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Canaloplasty 3yr Clinical Data
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Canaloplasty:
An Overview Restoration of normal aqueous
outflow pathway using a Flexible
Microcatheter in Schlemm's Canal for
treatment of POAG
___________, MD
(Insert Practice Name)
(Insert City, State)
Canaloplasty overview
• Anatomy and histology of Schlemm’s canal
• Outflow physiology and pathophysiology
• Evolution of Canaloplasty
• Rationale of Canaloplasty
• Tools for Canaloplasty
• Clinical study results 36 months data
3
Procedure of last resortInfection, bleeding swelling, loss of vision .9% of patients32,000 US proc./yr
Less effective over timePoor compliance45% of patients on two or more 2.3 MM patients treated
Laser treatment of trabecular meshworkSLT – multiple times15.5% patients450,000 US proc./yr
Multiple post procedure visits High complication rates Lasts 2-5 years3.5% of patients100,000 US proc./yr
Ocular Implant
Filtration Surgery
Laser Surgery
Medications
-Prostaglandins- Beta Blockers- Alpha Agonists- CAIs
LaserTrabeculoplasty Trabeculectomy Tube Shunts
Historic Glaucoma Treatment Algorithm
• Trabeculectomy with or w/o MMC achieves low pressures
– But with a high post-op complication rate...
• That’s why I’ve historically referred these patients…
Trabeculectomy: The “Gold” Standard?
*Trabeculectomy cumulative failure rate of 30.7% @ 3-yearsGedde, SJ et al Review of the results from the Tube vs. Trabeculectomy Study Current Opinion in Ophthalmology 2010, 21:123-128
Cross-Section of the Angle
Schlemm’s canal
1 2 3 4 5
1-Scleral Bed
2-Scleral Spur
3-Trabecular Meshwork
4-Descemet’s Window
5-Outer Wall (Roof) of Schlemm’s Canal
Schlemm’s canal
Outflow Pathway – Top View
Distal Outflow
System
Where is the Outflow Disorder?
Sources of Outflow Resistance
Collector Channels / Distal System
Trabecular Meshwork
Schlemm’s Canal
Canaloplasty
• Re-establish flow from anterior chamber to the restored
canal of Schlemm and the collectors:– Achieve physiologic control of IOP
– Without requiring a bleb
– Without developing bleb related post operative problems
• Non-penetrating surgical procedure with:
– 360º cannulation and viscodilation of Schlemm’s canal
– Circumferential suture tensioning of trabecular meshwork /
stenting of Schlemm’s canal
– Trabeculo-descemetic window
Evolution of Canaloplasty
• 1960s Sinusotomy
• 1980-2000 Deep Sclerectomy, Viscocanalostomy
• 2001 1st High resolution UBM images of canal
• 2003 Development of microcatheter
• 2004 360º canal viscodilation
• 2005 Canaloplasty: Viscodilation + suture
• 2007 JCRS 12-month canaloplasty follow-up
• 2009 JCRS 24-month canaloplasty follow-up
• 2010 JCRS 36-month canaloplasty follow-up
Canaloplasty Basics
• Viscoelastic injection – Dilates the canal
– May increase permeability of the trabecular meshwork
– Dilates the ostia of the collector channels
• Multipurpose 9-0 Polypropylene suture stent:– Maintains Schlemm’s Canal opening to allow fluid to flow
circumferentially
– Places tension on the trabecular meshwork to increase permeability
– The mechanical equivalent of Pilocarpine
Canaloplasty & Viscodilation
Preoperative Dilation of Schlemm’s
canal
Dilation of Schlemm’s
canal and collector
channels
Dilation of Schlemm’s canal visualized with UltraSound Imaging
Effects of Suture Tension
Ex-Vivo Perfusion Study, Utilizing Morton Grant Flow Model
– Pressurize globe to a range of physiologic pressures
– Apply tension to a suture implanted through the canal
– Measure outflow facility (uL/Min / mmHg)
Image: iScience Interventional
Effects of Suture Tension, Ex-Vivo
Perfusion Study
Experiments show significant increase in outflow
facility with suture tension over range of IOP
10-0 Prolene - Tension vs. Outflow Facility
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
0 2 4 6 8 10 12
Measured Tension (grams)
Ou
tflo
w F
ac
ilit
y (
ul/
min
/mm
Hg
)
10 mm Hg 15 mm Hg 20 mm Hg
Suture StentingEx-Vivo Histopathology
Close-up of Suture in Anterior Segment of canal
Images: iScience Interventional
Suture stenting of the canal
