Preliminary clinical results with 11-months
follow-up of intrastromal correction of
presbyopia (intraCOR ) using the FEMTEC®
TM
femtosecond laser system
Luis Antonio Ruiz, MD
Centro Oftalmológico Colombiano, Bogotá
Introduction
Since the early years of refractive surgery, new
procedures for minimal invasive correction of
ametropia were investigated [e.g. 1] and several
attempts have been directed towards the surgical
correction of presbyopia [e.g. 2]. However, current
techniques for correction of presbyopia have certain
limitations, although more than 26 million people
alone in the US suffer from this disease [3] and
almost everyone over the age of 51 is affected [4].
This article summarizes the worldwide first, still
preliminary clinical results of an ongoing pilot study
concentrating on non-invasive, intrastromal correc-
tion of presbyopia (intraCOR™), performed by
means of a FEMTEC® femtosecond laser system
(Fig. 1, 20/10 PERFECT VISION AG, Heidelberg,
Germany).
Fig. 1: FEMTEC® femtosecond laser system setup at the
Centro Oftalmológico Colombiano, Bogotá
Study Objectives and Design
The general purpose of this study is to quantify the
feasibility of non-invasive intrastromal corrections
of ametropic eyes(*). The first phase of this study
focuses on the non-invasive correction of presbyo-
pia.
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Until now, more than 200 presbyopic eyes under-
went intrastromal refractive surgeries with the
FEMTEC® femtosecond laser system. All treatments
were performed at “Centro Oftalmológico Colombi-
ano” in Bogotá, starting in October 2007.
The age of the patients ranged from 41 to 66 years
with an average of (53.5 ± 6.2) years.
Depending on the refractive properties as well as on
the individual biomechanical and geometrical prop-
erties of the cornea, a customized pattern for each
eye was calculated and the intrastromal laser
treatment was performed subsequently with treat-
ment times between 18 and 30 s. The calculation
was supported by means of Finite Element Modeling
[e.g. 5] using a spatial 3D grid adapted to the indi-
vidual curvature of the cornea (Fig. 2). With respect
to the intrastromal character of the performed sur-
geries, a certain distance of the interaction volume
to the corneal surface and the endothelium was
kept, not allowing for an anterior or posterior sur-
face incision and hence significantly reducing the
risk of healing issues.
Fig. 2: 3D Sketch of corneal FEM model used for the
calculation of individual treatment patterns
For a quantification of the refractive effect gener-
ated by the intrastromal surgery, the eyes were
examined before and in defined periods after the
treatment. The examinations included the determi-
nation of manifested refraction, Near Uncorrected
Visual Acuity (Near UCVA) obtained by Jaeger read-
ings as well as Distance UCVA and Distance Best
Spectacle Corrected Visual Acuity (Distance BSCVA)
obtained by means of Snellen readings under con-
sistent photopic conditions.
Principle of intraCORTM treatment
By means of the femtosecond laser a customized
pattern is applied into the cornea inducing a local
reorganization of the biomechanical forces. A sketch
of the principle is depicted in Fig. 3. In dependence
of the applied pattern the corneal surface can be
locally flattened or steepened.
Fig. 3: sketch of customized intrastromal treatment
pattern
In presbyopia treatment, the applied pattern leads
to a locally well defined central steepening of the
cornea, resulting in a central increase of refractive
power, as shown in Fig. 4. As the refractive power
change is only centrally induced, a significant in-
crease of near vision is evoked whereas the dis-
tance vision is only minimally affected.
a) b)
Fig. 4: True net power
change as obtained by
Pentacam Scheimpflug
camera.
a) pre op examination
b) post op examination
c) difference between
pre op and post op.
c)
Results
The analysis of these preliminary results focuses on
one specific group of eyes. All patients suffered
from fully developed presbyopia and were addition-
ally slightly hyperopic (approx. 0.5 D). On all eyes a
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similar pattern consisting of several ring structures
was applied.
Up to now this group consists of 62 eyes. 46 eyes
have a follow up time of 3 months and 2 eyes were
already examined 11 months post op.
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-
bility with only minor changes in the later examina-
tion periods.
In general, the patients showed an increase in
Near UCVA, occurring within some minutes up to a
few hours after the treatment. The induced increase
has been found to be stable within the observed
follow-up time of up to 11 months as shown in
Fig. 5. In this depiction, the number given at the
horizontal scale indicates the number of eyes exam-
ined on the specific follow up date.
0
Near UCVA (Jaeger lines)
6
average
8 standard deviation
10
12
pre 1D 1W 1M 3M 6M 9M 11 M
(62) (61) (60) (59) (46) (26) (17) (2)
Fig. 5: Efficacy and stability: Near UCVA change after
intrastromal correction of presbyopia
For a closer look at the gain in visual acuity in near
vision, the cumulative percentage distribution of
Near UCVA based on Jaeger readings is shown in
Fig. 6. For this evaluation only eyes with a follow up
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.
The diagram shows a significant shifting of the dis-
tribution towards smaller J-readings. After surgeries
more than 94 % of the treated eyes show a Near
UCVA of J2 or even better. More than 80 % result in
a Near UCVA of at least J1.
 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%

60% crease is even higher (7.2 ± 2.5).

