Five-Year Follow-Up After Anterior Iris-Fixated Intraocular Lens
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Eye (2012) 26, 321–326 & 2012 Macmillan Publishers Limited All rights reserved 0950-222X/12 www.nature.com/eye Five-year follow-up X Yuan, HZ Ping, WC Hong, D Yin and Z Ting CLINICAL STUDY after anterior iris-fixated intraocular lens implantation in phakic eyes to correct high myopia Abstract was proved to be effective, predictable and capable of reversibility to correct high myopia Purpose To evaluate the 5-year follow-up of in phakic eyes. It was a safety addition to the safety, efficacy, predictability, stability, and laser refractive surgery. However, longer complications of anterior iris-fixated phakic follow-up with larger numbers of patients is intraocular lens (pIOL) implantation to correct still necessary to evaluate long-term high myopia, and patients’ satisfaction after complications. implantation. Eye (2012) 26, 321–326; doi:10.1038/eye.2011.292; Design Prospective, nonrandomized, and published online 2 December 2011 comparative (self-controlled) trial. Methods A prospective clinical trial of Keywords: iris-fixated; IOL; phakic; high myopia 84 eyes of 43 patients with high myopia was conducted. Uncorrected visual acuity (UCVA), Introduction best spectacle-corrected visual acuity (BSCVA), refraction, endothelial cell count, The first surgical option to correct myopia is intraocular pressure (IOP), anterior chamber cornea refractive, such as laser in situ depth, slit lamp biomicroscopy, and keratomileusis (LASIK), photorefractive indirect ophthalmoscope were measured keratectomy, laser epithelial keratomileusis, preoperatively and postoperatively. epipolis LASIK, and so on. To treat high-myopia Results At the 5-year follow-up, UCVA was patients, the new techniques can make the Department of significantly improved, with 85.7% of eyes cornea flap thinner and thinner; however, this Ophthalmology, Jinling reaching 20/25 or better. No eyes experienced a increases the risk of corneal ectasia, thus Hospital, School of loss in BSCVA, and 71.4% gained one or more decreasing visual quality.1 In recent years, Medicine, Nanjing lines of their preoperative BSCVA. There was phakic lens implantation in the anterior or University, Jiangsu, China a significant reduction in spherical errors in all posterior chamber has gained increasing 2 Correspondence: HZ Ping, patients after operation. Loss of endothelial popularity for high-myopia treatment; it Department of cells was observed 3 years after operation and offers a promising alternative, particularly for Ophthalmology, Jinling no more loss was observed 4 years after high-myopia correction up to À20.0 diopters (D). Hospital,School of operation in statistical analysis. No increase in These intraocular operations retain the Medicine, Nanjing IOP was observed 5 years after operation in patients’ clear lens, and thus the accommo- University, 305#Zhong Shan East Road, Nanjing, Jiangsu statistical analysis. No intraoperative dation function is reserved; they maintain 210002, China complications were observed in this study. the original prolate shape of the cornea, as a Tel: þ 86 25 8086009; However, pigment precipitates of varying result of which the optical qualities of the E-mail: hzp19633@ intensities on the lens optic were noted in all cornea are not altered.3,4 Over the past few hotmail.com patients 1 day after operation, and only five years, many kinds of refractive lenses have been eyes were observed to have the pigment implanted with success in phakic eyes to correct Received: 24 March 2011 5,6 Accepted in revised form: residual five years after operation. myopia, hyperopic, and astigmatism. 24 September 2011 Conclusion At the 5-year follow-up, the In 1986, Worst and Fechner modified the Published online: 2 implantation of the anterior iris-fixated pIOL existing iris-fixated intraocular lens (IOL) into a December 2011 Five-year follow-up after intraocular lens implantation X Yuan et al 322 negatively biconcave IOL with a convex–concave optic IOL powers ranging from À3.0 to À23.5 D are available design. Initially, the lens was called the worst myopia- for the optic diameter of 5.0 mm, and IOL powers fixated IOL, later named the Artisan (Ophtec BV, ranging from 3.0 to À15.5 D are available for the optic Groningen, The Netherlands);7–9 now it is known as the diameter of 6.0 mm. The lens calculations were based on Verisyse (Advanced Medical Optics, Inc., Santa Ana, the special calculating software, VeriCalc1.1 (Advanced CA, USA). Medical Optics, Inc.), and also can be received by the This prospective study was to evaluate the 5-year IOL-MASTER (Zeiss, Minneapolis, MN, USA) directly. postoperative clinical and refractive results of anterior iris-fixated phakic IOL (pIOL) implantation for the Operation correction of high myopia. Thirty minutes before the operation, the miotic drop (1% pilocarpine) was given every 5 min, 