Eye (2011) 25, 1365–1370 & 2011 Macmillan Publishers Limited All rights reserved 0950-222X/11 www.nature.com/eye 1,2 1,2 Phakic intraocular MA Hassaballa and TA Macky CLINICAL STUDY lenses outcomes and complications: Artisan vs Visian ICL Abstract procedures offer many potential advantages: a broader range of treatable ametropia, faster Purpose To evaluate the safety and visual visual recovery, more stable refraction, and outcomes of two phakic intraocular lenses better visual quality.4–6 Two basic intraocular (IOLs) for correction of high myopia: Artisan refractive procedures exist: phakic intraocular and Visian ICL (ICL). lens (pIOL) implantation, and clear lens Patients and methods In this retrospective extraction with lens implantation. Refractive study, a phakic IOL was implanted in 68 lens exchange may increase the risk for retinal highly myopic eyes of 34 patients; 42 eyes detachment,7 and is generally not considered in received an Artisan IOL, and 26 eyes received myopic pre-presbyopic patients who can still ICL IOL. accommodate. Results All patients completed a 1-year The risks and benefits of pIOL implantation follow-up. The mean preoperative spherical in appropriate patients may be more favorable equivalent (SEQ) was À12.89±3.78, and than other refractive surgery techniques. The À12.44±4.15 diopters (D) for Artisan and pIOL is removable surgically, with fast visual ICL (P ¼ 0.078), respectively. The mean recovery, and preserved accommodation. postoperative (1-year) uncorrected distance However, it is important to realize that visual acuity was 0.39±0.13 and 0.41±0.15 complications relating to pIOLs can be more logMAR for Artisan and ICL, respectively disabling than those from keratorefractive (P ¼ 0.268). The mean postoperative (1-year) surgery.3 Several generations of both anterior corrected distance visual acuity was 0.36±0.12 and posterior pIOLs have been introduced in and 0.31±0.12 logMAR for Artisan and ICL, the past few years. respectively (P ¼ 0.128). The mean Multiple studies from different parts of the postoperative SEQ was À0.86±0.5 and world addressed the visual outcomes of both 1 À0.63±0.38 D for Artisan and ICL, Department of procedures, but only few studies were conducted Ophthalmology, Kasr El Aini respectively (P ¼ 0.67). Intraocular pressure in the Middle East. The purpose of this Hospital, Cairo University, change at 1 year was 0.64±2.7 and Cairo, Egypt assessment was to review the safety and 1.88±0.6 mm Hg for Artisan and ICL, outcomes of two pIOLs, which are currently respectively (P ¼ 0.77). 2Al Nour Eye Hospital, Cairo, approved by the FDA in our hospital. The Conclusion Artisan and ICL showed equal Egypt Verisyse phakic IOL marketed internationally as and comparable safety, predictability, and the Artisan lens by Ophtec (Boca Raton, FL, USA; efficacy. Correspondence: TA Macky, FDA approval 2004), and the Visian ICL (ICL), Department of Eye (2011) 25, 1365–1370; doi:10.1038/eye.2011.187; manufactured by STAAR Surgical Company Ophthalmology, Cairo published online 5 August 2011 University, 29th, 13th street, (Monrovia, CA, USA; FDA approval 2005). Apt. #11, Maadi, Cairo Keywords: Artisan; Visian ICL; phakic IOLs 11431, Egypt Tel: þ 20 12789288; Patients and methods Fax: þ 20 223388742. E-mail: tamermacky@ Approval for the study was obtained from the gmail.com Introduction hospital’s ethical committee, and followed the Keratorefractive surgeries, such as tenets of the Declaration of Helsinki. Received: 28 April 2011 Accepted in revised form: photorefractive keratectomy and LASIK, have This retrospective comparative study was 1 July 2011 limitations when used for the correction of high conducted in Al Nour Eye Hospital, searching Published online: 5 August refractive errors.1–3 Intraocular refractive files of all patients who underwent pIOL 2011 Artisan vs Visian ICL MA Hassaballa and TA Macky 1366 surgeries by either Artisan or ICL in the period from January 2007 to December 2009. This study included 68 eyes of 34 patients, 42 eyes were implanted with Artisan lens and 26 eyes were implanted with ICL. All patients completed a follow-up period of 1 year. The pIOL chosen for each patient was selected based only on the surgeons’ preferences, and there were no specific parameters used to decide which pIOL for each patient. Preoperative evaluation for implantation The preoperative evaluation of patients consists of a complete ophthalmologic examination, including a Figure 1 Artisan phakic intraocular lens postoperative. manifest and, where appropriate, cycloplegic refraction, corrected distance visual acuity (CDVA), white to white (W–W) measurement by caliper, slit-lamp biomicroscopy, central corneal thickness measurement, endothelial cell count, keratometry, axial eye length measurement, tonometry, anterior chamber depth, measurement of mesopic pupil diameter, and indirect ophthalmoscopy. A thorough peripheral retinal examination is necessary to rule out retinal tears, especially in highly myopic eyes. Exclusion criteria