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Inside Eyetube.net | Oct 2012

Decision-Making: RLE Versus Phakic IOLs

Many factors are involved in choosing which approach is best for each patient.

Refractive lens exchange (RLE) and phakic IOL implantation are alternative options to laser ablative refractive surgery. As intraocular procedures, both carry the very low but real risk of endophthalmitis. This risk has been reduced considerably by the incorporation of intraocular cefuroxime into current practice in Europe.1 Although rare, potential complications including retinal detachment and cystoid macular edema must be considered and discussed with a patient in detail before surgery.

Understanding RLE and Phakic IOLs

RLE is safe and effective for the correction of moderate to severe myopia2-7 and hyperopia.8-13 Monofocal, toric, multifocal, and accommodating IOLs are available options that can be chosen based on patient needs and expectations. The safety of the procedure has been enhanced by the introduction of microincision cataract surgery (MICS) and of lenses that can be inserted through 1.8-mm incisions. Because RLE causes loss of accommodation, the procedure should be avoided if a patient’s natural lens is still functional.14-18 Several available multifocal IOLs provide patients with increased depth of focus including near, intermediate, and distance vision and make RLE an attractive option for both patient and surgeon. The primary advantages of phakic IOLs are rapid visual recovery, reversibility, a broader range of treatable ametropia, high predictability rates, stability, and preservation of accommodation.19-27 Several phakic IOLs are commercially available, including the Visian Implantable Collamer Lens (ICL; STAAR Surgical); the iris-fixated Artisan/Verisyse and Artiflex/Veriflex (Ophtec BV/Abbott Medical Optics Inc.); and the AcrySof Cachet (Alcon Laboratories, Inc.). These implants are detailed in Figure 1.

The Visian ICL is inserted through a 3-mm incision and placed horizontally behind the iris, vaulting off the crystalline lens. Lens sizing is crucial. The horizontal white-to-white distance can be used for this, with the assumption that there is a relationship between the limbus and sulcus. Ultrasound biomicroscopy (UBM), which visualizes the sulcus, is a more accurate method of assessment. Peripheral iridotomies are required to prevent pupillary block; however, a new version of the Visian ICL, the V4c, has a 360-μm central perforation in the optic, obviating the need for iridotomies.

The compressed PMMA Artisan/Verisyse and the foldable silicone Artiflex/Veriflex are anterior chamber phakic IOLs that are attached onto the iris by enclavation and have thus been referred to as iris-claw lenses. A minimum anterior chamber depth (ACD) of 2.8 mm is required, and the iris preferably should not have a convex contour. A relatively new entry is the AcrySof Cachet lens, an anterior chamber lens made of a hydrophobic acrylic material. The lens footplates are supported by the angle, and the lens requires a minimum ACD of 2.7 mm. Toric varieties of the ICL and Artiflex/Verisyse are available in Europe.

Expectations, Personalities, and Selection Criteria

Get to know your patient. As with any surgical procedure, it is important to evaluate a patient’s needs, expectations, and personality. Often patients have unrealistic expectations regarding outcomes and may be highly demanding in their visual requirements. Evaluation should include a patient’s occupation, recreational activities, and day-to-day activities in terms of driving, computer use, and reading. This thumbnail view of a patient can be obtained by a questionnaire and elaborated on 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 of 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).

Preoperative examination. The preoperative work-up for RLE or phakic IOL implantation includes manifest and cycloplegic refraction; Snellen distance, intermediate, and near UCVA and BCVA; pupillometry; applanation tonometry; fundus evaluation; corneal topography; pachymetry; and biometry, preferably with a partial coherence interferometry device (eg, IOLMaster; Carl Zeiss Meditec). A careful fundus evaluation is vital to ensure that the peripheral retina is intact and to document the status of the macula and vitreous. If a phakic IOL is being considered, specular microscopy to measure the endothelial cell count, ACD, and white-to-white measurements are additional required investigations. Development of anterior segment imaging techniques such as optical coherence tomography (OCT), UBM, and Scheimpflug imaging have made it possible to accurately determine the internal diameter of the anterior chamber, the angle-to-angle distance, and, with UBM, sulcus-to-sulcus distance.

Age. RLE should not be considered in patients under the age of 50 years (in the authors’ opinion), except in high hyperopes (4.00 D and greater), or when the ACD is shallow and thus unsuitable for a phakic IOL. In this scenario, an age threshold of 45 years might be considered. Myopic patients in their late 40s who are highly motivated to retain their near vision can pose a dilemma, as they will become presbyopic if they receive a phakic IOL. Additionally, because of the higher risk of retinal detachment in myopes,5 RLE should not be considered unless patients are in their mid-50s and have a posterior vitreous detachment. The authors use both ICL and Artiflex lenses, and selection is essentially based on age. As there is a slightly higher risk of cataract in patients who are undergoing ICL implantation and are over 50 years of age, the Artiflex is used in this group. Monovision is an option that can be considered, with the implant in the nondominant eye targeted at -0.50 to -1.25 D.