3 times, then Patients and methods 0.4% oxybuprocaine hydrochloride topical anesthetic In all, 84 eyes of 43 patients had surgeries at the was given three times. A superior sclerocorneal self- Refractive Centre, Department of Ophthalmology, Jinling sealing 5.3- to 5.5-mm incision and two paracenteses Hospital, Nanjing, China, from March 2004 to December were created. A cohesive ophthalmic visco surgical 2005. All the patients were fully informed about the device (sodium hyaluronate 1% (Healon)) was injected details and risks of the procedure and provided written through the paracenteses to maintain ACD and protect informed consents. endothelial cells. Further, the IOL was placed into the anterior chamber and was enclavated onto the iris, after which the visco was removed. All eyes underwent a Indication peripheral iridotomy during the operation. Patients fulfilling the following criteria were included in the study: (1) they were aged between 18 and 40; (2) had Follow-up a stable refraction for at least 1 year; (3) had myopia 4À8.0 D and cannot undergo a cornea refractive All the eyes were examined 1 week, 1 and 6 months, and operation; (4) had a clear cornea and endothelial cell 1, 2, 3, 4, and 5 years after surgery. The examination count (ECC) 42200 cells/mm2; (5) had a central anterior includes uncorrected visual acuity (UCVA), best chamber depth (ACD) 43.2 mm; (6) had an otherwise spectacle-corrected visual acuity (BSCVA), IOP, IOL normal ophthalmologic examination and unsatisfactory position, pupil shape, computerized corneal topography, correction with spectacles or contact lenses. contrast sensitivity, ECC, and indirect ophthalmoscopes. Slit lamp biomicroscopy was used to determine IOL position and to evaluate crystalline lens changes after Contraindication mydriasis, as well as the shape of pupil. The IOL- Patients with the following conditions were excluded MASTER (Zeiss) was used to measure the ACD. The from the study: (1) anisometropia; (2) anterior segment UBM was used to examine the anterior chamber angle pathology; (3) inadequate eyelid closure; (4) ECC function. o1800 cells/mm2; (5) central ACD o3.0 mm; (6) abnormal iris or pupil function; (7) intraocular pressure Statistics (IOP) 421 mm Hg; (8) previous corneal or intraocular surgery; (9) any intraocular eye disease such as recurrent SPSS version 11.0. (SPSS Inc., New York, NY, USA) was or chronic uveitis, cataract, glaucoma, or family history used for descriptive statistical analysis. Continuous of glaucoma, retinal detachment or family history of variables were described using mean, SD, median, and retinal detachment, preexisting macular degeneration minimum and maximum values. Images are presented in or macular pathology; (10) systemic diseases, a data graph format. chronic treatment with corticosteroids or any immunosuppressive treatment or state, and pregnancy. Results In all, 84 eyes were enrolled in this prospective study Lenses between March, 2004 and December, 2005. All eyes were The biomaterial of the Verisyse anterior iris-fixated pIOL available for examination at 5 years. The mean is a plane–concave design, made by poly methyl preoperative sphere was À13.56±2.06 D (range, À8.05 to methacrylate, with effective ultraviolet light filtration up À22.0 D), the mean preoperative cylinder was to approximately 400 nm. The overall length is 8.5 mm, À0.95±0.56 D (range, À1.5 to 0.00 D), and the mean Eye Five-year follow-up after intraocular lens implantation X Yuan et al 323 Table 1 Summary of preoperative data for patients undergoing Table 3 BSCVA preoperative and 6 months after implantation implantation of an anterior iris-fixated lens of iris-fixated pIOP Variable Data BSCVA (eyes) 420/20 20/20 20/25 20/30 20/40 o20/40 Total patients (eyes) 43 (84eyes) Pre-O (84) 6 38 16 12 8 4 Average age (years) 27.22 5-year Post-O (84) 23 32 20 7 2 0 Range of age (years) 18–39 Abbreviations: BSCVA, best spectacle-corrected visual acuity; Post-O, Female (eyes) 28 (55eyes) postoperation; Pre-O, preoperation. Male (eyes) 15 (29eyes) Mean spherical equivalent±SD (D) 14.17±2.56 Range of SE (D) À8.75 to À22.5 Table 4 Gained and lost BSCVA 6 months, 3, and 5 years after ± ± Mean sphere SD (D) 13.56 2.06 implantation of iris-fixated pIOP, postoperative compared with Range of sphere (D) À8.05 to À22.0 preoperative Mean cylinder±SD (D) À0.95±0.56 Range of cylinder (D) À1.5 to 0.0 BSCVA Lost Unchanged Gained Gained Gained Range of anterior chamber depth (mm) 3.4 (eyes) one line two lines more lines Range of axial length (mm) 27.8 Implant power (D) À8.5 to À22.0 6 months (84) 0 51 18 13 2 Range of preoperative scoptopic pupil size (mm) 4.88–7.21 3 years (84) 0 50 25 6 3 Range of preoperative mesopic pupil size (mm) 2.8–4.66 5 years (84) 0 34 14 28 8 Post–pre 0 24 32 12 16 Abbreviation: D, diopter. Abbreviations: BSCVA, best spectacle-corrected visual acuity; Post–pre, the BSCVA at 6-month postoperative compared with preoperative.