- Email: [email protected]
Results of cataract extraction after implantable contact lens removal
J CATARACT REFRACT SURG - VOL 31, DECEMBER 2005
Results of cataract extraction after implantable contact lens removal Heinrich Bleckmann, MD, Richard J. Keuch, MD
PURPOSE: To evaluate the visual results following insertion of implantable contact lenses (ICLs) in ametropic eyes and the development of subcapsular opacification with visual loss and to examine the anterior capsule, including the subcapsular tissue alteration, by light microscopy. SETTING: Department of Ophthalmology, Schlosspark-Klinik, affiliated hospital of the Charite´ Berlin, Humbold University, Berlin, Germany. METHODS: A prospective noncomparative interventional case series of anterior subcapsular cataracts in 9 of 127 (7.1%) patient eyes receiving ICLs to correct myopia and hyperopia was studied. The cataracts were phacoemulsified due to visual loss, and an intraocular lens (IOL) was implanted in the bag. After capsulorhexis, the anterior capsule was withdrawn for light microscopy examination. Visual acuity in each eye was measured before and after ICL implantation and before and after cataract extraction. The age range of cataract patients was 39 to 53 years. RESULTS: Implantable contact lens removal and phacoemulsification with IOL implantation for emmetropia resulted in an increased visual acuity compared to initial vision. Four of 28 hyperopic eyes (14.3%) developed subcapsular central opacification after ICL implantation, whereas 5 of 99 myopic patients (5.1%) developed opacifications. CONCLUSIONS: Patients should be informed prior to ICL implantation, there is a possibility of secondary subcapsular cataract formation and vision reduction. Although the posterior chamber inlay as well as the cataract can be removed and better acuity can be restored, a possible complication due to the ICL implantation cannot be avoided and the accommodation in young patients lost. J Cataract Refract Surg 2005; 31:2329–2333 Q 2005 ASCRS and ESCRS
The correction of refractive errors in patients with high ametropia is an indication for using an implantable contact lens (ICL), especially in cases of epicorneal contact lens intolerance or insufficient vision with glasses. The development of a refractive lens to be implanted into the posterior chamber without removing the crystalline lens seemed to be superior to other procedures by keeping the accommodation in young patients, saving the corneal configuration,
Accepted for publication May 18, 2005. From the Augenzentrum DRK Kliniken Westend (Bleckmann) and the Eye Department of Schlosspark-Klinik (Keuch), Affiliated Hospital of the Humbold University Berlin, Berlin, Germany. Neither author has a financial or proprietary interest in any material or method mentioned. Reprint requests to Heinrich Bleckmann, MD, Augenzentrum DRK Kliniken Westend, Affiliated Hospital of the Humbold University Berlin, Spandauer Damm 130, 14050 Berlin, Germany. E-mail: [email protected]. Q 2005 ASCRS and ESCRS Published by Elsevier Inc.
and not leading to retinal complications. Early reports on staar surgical ICL implantation stated the high refractive prediction, extremely good tissue biocompatibility to all of the anterior segment, and low complication rate1 in myopic2 and hyperopic eyes.3 In addition, the phase 1 U.S. Food and Drug Administration clinical study with a 6-month follow-up has not shown any intraoperative or postoperative complications4,5 so far and revealed advantages over keratomileusis for high to moderate myopia.6 Even early designs of phakic posterior chamber plate intraocular lenses (IOLs) were implanted without later cataract formation7 up to 62 months. In 1998, there was a warning of cataractogenesis8 and pigment dispersion9 was noticed according to the narrow anterior chamber. In centers using ICL implantation shortly after introduction of phakic lenses, subcapsular anterior opacities were observed10–15 within and apart the optical axis. Decreased light transmittance of the crystalline lens was found by fluorophotometry,16 continuously increasing for 27 months,17 but anterior subcapsular opacities and 0886-3350/05/$-see front matter doi:10.1016/j.jcrs.2005.05.028
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decreased light transmittance did not always develop in parallel. When design and lens material were different from the ICL, the percentage of cataract formation increased to 82% over a follow-up of up to 2 years.18 The aim of this study was to investigate eyes that developed a central subcapsular cataract with a significant decrease of the best corrected visual acuity. They had phacoemulsification with posterior chamber IOL implantation and ICL explantation. Eyes with a decreased crystalline transmittance and those with subcapsular opacification far from the center not interfering with the optical axis were not included in the study. PATIENTS AND METHODS At the Department of Ophthalmology at Schlosspark-Klinik, Berlin, the charts of ICL recipients were reviewed for cataract development. Any adverse reaction to the crystalline lens, especially subcapsular opacification, was registered independently of the position around the center or midperiphery after the pupil was dilated. One hundred thirty-one eyes received ICL implantation between 1998 and 2003; 127 were followed by the staff of the department. Version 4 ICL-M model (n Z 99, 78%) was implanted in the case of myopia and the version 3 ICL-H model (n Z 28, 22%) was used in hyperopic eyes. Anterior chamber depth below 2.8 mm was a contraindication to posterior chamber lens implantation. The mean age of all patients was 42.7 years G 11.9 (SD). The mean refraction of hyperopic eyes was C3.62 G 1.72 diopters (D) (range C2.75 to C7.75 D) and ÿ8.56 G 4.30 D (range ÿ4.00 to ÿ19.25 D) in myopic eyes. All patients signed a detailed informed consent regarding the possibility of cataract formation, ocular hypertension, and pigment dispersion. White-to-white distance was determined with a corneal gauge, corneal thickness measured with a pachymeter (Pachymeter SP 2000, Tomey Corp.), and the position of the ICL within the anterior chamber and to the crystalline lens was visualized and measured by ultrasound biomicroscopy (UBM) (Ultrasound Biomicroscope System, Model 840, Humphrey Instruments). Anterior chamber central depth was recorded sonographically (Echo Scan, US 2500, Nidek). For applanation tonometry, Modell 900 (Haag-Streit) was used. Emmetropia was the reason for all lens implantations. Intraocular contact lens implantation began in 1998 with 14 and continued with 44 in 1999, 24 in 2000, 11 in 2002, 33 in 2001, and 5 in 2003. Mean follow-up time was 31 G 18 months. Five patients who developed ocular hypertension during the postoperative days were treated with antiglaucomateous drops and systemic drugs, with pressure normalization thereafter. One ICL-H was removed due to untreatable hypertension after 5 days. In all eyes, the manifest refraction, autorefraction, visual acuity, and intraocular pressure by Goldmann applanation tonometry were measured and ophthalmoscopy by 4-mirror contact glass was performed. Exclusion criteria were diabetes mellitus types I and II, any form of glaucoma, uveitis, and prior anterior surgical intervention. For ICL implantation, parabulbar anesthesia was used with injection of 2.5 mL of a 2% scandicain solution without adrenaline. Steep corneal incisions 90 degrees apart were created at 10 o’clock and 2 o’clock, and below the incisions either an iridectomy or later an iridotomy by Wecker’s scissors was performed to prevent angle-closure glaucoma. In all eyes, the ICL was injected into the hydroxymethylcellulose-filled anterior chamber through
