Read: 3/1/2010 - national news release -
Visian Implantable Collamer Lens provides U.S. Bobsled Pilot with the vision to lead his Team to first Olympic Gold in 62 Years.
Read: Columbus
Dispatch 3/3/2006 -
Front page: "Quick Fix for Nearsightedness"
View: 10TV
5PM News 3/2/2006 -
Dr. Erdey is among the first in the U.S. to implant
the ICL following FDA approval. His patient, Laurel
Santino, MD, an Obstetrician practicing in Lancaster
, is interviewed.
View: 10TV
11PM News 3/2/2006 -
Dr. Erdey's patient, Janet Knotts, relates her experience
since receiving the ICL 8 years ago (1998), as
part of the US FDA Study.
Read: Review
of Ophthalmology 2001 -
The Posterior-Chamber Implantable Contact Lens by
Richard A. Erdey, M.D.
View: NBC4
News 1998 -
Dr. Erdey's patient, Lisa Carson, is the first in
Ohio to receive myopia ICL in 1998
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The
Implantable Contact Lens (ICL™)
is a lens made of a highly biocompatible Collamer® material
that is permanently implanted into the eye,
providing an alternative to glasses, contact
lenses and Laser Vision
Correction (PRK/LASIK) surgery. It is similar
in design to implants inserted routinely during
cataract surgery. The implant focuses light
rays onto the retina resulting in clearer vision
(How
this works).
It is the only minimally-invasive foldable
lens of its kind approved for the U.S. market
by the Food and Drug Administration.
 As
a result of the unique foldable design, the
ICL procedure allows an incision up to 50%
smaller than competing technology, and its
placement in the eye in front of the natural
lens and behind the iris provides a more aesthetically
pleasing outcome. (Click
video clip above to play).
This sutureless procedure is typically painless
and visual rehabilitation is usually rapid.
Richard
A. Erdey, MD has been an investigator
for Staar Surgical’s Visian ICL™ U.S
FDA Study since 1998. (View: NBC4
News – Dr.
Erdey’s patient is first in Ohio to receive
myopia ICL in 1998) His interest in the
ICL continued to build throughout the approval
process; it was driven by superior clinical
outcomes, the stability and safety of the procedure
and the high patient satisfaction rate. (Read:
The Posterior-Chamber
Implantable Contact Lens by Richard Erdey,
M.D).
Gregory D. Searcy, MD also maintains an active
interest in this technology.
The
ICL offers patients opportunities to achieve
higher quality visual outcomes, particularly
in those cases where laser vision correction
is unsuitable because of moderate to severe
myopia and / or corneas that are too thin to
safely withstand laser reshaping.
STAAR
Surgical's Visian ICL™ is approved
for sale in 41 countries, including the European
Union and Canada. It has successfully been
implanted in more than 40,000 eyes worldwide.
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Who are the best candidates for the ICL
and
is the ICL better than Laser Vision
Correction (LASIK / PRK)? |
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Deciding on the vision correction procedure
that’s right for you is an important one.
The
VISIAN ICL/LASIK/PRK COMPARISON –
(Printable PDF) provides a general
comparison of the major differences between
the Visian ICL, LASIK and PRK.
It is NOT an exhaustive list, nor is it a
substitute for the advice of your doctor.
ONLY AN EXTENSIVE EXAMINATION BY YOUR EYE
CARE PROFESSIONAL CAN PROVIDE THE
INFORMATION NECESSARY TO DETERMINE WHICH
PROCEDURE IS UNIQUELY SUITED FOR YOU.
To determine if you are a suitable
candidate,
contact us to schedule a complimentary
evaluation.
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| What
are the U.S. FDA indications
for the ICL? |
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The
Visian ICL™ was
U.S. FDA approved in December
2005. It is intended for
use in adults with healthy
eyes and stable spectacle
and / or contact lens prescriptions. It
is designed for:
· The
correction of myopia
ranging from -3 to -15 diopters
(D) with less than or equal
to 2.5D of astigmatism
at the spectacle plane
· The
reduction of myopia ranging
from -15D to -20D with less
than or equal to 2.5D astigmatism
at the spectacle
plane
· Adults
21 years of age or
older with a stable refractive
history within 0.5D for 1
year before implantation
The
Visian ICL™ is
not yet approved for
patients with hyperopia.
A toric version for patients
with myopia and astigmatism
is still in FDA trials;
initial results are very
promising!
