Advances in Refractive/ Cataract Surgery: Optimizing the Ocular Surface. Toric IOLs. Cylinder Powers SN60T3-T5 1/27/2016

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1 Advances in Refractive/ Cataract Surgery: Optimizing the Ocular Surface James Thimons, O.D.,FAAO Medical Director, Founding Partner OCC Goals of Modern Cataract Surgery For patients to achieve: Distance Vision Intermediate Vision Near Vision Without correction! Traditional Cataract Surgery Corneal incisions via hand-held blade Manually created capsulorhexis via blunt needle or forceps Intraocular ultrasonic phacoemulsification for lens aspiration IOL Implantation Toric IOLs AcrySof Toric Cylinder Powers SN60T3-T5 AcrySof Toric Cylinder IOL Model IOL Plane SN60T SN60T SN60T *Based on an average pseudophakic human eye Initial Spherical Powers: D Cylinder Corneal Plane* Star Toric Accommodative IOLs

2 Accommodative IOLs Advantages: Small change in surgical technique Good Snellen visual acuity Good monocular and binocular contrast sensitivity Good depth perception, stereopsis Accommodative IOLs Disadvantages: Small increase glare and halo Increased post-operative complications Increased need for enhancements Full visual spectrum NO 1 diopter of accommodation Multifocal IOLs Multifocal IOLs Advantages: No change in surgical technique Good Snellen visual acuity Good monocular and binocular contrast sensitivity Good depth perception, stereopsis No increased postoperative complications Full visual spectrum - YES Multifocal IOLs Disadvantages: Increase glare and halo ReSTOR IOL Apodized Diffractive Optic UV and High-Energy Blue filtration Hydrophobic Acrylic Single piece Available in +4 and +3 add 2

3 Binocular Defocus Curve Tecnis Multifocal IOL Snellen 20/20 20/25 20/32 20/40 20/50 20/63 20/80 20/ Refraction (D) IQ ReSTOR IOL +3.0 D [N=117] IQ ReSTOR IOL +4.0 D [N=114] Modified prolate anterior surface Square-edge optic Diffractive multifocal posterior surface with 32 concentric zones UV-absorbing 3-piece foldable 50/50 near/far split in effective light distribution for all pupil sizes +4 D near add Source: AcrySof IQ ReSTOR IOL Package Insert Last 12 Months The Solution - Aspheric Optics Aspheric IOL Light Rays Aspheric Surface Aspheric optics align the light rays to compensate for positive corneal spherical aberration, resulting in enhanced image quality. Multifocal IOLs Pearls: Patient Selection Low myopes and emmetropes Accustomed to great near or distance vision Hyperopes and moderate myopes better candidates Multifocal IOLs: Pre-Operative Evaluation Optimize IOL calculations Confirm corneal topography Optimize ocular surface 3

4 Multifocal IOLs: OCT Analysis Trouble Shooting the Refractive IOL Patient Superior in detecting epiretinal membranes and lamellar holes Avoid multifocal IOLs in patients with maculopathy Macular thickness >230 µm pre-op correlated with worse VA post-op Pre-Operative Considerations The more chair time you spend before the surgery, the less you will spend after surgery. Chair time prior to surgery eases the patient - Expectations. Chair time after surgery puts the patient and ophthalmologist on defensive - Complications. Causes of Glare, Halo, and Loss of Contrast Sensitivity Cylinder and residual refractive error Cornea and ocular surface disease CME Capsular opacities Center Pupil on IOL Crazy Slit Lamp Limbal Relaxing Incision The Tear Film is the Most Important Refracting Surface of the Eye 4

5 Disruption of the Ocular Surface Induces Distortion that is Magnified by a Multifocal IOL Cyclosporine Improved Contrast Sensitivity With Multifocal IOLs 6 C yclos po rin e * 5 T ea rs Mean Score 4 3 ** *P = Don t Forget Meibomian Gland Disease ; 3 c pd ** P = cp d 12 cpd 1 8 c pd Donnenfeld, etal. Efficacy of Topical Cyclosporine versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation; ASCRS 2007 Pre-Operative Care to Optimize Outcomes: Treat Lid Disease Lid hyperthermia Hot compresses and/or lid scrubs Nutritional supplements Topical azithromycin bid 2 days then qd 1 month Severe cases Oral doxycycline Behrens A et al. Cornea. 2006;25(8): Donnenfeld ED. Ophthalmol Manag Accessed Jan 11, Myth: CME is Not Common Binocular Contrast Sensitivity Mesopic Conditions - With Glare Donnenfeld. ASCRS,

