Justin Schweitzer, OD, FAAO Vance Thompson Vision Sioux Fal s, South Dakota

Transcription

1 Adventures in Glaucoma: A to Almost Z Justin Schweitzer, OD, FAAO Vance Thompson Vision Sioux Falls, South Dakota Glaukos Bausch + Lomb Alcon Allergan Bio-Tissue Reichert Aerie Reichert TearScience Mentholatum Company Shire Sun Pharma Equinox Corneal Thickness Corneal Hysteresis SLT Glaucoma Medications ONH Appearance MIGS IOP OCT Glaucoma Filtration Surgery Family History Visual Field Drug Delivery Devices 1

2 Million Americans Strategy for Managing our Glaucoma Patients 2

3 Identify Treatment Goals Periodic Management 3, 6, 9, or 12 months 3

4 IOP Corneal Hysteresis Family History Corneal Thickness RNFL Analysis Visual Field ONH Appearance Ocular Hypertension Treatment Study Control Treatment 9.5% 5 years 4.4% Gordon, M., Beiser, J., Brandt, J., Heuer, D., Higginbotham, E., Johnson, C., & Keltner, J. (2002, June). The Ocular Hypertension Treatment Study. Archives of Ophthalmology, 120, What We Do Know- OHTS Coleman, A., Gordon, M., Kass, M., & Beiser, J. (2004, October). Baseline Risk Factors for the Development of Primary Open-Angle Glaucoma in The Ocular Hypertension Treatment Study. American Journal of Ophthalmology, 138(4),

5 Conservative Monitor MIGS Device Aggressive Filtration Surgery Cataract Surgery + MIGS Device Glaucoma Meds SLT Drug Delivery Cataract Surgery Slope > -1.5 Consider Treatment Adjustment 5

6 Fixation Losses 20% False Positives 20% False Negatives 33% Total Deviation Probability Plot Pattern Deviation Probability Plot MD compared to age matched norms PSD degree of which Field differs from reference field does not change with media Key Points To Interpretation Data needs to be Trustworthy 3-4 tests to achieve baseline Does it make sense with other findings? Mild MD < -6dB PD Plot less than 14 points are depressed below the 5% significance level and fewer than half of those points are depressed below the 1% level None of central four points has sensitivity of <15dB 6

7 Moderate MD -6dB to -12dB PD Plot points are depressed below the 5% significance level or 8-16 points are below the 1% level One central point measures < 15 db MD > -12db Severe PD Plot 28 points or more are depressed below the 5% significance level or more than 16 points are below the 1% level Any one central point at 0 db Both Hemifields in central 5 degrees <15dB IOP 7

8 Baltimore Eye Study Prevalence (%) Of POAG < > 350 IOP Sommer et al. Arch Ophthalmol Lowering IOP Reduces the Risk of Disease Progression Study IOP Progression (Tx/No Tx) OHTS 1 20% reduction 4.4%/9.5% (5 years) EMGT 2 25% reduction 45%/62% (6 years) CNTGS 3 30% reduction 12%/35% (7 years) CIGTS 4 (medicine) 35% reduction No progression (5 years) CIGTS 4 (surgery) 48% reduction No progression (5 years) AGIS 5 < 18 mm Hg No progression (6 years) AGIS 5 > 18 mm Hg 1.93 units (7 years) 1. Kass et al. Arch Ophthalmol. 2002; 2. Heijl et al. Arch Ophthalmol. 2002; 3. CNTG Study Group. Am J Ophthalmol. 1998; 4. Lichter et al. Ophthalmology. 2001; 5. AGIS Investigators. Am J Ophthalmol Influences on IOP Measurement CCT Post-Refractive Time of Day Medications Physical Activity and Posture 8

9 Bhorade AM, Gordon MO, Wilson B, et al. Ocular Hypertension Treatment Study Group. Variability of intraocular pressure measurements in observation participants in the ocular hypertension treatment study. Ophthalmol. 2009;116: Long-Term IOP Fluctuation Is Associated With VF Progression Advanced Glaucoma Intervention Study Change in AGIS Score Standard Deviation of IOP < 3.0 mm Hg ³ 3.0 mm Hg Time (months) Nouri-Mahdavi et al. Ophthalmology Relative Risk of Disease Progression Diurnal IOP Range 3.11 mm Hg Diurnal IOP Range 5.4 mm HG Arsani S, Zeimer R, Wilensky J, et al. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000;9:

