IOP in Perspective. IOP in Perspective

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1 IOP in Perspective Commercial Interest Disclosures Nature of Relevant Financial Relationship (Why are we so hung up on IOP?) Leo Semes, OD, FAAO Maculogix Honorarium Speaker Science Based Health Honorarium Speaker OptoVue Honorarium Speaker B&L Honorarium Advisor Allergan Honorarium Advisor Genentech Regneneron Shire ZeaVision Reichert/Ametek HPO Honorarium Honorarium Honorarium Honorarium Honorarium Stock options Advisor Speaker Speaker Advisor Speaker Advisor IOP in Perspective (Why are we so hung up on IOP?) Our working definition of POAG Primary open-angle glaucoma (POAG) is a chronic, progressive opgc neuropathy in adults in which there is a characterisgc acquired atrophy of the opgc nerve and loss of regnal ganglion cells and their axons. This condigon is associated with an open anterior chamber angle by gonioscopy. ala AAO PPP, January 2016 [What is conspicuous by its absence?] Our working definition of POAG There are some good reasons Primary open-angle glaucoma (POAG) is a chronic, progressive opgc neuropathy in adults in which there is a characterisgc acquired atrophy of the opgc nerve and loss of regnal ganglion cells and their axons. This condigon is associated with an open anterior chamber angle by gonioscopy. Primary open-angle glaucoma represents a spectrum of disease in adults in which the suscepgbility of the opgc nerve to damage varies among pagents. Although many paaents with POAG present with elevated intraocular pressure (IOP), nearly 40% of those with otherwise characterisac POAG may not have elevated IOP measurements. The vast majority of pagents with POAG have disc changes or disc and visual field changes, but there are rare cases where there may be early visual field changes before there are detectable changes to the opgc nerve. ala AAO PPP, January

2 There are some good reasons There are some good reasons Glaucoma perspectives from the experts Intraocular pressure (IOP) relates to, but does not define, glaucoma. Many condigons labeled glaucoma have an IOP sufficiently elevated that it may produce ocular symptoms such as visual acuity loss or pain. Also included in the glaucoma category are cases with characterisgc opgc nerve damage without elevated IOP. Chang TC, Ramulu R Hodapp E. Clinical Decisions in Glaucoma, 2e. Bascom Palmer Eye InsGtute Glaucoma perspectives from the experts The pathophysiology of chronic glaucomatous opgc nerve damage has received much a^engon but mostly remains clinically tangengal. In the future it may be possible to modify elements other than IOP that contribute to opgc nerve damage. Currently, however, IOP reducgon is the only established method of slowing or halgng glaucomatous progression. The goal of long-term glaucoma management is to lower the IOP enough to prevent visual loss related to opgc nerve damage. Chang TC, Ramulu R Hodapp E. Clinical Decisions in Glaucoma, 2e. Bascom Palmer Eye InsGtute Glaucoma perspectives from the experts 1. The higher the IOP, the greater the risk of acquiring glaucomatous damage, and the greater the rate of glaucomatous progression. 2. There are factors other than IOP that contribute to opgc nerve damage and determine an individual s suscepgbility to harm from IOP, but there is, at the moment, no effecgve treatment for glaucoma other than IOP reducgon. 3. In pagents with glaucoma, lowering IOP decreases the rate of glaucomatous damage, but there is no way to know with certainty at what IOP level glaucomatous damage ceases or will be acceptably slow for a given person. Chang TC, Ramulu R Hodapp E. Clinical Decisions in Glaucoma, 2e. Bascom Palmer Eye InsGtute Glaucoma perspectives from the experts 4. Every method of lowering the IOP causes side effects, costs money, and involves risk to the pagent. 5. The goal of treatment for glaucoma is to lower IOP enough to preserve good vision for the lifegme of the pagent while causing as few side effects and incurring as few costs as possible. Chang TC, Ramulu R Hodapp E. Clinical Decisions in Glaucoma, 2e. Bascom Palmer Eye InsGtute

