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ARTICLE
New supplementary intraocular lens for refractive
enhancement in pseudophakic patients
Günal Kahraman, MD, Michael Amon, MD
PURPOSE: To assess the efficacy and safety of implanting a secondary intraocular lens (IOL) in the
ciliary sulcus to correct pseudophakic ametropia.
SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
METHODS: This prospective nonrandomized study included patients who had implantation of a secondary IOL (Sulcoflex 653L) to correct residual refractive error after phacoemulsification with IOL
implantation in the capsular bag. After implantation of the secondary IOL in the ciliary sulcus, visual
and refractive outcomes were evaluated. Inflammation was measured with a laser flare–cell meter.
The position and rotation of the IOLs were documented at all control visits, and Scheimpflug images
were taken. Postoperative follow-up was at 1 week and 1, 6, 12, and 17 months.
RESULTS: Twelve eyes of 10 patients were evaluated. The mean spherical equivalent decreased
from –1.25 diopters (D) G 0.25 (SD) (range 2.00 to C4.00 D) preoperatively to 0.25 G
0.40 D (range 0.50 to C0.25 D) postoperatively. Uncorrected distance visual acuity improved
in all cases. There were no significant intraoperative or postoperative complications.
CONCLUSIONS: Sulcus implantation of the secondary IOL to correct pseudophakic refractive error
was safe and predictable. The IOL was well tolerated in all eyes.
Financial Disclosure: Neither author has a financial or proprietary interest in any material or
method mentioned. Additional disclosures are found in the footnotes.
J Cataract Refract Surg 2010; 36:1090–1094 Q 2010 ASCRS and ESCRS
Despite advances in intraocular lens (IOL) power
calculation formulas and the availability of accurate biometry techniques, pseudophakic refractive errors are
unavoidable in some cases. In 1993, Gayton and
Sanders1 first described the piggyback IOL technique
to provide adequate power in highly hyperopic
patients. The technique was extended to secondary
Submitted: April 24, 2009.
Final revision submitted: December 23, 2009.
Accepted: December 24, 2009.
From the Department of Ophthalmology, Medical University of
Vienna, Vienna, Austria.
Additional financial disclosure: Dr. Amon is a consultant to Rayner
Intraocular Lenses Ltd.
Presented at the XXV Congress of the European Society of Cataract
& Refractive Surgeons, Stockholm, Sweden, September 2007.
Corresponding author: Günal Kahraman, MD, Krankenhaus der
Barmherzigen Brüder, Abteilung für Augenheilkunde, Johannes
von Gott Platz 1, 1020 Vienna, Austria. E-mail: [email protected].
1090
Q 2010 ASCRS and ESCRS
Published by Elsevier Inc.
cases in which additional power is added or subtracted
in an underpowered or overpowered pseudophakic
eye. Since then, many surgeons have used piggyback IOL implantation in less extreme cases of
hyperopia in which a single IOL could not give the
required power.
Implanting 2 piggyback IOLs in the capsular bag raises concerns about the risk for interlenticular opacification (ILO) with Elschnig pearl proliferation in the
peripheral interface between 2 IOLs.2–4 This complication can decrease vision secondary to a postoperative hyperopic shift and cause opacification. Several methods
to prevent ILO in eyes with piggyback IOLs have been
discussed. One is to place the primary IOL in the capsular bag and the secondary IOL in the ciliary sulcus. The
first IOL is implanted in the bag posterior to the
continuous curvilinear capsulorhexis edge to help isolate lens equatorial cells from the interlenticular space.5,6
This study evaluated the visual outcomes and
safety of the newly introduced IOL designed for implantation in the ciliary sulcus to correct pseudophakic
refractive errors in the pseudophakic eye. The IOL was
implanted using a piggyback technique.
0886-3350/$dsee front matter
doi:10.1016/j.jcrs.2009.12.045
SECONDARY IOL IN CILIARY SULCUS FOR PSEUDOPHAKIC AMETROPIA
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PATIENTS AND METHODS
This prospective nonrandomized study included pseudophakic patients who had unsatisfactory far distance vision
with spectacles. The study was performed at the Department
of Ophthalmology, Medical University of Vienna, between
May 2007 and October 2008 according to the principles of
the Declaration of Helsinki and good clinical practice guidelines. All patients provided written informed consent before
surgery, and the local ethics committee approved the study.
