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High Risk LASIK Patients

Do you feel lucky?

Derek N. Cunningham, OD, FAAO

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Traditional Risk Assessment

•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

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Real Risk of Ectasia

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Professor H. Burkhard Dick Dr. Michael C Knorz Dr. Colman Kraff Dr. Marguerite McDonald Dr. Stephen Slade Dr. John A. Vukich Dr. Steve Schallhorn

Professor Jan Venter Dr. Mitchell C Brown Dr. Stephen Coleman Dr. Joseph Colin Dr. Steven J. Dell

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Enormous Dataset

Statistical Significance…

• 109,924 consecutive LVC Treatments (60,071 Patients) from April 1st, 2010 to June 30th, 2011.

• 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%) –

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Risk Factor Scoring System

Randleman JB, et al. J. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology. 2008 Jan;115(1):37-50

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Ongoing Ectasia after LVC Analysis

• 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

–Yielded402,583eyes of 205,285patients –Observational follow-up 0.5 to 4.5 years • Ectasia has been observed in 58patients (0.028%) • Compare preoperative parameters in ectasia cases and primary

cohort

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Demographics

Ectasia N = 58 Entire Cohort N = 205,285

Age (Mean) (yrs) 31.1 38.2 Gender (M/F) (%) 66 / 34 46 / 54 Preop Sphere (Mean) (D) -2.91 -1.96 Preop Cylinder (Mean) (D) -1.04 -0.81 Treatment (LASIK / PRK) (%) 90 / 10 90 / 10 Flap (IL / MK) (%) 54 / 46 63 / 37 Time to Diagnosis (Mean) (mo) 24 N/A

(Min, Max) (mo) 4, 55 N/A Measured Preop CCT (Mean) (u) 530 545 Estimated RSB (Mean) (u) 341 374

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Pre-op Central Corneal Thickness

thinnest of 3 ultrasonic pachymetry readings

Entire Cohort Mean: 545µ Stdev: 33µ 2 STD below: 479µ Ectasia Mean: 530µ

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Estimated Residual Stromal Bed

Entire Cohort Mean: 374µ Stdev: 46µ Ectasia Mean: 341µ

Still many ectasia cases with RSB thicker than 300

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Age

Entire Cohort Mean: 38.2 yrs Stdev: 11.8 yrs Ectasia Mean: 31.1 yrs

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Preop Sphere

Entire Cohort Mean: -1.96D Stdev: 2.53D Ectasia Mean: -2.91D

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Preop Cylinder

Entire Cohort Mean: -0.81D Stdev: 0.77D Ectasia Mean: -1.04D

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Residual Stromal Bed Sub-study

Measured - Estimated

•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

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Randleman JB, et al. J. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology. 2008 Jan;115(1):37-50

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Our Criticisms of Randleman Study

•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

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Ocular asymmetry

•Relative scales

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Posterior Corneal Float

•What is it?

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Float

•Red flags

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•Belin/Ambrosio Enhanced Ectasia Screening

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Post LASIK Ectasia

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1Month of Aggressive Treatment

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Risk Assessment

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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.

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Current Risk Assessment

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Autoimmune Disease and Ocular Pathology

• KCS

• Scleritis • Episcleritis • Keratitis

• Peripheral corneal ulceration • Choroiditis • Retinal vasculitis • Episcleral nodules • Retinal detachment • Macular edema

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Alio et al. (Ophthalmology 2005)

•LASIK on 42 eye with systemic Rheumatic

disease

•No complicaitons

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Smith and Maloney Study

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

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_{Laser in situ keratomileusis in patients with}

autoimmune diseases.

•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.2006 Aug;32(8):1292-5. Smith and

Maloney

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New TNF-α inhibitors

•Will drugs like Remicade make these patients

even safer for surgery?

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PRK vs Lasik

•PRK considered more of a risk than Lasik with autoimmune disease due to healing time and large epithelial defect

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RISK WITH LASIK

•No published cases of corneal or scleral melting in post LASIK patient with autoimmune disease . . .