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| What
will it accomplish? |
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The Visian ICL™ may
reduce or eliminate your dependence on
glasses or contact lenses. In a
clinical study of 294 patients implanted
with the Visian ICL™, 95 percent
had 20/40 or better vision (considered
standard vision necessary to obtain a driver's
license), and 59 percent had 20/20 or
better after three years.
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| What
preparation is required? |
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A tiny hole in the
iris is made with a laser before the day of
the ICL procedure to prevent a serious form
of intraocular pressure increase or Glaucoma
from developing. Increasingly, this iris
hole is made surgically at the same time as
the ICL implant, thus avoiding the laser
technique entirely.
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| Can
both eyes be implanted with an
ICL at once? If not, how long
must I wait before surgery is
performed on the second eye? |
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One eye is operated
on at a time. The second eye may be
implanted with the ICL as soon as several
hours of the same day or several days or
weeks after the first. Your doctor will help
you decide which strategy is best for you.
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| Can
the ICL dry out or
become soiled or damaged like
a contact lens? |
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No. The ICL is designed to remain
in place within the eye without maintenance.
We recommend an annual eye examination
to make sure that everything is fine.
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| Can
I feel the ICL once it is in
place? |
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The ICL is not noticeable
after it is implanted. It does not attach
to any structures within the eye and
does not move around after it is in position.
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| If
I receive an ICL will I always
remain free of corrective lenses? |
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1. In patients with
pre-operative corrections -3.0 to -15.0
Diopters (D), residual refractive error
after ICL implantation requiring corrective
lenses is possible, while in cases of
extreme myopia, -15 to -20 D or higher
(“Coke-bottle” spectacles), residual
refractive error is expected. In either
case, independence from corrective lenses
while very common, is not guaranteed and
glasses or contact lenses may be worn if
necessary. Some people may still need
glasses for night driving and other
activities performed in low light conditions
after ICL implantation. Some may benefit by
having supplemental Laser Vision Correction
to “fine tune” their result.
2. Individuals in their low to mid 20’s who
have received an ICL may eventually develop
progressive refractive error due to
continued growth of the eye. If this occurs,
corrective lenses for all or certain
activities such as night driving may be
required. Alternatively, supplemental Laser
Vision Correction to “fine tune” the result
can be considered. Implanting the ICL after
your spectacle or contact lens prescription
has remained stable for a year or more
reduces the chances you will experience this
situation.
3. In older patients (age 43 or higher) with
presbyopia the
ICL is capable of reducing or eliminating
the need for distance glasses, but reading
(near vision) glasses will still be
required.
4. As the eye ages,
cataract formation may shift the
refraction of the eye. If such a patient had
an ICL implanted years earlier without
subsequent need for distance corrective
lenses, they may once again require glasses
because of changes in the power of the
crystalline lens induced by the cataract.
More dramatic shifts in an eyes refraction
accompanied by optical degredation due to
cataract formation are reversed by removal
of the ICL followed by cataract surgery with
an intraocular lens.
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| What
should I expect if I eventually
require cataract surgery and
I have an
ICL? |
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Many patients who developed cataracts
years after they had a cornea refractive
procedure (LASIK,
PRK, RK) have had successful
cataract surgery and intraocular lens
(IOL) implantation with excellent results.
However, the required implant
power is sometimes difficult to predict,
and the optics of this combination are
typically not quite as good as the same
theoretical patient who develops a cataract
years after ICL implantation. In the
latter case, the ICL is easily removed,
the original corneal curvature is preserved
and cataract
surgery with an intraocular lens
is implanted, yielding superior optical
results.
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| Are
there risks to ICL implantation? |
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No surgical procedure is risk-free. The proximity of the ICL to the iris and natural lens raises the possibility of late onset pigment dispersion syndrome or lens opacities (cataracts). Fortunately, both are rare. In the FDA Study (age 21-45yrs), visually significant cataracts occurred in only 1.3% of patients at five-year follow-up. Experience suggests that the development of visually significant cataracts is somewhat higher in patients who receive an ICL above age 46 (“off FDA label”) and/or in those with very high myopia (> -15D) and
are considered far easier to fix than corneal
complications following LASIK surgery.
Current evidence supports ICLs as
being a very effective option
for most patients who are suitable candidates.
Your doctor will provide a more thorough
discussion of the risks and benefits of
this procedure during your office visit.
With this information, you can make an
informed decision about choosing this or
other options available to reduce or eliminate
your myopia (nearsightedness).
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