3 Glaucoma perspectives from theexperts Glaucoma perspectives from the experts Few dispute the importance of decreasing the IOP in pagents with glaucoma. However the relagonship between the degree of IOP elevagon and the rate of damage varies from person to person, and hence the benefit of lowering the IOP varies among individuals. So, IOP has some significance And, it is measured via tonometry For each pagent, the benefit of lowering IOP should outweigh the risks and cost of the treatment. Chang TC, Ramulu R Hodapp E. Clinical Decisions in Glaucoma, 2e. Bascom Palmer Eye InsGtute What is the IOP at this endpoint? What is the IOP at this endpoint? Advantages and disadvantages of contemporary tonometers Rebound tonometry FDA cleared + Well accepted + Generally convenient + Generally pagent friendly + ORA gives corneal hysteresis measurement + Tono-pen and air puff tend to underesgmate at higher IOP (> 28 mm Hg) Goldmann readings influenced by CCT Some require topical anesthesia Pascal is based on choroidal pulse but not influenced by CCT; essengally a pneumotonometer +/- ConGnuous IOP monitoring via a strain gauge (a 24-hour cycle) by Triggerfish device +/- 3

4 Alternative means of IOP measurement Self tonometry A^ributes* Portable Easy to use even by the inexperienced Does not require topical anesthegc Correlates will with GAT Rebound tonometry * ElMallah MK, Asrani SG. New ways to measure intraocular pressure. Curr Opin Ophthalmol Mar;19(2): Dynamic IOP Measurement The PASCAL Sensor Tip: Contour-matched concave Gp surface Ocular pulse analyzer DCT (dynamic contour tonometry)continuously reads the diastolic and systolic values of the Ocular Pulse Pressure curve Built-in pressure sensor Transparent Gp permits view of cornea interface for centering and control Clinical example IOP measurement is based on mean choroidal pulsaaons (diastolic IOP) Readings are not interchangeable with GAT. Another a^empt to measure True IOP. UGlizes ocular pulse amplitude. Comparison of methods Bias of tonometer readings Δp (cannulated globe): "True" manometric IOP 0 true IOP l DCT readings (PASCAL) l GAT readings (Goldmann) l Tonopen manometric IOP Stamper et al., Arch Ophthalmol 2004; 122:

5 Alternative means of IOP measurement ORA (ocular response analyzer) Goldmann (applanagon) Imbert-Fick law How is IOP measured? What was the CCT on which the original data were based? Factors affecting Goldmann tonometry values AssumpGons in the inigal design Imbert-Fick applies to: infinitely thin membranes surrounding perfect spheres of uniform elasgc properges GAT is based on CCT of 500 / 520u What we learned from the OHTS regarding Risk of conversion from OHT to glaucoma AND, the significance of CCT in glaucoma risk Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary openangle glaucoma. Arch Ophthalmol Jun;120(6): h^p:// What we learned from the OHTS regarding Risk of conversion from OHT to glaucoma AND, the significance of CCT in glaucoma risk NOT A CORRECTION OF MEASURED GOLDMANN IOP Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary openangle glaucoma. Arch Ophthalmol Jun;120(6): h^p:// Influences on IOP measurement We overesgmate Goldmann measurements in pagents with thick corneas and underesgmate when CCT is thin. What is the implicaaon for the post- [CORNEAL] refracave surgery paaent? 5

6 Is digital Goldmann the answer???? Influences on Goldmann IOP value Time of day Increases during sleep Place in the cardiac cycle at which measurement is recorded (remember that the usual endpoint is diastolic IOP) What surrounds the neck? What the pagent s occupagon / recreagonal habits are (neck posigon, plays a wind instrument, wears a Ge?) Posture (SIRSASANA pose in yoga pracgce, and sleeping posigon) Gold standard IOP = Goldmann tonometry, right? Situational influences on IOP What are some other influences on that measurement? OccupaGonal RecreaGonal SituaGonal What the pagent s occupagon / recreagonal habits are (neck posigon, plays a wind instrument?) Fluid intake Situational influences on IOP 60 mg oral prednisone (35 D) Increases (e. g., ang-cholinergics) or decreases (beta-blockers) in response to systemic medicagons; may decrease with marijuana smoking Increases with topical ang-inflammatories (Steroids AND NSAIDs); *Remember: 5% of a general populagon is steroid responsive (i.e., IOP goes up with steroid & NSAID applicagon) OD OS Tham CCY, et al. Am J Ophthalmol 2004;137:

