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One-Year Clinical Outcomes of a Corneal Inlay for Presbyopia

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CLINICAL SCIENCE One-Year Clinical Outcomes of a Corneal Inlay for Presbyopia Sandra M. C. Beer, MD, Rodrigo Santos, MD, Eliane M. Nakano, MD, Flavio Hirai, MD, Enrico J. Nitschke, Claudia Francesconi, MD, and Mauro Campos, MD phthalmologists have used a wide variety of procedures Purpose: To report the results of a 1-year follow-up analysis of the Oto correct for refractive errors. Corneal laser surgery safety and efficacy of the Flexivue Microlens corneal inlay. with multifocal patterns or monovision approaches have been Methods: The Flexivue Microlens corneal inlay was implanted in developed including laser-assisted in situ keratomileusis (LASIK),1,2 presbyLASIK,3 photorefractive keratectomy,4 the nondominant eye of patients with emmetropic presbyopia 5 2 laser epithelial keratomileusis thin-flap femto-LASIK, and (a spherical equivalent of 0.5 to 1.00 diopter) after the creation 6 7,8 of a 300-mm deep stromal pocket, using a femtosecond laser. The sub-Bowman keratomileusis. Conductive keratoplasty, patients were followed up according to a clinical protocol involving clear lens extraction, cataract surgery using multifocal, pseudoaccommodative intraocular lenses, or monovision refraction, anterior segment imaging analysis (Oculyzer), and optical 9–11 quality analysis (OPD-Scan). monofocal intraocular lenses have also been used to treat presbyopia. Results: Thirty-one patients were enrolled in this ongoing study. The necessity of a minimally invasive, removable, The mean age was 50.7 years (range 45–60 yrs), and 70% of the and safe surgical technique with a flat learning curve for patients were female. The mean uncorrected near visual acuity patients aged 45 to 60 years has led to the development of improved to Jaeger 1 in 87.1% of the eyes treated with the inlays. All refractive intracorneal lenses (inlays) such as the KAMRA, eyes improved 4 lines at all visits. The binocular uncorrected Raindrop, and Flexivue Microlens. These inlays are placed distance visual acuity was 20/20 in all patients. Ninety percent of inside a pocket in the corneal stroma, usually in the the patients reported that their near vision was good or excellent. nondominant eye. Some of the patients (16.1%) lost more than 3 lines of corrected In this prospective nonrandomized clinical study, we distance visual acuity. At the latest follow-up, induction of a corneal collected 1-year follow-up data on the safety and efficacy of spherical aberration to improve near visual acuity was statistically the Flexivue Microlens, which was implanted in 31 patients. significant. No other intraoperative or postoperative complication was noted. Conclusions: The Flexivue Microlens provided patients with PATIENTS AND METHODS improved near vision, as a result of a negative spherical This clinical trial was performed at the Department aberration. A significant loss of corrected distance visual acuity of Refractive Surgery, Federal University of São Paulo, São in the operated eyes was observed. Overall, this intracorneal inlay Paulo, Brazil. The study adhered to the tenets of the was an effective alternative to other procedures for the correction Declaration of Helsinki and obtained ethical approval from of presbyopia. the Institutional Ethics Committee (Hospital São Paulo). All participating patients provided informed consent before Key Words: bifocal refractive corneal inlay, intracorneal inlay, being studied. presbyopia, cornea Thirty-one patients were recruited from May 2012 to (Cornea 2017;36:816–820) June 2013. The inclusion criteria included were patients aged 45 to 60 years, uncorrected near visual acuity (UNVA) worse than J4, uncorrected distance visual acuity (UDVA) better than 20/40, corrected near visual acuity and corrected distance visual acuity (CDVA) better than 20/20, a spherical Received for publication September 4, 2016; revision received February 11, equivalent (SE) of 20.5 to 1.00 diopter (D), a refractive 2017; accepted February 14, 2017. Published online ahead of print April cylinder #20.75 D, the use of full-time reading glasses for 25, 2017. near visual tasks required for a minimum of 1 year, clearly From the Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo, São Paulo, Brazil. determined ocular dominance, central corneal thickness Sandra Beer is a consultant for Presbia. The remaining authors have no $500 mm, mesopic pupillary diameter $3 mm, and an funding or conflicts of interest to disclose. endothelial cell count (ECC) $2000 cells per millimeter Reprints: Sandra M. C. Beer, MD, Department of Ophthalmology, UNIFESP- square in the eye to be implanted. The exclusion criteria were Universidade Federal de São Paulo, Rua Vitor Meireles 523-Jardim São Caetano-São Caetano do Sul, São Paulo 9581-460, Brazil (e-mail: anterior or posterior segment pathology, previous intraocular [email protected]). or corneal surgery, chronic systemic or topical corticosteroid Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. treatment, the use of other immunosuppressive agents, 816 | www.corneajrnl.com Cornea Volume 36, Number 7, July 2017 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Cornea Volume 36, Number 7, July 2017 Outcomes of a Corneal Inlay for Presbyopia patients who used telescopes or microscopes for professional was determined using noncontact corneal specular micros- reasons, and patients who had high vision requirements or copy (Florence, Italy). Visante anterior chamber optical expectations such as surgeons, architects, accountants, pro- coherence tomography (Carl Zeiss, Oberkochen, German) fessional athletes, and pilots. The patients were examined was used to analyze the depth of the pocket, and contrast before inlay implantation and postoperatively at 1 day, 1 sensitivity was determined using a contrast sensitivity test week, 1 month, 3 months, 6 months, 1 year, 3 years, and (Stereo Optical, Chicago, IL). 5 years. Surgical Techniques Corneal Inlay Three experienced surgeons performed all surgeries The 3.2-mm Flexivue Microlens (Presbia, Irvine, CA) between August 2012 and June 2013. Centration was has a bifocal design with a central zone for distance vision, performed by identifying the line of sight (Purkinje line), with no refractive power and a peripheral positive refractive and the center of the pupil was marked with a pen using zone for near vision. The inlay comprises a biocompatible gentian violet. A pocket was created using an IntraLase hydrophilic acrylic material (Contaflex C126). The central femtosecond laser (60 kHz; Abbott Medical Optics, Milpitas, zone has a diameter of 1.6 mm and an edge thickness of CA). The pocket incision was always in the higher astigma- 15 mm. The available base power ranges from +1.50 D tism axis following the settings. The pocket tunnel entry and to +3.50 D in 0.25 D increments. There is a 0.5-mm diameter pocket bed had a diameter of 3.6 mm, and pockets were hole at the center of the disc that permits transfer of oxygen created at a depth of 300 mm. and nutrients through the lens. The lens power is determined Once the pocket was created, the inlay was loaded into by adding +0.25 D in the near power refraction in the an appropriate inserter. The instrument was then inserted into nondominant eye, according to the manufacturer’s instruc- the pocket, and the inlay was released at the centrally tions for inlay implantation. marked area. The postoperative topical medication regimen consisted of a combination of fourth-generation fluoroquinolone (Vigamox) Manifest Refraction and Visual Acuity for 7 days and a topical steroid such as 1.0% prednisolone (Pred Manifest refraction and visual acuity were measured Forte) eye drops given four times daily for 14 days, then tapered preoperatively and postoperatively from 1 week onward. All over 2 weeks. tests were performed monocularly and binocularly. All distance visual acuity measurements were performed using Snellen charts. Near visual acuity was tested using an Early Statistical Analyses Treatment Diabetic Retinopathy Study Chart (Precision Statistical analyses were performed using SPSS statis- Vision, Berkeley, CA) and a Jaeger chart at 16 inches under tical software for Windows, version 16 (SPSS, Inc., Chicago, a light source of 500 lux. All visual acuities are expressed in IL). A paired-sample t test was used to compare preoperative logMAR units and Jaeger. and postoperative data. P , 0.05 was considered statistically significant. The data are presented as mean 6 SD. Patient Satisfaction A subjective questionnaire was used to assess patient satisfaction during the clinical trial at 1, 3, 6, and 12 months RESULTS during the postoperative period. The result of the most recent The study cohort included 31 patients. The mean age questionnaire was used as the final result. Patients were asked was 50.7 years (range 45–60 years). The cohort included 9 to grade their overall satisfaction for near vision (excellent, males (29%) and 22 females (70.9%), and surgery was good, fair, or poor); satisfaction for binocular distance vision performed on 15 right eyes and 16 left eyes. The depth of (excellent, good, fair, or poor); satisfaction with distance the pocket varied from 266 to 311 mm (optical coherence vision in the operated eye (excellent, good, fair, or poor); tomography evaluation). frequency of glare and halos (never, sometimes, frequent, or At the slit-lamp, no signs of stromal reaction or always); dependence on reading glasses (never, ,50%, epithelial defects were noticed during the study period. The .50%, or always); and dependence on glasses for distance surgical interface was clear in all eyes with very subtle vision (never, ,50%, .50%, or always). opacities resembling an iLasik flap. Careful slit-lamp exam- ination of the inlay area disclosed slight implant folds. METHODS All tests were performed in the operated eye by 2 Efficacy examiners. The tests included corneal topography, pachyme- The mean SE refractive error decreased significantly try, and keratometry using the Scheimpflug WaveLight from 0.33 6 0.38 D preoperatively to 21.78 D 6 0.80 D Oculyzer and Topolyzer system (Pentacam HR, Alcon, Fort (P , 0.05) at the last follow-up visit.
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