Evolution in Visual Freedom.

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Transcription:

Evolution in Visual Freedom.

The EVO+ Visian ICL is an evolution in vision correction developed for patients with larger pupils including younger patients. Based on the proven EVO Visian ICL platform (formerly CentraFLOW V4c), EVO+ Visian ICL features an expanded optic (5. mm - 6.1 mm). EVO+ Visian ICL is designed to achieve a higher level of vision performance. 1

EVO+ Visian ICL Optics The new EVO+ Visian ICL Expanded Optical Zone Optic is an evolution in vision correction. Expanded Optical Zone Optic Larger True Optical Zone EVO+ s larger optical zone may provide benefit to patients with expanded pupils (such as night driving) 1 May reduce risk of halos and glare 1 Available from -.5 D to -14. D

Aqueous Flow Through Central Port Eliminates PIs and restores a more natural aqueous flow 2 Eliminates the need for PIs; increasing the efficiency for both the surgeon and patient 2 Enhanced convenience and comfort for the patient Restores a more natural aqueous flow 2 Facilitates OVD removal Superb quality of vision 3 Changes in Higher Order Aberrations (µm) Superb Quality of Vision 4 Low rate of higher order aberrations 4 HOAs 6mm Pupil.3.25.2.15.1.5. V4c with Central Port Coma Spherical Total V4 Significant increase in contrast sensitivity with the Visian ICL and Visian ICL V4c with Central Port 4 2.5 Mean IOP (mmhg) IOP Stability 3 No significant changes in IOP overtime were detected after implantation 2 19 18 17 16 15 14 13 12 11 1 9 8 Preop 1 7 3 Preop Postop Mean IOP ± SD (mmhg) Time (days) log contrast sensitivity log contrast sensitivity 2. 1.5 1..5.2.4.6.8 1 1.2 1.4 2.5 2. 1.5 1. log spatial frequency (cycles/degree) before Visian ICL V4 implantation after Visian ICL V4 implantation Mean contrast sensitivity ± SD.5.2.4.6.8 1 1.2 1.4 log spatial frequency (cycles/degree) before Visian ICL V4c implantation after Visian ICL V4c implantation Mean contrast sensitivity ± SD

Proven Long Term Results For more than 2 years, the Visian ICL family has continued to provides exceptional vision with more than 55, lenses implanted worldwide. * Stability Time course of spherical equivalent up to 9 years postop Visian ICL 5 2 -.8 -.28 -.28 -.3 -.29 -.43 -.59 -.58-2 Mean SE (D) -4-6 -8-1 -12-8.47 Pre 1D 1W 1M 6M 1Y 3Y 5Y last Time after Surgery visit High levels of predictability were achieved early after surgery and maintained nine years postop Safety Change in CDVA (lines) 5 Years Post-op with the Visian ICL 6 CDVA line changes measured at 5 years postop 4 38% 35 34% 3 Proportion of Eyes (%) 25 2 15 1 1% 14% 5 % lost <-2 2% lost -2 2% lost -1 unchanged gained +1 gained +2 gained >2 96% of eyes achieved the same or better UCDVA as their preoperative CDVA * Data as of December 215

Exceptional Vision Quality Visian ICL advanced lens technology with a unique lens material provides a superior vision performance. 7 Visual Performance of the Visian ICL versus Wavefront-Guided LASIK for Low to Moderate Myopia 7 HOAs 4 mm Pupil HOAs 6 mm Pupil.2.35 Changes in Higher Order Aberrations (µm).15.1.5 Changes in Higher Order Aberrations (µm).3.25.2.15.1.5. 3rd order. 4th order Total HOAs 3rd order 4th order Total HOAs Visian ICL implantation Wavefront-guided LASIK Visian ICL induces significantly fewer higher order aberrations than wavefront-guided LASIK 7 2.5 2.5 2. 2. log contrast sensitivity 1.5 1. log contrast sensitivity 1.5 1..5.5.2.4.6.8 1 1.2 1.4.2.4.6.8 1 1.2 1.4 log spatial frequency (cycles/degree) log spatial frequency (cycles/degree) before Visian ICL implantation after Visian ICL implantation Mean contrast sensitivity ± SD before wavefront guided LASIK after wavefront guided LASIK Mean contrast sensitivity ± SD Visian ICL outperforms wavefront-guided LASIK delivering improved contrast sensitivity 7