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a 3.2 mm corneal incision with the use of an injector cartridge (Staar Surgical). Subsequently, the viscoelastic substance was completely removed and acetylcholine ophthalmic (Miochol) was applied into the anterior chamber for the constriction of the pupil, and gentamycin (40 mg) and Fortecortin (4 mg) were injected subconjunctively. Thereafter, a therapy with eyedrops containing dexamethasone (1 mg) with neomycin sulfate (3500 IU) and polymyxin B sulfate (600 IU/mL) 3 times per day was recommended for 2 weeks. Postoperative follow-up was recorded at the first and third days and then at 1 and 3 weeks and 3 months. Each patient was asked to visit the outpatient ambulance in case of conjunctival redness, pain in the eye region, or visual loss. Before phacoemulsification, a clear corneal incision of 2.65 mm was performed at 12 o’clock and the ICL was pushed downward to bring the upper edge of the lens into a position to grasp and remove it from the posterior chamber through the incision. After capsulorhexis, the anterior capsule was fixed with formaline for light microscopy. Standard phacoemulsification was performed with capsulorhexis, intracapsular conquer technique of the nucleus, and IOL implantation into the capsular bag. For lens emulsification, the Millennium device (Bausch & Lomb) was used. RESULTS
Nine of 127 eyes (7.1%) with ICL implantation developed central subcapsular anterior opacification of the crystalline lens with visual impairment and have been proposed for cataract extraction, including implantation of an IOL (Table 1). Three of the patients had bilateral surgery. All eyes received an IOL due to emmetropia. Four right eyes developed central lens opacification underneath the anterior capsule, and 5 left eyes were recommended for ICL and cataract removal with IOL implantation. The sex distribution revealed 4 women with 5 eyes and 2 men with 4 eyes. During insertion of the ICL, no sign of surgically induced violation of the anterior capsule was noticed. More than 2 weeks following the procedure, no crystalline lenses showed local whitening of the anterior capsule leading to the disturbance or rupture of this membrane. To the Table 1. Age and time of cataract formation after ICL implantation.
Age (Y)
Eye
Months
UBM Distance ICL–Crystalline Lens* (mm)
53 53 54 54 49 54 44 39 39
R L R L R L L R L
26 27 13 4 15 10 14 15 17
75 65 150 150 ND 40 ND ND ND
ICL Z implantable contact lens; ND Z no data; UBM Z ultrasound biomicroscopy *The space between the ICL and the crystalline lens as measured by UBM.
J CATARACT REFRACT SURG - VOL 31, DECEMBER 2005
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contrary, the history of all patients’ eyes with the development of an anterior subcapsular opacification revealed a slow progression, including a loss of visual acuity over weeks, and did not seem to be correlated to a posttraumatic cause. As documented, the time of opacification of the subcapsular tissue was observed between 4 and 27 months after surgery (mean 15.67 G 6.80 months). The distance between the ICL and the crystalline lens was documented in each case with cataract development performed by UBM. In 4 hyperopic eyes, a distance was measured between 150 and 70 mm of the version 3 ICL-H and the opacified capsule. One myopic eye revealed a 40 mm distance between the phakic posterior chamber lens and the crystalline lens, but all other myopic eyes revealed no measurable spaces between the version 4 ICL-M and the surface of the crystalline lens with subcapsular opacification. This examination was not performed as a routine procedure in uneventful eyes with ICL implantations. The distance between the ICL and the crystalline lens of eyes followed up varied without a relation of development of anterior subcapsular clouding. The refraction of treated eyes before ICL implantation, the refraction of the phakic posterior lens used for the correction, and the refraction after ICL implantation, cataract removal, and IOL implantation are described in Table 2. The refraction values were divided into 2 parts based on the initial refraction to illustrate, separately, the refraction alteration in the hyperopic and myopic eyes, which demonstrates the efficacy in eyes with high ametropia. In the hyperopic group, the mean preoperative refraction was C4.19 G 1.08 D, the refraction of the ICL implantation C6.62 G 1.75 D, the refraction following ICL implantation was C0.63 G 0.22 D, and the final refraction after cataract removal with IOL implantation C0.31 G 0.27 D. Within the myopic group, the preoperative refraction was ÿ12.10 G 5.16 D, the refraction of the ICL implantation was ÿ15.10 G 5.3 D, the refraction after ICL implantation was ÿ0.65 G 0.51 D, and the refraction after cataract extraction and IOL implantation was ÿ0.40 G 0.41 D. All
myopic patients received version 4 ICLs in contrast to all hyperopic eyes, which received version 3 ICLs. In summary, the refraction after ICL implantation did not exceed the interval of G1 D from emmetropia in hyperopic patients and in 2 eyes within the myopic group with extreme myopia preoperatively. After cataract removal with IOL implantation, a refraction misdirection in all eyes never exceeded the value of 1 D independent of the initial refraction or dimension of hyperopia or myopia, respectively. All patients were questioned concerning the choice of a monofocal IOL or refractive or diffractive bifocal or multifocal IOL prior to cataract extraction. All these patients chose a monofocal IOL. Three patients had unilateral cataract extraction. Based on the refraction in all operated eyes, hyperopia included half the procedures performed, although hyperopia included only 22% of eyes with ICL implantation. The age of patients with a secondary cataract ranged from 39 to 53 years (mean 47.4 G 4.96 years). Best spectacle-corrected visual acuity (BSCVA) data are found in Figure 1. The small number of participants in this study includes both hyperopic and myopic eyes. Although it is known that refractive differences have an effect on the retinal image as well as amblyopia, the BSCVA can elucidate the development of cataract formation during the course of ICL implantation, cataract formation, and finally with IOL implantation. Gain and loss of BSCVA from all eyes before ICL implantation was set at 0. In this combined collection of hyperopic and myopic eyes, the ICL implantation led to a gain of 0.89 G 1.54 lines and a loss of 3.11 G 1.45 lines after cataract formation. After cataract extraction and IOL implantation for refractive adjustment, the BSCVA improved 1.44 G 1.33 lines, which is even more than ICL correction. Anterior capsule fragments were collected during phacoemulsification for histologic examination. As soon as the
Table 2. Refraction (D) in patients.