10 icare Home - What is it? A device is intended as an adjunct for monitoring IOP of adult patients (self-use). The HOME tonometer is designed for use at home or on the go. Continuous IOP Sensors SENSIMED Triggerfish Strain gauge monitors diameter change TF reading predictive of previous progression 10

11 Corneal Hysteresis An Indicator for Glaucoma Progression? Corneal Hysteresis Is A Piece to the Glaucoma Puzzle 11

12 Corneal Hysteresis (CH) Ocular Response Analyzer measurement signal Corneal Hysteresis reflects the ability of the corneal tissue to dissipate energy 1 Function of viscoelastic damping 2 Not a characterization of stiffness 3 Provides insight into ocular properties that were not previously understood or conceived of 1. Luce DA. J Cataract Refract Surg. 2005;31: Dupps WJ Jr. J Cataract Refract Surg. 2007;33: Glass DH et al. Invest Ophthalmol Vis Sci. 2008;49: Intro to Corneal Hysteresis Viscoelastic tissue with complex, interconnected microstructure Geometrical attributes are not a surrogate for biomechanical properties The eye appears to be a mechanical structural continuum More than 7500 papers published on hysteresis ORA Interpretation of measurements values Corneal Compensated IOP (IOPcc): An IOP measurement that is less influenced by corneal properties than Goldmann or other tonometers. This value is closer to the true pressure and has been shown to be a better indicator of glaucoma than Goldmann. Matches GAT on average, so numerical Scale is the same. Evaluation of the Influence of Corneal Biomechanical Properties on Intraocular Pressure Measurements Using the Ocular Response Analyzer. Felipe A. Medeiros, MD and Robert N. Weinreb, MD J Glaucoma 2006;15: Goldmann applanation tonometry compared With corneal-compensated intraocular pressure In the evaluation of primary open-angle glaucoma Joshua R Ehrlich, Nathan M Radcliffe, and Mitsugu Shimmyo BMC Ophthalmology 2012, 12:52 12

13 ORA Interpretation of measurements values Corneal Hysteresis: (CH): An indication of corneal biomechanical properties that Has been show to be independently predictive of future glaucoma progression. Typical average value is Typical range is Low is a risk factor ORA Interpretation of measurements values IOPg: A Goldmann-correlated IOP measurement for reference purposes so that clinicians can appreciate what a Goldmann would read simultaneously with the IOPcc value above. ORA Interpretation of measurements values Waveform Score: A signal analysis algorithm that rates the quality of The measurement signal on a scale of The higher the value, the more Reliable the IOP and CH values are excellent. 4-5 is not so good. 3 or below is poor. 13

14 Average CH in Normal Subjects Brazil UK China Japan Spain USA N CH / / / / / /- 1.2 CH does not display a 24-hour rhythm Diurnal CH, CCT, IOP Wake Sleep Wake 570 CCT 560 (μg) IOP 16 (mmhg) CH (mmhg) 3:30 PM 7:30 PM 11:30 PM 3:30 AM 7:30 AM 11:30 AM 1. Kida T et al. Invest Ophthalmol Vis Sci. 2006;47:

15 Corneal Hysteresis, IOP, CCT Clinical Evidence Why is CH relevant in Glaucoma? (Low) CH has been consistently shown to be independently and strongly associated with or predictive of glaucoma progression Corneal Hysteresis found to be associated with progression Congdon NG, Broman AT, Bandeen-Roche K, et al. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol 2006;141:868 15

16 Corneal Hysteresis found to be associated with progression OR LCL UCL P-value Age per year < Age per year > GAT IOP per mmhg Treatment IOP by treatment interaction CCT per 100 microns Years with glaucoma Baseline IOP CH per mmhg CH as a Predictor of Progression 114 POAG eyes followed at 6 month intervals for 4 years. Note NO rapid progressors in CH 10 mmhg group! CH was 2x more predictive of VF progression than GAT and 3X more predictive than CCT The prospective longitudinal design of this study supports the role of CH as an important factor to be considered in the assessment of risk for glaucoma progression Medeiros FA et al. Ophthalmology. 2013;120:

