REVIEW

URRENT
C
OPINION

Refractive lens exchange versus phakic

intraocular lenses
Mayank A. Nanavaty a and Sheraz M. Daya a,b

Purpose of review
To review the evidential basis of current practice in refractive lens exchange (RLE) vs. phakic intraocular
lens (pIOL).
Recent findings
Visual outcomes after pIOLs are better than RLE. With RLE, there still remain risks of retinal detachment,
cystoid macular oedema, glare, halos and posterior capsule opacification. With pIOLs, risks include
pigment dispersion, cataract formation, glaucoma and inflammation. The decision to choose between
either is broadly based on age and type of refractive error, and the choice follows thorough evaluation
and counselling taking into consideration patients needs and expectations.
Summary
With advancing technology, newer IOL models for RLE and phakic correction are becoming available.
pIOLs provide better visual outcomes for distance correction and currently do not provide near-vision
correction possible with RLE.
Keywords
hypermetropia, myopia, phakic intraocular lens, refractive lens exchange

INTRODUCTION
Alternative options to laser ablative refractive
surgery include refractive lens exchange (RLE) and
phakic intraocular lens (pIOL) implantation. In
determining the choice between RLE and pIOLs,
several parameters need to be considered, including
patient age, level of correction and the patients
desires in terms of visual correction such as correction of presbyopia. This assumes that anterior
segment dimensions are appropriate in the case
of pIOLs.
Both RLE and pIOLs have been demonstrated
to be well tolerated and effective options for the
correction of refractive error. Both options involve
ocular penetration and the very low but real risk of
endophthalmitis. This risk has been reduced considerably by the advent of intraocular cefuroxime [1]
and incorporation into current practice in Europe.
The other concern in patients undergoing elective
intraocular surgery for the correction is retinal
detachment, which has been reported for both
RLE and pIOLs [26]. The other possible complication that requires consideration following intraocular surgery is cystoid macular oedema (CME)
which can be transient but in cases of posterior
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hyaloid traction can become chronic and require

intervention.

REFRACTIVE LENS EXCHANGE

RLE is well tolerated and effective for the correction
of moderate-to-severe myopia [712] and hyperopia
[1318]. Monofocal, toric, multifocal and accommodative intraocular lenses are all used based on
patient needs and expectations. The safety of the
procedure is enhanced through the introduction of
microincision cataract surgery (MICS) and the introduction of lenses that can be inserted through
1.8 mm incisions. Because RLE causes loss of accommodation and in spite of the advent of multifocal
and accommodating lenses, the procedure is best to

a
Corneoplastic Unit, Queen Victoria Hospital and bCentre for Sight, East
Grinstead, UK

Correspondence to Sheraz M. Daya, MD, FACP, FACS, FRCSEd,

Centre for Sight, Hazelden Place, Turners Hill Road, East Grinstead
RH19 4RH, UK. E-mail: sdaya@centreforsight.com
Curr Opin Ophthalmol 2012, 23:5461
DOI:10.1097/ICU.0b013e32834cd5d1
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RLE Vs pIOLs Nanavaty and Daya

KEY POINTS

Refractive lens exchange and phakic intraocular lens
(IOL) implantation are well tolerated and
effective procedures.

Refractive lens exchange has the advantage of
providing greater depth of focus through the use of
multifocal and accommodative lenses.

Retinal detachment in myopes following refractive lens
exchange is a concern and this procedure is best
undertaken in older persons with myopia (>55 years)
with evidence of posterior vitreous detachment.

Phakic IOLs may be a safer option in younger myopic
eyes with deep anterior chambers, whereas in
hyperopia, phakic lenses may not be an option
because of anterior segment dimensions and refractive
lens exchange may be a better option which can be
undertaken at an earlier age (>48 years).

The choice of procedure should be made following a
thorough clinical workup and individualized to the
patient, their refractive error, age and their
visual needs.

be avoided when the natural lens is still functional

[1923]. Several multifocal IOLs are available in
the market, which include AcrySof Restor (Alcon
Laboratories, Forth Worth, Texas, USA), AcriLisa
(Acritec, Hennigsdorf, Germany) and Tecnis multifocal (Abbott Laboratories, Abbott Park, Chicago,
USA). Newer multifocal lenses such as the MPlus
(Oculentis, Eerbeeck, The Netherlands) and the
FINEvision trifocal (Physiol, Lie`ge, Belgium) provide
patients with increased depth of focus including
near, intermediate and distance vision and make
RLE a very attractive option for both patient and
surgeon.

