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Original Article

Artiflex versus STAAR implantable contact lenses for

correction of high myopia
Mohammad Ghoreishi, Amin Masjedi, Kobra Nasrollahi, Aminhossein Rahgozar, Keivan Jenab, Hamid Fesharaki
Department of Ophthalmology, Isfahan University of Medical Sciences, Persian Eye Clinic, Isfahan, Iran

Purpose: To compare two phakic intraocular lenses,

Artiflex and STAAR implantable contact lens (ICL),
in high myopia.
Setting: Isfahan Ophthalmology Clinic, Iran.
Materials and Methods: In a randomized, prospective
clinical trial study, 40 eyes of 20 patients who came
to Isfahan ophthalmology clinic to correct their
refractive error were examined. Artiflex was inserted
in 20 eyes and ICL in the other 20 eyes. After 1 year,
uncorrected visual acuity (UCVA), best corrected
visual acuity (BCVA), contrast sensitivity, intraocular
pressure (IOP), and specular microscopy of corneal
endothelium were assessed in both the groups.
Results: In this study, there was no statistical difference
between UCVA, BCVA, IOP, cataract incidence, contrast

Introduction
Refractive errors are one of the most common ophthalmologic
problems. For resolving this, there are several therapeutic methods
such as corrective spectacles, contact lenses, keratorefractive
surgeries, intraocular lenses (IOLs), and clear lens extraction.
There are many complications after keratorefractive surgeries of

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DOI:
10.4103/0974-620X.91266

sensitivity, and specular microscopy, 1 year after surgery.

40% of eyes in the Artiflex group developed anterior
chamber cell and flare reaction 1 year postoperatively,
but no patient in the ICL group developed the same.
So, there is obvious difference in the rate of anterior
chamber cell and flare reaction between these two
groups.
Conclusion: These two lenses have similar outcomes
except in the incidence rate of anterior chamber cell
and flare reaction that is greater in the Artiflex group.
So, these two lenses are safe with predictable outcome
in treating high myopia.
Keywords: Contrast sensitivity, intraocular pressure,
myopia, phakic intraocular lens, specular microscopy,
visual acuity

high refractive errors, such as glare, halo, and contrast sensitivity

loss due to higher order aberration induced by keratorefractive
surgery. The over flattening of the central cornea can cause higher
order aberration.[1-3]
IOLs can correct high refractive errors without any change in the
shape of cornea.[4,5]
Several types of phakic IOLs (pIOLs) are available, such as
anterior chamber phakic IOLs (ACpIOLs) and posterior chamber
phakic IOLs (PCpIOLs). An example of the ACpIOL is Artiflex;
the implantable contact lens (ICL) or STAAR lens is an example
of a PCpIOL. The Artiflex is made of polysiloxane and the ICL
(STAAR) is made of a hydrophilic material known as Collamer.
In this article, we compare the two types of pIOLs, Artiflex versus
STAAR, for correcting high myopia.

Copyright: 2011 Ghoreishi M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Correspondence:
Dr. Amin Masjedi, Isfahan University of Medical Sciences, Persian Eye Clinic, No.208, Mir Street, Isfahan, Iran. E-mail: Amin1827@yahoo.co.nz

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Ghoreishi, et al.: Comparison of Artiflex and STAAR phakic intraocular lenses