17 CH as a Predictor of Progression Medeiros FA et al. Ophthalmology. 2013;120: Corneal Hysteresis and Normal Tension Glaucoma Low CH 26 (66.7%) + for progression on VF 13 (33.3%) + for NO progression Park Et. Al Br J Ophthalmol Jan 2. pii: bjophthalmol doi: /bjophthalmol Corneal Hysteresis and Normal Tension Glaucoma High CH 15 (34.9%) + for progression on VF 28 (65.1%) + for NO progression Park Et. Al Br J Ophthalmol Jan 2. pii: bjophthalmol doi: /bjophthalmol

18 Susanna CN, Diniz-Filho A, Daga FB, Susanna BN, Zhu F, Ogata NG, Medeiros FA. A Prospective Longitudinal Study to Investigate Corneal Hysteresis as a Risk Factor Predicting Development of Glaucoma. American Journal of Ophthalmology (2018), doi: /j.ajo Wells AP, Garway-Heath DF, et a. Corneal hysteresis but not corneal thickness Correlates with optic nerve surface compliance in Glaucoma patients. Invest Ophthalmol Vis Sci 2008 CH and the structural continuum CH is Associated with ONH Deformation in Glaucoma Prospective experimental study of 100 subjects (38 with glaucoma, 62 without glaucoma) Data collected included SE, optic disc diameter, CCT, axial length, cylinder, GAT, Pascal IOP, OPA and CH. Elevation of IOP (approx 64 mm, 30 seconds) was induced OD on each subject with a modified LASIK suction ring. HRT-II was used to map the optic nerve surface before and during IOP elevation. Mean cup depth was calculated using built-in HRT data analysis software. Change in optic disc depth during IOP elevation was calculated for all right eyes, and tests for correlation with the parameters listed were performed. CH, but not CCT or other anterior segment parameters, is associated with increased deformation of the optic nerve during transient IOP elevations in glaucoma patients but NOT in normal controls. 1 18

19 Associated with Conversion to Glaucoma Low CH Associatied with Progressive Field Worsening Structural Changes to the ONH (less elasticity) -? GLC damage) Spectral domain OCT Pay attention to TSNIT curve. Pay attention to the actual numbers in the segmentation plot Pay attention to the numbers between eyes in the segmentation plot Look at the B Scan for accuracy 19

20 March 2016 December 2016 August 2017 OCT-Angiography 20

21 Swept Source OCT SS-OCT Takayama K., Hangai M., et al. Three-Dimensional Imaging of Lamina Cribrosa Defects in Glaucoma Using Swept-Source Optical Coherence Tomography. Inves Ophth & Vis Sci July 2013, Vol.54,

22 Anterior Angle Anatomy Schwalbe s Line Trabecular Meshwork Scleral Spur Posterior Ciliary Body (Band) Iris Insertion Treatment 22

23 Current Glaucoma Drug Classes PGA s Docasanoids Beta Blockers Alpha Agonists Topical CAI s Combos ROCK Inhibitor Prostaglandin analogues-branded Xalatan (latanoprost 0.005%) Travatan-Z (travaprost 0.004%) Lumigan (bimatoprost 0.03%) Zioptan PF (tafluprost 0.015%) Prostaglandin analogues-branded Increases uveoscleral outflow Peak effect occurs at least 8 hours following dosing 23

24 Vyzulta (latanoprostene bunod 0.024%) VOYAGER Study latanoprostene bunod 0.024% (Vyzulta) JUPITER Study latanoprostene bunod 0.024% (Vyzulta) 24

25 Single Agent Adjunctive Agents Beta-Blockers Timoptic (timolol 0.25, 0.5%; Merck) Non-selective B-Blocker and decreases aqueous production Dosing is q 12 h Beta-Blockers Timolol Alternative Formulations Timolol-XE-timolol maleate 0.25%,0.5% in Gel-rite Timoptic in Ocudose 0.25%, 0.5% Istalol Qd dosing Betoptic-S 25

