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 patient's 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  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 [2–6]. The other possible complication that requires consideration following intraocular surgery is cystoid macular oedema (CME) which can be transient but in cases of posterior 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 [7–12] and hyperopia [13–18]. 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 be avoided when the natural lens is still functional [19–23]. 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, Liège, 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-μm 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 patient's 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 patient's 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 between RLE and pIOLs is dependent on various factors, which are discussed below.
The preoperative workup for RLE or pIOL implantation includes manifest and cycloplegic refraction, Snellen uncorrected and corrected distance, intermediate and near visual acuity, pupillometry, 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 white-to-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.
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 patient's prior informed consent be adjusted to provide a degree of monovision (−0.5 to −1.25).
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 [7,8,12,14,23–26,27▪,28–32] published comparing different options. RLE with monofocal IOL implantation for correcting myopia [3,6,33] and hyperopia [31,34–40] is effective with acceptable predictability. Colin and Robinet  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. 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). Fernández-Vega et al. 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. 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.
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) . The incidence of retinal detachment after RLE ranges from 0 to 8% [7,8,10,28,29,41–43]. In the case of hyperopia, retinal detachment is less of a concern and RLE can be performed in younger patients (45–55 years old) with minimal risk . The risk of late retinal detachment for RLE in high myopes has been well reported [2–6]. Horgan et al. 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  found an incidence of retinal detachment of 1.9% at 4 years and Pucci et al. found an incidence of 4% at 12 months postsurgery. Fernández-Vega et al. 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. reported a single myopic case of retinal detachment after implantation of a posterior chamber phakic IOL in 124 eyes. Panozzo and Parolini  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 detachment 15 months after Visian ICL implantation . 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 . The largest series of retinal detachment after ICL surgery was published by Martinez-Castillo et al. 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., no case of retinal detachment was noted. For the AcrySof Cachet, no case of retinal detachment has been reported to date . In the European multicenter study of the Artisan pIOL over 8 years, retinal detachment occurred in two eyes . Stulting et al. 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 . Guell et al. 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▪▪,51–57].
CME remains one of the main causes of unfavourable visual outcome following uncomplicated phacoemulsification and IOL implantation . In a recent study , 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 5.2–5.5% was documented after 12 months. However, the pace of corneal endothelial cell loss slowed down substantially from 1 year to 2 years (6.6–7.9%) [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 . A study by Kamiya et al. 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 . These figures also suggest that corneal endothelial cell density stabilizes over time. Alfonso et al. 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 follow-up study, Alio et al. 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 .
Long-term inflammation has not been observed at 2–3 years after ICL implantation . 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 optic–haptic junction and the iris plane, the inflammatory reaction disappeared in the case reported by Tahazib et al..
Cataract and posterior capsular opacification
Posterior capsule opacification (PCO) is the most frequent postoperative complication after RLE. Colin and Robinet  reported an incidence of Nd:YAG capsulotomy of 36.7% at 4 years and Fernández-Vega et al. of 77.89%, with a mean time of 21.72 ± 11.16 months (range, 2.60–63.20 months). Siganos and Pallikaris  reported PCO in 54.2% of eyes 5 years following RLE for high hyperopia, and Preetha et al. found a 30% of PCO after RLE in hyperopic eyes at a mean of 17.16 months. Kohnen et al. have reported a 3-year cumulative Nd:YAG capsulotomy rate of 2.1% for the AcrySof lens.
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 blood–aqueous 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 [75–78]. 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 6–7% of anterior subcapsular opacities was found 7 years after implantation of the ICL . However, only 1–2% progressed to a clinically significant cataract. With the V4 model, the recently published FDA study showed an incidence of 2.1% anterior subcapsular opacities .
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 .
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 new-onset cataract . 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 . 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.
Using UBM, contact between ICL and the posterior surface of the iris has been demonstrated [62,77,78]. Pigment dispersion and consecutive pigment 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. reported an IOP increase of 1.5 mmHg over 3 years after ICL implantation which was not statistically significant. Another study  did not find any increase in IOP over 18 months and 4 years after ICL implantation. Zaldivar et al. 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. 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. 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. 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. 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. 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 90°degrees 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 . Malignant glaucoma after posterior chamber pIOL implantation is rare and has only been described by Kodjikian et al. 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  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 .
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 patient's 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.
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.
REFERENCES AND RECOMMENDED READING
Papers of particular interest, published within the annual period of review, have been highlighted as:
- ▪ of special interest
- ▪▪ of outstanding interest
Additional references related to this topic can also be found in the Current World Literature section in this issue (pp. 76–77).
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