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ARTICLE
Purpose: To report the indications, frequency, and outcomes (range 0–343 months). Primary indication for explantation was IOL
regarding intraocular lens (IOL) exchange in 2 university hospital opacification, and the most common ophthalmic comorbidity was a
tertiary referral settings over a period of 15 years. previous history of vitreoretinal surgery. Preoperatively, the mean
uncorrected visual acuity (UCVA) and corrected distance visual
Setting: Ophthalmology departments of the University Hospital
Downloaded from http://journals.lww.com/jcrs by BhDMf5ePHKbH4TTImqenVA+lpWIIBvonhQl60EtgtdlLYrLzSPu+hUapVK5dvms8 on 12/12/2020
acuity (CDVA) were 0.47 ± 0.27 (range 0–1) and 0.61 ± 0.32 (range
Antwerp and the University Hospital Leuven, Belgium. 0–1.2), respectively. Postoperative UCVA and CDVA was 0.7 ± 0.3
(range 0–1.2) and 0.8 ± 0.28 (range 0.05–1.6), respectively. The
Design: Retrospective cross-sectional study. increase in both CDVA and UCVA was statistically significant (P <
.001, paired t test). The most common complication perioperatively
Methods: In this retrospective study, included were patients who was vitreous prolapse, which occurred in 61 eyes (16%).
underwent an IOL exchange between 2002 and 2017. Patient
demographics, surgical indication, comorbidities, visual outcomes, Conclusions: IOL exchange is a challenging yet valuable treat-
and complications were reported. Patients who underwent IOL ment option for a wide spectrum of problematic IOL outcomes.
repositioning or add-on IOL implantation or extraction, and patients The most common indication remains IOL opacification, although
who were left aphakic, were excluded. IOL dislocation and patient dissatisfaction are increasing as
indications.
Results: Included in the study were 492 eyes. The mean age was
66.0 ± 13.3 years (range 19–91 years). The mean time between J Cataract Refract Surg 2020; 46:1596–1603 Copyright © 2020 Published
primary surgery and IOL exchange was 54.61 ± 67.07 months by Wolters Kluwer on behalf of ASCRS and ESCRS
C
ataract is believed to affect 18 million people Although these changes in biomaterials and manufacturing
globally.1 As a result, cataract surgery is the most processes have resulted in improvements, they have also been
commonly performed surgery worldwide.2,3 Al- associated with rare, but significant, outbreaks of IOL opa-
though advances in surgical technique, intraocular lenses cification, particularly in hydrophilic IOL materials.2,6,7
(IOLs), biometric analysis, and lens calculation formulas Calcifications are known to occur sporadically in almost
have all made cataract surgery one of the safest surgical every hydrophilic acrylic IOL type, in both primary and
interventions, situations still arise in which the explantation secondary calcification patterns.8 Occasionally, a cluster of
of an IOL might be required. Historically, the leading in- calcifications will be seen in a single-piece IOL type between 2
dications for explantation included implant dislocation, and 4 years after implantation. This event is known as pri-
refractive surprise, and inflammation.4 The evolution and mary calcification; when this occurs, it is often attributed to a
improvements in acrylic posterior chamber IOL designs IOL manufacturing fault. Secondary calcification is thought
have reduced the incidence of endothelial decompensation to be due to a slow IOL reaction to the patient’s ocular
associated with anterior chamber IOLs and uveitis– microenvironment, rather than to a IOL defect, and seems to
glaucoma–hyphema syndrome. This was seen previously be increasing as the time after implantation and life expec-
with IOL designs, particularly those with a closed-loop tancy increases.9 As a result, IOL opacification has become a
design, which were prone to iris chafing and an erosive major cause of IOL explantation.10
“cheese wiring” effect where the older IOL could erode The success of cataract surgery has also led to the desire
through the peripheral iris angle.5 for still better outcomes, namely spectacle independence in
Submitted: May 12, 2020 | Final revision submitted: July 5, 2020 | Accepted: July 7, 2020
From the Department of Ophthalmology, Antwerp University Hospital (Goemaere, Denissen, Dragnea, Tassignon, Dhubhghaill) Wilrijk, Belgium, Department of Medicine,
University of Antwerp (Goemaere, Denissen, Dragnea, Tassignon, Dhubhghaill), Wilrijk, Belgium, Department of Ophthalmology, Leuven University Hospital (Trigaux, Hua),
Leuven, Belgium, and Department of Medicine, Leuven University Hospital (Trigaux, Hua), Leuven, Belgium.