Canaloplasty & Suture Tension
Grade 0- No distension Grade 1 – Good distension Grade 2 – Maximum desired
distension
Distension of Trabecular Meshwork visualized with UltraSound Imaging
Aqueous Flow After Canaloplasty
Schlemm’s Canal
Scleral LakeDescemet’s Window
Collector Channels
Nasal TemporalAC
Use of Microcatheter in Canal
– A flexible microcatheter
with lighted beacon tip
– Injects viscoelastic to dilate
the entire 360° of the
canal and collector system
– Facilitates passage of
tensioning suture to
maintain patency of the
canal
Canaloplasty – Clinical Update
A. Data from multi-center clinical trial with
three - year follow-up
B. IOP reduction of 35-41%
C. Low post-operative complication rate
D. No late hypotony or other late complications
• United States– Bruce Cameron
– Garry Condon
– Ron Fellman
– Michael Field
– Jack Kearney
– Richard Lehrer
– Richard Lewis
– Marlene Moster
– Alan Robin
– Tom Samuelson
– Brad Shingleton
– Howard Weiss
• Germany– Norbert Körber
– Manfred Tetz
– Kurt von Wolff
• South Africa– Robert Stegmann
• iScience Interventional– Menlo Park, CA
Acknowledgements
Canaloplasty Multicenter Study
• Prospective study
• Inclusion criteria:– Baseline treated IOP of ≥ 16 mmHg with history of IOP ≥ 21– Age ≥ 18 Years– Diagnosed with primary open angle glaucoma, pigmentary
glaucoma, pseudoexfoliation glaucoma, or mixed mechanism glaucoma of the above types
• Exclusion criteria:– More than 2 laser trabeculoplasty– Chronic uveitis or neovascular disease– PAS or history of angle closure– Previous surgery involving dissection in the area near
Schlemm’s canal or the TM
Study Group DemographicsParameter Value
Enrollees, n 154
Eyes, n 154
Mean Age (yrs) SD, Range 68 12, 37 - 89
Sex, n (%)
Female 85 (55.2)
Male 68 (44.2)
Unrecorded 1 (0.6)
Race, n (%)
Caucasian 140 (90.0)
African American or African Descent 9 (6.0)
Hispanic 4 (3.0)
Asian 1 (1.0)
Pseudophakic at baseline, n (%) 25 (16.2)
Diagnosis, n (%)
Primary Open Angle Glaucoma (POAG) 138 (89.6)
Pseudoexfoliation Glaucoma (PXF) 8 (5.2)
Mixed Mechanism, POAG & PXF 2 (1.3)
Mixed Mechanism, POAG & acute angle closure 2 (1.3)
Pigmentary Dispersion Glaucoma 2 (1.3)
Previous Ocular Surgeries, n (%)
Laser Trabeculoplasty (LT) 25 (16.2)
Peripheral Laser Iridotomy (LPI) 10 (6.5)
YAG Capsulotomy 1 (0.6)
Successful Placement of Intracanalicular Suture, n (%) 131 (85)
Combined Procedures (Phacocanaloplasty), n (%) 37 (24)
Analysis Group Definitions
For efficacy analysis the patients were divided into 2
groups as follows:
• Group 1 – all patients with successful suture implantation
during canaloplasty alone that met inclusion and exclusion
criteria
– Group 1A – all group 1 patients without observed TM distension
– Group 1B – all group 1 patients with observed TM distention
• Group 2 – all patients with successful suture implantation
during canaloplasty combined with cataract surgery that met
inclusion and exclusion criteria
• 35% Mean IOP
decrease vs.
baseline
• 53% Mean
reduction in Rx
from baseline
Data Point Baseline 6 Month 12 Month 24 Month 36 Month
Canaloplasty Only
N 100 85 85 87 84
Mean IOP 23.6 4.4 16.3 3.6 16.1 3.9 16.0 3.7 15.4 3.3
Mean
Medications
1.9 0.8 0.4 0.7 0.6 0.8 0.7 0.8 0.9 0.9
PhacoCanaloplasty™
N 31 26 27 26 23
Mean IOP 23.7 5.4 12.8 2.9 13.6 4.1 13.5 3.2 13.1 3.6
Mean
Medications
1.5 1.0 0.1 0.3 0.1 0.4 0.2 0.4 0.3 0.6
Canaloplasty & PhacoCanaloplasty:
3-Year Clinical results
• 45% Mean IOP
decrease vs.
baseline
• 81% Mean
reduction in Rx from
baseline
3-Year Canaloplasty &
PhacoCanaloplasty: IOP Results
Mean decrease from Baseline 35%
Mean decrease from Baseline 41%
Age Normal IOP vs. Canaloplasty
0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
35 45 55 65 75 85
Age
IOP
(m
m H
g)
24M Canaloplasty
Age Normal IOP
Pre-Op IOP
24M Phacocanaloplasty
Age Normal IOP data obtained from consolidated studies: The Framingham Eye Study and Des Moines Eye Study. Ages adjusted for scale. 24M Canaloplasty and Pre-
Op IOP data obtained from Canaloplasty 2 Yr Clinical Study Results, J Cataract Refract Surg. 2009 May;35(5):814-24.