PHAKIC INTRAOCULAR LENSES

Several phakic lenses are available commercially
and include the Visian Implantable Contact Lens
(Staar Surgical, Monrovia, California, USA). This is
made of flexible Collamer and can be folded and
inserted through a 3 mm incision. The implant is
placed horizontally behind the iris vaulting off the
crystalline lens. The toric variety of the lens is available outside the USA and can be used to correct up to
6.0D of astigmatism. Lens sizing is critical and the
horizontal white-to-white measurement is used.
This assumes there is a relationship between the
limbus and sulcus. Ultrasound biomicroscopy
(UBM) visualizes the sulcus and is a more accurate
method of assessment. A specific device, the STS
UBM (Quantel, France), has been designed

specifically for the implantable collamer lens (ICL)

and in an automated manner takes 10 readings of
the sulcus-to-sulcus as well as other dimensions
including anterior chamber depth (ACD). Peripheral
iridotomies are required to prevent pupillary block;
however, a new version of the lens the Staar V4C has
a 360-mm central perforation in the optic that obviates the need for iridotomies.
The compressed polymethyl methacrylate
(PMMA) Artisan (Veriseyes) (Ophtec, Gronningen,
The Netherlands) and foldable variety the silicon
Artiflex (Veriflex) are anterior chamber phakic lenes
that are attached onto the iris by a process known as
enclavation and thus commonly referred to as the
iris-claw lens. A minimum ACD of 2.8 mm is
required and the iris preferably should not have a
convex contour. Toric lenses are also available with
a cylinder up to 7.0D.
A relatively new entrant is the Cachet lens
(Alcon, Fort Worth, Texas, USA), which is an
anterior chamber lens made of a hydrophobic
acrylic material. The lens footplates are supported
by the angle. The lens is presently only available for
the correction of myopia. The lens requires a minimum ACD of 2.7 mm.

Patient expectation and personality

Like any surgical procedure, the patients needs,
expectations and personality require assessment.
Often patients have unrealistic expectations of
outcomes and may be highly demanding in their
visual requirements. Evaluation should include the
patients occupation, recreation activities as well as
day-to-day activities in terms of driving, computer
use and reading. This thumbnail view of the
patient can be obtained by a questionnaire and
elaborated upon during the consultation process.
The best candidates for refractive surgery are flexible
and open-minded individuals who understand the
need for postoperative visual adaptation, the
possible presence halos and glare, and in the case
of RLE the possibility of laser retreatment (Nd:YAG
capsulotomy or excimer laser correction of residual
refractive error).

Selection criteria
Selection between RLE and pIOLs is dependent on
various factors, which are discussed below.
Preoperative examination
The preoperative workup for RLE or pIOL implantation includes manifest and cycloplegic refraction,
Snellen uncorrected and corrected distance, intermediate and near visual acuity, pupillometry,

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Cataract surgery and lens implantation

applanation tonometry, fundus evaluation, corneal

topography, pachymetry and lens biometry preferably with partial coherence interferometry devices
(e.g. IOLMaster, Zeiss Meditec, Jena, Germany). A
careful fundus evaluation is vital to ensure the peripheral retina is intact and to document the status of
the macula and vitreous. If a phakic lens is being
considered than specular microscopy to measure
the endothelial cell count (ECC), ACD and whiteto-white measurements are additional required
investigations. Development of anterior segment
imaging techniques such as anterior segment optical coherence tomography (ASOCT), UBM and
Scheimpflug imaging have made it possible to accurately determine the internal diameter of the
anterior chamber, the angle-to-angle distance and
in the case of UBM sulcus-to-sulcus distance.
Age
RLE would not be considered in patients under the
age of 50 except in high hyperopes (4.00 and
greater) and where the anterior chamber depth is
shallow and thus unsuitable for a pIOL. In this type
of situation, an age threshold of 45 years might be
considered. Myopes are highly motivated to retain
their near vision and pose a dilemma as they would
become presbyopic if they received a pIOL and were
in their late 40s. Additionally, because of the higher
risk of retinal detachment, RLE would not be considered unless the patients were in their mid-50s and
had a posterior vitreous detachment. If the patient
were less than 50 years, then the ICL would be a
consideration and in patients older than 50, the
Artiflex or Artisan and the implant in the nondominant eye would with the patients prior informed
consent be adjusted to provide a degree of monovision (0.5 to 1.25).