included the presence of hyperopia, cataract, glaucoma or ocular hypertension, history of retinal detachment, corneal affection, pupil abnormalities, endothelial cell count less than 2000 mm2, uveitis, less than 20 years old, or unstable refraction. Operative technique Figure 2 Visian ICL phakic intraocular lens intraoperative. For eyes undergoing implantation of anterior-chamber, iris-fixated pIOLs, the pupil was constricted with miotic iris. Once the pIOL is well positioned, the viscoelastic drops, and the procedure was performed under was removed, a peripheral surgical iridotomy was peribulbar anesthesia. Two paracenteses were created, performed, and the corneal wound was checked for and the anterior chamber was filled with viscoelastic. integrity. Generally, the procedure on the other eye A limbal incision was made, usually in the steepest follows in 1 or 2 weeks (Figure 2). corneal meridian, which is approximately equal to the lens optic diameter. The pIOL was inserted and rotated into a horizontal position. A fold of the peripheral iris Postoperative management was then captured by the pincher-like lens haptics in a process called enclavation. A peripheral surgical Follow-up examinations are typically scheduled at 1 day, iridotomy was performed. The incision was closed with 1 week, 1 month, 3 months, 6 months, and 1 year after an appropriate suture and the viscoelastic was then surgery. Postoperative examinations included slit-lamp removed. Generally, the procedure on the other eye biomicroscopy, keratometry, applanation tonometry, follows in 1 or 2 weeks (Figure 1). subjective and objective refraction, and measurement of For eyes undergoing implantation of posterior- uncorrected distance visual acuity (UDVA), and CDVA. chamber pIOLs, the pupil was dilated with mydriatic Within the first six-postoperative weeks, the sutures were drops, and the procedure was performed under cut or removed if it has created undesirable corneal peribulbar anesthesia. A 3.2-mm temporal clear corneal astigmatism in cases implanted with Artisan lens. Each incision was created, as well as 1 or 2 paracenteses. The procedure safety index and efficacy index were anterior chamber was filled with viscoelastic. The pIOLs calculated as follows: safety index ¼ mean postoperative was then injected into the anterior chamber, anterior and CDVA/mean preoperative CDVA, and efficacy parallel to the iris plane, and allowed to unfold. Each index ¼ mean postoperative UDVA/mean preoperative corner of the footplates was gently tucked beneath the CDVA (using decimals for visual acuity). Eye CDVA and UDVA were 0.41 À ( postoperative sphere, cylinder, and SEQ were For the Artisan group at 1 weekPostoperative (Table period 1), (first the 1–2 mean weeks) 16.2 The mean preoperative IOP was 15.4 logMAR for the Artisan and ICL ( The mean anterior chamber depth was 3.45 3.4 CDVA and UDVA were 0.39 preoperative CDVA was 0.42 À À sphere, cylinder, spherical equivalent (SEQ)characteristics were for both groups. Theand ICL, mean respectively. preoperative Tables 1 and 2 show the baseline was 2 : 1 ( Artisan and ICL, respectively. Theyears male (range 20–38), to and female 29.85 ratio follow-up years (range period 21–39) of for one the 26 year. The eyes mean received age ICL was pIOLs.retrospective 25.85 study; All 42 patients eyes completed received the Sixty-eight Artisan eyes pIOLs, of and 34 patients were Results included in this USA) version 15 forPackage Microsoft for Windows. the SocialCorporation, Science; New SPSS York, Inc., NY, Chicago, USA),computer IL, and programs SPSS Microsoft (Statistical Excel 2007significant. (Microsoft All statistical calculations were done using À Artisan and ICL ( 11.83 logMAR, respectively. The mean change of SEQ was first week, when excluding thisdropped case, back is 0.85 to 16 mm Hg.anterior The vitrectomy mean was change done inon immediately, and IOP the the in second IOP postoperative day with IOP 46 mm Hg, postoperative sphere, cylinder, and SEQ were Pigment dispersion occurred in 12 eyes (28.6%). Mann–Whitney Comparison between the studywas groups converted was to done logMAR using for proper statistical analysis. variables. Spearman rank correlation equation forCorrelation between non-normal various variables was done using mean P 1.45 0.94 12.15 11.41 For the ICL group at 1 week (Table 2), the mean Data were statistically described in terms of range, ¼ ± ± 0.247), respectively. ± 0.3 mm for Artisan and ICL ( ± ± ± 3.4 (11–18) mm Hg for the Artisan and ICL ± ± 6.6 D. There was one case of malignant glaucoma SD, and median when appropriate. Visual acuity 0.9, and 0.9, and 2.0, 0.7, n P ¼ -values À À 14 : 7), and 3 : 1 ( 1.87 1.69 U À À P -test for independent samples. 1.14 0.82 ± ± o ¼ 2.2, and 0.8, and 0.078), respectively. The mean 0.05 was considered statistically ± ± 0.8 respectively. The mean 0.64, respectively. The mean ± ± ± À À n 0.26 and 0.43 0.14 and 0.41 0.23 and 0.40 12.44 ¼ 12.89 10 : 3) for the Artisan P P ¼ ¼ ± ± ± 0.675), respectively.