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1 Slide 1 High Risk LASIK Patients Do you feel lucky? Slide 4 Derek N. Cunningham, OD, FAAO Slide 2 Traditional Risk Assessment Slide 5 Randelman Scale What s the point Topography (unilateral keratoconics?) Residual stromal bed (only measured in very few cases, mostly calculated) Age? Preoperative corneal thickness Preoperative spherical equivalent Dr. Steve Schallhorn Professor Jan Venter Dr. Mitchell C Brown Dr. Stephen Coleman Dr. Joseph Colin Dr. Steven J. Dell Professor H. Burkhard Dick Dr. Michael C Knorz Dr. Colman Kraff Dr. Marguerite McDonald Dr. Stephen Slade Dr. John A. Vukich Slide 3 Real Risk of Ectasia Slide 6 Enormous Dataset Statistical Significance 109,924 consecutive LVC Treatments (60,071 Patients) from April 1st, 2010 to June 30th, Follow-up availability as follows: 1 Week 79,695 (72.5%) 1 Month 78,266 (71.2%) 3 Month 54,083 (49.2%) 6 Month 21,655 (19.7%) Preoperative Refractive Stratification as follows: Low/Mod Myopia 85,905 (78.2%) High Myopia 5,365 (4.9%) Low/Mod Hyperopia 12,675 (11.5%) High Hyperopia 2,159 (2.0%) Mixed Astigmatism 3,820 (3.5%)

2 Slide 7 Risk Factor Scoring System Randleman JB, et al. J. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology Jan;115(1):37-50 Slide 10 Pre-op Central Corneal Thickness thinnest of 3 ultrasonic pachymetry readings Entire Cohort Mean: 545µ Stdev: 33µ 2 STD below: 479µ Ectasia Mean: 530µ Slide 8 Ongoing Ectasia after LVC Analysis Slide 11 Estimated Residual Stromal Bed Purpose: To understand risk factors for ectasia after LVC Methods: Optical Express data query Treated 1/1/07 to 4/30/11 LASIK and ASA LASIK: Femtosecond or mechanical keratome flaps Standard or WFG Yielded 402,583 eyes of 205,285 patients Entire Cohort Mean: 374µ Stdev: 46µ Ectasia Mean: 341µ Observational follow-up 0.5 to 4.5 years Ectasia has been observed in 58 patients (0.028%) Compare preoperative parameters in ectasia cases and primary cohort Still many ectasia cases with RSB thicker than 300 Slide 9 Demographics Ectasia N = 58 Entire Cohort N = 205,285 Age (Mean) (yrs) Gender (M/F) (%) 66 / / 54 Preop Sphere (Mean) (D) Preop Cylinder (Mean) (D) Treatment (LASIK / PRK) (%) 90 / / 10 Flap (IL / MK) (%) 54 / / 37 Time to Diagnosis (Mean) (mo) 24 N/A (Min, Max) (mo) 4, 55 N/A Measured Preop CCT (Mean) (u) Estimated RSB (Mean) (u) Slide 12 Age Entire Cohort Mean: 38.2 yrs Stdev: 11.8 yrs Ectasia Mean: 31.1 yrs

3 Slide 13 Preop Sphere Slide 16 Risk Factor Scoring System Randleman JB, et al. J. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology Jan;115(1):37-50 Entire Cohort Mean: -1.96D Stdev: 2.53D Ectasia Mean: -2.91D Slide 14 Preop Cylinder Slide 17 Our Criticisms of Randleman Study Entire Cohort Mean: -0.81D Stdev: 0.77D Ectasia Mean: -1.04D Vast majority of RSBs were calculated, and thus incorrectly assumed to be thick, when actually thin Many Topos were called normal when actually other eye was scored KC Age, CCT, higher myopia, thin RSB mildly associated, but of VERY low predictive value Topo is the main determinant Slide 15 Residual Stromal Bed Sub-study Measured - Estimated Slide 18 Risk Factor Scoring System Randleman JB, et al. J. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology Jan;115(1):37-50 Intralase mean -36u +/- 42 (n=13) Moria mean -43u +/- 54 (n=22) MK Flaps were thicker (RSBs were thinner) than anticipated as compared to IL