Materials and Methods

This was a randomized, prospective clinical trial. This study was
performed on 40 eyes of 20 patients with high myopia, seeking
correction of their refractive error. Patients with underlying
systemic diseases such as hypertension, diabetes mellitus,
malignancies or other ocular diseases were excluded from the
study. The procedure, advantages, probable complications and
other therapeutic alternatives were described to all the patients.
This study was performed after obtaining informed consent from
the patients.
All the patients were over 20 years of age and underwent
complete ophthalmologic examination. The best corrected and
uncorrected visual acuities were similar between two eyes. The
refractive error was 6 to 14 diopters, with the astigmatism up
to 2 diopters. There was no anisometropia in the patients. The
anterior chamber depth was greater than 3 mm in all the patients,
determined ultrasonographically from the endothelial surface of
cornea to anterior surface of the iris. Randomly, an Artiflex pIOL
was inserted in one eye and an ICL (STAAR) was implanted in
the other eye with 2 weeks interval. This interval was chosen
to prevent binocular complication of intraocular surgery or
reaction to IOL material. All of the patients underwent surgery
under local anesthesia, with small temporal incision (3.2 mm). A
surgical peripheral iridectomy (PI) was performed in all patients
and the incision was closed with corneal stromal hydration.
Postoperatively, all the patients were followed at regular intervals
(day 1, week 1, week 2, month 1, month 2, month 6, and year
1) to evaluate the outcomes and complication. After 1 year,
all the patients were reevaluated. Visual acuities, intraocular
pressure (IOP), intraocular inflammation, cataract formation,
contrast sensitivity (3, 6, 12, 18 cycles per degree), and specular
microscopy for corneal endothelium were assessed.

Results
All patients were between 26 and 29 years old (mean = 27 years).
Ten patients were males and the other 10 were females.
Artiflex pIOL group: In this study, the Artiflex pIOL was inserted
in 20 eyes. The mean postoperative sphere equivalent was 0.75
diopters in the ICL group and 0.84 diopters in Artiflex group.
The postoperative mean cylinder power was lesser than 0.25
diopters in both groups. The preoperative uncorrected visual
acuities (UCVA) were counting finger (CF) at 1 m for 12 eyes,
CF at 2 m for 7 eyes, and CF at 3 m for 1 eye. The preoperative
best corrected visual acuities (BCVA) were 10/10 for 10 eyes, 9/10
for 8 eyes, and 7/10 for 2 eyes. One year after surgery, the UCVAs
were 10/10 for 12 eyes, 9/10 for 3 eyes, 8/10 for 3 eyes, and 7/10
for 2 eyes. The BCVAs were 10/10 for 17 eyes and 9/10 for 3 eyes.
There was a statistically significant difference between preoperative
and postoperative UCVA in Artiflex group (P = 0.000). There was
also a statistically significant difference between preoperative and
postoperative BCVA in this group (P = 0.011).
Oman Journal of Ophthalmology, Vol. 4, No. 3, 2011

STAAR ICL group: For other eyes of 20 patients, we inserted ICL.

Preoperative UCVAs were CF at 1 m for 13 eyes, CF at 2 m for 6
eyes, and CF at 3 m for 1 eye. Preoperative BCVAs were 10/10 for
10 eyes, 9/10 for 8 eyes, and 7/10 for 2 eyes. Postoperative UCVAs
were 10/10 for 11 eyes, 9/10 for 6 eyes, 8/10 for 1 eye, 7/10 for 1
eye, and 6/10 for 1 eye. Postoperative BCVAs were 10/10 for 17
eyes and 9/10 for 3 eyes [Tables 14].
There was a statistically significant difference between preoperative
and postoperative UCVA in the ICL group (P = 0.000). There was
also a statistically significant difference between preoperative and
postoperative BCVA in this group (P = 0.011).
There was no statistically significant difference between
postoperative UCVA or BCVA between Artiflex and ICL groups
(P = 0.786).
In assessing the IOP that was measured by Goldman tonometry,
there was no significant difference of preoperative IOP between
the two groups (P = 0.76). There was statistically significant
difference between preoperative and postoperative IOP in Artiflex
and ICL groups (P = 0.001) [Table 5]. There was no case of
glaucoma or IOP greater than 21 mm Hg, 1 year after surgery.
There was no statistical difference of IOP between two groups 1
year postoperatively (P = 0.604).
In assessing the crystalline lens opacity, there was one case of
posterior subcapsular cataract 1 year after surgery in each group.
There was no significant difference in cataract formation rate after
surgery between the two groups (P = 1.0).
In assessing the status of the corneal endothelium by specular
microscopy, no statistically significant difference of postoperative
mean endothelial cell count and coefficient of variation (CV)
between two groups was found (P = 0.72 and 0.25, respectively)
[Table 6]. The hexagonal endothelial cell percent was similar
between the two groups 1 year postoperatively (P = 0.73).
With respect to the anterior chamber cell and flare, in the Artiflex
group, eight eyes developed trace cell and flare in the anterior
chamber 1 year after operation, but there was no case of anterior
chamber cell and flare in the ICL group postoperatively. The
difference was statistically significant (P = 0.03).
There was no statistically significant difference in contrast
sensitivity between the two groups [Table 7].

