1. Minimally Invasive Glaucoma Surgery
MIGS:
Minimally Invasive Glaucoma Surgery
Ilya Rozenbaum, MD
Matossian Eye Associates
June 2014
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2. Disclosures Speaker/Consultant: Allergan Alcon
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3. Understanding Glaucoma3
Human Cost of Glaucoma
Glaucoma is the second leading cause of blindness worldwide
Global estimates of glaucoma cases exceeded 60M in 2010 and are estimated to grow to 78M by 2020
Bilateral blindness is occurring at an alarming 7.5% of OAG cases globally, growing from 4.4M to 6M patients between 2010 and 2020
In the US, there are an estimated 2.2M cases of OAG, growing to more than 3M cases by 2020, with more than 88,000 of these patients going blind
Notes:
Primary Open-angle glaucoma affects approximately 66 million people in the world and is the second leading cause of blindness.
According to Dr. Quigley’s research, of the 66 million people with glaucoma, just under 6 million will go blind.
In the US, the estimates are 2.2 million cases of primary open-angle glaucoma with 87,800 expected to go blind as a result.
The incidence is expected to increase to just under 3 million cases by 2020.
In the United States, approximately 2% of the population has the disease, and the probability of undergoing conventional filtration surgery is 23% in one eye after 20 years of having the disease.
As surgery is usually done at a late stage in the disease after medical and laser treatments have failed, an earlier, more aggressive treatment is warranted.
1.Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 2006 March; 90(3): 262–267.
2.Congdon NG, De Jong PT, Klein BE et al.Glaucoma as a cause of blindness in the United States. American Glaucoma Society Annual Meeting 2003; abstract.
3.Friedman DS, De Jong PT, Klein BE, et al. Glaucoma prevalence in the United States: results of a meta-analysis. American Glaucoma Society Annual Meeting 2003; Abstract.
Reference
Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol 1996;80:
Congdon NG, De Jong PT, Klein BE et al. Glaucoma as a cause of blindness in the United States. American Glaucoma Society Annual Meeting 2003; Abstract.
Friedman DS, De Jong PT, Klein BE, et al. Glaucoma prevalence in the United States: results of a meta-analysis. American Glaucoma Society Annual Meeting 2003; Abstract.

4. Problems with Glaucoma Meds
Future surgery success rate may be lower
Quality of life
Cost
Compliance
Side effects:
Death from beta-blockers
Fatal aplastic anemia (CAIs)
Severe allergic reactions
Retinal detachment (pilocarpine)
Irritation, redness, etc
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5. Glaucoma: Surgical Disease5
Understanding Glaucoma
Glaucoma: Surgical Disease
CIGTS:
Glaucomatous optic disc progression is higher in patients on medical treatment than surgical patients
Notes:
Primary Open-angle glaucoma affects approximately 66 million people in the world and is the second leading cause of blindness.
According to Dr. Quigley’s research, of the 66 million people with glaucoma, just under 6 million will go blind.
In the US, the estimates are 2.2 million cases of primary open-angle glaucoma with 87,800 expected to go blind as a result.
The incidence is expected to increase to just under 3 million cases by 2020.
In the United States, approximately 2% of the population has the disease, and the probability of undergoing conventional filtration surgery is 23% in one eye after 20 years of having the disease.
As surgery is usually done at a late stage in the disease after medical and laser treatments have failed, an earlier, more aggressive treatment is warranted.
Five-year Follow-up Optic Disc Findings of the Collaborative Initial Glaucoma Treatment Study. Am J Ophthalmol 2009;147:717–724.
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Reference
Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol 1996;80:
Congdon NG, De Jong PT, Klein BE et al. Glaucoma as a cause of blindness in the United States. American Glaucoma Society Annual Meeting 2003; Abstract.
Friedman DS, De Jong PT, Klein BE, et al. Glaucoma prevalence in the United States: results of a meta-analysis. American Glaucoma Society Annual Meeting 2003; Abstract.

6. Glaucoma: Surgical Disease
Surgical options
Trabeculectomy or ExPress
Tube shunts
Ahmed, Baerveldt, Molteno
Laser trabeculoplasty
Trans-scleral laser
Canaloplasty
MIGS
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7. Glaucoma: Surgical Disease
Trabeculectomy 2014
Advantages
Still the gold standard surgery
No device needed - available, cost-effective
Can achieve low IOPs
Disadvantages
Less standardized (hasn’t significantly changed in 50 years)
Complications in up to 40%
Failure in up to 50% at 5 years
Cataract in 50% at 5 years
Gedde SJ, Schiffman JC, Feuer WJ, et al. Am J Ophthalmol. 2012;153: e2.

