Canaloplasty Overview 3 Year Clinical Results Burchfield111510

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