9/6/2013. Evidence Based Guidance on Glaucoma Laser Trabeculoplasty and Early Surgery. Simon K. Law, MD. Clinical Professor of Health Sciences

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1 Evidence Based Guidance on Glaucoma Laser Trabeculoplasty and Early Surgery Simon K. Law, MD Clinical Professor of Health Sciences 25.5 mmhg 24 mmhg 1

2 Additional Opinions. First ophthalmologist diagnosed the patient with glaucoma and scheduled laser trabeculoplasty. A second opinion disagreed with the diagnosis and suggested that no treatment was needed. 3/03 Another Scenario. 63 yo BF with advanced glaucoma Received Laser trabeculoplasty in both eyes each year for the last 10 years 2

3 20 years ago. Stepwise approach Medication (MTMT) Laser Surgery Evolving. Medications Prostaglandins (1996) Selective alpha agonists (1996) Topical carbonic anhydrase inhibitors (CAI) (1995) Beta Blockers (1978) Parasympathomimetics (Grandfather s generation) Systemic CAI Problems remain New medications have new adverse reactions Generic equivalence or Nonequivalence Interaction with other treatment modalities Compliance Cost 3

4 Where are the appropriate p places for laser and surgery in glaucoma management? Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? 4

5 Glaucoma Laser Trial (GLT) Randomized one eye to ALT & fellow eye to med (IOP > 21) 271 patients enrolled, 203 had follow up ALT 2 sessions: spots over 180⁰ each (1 m apart) Med Timolol, Dipivefrin, Pilocarpine GLT Research Group. Controlled Clinical Trials 12: (1989) GLT Follow up (7 yrs) Mean preop IOP 27mmHg Mean IOP reduction 9mmHg (33%) Controlled by ALT alone 1 year: 63% 2 years: 44% IOP spike > 5mmHg: 29% >10mmHg: 9% PAS: 46% Arch Ophth 1989;107: , Ophth 1990;97: GLT Follow up (7 yrs) Eye treated with ALT initially: Lower IOP (1.2 mmhg) & better VA Better optic disc status (0.01) & VF status (0.6 db) Caveats: Cross over effect of medications Outdated regimen GLT Research Group. AJO 1995;120:

6 Trabeculoplasty as 1⁰ Tx ALT (Level I evidence) Samples JR et al. Ophthalmology 2011;118: Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? Trabeculoplasty as 1⁰ Tx ALT (Level I evidence) SLT (Level II evidence) Samples JR et al. Ophthalmology 2011;118:

7 SLT Q switched (i.e. pulsed), 3 nanosecond, frequency doubled Nd:YAG; 532 wavelength green laser Short pulse duration Low level of energy Target the pigment granules inside TM cells Little or no thermal damage to adjacent cells or structures Kramer TR, et al. Ophthalmology 2001;108:773 9 ALT SLT ALT vs. SLT Studies ALT IOP SLT IOP Duration Tzimis mmhg 2.7 mmhg 12 months Rosenfeld mmhg 4.3 mmhg 12 months Birt mmhg 5.8 mmhg 12 months Damji mmhg 5.9 mmhg 12 months Russo mmhg 6.0 mmhg 12 months Kent mmhg 6.8 mmhg 6 months Bovell mmhg 7.4 mmhg 60 months Prospective and large cohort studies 7

8 SLT as 1⁰ treatment Studies Pre SLT Post SLT Post Pre % reduction Success rate Duration Nitta % 40% 3 years Realini % 78% 1 year 2013 Katz % 89% 1 year McIlraith % 83% ( 20%) 55% ( 30%) Response rate* * Question: What proportion of patients responds to SLT? Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? SLT vs. PG Studies PG SLT Duration Katz mmhg IOP 6.3 mmhg IOP 9 12 months Nagar 73% with 20% ; 75% with 20% ; 4 6 months % success in 50% 83% success in 50% fluctuation reduction fluctuation reduction Nagar % with 20% 59% with 30% 10 months Prospective studies 8

9 Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? Additive effect of LT Studies Medication Additive effect of SLT/ALT Bruen 2012* PG SLT IOP reduction effect lower than SLT alone Heijl 2011* Betaxolol 13% additional IOP reduction with ALT Kara 2011 PG 4.7mmHg reduction (1 year), 78%success TDFC 6.5 mmhg reduction (1 year), 50% success Klamann MTMT 19 mmhg to 14 mmhg (3 months) 2012* Hirn 2012* MTMT w/o PG MTMT w PG 14% additional IOP reduction with SLT SLT IOP reduction effect lower Bovell 2011* MTMT 6.7 mmhg reduction (3 years) 50% success in 2 years * Prospective studies Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? 9

10 Baseline IOP. Studies IOP more in eyes with higher baseline? Bruen 2012* Yes Hirn 2012* Heijl 2011* Ayala 2011 Mao 2008** Martow 2011 Singh 2009 Yes Each 3 mmhg higher IOP before ALT = 2 mmhg additional reduction Yes Yes No difference No difference * Prospective studies; ** Large cohort Why. Tonographic outflow facility increased 56% No change in aqueous production Outflow pressure theory Outflow P = IOP Episcleral venous P (EVP) Beltran Agullo 2012 Goyal 2010 Examples Baseline IOP = 25 mmhg EVP = 10 Outflow Pressure = 15 50% outflow = 7.5 IOP = 17.5 mmhg Baseline IOP = 20 mmhg EVP = 10 Outflow Pressure = 10 50% outflow = 5 IOP = 15 mmhg Absolute reduction = 7.5 Percent reduction = 7.5/25 = 30% Absolute reduction = 5 Percent reduction = 5/20 = 25% 10

