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1 Slide 1 Use of Steroids After Cataract Surgery March 16, 2016 Erica Person, MD MS FAAO Slide 2 Outline Results from prednisolone vs. difluprednate Evaluation of new agent for cataract surgery Laser alternative to glaucoma medication Slide 3 Prednisolone vs. Difluprednate Erica Person TLC Marius Tijunelis UM Kellogg Paul Ernest TLC Shahzad Mian UM Kellogg Madeline McBain MSU

2 Slide 4 Topical steroids for cataract surgery Standard of care Controls pain and inflammation Wide variety of treatment regimens Multiple steroid agents Prednisolone acetate 1% four times daily for 30 days Until April 2014 change to difluprednate 0.05% Slide 5 Steroid Inhibits phospholipase A2 and COX-2 Mechanism: Inhibits formation of prostaglandins, leukotreines, prostacyclin, and thromboxane Actions: Decreases inflammation Suppresses T lymphocytes Prevents migration of phagocytic cells Side effects: Hyperglycemia Increased IOP Insomnia, anxiety, depression, psychosis Slide 6

3 Slide 7 Slide 8 Slide 9 Difluprednate Due to fluorination at C-6 and C-9 creating a higher binding affinity for the glucocorticoid receptor

4 Slide 10 Drop comparison Prednisolone As a suspension, the dosing is not consistent throughout the treatment course 17% endothelial cell loss No significant difference in intraocular pressure Highest IOP =22 Difluprednate As an emulsion, the dose is consistent throughout the treatment course 8% endothelial cell loss Less corneal edema Thinner retinal OCT Highest IOP = 32 Donnenfeld et al Slide 11 Patient Experience Favorable response to BID vs QID dosing: Easier on family members. Compliance Mixed response to access: Lower co-pays Higher co-pays Pharmacy cards +/- Slide 12 Incidence of increased intraocular pressure with difluprednate 2 of 104 patients (1.9%) with QID dosing 3.7% incidence BID dosing 35% incidence in vitreoretinal surgical patients 39% in uveitis patients Pediatric uveitis patients with 50% 3-6% when dosed two to four times daily. 16.1% in cataract patients QID *Studies did exclude glaucoma patients

5 Slide 13 Retrospective chart review Prednisolone BID or Difluprednate QID Did not exclude glaucoma or glaucoma suspect patients Increased pressure was defined as >21 mmhg And an increase >6 and 10mmHg over baseline Institutional Review Board approval was obtained through the University of Michigan Statistical significant was determined to be found with N=151. Slide 14 Patients 224 patient eyes in the prednisolone group 225 patient eyes in the difluprednate group Inclusion criteria: Any patient >18 years old with cataract surgery Exclusion criteria: Co-managed or incomplete data Complex/mature cataract H/o tube shunt or trabeculotomy Slide 15 Statistics 2-sample t-test for person-based measures; linear mixed regression for eye-based measures Chi-square or Fisher's exact test for personbased measures; Repeated measures logistic regression for eye-based measures Accounting for correlation between eyes of a subject

9 Minimum = 8 Maximum = 23 Median = 16 Prednisolone Mean = 14.

6 Slide 16 Results Slide 17 Percent with glaucoma Slide 18 Pre-operative IOP Difluprednate Mean = 15.4 Standard deviation = 2.9 Minimum = 8 Maximum = 23 Median = 16 Prednisolone Mean = 14.8 Standard deviation = 3.4 Minimum = 7 Maximum = 29 Median = 14 P value =

Slide 19 Post-op week 1 Difluprednate Mean = 16.5 Standard deviation = 5.2 Minimum = 5 Maximum = 37 Median = 16 Change mean = 1.1 Prednisolone Mean = 17.0 Standard deviation = 5.

