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Principle of intraCORTM treatment similar pattern consisting of several ring structures
By means of the femtosecond laser a customized was applied.
pattern is applied into the cornea inducing a local Up to now this group consists of 62 eyes. 46 eyes
reorganization of the biomechanical forces. A sketch have a follow up time of 3 months and 2 eyes were
of the principle is depicted in Fig. 3. In dependence already examined 11 months post op.
of the applied pattern the corneal surface can be
locally flattened or steepened. Before the treatments, the Near UCVA of the pa-
tients was J8.3 ± 2.7 on average according to Jae-
ger readings. After 1 day follow-up time, the Near
UCVA increased significantly and even better values
towards the end of the current observation period
were observed. The mean values of every observa-
tion period are summarized in Table 1(a). Pre op
examinations reveal J-readings down to J12 with an
average of J8.3 ± 2.7 in Jaeger lines. 1 day post op,
the mean visual acuity increases to a value of J2.1
± 1.7. The post op visual acuity shows a good sta-
Fig. 3: sketch of customized intrastromal treatment bility with only minor changes in the later examina-
pattern tion periods.
In general, the patients showed an increase in
In presbyopia treatment, the applied pattern leads Near UCVA, occurring within some minutes up to a
to a locally well defined central steepening of the few hours after the treatment. The induced increase
cornea, resulting in a central increase of refractive has been found to be stable within the observed
power, as shown in Fig. 4. As the refractive power follow-up time of up to 11 months as shown in
change is only centrally induced, a significant in- Fig. 5. In this depiction, the number given at the
crease of near vision is evoked whereas the dis- horizontal scale indicates the number of eyes exam-
tance vision is only minimally affected. ined on the specific follow up date.
0
Near UCVA (Jaeger lines)
6
average
8 standard deviation
10
a) b) 12
pre 1D 1W 1M 3M 6M 9M 11 M
(62) (61) (60) (59) (46) (26) (17) (2)
Fig. 4: True net power Fig. 5: Efficacy and stability: Near UCVA change after
change as obtained by intrastromal correction of presbyopia
Pentacam Scheimpflug
camera.
a) pre op examination For a closer look at the gain in visual acuity in near
b) post op examination vision, the cumulative percentage distribution of
c) difference between Near UCVA based on Jaeger readings is shown in
pre op and post op. Fig. 6. For this evaluation only eyes with a follow up
c) time of at least 6 months were taken into account
(n = 36). Additionally, for all eyes only the data
from the most recent examination were used, here.
Results
The diagram shows a significant shifting of the dis-
The analysis of these preliminary results focuses on tribution towards smaller J-readings. After surgeries
one specific group of eyes. All patients suffered more than 94 % of the treated eyes show a Near
from fully developed presbyopia and were addition- UCVA of J2 or even better. More than 80 % result in
ally slightly hyperopic (approx. 0.5 D). On all eyes a a Near UCVA of at least J1.
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The corresponding mean values of the depicted
Cumulative Distribution of Near UCVA
data and standard deviations are given in Table
100% 1(b). The average gain of Near UCVA 3 months post
100.0%
100.0%
97.2%
97.2%
94.4%
op is 6.2 ± 2.8 lines (n = 46) and after 9 months,
91.7%
91.7%
80% ≥ 6 M (36)
for which already data of 17 eyes exists, the in-
80.6%
pre op (36)
72.2%
47.2%
47.2%
40% One important indicator, that needs to be consid-
ered when using this new technique for the in-
30.6%
20%
trastromal correction of presbyopia, is safety. Any
0%
approach for improving near vision is only viable if
the Distance UCVA and Distance BSCVA are either
or ter
or ter
or ter
or ter
or er
or ter
or er
or ter
or er
or er
or ter
r
tte
unaffected or, at worst, only minimally affected.
J7 bett
J5 bett
J3 bett
J2 bett
t
t
J9 bet
J8 bet
J6 bet
J4 bet
J1 bet
J1 r be
J1 be
be
o
0
J1
5
r
r
40%
/6
/1
tte
tte
tte
tte
tte
20
20
be
be
be
be
be
or
or
or
or
or
20%
0
0
/5
/4
/3
/2
/2
20
20
20
20
0% 20
Fig. 8: Cumulative distribution of Distance UCVA of
d
ed
or
or
or
or
or
in
m
an
ga
or
or
or
or
or
ch
un
10
ed
ed
ed
ed
in
in
in
in
in
ga
ga
ga
ga
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The results of Distance BSCVA are shown in Fig. 9 Outlook
for the eyes which had undergone intrastromal cor- This status report shows the preliminary outcome of
rection of presbyopia and the mean change of this an ongoing clinical study. The promising initial re-
value is given in Table 1(d). sults will need to be further supported by a larger
number of procedures performed at several clinical
sites in the near future. Parallel to the very success-
1,4 ful investigation of intrastromal presbyopia correc-
tion, further treatment strategies for non-invasive
1,2
Distance BSCVA (dec)
Summary
The preliminary results of the ongoing clinical study Acknowledgement
for an intrastromal correction of presbyopia using The author is grateful to the team of 20/10 Perfect
the FEMTEC® femtosecond laser system are very Vision AG for supporting this study and for their
promising and motivate to proceed with this study. helpful contribution to this project.
This non-invasive technique inheres a huge poten-
tial to improve the near vision instantaneously by
several lines (acc. to Jaeger chart) whereas signifi-
cant long-term down-sides are not seen so far. An
average gain of 6.2 ± 2.8 Jaeger lines is achieved in
Near UCVA after 3 months post op by inducing only
minor effects on the Distance UCVA. Further information
The laser induced biomechanical response of the Luis Antonio Ruiz, MD
cornea, which subsequently leads to the beneficial Centro Oftalmológico Colombiano
refractive effect on visual acuity mostly manifests Carrera 20 No. 85-11, Bogotá, Colombia.
itself within some minutes up to a few hours post Tel.: +57-1-236 00 00
op and shows a high stability towards longer obser- 20/10 PERFECT VISION AG
vation periods. In Distance BSCVA minimal changes manufacturer of the FEMTEC® femtosecond laser
occur after the treatment. This effect is only tempo- system
Am Taubenfeld 21/1, D-69123 Heidelberg, Germany
rary resulting in an unchanged average value
Tel.: +49-6221-7502-0
1 month post op. website: www.2010pv.com
(*)
Note: The procedure software module, being used in this study, is currently neither FDA nor CE Mark approved
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