6 Posterior Capsular Opacities Minimal posterior capsule opacities can markedly degrade quality of vision, however: If I Break it.... You Buy it Need to discuss with patients that once a posterior capsulotomy is performed it is much more dangerous to exchange the IOL. IOL Centration on Pupil Argon Laser Iridoplasty 4 spots in iris mid periphery 500 milliwatt energy 500 micron diameter 500 millisecond duration Center the Pupil on the IOL BCVA Pre-Argon Laser Iridoplasty vs. BCVA Post-Argon Laser Iridoplasty 60 BCVA (20/ ) Pre-ALI Post-ALI Donnenfeld, et al.; Argon Laser Iridoplasty to Improve Visual Function Following Multifocal IOL Implantation AAO 2007 Eyes The Bottom Line: Presbyopic IOLs Surgeon and patient perspective Multifocal IOLs Homeruns - true spectacle independence Outs - more demanding surgically and psychologically. Rare IOL removal Accommodating IOLs Singles - many happy patients who still wear glasses Walks - some patients do not read any better than a monofocal IOL Errors - many more refractive enhancements Limitations of Manual Cataract Surgery Visual Outcomes Distance Correction Predictability Half that of LASIK Astigmatism Correction Effective Power of IOL Limits Presbyopia Correction Safety Complications 10x LASIK Ultrasound use in phaco associated with post-op complications such as corneal burn, corneal edema and endothelial Common cell loss (1,2) Incidence Vision Threatening Incidence Posterior Capsular Opacification 10-30% Retinal Detachment % Cystoid Macular Edema (transient) 2-10% Cystoid Macular Edema (persistent) 1-2% Vitreous Loss 1-5% IOL Malposition 0.3% Corneal Endothelial Cell Loss 4-10% Need for Corneal Transplant 0.3% 1 Pereira et al. JCRS 2006 Oct;32(10): Park et al. Ophthalmic Surg Lasers Imaging Mar-Apr;41(2): Endopthalmitis 0.1% 36 6

7 Incidence of Capsular Tear Unal M, Yücel I, Sarici A, Artunay O, Devranoğlu K, Akar Y, Altin M. Phacoemulsification with topical anesthesia: Resident experience. J Cataract Refract Surg Aug;32: Anterior tear of capsulorhexis in 5.3% Irregular anterior capsulorhexis in 9.3% Posterior capsule tears with vitreous loss in 6.6% Goals of Laser Refractive Cataract Surgery Improve every procedure, technology and surgeon Presbyopia, astigmatism and monofocal Refractive precision and integration Key Step Current Surgery Refractive Impact Safety Impact Corneal incision Underutilized not optimized Astigmatism Infection Capsulorrhexis Variable sized, Variable IOL position Capsular tears, vitreous New laser-based not standard, centered synonymous and effective lens power with patient pay loss posterior capsule opacification Lens fragmentation Excessive ultrasound Delayed visual recovery Loss of endothelial cells, power capsule rupture 37 The LenSx Laser Laser Refractive Cataract Surgery Current Manual Srgery A New Category in Ophthalmic Surgery One precise, image-guided femtosecond laser procedure to: Effectively liquefy or fragment the nucleus Create a perfectly centered and sized capsulotomy Perform complex multi-planar corneal incisions, and Arcuate incisions to address pre-existing astigmatism Image-Guided LenSx Femtosecond Laser Refractive Capsulotomy Optimized Effective Lens Position for Optimized IOL Performance Capsulotomy Diameter Accuracy (Absolute difference between Attempted and Achieved) Percent of Sample (%) Integrated OCT scans entire anterior segment; projects images of cornea, lens, iris, capsule onto video microscope Surgeon selects incisions and lens treatment; patterns are projected onto OCT images and confirmed Procedure time < 1 minute. Intraoperative OCT projects real-time images as lens is fragmented, capsulotomy is created and then all corneal incisions. Diameter Error (mm) Laser (n=60) Manual (n=60) 100% of LenSx procedures achieved an accuracy of ± 0.25 mm Only 10% of manual procedures achieved an accuracy of ±0.25 mm No radial tears Nagy Z, Takacs 42 A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):

8 Safer/Faster Lens Removal 43% reduction 51% reduction Laser Corneal Incisions Computer-controlled depth, shape and location Precise, OCT corneal thickness measurement Flexible femtosecond laser incision architecture Automated reproducibility allows surgeon to address astigmatism Efficacy of femtosecond lasers established in more than 3 million corneal incision procedures for LASIK flaps and keratoplasty LRIs, which were previously an art form, have now become a science Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12): Effective Lens Position Variability Accuracy to Target Cataract Outcomes vs. LASIK UCVA < 20/20: 94% Standard Deviation Preop 1 Week 1 Month LenSx (n=25) Manual (n=12) Procedures performed by Zoltan Nagy, MD at Semmelweis University, Budapest, Hungary; Clinical Evaluation of FS Laser-Assisted Cataract Surgery Improved Refractive Cataract Surgery Image-Guided Refractive Cataract Surgery IOL Position Predictability Corneal Astigmatism Early WOW Factor Uniform shape and size of capsulotomy Reproducible corneal entry and arucate incisions Reduced phaco power and corneal edema Integrated OCT scans entire anterior segment; projects images of cornea, lens, iris, capsule onto video microscope Surgeon selects incisions and lens treatment; patterns are projected onto OCT images and confirmed Procedure time < 1 minute. Intra-operative OCT projects real-time images as lens is fragmented, capsulotomy is created and then all corneal incisions. 8