Visual Outcomes

Excellent visual outcomes have been reported for both RLE and phakic IOLs. In practice, phakic IOLs (ICL, iris claw, and angle-supported) demonstrate better postoperative visual outcomes compared with RLE. Table 1 lists large published studies2,3,7,10,16,28-36 comparing different options. RLE with monofocal IOL implantation for correcting myopia37-39 and hyperopia30, 40-46 is effective, with acceptable predictability. Colin and Robinet37 conducted a study in 49 highly myopic eyes (more than 12.00 D) following RLE and found a BCVA of 20/40 or better in 82% of eyes and a postoperative mean of -0.92 D. In a series of 25 highly myopic eyes (more than 12.00 D), Pucci and associates39 found that the mean postoperative BCVA improved by an average of 1 line (mean follow-up, 42.92 ±3.76 months). Blaylock et al40 conducted a study of 60 eyes following RLE with the AcrySof ReStor (Alcon Laboratories, Inc.) multifocal and reported a UCVA of 20/20 or better for both distance and near vision in all patients, and 88% of patients with a postoperative refractive mean within 0.50 D.

The authors’ experience suggests that newer diffractive lenses, such as the FineVision trifocal lens (PhysIOL), can provide even better visual outcomes at distance (90% achieving 20/20), intermediate (89% achieving 20/25 or better), and near (92% achieving 20/25 or better).

Complications

In selecting which option to use, as indicated above, several factors must be considered, principally to ensure optimal outcome and patient safety. Some of the documented complications of these procedures are detailed below.

Retinal detachment. RLE remains controversial not only because it is an irreversible and invasive procedure but also because it carries an increased risk of retinal detachment. The risk of retinal detachment is higher in highly myopic eyes, younger patients (under age 50 years), and eyes with long axial lengths (more than 26 mm).5 The reported incidence of retinal detachment after RLE ranges from 0% to 8%.2,5,31,35,47-50 In hyperopia, retinal detachment is less common, and RLE can be performed in younger patients (45 to 55 years) with minimal risk.46 The risk of late retinal detachment after RLE in high myopes has been well reported.37,39,51-53

As with all intraocular surgeries, implantation of the ICL carries a potential risk for vitreoretinal complications and retinal detachment. Most ICL implantations are performed in patients with high myopia and long axial length, who therefore have a predisposition for spontaneous retinal detachment. Thorough pre- and postoperative fundoscopic investigation is mandatory to rule out retinal changes and to perform prophylactic laser photocoagulation, if required. In a study reporting outcomes up to 12 years after phakic angle-supported ZB5M (Domilens-Chiron; no longer available) implantation, 23 no case of retinal detachment was noted. For the AcrySof Cachet IOL, no case of retinal detachment has been reported to date.3 In the European multicenter study of the Artisan phakic IOL, over 8 years retinal detachment occurred in 2 eyes.2 Stulting et al35 reported a retinal detachment rate of 0.3% per year after Artisan/ Verisyse implantation (mean preoperative spherical equivalent, -11.50 to -18.60 D). This is similar to retinal detachment rates that have been reported in a highly myopic population not undergoing refractive surgery.54

Macular problems. Cystoid macular edema (CME) remains one of the main causes of unfavorable visual outcomes following uncomplicated phacoemulsification and IOL implantation.55 In a recent study,56 the incidence of postoperative subclinical CME diagnosed with OCT was 5%, and the presence of clinically significant CME was 3%. The incidence of OCT-diagnosed subclinical CME in this study was similar to or slightly higher than that reported by some authors.57,58

Endothelial cell loss. With phakic IOLs, early loss of corneal endothelial cells can result from direct trauma during surgery, and long-term loss can result from close proximity of the implant to the cornea or low-grade inflammation. In ICL studies, immediate corneal endothelial cell loss of 5.2% to 5.5% has been documented after 12 months. However, the pace of corneal endothelial cell loss slowed substantially from 1 to 2 years (6.6% to 7.9%).59,60 The authors of these reports considered surgery to be the cause of the early corneal endothelial cell loss. At 4 years postoperative, corneal endothelial cell counts demonstrated 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.59

Inflammation. Long-term inflammation was not observed 2 to 3 years after ICL implantation.61 Two studies48,62 suggest that pigment dispersion and subsequent inflammatory reaction observed after the implantation of Artisan phakic IOLs may be caused by abnormal pressure on the iris, which can become sandwiched between the crystalline lens and the phakic IOL, especially in hyperopic eyes. After IOL exchange, the inflammatory reaction disappears.63

Cataract and posterior capsular opacification. Posterior capsular opacification (PCO) is the most frequent postoperative complication after RLE. Authors have reported incidences of Nd:YAG capsulotomy rates at 36.7%,37 77.89%,30 54.2%,46 30%,45 and 2.1%,64 with various IOLs and varying follow-up durations.