Results vs. Age-Normal IOP
Safety Summary at 3-Years
Early Postoperative / Surgical Complications ( ≤ 90 Days)
Microhyphema: <1mm layered blood (1D, 1Wk) 13% / n=20
Early elevated IOP (0-3months) 8.4% / n=13
Hyphema: > 1.0 mm layered blood (1D) 5.8% / n=9
Descemet's membrane detachment / perforation 5.2% / n=8
Wound hemorrhage 2.6% / n=4
Gross hyphema (1D) 1.9% / n=3
Suture extrusion through trabecular meshwork (Sx) 1.3% / n=2
Hypotony (1D) 0.6% / n=1
Late Postoperative Complications (> 90 Days)
Late elevated IOP (>3 months PO) 3.9% / n=6
Blebs at 36 months 2.6% / n=4
Suture extrusion through trabecular meshwork (30 months) 0.6% / n=1
Endophthalmitis 0.0%
Choroidal Effusion 0.0%
Hypotony 0.0%
Hyphema 0.0%
Group 1
Canaloplasty Alone
Group 2
PhacoCanaloplasty
NLogMAR BCVA
(avg ± SD) N
LogMAR BCVA
(avg ± SD)
Baseline 100 0.23 ± 0.37 31 0.29 ± 0.19
6 Month 100 0.23 ± 0.45 31 0.13 ± 0.15
12 Month 99 0.25 ± 0.46 31 0.15 ± 0.17
24 Month 98 0.22 ± 0.41 29 0.21 ± 0.28
36 Month 94 0.21 ± 0.25 30 0.18 ± 0.30
Visual Acuity results
G r o u p 1 : The mean BCVA at 36 months was not significantly different than at Baseline
G r o u p 2 : The mean BCVA at 36 months was significantly improved vs. Baseline
Historical Analysis – Complications*
Procedure Trial Complication Rate
Canaloplasty/
PhacoCanaloplasty
Canaloplasty Multicenter Study
(CMS)11%
Tube Shunts TVT 34%
Trabeculectomy TVT 57%
*Based on Canaloplasty Multicenter Trial 36-Month Results
Ahmed, I. K. et al Non-Penetrating Schlemm’s Canaloplasty
Versus Trabeculectomy: A Head-to-Head Comparison*
Canaloplasty Trabeculectomy
Time point N Avg ± SD (Range) N Avg ± SD (Range)
p-value
(CP v Trab)
Baseline 50 26.4 ± 6.5 (13-42) 51 26.8 ± 8.1 (15-50) 0.803
1 Day 50 10.9 ± 6.1 (2-31) 50 9.6 ± 7.6 (0-44) 0.356
1 Week 49 13.1 ± 5.5 (2-25) 48 9.0 ± 5.5 (0-22) <0.001*
1 Month 49 14.1 ± 4.6 (6-29) 45 13.9 ± 6.4 (4-32) 0.838
3 Months 44 13.9 ± 3.8 (4-24) 44 13.1 ± 4.4 (3-23) 0.349
6 Months 45 13.4 ± 3.3 (7-22) 43 12.5 ± 3.3 (3-18) 0.172
12 Months 48 13.4 ± 2.7 (7-18) 49 12.3 ± 3.5 (6-20) 0.103
12M % Δ 49% 54%
*Presented @ AGS 2009; Article under review by Ophthalmology, Journal of the American Academy of Ophthalmology
Post-op IOP Results
Ahmed, I. K. et al Non-Penetrating Schlemm’s Canaloplasty
Versus Trabeculectomy: A Head-to-Head Comparison*
Canaloplasty Trabeculectomy
Time point N Avg ± SD (Range) N Avg ± SD (Range)
p-value
(CP v Trab)
Baseline 50 3.6 ± 0.9 (2-6) 51 3.6 ± 1.1 (0-5) 0.971
1 Day 50 0.3 ± 0.8 (0-4) 46 0.3 ± 1.0 (0-4) 0.897
1 Week 49 0.3 ± 0.9 (0-4) 45 0.3 ± 0.9 (0-4) 0.935
1 Month 49 0.7 ± 1.2 (0-5) 47 0.6 ± 1.3 (0.4) 0.954
3 Months 41 0.9 ± 1.4 (0-5) 46 0.5 ± 1.1 (0-4) 0.247
6 Months 46 0.7 ± 1.3 (0-4) 45 0.4 ± 0.9 (0-3) 0.222
12 Months 48 0.6 ± 1.1 (0-4) 49 0.7 ± 1.3 (0-6) 0.839
12M % Δ 83% 82%
Post-op Rx Dependence
Ahmed, I. K. et al Non-Penetrating Schlemm’s Canaloplasty
Versus Trabeculectomy: A Head-to-Head Comparison
