ASCRS ♦ ASOA Symposium & Congress

Technicians & Nurses Program

May 6-10, 2016 – New Orleans

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MIGS: Micro-Invasive Glaucoma Surgery

The Old and the New

Rahul T. Pandit, M.D.

Associate Professor of Clinical Ophthalmology, Weill Cornell MedicineBlanton Eye Institute, Houston Methodist Hospital

May 8, 2016

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• I have no financial disclosures.

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Anterior Segment Anatomy

https://faculty.washington.edu/chudler/gif/glaucl.gif3

What is MIGS?

• Originally known as Minimally Invasive Glaucoma Surgery

• Encompasses “a group of IOP-lowering surgeries that avoid disruption of the conjunctiva by leveraging an ab interno approach through a clear cornea incision.”

• Usually combined with cataract surgery

• Minimal collateral damage.

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What is MIGS?

• Micro-Invasive Glaucoma Surgery– term attributed to Dr. Ike Ahmed in 2009

• According to Dr. Ahmed, the 5 cardinal features of MIGS:– an ab interno procedure– biocompatibility with minimal disruption of normal

anatomy/physiology

– very high safety profile– efficacy of IOP lowering

– and quick recovery time

• The ab interno procedure uses small incisions without making conjunctival incisions.

• Not just about incision size– minimal alternation of normal anatomy and physiology of the eye

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Why MIGS?

• Easily combined with phacoemulsification

• May further lower IOP over phacoemulsification

alone

• May reduce glaucoma medications

• Simpler follow-up

• Lower severe complication rates compared to

trabeculectomy

• Does not preclude subsequent surgery (spares

conjunctiva)

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MIGS Dilemma

• MIGS is usually performed at the time of cataract

surgery

• How do we know if IOP reduction in our patient is

due to cataract surgery alone or the concurrent

MIGS procedure?

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Reduction in IOP after

Cataract Extraction (OHTS*)

• Phaco lowered IOP for at

least 36 months

• 16.5% average decrease in

IOP with phaco

• 39.7% of eyes had postoperative IOP ≥ 20%

below preoperative IOP.

• Greater reduction in

postoperative IOP occurred

in eyes with the highest

preoperative IOP.

*Mansberger SL, Gordon MO, Jampel H, Bhorade A, Brandt JD, Wilson B, Kass MA; Ocular Hypertension Treatment Study Group. Reduction in intraocular pressure after cataract extraction: the Ocular Hypertension Treatment Study. Ophthalmology 2012 Sep;119(9):1826-31.

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Theories for IOP Reduction

With Phaco

• Increase in anterior chamber depth and angle opening– supported by significant peer-

reviewed publications

• Biochemical alterations to stress from surgery– ultrasound causing release of

interleukin 1-alpha from glaucomatous (but not normal) trabecular meshwork endothelial cells

• Schuman JS; data on cadaver eyes

– cytokine release from surgery causing trabecular meshwork changes resulting in increased outflow

http://www.medrounds.org/glaucoma-

guide/uploaded_images/xfig3-2-799969.jpg.pagespeed.ic.JQrLpr9MOx.jpg

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Modalities of IOP

Reduction

• Decrease aqueous

production

• Increase aqueous

outflow

– Traditional pathway

(trabecular meshwork &

Schlemm’s canal)

– Alternative pathway

(suprachoroidal space)

– Through sclera into

subconjunctival space http://www.slideshare.net/RohitRao2/physiology-of-aqueous-humor

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Outline

• Endocyclophotocoagulation (ECP)

• Trabectome (ab interno trabeculotomy)

• iStent

• Supraciliary and other shunts

• Other

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ECP ECP ECP ECP EndocyclophotocoagulationEndocyclophotocoagulationEndocyclophotocoagulationEndocyclophotocoagulation

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Endocyclophotocoagulation

• Ciliary processes behind iris produce aqueous humor

• Destruction of ciliary processes results in decrease in aqueous production, thereby lowering intraocular pressure (IOP)