26 Alpha-adrenergic Agonists (brimonidine 0.2%, 0.15%, 0.1%) Mechanism: Aqueous production, uveoscleral outflow Neuroprotective (?????) Most frequent SE in clinical trials was dry mouth, but allergic issues as well Carbonic Anhydrase Inhibitors Trusopt (dorzolamide HCL solution 2%) reduces aqueous production ph = 5.6 Azopt (brinzolamide 1% suspension) reduces aqueous production ph = 7.5 (stings less) Combination Therapy CoSopt Ophthalmic Suspension Timolol 0.5% Dorzolamide 0.2% Generic and Branded Preservative Free Combigan Ophthalmic Solution Brimonidine 0.2% Timolol 0.5% 26

27 Combination Therapy Simbrinza Brinzolamide 1% Brimonidine 0.2% Rhopressa (netarsudil 0.02%) Ren R, Li G, Le TD, et al. Netarsudil increases outflow facility in human eyes through multiple mechanisms. Invest Ophthalmol Vis Sci. 2016;57: Diurnal Outflow Facility Increased from / ul/min/mmhg to / ul/min/mmhg Diurnal EVP decreased from 7.9 +/- 7.9 mmhg to 7.2 +/- 1.8 mmhg 27

28 Aqueous Humor Flow Rates 20% to 23% Rhopressa (netarsudil 0.02%) Rocket 1 Rocket 2 Rhopressa (netarsudil 0.02%) Rocket 2 28

29 Rhopressa (netarsudil 0.02%) 50.0% 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% Conjunctival Hyperemia Mild Moderate or Severe None Mild Moderate or Severe None ~ 15-20% Hyperemia at baseline 6% dropout rate for hyperemia Serle et al. Am J Ophthalmol. 2018; 186; Simple Drops Imprimis Pharmaceuticals Preservative free combination drops LAT, TIM-LAT, BRIM-DOR, TIM-BRIM-DOR, TIM-DOR-LAT, TIM-BRIM-DOR-LAT The Future 29

30 Roclatan (netarsudil 0.02% + latanoprost 0.005%) Roclatan. Mercury 1 Phase 3 Topline Results. (2016, September 14). aerie pharmaceuticals. Innovations in Glaucoma Drug Delivery What the Future Holds More than 90% of patients are nonadherent to their ocular medication dosing regimens, and nearly 50% discontinue taking their medications before 6 months 1 Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:

31 Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140: Skepticism of Vision Loss Mistrust of Doctor Poor Self-Efficacy Poor Knowledge Regarding the Disease Skepticism Meds will Mitigate Vision Loss 31

32 Drop-Instillation Difficulty Drug Cost Drug Side Effects Patient Forgetfulness Issues with Medication Schedule Life Stress The eye has many protective barriers, which efficiently clear foreign substances but restrict the bioavailability of applied topical agents. Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2): Spillage or nasolacrimal drainage Tearing & Blinking Tear Film Turnover Irritation and discomfort cause reflex tearing and blinking Ocular surface contact time < 5 minutes Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2):

33 Conjunctival & Scleral Absorption greater surface area than cornea Corneal Absorption 5% of dose reaches target tissues Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3): Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2): Bimatoprost Ring Bimatoprost Ring 23.9 n = 49 eyes IOP mm Hg Baseline 1 mo 6 mo Month Goldberg I, Laganovska G, Baumane K, et al. The novel topical ocular insert (Helios) for sustained delivery of bimatoprost in glaucoma and ocular hypertension. Poster presented at: American Academy of Ophthalmology Annual Meeting; October 20, 2014; Chicago, IL. 33

34 Bimatoprost Ring Re Retention Rate 89% Brandt J, Sall K, DuBiner H, et al. Six-month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8): Ophthalmology , DOI: ( /j.ophtha ) Copyright 2016 American Academy of Ophthalmology Terms and Conditions Bimatoprost Ring Re Brandt J, Sall K, DuBiner H, et al. Six-month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8): Helios Ring 34

35 Travoprost Punctum Plug (OTX-TP, Ocular Therapeutix) Travoprost Punctum Plug (OTX-TP, Ocular Therapeutix) mm Hg IOP Reduction mm Hg OTX-TP timolol No hyperemia in OTX-TP Retention Rates 91, 88, days 60, 75, 90 Ocular Therapeutix, Inc. Ocular Therapeutix TM reports on topline results of phase 2b glaucoma clinical trial. Press Release. 22 October investors.ocutx.com/phoenix.zhtml?c=253650&p=irolnewsarti- cle&id= [Accessed 6 September 2016] 35