Preoperative C4.00 C6.00 C3.50 C3.25 ÿ5.75 ÿ7.00 ÿ12.00 ÿ17.50 ÿ18.25
ICL C7.50 C9.00 C5.50 C4.50 ÿ8.00 ÿ9.50 ÿ17.50 ÿ20.50 ÿ20.00
After ICL Implantation IOL Implantation ÿ0.50 ÿ1.00 ÿ0.50 ÿ0.50 ÿ0.50 ÿ0.25 0.00 ÿ1.25 ÿ1.25
C0.75 0.00 C0.50 C0.25 C0.25 ÿ0.25 ÿ0.25 ÿ0.75 ÿ1.00
ICL Z implantable contact lens; IOL Z intraocular lens
Figure 1. Change in BSCVA after ICL implantation, cataract development, and cataract and ICL removal and IOL implantation. The values are presented as gain and loss of Snellen lines.
J CATARACT REFRACT SURG - VOL 31, DECEMBER 2005
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CATARACT EXTRACTION AFTER ICL REMOVAL
anterior capsule was removed with capsulorhexis and before phacoemulsification was started, the biopsy was removed from the anterior chamber and immediately submerged into formalin. Microscopic examination revealed differences in the subcapsular parts of each of the 4 specimens examined. Part of the epithelial monolayer was completely preserved subcapsularly with cubic cells, the cells themselves were surrounded by a small epithelial cytoplasmic margin, and the staining of the nucleus was markedly pronounced and the configuration was round or slightly ovoid (Figure 2, top). In contrast to these findings, there were areas of subcapsular cell proliferation 5 to 6 cell layers deep. The nuclei were smaller compared to the monolayer when observed at the same magnification. The cytoplasmic space seemed bigger, the staining weakened, and the figuration more ovoid than round. The thickness of the capsule was greater than within the unchanged areas at a ratio of 1.0:1.4, and the staining of the capsule was slightly diminished. Although an oblique cut during preparation could not completely disclose, it seems that subcapsular cell proliferation was combined with an epicellular basement membrane increment (Figure 2, bottom). It remains uncertain, due to the fact that an exact orientation was difficult to ascertain by biomicroscopy and histology, whether the areas with histologic changes were areas in direct contact with the ICL and the crystalline lens. DISCUSSION
Patients with a high degree of ametropia requesting ICL implantation must be informed that subcapsular
Figure 2. Light microscopy of a single anterior capsule after capsulorhexis obtained during phacoemulsification due to implantable contact lens touch onto the center of the crystalline lens. Top: Monolayer of lens epithelial cells; Bottom: Proliferated lens epithelial cells.
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opacification cannot be excluded. Most patients want to know their final visual acuity even when cataract removal and IOL implantation are needed. All reviewed eyes revealed a vision loss at a percentage of 7.1% related to all ICL implantations. In hyperopic eyes with version 3 ICLs, the adverse reaction was about 3 times more frequent than in myopic patients, which is in contrast to other reports.12 The time of occurrence of 14 anterior subcapsular opacities of 170 (8.2%) consecutive eyes with high ametropias was even earlier19 than the results in this study, with a mean time of about 16 months, and in 7.1% of the eyes with ICL implantations, including hyperopic eyes, which apparently had an increased rate of anterior clouding. The lowest complication rate with the ICL was in the myopia study group, with anterior cataracts in only 11 of 524 eyes (2.1%) and only 2 cataract extractions during the first 12 months after the surgical procedure. A time relation of the subcapsular opacification is presented by Lackner et al.,17 who showed that the cumulative survival rate free from visual impairment was not observed after 32 months, which means that all cataract development should be evident at this time. Up to this time, a continuing number of cataracts might be evident. Our results in 9 eyes with central subcapsular cataracts leading to extraction and IOL implantation do not include a few peripheral subcapsular densities. Those were observed in some eyes as nonprogressive and were not noted by the patients, even in mesopic conditions. When contact between the ICL and crystalline lens is the reason for subcapsular cataract, these peripheral anterior cloudings can be explained due to ICL contact haptics and anterior lens capsule and demonstrated by ultrasound observations.20 According to this study, the distance between the ICL and the crystalline lens might be only 1 of several factors because in 5 of 9 subcapsular cataracts, the space between the implant and the central capsule varied from 40 to 150 mm, and we even found eyes with a nonmeasurable distance without any subcapsular cataract formation. Histologic alteration of the anterior subcapsular space in eyes with phakic posterior chamber lens implantations resembles the aberrant growth and differentiation of epithelial cells in eyes following trauma or anterior ocular inflammation.21,22 The metabolism of these fibroblastlike cells synchronously proceeds to produce different types of collagen23 and a–smooth muscle actin24 in subcapsular cataracts and cultured bovine lens-forming cells. Immunochemistry for a–smooth muscle actin, collagen I, and collagen III was also noticed after polyHEMA/HOHEXMA hydrogel IOL implantation with anterior capsule opacification.25 The influence of transforming growth factor–b on morphologic and molecular changes in transgenic mice and rat cells in culture was recently reported,26 showing collagen I and III, a–smooth muscle actin, tenascin, and fibronectin when anterior subcapsular cataract is evident.
