Clinical Results of 75 cases for Myopia and Hyperopia combined

Astigmatism with Kera IsoBeam D200

Dr. Eduardo Murube Jiménez, Marcos Garcia Pérez

Centro Oftamologico Retire-Lasik Center, Madrid, Spain

Abstract

This paper presents our LASIK results for myopic astigmatism and hyperopic
astigmatism. The experimental set-up consisted of splitting a 193nm excimer laser
beam into two laser beams which simultaneously ablated the corneal surface in a
symmetrical, flying spot fashion (dual flying spots). Each beam with 0.6mm square
size was guided by an independent X-Y positioning device. The randomly non-
sequential ablation positions were determined from a pre-calculated linear pattern
database (random projection). The fractal algorithm was also applied to achieve
diopter by diopter ablation (fractal). Eye fixation was achieved by a concentric ring
together with a line that was projected by a distant illumination light and tracking.

The Lasik Center, located in Madrid, Spain, registry consisted of 54 eyes with myopia
combined with astigmatism. These patients were enrolled between September, 2002 to
December, 2002. The pre-operative spherical equivalent ranged from -1.0D to
-12.75D. The correction factors attempted ranged from 1.0D to 12.0D. Follow up was
12 months. Fifty-two eyes that underwent LASIK myopia and astigmatism were
within 1.0D of the intended spherical equivalent refraction correction and forty-eight
eyes were within 0.5D of the intended spherical equivalent refraction correction. The
Lasik Center registry had 21 eyes with hyperopia combined with astigmatism. These
patients were enrolled between September, 2002 to December, 2002. The pre-
operative spherical equivalent ranged from +0.25D to +5.75D. The correction factors
attempted range from -0.75D to -5.75D. Follow up was 12 months. Nineteen eyes that
underwent LASIK for hyperpoia and astigmatism were within 1 D of the intended
spherical equivalent refraction correction and fourteen eyes were within 0.5D of the
intended spherical equivalent refraction correction.

1. Introduction

Excimer lasers (at 193nm wavelength) have long been used, both safely and
effectively, in the ablation of cornea tissue for refractive corrections such as myopia,
hyperopia and astigmatism. Great care must be taken, however, in transferring energy
from the laser to the cornea so that the laser energy distribution on the surface is both
spatially and temporally homogeneous. Diaphragm-related delivery methods, (1,2)
where a “wide spot” or “line-shape” laser beam is passed through a computer
controlled diaphragm, have shown uncertain ablation predictability and central islands
due to has difficulty in treating dependent hydration effects. (3, 4 and 5) The
diaphragm method also has difficulty in treating hyperopia and astigmatism and can
not handle irregular corneas. The scanning delivery method, (6) where a single small
laser beam scans sequentially over the corneal surface, can result in uneven hydration
effects leading to lateral islands.

In this paper we present a new “dual flying spot, random projection” delivery method
designed to solve both spatial and temporal energy distribution problems discovered
in other delivery approaches by matching the random nature of the factors in
refractive surgery that can not be avoided or adequately predicted, such as hydration,
ablation debris, energy stability and eye movement. A new fractal algorithm was also
used to achieve diopter by diopter ablations. Results of clinical studies performed
using these new delivery approaches and covering a range of refractive procedures are
reported. Procedures include LASIK for the correction of myopic astigmatism (54
cases), correction of hyperopic astigmatism (21 cases). Follow up data of twelve
months are also presented.

2. Principle of System

In the dual flying spot, random projection method a single source laser beam (193nm)
is split into two small flying spots that have the same timing, power and beam
characteristics but are 90 degree out of phase spatially. Each spot is focused to a
0.6mm square size and positioned by the system’s (galvanometric) optics
symmetrically about the optical axis on the patient’s cornea. The flying spots are
flexible enough to perform a wide range of refractive corrections including myopic,
hyperopic and astigmatism (both myopic and hyperopic) corrections as well as
enhancement features for corneal irregularities. By using two beams simultaneously,
however, the frequency of the laser is effectively doubled (from 300 Hz to 600 Hz).
This significantly shortens corneal ablation time thus reducing centration related
problems.

The ablation patterns are computer randomly generated from a sequential scanning
data base. The new non sequential data base were stored in a linearly array for
delivering through optical system to corneal surface. These dual flying spots
simultaneous ablations at symmetrical locations balance the hydration effect and
compensate spot energy profiles both spatially and temporally, while the random
projection effectively matches the random nature of such factors as hydration,
ablation debris, energy stability and eye movement.

“Flat” layer ablations, as performed by most current excimer laser systems, cover only
portions of the optical zone at various times, which would limit the full benefits of
random projection delivery. Therefore the fractal algorithm was constructed to divide
the entire treatment procedure into similar sub-treatment procedures. In this algorithm
each ablation “layer” covers the entire optical zone to varying depths rather than
successive portions of the zone at one “flat” depth. Thus true temporal averaging can
occur throughout the procedure. The unique combination of both the random and
fractal methods is called “Fractal Projection”.