36 Latanoprost-Eluting Contact Lens Attractive option secondary to large residence time in the eye. Latanoprost-Eluting Contact Lens Comfort of Lens Patient Compliance Vision with Lens Dry Eye/Ocular Surface Disease Replacement Schedule 36

37 Preclinical Trial and Results CLHI (149g latanoprost) CLLO (97g latanoprost) VS Topical latanoprost ~ 1 week Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost-eluting contact lenses in glaucomatous monkeys. Ophthalmology 2016; 123: Preclinical Trial and Results Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost-eluting contact lenses in glaucomatous monkeys. Ophthalmology 2016; 123: Bimatoprost Intraocular Implant (Bimatoprost SR, Allergan) 37

38 24 Month Phase I/II Clinical Trial bimatoprost pellet (6, 10, 15, or 20 micrograms) 75 Patients topical bimatoprost 0.03% 24 Month Phase I/II Clinical Trial bimatoprost pellet (6, 10, 15, or 20 micrograms) topical bimatoprost 0.03% Sustained at 6 mos. in 71% 4 months IOP reduction 7.2, 7.4, 8.1, 9.5 mm Hg 92% of patients 4 months IOP reduction of 8.4 mm Hg Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results from Phase I/II Clinical Trial. Lewis et al. Am J Ophthmol Conjunctival Hyperemia % Safety Side Effects 52% Implant group 30.7% Topical group 38

39 Travoprost intraocular implant (idose, Glaukos) Resides in AC angle, anchored behind TM Length: Diameter: Titanium Non-ferrous 1.8 mm 0.5 mm Travoprost intraocular implant 39

40 First idose implant in the U.S. performed by Dr. John Berdahl M.D. in Sioux Falls SD, Vance Thompson Vision on March 29, 2016 X + 40

41 Surgical Treatment and Considerations SLT Selective Laser Trabeculoplasty Selectively targets and laser burns pigmented TM cells PDG and Pseudoexfoliative Glaucoma (PXG) High number of pigmented TM cells?? More effective. IOP (mm Hg) Mean IOP Reduction Over 12 Months SLT Latanoprost Pre-Tx 1 month 3 month 6 month 12 month Mcllraith, Strasfeld, Colev, & Hutnik,. (2006, April). Selective laser trabeculoplasty as initial and adjunctive treatment for open-angle glaucoma. Journal of Glaucoma, 15,

42 Minimally Invasive Glaucoma Surgery WHY MIGS More than 90% of patients are nonadherent to their ocular medication dosing regimens, and nearly 50% discontinue taking their medications before 6 months 1 Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:

43 43

44 Minimally Invasive Glaucoma Surgery (MIGS) Procedures that have an ab-interno approach, are minimally atraumatic, with at least modest efficacy, extremely high safety and rapid recovery. Saheb H, Ahmed, IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2): How Effective are MIGS? Cataract surgery alone may be the most common glaucoma surgery today. 44

45 Pre and Post-Operative IOP: Hypertensive and Normotensive Eyes % IOP Reduction Sustained: Surg-1 Yr Surg-final Ave 4.5 years 45

46 A Case for Tubes and Trabs? Powerful and effective at lowering IOP Covered by the vast majority of insurance companies TVT 5 year data Tube Trab IOP # of Meds Failure Rate 30% 47% Complications Post-op Complications Surgical 39% 60% 22% 27% Reoperation 9% 29% Gedde, S. J., Schiffman, J. C., Feuer, W. J., Herndon, L. W., Brandt, J. D., Budenz, D. L., Tube versus Trabeculectomy Study Group. (2012). Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. American journal of ophthalmology, 153(5), e2. doi: /j.ajo

47 Complications of Filtering Surgery Uveitis Tube shunt erosion Retinal detachment Diplopia Bleb infection Vitreous hemorrhage Cataract Formation 47

48 Safety First MIGS Many as Safe as Cataract Similar Recovery Combine with FLACS Efficacy a Close 2nd Schlemm s Canal Suprachoroidal Subconjunctival Stents Dilation Cutting Ablation istent istent Inject Hydrus* Visco360 ABiC (Ab-interno Canaloplasty) Kahook Dual Blade, OMNI Trabectome Cypass istent Supra* Xen InnFocus* 48