8. Glaucoma: Surgical Disease
TVT study: complications
Early postoperative complications:
21% (tube) and 37% (trab)
Late postoperative complications (up to 5 years after surgery):
34% (tube) and 36% (trab)
Cataract surgery:
54% of phakic tube eyes and 43% of phakic trab eyes
Reoperation for surgical complications:
22% (tube) and 18% (trab)
Gedde SJ, Herndon LW, Brandt JD, et al. Am J Ophthalmol. 2012;153: e1.

9. Bleb Leak Evaluation must be done with high concentration fluorescein
Cascading darker/clear fluid with fluorescent edges is a leak

10. Endophthalmitis
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11. Tube Erosion
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12. Plate Erosion
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13. Ideal glaucoma surgery?
As effective as trabeculectomy but safer
Reproducible/Predictable
No bleb
Easy to perform
Less post-operative effort
Cost-effective
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14. Cataract surgery vs. controls from OHTS:
16.5% reduction in IOP sustained for 36 months
Mansberger SL, et al. Reduction in intraocular pressure after cataract extraction: the ocular hypertension treatment study. Ophthalmology Sep;119:

15. Concomitant Cataract & Glaucoma (US)
1 in 5 Cataract Eyes on OHT Medication
Centers for Medicare and Medicaid Services – Medicare Standard Analytical File. Baltimore, MD. 2007 .
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16. SITA-Standard HVF 24-2
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17. MIGS Minimally Invasive Glaucoma Surgery
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18. Minimally Invasive Glaucoma Surgery (MIGS)
Ab interno microincisional approach
Minimally traumatic to the target tissue
Safe and (at least modest) IOP reduction
Rapid recovery with minimal impact on the patient’s quality of life
Typically indicated for mild to moderate POAG
Curr Opin Ophthalmol 2012, 23:96–104
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19. iStent Trabecular Micro-Bypass Stent (Glaucos)
1 mm x 0.33 mm
Snorkel: 0.25 mm x 120 µm (bore diameter)
Weight: 60 µg
Surgical grade nonferromagnetic titanium
Heparin-coated to promote self- priming and facilitate outflow
Snorkel
0.3 mm
Open Half Pipe
Retention Arches
Lumen 120 µm
Self-Trephining Tip
The iStent was designed to be as small as possible in order to require a micro- invasive surgical procedure. It is the smallest device known to be implanted in humans.
The iStent is 1.0 mm in length and 0.33 mm in height, with a snorkel length of mm and diameter of 120 µm. has an “L”- shaped structure with a snorkel (inlet) on the short side (which sits in the anterior chamber) and an open half-pipe lumen. The convex side of the iStent sits against the inner wall of Schlemm’s canal and the open half-pipe against the outer wall. The snorkel of the device is designed to extend slightly into the anterior chamber to allow aqueous to exit from the anterior chamber. The size of the lumen (120µm) has more than adequate capacity to accommodate flow of aqueous humor produced.
The iStent is manufactured from titanium (Ti6Al4V ELI), a material commonly used in medical implants with proven biocompatibility in the body. It is non- ferromagnetic for safety in magnetic resonance imaging. The heparin coating is used to ensure wetting ability of the lumen for self-priming.
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada 19

20. iStent
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21. For patients with OAG/OHTN who also need cataract surgery
iStent: Indication
In conjunction with cataract surgery
Mild to moderate open- angle glaucoma
Currently treated with ocular hypotensive medication
For patients with
OAG/OHTN
who also need
cataract surgery
The iStent was designed to be as small as possible in order to require a micro-invasive surgical procedure. It is the smallest device known to be implanted in humans.
The iStent is 1.0 mm in length and 0.33 mm in height, with a snorkel length of 0.25 mm and diameter of 120 µm. has an “L”-shaped structure with a snorkel (inlet) on the short side (which sits in the anterior chamber) and an open half-pipe lumen. The convex side of the iStent sits against the inner wall of Schlemm’s canal and the open half-pipe against the outer wall. The snorkel of the device is designed to extend slightly into the anterior chamber to allow aqueous to exit from the anterior chamber. The size of the lumen (120µm) has more than adequate capacity to accommodate flow of aqueous humor produced.
The iStent is manufactured from titanium (Ti6Al4V ELI), a material commonly used in medical implants with proven biocompatibility in the body. It is non-ferromagnetic for safety in magnetic resonance imaging. The heparin coating is used to ensure wetting ability of the lumen for self-priming.
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada 21

22. Done with cataract surgery
iStent
Done with cataract surgery
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23. iStent: Mechanism
Designed to improve aqueous outflow thru the natural physiologic pathway
Creates a bypass thru trabecular meshwork to Schlemm’s canal
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada

24. iStent
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25. iStent Surgical Video
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26. At 12 months:
68% of iStent subjects with IOP ≤ 21 mm Hg without medication vs. 50% with cataract surgery alone (p=0.004)
Ophthalmology Mar;118(3):
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27. 35% cataract group on medication (p=0.001)
At 12 months:
15% of iStent vs.
35% cataract group on medication (p=0.001)
Ophthalmology Mar;118(3):
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28. iStent + Cataract Surgery N = 111
Complication
iStent + Cataract Surgery N = 111
Cataract Surgery N = 122
Anticipated early postoperative event
14(13%)
15(12%)
Stent obstruction by iris, vitreous, fibrous overgrowth, fibrin, blood, and so forth
4(4%)
0(0%)
Posterior capsular opacification
3(3%)
8(7%)
Stent malposition
Subconjunctival hemorrhage
2(2%)
Elevated IOP, other
1(1%)
Epiretinal membrane
Iris atrophy
Blurry vision or visual disturbance
6(5%)
Iritis
Dry eye
Elevated IOP requiring treatment with oral or intravenous medications or with surgical intervention
Macular edema
Foreign body sensation
3(2%)
Allergic conjunctivitis
Mild pain
Rebound inflammation from tapering steroids

29. iStent Lower IOP Fewer medications No bleb!!
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30. What's in the Pipeline? 2 “iStent inject” vs latanoprost/timolol
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31. Endoscopic Cyclo Photocoagulation
(ECP) - EndoOptiks
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32. ECP
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33. ECP
ECP is the selective ablation of aqueous producing ciliary processes via an ab interno approach
Inhibits aqueous production, therefore reducing IOP and medication use
ECP has been performed globally for over 12 years
More than 50,000 patients treated to date
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34. ECP Indications Mild to moderate glaucoma (any type) or
Refractory glaucoma (after multiple failed glaucoma surgeries)
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35. Phaco-ECP: Combined ECP and Cataract Surgery
Lindfield D, Ritchie RW, Griffith MF. BMJ Open 2012
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36. ECP COLLABORATIVE STUDY GROUP SAFETY STUDY: COMPLICATIONS
5824 PATIENTS
IOP Spike %
Hemorrhage %
Serous Choroidal Effusion %
IOL Dislocation %
CME %
RD %
Massive Choroidal Hemorrhage 0.09%
Hypotony or Phthisis %
NLP Vision %
Cataract %
Acute Graft Rejection 5.3%
Chronic Graft Rejection 0
Chronic Inflammation 0
Flat AC 0
Endophthalmitis 0
Diplopia 0
Wound Leak 0
Bleb Complications 0