3. Subjects and Methods

3.A Myopia Combined with Astigmatism

The Lasik Center registry consisted of 31 consecutive patients from September, 2002
to December, 2002 who were recruited into a prospective study for a total 54 eyes
treated. All patients signed fully informed written consents. Criteria for patient
participation included: 18 years or older, spherical equivalent of -0.25D to -12.0D,
stable myopic for the past two years, no contact lens worn for at least 2 weeks prior to
preoperative evaluation and surgery, and no active or residual corneal disease in either
eye. Bilateral LASIK surgeries were performed.

The patients were 20 females and 11 males with ages ranging from 19 to 48 years old.
Preoperative best spectacle corrected visual acuities were 20/20. Spherical equivalent
refractions before surgery ranged between -1.0D and -12.75D and attempted
corrections were from 1.0D to 12.0D.

Preoperative examinations included slit lamp microscopy, uncorrected visual acuity,

best corrected visual acuity, manifest and cycloplegic refraction, corneal topography
and pachymetry of the central cornea.
3.B Hyperopia Combined with Astigmatism

The Lasik Center registry consisted of 12 consecutive patients from September, 2002
to December, 2002 who were recruited into a prospective study for a total 21 eyes
treated. All patients signed fully informed written consents. Criteria for patient
participation included: 18 years or older, spherical equivalent of +0.25D to +6.0D,
stable hyperopic for the past two years, no contact lens worn for at least 2 weeks prior
to preoperative evaluation and surgery, and no active or residual corneal disease in
either eye. Bilateral LASIK surgeries were performed.

The patients were 9 females and 3 males with ages ranging from 18 to 47 years old.
Preoperative best spectacle corrected visual acuities were 20/20. Spherical equivalent
refractions before surgery ranged between +0.25D and +5.75D and attempted
corrections were from -0.75D to -5.75D.

Preoperative examinations included slit lamp microscopy, uncorrected visual acuity,

best corrected visual acuity, manifest and cycloplegic refraction, corneal topography
and pachymetry of the central cornea.

4. Surgical Technique

The surgeries were performed with the 193nm Kera IsoBeam D200 laser at a
repetition rate of 300Hz (600Hz effective rep. rate) with dual 0.6mm square spot size
and a fluence of 92mj per cm square each. The eye tracking is a 300 Hz infrared pupil
detection system. For spherical correction, the optical zones were chosen to minimize
the ablated tissue thickness but were larger than 5.5mm with an additional 1mm
transition zone. Cylinder corrections used optical zones with the same sizes as used in
the spherical corrections but with transition zones 2mm larger than the optical zones.

An eyelid speculum was put securely in place and the eye cleaned with a normal solan
sponge. A nasally based, 160 micron flap was made with a Moria’s automatic
microkeratome. After the corneal flap was formed, the microkeratome and its suction
ring were removed and the flap was lifted and displaced nasally. Laser procedure was
performed on the stroma bed with the IsoBeam D200 excimer laser system. After
surgery, the flap was folded back to its original position.

Patients were examined at 24 hours, 1 week, 1 month and 6 months and 12 months
with a slit-lamp microscope, and for uncorrected visual acuity, best corrected visual
acuity, manifest refraction and corneal topography.

5. Clinical Results

Table 1 shows preoperative and postoperative 12 months data for 54 eyes with
myopia combined with astigmatism. Table 3 shows the postoperative unaided visual
acuity and its successful rate. In 54 of 54 eyes an unaided visual acuity of 20/40 or
better was obtained. In 52 of 54 eyes an unaided visual acuity of 20/32 or better was
obtained. In 37 of 54 eyes an unaided visual acuity of 20/20 or better was obtained.
There have no eyes lost more than 1 line of the best corrected visual acuity at 6
months follow up.

Table 2 shows preoperative and postoperative data of 21 eyes with hyperopia

combined with astigmatism. Table 3 shows the postoperative unaided visual acuity
and its successful rate. In 21 of 21 eyes an unaided visual acuity of 20/40 or better
was obtained. In 19 of 21 eyes an unaided visual acuity of 20/32 or better was
obtained. In 12 of 21 eyes an unaided visual acuity of 20/20 or better was obtained.
There have no eyes lost more than 1 line of the best corrected visual acuity at 6
months follow up.