7 Slide 19 Post-op week 1 Difluprednate Mean = 16.5 Standard deviation = 5.2 Minimum = 5 Maximum = 37 Median = 16 Change mean = 1.1 Prednisolone Mean = 17.0 Standard deviation = 5.7 Minimum = 8 Maximum = 52 Median = 16 P value = Change mean = 2.2 P value = Slide 20 Post-op Month 1 Difluprednate Mean = 14.5 Standard deviation = 3.6 Minimum = 6 Maximum = 35 Median = 14 Change mean = -1.0 Prednisolone Mean = 14.3 Standard deviation = 3.4 Minimum = 6 Maximum = 25 Median = 14 P value = Change mean = -0.4 P value = Slide 21 Clinically Meaningful

8 Slide 22 Conclusions Post-operative steroid response glaucoma occurs at a low rate with both groups Additional treatment and significant potential morbidity is possible In contrast to previous publications, this study included glaucoma and glaucoma suspect Patients with a previous trabeculotomy or tube shunt were excluded Slide 23 Discussion Moderate intraocular pressure increase (21 to 25mmHg) may resolve with discontinuation or taper of the steroid Pressure over 30mmHg longer to resolve require additional medication may lead to a decrease in visual field Slide 24 Clinical decision making Experience Patient outcomes Cost and availability Questions?

9 Slide 25 Evaluation of new agent for cataract surgery Erica Person Special Thanks to Omeros Coorp. Slide 26 During cataract surgery Iris prolapse video Slide 27 IFIS = Intraoperative Floppy Iris Syndrome More common with h/o Tamsulosin (Flomax) Treats Benign Prostatic Hyperplasia Urinary retension Alpha1 adrenoceptor blocking agent Blocks the adrenergic effect of the dilating drops Higher incidence of IFIS

Slide 28 Injection of Shugarcaine Use of dispersive viscoelastic Iris hooks Iris rings Omidria in irrigation solution Management of IFIS Slide 29 Omidria 1% phenylephrine / 0.

10 Slide 28 Injection of Shugarcaine Use of dispersive viscoelastic Iris hooks Iris rings Omidria in irrigation solution Management of IFIS Slide 29 Omidria 1% phenylephrine / 0.3% ketorolac Added to the irrigation solution Indications and usage: Maintaining pupil size Preventing intraoperative miosis Reducing postoperative ocular pain Slide 30 Shugarcaine Developed by Dr. Joel Shugar 9mL BSS plus mixed with 4 ml of 1:1,000 bisulfite-free epinephrine and 3 ml of 4% preservative free lidocaine Indications and usage: Maintaining pupil size Reducing intraoperative pain

11 Slide 31 Phenylephrine Mechanism of action Sympathomimetic Alpha 1 receptor agonist Onset min Duration 5-7 hrs Side effects vasoconstriction May cause transient fall in IOP in glaucoma or precipitate an acute angle closure Slide 32 Ketorolac Mechanism of Action Inhibits COX-1 and 2 Decreased prostaglandin, thromboxane and prostacylin Moderate anti-inflammatory and analgesic Slide 33 NSAID Prostaglandin Vasodilator (less edema) Desensitizes nerve endings (analgesia) Other effects Maintenance of blood aqueous barrier Decreased Cystoid Macular Edema Allergic conj. Preventing intra-operative miosis Side effects Burning Irritation Epithelial growth delay Eyelid edema Chemosis

Slide 34 Epinephrine Mechanism of action: direct-acting sympathomimetic alpha and beta contracts the dilator pupillae Onset: immediate Duration: short <1 hr Slide 35 Lidocaine Amide (inject)

1:100,000 (increases duration, prevents systemic absorption, decreases bleeding) Duration: 1-2 hrs local Systemic toxicity: hypotension, convulsions, nausea, vomiting Midbrain effect with respiratory

12 Slide 34 Epinephrine Mechanism of action: direct-acting sympathomimetic alpha and beta contracts the dilator pupillae Onset: immediate Duration: short <1 hr Slide 35 Lidocaine Amide (inject) Reversible blockade of nerve conduction ph dependent less effect in low ph/inflamed tissues longer duration than ester metabolized in liver by amidase For lid or skin procedures +/- epinephrine 1:100,000 (increases duration, prevents systemic absorption, decreases bleeding) Duration: 1-2 hrs local Systemic toxicity: hypotension, convulsions, nausea, vomiting Midbrain effect with respiratory suppression possible Retrobulbar Anesthesia Slide 36 Study Design Consent was obtained as part of surgical informed consent process. Double blind study: Neither surgeon or patient knew which agent Epinephrine/lidocaine was injected Phenylephrine/ketorolac was in the irrigation solution, balanced saline solution was injected. Fellow eye study 50% of patients received phenylephrine/ketorolac in the right eye and 50% in the left eye.