J CATARACT REFRACT SURG - VOL 31, DECEMBER 2005
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Different growth factors induce actomyosin cytoskeleton reorganization and formation in lens epithelial cells through Rho/Rho kinase.27 Next to cell proliferation by the matricellular glycoprotein SPARC, the structural integrity of the lens capsule is dependent on its normal structure,28 which can possibly act as an initiator after anterior capsule trauma. Without a direct trauma to the anterior capsule during surgery, a visible destruction has not occurred after ICL implantation. There is some evidence that contact or close proximity of the refractive phakic lens to the crystalline capsule provokes permeation disturbances that lead to a cascade of metabolic disturbances and transforms epithelial cells, which can be compared to the laboratory investigations. Possibly the smaller anterior chamber and 3 times greater incidence in hyperopic eyes might support this hypothesis, but still it remains unclear how aqueous fluid acts in the way laboratory findings have shown. REFERENCES 1. Assetto V, Benedetti S, Pesando P. Collamer intraocular contact lens to correct high myopia. J Cataract Refract Surg 1996; 22:551–556 2. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber phakic intraocular lens for myopia of ÿ8 to ÿ19 diopters. J Refract Surg 1998; 14: 294–305 3. Davidorf JM, Zaldivar R, Oscherow S. Results and complications of laser in situ keratomileusis by experienced surgeons. J Refract Surg 1998; 14:114–122 4. Sanders DR, Brown DC, Martin RG, et al. Implantable contact lens for moderate to high myopia: phase 1 FDA clinical study with 6 month follow-up. J Cataract Refract Surg 1998; 24:607–611 5. Sanders DR, Martin RG, Brown DC, et al. Posterior chamber phakic intraocular lens for hyperopia. J Refract Surg 1999; 15:309–315 6. Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea 2003; 22:324–331 7. Kaya V, Kevser MA, Yilmaz O¨F. Phakic posterior chamber plate intraocular lenses for high myopia. J Refract Surg 1999; 15:580–585 8. Trinidade F, Pereira F. Cataract formation after posterior chamber phakic intraocular lens implantation. J Cataract Refract Surg 1998; 24: 1661–1663 9. Rosen E, Gore C. Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg 1998; 24:596–606 10. Fink AM, Gore C, Rosen E. Cataract development after implantation of the Staar Collamer posterior chamber phakic lens. J Cataract Refract Surg 1999; 25:278–282 11. Pesando PM, Ghiringhello MP, Tagliavacche P. Posterior chamber collamer phakic intraocular lens for myopia and hyperopia. J Refract Surg 1999; 15:415–423 12. Gonvers M, Bornet C, Othenin-Girard P. Implantable contact lens for moderate to high myopia; relationship of vaulting to cataract formation. J Cataract Refract Surg 2003; 29:918–924
13. Sanders DR, Vukich JA. Incidence of lens opacities and clinically significant cataracts with the Implantable Contact Lens: comparison of two designs; the ICL in Treatment of Myopia (ITM) Study Group. J Refract Surg 2002; 18:673–682 14. Gonvers M, Othenin-Girard P, Bornet C, Sickenberg M. Implantable contact lens for moderate to high myopia; short-term follow-up of 2 models. J Cataract Refract Surg 2001; 27:380–388 15. The Implantable Contact Lens in Treatment of Myopia (ITM) Study Group. U.S. Food and Drug Administration clinical trial of the implantable contact lens for moderate to high myopia. Ophthalmology 2003; 110:255–266 16. Jime´nez-Alfaro I, Benı´tez del Castillo JM, Garcı´a-Feijoo´ J, et al. Safety of posterior chamber phakic intraocular lenses for high myopia; anterior segment changes after posterior chamber phakic intraocular lens implantation. Ophthalmology 2001; 108:90–99; discussion by SM MacRae, 99 17. Lackner B, Pieh S, Schmidinger G, et al. Outcome after treatment of ametropia with implantable contact lenses. Ophthalmology 2003; 110:2153–2161 18. Brauweiler PH, Wehler T, Busin M. High incidence of cataract formation after implantation of a silicone posterior chamber lens in phakic, highly myopic eyes. Ophthalmology 1999; 106:1651–1655 19. Sanchez-Galeana CA, Smith RJ, Rodriguez X, et al. Laser in situ keratomileusis and photorefractive keratectomy for residual refractive error after phakic intraocular lens implantation. J Refract Surg 2001; 17:299– 304 20. Garcı´a-Feijoo´ J, Jime´nez-Alfaro I, Cuin˜a-Sardin˜a R, et al. Ultrasound biomicroscopy examination of posterior chamber phakic intraocular lens position. Ophthalmology 2003; 110:163–172 21. Pau H, Novotny GK, Arnold G. Ultrastructural investigation of extracellular structures in subcapsular white corrugated cataract (anterior capsular cataract). Graefes Arch Clin Exp Ophthalmol 1985; 223: 96–1000 22. Saika S, Miyamoto T, Ohnishi Y. Histology of anterior capsule opacification with a polyHEMA/HOHEXMA hydrophilic hydrogel intraocular lens compared to poly(methyl methacrylate), silicone, and acrylic lenses. J Cataract Refract Surg 2003; 29:1198–1203 23. Hatae T, Ishibachi T, Yoshitomi F, Shibata Y. Immunocytochemistry of types I-IV collagen in human anterior subcapsular cataracts. Graefes Arch Clin Exp Ophthalmol 1993; 231:586–590 24. Schmitt-Graff A, Pau H, Spahr R, et al. Appearance of a-smooth muscle actin in human eye lens cells of anterior capsular cataract and in cultured bovine lens-forming cells. Differentiation 1990; 43:115–122 25. Saika S, Kawashima Y, Miyamoto T, et al. Immunolocalization of prolyl 4-hydroxylase subunits, a-smooth muscle actin, and extracellular matrix components in human lens capsules with lens implants. Exp Eye Res 1998; 66:283–294 26. Lovicu FJ, Schulz MW, Hales AM, et al. TGFb induces morphological and molecular changes similar to human anterior subcapsular cataract. Br J Ophthalmol 2002; 86:220–226 27. Maddala R, Reddy VN, Epstein DL, Rao V. Growth factor induced activation of Rho and Rac GTPases and actin cytoskeletal reorganization in human lens epithelial cell. Mol Vis 2003; 9:329–336 28. Yan Q, Blake D, Clark JI, Sage EH. Expression of the matricellular protein SPARC in murine lens: SPARC is necessary for the structural integrity of the capsular basement membrane. J Histochem Cytochem 2003; 51:503–511
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Results of cataract extraction after implantable contact lens removal Heinrich Bleckmann, MD, Richard J. Keuch, MD