4 Slide 19 Ocular asymmetry Slide 22 Relative scales Belin/Ambrosio Enhanced Ectasia Screening Slide 20 Posterior Corneal Float Slide 23 Post LASIK Ectasia What is it? Slide 21 Float Slide 24 Asymmetry questions? Red flags

5 Slide 25 Slide 28 Risk Assessment Slide 26 Slide 29 First, Fix the Surface Better pre-op data, better quality post-op Artificial Tears. All pts. O-3 FA. Almost all pts. Topical Cyclosporin. Topical Azithromycin Topical steroids Plugs. Slide 27 1Month of Aggressive Treatment Slide 30 Current Risk Assessment History of Risk Assessment for corneal surgery

6 Slide 31 Autoimmune Disease and Ocular Pathology Slide 34 Laser in situ keratomileusis in patients with autoimmune diseases. KCS Scleritis Episcleritis Keratitis Peripheral corneal ulceration Choroiditis Retinal vasculitis Episcleral nodules Retinal detachment Macular edema Forty-nine eyes of 26 patients with inactive or stable autoimmune disease were identified. No eye developed corneal thinning, melting, persistent epithelial defect, persistent keratitis, scleral thinning, scleritis, or scleromalacia. J Cataract Refract Surg Aug;32(8): Smith and Maloney Slide 32 Alio et al. (Ophthalmology 2005) Slide 35 New TNF-α inhibitors LASIK on 42 eye with systemic Rheumatic disease No complicaitons Will drugs like Remicade make these patients even safer for surgery? Slide 33 Smith and Maloney Study Slide 36 PRK vs Lasik Disease Sample size Crohn s Disease 1 Fibromyalgia 2 Graves Disease 2 Psoriatic arthritis 3 Reiters s Syndrome 2 Relapsing Polychondritis 1 Rheumatoid Arthritis 6 Sjogren s syndrome 1 SLE 7 Ulcerative colitis 1 PRK considered more of a risk than Lasik with autoimmune disease due to healing time and large epithelial defect

7 Slide 37 RISK WITH LASIK Slide 40 Rheumatological Disease No published cases of corneal or scleral melting in post LASIK patient with autoimmune disease... Sterile corneal ulceration and necrotizing scleritis after cataract surgery (Perez- Semin Ophthalmol 2002), (Lahners J Refract Surg 2003) Lahners reported one case of peripheral keratisis 5 days after LASIK fully resolved with corticosteroid treatment Slide 38 Slide 41 Rheumatoid Arthritis Autoimmune disease is likely less likely to develop ectasia because they would drive fibroblasts to the cornea. Pahor ( Ophthalmologica 2001) Cataract surgery study noted a higher level of postoperative anterior chamber inflammation in the early postoperative period that resolved in all cases. Slide 39 Surgically induced corneal necrotizing keratitis following LASIK in a patient with inflammatory bowel disease. Slide 42 Systemic Vasculitis Patient had undiscovered severe disease Associated with Ulcerative Keratitits (Messmer - Surv Ophthalmol 1999) Inflammatory corneal disease was responsive to topical and systemic steroids. No relapse for at least 12 months after J Cataract Refract Surg Oct;36(10):

8 Slide 43 Autoimmune Disease With Strong Association to Corneal Melting Slide 46 Autoimmune disease indirectly linked to corneal ulceration Wegener s Granulomatosis Relapsing polychondritis Polyarteritis nodosa Graves lagophthalmos and exposure can cause problems Scleroderma lagophthalmos or severe malnutrition Slide 44 Autoimmune Disease With a Loose Association to Corneal Melting Slide 47 Liability SLE Crohn s disease Ulcerative colitis LASIK may not be clinically contraindicated in patients with autoimmune disease, but the FDA labels it as such. Slide 45 Autoimmune Disease With No Associated Corneal Melting Slide 48 Post-op Treatment Hashimoto s disease Reiter s syndrome Fibromyalgia Any post-op complication should be treated aggressively (like epithelial ingrowth)