49 49

50 Efficacy a Close 2nd Severe Glaucoma PseudoX Glaucoma 50

51 Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open angel glaucoma subjects on topical hypotensive medication: 42-month outcomes IOP 90 Med Free 91% 91% % mmhg % 1 stent 2 stent 3 stent 1 stent 2 stent 3 stent Preoperative Mean Medicated IOP 19.8 mmhg 1 stent 20.1 mmhg 2 stent 20.4 mmhg 3 stent istent inject Head (resides in Schlemm s Canal) Neck (Trabecular Meshwork) 0.4 mm Flange (in Anterior Chamber) 0.3 mm dia Two stents pre-loaded per injector istent inject MIGS Study Group 2 stents implanted in 57 subjects (phakic and pseudophakic) All patients were on 1 pre-op medication Patients were washed off medications Preop IOP medicated 19.5 IOP after washout Subjects have completed 42 months of follow-up 51

52 MIGS Study Group istent inject 2 stents implanted in 57 subjects (phakic and pseudophakic) All patients were on 1 pre-op medication Patients were washed off medications Preop IOP medicated 19.4 IOP after washout 24.4 Postoperative mean IOP 42 months 13.2 mmhg (+/- 1.9) All but 3 eyes remained medication free Kahook Dual Blade 52

53 Kahook Dual Blade Ab Interno Canaloplasty (ABiC) Ab Interno Canaloplasty (ABiC) Lewis RA, et al. Canaloplasty: Three-year results of circumferential Viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J Cataract Refract Surgery

54 OMNI Hydrus Microstent HORIZON Trial Stent + Cataract (n=369) Cataract Only (n=187) Baseline IOP (mm Hg) after washout 25.5 (+/- 3.0) 25.4 (+/-2.9) 24 months IOP (mm Hg) after washout 18.0 (+/-4.1) 20.2 (+/-3.9) Unmedicated at 24 months 82.4% 58.8% Hydrus Microstent 54

55 Suprachoroidal Space CyPass Micro-Stent 55

56 Compass Trial- 2 year data Vold, S., Ahmed, I., Craven, R., Mattox, C., Stamper, R., Packer, M., & Brown, R. (2016, October). Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology, 123(10),

57 istent SUPRA Product Description Lumen Size: mm Outer Diameter: mm Length: 4 mm Length of Sleeve: 1.1 mm US IDE Trial Under Way 169 istent SUPRA Xen 57

58 Xen 45 Gel Stent: US Pivotal Clinical Trial Visits IOP and Medications Mean Baseline Medicated IOP 25.1 (3.7) Glaucoma Meds 3.5 (1.0) 12 Month IOP 15.9 (5.2) Glaucoma Meds 1.7 (1.5) 76.3% of patients reported a mean diurnal IOP reduction of > 20% from medicated baseline at 12 months Postoperative Adverse Events Hypotony 16 (24.6%) (IOP < 6 mmhg at any time) Anterior chamber shallow 1 (1.5%) with peripheral irido-corneal touch Anterior chamber fill 1 (1.5%) Bleb Needling 21 (32.3%) 58

59 Post-operative Considerations with MIGS 1. IOP Fluctuations, new baseline 2. IOP Spikes 3. Hyphema 4. Hypotony IOP Spikes 59

60 Hyphema Ocular Hypotony Is AC formed? If so just monitor Choroidal detachment 2 0 to choroidal effusion Typically monitored unless visually threatening or kissing choroidals Resolution as IOP increases r/o RD PAS to Stents Not common YAG laser considered to open stent 60

61 How do we decide? Trabecular Meshwork Supraciliary Sub-Conjunctival IOP Safety IOP Safety IOP Safety Secondary Glaucoma s and A Few Cases to the Finish Pigment Dispersion Syndrome/PD-Glaucoma Mechanism of Disease Abnormal Irido-zonular/Irido-lens contact Iris pigment deposited on Cornea, Lens, AC angle Concave Iris approach Triad Elevation in IOP and IOP spikes secondary to pigment occlusion of physiologic outflow. 61