PURPOSE: To evaluate the visual results following insertion of implantable contact lenses (ICLs) in ametropic eyes and the development of subcapsular opacification with visual loss and to examine the anterior capsule, including the subcapsular tissue alteration, by light microscopy. SETTING: Department of Ophthalmology, Schlosspark-Klinik, affiliated hospital of the Charite´ Berlin, Humbold University, Berlin, Germany. METHODS: A prospective noncomparative interventional case series of anterior subcapsular cataracts in 9 of 127 (7.1%) patient eyes receiving ICLs to correct myopia and hyperopia was studied. The cataracts were phacoemulsified due to visual loss, and an intraocular lens (IOL) was implanted in the bag. After capsulorhexis, the anterior capsule was withdrawn for light microscopy examination. Visual acuity in each eye was measured before and after ICL implantation and before and after cataract extraction. The age range of cataract patients was 39 to 53 years. RESULTS: Implantable contact lens removal and phacoemulsification with IOL implantation for emmetropia resulted in an increased visual acuity compared to initial vision. Four of 28 hyperopic eyes (14.3%) developed subcapsular central opacification after ICL implantation, whereas 5 of 99 myopic patients (5.1%) developed opacifications. CONCLUSIONS: Patients should be informed prior to ICL implantation, there is a possibility of secondary subcapsular cataract formation and vision reduction. Although the posterior chamber inlay as well as the cataract can be removed and better acuity can be restored, a possible complication due to the ICL implantation cannot be avoided and the accommodation in young patients lost. J Cataract Refract Surg 2005; 31:2329–2333 Q 2005 ASCRS and ESCRS
The correction of refractive errors in patients with high ametropia is an indication for using an implantable contact lens (ICL), especially in cases of epicorneal contact lens intolerance or insufficient vision with glasses. The development of a refractive lens to be implanted into the posterior chamber without removing the crystalline lens seemed to be superior to other procedures by keeping the accommodation in young patients, saving the corneal configuration,
Accepted for publication May 18, 2005. From the Augenzentrum DRK Kliniken Westend (Bleckmann) and the Eye Department of Schlosspark-Klinik (Keuch), Affiliated Hospital of the Humbold University Berlin, Berlin, Germany. Neither author has a financial or proprietary interest in any material or method mentioned. Reprint requests to Heinrich Bleckmann, MD, Augenzentrum DRK Kliniken Westend, Affiliated Hospital of the Humbold University Berlin, Spandauer Damm 130, 14050 Berlin, Germany. E-mail: [email protected]. Q 2005 ASCRS and ESCRS Published by Elsevier Inc.
and not leading to retinal complications. Early reports on staar surgical ICL implantation stated the high refractive prediction, extremely good tissue biocompatibility to all of the anterior segment, and low complication rate1 in myopic2 and hyperopic eyes.3 In addition, the phase 1 U.S. Food and Drug Administration clinical study with a 6-month follow-up has not shown any intraoperative or postoperative complications4,5 so far and revealed advantages over keratomileusis for high to moderate myopia.6 Even early designs of phakic posterior chamber plate intraocular lenses (IOLs) were implanted without later cataract formation7 up to 62 months. In 1998, there was a warning of cataractogenesis8 and pigment dispersion9 was noticed according to the narrow anterior chamber. In centers using ICL implantation shortly after introduction of phakic lenses, subcapsular anterior opacities were observed10–15 within and apart the optical axis. Decreased light transmittance of the crystalline lens was found by fluorophotometry,16 continuously increasing for 27 months,17 but anterior subcapsular opacities and 0886-3350/05/$-see front matter doi:10.1016/j.jcrs.2005.05.028
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decreased light transmittance did not always develop in parallel. When design and lens material were different from the ICL, the percentage of cataract formation increased to 82% over a follow-up of up to 2 years.18 The aim of this study was to investigate eyes that developed a central subcapsular cataract with a significant decrease of the best corrected visual acuity. They had phacoemulsification with posterior chamber IOL implantation and ICL explantation. Eyes with a decreased crystalline transmittance and those with subcapsular opacification far from the center not interfering with the optical axis were not included in the study. PATIENTS AND METHODS At the Department of Ophthalmology at Schlosspark-Klinik, Berlin, the charts of ICL recipients were reviewed for cataract development. Any adverse reaction to the crystalline lens, especially subcapsular opacification, was registered independently of the position around the center or midperiphery after the pupil was dilated. One hundred thirty-one eyes received ICL implantation between 1998 and 2003; 127 were followed by the staff of the department. Version 4 ICL-M model (n Z 99, 78%) was implanted in the case of myopia and the version 3 ICL-H model (n Z 28, 22%) was used in hyperopic eyes. Anterior chamber depth below 2.8 mm was a contraindication to posterior chamber lens implantation. The mean age of all patients was 42.7 years G 11.9 (SD). The mean refraction of hyperopic eyes was C3.62 G 1.72 diopters (D) (range C2.75 to C7.75 D) and ÿ8.56 G 4.30 D (range ÿ4.00 to ÿ19.25 D) in myopic eyes. All patients signed a detailed informed consent regarding the possibility of cataract formation, ocular hypertension, and pigment dispersion. White-to-white distance was determined with a corneal gauge, corneal thickness measured with a pachymeter (Pachymeter SP 2000, Tomey Corp.), and the position of the ICL within the anterior chamber and to the crystalline lens was visualized and measured by ultrasound biomicroscopy (UBM) (Ultrasound Biomicroscope System, Model 840, Humphrey Instruments). Anterior chamber central depth was recorded sonographically (Echo Scan, US 2500, Nidek). For applanation tonometry, Modell 900 (Haag-Streit) was used. Emmetropia was the reason for all lens implantations. Intraocular contact lens implantation began in 1998 with 14 and continued with 44 in 1999, 24 in 2000, 11 in 2002, 33 in 2001, and 5 in 2003. Mean follow-up time was 31 G 18 months. Five patients who developed ocular hypertension during the postoperative days were treated with antiglaucomateous drops and systemic drugs, with pressure normalization thereafter. One ICL-H was removed due to untreatable hypertension after 5 days. In all eyes, the manifest refraction, autorefraction, visual acuity, and intraocular pressure by Goldmann applanation tonometry were measured and ophthalmoscopy by 4-mirror contact glass was performed. Exclusion criteria were diabetes mellitus types I and II, any form of glaucoma, uveitis, and prior anterior surgical intervention. For ICL implantation, parabulbar anesthesia was used with injection of 2.5 mL of a 2% scandicain solution without adrenaline. Steep corneal incisions 90 degrees apart were created at 10 o’clock and 2 o’clock, and below the incisions either an iridectomy or later an iridotomy by Wecker’s scissors was performed to prevent angle-closure glaucoma. In all eyes, the ICL was injected into the hydroxymethylcellulose-filled anterior chamber through