Visual outcomes
Both RLE and pIOLs have shown to have excellent
visual outcomes. In practice, phakic IOLs (ICL, iris
claw and angle supported) demonstrate better postoperative visual outcomes comparatively. Table 1
lists the large studies [7,8,12,14,2326,27 ,2832]
published comparing different options. RLE with
monofocal IOL implantation for correcting myopia
[3,6,33] and hyperopia [31,3440] is effective with
acceptable predictability. Colin and Robinet [3]
found in 49 high myopic eyes (>12D) following RLE,
a best corrected visual acuity (BCVA) of 20/40 or
better in 82% of eyes and a postoperative mean of
0.92D. Pucci et al. [6] found in a series of 25 high
myopic eyes (>12D) that the mean postoperative
BCVA improved by an average of 1 line (mean
follow-up: 42.92  3.76 months). Fernandez-Vega
&

56

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et al. [31] reported outcomes following RLE with

the ReSTOR multifocal lens in 224 eyes. Uncorrected
visual acuity (UCVA) of 20/30 and J4 or better was
observed in all patients and 90% had a postoperative
refractive mean within 0.5D. Blaylock et al. [40] in
their study of 60 eyes following RLE with the
ReSTOR multifocal reported an UCVA of 20/20 or
better both for distance and near vision in all
patients and 88% with a postoperative refractive
mean within the 0.5D.
In selecting which option to use, as indicated
above, several factors need to be considered principally to ensure optimal outcome and patient safety.
The following list illustrates relevant concerns and
their evidential basis.
Retinal detachment
RLE remains a controversial technique because it is
an invasive procedure and carries an increased risk
of retinal detachment. The risk of retinal detachment is higher in RLE especially in highly myopic
eyes younger patients (<50 years old) and in eyes
with long axial lengths (>26 mm) [10]. The incidence of retinal detachment after RLE ranges from
0 to 8% [7,8,10,28,29,4143]. In the case of hyperopia, retinal detachment is less of a concern and RLE
can be performed in younger patients (4555 years
old) with minimal risk [35]. The risk of late retinal
detachment for RLE in high myopes has been well
reported [26]. Horgan et al. [4] recently reported a
3.2% retinal detachment rate in 62 myopic cases of
RLE over an 11-year period, occurring at intervals of
2 and 5 months after surgery. Colin and Robinet [3]
found an incidence of retinal detachment of 1.9% at
4 years and Pucci et al. [6] found an incidence of
4% at 12 months postsurgery. Fernandez-Vega et al.
[33] reported retinal detachment in a 2.10% 28
39 months after surgery. The incidence of retinal
detachment in RLE varies considerably from study
to study ranging from 0 to 8% [2,4,5].
As for all intraocular surgeries, implantation of
an ICL carries a potential risk for vitreoretinal complications and retinal detachment. Most implantations of ICL are performed in patients with high
myopia and long axial length, who therefore have a
predisposition for spontaneous retinal detachment.
Thorough preoperative and postoperative fundoscopic investigation is mandatory to rule out retinal
changes and to perform prophylactic laser photocoagulation, if required. Zaldivar et al. [25] reported
a single myopic case of retinal detachment after
implantation of a posterior chamber phakic IOL
in 124 eyes. Panozzo and Parolini [44] described
four cases of retinal detachment after ICL implantation in a consecutive case series. In a prospective
study comprising 61 eyes, one eye developed retinal
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RLE Vs pIOLs Nanavaty and Daya

Table 1. Few large studies published in literature
Number of
eyes

Study

Follow-up
(months)

Mean Preoperative
spherical equivalent

Mean postoperative
spherical equivalent

Postoperative
UCVA 20/20
(% eyes)

Postoperative
UCVA 20/40
(% eyes)

ICL
Sanders et al. [24]

258

12

10.05

0.56

50.9

Zaldivar et al. [25]

124

136

13.38

0.78

Sanders [26]