9 LenSx Laser Corneal Incisions Customized wound architecture and placement Self-sealing incisions LenSx Laser Arcuate Incisions Image-guided surgical planning with 3D visualization Real time corneal thickness Computer programmed incisions %depth Incision length and position 3D visualization of incision placement Predictable incision eidth, tunnel length Titratable inciisions Adjustable during surgery Adjustable post-op at slit lamp *510(k) Premarket Notification to the FDA, LenSx Laser System, K101626, Laser Corneal Incisions 1.2 Effective Lens Position Variability Computer-controlled depth, shape and location Precise, OCT corneal thickness measurement Flexible femtosecond laser incision architecture Automated reproducibility allows surgeon to address astigmatism Efficacy of femtosecond lasers established in over 3 million corneal incision procedures for LASIK flaps and keratoplasty 1 Standard Deviation Preop 1 Week 1 Month LenSx (n=25) Manual (n=12) Procedures performed by Zoltan Nagy, M.D. at Semmelweis University, Budapest, Hungary; Clinical Evaluation of FS Laser Assisted Cataract Surgery Unmet Need: Astigmatic Correction Importance of Astigmatic Treatment Percentage of Respondent s What Characteristic of current premium cataract surgery does NOT deliver on your Expectations: 55% Refractive Accuracy 45% Management of Astigmatism 45% Need for Accommodating IOL 35% Managing Patient Expectations versus High Price Ability to Treat Pre-Existing Astigmatism Impacts: Patient Satisfaction Premium IOL % Quality of Vision Glare Halo Snellen Visual Acuity As little as 0.50D of residual cylinder may leave a patient symptomatic High Grade Near Vision (without night 25% vision complaints) Others, including: High percentage of Source: LenSx Survey 10% enhancements, need for leak free Refractive IOL surgeons must be willing and able to treat postoperative astigmatism to make patients happy postoperatively 9

10 Astigmatism is Common in Patients Undergoing Cataract Surgery Astigmatism and Cataract Surgery 70% of patients have > 0.5 D of pre-op astigmatism 39% of patients have > 1.0 D of pre-op astigmatism 35% Grabow and Martin 31% 30% 30% 3.00 D or greater 2.75 D or greater 2.50 D or greater 2.25 D or greater 2.00 D or greater 1.75 D or greater 1.50 D or greater 1.25 D or greater 1.00 D or greater 0.75 D or greater 0.50 D or greater 0.25 D or greater Less than 0.25 D N=1,831 25% 20% 1.5 D to 3.5 D = 20% 19% 15% 10% 10% 5% 5% 0% Astigmatism Prevalence 6,000 Patients Warren Hill MD % 2.5 1% 1% 0% 0% 0% Astigmatism Treatment Options Excimer Laser Photoablation Toric IOLs Astigmatism Treatment Options Options for Treating Pre-Existing Astigmatism: Excimer Laser Photoablation (+ accuracy) Toric IOLs (+ simplicity and safety) Easy to perform Limbal Relaxing Incisions/AK Incisions Inexpensive Lack of side effects Repeatable Performed at time of cataract surgery Fast recovery Increase the percentage of patients who fulfill inclusion criteria for premium IOLs Does not preclude future excimer treatment Reimbursement (additional revenue stream) Laser Refractive Cataract Surgery Arc Incisions Challenges of Astigmatic Incisions Limbal Relaxing Incisions/AK Incisions PREOPERATIVE MEASURES Determining the exact quantity and location of cylinder TREATMENT Variable response to limbal relaxing incisions due to imprecise depth, length and position of incision. Risk of perforation LRIs are an art form not a science Reason: Imprecise, NonRepeatable Incision Architecture 2% 3% 5% 6% 9% 12% 18% 26% 38% 53% 72% 89% 10.95% Fully Customizable and adjustable Refractive incisions are no long an art form. They are a science. Place Desired Incisions: Of the EXACT Size, In the EXACT Place, With the EXACT Depth, Every Time. LenSx Femtosecond Laser 10

11 Increased Accuracy of all Femtosecond Corneal Incisions Keratome limbal and corneal cataract incisions are less accurate than femtosecond incisions Femtosecond cataract incisions are more reproducible, stable, do not leak and are more refractively predictable Image-Guided Laser Refractive Cataract Surgery for LRI Self sealing 2 plane cataract incision Programming FS Laser Arc Incisions Laser Procedure Fully Customizable and Precise Arc Incisions Laser Precise: Size Length Depth Location Phaco Conclusion A new Category is emerging in private pay ophthalmic surgery LenSx technology will drive innovation for true Laser Refractive Cataract Surgery Patients already thought they were having laser surgery anyway! Unique precision for capsulotomy and corneal incisions Smaller incisions and laser optimized wound architecture Improved IOL performance via Effective Lens Positioning Correction of pre-existing astigmatism at time of surgery A more predictable, safe and reproducible procedure Technology that will enable surgeons to deliver better vision 11