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a 3.2 mm corneal incision with the use of an injector cartridge (Staar Surgical). Subsequently, the viscoelastic substance was completely removed and acetylcholine ophthalmic (Miochol) was applied into the anterior chamber for the constriction of the pupil, and gentamycin (40 mg) and Fortecortin (4 mg) were injected subconjunctively. Thereafter, a therapy with eyedrops containing dexamethasone (1 mg) with neomycin sulfate (3500 IU) and polymyxin B sulfate (600 IU/mL) 3 times per day was recommended for 2 weeks. Postoperative follow-up was recorded at the first and third days and then at 1 and 3 weeks and 3 months. Each patient was asked to visit the outpatient ambulance in case of conjunctival redness, pain in the eye region, or visual loss. Before phacoemulsification, a clear corneal incision of 2.65 mm was performed at 12 o’clock and the ICL was pushed downward to bring the upper edge of the lens into a position to grasp and remove it from the posterior chamber through the incision. After capsulorhexis, the anterior capsule was fixed with formaline for light microscopy. Standard phacoemulsification was performed with capsulorhexis, intracapsular conquer technique of the nucleus, and IOL implantation into the capsular bag. For lens emulsification, the Millennium device (Bausch & Lomb) was used. RESULTS
Nine of 127 eyes (7.1%) with ICL implantation developed central subcapsular anterior opacification of the crystalline lens with visual impairment and have been proposed for cataract extraction, including implantation of an IOL (Table 1). Three of the patients had bilateral surgery. All eyes received an IOL due to emmetropia. Four right eyes developed central lens opacification underneath the anterior capsule, and 5 left eyes were recommended for ICL and cataract removal with IOL implantation. The sex distribution revealed 4 women with 5 eyes and 2 men with 4 eyes. During insertion of the ICL, no sign of surgically induced violation of the anterior capsule was noticed. More than 2 weeks following the procedure, no crystalline lenses showed local whitening of the anterior capsule leading to the disturbance or rupture of this membrane. To the Table 1. Age and time of cataract formation after ICL implantation.
Age (Y)
Eye
Months
UBM Distance ICL–Crystalline Lens* (mm)
53 53 54 54 49 54 44 39 39
R L R L R L L R L
26 27 13 4 15 10 14 15 17
75 65 150 150 ND 40 ND ND ND
ICL Z implantable contact lens; ND Z no data; UBM Z ultrasound biomicroscopy *The space between the ICL and the crystalline lens as measured by UBM.
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contrary, the history of all patients’ eyes with the development of an anterior subcapsular opacification revealed a slow progression, including a loss of visual acuity over weeks, and did not seem to be correlated to a posttraumatic cause. As documented, the time of opacification of the subcapsular tissue was observed between 4 and 27 months after surgery (mean 15.67 G 6.80 months). The distance between the ICL and the crystalline lens was documented in each case with cataract development performed by UBM. In 4 hyperopic eyes, a distance was measured between 150 and 70 mm of the version 3 ICL-H and the opacified capsule. One myopic eye revealed a 40 mm distance between the phakic posterior chamber lens and the crystalline lens, but all other myopic eyes revealed no measurable spaces between the version 4 ICL-M and the surface of the crystalline lens with subcapsular opacification. This examination was not performed as a routine procedure in uneventful eyes with ICL implantations. The distance between the ICL and the crystalline lens of eyes followed up varied without a relation of development of anterior subcapsular clouding. The refraction of treated eyes before ICL implantation, the refraction of the phakic posterior lens used for the correction, and the refraction after ICL implantation, cataract removal, and IOL implantation are described in Table 2. The refraction values were divided into 2 parts based on the initial refraction to illustrate, separately, the refraction alteration in the hyperopic and myopic eyes, which demonstrates the efficacy in eyes with high ametropia. In the hyperopic group, the mean preoperative refraction was C4.19 G 1.08 D, the refraction of the ICL implantation C6.62 G 1.75 D, the refraction following ICL implantation was C0.63 G 0.22 D, and the final refraction after cataract removal with IOL implantation C0.31 G 0.27 D. Within the myopic group, the preoperative refraction was ÿ12.10 G 5.16 D, the refraction of the ICL implantation was ÿ15.10 G 5.3 D, the refraction after ICL implantation was ÿ0.65 G 0.51 D, and the refraction after cataract extraction and IOL implantation was ÿ0.40 G 0.41 D. All
myopic patients received version 4 ICLs in contrast to all hyperopic eyes, which received version 3 ICLs. In summary, the refraction after ICL implantation did not exceed the interval of G1 D from emmetropia in hyperopic patients and in 2 eyes within the myopic group with extreme myopia preoperatively. After cataract removal with IOL implantation, a refraction misdirection in all eyes never exceeded the value of 1 D independent of the initial refraction or dimension of hyperopia or myopia, respectively. All patients were questioned concerning the choice of a monofocal IOL or refractive or diffractive bifocal or multifocal IOL prior to cataract extraction. All these patients chose a monofocal IOL. Three patients had unilateral cataract extraction. Based on the refraction in all operated eyes, hyperopia included half the procedures performed, although hyperopia included only 22% of eyes with ICL implantation. The age of patients with a secondary cataract ranged from 39 to 53 years (mean 47.4 G 4.96 years). Best spectacle-corrected visual acuity (BSCVA) data are found in Figure 1. The small number of participants in this study includes both hyperopic and myopic eyes. Although it is known that refractive differences have an effect on the retinal image as well as amblyopia, the BSCVA can elucidate the development of cataract formation during the course of ICL implantation, cataract formation, and finally with IOL implantation. Gain and loss of BSCVA from all eyes before ICL implantation was set at 0. In this combined collection of hyperopic and myopic eyes, the ICL implantation led to a gain of 0.89 G 1.54 lines and a loss of 3.11 G 1.45 lines after cataract formation. After cataract extraction and IOL implantation for refractive adjustment, the BSCVA improved 1.44 G 1.33 lines, which is even more than ICL correction. Anterior capsule fragments were collected during phacoemulsification for histologic examination. As soon as the
Table 2. Refraction (D) in patients.