7 10 mg oral prednisone (28 D) (same 9 yo f) IOP and Topical NSAIDS 39 N = 13 normals OD OS Latanoprost qd OU X 8 wks; + bromfenac (one eye) X 2 wk 6 Max r, IOP (non-n) = 10.18, IOP (N) = (p < 0.01) Tham CCY, et al. Am J Ophthalmol 2004;137: Kashiwagi K, Tsukahara S. Br J Ophthalmol 2003;87: IOP and Topical NSAIDS N = 16 eyes of glaucoma patients IOP r 40 Situational influences on IOP Physical activity Following min of aerobic exercise, IOP decreases for 1-3 hrs by 2-6 mmhg 1 With head inversion, IOP increases quickly but returns to normal within < 60 min Najmanova E1, Pluhacek F, Botek M. Intraocular Pressure Response to Moderate Exercise during 30-Min Recovery. Optom Vis Sci Mar;93(3): doi: /OPX Roddy G1, Curnier D, Ellemberg D. ReducGons in intraocular pressure aver acute aerobic exercise: a meta-analysis. Clin J Sport Med Sep;24(5): doi: /JSM Jasien JV, Jonas JB, de Moraes CG, Ritch R. Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga PosiGons. PLoS One Dec 23;10(12):e doi: /journal.pone ecollecgon Latanoprost qd OU X 8 wks; + bromfenac (one eye) X 2 wk 6 Max r Read SA1, Collins MJ. The short-term influence of exercise on axial length and intraocular pressure. Eye (Lond) Jun;25(6): doi: /eye Epub 2011 Mar 18. Chiba T, et al. Br J Ophthalmol 2006;90: Situational influences on IOP Breaking News! Posture (yoga 1 ; sleeping posigon*) Baser G, et al. EvaluaGon of the effect of daily acgviges on IOP in healthy people. IS the 20 mmhg border safe? InternaGonal Ophthalmology. Online first, 7 August During the exam following scleral indentagon, IOP increases 2. RESULTS (n = 44) No IOP change following reading for 5 min. IOP increased following carrying a shopping bag for 5 min.* 1.Jasien JV, Jonas JB, de Moraes CG, Ritch R Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga PosiGons. PLoS One Dec 23;10(12):e doi: /journal.pone ecollecgon Semes LP, Blash MM, Woolley T. Intraocular pressure response to scleral indentagon. Optom Vis Sci Sep;70(9): IOP increased aver speaking for 5 min.* * IOP began to decrease at 15 min following cessagon of the acgvity and returned to normal in 60 min. Increases were most significant in pagents whose IOP was 20 mmhg and above! 7

8 Situational influences on IOP CSF pressure (low may adversely affect ONH integrity) Likely increases if Sleep Apnea Syndrome, SAS, is diagnosed) IOP sampling How long does it take to get a Goldmann measurement? sec. How many seconds elapses in the 3- month interval between IOP measurements for a managed glaucoma pagent? sec. IOP by the numbers IOP by the numbers 3-6 (# seconds to perform Goldmann IOP) 3-6 (# seconds to perform Goldmann IOP) 17.2 (mean IOP) IOP by the numbers 3-6 (# seconds to perform Goldmann IOP) 17.2 (mean IOP) (staasacally normal (95%) range) IOP by the numbers 3-6 (# seconds to perform Goldmann IOP) 17.2 mm Hg (mean IOP) mm Hg (stagsgcally normal (95%) range) 7,862,400 (# seconds elapsing between quarterly visits) 8

9 Time of day When is IOP highest? When is IOP highest? A. During the night (asleep) B. Shortly aver awakening C. Middle of the day D. Following the evening meal Not so fast, my friend. Not so fast, my friend. Jonas JB, Budde W, Stroux A, Oberacher-Velten IM, Jünemann A. Single intraocular pressure measurements and diurnal intraocular pressure profiles. Am J Ophthalmol Jun; 139(6): What happens to IOP during sleep? And two recent comments IOP is generally thought to peak during sleep Nocturnal IOP is influenced by body posigon (e.g., with the head elevated during sleep may minimized this rise) Sleep apnea may influence both IOP an consequently glaucoma progression There is no good evidence to suggest that IOP variability is an appropriate subsgtute for measuring true diural IOP (i.e., 24-hour fluctuagon). Paraphrased from: Singh K, Sit AJ. (Editorial) Intraocular pressure variability and glaucoma risk: complex and controversial. Arch Ophthalmol Aug;129(8): Otherwise unexplained progression of glaucoma may be explained by peak IOP occurring outside of tradigonal office hours and an early morning IOP may serve as a surrogate for overnight monitoring. Paraphrased from: Gautam N, et al. Br J Ophthalmol 2016;100: doi: / bjophthalmol