Proven Predictability and Stability of the Visian Toric ICL Clinical studies have shown the Visian Toric ICL has excellent predictability and stability for the correction of moderate to high myopic astigmatism 8 Predictability Manifest refraction spherical equivalent (MRSE) attempted versus achieved correction with the Visian Toric ICL 8 Stability Time course of manifest refractive cylinder afer Visian Toric ICL implantation 8 Achieved Correction (D) 2 15 1 5 Manifest Refractive Cylinder (D) -1-2 -3-2.23 -.53 -.5 -.52 -.57 -.58 -.49 5 1 15 2 Attempted Correction (D) -4 Pre 1 Mo 3 Mo 6 Mo 1Y 2Y 3Y Time after Surgery 82% of eyes were within.5 D of expected MRSE 98% of eyes were within 1. D of expected MRSE Excellent Rotational Stability for Precise Astigmatism Correction 92% of eyes implanted with the Visian Toric ICL had a change in axis of 1º 9 87% of eyes implanted with the Visian Toric ICL had a change in axis of 5º 9 Only one eye (.47%) needed to be repositioned due to misalignment 9

Designed to Satisfy Patients Preserving the integrity of the cornea provides advantages today and for the future. Treatment options for the future The Visian ICL is an additive procedure that can easily be removed. There is no permanent removal of corneal tissue More accurate biometry may be achieved because the Visian ICL does not remove corneal tissue. This may result in more predictable future IOL calculations which may potentially avoid refractive surprises 1 The Visian ICL refractive procedure allows for future surgical interventions including corneal based treatments Placement is safe and discreet The lens is positioned for stability in the sulcus, behind the iris and in front of the crystalline lens The placement of the Visian ICL provides provides a safe distance beween the corneal endothelium and the lens Exceptional patient satisfaction rate that s over 99% 11 Short procedure time in an outpatient setting, small incision and sutureless surgery, a WOW factor of vision, no induction of dry eye 12 and a quick patient recovery create an exceptional patient experience High patient satisfaction leads to a high patient referral potential. New patient referrals are the number one practice building method Higher Satisfaction Rates for Phakic IOLs versus LASIK 13 In a recent study comparing excimer laser refractive surgery versus phakic intraocular lenses, phakic IOLs scored more highly on the patient satisfaction preference questionaire 13

A Proven Visual Performance 14,15 A proprietary lens material composed of collagen and co-polymer composition setting a new standard in IOLs. Transmitted images Hydrophilic Collamer Features Anti-Reflectance Properties 18 Light source The risk of dysphotopsia due to internal reflections increases as light passes through materials with more greatly differing refractive indexes (RI) 19,2 The hydrophilic nature of Collamer promotes a high water content (4%) in the lens minimizing the difference in RI between the lens and aqueous of the eye The RI of Collamer minimizes reflections and may Aqueous Lens Surface Inner lens Lens Surface Aqueous contribute to a lower potential for dysphotopsia Hydrophilic Collamer Water Concentration % Water Content Refractive Index Difference in Refractive Index Len vs Aqueous 1.336 Hydrophobic Acrylic AcrySof IOL (Alcon) % 1.55 21.214 1.442 1.55 Collamer 4% 1.442 14.16 1.336 1.336 Aqueous >99% 1.336 - Hydrophilic Collamer Hydrophobic Acrylic (Alcon) Postoperative Total Higher Order Aberrations 16 1.4 1.4 Competitive lenses were associated with higher order aberrations between 11% and 14% greater than the Collamer lens at both one week and one month postoperatively 16 RMS Value 1.2 1..8.6.58.9.4.2 STAAR Collamer Alcon SA6 AMO Sensar