164

16

6.01

0.09

63

116

12

8.83

No data

78.5

190

12

10.38

0.23

72.7

95.7

249

636

12.95

0.06

34

76.8
83

Rayner et al. [27 ]

&

93.3
68
99
100

Angle-supported IOL (AcrySof Cachect)

Kohnen et al. [8]
Iris-claw lens (Artisan/Verisyse)
Budo et al. [7]
Maloney et al. [12]

155

0.56

12.69

0.54

26

Menezo et al. [14]

137

38154

16.17

0.78

84

Stulting et al. [28]

662

1236

12.3

No data

34.6

88

Guell et al. [29]

173

1260

11.27

0.64

Dick et al. [23]

290

24

7.33

0.15

No data

Alfonso et al. [30]

162

No data

0.24

No data

No data

Fernandez-Vega et al. [31]

158

3.9

No data

No data

No data

Alfonso et al. [32]

660

0.47

0.03

84

96.9

Alfonso et al. [32]

670

0.24

0.17

91

98.2

2.9

42.8
97.2

Multifocal IOL

ICL, implantable collamer lens; IOL, intraocular lens; UCVA, uncorrected distance visual acuity.

detachment 15 months after Visian ICL implantation [45]. This case was attributed to the preexisting axial length of 31.0 mm and not to the ICL
surgery. The largest clinical trial reporting results
in 526 eyes after Visian ICL implantation found
only three retinal detachments [46]. The largest
series of retinal detachment after ICL surgery was
published by Martinez-Castillo et al. [47] and
included 16 eyes after ICL implantation (incidence
rate of 2.07%).
In a recent study reporting outcomes up to
12 years after phakic angle-supported ZB5M implantation by Javaloy et al. [48], no case of retinal detachment was noted. For the AcrySof Cachet, no case of
retinal detachment has been reported to date [8]. In
the European multicenter study of the Artisan pIOL
over 8 years, retinal detachment occurred in two
eyes [7]. Stulting et al. [28] reported a retinal detachment rate of 0.3% per year after Artisan/Verisyse
implantation (mean spherical equivalent 11.50 to
18.6D). This is similar to retinal detachment rates
that have been reported in a highly myopic population not undergoing refractive surgery [49]. Guell
et al. [29] reported one case of retinal detachment
in a series of 399 eyes with the Artisan/Verisyse
pIOL. Retinal detachment in these studies was not
thought to be related to the pIOL implantation.

Loss of accommodation
The primary advantages of phakic lenses are
rapid visual recovery, reversibility, broader range
of treatable ametropia, high predictability rates
and stability with preservation of accommodation
[48,50 ,5157].
&&

Macular problems
CME remains one of the main causes of unfavourable visual outcome following uncomplicated
phacoemulsification and IOL implantation [58].
In a recent study [59], the incidence of postoperative
subclinical CME diagnosed with optical coherence
tomography (OCT) was 5% and the presence of
clinically significant CME was 3%. The incidence
of OCT diagnosed subclinical CME in this study was
similar or slightly higher than that reported some
authors [60,61].
Endothelial cell loss
With pIOLs, loss of corneal endothelial cells can be
divided into direct trauma loss caused by surgery
and long-term loss. In various studies of the ICL,
immediate corneal endothelial cell loss of 5.25.5%
was documented after 12 months. However, the
pace of corneal endothelial cell loss slowed down

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Cataract surgery and lens implantation

substantially from 1 year to 2 years (6.67.9%)

