1. Sulcus-Placed Single-Piece Acrylic IOL After Posterior Capsule Tear A.K. Junk, S. R. Wellik Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami Miami Veterans Health Care System 1 CORE GRANT P30-EY14801 The authors have no financial interest and no conflict of interest in the subject matter to disclose.

2. Introduction With the advent of small incision cataract surgery foldable single- piece acrylic (SPA) intraocular lenses (IOLs) have gained in popularity and account for approximately one half of the IOLs implanted in the U.S. Alcon estimates that worldwide more than 30 million AcrySof® IOLs have been implanted. With its square edge SPA IOLs achieve better apposition to the lens capsule, thus inhibiting lens epithelial migration. The “tacky” IOL surface restricts lens epithelial cell access of aqueous and nutrients and induces cell atrophy and apoptosis. The IOL material has excellent biocompatibility, great stability in the capsular bag, and reduced rates of posterior capsule opacification (PCO). The manufacturer does not recommend sulcus placement of this IOL style as the zero angulation of the haptic-optic junction may induce iris chaffing. 2

3. Introduction The peer reviewed literature is controversial on the question whether SPA IOLs can be placed safely in the sulcus. Two reports in in favor of sulcus placement are in contradiction with several case reports of iris chafing, uveitis-glaucoma-hyphema (UGH) syndrome or vitreous hemorrhage after sulcus placed SPA IOL. Two articles from one center are in support of sulcus placed SPA IOLs, reporting elevated IOP in 19% of patients, no need for IOL exchange, and rare surgical revision[1, 2]. Prior reports of sulcus placed SPA IOLs are case reports[3-7] or comprised of patients referred to tertiary care centers for management of complications[8, 9]. At the “Spotlight on Cataract Complications Symposium” during the 2008 AAO meeting the audience was surveyed on the issue of sulcus placed SPA IOLs. Over 40% said a SPA IOL should be placed in the sulcus “if capsular support was adequate”, 47% said “never”, 2% said “yes”, if suture fixated, and 11% said “yes, if no other PC IOL was available”. 3

4. Patients and Methods This is a retrospective chart review of nine consecutive patients who had cataract surgery complicated by posterior capsule tear or anterior capsule rent and sulcus placed SPA IOL at one medical center. Patient demographics are depicted in Table 1. 4 Age at the time of surgery Mean79 Range70 - 87 Sex male9 Female0 Year of initial surgery 20062 20073 20083 20091 Table 1. Patient demographics at the time of surgery

5. Patients and Methods Please refer to Table 2. Surgical Complications and Outcomes, to view details about the surgical cases. Table 2 is available by clicking on the link “View additional images/videos” 5

6. Patients and Methods In 89% of surgeries a posterior capsule tear was noted after phaco- fragmentation and anterior vitrectomy was performed prior to sulcus placement of SPA IOL. An Acrysof® SA60WF implant was used in 67% of cases, three patients had toric SPA IOLs, SN60T4 or SN50T5 respectively. Suture fixation was not used. One patient was lost of follow up after one month, two patients expired six, respectively 14 month after cataract surgery. Three patients required surgical intervention. The SPA IOLs were de- centered in 66% of cases causing increased refractive astigmatism compared to preoperative, spectacle correction yielded corrected visual acuity of 20/40 or better. 6

7. Results This case series demonstrates good final corrected visual acuity of 20/25 or better in 78% with SPA IOL in the sulcus (Table 3). However, postoperative visits were more frequent and visual recovery was prolonged, 33% needed additional surgery, seven patients (77%) require distance spectacle correction, six patients (67%) had a final refractive astigmatism of 1.50 D or more, 6 patients developed glaucoma and continue to need ophthalmic therapy. Surprisingly, only 33% developed CME. This resolved with medical treatment in all patients. Only one patient had IOL exchange. 7 IOL exchange and anterior vitrectomy 1MA60AC20/25 Glaucoma drainage implant 1Baerveldt 101-350CF Repair of wound leak1n/a20/20 Observation/medical treatment 620/40 – 20/20 Table 3. Final corrected visual acuity at last follow up

8. Discussion SPA IOL rotation within the sulcus, even months after implantation, is common in our patients and lead to monocular diplopia (22.%) and unstable refractive error (44%). The AcrySof® SPA IOL has a diameter of less than 13 mm from end to end and is too short for most eyes. There is no accurate way to estimate the ciliary sulcus diameter by external measurements. In addition, the horizontal sulcus diameter is typically shorter than the vertical diameter[10]. An initially well centered IOL may rotate into a wider sulcus meridian and decenter. SPA IOL decentration after initial excellent placement is particularly undesirable in patients with high visual expectations after toric, accommodative or multifocal IOL implantation. Given the likely resulting higher manifest astigmatism and spherical aberration after sulcus implantation of toric SPA IOL, it appears advisable to rather implant an alternate three piece lens without astigmatism correction. This also holds true if the patient has already paid out of pocket for the advanced optic IOL. 8