55.6%

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

Intrastromal correction of presbyopia affects dis-

2

0
J1

tance vision in a minor way. The next diagram

Fig. 6: Refractive outcome distribution of Near UCVA (Fig. 8) shows the cumulative distribution of Dis-
according to Jaeger readings, pre op and after the
maximum observation period of at least 6 months
tance UCVA for pre op observation and follow up
periods between 1 month and 9 months.
In Fig. 7 the effect on the visual acuity can directly
be seen. This diagram shows the cumulative change Cummulative Distribution of Distance UCVA
9 M (17)
in Near UCVA related to the pre op examination 100%
6 M (26)
data. For purposes of clarity, only follow up data
80% 3 M (46)
between 1 month and 9 months are depicted.
1 M (59)
60%
pre (62)
Cumulative Change of Near UCVA
1 M (59) 40%
100%
3 M (46)
80% 6 M (26) 20%
9 M (17)
60% 0%
0

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

patients undergoing intrastromal presbyopia correction

ge

or

or

or

or

or
in

m
an

ga

or

or

or

or

or
ch
un

10

The depiction reveals that the Distance UCVA is only

ed

ed

ed

ed

ed
in

in

in

in

in

minimally affected by this treatment method. The

ga

ga

ga

ga

ga

average change of Distance UCVA, given in Table

Fig. 7: Change of Near UCVA (according to Jaeger 1(c), proves the high stability.
chart) after intrastromal correction of presbyopia

No eye shows a decrease of Near UCVA after treat-

ment and all eyes but one showed an increase in
Near visual acuity with the maximum being an in-
crease of 12 Jaeger lines.
(a) (b) (c) (d)
mean Near UCVA Change of Near UCVA Change of Distance UCVA Change of Distance BSCVA
[Jaeger lines] [Jaeger lines] [Snellen lines] [Snellen lines]
Pre op (n = 62) J8.3 ± 2.7 - - -
1 day post op (n = 61) J2.1 ± 2.7 6.2 ± 2.8 -0.2 ± 1.3 -0.5 ± 0.7
1 week post op (n = 60) J2.3 ± 1.6 6.0 ± 2.5 +0.2 ± 1.2 -0.2 ± 0.6
1 month post op (n = 59) J2.0 ± 1.4 6.3 ± 2.6 +0.1 ± 1.4 +0.1 ± 0.5
3 months post op (n = 46) J1.6 ± 1.0 6.2 ± 2.8 +0.2 ± 1.3 +0.0 ± 0.6
6 months post op (n = 26) J1.4 ± 0.9 5.2 ± 2.8 -0.5 ± 1.4 +0.0 ± 0.0
9 months post op (n = 17) J1.1 ± 0.2 7.2 ± 2.5 -0.1 ± 1.5 +0.0 ± 0.5
11 months post op (n = 2) J1.0 ± 0.0 9.0 ± 0.0 -1.0 ± 0.0 +0.0 ± 0.0
Table 1: Mean values for Near UCVA and the change of Near and Distance UCVA as well as Distance BSCVA
related to pre op data according to Jaeger and Snellen chart readings, respectively

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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)

correction of other forms of ametropia (myopia,

1,0 hyperopia, astigmatism) are currently under inves-
tigation. The preliminary results of these treatments
0,8
are equally promising for using the FEMTEC® laser
0,6 average system for all kinds of such intrastromal correc-
standard deviation tions.
0,4
For this purpose, the currently used FEM modeling
0,2
will be refined with the goal of calculating an ideal
0,0 intrastromal pattern for each kind of ametropia.
pre 1D 1W 1M 3M 6M 9M 11 M
(62) (61) (60) (59) (46) (26) (17) (2)
References
[1] Machat JJ (Ed.), “Excimer Laser Refractive Surgery: Prac-
Fig. 9: Cumulative distribution of Distance BSCVA of tice and Principle”, Slack Inc. (1996)
patients undergoing intrastromal presbyopia correction
[2] Alió JL, Chaubard JJ, Caliz A, Sala E, Patel S, “Correction
of presbyopia by technovision central multifocal LASIK (pres-
The diagram and table show that the average value byLASIK)”, J Refract Surg. 22(5), p.453-60 (2006)
of 1.15 (pre op) slightly decreases 1 day post op to [3] “Products, Technologies, Markets and Opportunities in
1.02, but 1 month after the treatment the average Ophthalmology Surgical, Device and Drug Markets Worldwide,
value is the same as before treatment. The drop at 2007”, MedMarket Diligence, LLC, Report #G125 (2006)
11 months post op is only due to the limited num- [4] “2007 Comprehensive Report on The Global Refractive
ber of examined eyes for this observation period Surgery Market”, Market Scope, LLC (2007)
(n = 2). Both of these eyes have kept the same [5] Hennighausen H, Bille J, “Computer simulation of corneal
BSCVA as pre op (1.0). curvature change caused by intrastromal ablations using a
pico-second lasersystem” SPIE 2330 (1994)

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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