Discussion
The aim of this study was to compare the outcomes and
complications of two pIOLs in patients with high myopia. In
several studies, pIOL has been reported as a safe, effective, stable,
and predictable method for correcting refractive errors such as
high myopia and hyperopia.[6-8]
This method has also been used for correcting high myopic
astigmatism.[9]
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Ghoreishi, et al.: Comparison of Artiflex and STAAR phakic intraocular lenses

Table 1: The preoperative uncorrected visual

acuity (Log MAR) of implantable contact lens and
Artiflex group
Artiflex
Implantable
contact lens

Log MAR=1.8
12
13

Log MAR=1.5
7
6

Log MAR=1.3
1
1

Table 3: The postoperative uncorrected visual

acuity of implantable contact lens and Artiflex
group
Artiflex
Implantable contact lens

Log MAR<0.1

Log MAR>0.1

18
18

2
2

Table 5: The mean pre and postoperative

intraocular pressure of implantable contact lens
and Artiflex group. (mm Hg)
Artiflex
Implantable
contact lens

Preoperative
IOP
12.90
13.05

Postoperative
IOP
14.68
14.37

P-value
0.001
0.001

IOP: Intraocular pressure

Table 7:The postoperative contrast sensitivity of

implantable contact lens and Artiflex group.
(mm Hg) and Artiflex group
Lens type
3 cycles/
degree
6 cycles/
degree
12 cycles/
degree
18 cycles/
degree

ICL
Artiflex
ICL
Artiflex
ICL
Artiflex
ICL
Artiflex

Mean
value
1.44
1.52
1.56
1.58
1.06
1.07
0.62
0.61

Standard
deviation
0.18
0.21
0.19
0.27
0.27
0.27
0.26
0.29

P-value=0.80

P-value=0.33
P-value=0.88
P-value=0.70

In our study, the Artiflex pIOL was inserted in one eye and the
ICL in the other eye of 20 patients randomly, to exclude the effects
of sex, age, and person as confounding effects. As mentioned
previously, no significant difference in visual acuity improvement
was detected between the two groups. In a study conducted in
the USA, two pIOLs (Visian ICL versus Verisyse) were compared.
In that study, only the binocular UCVA was better in Visian ICL
group; there was no difference in monocular UCVA between the
two groups. A better refractive outcome was reported in the Visian
ICL group.[10]
As mentioned previously, a postoperative IOP rise was noted
in both groups 1 year after surgery; but there was no case of
glaucoma or IOP greater than 21 mm Hg. This may be due to
118

Table 2: The preoperative best corrected visual

acuity (Log MAR) of implantable contact lens and
Artiflex group
Artiflex
Implantable
contact lens

Log MAR=0.04

Log MAR=0

Log MAR=0.15

10
10

8
8

2
2

Table 4: The postoperative best corrected visual

acuity of implantable contact lens and Artiflex
group
Artiflex
Implantable contact lens

Log MAR=0

Log MAR=0.04

17
17

3
3

Table 6: The postoperative mean and standard

deviation of endothelial cell count of implantable
contact lens and Artiflex group
Mean cell
count/mm2
Coefficient of
variation