9. Discussion Further consideration should address the IOL power. Only with capsulorhexis capture, the same IOL power calculated for capsular bag placement can generally be used for sulcus placement. Placement of the optic behind the intact anterior capsulorhexis will sequester the square edge of the optic away from the posterior surface of the iris. Iris chafing and pigment dispersion may still ensue due to contact of the SPA IOL haptics with the posterior iris. However, stable and centered SPA IOL position can be achieved using capsulorhexis capture. SPA IOLs have successfully been suture fixated onto the sclera[11]. It seems that the “tacky” surface constitutes an advantage for suture fixation as the haptic will not slip through the suture material. Scleral suture fixation has proven successful even after spontaneous dislocation of a SPA IOL haptic into the anterior chamber[12]. While scleral suture fixation can be considered intraoperatively to securely place a SPA IOL into the sulcus, the surgeon must consider the additional time needed in a soft, vitrectomized eye often under topical anesthesia. The more anterior optic location in the sulcus requires that the lens power be reduced by 0.5 to 1.0 D when the entire PCIOL is placed in the sulcus. This eliminates the desirable use of SPA IOL calculated for capsular bag placement in most cases with insufficient capsular support or the final refraction cannot meet the set target. 9

10. Discussion Placement of any posterior chamber IOL in the ciliary sulcus carries the potential to cause complications such as pigment dispersion. However, a 3-piece posterior chamber IOL with posterior angulation of the haptics will move the optic away from the posterior pigment epithelium of the iris. Additionally, a 3-piece IOL with a relatively thin optic edge and small, round haptics will reduce potential problems when placed in the sulcus. Though none of the patients in this series manifested heavy pigment deposition in the trabecular meshwork of the operated eye or iris transillumination defects as evidence of iris chafing, chronic secondary glaucoma developed in 66% of patients, necessitating glaucoma drainage implant surgery in one individual. One patient developed uveitic glaucoma, however the full picture of uveitis-glaucoma-hyphema (UGH) syndrome was not observed. A recent report on complications after SPA IOL implantation into the sulcus[8] and the corresponding editorial[13] provide a comprehensive review and discussion of associated risks, complications, and management of complications. Surgical alternatives for SPA IOL placement in the sulcus are detailed and discussed. Technological advancement in cataract surgery has raised today’s patients’ and surgeons’ expectations for an elegant, fast surgery followed by a smoothe postoperative course and rapid visual recovery to excellent uncorrected visual acuity. There is no place for SPA IOLs in the sulcus. 10

11. References 1.Taskapili, M., et al., Comparison of sulcus implantation of single-piece hydrophilic foldable acrylic and polymethylmethacrylate intraocular lenses in eyes with posterior capsule tear during phacoemulsification surgery. Eur J Ophthalmol, 2007. 17(4): p. 595-600. 2.Taskapili, M., et al., Single-piece foldable acrylic intraocular lens implantation in the sulcus in eyes with posterior capsule tear during phacoemulsification. J Cataract Refract Surg, 2005. 31(8): p. 1593-7. 3.Uy, H.S. and P.S. Chan, Pigment release and secondary glaucoma after implantation of single-piece acrylic intraocular lenses in the ciliary sulcus. Am J Ophthalmol, 2006. 142(2): p. 330-2. 4.Masket, S., Pseudophakic posterior iris chafing syndrome. J Cataract Refract Surg, 1986. 12(3): p. 252-6. 5.Micheli, T., et al., Acute haptic-induced pigmentary glaucoma with an AcrySof intraocular lens. J Cataract Refract Surg, 2002. 28(10): p. 1869-72. 6.Wintle, R. and M. Austin, Pigment dispersion with elevated intraocular pressure after AcrySof intraocular lens implantation in the ciliary sulcus. J Cataract Refract Surg, 2001. 27(4): p. 642-4. 7.LeBoyer, R.M., et al., Acute haptic-induced ciliary sulcus irritation associated with single-piece AcrySof intraocular lenses. J Cataract Refract Surg, 2005. 31(7): p. 1421-7. 8.Chang, D.F., et al., Complications of sulcus placement of single-piece acrylic intraocular lenses: recommendations for backup IOL implantation following posterior capsule rupture. J Cataract Refract Surg, 2009. 35(8): p. 1445-58. 9.Mamalis, N., et al., Complications of foldable intraocular lenses requiring explantation or secondary intervention--2003 survey update. J Cataract Refract Surg, 2004. 30(10): p. 2209-18. 10.Oh, J., et al., Direct measurement of the ciliary sulcus diameter by 35-megahertz ultrasound biomicroscopy. Ophthalmology, 2007. 114(9): p. 1685-8. 11.Packer, M., I.H. Fine, and R.S. Hoffman, Suture fixation of a foldable acrylic intraocular lens for ectopia lentis. J Cataract Refract Surg, 2002. 28(1): p. 182-5. 12.Bhattacharjee, S., A. Chakrabarti, and A. Ghosh, Minimally invasive relocation of subluxated single piece AcrySof intraocular lens. Br J Ophthalmol, 2008. 92(6): p. 746. 13.Mamalis, N., Sulcus placement of single-piece acrylic intraocular lenses. J Cataract Refract Surg, 2009. 35(8): p. 1327-8. 11