CRT®?
Not everyone can wear Paragon CRT.
This lens is intended for individuals with low to moderate myopia
(nearsightedness up to -6 diopters) and moderate astigmatism. During the U.S.
clinical study 121 subjects of the 205 enrolled completed nine months of lens
wear.
3. What is in the future of
Ortho Keratology and or CRT?
Advanced Corneal
Systems is developing an alternative to LASIK --
Corneaplasty, a
non-surgical procedure that permanently changes the shape of the cornea. A
three-step process using ortho-k lenses similar to CRT molds the cornea.
First the cornea is made softer and more malleable with a derivative of
hyaluronidase. The cornea is then molded into the desired shape with
custom-fitted ortho-K contact lenses. Lastly, a cross-linking "fixative" agent
sets the cornea in its optimum shape. Sandoz, a pharmacologic company, is
partnering with Advanced Corneal Systems in the FDA clinicals. Advanced Corneal
Systems expects approval of this non-surgical, reversible procedure within one
to two years.
4.
How do I care for my lenses?
Your lenses should be chemically
disinfected after every use (not heat). Our staff will instruct you about
what care system is best for you. Your lenses should be replaced as your eye
care practitioner sees fit.
5. How likely is it that Paragon
CRT® will work for me?
Of the 159 eyes targeted for 20/20
vision (who had this acuity with their best spectacles), 59% obtained 20/20 or
better without other correction and 92% obtained 20/40 or better at 9 months.
(20/40 vision is the acuity required in most states to drive without glasses).
67% Of the subjects obtained 20/20 vision in at least one eye (their better
seeing eye) and 94% achieved 20/40.
6. How long does it take to
reach good vision?
Most patients have rapid
improvement in the first few days of treatment and have achieved nearly their
optimum vision in 10 to 14 days. A small percentage of patients will not improve
enough to function under all conditions without additional correction.
7. Is Corneal Refractive Therapy
Permanent?
No, it is temporary. If you stop
wearing the lenses regularly while you sleep your lens-free vision will return
to its original state in as little as 72 hours.
8.
What are some important things for me
to remember?
If you feel like you are having a
problem with your vision or contact lenses, immediately remove your lenses and
call our office. Always follow the instructions given to you about lens wear, follow-up and care systems.
9. What are the risks of wearing
Paragon CRT®?
There is a small risk involved when
any contact lens is worn. It is not expected that the Paragon CRT Contact Lenses
for Corneal Refractive Therapy will provide a risk that is greater than other
rigid gas permeable contact lenses. Because this procedure is reversible some
patients may notice changes in their vision late in the day.
The two most common side effects
that occur in rigid contact lens wearers are corneal edema and corneal staining.
It is anticipated that the same side effects will also occur in some wearers of
Paragon CRT. Other side effects that sometimes occur in all contact lens wearers
are pain, redness, tearing, irritation, discharge, abrasion of the eye or
distortion of vision. These are usually temporary conditions if the contact
lenses are removed promptly.
In very rare instances, infections
of the eye, corneal ulcer, iritis, or neovascularization, corneal scarring,
permanent decreased vision may occur. The occurrence of these side effects
should be minimized or completely eliminated if proper lens care is exercised.
10. What do I do in the period
of time between when I start Paragon CRT® and when I achieve treatment?
It is important to understand that
for a time after you have begun initial treatment but before sufficient
treatment is realized, your old glasses will no longer be the appropriate
prescription. We will discuss what your options are for visual correction during
that period of time.
11. What if I have questions
about Paragon CRT®?
It is essential that you discuss
any issues you may have about your eye health or contact lens wear with your eye
care professional. If you need any further information about Paragon CRT lenses,
please contact us.
12. Who should not wear Paragon
CRT®?
Persons who exhibit any of the
following conditions should not wear Paragon CRT:
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1. What is Paragon
CRT®? |
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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 throughout the day without any
other correction. |
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2. How new is Paragon CRT? |
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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? |
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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? |
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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). 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. 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? |
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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. We
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? |
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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 adverse events
reported in the Paragon CRT FDA clinical study. |
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8. Can I see with my Paragon CRT lenses
in? |
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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? |
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Generally speaking the
Paragon CRT lenses will have to be replaced once a year. However, depending
on factors such as protein buildup, 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? |
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Your lenses should be
chemically disinfected after every use (not heat). Currently we are
recommending Unique Ph by Alcon |
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11. How
much does Corneal Refractive Therapy with Paragon CRT cost? |
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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. We offer optional payment plans, which
they will be happy to review with you. |
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12. Is Corneal
Refractive Therapy painful?
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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?
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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?
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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?
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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. |
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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 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). |
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Visual requirements due
to age or activities can only be assessed after a thorough eye exam. We
will recommend what is best for you. |
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16. Are the Paragon CRT
lenses difficult to insert or remove?
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These lenses are
generally no more difficult to insert or remove than any other similar
contact lens modality. 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?
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We can supply you with a document that states you are participating in a
visual therapy program that eliminates the need for corrective lenses while
operating a motor vehicle. The document should have an expiration date for
this treatment 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?
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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?
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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?
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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?
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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?
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Paragon CRT is designed
to correct myopia with to 1.75 diopters of astigmatism. Each individual
should be evaluated 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?
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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?
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Each lens is laser marked
to assure you that you have the original Paragon CRT therapeutic contact
lens.
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