11 T/F Questions The higher the baseline pressure, the better the response to SLT T/F SLT lower IOP more in eyes with higher baseline IOP..T/F SLT efficacy is adversely associated with the Tmax.T/F Nagar Ophthalmology Times 2011 Mao 2008 Does LT work? Is LT effective and safe? How does SLT compare to ALT? How effective is SLT compare to PG? Is SLT additive to: Prostaglandin, Beta blocker, Fixed combination, MTMT Does SLT work better with higher IOP? Does repeated SLT work? Does repeated SLT work? Studies Design Does repeated SLT work? Avery 2013* Samples 2011 Hong 2009* Repeat SLT after 1 st SLT (40 50 spots over 360 degree) failed to reduce IOP by 20% Evidence based review (AAO) Repeat SLT on eyes with SLT (360 degree) failed after 6 months Similar success rate Level III evidence Lower IOP reduction in repeated SLT * Retrospective study 11

12 Limitations Retrospective studies Selection bias Regression to the mean IOP fluctuation (short term te and long term) Treatment protocol variation Preop and Postop Managements variation Both eyes of a patient enrolled Possible conflict of interest Be Practical. Laser Trabeculoplasty lowers IOP by increasing the trabecular outflow It can be used alone or in combination with medications depending di on IOP targett Efficacy decreases in multiple therapy Stepwise approach gives way to patientoriented approach Early Surgery Evidence Based Guidance on Glaucoma Laser Trabeculoplasty and Early Surgery Considerations: Metabolites used Medications availability Stages of disease New surgeries Numerous variables 12

13 Studies Glasgow Trial Moorfield s Primary Treatment Trial Advanced Glaucoma Intervention Study Collaborative Initial Glaucoma Treatment Glasgow Trial Patients 99 Dx POAG F/U 5 years Methods Group A: Trab as secondary tx Group B: Trab as primary tx Results VF progression: 47% in gp A, 26% in gp B Jay JL, Murray SB. BJO 1988;72:881 9 Moorfield s Primary Treatment Trial Patients 168 Dx POAG F/U >5 years Methods Initial medicine* vs ALT vs Trab Results Initial tx with surgery works better than ALT of medicines *timolol, dipivefrine, pilocarpine, ±CAI Migdal et al. Ophthamology 1994;101:

14 Moorfield s Primary Treatment Trial Surgery group: No deterioration of VF Moorfield s Primary Treatment Trial Surgery: Lower IOP & less diurnal variations Advanced Glaucoma Intervention Study Patients Dx F/U Methods Results 591 (789 eyes) POAG 7 years T A T vs. A T T Lower IOP after surgery protects against VF loss more effectively in whites > blacks Ophthalmol 1998;105:1146 AJO 2000;130:428 AJO 2003;134:499 14

15 Advanced Glaucoma Intervention Study Group A 100% Group B 75 99% Group C 50 74% Group D <50% <18 mm Hg Avg. IOP 20.2 Mean Change in i VFD Score Follow up Month Collaborative Initial Glaucoma Treatment Patients 607 Dx POAG F/U >5 years Methods Stepped medications* vs. trab Results Similar VF loss in both groups. VF loss associated with Max IOP, SD of IOP, and IOP range *beginning with beta blocker Ophthalmology 2001:108:1943 Ophthalmology 2011;118:1766 Collaborative Initial Glaucoma Treatment 15

16 Collaborative Initial Glaucoma Treatment Musch et al. Ophthalmol 20111;118:1766 Collaborative Initial Glaucoma Treatment Risk of blebitis 1.5% Risk of hypotony..1.5% Risk of endophthalmitis..1.1% In 5 years Ophthalmology 2013;155:674 Topical medical therapy & Trab success Effects on conjunctiva and Tenon s Capsule Increase of inflammatory cells and fibroblasts Decrease of epithelial goblet cells Effects on eyelids Problems with clinical studies Patient selection bias Poor control of baseline characteristics Outdated medical therapy Sherwood et al. Ophthalmol 1989;96:327 Broadway DC, et al. Arch Ophth 1994;112:1437 Lavin MJ et al. Arch Ophth 1990;108:1543 Flach AJ. Trans Am Ophth 2004;102:219 16

17 Medication factors: Safety/Efficacy Ease/Compliance QoL Balance Doctor/Patient factors: Competence/Difficulty Target IOP/Dz severity Patient s preference Cost/Reimbursement Surgery factors: Safety/Efficacy Long term results QoL/Compliance Level of Evidence. High: SLT effect similar to ALT SLT mean IOP reduction similar to PG Moderate: 60% response rate of 30% reduction Lower baseline IOP = Lower IOP reduction Low: Repeated SLT Initial SLT Level of Evidence. High: Trabeculectomy lowers IOP more Moderate: Trabeculectomy preserves VF better Low: Trabeculectomy should be used sooner 17

18 Thank You 18