Collamer Provides a Quiet Eye, UV Light Protection, and Years of Proven Experience Highly Biocompatible Collamer Inhibits Inflammatory Responses to Achieve a Postop Quiet Eye 15,17 The unique properties of Collamer minimize inflammation, flare and cellular reaction 15,17 Offers UV Protection The Collamer material is bonded with UV absorbing chromophore into a poly-hema based copolymer that offers UV protection 15 A Proven Performance Collamer is exclusive to STAAR. It has a proven history for over 2 years with more than 1 million lens implants worldwide Indications The EVO Visian ICL is indicated for use in phakic eye treatment in adults 21-45 years of age for: The correction/reduction of myopia in adults ranging from -.5 D to -2. D at the spectacle plane. With an anterior chamber depth (ACD) equal to or greater than 3. mm, as measured from the corneal endothelium to the anterior lens capsule

Spherical Lenses Diopter Current Optical Diameter (mm) EVO+ Optical Diameter (mm) Approximate Equivalent OZ at Corneal Plane 22,23 (mm) -.5 to -9. 5.8 6.1 7.6-9.5 to -1. 5.5 5.9-6.1 7.4-7.6-1.5 to -12.5 5.3 5.3-5.8 6.6-7.3-13. to -14. 4.9 5. - 5.2 6.3-6.5-14.5 to -18. 4.9 N/A 6.1 +.5 to +1.* 5.8 N/A 7.3 Available in.25 D increments from -.5 D to -3. D and.5 D increments from -3. D to -18. D *The Hyperopic Model is not EVO and has no central port in the optic. Data in this brochure relates to the myopic and toric myopic versions. For information on the hyperopic range, please contact STAAR Surgical Lens lengths: **11.6 mm / 12.1 mm / 12.6 mm / 13.2 mm / ***13.7 mm ** Available only in the Hyperopic Model *** Available only in the Myopic Model Toric Lenses Diopter Cylinder Current Optical Diameter (mm) EVO+ Optical Diameter (mm) Approximate Equivalent OZ at Corneal Plane 22,23 (mm) -.5 to -9. +.5 to +6. 5.8 6.1 7.6-9.5 to -1. +.5 to +6. 5.5 5.9-6.1 7.4-7.6-1.5 to -12.5 +.5 to +6. 5.3 5.3-5.8 6.6-7.3-13. to -14. +.5 to +6. 4.9 5. - 5.2 6.3-6.5-14.5 to -18. +.5 to +6. 4.9 N/A 6.1 +. to 1.* +.5 to +6. 5.8 N/A 7.3 Available in.5 D increments *The Hyperopic Model is not EVO and has no central port in the optic. Data in this brochure relates to the myopic and toric myopic versions. For information on the hyperopic range, please contact STAAR Surgical Lens lengths: **11.6 mm / 12.1 mm / 12.6 mm / 13.2 mm / ***13.7 mm ** Available only in the Hyperopic Model *** Available only in the Myopic Model References 1. Domínguez-Vicent A, Esteve-Taboada J, Ferrer-Blasco T, Montes-Mico R, Perez-Vives C. Optical quality comparison between 2 collagen copolymer posterior chamber phakic intraocular lens designs. J Cataract Refract Surg 215; 41:1268 1278 2. Alfonso JF, Lisa C, Fernández-Vega Cueto L, Belda-Salmerón L, Madrid-Costa D, Montés-Micó R. Clinical outcomes after implantation of a posterior chamber collagen copolymer phakic intraocular lens with a central hole for myopic correction. J Cataract Refract Surg. 213 Jun;39(6):915-21 3. Intraocular Pressure during the Early Postoperative Period after 1 Consecutive Implantations of Posterior Chamber Phakic Intraocular Lenses with a Central Hole By F. González- Lopez et al. J Cataract Refract Surg 213 Dec;39(12):1859-63 4. Intraindividual Comparison Of Visual Performance After Posterior Chamber Phakic Intraocular Lens With And Without A Central Hole Implantation For Moderate To high Myopia By K.Shimizu, K.Kamiya, A. Igarashi, K.Shimizu, and T.Shiratani. Am J Ophthalmol 212.Sep;154(3):486-494.e1. 