*Statistically significant
Post-op Adjunctive Procedures
Procedure Canaloplasty N, (%) Trabeculectomy N, (%) CP vs Trab p-value
Laser goniopuncture 17 (34) 1 (2) <0.001*
Laser suture lysis 1 (2) 13 (26) <0.001*
Bleb needling 1 (2) 6 (12) 0.027*
AC reformation with OVD 1 (2) 8 (16) 0.008*
Iris sweep 5 (10) 1 (2) 0.046*
Bleb re-suture of wound leak 0 1 (2) 0.161
Autologous blood injection 0 1 (2) 0.161
Laser iridotomy 1 (2) 0 0.161
Laser capsulotomy 0 1 (2) 0.161
Laser Iridozonulohyaloidotomy 0 1 (2) 0.161
Ahmed, I. K. et al Non-Penetrating Schlemm’s Canaloplasty
Versus Trabeculectomy: A Head-to-Head Comparison
Post-op Complications
Complication Canaloplasty N, (%) Trabeculectomy N, (%)
CP vs Trab
p-value
Choroidal effusion 1 (2) 14 (28) <0.001*
Transient hypotony (IOP ≤ 6mmHg for at least 2 visits
which resolved)
1 (2) 13 (26) <0.001*
Hyphema/Microhyphema 9 (18) 9 (18) 0.482
Shallow/flat AC 0 8 (16) 0.002*
Inadvertent bleb formation 11 (22) N/A --
Loss of >2 lines Snellen 1 (2) 8 (16) 0.008*
Bleb fibrosis 0 6 (12) 0.006*
IOP spike (IOP ≥ 10mmHg from one visit to next) 5 (10) 2 (4) 0.118
Wound leak 0 5 (10) 0.012*
Bleb encapsulation 0 4 (8) 0.022*
Cataract 3 (6) 3 (6) 0.490
Iris incarceration 3 (6) 2 (4) 0.317
Persistent hypotony (IOP ≤ 6mmHg for at least 2 visits
which did not resolve)
1 (2) 2 (4) 0.286
Localized descemet's detachment 2 (4) 0 0.080
Iris bombe 1 (2) 0 0.161
*Statistically significant
Sig
ht
Th
rea
ten
ing
Summary of U.S. Peer-Reviewed Evidence
• Ahmed, I. K. et al Non-Penetrating Schlemm’s Canaloplasty Versus Trabeculectomy: A Head-to-Head Comparison. (In final review - Ophthalmology , Journal of the American Academy of Ophthalmology)
• Lewis et al Canaloplasty - Three Year Results of Circumferential Viscodilation and Tensioning of Schlemm's Canal Using a Microcatheter for the Treatment of Open Angle Glaucoma J Cataract Refract Surg (JCRS-10-623R2)
• Koerber et al "Canaloplasty in One Eye Compared to Viscocanalostomy in the Contralateral Eye in Patients with Bilateral Open Angle Glaucoma” Journal of Glaucoma JOG-D-10-00140R1
• Fellman et al Canal Surgery in Adult Glaucoma - Current Opinion in Ophthalmology 2009, 20:116–121
• Lewis RA, et al. Canaloplasty – Circumferential viscodilation and tensioning of Schlemm's Canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults, Two-year interim clinical study results.
J Cataract Refract Surg 2009; 35:814-824.
• Shingleton B, et al. Circumferential viscodilation and tensioning of Schlemm's canal (canaloplasty) with temporal clear cornea Phacoemulsification cataract surgery for open-angle glaucoma and visually significant cataract, one-year results. J Cataract Refract Surg 2008; 34:433-440
• Lewis RA, et al. Canaloplasty: Circumferential viscodilation and tensioning of Schlemm’s canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults. J Cataract Refract Surg 2007; 33:1217-1226.