Table 1: 12 months results for myopia combined astigmatism

treatment

# Eye Sex Preop Postop UCVA

1 OD F -5.5+2.0x90 0 0.8
2 OS F -4.0+2.0x90 -0.5x180 0.9
3 OD F -7.5+1.25x30 0 1.0
4 OS F -9.25+0.75x140 -0.75+0.75x130 1.0
5 OD F -1.25+1.0x100 0 1.2
6 OS F -1.25+1.0x100 0 1.2
7 OD M -4.75+1.75x110 0 1.0
8 OS M -4.50+0.75x90 -0.25 1.0
9 OD M -4.25+0.25x90 0 1.2
10 OS M -4.75+1.0x90 +0.25 1.2
11 OD F -2.25 0 1.0
12 OS F -2.0 +0.5 1.0
13 OD M -2.0+1.75x175 0 1.2
14 OS M -3.0+2.25x5 0 1.2
15 OD F -7.0+1.5x105 -0.5 0.8
16 OS F -6.75+0.75x90 0 1.0
17 OD M -2.25 0 1.2
18 OS M -2.75 0 1.2
19 OD F -4.5+0.75x110. -0.5 1.0
20 OS F -7.5+1.5x65 -0.25+0.25x40 1.2
21 OD F -3.75+2.25x105 0 1.2
22 OS F -4.75+1.75x105 0 1.2
23 OD F -3.75+1.25x90 0 1.0
24 OD F -6.25+1.25x95 +0.25 1.0
25 OS F -7.0+2.25x85 -1.25+1.25x125 0.8
26 OD M -2.0+1.25x80 0 1.2
27 OS M -2.25+1.25x100 0 1.0
28 OD F -4.25+1.0x70 0 1.0
29 OD F -6.0+0.25x90 0 0.6
30 OS F -6.5+0.5x90 +0.5 0.8
31 OD M -1.0 0 1.2
32 OS M -1.5+0.5x160 0 1.5
33 OD F -3.75+0.5x100 0 1.2
34 OS F -4.0+1.0x85 0 1.5
35 OD F -10.25+2.75x95 +0.5 0.6
36 OS F -11.25+1.75x90 -2.75+2.75x95 0.6
37 OD F -6.5+1.25x30 -0.75 0.6
38 OS F -7.5+3.0x140 0 1.0
39 OD M -2.0+2.0x80 -0.5x18 1.2
40 OS M -1.75+1.25x115 -0.5x166 1.0
41 OD M -1.25 +0.75 1.5
42 OS M -1.5 0 1.2
43 OS F -3.0 -0.75+0.75x130 1.2
44 OD F -6.5+1.5x95 -0.5x10 1.0
45 OS F -7.0+0.75x75 0 0.6
46 OD M -12.75+1.25x120 -0.5x60 0.8
47 OS M -11.5+0.5x105 0 0.9
48 OD F -10.5+2.0x90 0 0.8
49 OS F -9.0+2.5x105 0 0.8
50 OD F -5.0+0.5x165 0 1.0
51 OS F -5.0+0.5x135 0 1.0
52 OD M -6.0+0.5x160 0 0.8
53 OS M -6.5+0.75x50 0 1.0
54 OD F -6.75+2.25x90 -0.25-0.25x90 0.8

Table 2: 12 months results for hyperopia combined astigmatism

treatment

# Eye Sex Preop Postop UCVA

1 OD F +4.25 -0.75+0.5x130 1.2
2 OS F +4.25+0.5x150 -1.0+0.75x170 1.0
3 OD F +0.25+1.0x90 -1.25+0.75x70 0.9
4 OS F +2.0x70 0 1.0
5 OD M +2.0-0.5x138 +0.25 1.0
6 OS M -1.0+1.0x10 +0.75 1.0
7 OD F -0.75+1.25x130 -0.5 1.0
8 OS F +0.25+1.25x85 -0.75 1.2
9 OD M +3.25+2.5x85 +0.5 1.0
10 OS M +3.0+2.0x110 +0.5 1.2
11 OD F +5.50 +1.0 0.6
12 OS F +5.57 +1.5 0.6
13 OD F -0.5+6.25x110 -0.5x10 0.8
14 OS F +5.25x85 -0.5x160 0.8
15 OD M +2.5+2.25x100 -0.5x15 0.8
16 OS M +1.75+1.25x90 0 1.2
17 OS F -0.75+2.0x80 -0.25 0.8
18 OD F +0.75+1.75x45 0 1.0
19 OS F +1.5x120 0 1.0
20 OD F +3.0+0.5x145 0 1.2
21 OS F -1.25+2.25x85 -0.5+0.75x45 0.8

Table 3: 12 months post-operative visual acuity achievement chart

20/40 or better 20/32 or better 20/20 or better

Myopic astigmatism 54/54 52/54 37/54

Hyperopic astigmatism 21/21 19/21 12/21

6. Conclusion

The result from the myopia combined with astigmatism and hyperopia combined with
astigmatism clinical study demonstrate that Kera’s IsoBeam D200 excimer laser is a
safe and effective surgical laser system for correcting mild, moderate and severe
refraction defect. The good predictability and lack of island side effects prove the
value of the dual flying spots, random projection, fractal algorithm excimer laser
delivery method.

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3. Wilson SE, Klyce SD, McDonald MB, et. al., Changes in corneal topography after
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Presented by :

Dr. Eduardo Murube Jimérez Marcos Garcia Pérez

April 12th, 2005