Corresponding author: Jordy Goemaere, MD, Department of Ophthalmology, Antwerp University Hospital, Wilrijkstraat 10, 2650 Edegem, Belgium 04792373.
Email: jordy.goemaere@uza.be.
Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS 0886-3350/$ - see frontmatter
Published by Wolters Kluwer Health, Inc. https://doi.org/10.1097/j.jcrs.0000000000000349
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FIFTEEN YEARS OF IOL EXCHANGE 1597
Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.
1598 FIFTEEN YEARS OF IOL EXCHANGE
at 4 weeks postoperatively. Complicated cases that required more within 1 month of IOL implantation, and the longest time
than 4 weeks of follow-up had regular check-ups until they had a between primary and secondary surgery was 28.6 years.
full recovery or were refractory to further treatment.
All data were analyzed using IBM SPSS Statistics for Mac
Surgical Indications
software (version 24, IBM Corp.). Descriptive statistics (mean, SD,
and range) was used for patient age, time between initial surgery The indications for explantation are summarized in
and IOL exchange, and preoperative and postoperative visual Table 2, and representative examples of cases included in
acuity values. Data were expressed as mean ± SD. All visual data the cohort are shown in Figure 1. IOL opacification was the
are represented in decimal Snellen values after converting to most frequent cause for explantation, representing 138
decimal values. A paired t test was used to evaluate the significance
(28%) of all cases (Figure 2). A full list of explanted opa-
of the difference of visual acuity preoperatively vs postoperatively.
A P value less than .05 was considered statistically significant. cified IOLs are summarized in Table 3. The term “multi-
focal intolerance” was used in cases in which mIOLs were
RESULTS well positioned surgically but where persistent dyspho-
Demographics topsias and reduced contrast sensitivity were intolerable to
Data from a total of 492 eyes were included in the analysis the patients. These mIOLs are tabulated in Table 4. Al-
(Table 1). Over the entire cohort, there was higher pro- though these explantations account for only 75 cases (15%),
portion of women (284 [(57.7%]) than men (208 [42.3%]). they do seem to be increasing over time. Explants due to
The sex difference was slightly more pronounced in the “IOL damage” were related to traumatic or iatrogenic IOL
multifocal intolerance group with 45 eyes (60.5%) from damage rather than to IOL biomaterial opacification. IOL
women vs 30 eyes (39.5%) from men. The mean age was 66 dislocation with evident zonular damage was another major
± 13.3 years (range 19–91 years). In total, 244 right eyes cause of explantation in this cohort. Visually problematic
(49.6%) and 248 left eyes (50.4%) were included. The mean
time between the primary surgery and IOL exchange was
54.61 ± 67.07 months. The earliest exchange was performed Table 4. Summary of explanted mIOLs.
Model Number (%)
AcrySof Iq ReSTOR (Alcon Laboratories, Inc.) 11 (15)
Table 3. Summary of opacified IOLs. Trifocal hydrophobic IOL (Physiol) 4 (5)
Acri-Tec Acri.Twin (Acri.Tec GmbH) 4 (5)
Model Number (%)
Mplus Toric LU-313 MF30TY (Oculentis) 3 (3)
Hydroview H60M (Bausch & Lomb, Inc.) 63 (46) Acri-Tec Acri.LISA (Acri.Tec GmbH) 3 (3)
Lentis LS-312Y (Oculentis GmbH) 25 (18) AMO Rezoom (AMO) 2 (2)
Akreos Adapt AO (Bausch & Lomb, Inc.) 7 (5) Array SA40N (AMO) 2 (2)
AcrySof SA60AT (Alcon Laboratories, Inc.) 7 (5) Crystalens AO (Bausch & Lomb, Inc.) 2 (2)
Morcher 89A (Morcher GmbH) 4 (2) Abbot TECNIS multifocal (Abbott Medical Optics) 2 (2)
Morcher 92s (Morcher GmbH) 3 (1) Unknown at time of surgery 42 (61)
Unknown at time of surgery 39 (23)
mIOL = multifocal IOL
This table represents the different types of IOL explanted because of This table represents the different types of mIOL explanted because of
opacification. intolerance.