Lens type
ICL
Artiflex
ICL
Artiflex

Cell count
2642269
2698304
39.255.39
39.558.21

P value
0.75
0.25

performance of a routine surgical peripheral iridectomy during the

surgery. The high vaulting of ICL can cause pupillary block and
close angle glaucoma. The Artiflex can also cause angle closure
glaucoma induced by pupillary block. Iris pigment release can
also cause increased IOP. In a study that assessed the effect of ICL
on anterior chamber angle and pigmentation, it was noted that
the ICL caused narrowing of anterior chamber angle from 30 to
20 in 20% of patients. Pigment in the anterior chamber increased
following iridotomy. Pigment release may also be attributed to iris
rubbing over the ICL. However, this increased pigmentation is
transient and improved over 12 months. In this study, the elevated
IOP may be due to application of topical steroid 1 week and 1
month postoperatively, which reaches the normal level gradually
during 12 months after surgery. So, the ICL insertion seems to
be a safe method, but can cause pigmentary change in trabecular
meshwork.[11]
Incidence of cataract formation does not differ between these
two groups. In each group, only one case developed posterior
subcapsular cataract. The ICL with small size has small vault, so
the probability of cataract formation does increase. In one study,
PCpIOLs induced anterior subcapsular cataract.[12]
The causes of the cataract formation are unknown, but may be
due to altered aqueous humor dynamics or restricted perfusion.[13]
A major concern about pIOLs is endothelial cell damage.[14,15] Our
study showed no significant difference of endothelial cell density
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Ghoreishi, et al.: Comparison of Artiflex and STAAR phakic intraocular lenses

and CV of endothelial cell between two eyes 1 year after surgery. A
longer follow-up is necessary. In one study where the effect of irisfixated pIOL on endothelium was evaluated, the endothelial cell
loss was shown during the 5 years after surgery, especially in the
first 2 years. However, decrease in CV and increase in hexagonal
cells was detected gradually during 5 years after surgery. This may
indicate increased stability and remodeling of endothelial cells.[16]
ICL can cause rapid endothelial cell loss initially. However, the
hexagonal cell percentage and CV are stable during 5 years after
surgery.[17]
Long-term follow-ups reveal that there is no ongoing chronic cell
loss in endothelium layer 4 years after ICL insertion.
In our study, there was a higher incidence of anterior chamber
cell and flare in the Artiflex group, which may be attributed to iris
rubbing between IOL and crystalline lens.[18]
Anterior uveitis after pIOL insertion has been reported in several
studies.[19,20] This complication may be recurrent in the Artiflex
group.[21] The patients with anterior chamber cell and flare have
no pain, conjunctival hyperemia, keratic precipitate or other signs
of uveitis. So, we cannot consider this evident as anterior uveitis.
Recurrent uveitis can lead to occlusion of iridectomy.[22]

5.
6.

7.

8.

9.

10.

11.

12.

13.

14.

There is no significant difference of contrast sensitivities between

two groups postoperatively. It seems that pIOL cause less decrease
in contrast sensitivity due to less spherical aberration in contrast
to corneal laser ablation.

15.

In summary, these two pIOLs have similar visual outcomes and

short-term complication rates with the exception of greater
anterior chamber cell and flare in the Artiflex group.

17.

Our study reveals that both these pIOLs are effective and safe, and
their implantation is a predictable method for refractive surgery
in high myopia.

16.

18.

19.

References

20.

1.

21.

2.
3.

4.

Hersh PS, Brint SF, Maloney RK. Photorefractive keratectomy versus

laser in situ kerato mileusis for moderate to high myopia: A randomized
prospective study. Ophthalmology 1998;105:1512-22.
Kawesh GM, Kezerian GM. Laser in situ keratomileusis for high myopia
with the VISX star laser. Ophthalmology 2000;107:653-61.
Pallikaris IG, Siganos DS. Eximer laser is situ kerato mileusis and
photorefractive keratectomy for correction of high myopia. J Refract
Corneal Surg 1994;10:498-510.
Arne JL, Lesueur LC. Phakic posterior chamber lens for high myopia:
Functional and anatomical outcomes. J Cataract Refract Surg
2000;26:369-74.

Oman Journal of Ophthalmology, Vol. 4, No. 3, 2011

22.