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.65,66 Possible reasons are operative trauma, continuous or intermittent contact of the ICL with the crystalline lens, insufficient aqueous flow and nutrition between the ICL and the crystalline lens, and chronic subclinical inflammation with disruption of the blood-aqueous barrier due to friction between the ICL and posterior iris or the haptic and the ciliary sulcus.65,67,68 Studies with UBM and Scheimpflug imaging techniques have shown a gap between the central ICL and the crystalline lens but contact in the midperiphery. 69-72 Moreover, anteroposterior movement of the ICL during iris contraction or accommodation can lead to intermittent central contact.69,70 As the position of anterior chamber angle-supported phakic IOLs is away from the lens, the formation of cataract is less significant than with posterior chamber phakic IOLs. Excessive postoperative use of steroids should be avoided because of the potential risk for delayed cataract formation.73 Formation of cataract due to iris-fixated phakic IOLs is unlikely because the lens is inserted over a miotic pupil without contact with the crystalline lens.

A meta-analysis of cataract development after phakic IOL surgery reported that 20 of 2,781 eyes developed new-onset cataract.74 The overall incidence of cataract formation for posterior chamber phakic IOLs is significantly higher than the incidence for anterior chamber and iris-fixated phakic IOLs.

Glaucoma. UBM has demonstrated contact between ICLs and the posterior surface of the iris.60,70,71 Pigment dispersion with consecutive pigment accumulation in the anterior chamber angle is one possible consequence;71,75,76 however, development of secondary glaucoma has not been observed.77 Nevertheless, eyes with pigment dispersion must be kept under observation for increases in IOP. In contrast to anterior chamber phakic IOLs, no cases of pupil ovalization or iris retraction have been reported to date with ICLs. Due to the position of the ICL, the iris can be pushed forward, causing acute pupillary block glaucoma, especially in hyperopic eyes.36,69,75

To prevent pupillary block glaucoma, pre- or intraoperative iridotomies or iridectomies must be performed,36,78 and two are recommended 90˚ apart. In some cases, preoperative iridotomies become impermeable over time because they are too small or are obstructed by the haptic of the posterior chamber phakic IOL. This may cause acute pupillary block glaucoma. A second iridotomy is needed in these cases.69 In hyperopes, preoperative iridotomy is even more important to prevent early pupillary block; two peripheral and sufficiently sized iridotomies should be made preoperatively with an Nd:YAG laser or during implantation surgery using a vitrectome or scissors.75 Malignant glaucoma after posterior chamber phakic IOL implantation is rare and has been described only by Kodjikian et al79 in a myopic eye that had an IOP of 54 mm Hg 3 days after ICL implantation.

Conclusion

For patients in whom laser ablative surgery is not possible, RLE and phakic IOL implantation can be considered. Phakic IOLs are additive procedures and a safe option in myopic eyes with a sufficiently deep anterior chamber. In hyperopic eyes, RLE may be a better option. Age, axial length, type and magnitude of refractive error, anterior segment configuration, endothelial cell count, and a patient’s desire for correction of presbyopia are relevant factors when selecting the appropriate procedure. Most important, providing a patient with valid informed consent detailing the risks, benefits, and alternatives to the procedures, specific to each category and based on current evidence, is vital before proceeding.

Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed), FRCOphth, is Director and Consultant at Centre for Sight, East Grinstead, United Kingdom. Dr. Daya is a Chief Medical Editor of CRST Europe. He states that he is a consultant to STAAR Surgical, Carl Zeiss Meditec, Technolas Perfect Vision GmbH, and Bausch + Lomb. He may be reached at e-mail: sdaya@centreforsight.com.

Mayank A. Nanavaty, DO, MRCS(Ed), FRCOphth, practices in the Department of Ophthalmology, East Surrey Hospital, in Redhill, United Kingdom. Dr. Nanavaty states that he has no financial or proprietary interest in the products, companies, or procedures mentioned.

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