Preoperative C4.00 C6.00 C3.50 C3.25 ÿ5.75 ÿ7.00 ÿ12.00 ÿ17.50 ÿ18.25
ICL C7.50 C9.00 C5.50 C4.50 ÿ8.00 ÿ9.50 ÿ17.50 ÿ20.50 ÿ20.00
After ICL Implantation IOL Implantation ÿ0.50 ÿ1.00 ÿ0.50 ÿ0.50 ÿ0.50 ÿ0.25 0.00 ÿ1.25 ÿ1.25
C0.75 0.00 C0.50 C0.25 C0.25 ÿ0.25 ÿ0.25 ÿ0.75 ÿ1.00
ICL Z implantable contact lens; IOL Z intraocular lens
Figure 1. Change in BSCVA after ICL implantation, cataract development, and cataract and ICL removal and IOL implantation. The values are presented as gain and loss of Snellen lines.
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anterior capsule was removed with capsulorhexis and before phacoemulsification was started, the biopsy was removed from the anterior chamber and immediately submerged into formalin. Microscopic examination revealed differences in the subcapsular parts of each of the 4 specimens examined. Part of the epithelial monolayer was completely preserved subcapsularly with cubic cells, the cells themselves were surrounded by a small epithelial cytoplasmic margin, and the staining of the nucleus was markedly pronounced and the configuration was round or slightly ovoid (Figure 2, top). In contrast to these findings, there were areas of subcapsular cell proliferation 5 to 6 cell layers deep. The nuclei were smaller compared to the monolayer when observed at the same magnification. The cytoplasmic space seemed bigger, the staining weakened, and the figuration more ovoid than round. The thickness of the capsule was greater than within the unchanged areas at a ratio of 1.0:1.4, and the staining of the capsule was slightly diminished. Although an oblique cut during preparation could not completely disclose, it seems that subcapsular cell proliferation was combined with an epicellular basement membrane increment (Figure 2, bottom). It remains uncertain, due to the fact that an exact orientation was difficult to ascertain by biomicroscopy and histology, whether the areas with histologic changes were areas in direct contact with the ICL and the crystalline lens. DISCUSSION
Patients with a high degree of ametropia requesting ICL implantation must be informed that subcapsular
Figure 2. Light microscopy of a single anterior capsule after capsulorhexis obtained during phacoemulsification due to implantable contact lens touch onto the center of the crystalline lens. Top: Monolayer of lens epithelial cells; Bottom: Proliferated lens epithelial cells.
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opacification cannot be excluded. Most patients want to know their final visual acuity even when cataract removal and IOL implantation are needed. All reviewed eyes revealed a vision loss at a percentage of 7.1% related to all ICL implantations. In hyperopic eyes with version 3 ICLs, the adverse reaction was about 3 times more frequent than in myopic patients, which is in contrast to other reports.12 The time of occurrence of 14 anterior subcapsular opacities of 170 (8.2%) consecutive eyes with high ametropias was even earlier19 than the results in this study, with a mean time of about 16 months, and in 7.1% of the eyes with ICL implantations, including hyperopic eyes, which apparently had an increased rate of anterior clouding. The lowest complication rate with the ICL was in the myopia study group, with anterior cataracts in only 11 of 524 eyes (2.1%) and only 2 cataract extractions during the first 12 months after the surgical procedure. A time relation of the subcapsular opacification is presented by Lackner et al.,17 who showed that the cumulative survival rate free from visual impairment was not observed after 32 months, which means that all cataract development should be evident at this time. Up to this time, a continuing number of cataracts might be evident. Our results in 9 eyes with central subcapsular cataracts leading to extraction and IOL implantation do not include a few peripheral subcapsular densities. Those were observed in some eyes as nonprogressive and were not noted by the patients, even in mesopic conditions. When contact between the ICL and crystalline lens is the reason for subcapsular cataract, these peripheral anterior cloudings can be explained due to ICL contact haptics and anterior lens capsule and demonstrated by ultrasound observations.20 According to this study, the distance between the ICL and the crystalline lens might be only 1 of several factors because in 5 of 9 subcapsular cataracts, the space between the implant and the central capsule varied from 40 to 150 mm, and we even found eyes with a nonmeasurable distance without any subcapsular cataract formation. Histologic alteration of the anterior subcapsular space in eyes with phakic posterior chamber lens implantations resembles the aberrant growth and differentiation of epithelial cells in eyes following trauma or anterior ocular inflammation.21,22 The metabolism of these fibroblastlike cells synchronously proceeds to produce different types of collagen23 and a–smooth muscle actin24 in subcapsular cataracts and cultured bovine lens-forming cells. Immunochemistry for a–smooth muscle actin, collagen I, and collagen III was also noticed after polyHEMA/HOHEXMA hydrogel IOL implantation with anterior capsule opacification.25 The influence of transforming growth factor–b on morphologic and molecular changes in transgenic mice and rat cells in culture was recently reported,26 showing collagen I and III, a–smooth muscle actin, tenascin, and fibronectin when anterior subcapsular cataract is evident.