Davidorf JM, Zaldivar R, Oscherow S. Posterior chamber phakic intraocular

lens for hyperopia of +4 to +11 diopters. J Refract Surg 1998;14:306-11.
Huang D, Schallhorn SC, Sugar A, Farjo AA, Majmudar PA, Trattler
WB, et al. Phakic intraocular lens implantation for correetion of myopia:
A report by the American academy of ophthalmology. Ophthalmology
2009;116:2244-58.
Pesando PM, Ghiringhello MP, Di Megilo G, Fanton G. Posterior chamber
phakic intraocular lens for hyperopia: Ten-year follow-up. J Cataract
Refract Surg 2007;33:1579-84.
Tehrani M, Dick HB. Short term follow up after implantation of a foldable
iris fixated intraocular lens in phakic eyes. Ophthalmology 2005;112:
2189-95.
Schallhorn S, Tanzer D, Sanders DR, Sanders ML. Randomized
prospective comparison of visian toric implantable collamer lens and
conventional photorefractive keratectomy for moderate to high myopic
astigmatism. J Refract Surg 2007;23:853-67.
Boxer Wachler BS, Scruggs RT, Yuen LH, Jalali S. Comparison of the
visian ICL and Verisyse phakic intraocular lenses for myopia from 6.00 to
20.00 diopters. J Refract Surg 2009;25:765-70.
Chun YS, Park IK, Lee HI, Lee JH, Kin JC. Iris and trabecular meshwork
pigment changes after posterior chamber phakic intraocular lens
implantation. J Cataract Refract Surg 2006;32:1452-8.
Brauweiler PH, Wehler T, Busin M. High incidence of cataract formation
after implantation of a silicone posterior chamber lens in phakic, highly
myopic eyes. Ophthalmology 1999;106:1651-5.
Shirantani T, Shimizu K, Fujisawa K, Uga S, Nagano K, Murakami Y.
Crystalline lens change in porcine eyes with implanted phakic IOL (ICL)
with a central hole. Graefes Arch Clin Exp Ophthalmol 2008;246:719-28.
Edelhanser HF, Sanders DR, Azar R, Lamielle H. Corneal endothelial
assessment after ICL implantation. J Cataract Refract Surg 2004;30:
576-83.
Perez-Santonja JJ, Iradier MT, Sanz-Iglesias L, Serrano JM, Zato MA.
Endothelial change in phakic eyes with anterior chamber intraocular lens
to correct high myopia. J Cataract Refract Surg 1996;22:1017-22.
Benedetti S, Casamenti V, Benedetti M. Long term endothelial changes in
phakic eyes after Artisan intraocular lens implantation to correct myopia:
Five year study. J Cataract Refract Surg 2007;33:784-90.
Dejaco-Ruhswurm I, Scholz U, Pieh S, Hanselmayer G, Lackner B, Italon
C, et al. Long term endothelial changes in phakic eyes with posterior
chamber intraocular lenses. J Cataract Refract Surg 2002;28:1589-93.
Dick HB, Budo C, Malecaze F, Gell JL, Marinho AA, Nuijts RM, et al.
Foldable artiflex phakic intraocular lens for the correction of myopia:
Two year follow-up results of a prospective European multicenter study.
Ophthalmology 2009;116:671-7.
Perez-Santonja JJ, Iradier MT, Benitez-Del Castillo JM, Zato MA. Chronic
subclinical inflammation in phakic eyes with intraocular lenses to correct
myopia. J Cataract Refract Surg 1996;22:183-7.
Leccisotti A. Iridiocyclitis associated with angle- supported phakic
intraocular lenses. J Cataract Refract Surg 2006;32:1007-10.
Tahzib NG, Eggink FA, Fredrik PM, Nuijts RM. Recurrant intraocular
inflammation after implantation of the Artiflex phakic intraocular lens for
the correction of high myopia. J Cataract Refract Surg 2006;32:1388-9.
Park IK, Lee JM, Chun YS. Recurrent occlusion of laser iridotomy sites
after posterior chamber phakic IOL implantation. Korean J Ophthalmol
2008;22:130-2.

Cite this article as: Ghoreishi M, Masjedi A, Nasrollahi K, Rahgozar A,

Jenab K, Fesharaki H. Artiflex versus STAAR implantable contact lenses for
correction of high myopia. Oman J Ophthalmol 2011;4:116-9.
Source of Support: Nil, Conflict of Interest: No.

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