Only patients without preexisting ocular pathology other
than previous cataract extraction by phacoemulsification
with in-the-bag IOL implantation were selected. Patients
with more than 1.00 diopter (D) of corneal astigmatism
were excluded.
Preoperative Assessment
Before surgery, all patients had a complete eye examination that included uncorrected (UDVA) and corrected
(CDVA) distance visual acuity, Goldmann applanation
tonometry, and fundoscopy. The axial length (AL), anterior
chamber depth (ACD), back vertex distance, and
keratometric values were determined using biometry (IOLMaster, Carl Zeiss Meditec). The power of the secondary
IOL was determined using the Haigis formula based on
ACD and effective lens power.A
Figure 1. Photograph of the secondary IOL.
Intraocular Lens
The secondary IOL in this study was a foldable aspheric
model designed for fixation in the ciliary sulcus (Sulcoflex
653L, Rayner Intraocular Lenses Ltd.) (Figure 1). The
single-piece hydrophilic acrylic IOL has an overall size of
13.5 mm. The 6.5 mm optic has a rounded edge and a concave
posterior surface. The haptics have 10 degrees of posterior
angulation and an undulating configuration with rounded
edges.
Surgical Technique
The same surgeon (M.A) performed all secondary IOL
implantations through a self-sealing clear corneal incision
(2.75 mm) under topical and intracameral anesthesia using
a standardized technique. Before surgery, pupils were
dilated with tropicamide, phenylephrine hydrochloride
2.5%, cyclopentolate 1.0%, and diclofenac sodium 0.1%.
The anterior chamber and retroiridial space were filled
with sodium hyaluronate 1% (Healon). The secondary IOL
was implanted in the ciliary sulcus using the supplied
1-piece single-use injector. The surgeon then checked to
ensure the IOL was well centered. The ophthalmic viscosurgical device was washed out, acetylcholine 1% was injected
intracamerally, and cefuroxime 1.0 mg (0.3 mL) was administered. After surgery, all patients received topical gentamicin–dexamethasone and diclofenac sodium 0.1% eyedrops
3 times a day for 4 weeks.
Postoperative Assessment
Postoperative examinations were performed at 1 week and
1, 6, 12, and 17 months. The primary outcome measures were
UDVA, CDVA, and complications. A laser flare–cell meter
(FC-1000, Kowa Co., Ltd.) was used to measure anterior chamber inflammation at each visit. The measurements were taken
after visual acuity was tested and 20 minutes after administration of phenylephrine 2.5% and tropicamide 0.5%.
At slitlamp examination was performed using a standardized evaluation form and the following were subjectively assessed: IOL position and centration, distance between the iris
and the secondary IOL, distance between the primary IOL
and the secondary IOL, haptic position, and pigment dispersion. At each visit, digital retroillumination images of the
IOLs were obtained using a digital camera (Nikon/Kodak
NC2000e, Eastman Kodak Co.) mounted on a modified Zeiss
30 slitlamp (Carl Zeiss Meditec) with an external light and
flashlight source. The flashlight provides coaxial illumination
from a flash pack through a fiber-optic cable to the camera. Rotating Scheimpflug photographs (Pentacam, Oculus Optikgeräte GmbH), and in some cases ultrasound biomicroscopy
(UBM) images, were taken. Intraocular pressure (IOP) measurement was followed by a retinal examination.
RESULTS
The study evaluated 12 eyes of 10 patients. The median
age of the 6 women and 4 men was 53.58 years (range
32 to 74 years). Table 1 shows the patients’ demographics and power of the secondary IOL. The mean
follow-up after secondary IOL implantation was 12
months (range 6 to 17 months).
The residual refractive error ranged from 2.00 D
to C4.00 D. The mean spherical equivalent decreased
from 1.25 D G 0.25 (SD) (range 2.00 to C4.00 D)
preoperatively to 0.25 G 0.40 D (range 0.50 to
C0.25 D) postoperatively. All patients had improved
UDVA postoperatively; the mean Snellen UDVA
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SECONDARY IOL IN CILIARY SULCUS FOR PSEUDOPHAKIC AMETROPIA
Table 1. Patient demographics and supplementary IOL power.
Eye
1
2
3
4
5
6
7
8
9
10
11
12
Age (Y)
Sex
32
32
54
54
63
66
47
74
67
49
51
54
F
F
F
F
M
F
M
F
M
F
F
M
IOL Power (D)
2.00
2.00
2.00
2.00
1.00
0.50
4.00
2.00
3.00
1.50
2.00
2.00
Figure 2. Secondary IOL 15 months postoperatively. The arrows
indicate the haptic shoulder of the secondary IOL.