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Different growth factors induce actomyosin cytoskeleton reorganization and formation in lens epithelial cells through Rho/Rho kinase.27 Next to cell proliferation by the matricellular glycoprotein SPARC, the structural integrity of the lens capsule is dependent on its normal structure,28 which can possibly act as an initiator after anterior capsule trauma. Without a direct trauma to the anterior capsule during surgery, a visible destruction has not occurred after ICL implantation. There is some evidence that contact or close proximity of the refractive phakic lens to the crystalline capsule provokes permeation disturbances that lead to a cascade of metabolic disturbances and transforms epithelial cells, which can be compared to the laboratory investigations. Possibly the smaller anterior chamber and 3 times greater incidence in hyperopic eyes might support this hypothesis, but still it remains unclear how aqueous fluid acts in the way laboratory findings have shown. REFERENCES 1. Assetto V, Benedetti S, Pesando P. Collamer intraocular contact lens to correct high myopia. J Cataract Refract Surg 1996; 22:551–556 2. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber phakic intraocular lens for myopia of ÿ8 to ÿ19 diopters. J Refract Surg 1998; 14: 294–305 3. Davidorf JM, Zaldivar R, Oscherow S. Results and complications of laser in situ keratomileusis by experienced surgeons. J Refract Surg 1998; 14:114–122 4. Sanders DR, Brown DC, Martin RG, et al. Implantable contact lens for moderate to high myopia: phase 1 FDA clinical study with 6 month follow-up. J Cataract Refract Surg 1998; 24:607–611 5. Sanders DR, Martin RG, Brown DC, et al. Posterior chamber phakic intraocular lens for hyperopia. J Refract Surg 1999; 15:309–315 6. Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea 2003; 22:324–331 7. Kaya V, Kevser MA, Yilmaz O¨F. Phakic posterior chamber plate intraocular lenses for high myopia. J Refract Surg 1999; 15:580–585 8. Trinidade F, Pereira F. Cataract formation after posterior chamber phakic intraocular lens implantation. J Cataract Refract Surg 1998; 24: 1661–1663 9. Rosen E, Gore C. Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg 1998; 24:596–606 10. Fink AM, Gore C, Rosen E. Cataract development after implantation of the Staar Collamer posterior chamber phakic lens. J Cataract Refract Surg 1999; 25:278–282 11. Pesando PM, Ghiringhello MP, Tagliavacche P. Posterior chamber collamer phakic intraocular lens for myopia and hyperopia. J Refract Surg 1999; 15:415–423 12. Gonvers M, Bornet C, Othenin-Girard P. Implantable contact lens for moderate to high myopia; relationship of vaulting to cataract formation. J Cataract Refract Surg 2003; 29:918–924
13. Sanders DR, Vukich JA. Incidence of lens opacities and clinically significant cataracts with the Implantable Contact Lens: comparison of two designs; the ICL in Treatment of Myopia (ITM) Study Group. J Refract Surg 2002; 18:673–682 14. Gonvers M, Othenin-Girard P, Bornet C, Sickenberg M. Implantable contact lens for moderate to high myopia; short-term follow-up of 2 models. J Cataract Refract Surg 2001; 27:380–388 15. The Implantable Contact Lens in Treatment of Myopia (ITM) Study Group. U.S. Food and Drug Administration clinical trial of the implantable contact lens for moderate to high myopia. Ophthalmology 2003; 110:255–266 16. Jime´nez-Alfaro I, Benı´tez del Castillo JM, Garcı´a-Feijoo´ J, et al. Safety of posterior chamber phakic intraocular lenses for high myopia; anterior segment changes after posterior chamber phakic intraocular lens implantation. Ophthalmology 2001; 108:90–99; discussion by SM MacRae, 99 17. Lackner B, Pieh S, Schmidinger G, et al. Outcome after treatment of ametropia with implantable contact lenses. Ophthalmology 2003; 110:2153–2161 18. Brauweiler PH, Wehler T, Busin M. High incidence of cataract formation after implantation of a silicone posterior chamber lens in phakic, highly myopic eyes. Ophthalmology 1999; 106:1651–1655 19. Sanchez-Galeana CA, Smith RJ, Rodriguez X, et al. Laser in situ keratomileusis and photorefractive keratectomy for residual refractive error after phakic intraocular lens implantation. J Refract Surg 2001; 17:299– 304 20. Garcı´a-Feijoo´ J, Jime´nez-Alfaro I, Cuin˜a-Sardin˜a R, et al. Ultrasound biomicroscopy examination of posterior chamber phakic intraocular lens position. Ophthalmology 2003; 110:163–172 21. Pau H, Novotny GK, Arnold G. Ultrastructural investigation of extracellular structures in subcapsular white corrugated cataract (anterior capsular cataract). Graefes Arch Clin Exp Ophthalmol 1985; 223: 96–1000 22. Saika S, Miyamoto T, Ohnishi Y. Histology of anterior capsule opacification with a polyHEMA/HOHEXMA hydrophilic hydrogel intraocular lens compared to poly(methyl methacrylate), silicone, and acrylic lenses. J Cataract Refract Surg 2003; 29:1198–1203 23. Hatae T, Ishibachi T, Yoshitomi F, Shibata Y. Immunocytochemistry of types I-IV collagen in human anterior subcapsular cataracts. Graefes Arch Clin Exp Ophthalmol 1993; 231:586–590 24. Schmitt-Graff A, Pau H, Spahr R, et al. Appearance of a-smooth muscle actin in human eye lens cells of anterior capsular cataract and in cultured bovine lens-forming cells. Differentiation 1990; 43:115–122 25. Saika S, Kawashima Y, Miyamoto T, et al. Immunolocalization of prolyl 4-hydroxylase subunits, a-smooth muscle actin, and extracellular matrix components in human lens capsules with lens implants. Exp Eye Res 1998; 66:283–294 26. Lovicu FJ, Schulz MW, Hales AM, et al. TGFb induces morphological and molecular changes similar to human anterior subcapsular cataract. Br J Ophthalmol 2002; 86:220–226 27. Maddala R, Reddy VN, Epstein DL, Rao V. Growth factor induced activation of Rho and Rac GTPases and actin cytoskeletal reorganization in human lens epithelial cell. Mol Vis 2003; 9:329–336 28. Yan Q, Blake D, Clark JI, Sage EH. Expression of the matricellular protein SPARC in murine lens: SPARC is necessary for the structural integrity of the capsular basement membrane. J Histochem Cytochem 2003; 51:503–511
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