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•Autoimmune disease is likely less likely to develop ectasia because they would drive fibroblasts to the cornea.

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_{Surgically induced corneal necrotizing keratitis following}

LASIK in a patient with inflammatory bowel disease.

•Patient had undiscovered severe disease

•Inflammatory corneal disease was responsive

to topical and systemic steroids. No relapse for at least 12 months after

• J Cataract Refract Surg.2010 Oct;36(10):1786-9.

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Rheumatological 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

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Rheumatoid Arthritis

•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.

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Systemic Vasculitis

•Associated with Ulcerative Keratitits (Messmer - Surv Ophthalmol 1999)

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Autoimmune Disease With Strong

Association to Corneal Melting

•Wegener’s Granulomatosis

•Relapsing polychondritis •Polyarteritis nodosa

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Autoimmune Disease With a Loose

Association to Corneal Melting

•SLE

•Crohn’s disease •Ulcerative colitis

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Autoimmune Disease With No Associated

Corneal Melting

•Hashimoto’s disease

•Reiter’s syndrome

•Fibromyalgia

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Autoimmune disease indirectly linked to

corneal ulceration

•Graves – lagophthalmos and exposure can

cause problems

•Scleroderma – lagophthalmos or severe

malnutrition

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Liability

•LASIK may not be clinically contraindicated in patients with autoimmune disease, but the FDA labels it as such.

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Post-op Treatment

•Any post-op complication should be treated

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Cobo-Soriano (Ophthalmology 2006)

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

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Recurrent Uveitis

•Patients at high risk of developing recurrent flares of acute anterior uveitis, such as those with spondyloarthropathies should be carefully considered

•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

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Diabetes and Eye Disease

•Diabetic Keratopathy

–SPK

–Recurrent corneal erosions –Neurotrophic keratopaty –Tear dysfunction –Endothelial dysfunction

•Increased risk of infection

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Diabetes and LASIK

•Shown to be safe if patient is well controlled

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Nerve Regeneration

•Topical cyclosporine significantly improved corneal sensitivity at 3 months post LASIK (Peyman – J Refract Surg 2008)

•Suggests that Restasis may enhance nerve

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New Study on Nerve Regeneration

•Allergan Post Lasik study

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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)

•Extended wear carries more patient risk than

LASIK

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Diabetes

•Stability Issues

•Protective against ectasia?

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Herpes

•Simplex vs Zoster

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_{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 •perioperative systemic antiviral prophylaxis

• J Cataract Refract Surg.2007 Nov;33(11):1855-9.

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Herpes

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Hx of Keloid Scarring

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Systemic Meds

•General precautions •Obtaining clearance

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Steroids

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Immunosuppressants

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Accutane

•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)

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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 triptans before proceeding with LASIK.

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Patient Populations

•Be careful of generalizing patients

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Pregnancy

•Decreased Corneal sensitivity

•Increased corneal thickness and curvature

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Amblyopes

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Monocular Patients

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Ocular Surface DX

•Liability vs Results

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Blepharitis

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Dry Eye

•Severity Scale

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Dry Eye

•How dry is too dry?

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Sjogren’s Syndrome

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Allergy

•Atopic disease has been historically linked to DLK, haze and myopic regression after PRK (Yang – AmJ Ophthalmol 1998)

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Comorbidities and Flap Stability

•Does ocular surface disease decrease flap stability

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Macro Striae Case

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Steepness/Topography

•Too steep vs Too flat

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Keratoconus

•LASIK with Riboflavin

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Forme Fruste KK

•Do We Dare?

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-0.25-450x015 20/40 UCVA -0.50-450x163 UCVA 20/60

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+0.50-100x005 20/20 UCVA +0.75-1.50x160 20/25 UCVA

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Recurrent Corneal Erosions

•Are they ever stable?

•How bad can they get?

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Recurrent Corneal Erosions

•Perisurgical prophylaxis

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Previous RK

•LASIK vs Surface Ablation

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Thank You

derek.n.cunningham@gmail.com