10 *Healio Ocular Surgery News June 27, 2016 SENSIMED Triggerfish temporary continuous IOP monitoring Now FDA approved 57 Sleeping in lateral decubitus posigon may cause visual loss in normal-, high-tension glaucoma pagents PRAGUE Lateral decubitus posigon during sleeping may be the cause of asymmetric IOP increase and visual field damage in glaucoma pagents. Ki Ho Park, MD, PhD. European Glaucoma Society Congress. Prague, Czech Republic 2016 h^p:// %7B0a332bb4-20ab cbd-44c1b6a894a8%7D/sleeping-in-lateral-decubitusposiGon-may-cause-visual-loss-in-normal--high-tension-glaucoma-paGents? utm_source=maestro&utm_medium= &utm_campaign=ophthalmology%20news Is the answer overnight 24-hour ambulatory IOP monitoring? Continuous IOP monitoring with a wireless ocular telemetry sensor: initial clinical experience in patients with OAG. 59 Results from 15 pagents (single 24-hour monitoring period) Peaks (>1 hr) observed in 12/15 (80%)of pagents Management was changed in 11/15 (73%) based on the data! Mansouri K, Shaarawy T. BJO 2011;95: 627. (April) Example Example 53 yo treated glaucoma pagent (PGA qhs + Gmolol/tCAI comb); excellent reproducibility for two overnights blue & yellow. Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. ConGnuous 24-Hour Monitoring of Intraocular Pressure Pa^erns With a Contact Lens Sensor: Safety, Tolerability, and Reproducibility in PaGents With Glaucoma. Arch Ophthalmol. 2012; 13: YO Asian female glaucoma suspect (PGA qhs Rx d but may have been noncompliant); good reproducibility pa^ern for two overnights blue & yellow. Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. ConGnuous 24-Hour Monitoring of Intraocular Pressure Pa^erns With a Contact Lens Sensor: Safety, Tolerability, and Reproducibility in PaGents With Glaucoma. Arch Ophthalmol. 2012; 13:

11 Example Example LS Moderate reproducibility in a 59 GS for two overnights blue & yellow. Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. ConGnuous 24-Hour Monitoring of Intraocular Pressure Pa^erns With a Contact Lens Sensor: Safety, Tolerability, and Reproducibility in PaGents With Glaucoma. Arch Ophthalmol. 2012; 13:1-6. Poor reproducibility in a 20 GS for two overnights with spikes (n.b., pt has poor sleep habits). [app on your iphone] Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. ConGnuous 24-Hour Monitoring of Intraocular Pressure Pa^erns With a Contact Lens Sensor: Safety, Tolerability, and Reproducibility in PaGents With Glaucoma. Arch Ophthalmol. 2012; 13:1-6. Sensimed Triggerfish FDA cleared 64 Schematic of implantable continuous IOP monitoring device FDA News Release FDA permits markesng of device that senses opsmal Sme to check pasent s eye pressure Increased eye pressure is associated with nerve damage common in glaucoma For Immediate Release: March 4, 2016 What about a wearable? 66 Correlation with GAT 67 An Implantable IOP Transducer Implanted at cataract surgery Implandata, GMBH >/= 3 measurements (each device) 11

12 In Summary it s complicated There are many variables in the IOP value that we record Yet elevated IOP remains the greatest risk factor for developing glaucomatous damage And, lowering IOP is the only FDA-approved means to manage OHT and glaucoma h^ps:// In Summary IOP is complicated There are many variables in the IOP value that we record as a single value Yet elevated IOP remains the greatest risk factor for developing glaucomatous damage And, lowering IOP is the only FDA-approved means to manage OHT and glaucoma Thank you, Heart of America