IOL Z intraocular lens
1 month postoperatively was 0.9 G 0.1, which remained stable throughout the study.
Three eyes (25.0%) had a neodymium:YAG
(Nd:YAG) laser capsulotomy before secondary IOL
implantation. Two eyes (16.6%) of 1 patient had
implantation of a refractive multifocal IOL (Acri.Sil
737D, Acri.Tec GmbH) (Figure 2).
All surgeries were uneventful. One eye (8.3%) had
an IOP increase to 28 mm Hg on the first postoperative
day. After 7 days of dorzolamide hydrochloride timolol
maleate eyedrops twice daily, the IOP was 12 mm Hg
and the antiglaucoma therapy was discontinued.
The IOP remained stable (maximum 16 mm Hg)
throughout the follow-up (17 months). No other eye
had increased IOP postoperatively.
No signs of pigment dispersion, iris bulging,
foreign-body giant cell formation, or ILO were observed during the follow-up (Figure 3). Decentration
of the secondary IOL occurred in 1 eye (8.3%); the
decentration was less than 0.5 mm 1 day postoperatively and remained stable throughout the follow-up
(17 months). The other IOLs were well centered at all
postoperative visits. There were no cases of IOL
rotation or tilt. The Scheimpflug images showed the
same IOL lens distances at all postoperative visits
(Figure 4). The UBM images confirmed that the IOL
position was stable in all cases (Figure 5).
Table 2 shows laser flare values over time. There
was no significant difference between the preoperative
value and any postoperative value.
pseudophakic refractive errors. A study by HabotWilner et al.7 found that piggyback implantation of
an appropriate IOL in the ciliary sulcus is a reasonable
option for correcting pseudophakic refractive error,
and our results confirm this.
Werner et al.8 suggest that implantation of a posterior IOL in the capsular bag and an anterior IOL in
the ciliary sulcus prevents ILO formation. The results
in our pilot study agree with this because no eye developed ILO. In all eyes, the distance between the primary IOL and secondary IOL remained stable over
the postoperative follow-up. We used Scheimpflug
photography to evaluate the distance between the
optics of 2 IOLs, although the method did not allow
assessment of the relationship between the haptic
and the iris. The Scheimpflug photography showed
a well-centered IOL except in 1 case (eye 1), in which
the secondary IOL was decentered by less than
0.05 mm. The distance was always good in the optic
zone (Figures 6 and 7). The eye with slight IOL
DISCUSSION
Before cataract surgery, patients have high visual expectations. Postoperative residual refractive error is
frustrating for surgeon and patient. Our results show
that secondary IOL implantation in the ciliary sulcus
is safe, less traumatic, and predictable in correcting
Figure 3. Digital retroillumination image 6 months postoperatively
shows no signs of pigment dispersion and 2 clear IOLs. The arrows
indicate the optic edge of the secondary IOL.
J CATARACT REFRACT SURG - VOL 36, JULY 2010
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SECONDARY IOL IN CILIARY SULCUS FOR PSEUDOPHAKIC AMETROPIA
Figure 4. Scheimpflug image (eye 8) shows good distance between
the 2 IOLs (I Z anterior surface of secondary IOL; II Z posterior
surface of secondary IOL; III Z anterior surface of primary IOL;
IV Z posterior surface of primary IOL).
Figure 5. Ultrasound biomicroscopy (eye 2) shows good distance
between the iris and optic (I), secondary IOL haptics in the ciliary
sulcus (II), the primary IOL in the capsular bag (III), and the pupillary margin (IV).
decentration had an AL of 31.53 mm. We believe that
the eye’s large ciliary diameter and weak zonular
support caused the secondary IOL to decenter, which
did not negatively affect the patient’s vision. We also
believe that the posterior concave design of the
secondary IOL prevented contact between and
distortion of the optical zones.
Implanting a secondary IOL with thick haptics and
square-edged haptics or optic in the ciliary sulcus may
cause sulcus irritation followed by pigment dispersion. The incidence of pigment dispersion syndrome,
iris chafing syndrome, and intermittent uveitis–
glaucoma–hyphema syndrome is higher after secondary IOL implantation in the ciliary sulcus.9,10 Pigment
dispersion has been observed when the optic margin
or haptics chafe against the iris pigment epithelium.