9 Slide 49 Cobo-Soriano (Ophthalmology 2006) Slide 52 Diabetes and Eye Disease DX # 0f eyes Rheumatiod Arthiritis 29 SLE 31 Spondylitis 2 Psoriasis 91 Crohn s Disease/UC 67 Keloids 18 Diabetes Mellitus 44 Immunosuppressicve therapy 56 Diabetic Keratopathy SPK Recurrent corneal erosions Neurotrophic keratopaty Tear dysfunction Endothelial dysfunction Increased risk of infection Slide 50 Recurrent Uveitis Slide 53 Diabetes and LASIK Patients at high risk of developing recurrent flares of acute anterior uveitis, such as those with spondyloarthropathies should be carefully considered Shown to be safe if patient is well controlled A patient developed acute DLK three years after LASIK while he was having an recurrent acute anterior uveitis attack (Diaz-Valle J Refract Surg 2009) Treated with good results Slide 51 Slide 54 Nerve Regeneration Topical cyclosporine significantly improved corneal sensitivity at 3 months post LASIK (Peyman J Refract Surg 2008) Suggests that Restasis may enhance nerve regeneration

10 Slide 55 New Study on Nerve Regeneration Slide 58 Herpes Allergan Post Lasik study Simplex vs Zoster Slide 56 Risk Lasik vs Contact lens wear McGee J Cataract Refract Surg 2009 Risk to eye health and permanent vision loss RGPs are still safer than LASIK Daily wear lenses are equally safe to LASIK (ONLY IF THE PATIENT IS 100% COMPLIENT) Slide 59 Laser in situ keratomileusis in patients with a history of ocular herpes. Laser in situ keratomileusis was safe in patients with a history of ocular herpes inactive for 1 year before surgery Extended wear carries more patient risk than LASIK perioperative systemic antiviral prophylaxis J Cataract Refract Surg Nov;33(11): Slide 57 Diabetes Slide 60 Herpes Stability Issues Dormancy Protective against ectasia?

11 Slide 61 Hx of Keloid Scarring Slide 64 Immunosuppressants Slide 62 Systemic Meds Slide 65 Accutane General precautions Obtaining clearance Lack published reports of complications with LASIK. Don t test it. Accutane = severe dry eye (temporary) Decrease photoreceptor turnover (night blindness) LASIK = possible dry eye (femto probably not) Slide 63 Steroids Slide 66 Imitrex and LASIK Triptans and the incidence of epithelial defects during laser in situ keratomileusis. There is no correlation between the use of sumatriptan for relief of migraine headaches and the generation of epithelial defects during LASIK. There appears to be no reason to stop triptansbefore proceeding with LASIK. J Refract Surg Jan-Feb;21(1):72-6.

12 Slide 67 Patient Populations Slide 70 Monocular Patients Be careful of generalizing patients Slide 68 Pregnancy Slide 71 Ocular Surface DX Decreased Corneal sensitivity Increased corneal thickness and curvature Liability vs Results Slide 69 Amblyopes Slide 72 Blepharitis

13 Slide 73 Dry Eye Slide 76 Dry Eye Severity Scale How dry is too dry? Slide 74 Slide 77 Sjogren s Syndrome Slide 75 Slide 78

14 Slide 79 Allergy Slide 82 Atopic disease has been historically linked to DLK, haze and myopic regression after PRK (Yang AmJ Ophthalmol 1998) Slide 80 Comorbidities and Flap Stability Slide 83 Steepness/Topography Does ocular surface disease decrease flap stability Too steep vs Too flat Slide 81 Macro Striae Case Slide 84 Keratoconus

15 Slide 85 LASIK with Riboflavin Keratoconus Slide 88 Slide 86 Do We Dare? Forme Fruste KK Slide 89 Slide 87 Slide x015 20/40 UCVA x163 UCVA 20/ x005 20/20 UCVA x160 20/25 UCVA

16 Slide 91 Slide 94 Recurrent Corneal Erosions Perisurgical prophylaxis Slide 92 Slide 95 Previous RK LASIK vs Surface Ablation Slide 93 Recurrent Corneal Erosions Are they ever stable? Slide 96 How bad can they get?

17 Slide 97 Thank You