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FIFTEEN YEARS OF IOL EXCHANGE 1599
IOL decentrations, involved cases in which mIOLs were comorbidity was previous vitreoretinal surgery (Figure 4).
decentered, were due to capsular fibrosis in the absence of Eighty-three eyes (21.78%) had a history of Nd:YAG
obvious zonular lysis (Figure 1). These cases appeared ir- capsulotomy, whereas 16 eyes (4.19%) were known to have
regularly throughout the 15 years and did not seem to had a capsular tear prior to explantation surgery. PCO was
follow any trend. Lens exchange due to capsular contrac- documented in 66 eyes (17.23%).
tion that could not be resolved by capsulotomy accounted
for 21 cases (4%). Explantation due to corneal de- Time to Secondary Intervention
compensation was more frequent in the earlier years but The mean time between initial and secondary surgeries was
has been decreasing (Figure 2) and was infrequently seen shortest in the incorrect IOL power/refractive error fine-
after 2010. Similarly, explantation due to uveitis was more tuning group (29.42 ± 42.46 months) and longest in the
frequent in the early years of the study but occurred even corneal decompensation group (151.83 ± 111.07 months).
less often than corneal decompensation after 2010. The mean time to explantation for IOL opacification, in-
correct IOL power, toric misalignment, IOL decentration,
Surgery multifocal intolerance, and capsular contraction were all
Regarding the initial surgery, most IOLs requiring explan- under 5 years. Conversely, the mean time for cases of
tation had been placed in the capsular bag (350 [71%]), corneal decompensation, damaged IOLs, IOL-related
followed by the BIL implant (52 [14%]) (Figure 3). The uveitis, and IOL dislocation were all more than 5 years
sulcus-supported, the angle-supported, and the iris- after the primary surgery (Table 5).
supported IOLs represented 58 (15%) of the total number
of explanted lenses. Two hundred four (53%) of the ex- Visual Outcomes
planted IOLs were replaced by a BIL implant, followed by iris The visual outcomes for the entire group can be seen in
claw placement. Only 45 (12%) of the explanted IOLs could Figure 5. The mean uncorrected visual acuity (UCVA) and
be replaced by a LIB approach. Anterior chamber angle– corrected distance visual acuity (CDVA) values pre-
supported IOLs represented 12 (4%) of all explanation cases. operatively were 0.47 ± 0.27 (range 0–1) and 0.61 ± 0.32
(range 0–1.2) respectively,. Postoperative UCVA and
Preoperative Risk Factors CDVA were 0.7 ± 0.3 (range 0–1.2) and 0.8 ± 0.28 (range
The most common systemic comorbidity was cardiovas- 0.05–1.6), respectively. Despite the wide range of values,
cular disease, whereas the most common ophthalmic the improvement in CDVA was statistically significant
Figure 4. Different types of IOL before and after the exchange in the study population.
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1600 FIFTEEN YEARS OF IOL EXCHANGE
This table shows the time between primary surgery and the IOL exchange Figure 5. Visual acuities in decimal Snellen both before and after the
for each indication. exchange.
(P < .001, paired t test). As might be expected, the change in was considered to be insufficient for a BIL implant alone,
UCVA was also significant (P < .001). The postoperative requiring supplementary support from bean-shaped ring
spherical equivalent refractive accuracy for the different implants.13 Because these implants are positioned in the
positions of IOL are represented in Figure 6. When examined sulcus, the BIL implants were considered as “sulcus-sup-
based on surgical indication (Table 6), the CDVA signifi- ported” IOLs. A capsule tension ring was used in 33 eyes
cantly improved in cases of IOL opacification (P < .001), (8.5%). Iris reconstruction was needed in 29 eyes (75%).
incorrect power/refractive fine-tuning (P = .022), IOL de- The full list of coincident interventions and complications
centration (P < .001), and mIOL intolerance (P < .001). is shown in Figure 7. Postoperative complications were rise
Although cases explanted for capsular contraction, corneal in IOP and cystoid macular edema in 23 (6.5%) and 8 (2%)
decompensation, IOL damage, and IOL-related uveitis did eyes, respectively (Table 7).
not meet the level of significance, it is likely that these
numbers are too small for a reliable analysis. DISCUSSION
Both the University Hospital of Leuven and Antwerp
Complications University Hospital are major referral centers for lens
The most common complications during the intervention explantations in Belgium. Over the past 15 years, the
were vitreous prolapse in 61 cases (16%) and zonular number of patients undergoing explantation each year
dehiscence in 21 eyes (5.5%). One hundred cases (26%) seems to have remained unchanged, despite the significant
required an anterior vitrectomy, whereas 16 eyes (4%) improvement in IOL design and manufacturing. In the
underwent a total vitrectomy. This was most frequently 1990s, the leading indications for lens explantation were
performed in cases of lens luxation or dislocation, where the corneal decompensation and uveitis–glaucoma–hyphema
IOL was either partially in the posterior segment or was syndrome.14–18 This was predominantly seen because of
totally subluxated. In 35 cases (9%), the capsular support the anterior chamber IOLs of that time, which, although
Figure 6. Postoperative spherical equivalent refractive accuracy for the different positions of IOL.