[62,63]. Researchers therefore considered surgery
to be the cause of the early corneal endothelial cell
loss. Four years postoperatively, corneal ECCs
showed further decrease in cell density, which
may be due to the implanted ICL, the learning curve
of the surgeon, or natural cell loss, which is in the
range of 0.5% in the normal population [63]. A study
by Kamiya et al. [64] reported corneal endothelial
cell loss of 3.7% 4 years after ICL implantation.
Another study shows a cumulative corneal endothelial cell loss of 8.5% 3 years after surgery and
8.4% 4 years after surgery [46]. These figures also
suggest that corneal endothelial cell density stabilizes over time. Alfonso et al. [65] showed corneal
endothelial cell loss of 8.1% 2 years after toric ICL
implantation in eyes after penetrating keratoplasty.
With the angle-supported IOLs, a 7-year followup study, Alio et al. [66] reported an early postoperative loss of corneal endothelial cells of 3.8%,
gradually decreasing to about 0.5% per year after the
second postoperative year. For the AcrySof Cachet
pIOL, the corneal endothelial cell loss was 4.8% after
1 year [8].
Inflammation
Long-term inflammation has not been observed at
23 years after ICL implantation [67]. However, two
studies [43,68] suggest pigment dispersion and subsequent inflammatory reaction observed after the
implantation of Artisan pIOLs may be caused by
abnormal pressure on the iris, which can become
sandwiched between the crystalline lens and the
pIOL, especially in hyperopic eyes. After the
exchange of the Artiflex pIOL for the Artisan pIOL,
which has a larger vault between the optichaptic
junction and the iris plane, the inflammatory reaction disappeared in the case reported by Tahazib
et al. [69].
Cataract and posterior capsular
opacification
Posterior capsule opacification (PCO) is the most
frequent postoperative complication after RLE.
Colin and Robinet [3] reported an incidence of
Nd:YAG capsulotomy of 36.7% at 4 years and
Fernandez-Vega et al. [33] of 77.89%, with a mean
time of 21.72  11.16 months (range, 2.60
63.20 months). Siganos and Pallikaris [35] reported
PCO in 54.2% of eyes 5 years following RLE for high
hyperopia, and Preetha et al. [37] found a 30% of
PCO after RLE in hyperopic eyes at a mean of
17.16 months. Kohnen et al. [70] have reported a
3-year cumulative Nd:YAG capsulotomy rate of
2.1% for the AcrySof lens.
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Cataracts after ICL implantation often remain

stable over a long period and rarely lead to a
reduction in visual acuity. The most common type
of cataract after ICL implantation is anterior subcapsular [71,72]. Possible reasons are operative
trauma, continuous or intermittent contact of the
ICL with the crystalline lens, insufficient nutrition
through anterior chamber flow between the ICL and
the crystalline lens, or chronic subclinical inflammation with disruption of the bloodaqueous
barrier due to friction between the ICL and posterior
iris or the haptic on the ciliary sulcus [71,73,74].
Studies with UBM and Scheimpflug imaging techniques have shown a central gap between the
ICL and the crystalline lens but contact in the
mid-periphery [7578]. Moreover, anteroposterior
movement of the ICL during iris contraction or
accommodation has led to intermittent central contact [75,78]. In an FDA trial with a mean follow-up of
4.7 years, a cumulative probability estimate of 67%
of anterior subcapsular opacities was found 7 years
after implantation of the ICL [79]. However, only
12% progressed to a clinically significant cataract.
With the V4 model, the recently published FDA
study showed an incidence of 2.1% anterior subcapsular opacities [24].
With the angle-supported pIOLs, as the position
of anterior chamber pIOLs is away from the lens, the
formation of cataract is less significant than with a
posterior chamber pIOL. A recent study by Kohnen
and Klaproth [80 ] using Scheimpflug imaging
reports a stable distance between the AcrySof pIOL
and the crystalline lens over a period of 3 years.
Excessive postoperative use of steroids should be
avoided because of the potential risk for delayed
cataract formation [81].
Formation of cataract from the iris-fixated pIOL
is unlikely because the lens is inserted over a miotic
pupil without contact with the crystalline lens. A
meta-analysis of cataract development after pIOL
surgery reported 20 of 2781 eyes developed newonset cataract [82]. In this meta-analysis, the
incidence of cataract formation was 1.1% for the
iris-fixated pIOL, 2.2% for the Worst-Fechner biconcave pIOL, 1.1% for the myopic Artisan/Verisyse
pIOL and 0.3% for the hyperopic Artisan/Verisyse
pIOL. No cataracts have been reported to date with
the Artiflex Piol [82]. The overall incidence of
cataract formation for posterior chamber phakic IOLs
(pIOL) is significantly higher than the incidence for
anterior chamber and iris-fixated phakic IOLs.
&

