1. What side effects
have been associated with NearVision CK (Conductive Keratoplasty)?
2. How is a precise
amount of radiofrequency (RF) energy and depth of treatment
ensured during the NearVision CK procedure?
3. How can I ensure
accurate placement of treatment spots, especially if the ink
applied with the corneal marker begins to wear away during
the procedure?
4. Can NearVision CK
be performed on patients who have a pacemaker?
5. Is there a critical
time limit within which the NearVision CK procedure must be
completed?
6. What are the
key differences between NearVision CK and LTK?
7. How does NearVision
CK differ from Fyodorov's techniques?
8. What is the range
of correction for NearVision CK?
9. How often should
the Keratoplast™ Tip be replaced?
10. What enables NearVision
CK to be performed in-office?
1. What side effects have been associated
with NearVision CK?
In two different U.S. Phase III Clinical Trials, CK was performed
on hundreds of eyes and found to provide excellent patient
satisfaction with a low incidence of complications and adverse
events. The only short-term side effects observed were minimal
discomfort described as a foreign-body sensation during the
first 24 to 48 hours, and slight (< 0.75 D on average at
one-week post-op) initial over-correction that reverts to
emmetropia over time.
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2. How is a precise amount of radiofrequency
(RF) energy and depth of treatment ensured during the NearVision
CK procedure?
The ViewPoint® CK System was engineered specifically for
the CK procedure. This means that the precise amount of energy
needed to affect the corneal collagen and the exact depth
needed to distribute that energy without affecting the endothelium
were meticulously investigated and defined. The Keratoplast™
Tip penetrates the cornea to a depth of 450 µm and utilizes
a plastic stop to assure correct depth of penetration.
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3. How can I ensure accurate placement
of treatment spots, especially if the ink applied with the
corneal marker begins to wear away during the procedure?
This potential problem can be avoided with thorough training
and careful preparation. It is important to mark the cornea
as clearly and accurately as possible using even, downward
pressure. Carefully rinsing away the excess ink and thoroughly
drying the eye should preserve the mark for the short period
of time needed to perform CK.
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4. Can NearVision CK be performed on patients who
have a pacemaker?
High-frequency surgical equipment such as the ViewPoint®
CK System can produce interference that may adversely influence
the operation of other electronic equipment. Therefore, using
the CK System on patients who are wearing a pacemaker is contraindicated.
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5. Is there a critical time limit
within which the NearVision CK procedure must be completed?
The target treatment time is one minute or less per series
of eight treatment spots. Because the corneal tissue is affected
immediately upon treatment, it is important to administer
the treatment spots consecutively and in the recommended order.
This will ensure that the ring of tissue tightens uniformly,
potentially minimizing the risk of induced astigmatism.
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6. What are the key differences between NearVision
CK and LTK?
Laser thermal keratoplasty (LTK) utilizes a focused beam to
deliver treatment to specific spots on the corneal surface.
This method produces a gradient thermal effect and a cone-shaped
zone of collagen shrinkage. CK, on the other hand, uses RF
energy applied via a hair-thin tip to penetrate the cornea.
This affects deeper layers to create uniform "columns"
of collagen shrinkage.
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7. How does NearVision CK differ
from Fyodorov's techniques?
Fyodorov used a thermokeratoplasty technique involving the
insertion of a hot wire into the cornea. CK uses a cool tip
that is inserted into the cornea. The tip then emits radiofrequency
(RF) energy into the eye. It is the tissue's resistance to
the RF energy that induces the increase in temperature. With
CK, the tip of the probe never gets hot. The results are more
permanent than with Fyodorov's original thermokeratoplasty
techniques.
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8. What is the range of correction
for NearVision CK?
Approval of the premarket approval application supplement
for the ViewPoint® CK System is for the temporary induction
of myopia (-1.00 D to -2.00 D) to improve near vision in the
non-dominant eye of presbyopic hyperopes or presbyopic emmetropes,
via spherical hyperopic treatment of 1.00 D to 2.25 D, in
patients 40 years of age or greater with a documented stability
of refraction for the prior 12 months, as demonstrated by
a change of < 0.50 D in spherical and cylindrical components
of the manifest refraction, and with = 0.75 D of cycloplegic
refractive cylinder and with a successful preoperative trial
of monovision or history of monovision wear (i.e., dominant
eye corrected for distance vision and non-dominant eye corrected
for near vision).
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9. How often should the Keratoplast™
Tip be replaced?
The Keratoplast™ Tip is a sterile, single-use device,
and must be replaced after each CK procedure to ensure optimal
performance.
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10. What enables NearVision CK to
be performed in-office?
CK is a minimally invasive procedure that does not require
cutting of the cornea, resulting in few complications related
to surgical treatment. The procedure is relatively quick and
easy to perform — taking an average of just three minutes.
The portable ViewPoint® CK System can be easily moved
to different areas of your office (note: they do not need
to be surgical suites). Setup and maintenance are also very
straightforward. All of these factors make CK ideal for in-office
use.
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