62 Risk of PDS becoming PDG PRE LPI POST LPI Pseudoexfoliation Syndrome/PXG-Glaucoma Mechanism of Disease Unknown Etiology Ocular and Systemic condition Excessive gray/white protein fiber-like material Iris, lens/zonules, endothelium, ciliary body, Tm Demographics Increases with age, >50 Caucasian/Scandinaivan patients Bilateral in time #1 cause of Secondary Glaucoma Aggressive Glaucoma Elevation in IOP and IOP spikes secondary to PseudoX mechanical rubbing and deposition in TM. 62

63 Cataract Considerations in PXF Dilate poorly Weak zonules IOP spikes Traumatic Glaucoma: Angle Recession Mechanism of Disease Cleavage of ciliary body muscles Widening and deepening of angle Problems occur years after trauma 1 st thought when encountering unilateral glaucoma 10-20% angle recession patients develop secondary glaucoma Elevation of IOP and IOP spikes are secondary to trabecular meshwork scarring and sclerosis secondary to trauma Traumatic Glaucoma: Angle Recession Treatment Topical GLC Medications Fair to poor response Selective Laser Trabeculoplasty Poor response if recession > 180 degrees Filtration Surgery Works well, but risks are high Minimally Invasive Glaucoma Surgery may have to be aggressive 63

64 Steroid Induced Glaucoma Mechanism of Disease Outflow difficulty Glycoaminoglycan accumulation in the TM Loss of phagocytotic ability in TM Topical and oral corticosteroids can cause IOP rise Ointment/creams and inhaled steroids can cause IOP rise 2/3 of population is steroid responders response is dependent on frequency and dose Patients with POAG, myopes, and children are higher risk + Glaucoma Medication X Steroid Uveitic Glaucoma "Hot eye Injection Low/High IOP AC reaction Patient discomfort Photophobia Acute iridocyclitis Quiet eye No Injection High IOP AC reaction Comfortable Chronic iridocyclitis 64

65 Uveitic Glaucoma Classifications and Mechanisms Angle closure with pupil block Angle closure without pupil block Open angle Combination involving all of the above Angle Closure with Pupil Block Inflammatory cells, etc are released into AC and iris becomes sticky Posterior synechiae form leading to iris bombe and posterior chamber pressure rises Angle Closure without Pupil Block Inflammatory cells, etc are released into AC and iris becomes sticky Peripheral iris is pulled over the TM causing a progressive closure by peripheral anterior synechiae (PAS) 65

66 Open Angle Inflammatory cells and infacility of proteinacious aqueous humor associated with flare Trabecular meshwork outflow is impeded 1. Aggressively reduce inflammation Steroid 2. Cycloplegia Prevent PAS and break posterior synechiae Initially atropine 1% or scopolamine ¼% Additional Treatment 10% Phenylephrine 66

67 3. Lower IOP Beta-blockers, alpha-2 adrenergic agonists, and CAI s Avoid miotics and prostaglandin analogs Iridectomy Multiple Laser PI s Glaucomatocyclitic Crisis / Posner-Schlosssman Unilateral Acute trabeculitis w/ high IOP (40-65) Mostly quiet eye, minimal A/C cell Stellate KP No ant. or post. synechiae 67

68 Neovascular Glaucoma Ischemia - iris, angle, ONH, retina Neovascularization à unhealthy and leaky blood vessels Angle Closure Glaucoma fibrovascular tissue, neo-vessels, inflammatory cells Acute painful eye, K-edema, IOP>40 Kaiser, P. K. (2014). The Massachusetts Eye and Ear Infirmary Illustrated Manual of Ophthalmology (4th ed). N.p.: Elsevier Health Sciences. NVG Causes CRVO PDR Morrison, JC and Pollack IP, Glaucoma : Science and Practice, New York, NY: Thieme; 2003: Kaiser, P. K. (2014). The Massachusetts Eye and Ear Infirmary Illustrated Manual of Ophthalmology (4th ed). N.p.: Elsevier Health Sciences. CRAO Neovascular Glaucoma Treatment Very Difficult to treat Refractory glaucoma Meaningful BCVA = lower IOP HM/NLP = comfort control Drainage shunt >> Trabeculectomy 68

69 In Conclusion... Corneal Thickness SLT Glaucoma Medications MIGS ONH Appearance Filtration Surgery Glaucoma Drug Delivery Devices IOP Family History OCT Visual Field Thank You! 69