Glaucoma
Using UBM, contact between ICL and the posterior
surface of the iris has been demonstrated [62,77,78].
Pigment dispersion and consecutive pigment
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RLE Vs pIOLs Nanavaty and Daya

accumulation in the anterior chamber angle is one

possible consequence [14,77,83]. However, development of secondary glaucoma has not been observed
[84 ]. Nevertheless, eyes with pigment dispersion
must be kept under observation in case of an
increase in IOP. Menezo et al. [14] reported an
IOP increase of 1.5 mmHg over 3 years after ICL
implantation which was not statistically significant.
Another study [64] did not find any increase in IOP
over 18 months and 4 years after ICL implantation. Zaldivar et al. [25] reported 2 of 124 eyes with
IOL-related IOP spikes. One of these eyes with a
decentered ICL had excessive pigment deposition
on the ICL surface. It remained unclear whether the
pigment dispersion was related to the decentration
or to the ICL itself. Sanchez-Galeana et al. [85]
reported a case of refractory IOP increase due to
pigment dispersion after ICL implantation. Despite
medical therapy and ICL removal, this patient
needed a trabeculotomy to control IOP. Although
Jimenez-Alfaro et al. [62] observed contact of the ICL
and posterior iris with UBM in all cases, they did
not find pigment dispersion. The authors suggest
that the similarity between the Collamer and the
anterior capsule of the crystalline lens could prevent
mechanical pigment loss. Davidorf et al. [83] report
that the pigment deposition on the ICL surface
remained stable over time in all eyes, with no occurrence of pigment dispersion glaucoma. Verde et al.
[86] reported an increase in mean postoperative IOP
compared with the preoperative values; the mean
IOP was within normal limits in the follow-up. Only
1 of 90 eyes required antiglaucomatous medication.
Davidorf et al. [83] reported one case of increasing
vascularization of the anterior chamber angle and
development of secondary glaucoma after ICL
implantation in a hyperopic eye.
In contrast to anterior chamber phakic IOLs, no
cases of pupil ovalization or iris retraction have been
reported to date with ICLs. Because of the position of
the ICL, the iris may be pushed forward and cause
acute pupillary block glaucoma, especially in hyperopic eyes [25,75,83,87,88].
To prevent pupillary block glaucoma, preoperative or intraoperative iridotomies or iridectomies
must be performed [25,65] and both are recommended 908degrees apart. In some cases, preoperative iridotomies become nonpermeable over time
because they are too small or are obstructed by the
haptic of the posterior chamber pIOL. This situation
may cause acute pupillary block glaucoma. A second
iridotomy had to be performed in these cases
[75,89,90]. For hyperopic treatment, preoperative
iridotomy is even more important to prevent early
pupillary block. In such cases, it is necessary to make
two peripheral and sufficiently sized iridotomies
&&

preoperatively with the Nd:YAG laser or during

implantation surgery using the vitrectome or
scissors [83]. Malignant glaucoma after posterior
chamber pIOL implantation is rare and has only
been described by Kodjikian et al. [91] in a myopic
eye that had an IOP of 54 mmHg 3 days after ICL
implantation. Despite medical treatment, the IOP
remained 50 mmHg; 5 days after implantation, ICL
explanation had to be performed.
For the AcrySof pIOL, a peripheral iridectomy
does not seem to be mandatory, even though reports
of acute angle closure or pupillary block glaucoma
have been published [8] and have been attributed to
incomplete OVD removal.
For the Artiflex pIOL, inflammatory pigment
precipitates were reported in 4.8% of eyes, nonpigmented precipitates in 1.4% and synechiae formation in 1.4% 2 years after surgery [23].

CONCLUSION
In patients where laser ablative surgery is not
possible, RLE and pIOL are options that can be
considered. Phakic IOLs and additive procedure
are a safe option in myopic eyes with deep anterior
chamber, whereas in hyperopia, RLE may be a better
option. Age, axial length, type and magnitude of
refractive error, anterior segment configuration,
ECCs and patients desire for correction of presbyopia are all relevant factors when selecting the
appropriate procedure. Most importantly, providing
the patient with valid and informed consent detailing the risks, benefits and alternatives to the procedures and specific to their category and based on
current evidence is vital before proceeding.
Acknowledgements
None.
Conflicts of interest
S.D. is a consultant to Staar Surgical, Zeiss and Bausch &
Lomb.
M.N. has no financial or proprietary interest in any
product or procedure discussed in this article.

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&
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Cataract surgery and lens implantation

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RLE Vs pIOLs Nanavaty and Daya

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