Slide 37 Data Collection Pupil diameter at start Pupil diameter at end Ring or hook used Pt on flowmax Cataract rating Cumulative dissipated energy (CDE) Mobility rating 0 no movement 1 minimal

13 Slide 37 Data Collection Pupil diameter at start Pupil diameter at end Ring or hook used Pt on flowmax Cataract rating Cumulative dissipated energy (CDE) Mobility rating 0 no movement 1 minimal movement 2 moderate movement 3 marked movement 4 iris prolapse partial 5 iris prolapse total Slide 38 Patients 14 patients total Average age = 63.5 Range patients had laser assisted cataract surgery with LenSx 1 patient required Maluygin ring OU 4+ brunescent with miosis No patients on tamsulosin Slide 39 Effect on Pupil Students 2 tailed t-test

14 Slide 40 Additional data * Scale from 0 to 5 ** Cumulative dissipated energy excluded brunescent cataract patient Slide 41 Case #1 Poorly dilated pupil at pre-op OD Pre-op 4.5 mm After injection of Shugarcaine: 7.0 mm Post-op 8.0 mm Mobility rating 5 (iris prolapse) OS normal dilation Pre-op 8.5 mm Post-op 9.0 mm Mobility rating 3 Slide 42 Observations Not a statistical difference in a small sample population. Likely non-inferiority of phenylephrine/ketorolac agent compared to epinephrine/lidocaine. May be advantage of direct injection vs. irrigation fluid. I will never get a funded study with data like this.

Slide 43 Case Presentation Erica Person William Buckingham Slide 44 Patient Presentation Pt is a 81 yo WM with h/o POAG treated with Travaprost, Dorzolamide, & Brimonidine VAcc: 20/25 IOP: OD = 24 OS

15 Slide 43 Case Presentation Erica Person William Buckingham Slide 44 Patient Presentation Pt is a 81 yo WM with h/o POAG treated with Travaprost, Dorzolamide, & Brimonidine VAcc: 20/25 IOP: OD = 24 OS = 28 NFL: OD: 63 superior thinning OS: 76 C/D (UDFE): OD: 0.7 OS: 0.4 Slide 45 Selective Laser Tabeculoplasty In-office laser procedure that takes 4-7 min Targets intracellular melanin without disturbing the non-pigmented cells of the trabecular meshwork Macrophages act on the meshwork and decrease fluid outflow resistance Discuss with patients that the intention is to discontinue a medication vs. avoid another drop

Slide 46 Who is a good candidate? Patients on a prostaglandin analog who need a second agent. First line treatment, especially in non-compliant patients. Patients with an allergy to drops.

16 Slide 46 Who is a good candidate? Patients on a prostaglandin analog who need a second agent. First line treatment, especially in non-compliant patients. Patients with an allergy to drops. Pigment dispersion syndrome. Pseudoexfoliation syndrome. Individuals that cannot afford expensive drops. Patients who travel or have an active lifestyle. Any patient that wants to avoid or delay surgery. Patients with a drance hemorrhage. Most glaucoma patients are candidates for SLT. Slide 47 Slide 48 2 visits for the patient Initial un-dilated visit with: Gonio Nerve fiber layer and HVF (for ICD-10 staging) SLT on worse eye Pred 2 x day or lotemax 3 x day for 7 days 1-2 weeks SLT on second eye 1 month follow up visit back with Eye Doctor

17 Slide 49 Patient outcome IOP 18 OU Avoided glaucoma surgery Continued drops Slide 50 Questions?

Collaboration in the care of glaucoma patients and glaucoma suspects. Barry Emara MD FRCS(C) Nico Ristorante November 29, 2012

Collaboration in the care of glaucoma patients and glaucoma suspects Barry Emara MD FRCS(C) Nico Ristorante November 29, 2012 Goals of Collaboration Patient-centred and evidence based approach Timely access