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FIFTEEN YEARS OF IOL EXCHANGE 1601
innovative, displayed faulty sizing and problematic tissue particularly in hyperopic outcomes—are not simple.27 The
interaction.19 These anterior chamber IOLs were seen in approach, therefore, is often early IOL exchange, and in the
15 cases from our cohort but accounted for most of UZA, we use a BIL implant because they are very simple to
corneal decompensation, although other lens types, such exchange.27 The first-line management for the toric mis-
as anterior iris-fixated IOLs and 1-piece IOLs placed in the alignment was always rotation of the IOL. Explantation was
sulcus, also damaged the endothelium, albeit far less only performed in cases where the capsular bag could no
frequently.20 Overall, these complications have been di- longer be opened to facilitate rotation. In other cases, it can
minishing over the years through better IOL design and be difficult to achieve the target refraction due to previous
surgical technique. refractive surgery or corneal disease. The biometric cal-
IOL opacification remains a significant problem in culations of patients with keratoconus or a history of RK,
modern IOLs. In our cohort, 28% of IOLs were explanted for example, can be unreliable and result in a higher rate of
due to a loss of IOL clarity, most being hydrophilic acrylic refractive surprise. In this subgroup, we typically implanted
IOL calcifications. Opacification explantation rates of 5% to the BIL implant. The BIL implant does not have classic
12% have been reported by other investigators with the haptics and is easier to disengage from the capsular bag,
largest explantation cohort, prior to this study, reporting a even many years after implantation.28 The “exchange-
rate of 11% of all explantations in 2013.1,21–23 Jiraskova ability” of the BIL allows the option of simplified lens
et al. reported an explantation rate of 52% due to opaci- exchange in cases of refractive surprise where secondary
fication, mainly because of a single faulty acrylic hydro- laser correction is not straightforward, such as in kerato-
philic IOL (Aqua-Sense).24 Our study has a similarly high conus and post-RK. In exchanges between a LIB and BIL,
rate due to LENTIS and Hydroview IOLs of Oculentis the form of the haptics make it possible for the IOL to be
GmbH and Bausch & Lomb, Inc., respectively, which had implanted, either alone or with “bean-shaped” segments, in
been a very popular IOL at the time. The company’s own a heavily fibrotic capsule in which a classic LIB would be
research determined the cause, and in September 2017, impossible. It also diminishes the chance of capsular
Oculentis GmbH issued a voluntary recall of all possible
contaminated lenses and a Field Safety Notice.25 Many
IOLs that have already been implanted, however, might still
pose a problem for patients in the future. Thankfully, these
patients might have a 0.23 decimal Snellen improvement in
their vision after explantation (P < .0001) with a low rate of
complication, particular if no capsulotomy had been
performed.
Incorrect IOL implantation or “refractive surprise” re-
mains a leading cause for explantation that should be
addressed. The term refractive surprise is a bit of a mis-
nomer because, often, a thorough examination of the
preoperative data will indicate where the error lies. Im-
plantation of an incorrect lens power could be significantly
reduced through the implementation of checklists and
control measures.26 In Belgium, however, a large number of
the refractive outcome errors are due to the popularity of
radial keratotomies (RKs) 30 years ago. RKs render the
refractive predictions of IOL formulas less accurate, and Figure 7. Intraoperative and postoperative complications and ad-
when a poor outcome occurs, laser corrections— ditional surgical procedures of IOL exchange.
Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.
1602 FIFTEEN YEARS OF IOL EXCHANGE
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FIFTEEN YEARS OF IOL EXCHANGE 1603
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Disclosures: M.-J. Tassignon has intellectual property rights to the
D, Brady SE, Olson RJ. Complications of intraocular lenses. A historical and bag-in-the-lens intraocular lens (U.S. patent 6 027 531; EU patent
histopathological review. Surv Ophthalmol 1984;29:1–54 009406794.PCT/120268), which is licensed to Morcher GmbH,
20. Chang DF, Masket S, Miller KM, Braga-Mele R, Little BC, Mamalis N, Stuttgart, Germany. None of the other authors have a financial or
Oetting TA, Packer M. Complications of sulcus placement of single-piece proprietary interest in any material or method mentioned.
Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.