37. Trabectome (Neomedix)
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38. Surgical Treatment
Trabectome
Ablates and removes a strip of trabecular meshwork and re- establishes access to the eye’s natural drainage pathway
Notes: Trabectome (developed by NeoMedix) ablates and removes a strip of trabecular meshwork and re-establishes access to the eye’s natural drainage pathway.
HOW IT WORKS
It all happens at the tip. The Trabectome handpiece is positioned across the anterior chamber and the tip enters the Schlemm’s canal. At the tip, the Trabectome handpiece incorporates a bipolar micro-electrocautery which ablates and removes a strip of trabecular meshwork. Simultaneous irrigation and aspiration washes away the debris and provides a stable anterior chamber while protecting the adjacent tissues. The main difficulty is identifying Schlemm’s canal.
Trabectome has an excellent operative and post operative safety profile and has not resulted in any of the following postoperative conditions: Flat or shallow anterior chamber, Persisting corneal edema, Iris injury, Hypotony or hypotony maculopathy, Infection, Cataract progression, Wound leak, Bleb formation and infection, Choroidal effusion; choroidal hemorrhage, Visual acuity decrease (>2 Lines)
Trabectome Tip is bent to create the triangular Protective Footplate.
The Protective Footplate:
  provides protection from heat injury to adjacent structures.  is coated with a smooth insulating material.  easily penetrates the trabecular meshwork.  acts as a guide and glide inside Schlemm's canal to protect the collector channels, outer wall of Schlemm's canal and adjacent tissues. Feeds trabecular and juxtacanalicular tissues into the ablative bipolar electrodes as the instrument tip is advanced.
Complications (49 patients) from latest study
  • Intraoperative blood reflux when instrument removed in majority of cases   • Hyphema cleared by days •20% hyphema largest in this series •Minimized by wound suture/air tamponade/ Intra-operative Iopidine  •2% Pilocarpine pre-op & 2 – 6 weeks post-op   • Transient Corneal injuries: 6/49 (12.2%) •Epithelial defect: 3/49(6%) •Decemet’s hemorrhage: 1/49(2%) •Decemet’s scroll/detach: 1/49 (2%) •Persisting Decemet’s injury: 1/49(2%)   • Partial PAS/goniosynechiae: 14/49(28.5%)
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39. Review of 115 Trabectome patients vs. 102 trab-MMC patients.
Success rates (IOP<21 mmHg or >20% reduction) at 2 years:
22.4% for trabectome and 76.1% for trab (P=0.001)
Ophthalmology Jan;119(1):36-42.
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40. Trabectome had 100% hyphema POD #1, plus 4
Trabectome had 100% hyphema POD #1, plus 4.3% other complications, compared to 35.3% complication rate for trabeculectomy (P=.001)
Ophthalmology Jan;119(1):36-42.
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41. Trabectome Side Effects and Complications Descemet’s injury
Surgical Treatment
Trabectome
Side Effects and Complications
Descemet’s injury
Ciliary body injury
Reflux bleeding, hyphema
Zonule injury
Notes: Trabectome (developed by NeoMedix) ablates and removes a strip of trabecular meshwork and re-establishes access to the eye’s natural drainage pathway.
HOW IT WORKS
It all happens at the tip. The Trabectome handpiece is positioned across the anterior chamber and the tip enters the Schlemm’s canal. At the tip, the Trabectome handpiece incorporates a bipolar micro-electrocautery which ablates and removes a strip of trabecular meshwork. Simultaneous irrigation and aspiration washes away the debris and provides a stable anterior chamber while protecting the adjacent tissues. The main difficulty is identifying Schlemm’s canal.
Trabectome has an excellent operative and post operative safety profile and has not resulted in any of the following postoperative conditions: Flat or shallow anterior chamber, Persisting corneal edema, Iris injury, Hypotony or hypotony maculopathy, Infection, Cataract progression, Wound leak, Bleb formation and infection, Choroidal effusion; choroidal hemorrhage, Visual acuity decrease (>2 Lines)
Trabectome Tip is bent to create the triangular Protective Footplate.
The Protective Footplate:
  provides protection from heat injury to adjacent structures.  is coated with a smooth insulating material.  easily penetrates the trabecular meshwork.  acts as a guide and glide inside Schlemm's canal to protect the collector channels, outer wall of Schlemm's canal and adjacent tissues. Feeds trabecular and juxtacanalicular tissues into the ablative bipolar electrodes as the instrument tip is advanced.
Complications (49 patients) from latest study
  • Intraoperative blood reflux when instrument removed in majority of cases   • Hyphema cleared by days •20% hyphema largest in this series •Minimized by wound suture/air tamponade/ Intra-operative Iopidine  •2% Pilocarpine pre-op & 2 – 6 weeks post-op   • Transient Corneal injuries: 6/49 (12.2%) •Epithelial defect: 3/49(6%) •Decemet’s hemorrhage: 1/49(2%) •Decemet’s scroll/detach: 1/49 (2%) •Persisting Decemet’s injury: 1/49(2%)   • Partial PAS/goniosynechiae: 14/49(28.5%)
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42. The ICE Procedure Cataract Extraction iStent ECP
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43. What is ICE? 16.5% IOP lowering at 3 years
Mansberger. Ophthal. 2012; 119:
33% IOP lowering with cataract extraction
Samuelson. Ophthal. 2011;118:
43% IOP lowering with cataract extraction
Kahook; J Glaucoma. 2007;16:

44. Mechanisms of ICE? ? Angle widening ? Decreased aqueous production
Increased trabecular outdlow
Decreased aqueous production

45. Preoperative vs. Month 3-6 IOP Reduction (n=48)
% of eyes
Preoperative vs. Month 3-6 IOP Reduction (n=48)
From Glaukos Panel Executive Summary pgs
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46. Preoperative vs. Month 3-6 IOP
% of eyes
Preoperative vs. Month 3-6 IOP
From Glaukos Panel Executive Summary pgs
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47. What about Cost? Projected cost savings at 6 years in $: 1 drop
2 drops
3 drops
iStent
-20.77
ECP
779.23
Trabectome
279.23
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Iordanous Y et al. J Glaucoma Feb;23(2):e112-8.

48. Summary
Appreciation for the risks and complications associated with traditional glaucoma surgery has ignited the MIGS revolution
MIGS, combined with cataract surgery, provides safe new options for IOP reduction
Lots of options, data is forthcoming
Trabeculectomy and tube shunt surgery for significant IOP reduction
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49. Thank you! Hopewell office 609-882-8833 Doylestown office 215-230-9200
Cell
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