In our study, no eye had signs of pigment dispersion
or iris chafing. This is because the haptic and optic
edges of the secondary IOL are rounded. Also, the haptics have a posterior angulation of 10 degrees, keeping
the optic away from the iris. Theoretically, the rounded
optic and haptic edges prevent the complications that
can occur with single-piece IOLs with square, thick
edges and no haptic angulation. At the last follow-up,
no eye had damage to the iris. Long-term observation
is needed to confirm this observation.
The rotational stability of any sulcus-placed IOL is
crucial because rotation in the sulcus not only causes
optical distortion, but also increases the risk for ciliary
body irritation. This, in turn, can lead to pigment dispersion. The undulating configuration of the outer
haptic edges of the secondary IOL was designed to
preserve IOL stability and reduce the risk for IOL
rotation in the sulcus.
In addition to pigment dispersion, there is a risk for
elevated IOP after IOL implantation in the sulcus. One
eye in our study (eye 1) had a rise in IOP, which we believe was the result of residual OVD postoperatively.
Secondary piggyback implantation can also cause pupil capture of the optic.11,12 In our study, there were no
cases of optic capture because the secondary IOL has
a large optic (6.5 mm) with 10 degrees of posterior haptic angulation.
A study by Caporossi et al.13 found that the strength
and memory of haptics of 1-piece hydrophobic acrylic
IOLs are excellent and that these IOLs can be folded
without damaging the haptics during implantation.
In addition, the compression force of 1-piece IOLs is
low and the decay of this force is more stable than
that of IOLs with poly(methyl methacrylate) haptics,
which require higher compression forces that diminish
rapidly.14 Therefore, 1-piece hydrophilic acrylic IOLs
can withstand the stress of implantation through
a small incision and thus minimize haptic damage.
In contrast, 3-piece IOLs lose their memory in the capsular bag, causing the IOL optic to shift.15,16 Our UBM
Table 2. Laser flare values and differences over time.
Laser Flare
Value (Photons/ms)
Postop
Eye
1
2
3
4
5
6
7
8
9
10
11
12
Preop
1 Mo
6 Mo
12.2
16.3
9.6
4.3
4.0
14.2
11.3
6.1
1.3
9.1
12.3
5.5
14.2
16.7
6.4
9.3
6.9
12.2
9.3
7.6
7.6
16.6
14.9
12.1
13.3
14.2
7.2
5.1
4.7
11.3
12.5
8.3
3.2
6.1
13.2
5.0
J CATARACT REFRACT SURG - VOL 36, JULY 2010
Difference
Preop to 1 Mo
2.0
0.4
3.2
5.0
2.9
2.0
2.0
1.5
6.3
7.5
2.6
6.6
1 Mo to 6 Mo
1.1
2.1
2.4
0.8
0.7
2.9
1.2
2.2
1.9
3.0
0.9
0.5
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SECONDARY IOL IN CILIARY SULCUS FOR PSEUDOPHAKIC AMETROPIA
Figure 6. Photograph (eye 3) taken 12 months postoperatively shows
that the distance between the 2 IOLs has remained stable (I Z posterior surface of secondary IOL; II Z anterior surface of secondary
IOL; III Z anterior surface of primary IOL).
evaluation of the relationship between the haptic and
iris in 5 eyes showed the secondary IOL was in the sulcus with no iris touch. Despite the flexibility of the
IOL’s material, and thus its haptics, the optic is far
enough away from the iris–pupil edge because of the
high memory of the hydrophilic acrylic material.
This may also contribute to the IOL’s stability in the
sulcus and the decreased risk for tilt and decentration.
In conclusion, our pilot study found that implantation of a secondary IOL in the ciliary sulcus was safe,
causing less trauma to surrounding tissues than would
occur after IOL exchange. Follow-up examinations to
date have found no complications.
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Figure 7. Photograph (eye 1) taken 12 months postoperatively shows
a slightly decentered primary IOL after Nd:YAG laser capsulotomy
and before secondary IOL implantation (I Z haptic edge of primary
IOL; II Z optic edge of primary IOL in the capsular bag; III Z optic
edge of secondary IOL; IV Z Nd:YAG laser pits in primary IOL).
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OTHER CITED MATERIAL
A. Wolfgang Haigis, MS, PhD, personal communication, May
2007).
J CATARACT REFRACT SURG - VOL 36, JULY 2010
First author:
Günal Kahraman, MD
Department of Ophthalmology,
Academic Teaching Hospital of
St. John, Vienna, Austria