• Kearney J, et al. Circumferential viscodilation of Schlemm’s canal with a flexible microcannula during non-penetrating glaucoma surgery. Digital Journal of Ophthalmology 2006, available at: http://www.djo.harvard.edu/site.php?url=/physicians/oa/929.
Canaloplasty Procedure
• Benefits of Canaloplasty Surgery– Canaloplasty restores the natural outflow system of the eye
• No Bleb Necessary
– Canaloplasty effectively controls intraocular pressure• 3-Year data demonstrates sustained IOP control
• Significant reduction in Rx dependence for IOP management
• Eliminates significant sight threatening post-operative complications associated with trabeculectomy (hypotony and choroidal effusions)
• Virtually eliminates long-term complications/secondary interventions associated with trabeculectomy and Express™ trabs (needling bleb / bleb failures and endophthalmitis)
– Canaloplasty eliminates the ocular irritation and discomfort associated with an external bleb
Ocular Implant
Filtration Surgery
Laser Surgery
Medications
-Prostaglandins- Beta Blockers- Alpha Agonists- CAIs
LaserTrabeculoplasty Trabeculectomy Tube Shunts
Canaloplasty & Canaloplasty w/Cataract Removal:
Revising the POAG treatment algorithm
• > 300 surgeons trained in US;
>400 globally
• > 10,000 total procedures performed
globally
• Commercialized 1/2007 in U.S.
• Received FDA expanded labeling
for POAG in July 2008
• >3500 procedures performed
annually in U.S.
Canaloplasty
Canaloplasty/PhacoCanaloplasty:Patient Selection Criteria
• Those patients where trabeculectomy is expected to fail– Failed trabeculectomy in fellow eye
– Bleb related complicationin fellow eye
– Significant ocular surface disease unresponsive to medical treatment
– Ocular pemphagoid or Keloid former
• Those patients who have a potential threat for additional irreversible loss of vision– High myopia
– Advanced previous glaucoma damage where the visual field has been lost and visual fixation is split
– Ocular hypotony in fellow eye 2o to trabeculectomy
– Immunosuppression or Anti-coagulation
– Diabetic mellitus with early retinopathy or diabetic macular edema
• Those patients whose jobs and/or lifestyle cannot tolerate the post operative period of incapacity which often occurs following trabeculectomy
Environmental Assessment
• PhacoCanaloplasty delivers– Premium results that appeal to patient and surgeon
– Superior clinical results vs. existing/future technologies
• IOP = 13.1mmHg; @ 36 months
• Low post-op complication rate
• Rapid VA recovery vs. other cataract/glaucoma surgery options
• “Cataract like” post-op management
• Compatible with OD co-management
Why PhacoCanaloplasty™
• Patient Benefits of Adopting PhacoCanaloplasty– Effectively controls intraocular pressure
• Sustained IOP control – ~45% IOP reduction @ 3-Years
– Effectively reduces medication dependence• ~81% mean daily medication reduction @ 3-Years
• ~88% of patients require no medication for IOP management
– Low post-op complication rates • No Bleb Necessary
• Virtually eliminates significant sight threatening post-operative complications associated with trabeculectomy
• Significantly reduces long-term complications/secondary interventions associated with trabeculectomy
Why PhacoCanaloplasty™
• Practice Benefits of Adopting PhacoCanaloplasty– Low post-op complication rates
– “Cataract-like” post-op management
– Co-manageable via OD network
– Healthy, Happy patients
– Rapid VA recovery
• These patients are in your practice– Low/No patient acquisition cost
• No regulatory or reimbursement barriers to adoption– On-label indication for reduction of IOP in POAG
– CAT I code effective January 1st, 2011
– Covered by CMS and numerous major private insurance plans
Insert Video from Dr. Burchfield
Canaloplasty - Coverage
• CMS contractor coverage – All contractors cover Canaloplasty
• AMA CPT Panel granted CAT I code in February, 2010
• New CAT I CPT code will be effective 1/1/11 (CPT 66175)
• Progress being made with private insurers (AETNA, United Healthcare, Group Health)
• Reimbursement process support available via The Reimbursement Group (TRG)
2011 Canaloplasty Coverage* National CMS Contractor Payment Averages
Surgeon Fee $1,210.54
Ambulatory Surgery Center $1,675.21
Hospital Outpatient Department $2,978.11
*Amounts based on 2011 CMS RVU valuation published November, 2010 and 2010 conversion factor of $36.8729