5. Long-term clinical results of posterior chamber phakic intraocular lens implantation to correct myopia. J.S. Lee, Clin Experiment Ophthalmol. 215 Dec 12. doi: 1.1111/ceo.12691. 6. Alfonso J, Baamonde B, Fernandez-Vega L, Fernandes P, Gonzalez-Meijome J, Montes-Mico R. Posterior Chamber Collagen Copolymeer Phakic Intraocular Lenses to Correct Myopia: Five Year Follow-Up. J Cataract Refract Surg 211;37:873-88. 7. Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual Performance After Posterior Chamber Phakic Intraocular Lens Implantation and Wavefront-Guided Laser In Situ Keratomileusis for Low to Moderate Myopia. Am J Ophthalmol. 212;153:1178 1186. 8. Kamiya K, Shimizu K, Igarashi A, Komatsu M. Three-year follow-up of posterior chamber toric phakic intraocular lens implantation for moderate to high myopic astigmatism. PLoS One 213;8(2):e56453. 9. D.R.Sanders et al. Toric Implantable Collamer Lens for moderate to High Myopic Astigmatism. Ophthalmology 27;114-54:61 1. Ravi H. Patel, MD; Carol L. Karp, MD; Sonia H. Yoo, MD; Guillermo Amescua, MD; Anat Galor, MD, MSPH, Cataract Surgery After Refractive Surgery. Int Ophthalmol Clin. 216;56(2):171-182. 11. UV-absorbing collamer implantable contact lens (ICL) for the correction of myopia. PMA# P316. Presentation to the Ophthalmic Devices Advisory Panel. October 23. 12. Naves, J.S. Carracedo, G. Cacho-Babillo, I. Diadenosine Nucleotid Measurements as Dry-Eye Score in Patients After LASIK and ICL Surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 212. 13. Barsam A. Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia (Review). The Cochrane Collaboration 212;1. 14. Collamer Ultraviolet-Absorbing Posterior Chamber Single-Piece Foldable Intraocular Lens (Directions for use) STAAR Surgical. 15. Brown DC1, Ziémba SL; Collamer IOL FDA Study Group. Collamer intraocular lens: clinical results from the US FDA core study. J Cataract Refract Surg. 21 Jun;27(6):833-4. 16. Martin R, Sanders D. A comparison of higher order aberrations following implantation of four foldable intraocular lens designs. J Refract Surg. 25; 21(6):716-21. 17. Schild G, Amon M, Abela-Formanek C, et al. Uveal and capsular biocompatibility of a single-piece, sharp-edged hydrophilic acrylic intraocular lens with collagen (Collamer): 1-year results. J Cataract Refract Surg. 24 Jun;3(6):1254-8. 18. N. A. Peppas. Hydrogels in Medicine and Pharmacy Volume 1: Fundamentals. Boca Raton, Florida. CRC Press Inc. 1986. 19. Radford S, BM, BCh, Carlsson A, MD, FRCSC, Barrett G, FRACS, FRACO. Comparison of pseudophakic dysphotopsia with Akreos Adapt and SN6-AT intraocular lenses. J Cataract Refract Surg. 27;33(1):88-93. 2. Tester R, Pace Nl, Samore M, et al. Dysphotopsia in phakic and pseudophakic patients: Incidence in relation to intraocular lens type. J Cataract Refract Surg. 2;26:81-816. 21. AcrySof IQ IOL Directions for Use. Alcon. 22. Alió JL, Perez-Santonja JJ. Refractive Surgery with Phakic IOLs: Fundamentals and Clinical Practice. New Delhi, India. Jaypee Brothers Medical Publishers Ltd. 213. 23. Lovisolo CF, Pesando PM. The Implantable Contact Lens (ICL) and Other Phakic IOLs. Canelli, ItalyFabione Editore s.r.l. 1999. ATTENTION: Reference the EVO and EVO+ Visian ICL Product Information for a complete listing of indications, warnings and precautions. For more information, please visit www.staar.com or contact STAAR Customer Service at customerservice@staarag.ch 344 216 STAAR Surgical Company 1965 Rev A STAAR Surgical AG Hauptstrasse 14 CH - 256 Nidau / Switzerland www.staar.com www.discoverevo.com