• vs. CCP: cyclophotocoagulation– CCP is external with retrobulbar block

– titration of effect is difficult—easy to overtreat and cause hypotony

– induces significant inflammation due to larger amount of tissue destruction

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Laser endoscope

• 17,000 pixel image

• High Resolution

• 140 Degree FOV

• 19 Gauge

• Straight & Curved Tips

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E2 Laser and

Endoscopy System

• 810nm Diode Laser, 1.2 Watt

Output

• 175 or 300 watt Xenon Light

• High Resolution Video Camera15

Fiber Optic Imaging

Bundles

3000 pixel image

20 gauge

6000 pixel image

23 gauge

10,000 pixel image

20 gauge

17,000 pixel image

19 gauge

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Phaco-ECP vs

Phaco Alone*

• 707 Patients

– 626 Randomized to Phaco-ECP

Group

– 81 Randomized to Phaco Alone

• 5 Surgeons

• VA, IOP, medications, and

complications were followed

• Mean follow-up was 3.2 years

(0.5 to 5.8 years)

*Berke SJ. Endolaser Cyclophotocoagulation in Glaucoma Management.

Techniques in Ophthalmology 2006; 4(2): 74-81.17

Phaco-ECP vs

Phaco Alone*

• At three years, phacoalone had no impact on medication levels and the group showed a 4% increase in IOP.

• ECP/Phaco patients reduced the number of medications used by 58% PLUS averaged a 16% reduction in IOP from pre-op levels.

• saved approximately $1,500 per year on glaucoma meds compared to those who had phaco only.

Mean IOP Over TimemmHg

1.53 Meds

1.20 Meds

0.65 Meds

1.20 Meds

*Berke SJ. Endolaser Cyclophotocoagulation in Glaucoma Management.

Techniques in Ophthalmology 2006; 4(2): 74-81.

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1 Site vs 2 Site ECP

• 2 Site ECP is more effective than 1 Site without

increasing complications

– Retrospective analysis

– Nonrandomized

– 15 patients in the 1-site group

– 25 patients in the 2-site group.

• 6 months of follow-up

– 2-site vs. 1-site group mean IOP 13.0 vs 16.0 mm Hg

– 2-site vs. 1-site group mean medications 0.52 vs. 1.93

Kahook MY, Lathrop KL, Noecker RJ. One site versus two site endoscopic cyclophotocoagulation.

Journal of Glaucoma 2007;16:527-530 MY, Lathrop KL, Noecker RJ. One site versus two site endoscopic cyclophotocoagulation. Journal of Glaucoma 2007;16:527-530 19

5824 PATIENTSIOP Spike 14.5%Hemorrhage 3.8%Serous Choroidal Effusion 0.36%IOL Dislocation 0.36%

CME 1.03%RD 0.27%Massive Choroidal Hemorrhage 0.09%Hypotony or Phthisis 0.12%NLP Vision 0.12%Cataract 24.5%Acute Graft Rejection 5.3%Chronic Graft Rejection 0Chronic Inflammation 0Flat AC 0Endophthalmitis 0Diplopia 0Wound Leak 0Bleb Complications 0

ECP Collaborative Study

Group Safety Study

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ECP and Glaucoma Glaucoma Glaucoma Glaucoma

Medication Cost AnalysisMedication Cost AnalysisMedication Cost AnalysisMedication Cost AnalysisPre-Op Post-Op Savings/Loss

Phaco-ECP monthly patient cost $220.08 $94.78 $125.30

Phaco-ECP annual patient cost $2,640.92 $1,137.35 $1,503.57

Phaco Alone monthly patient cost $144.45 $160.28 ($15.83)

Phaco Alone annual patient cost $1,733.40 $1,923.36 ($189.96)

Estimated US annual savings* $846,765,000

*2.5 million cataract procedures annually. 20% of cataract surgery patients concurrently treated with glaucoma medications.

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TrabectomeTrabectomeTrabectomeTrabectome

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Trabectome Surgical

System

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Device Features

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Handpiece in Surgical

Position Inside Eye

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Trabectome Unique

Function

Trabectome un-roofing Schlemm’s Canal directly

connects anterior chamber to collector channels

SEM of Trabecular Meshwork and

Schlemm’s Canal

Schlemm’s CanalSchlemm’s Canal Trabecular MeshworkTrabecular Meshwork

Exposed CCExposed CC

Exposed outer wall of SCExposed outer wall of SC

BEFORE AFTER

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Trabectome and Phaco vs.

Phaco

• Prospective, Non-Randomized, Controlled,

Comparative Analysis

• Consecutive patients, 1 surgeon

• 2 Groups:

– Trabectome and PCE (N=114)

– PCE alone (N=145)

• Matched pair analysis

Francis B.A. Trabectome Combined with

Phacoemulsification versus Phacoemulsification Alone:

A Prospective, Non-Randomized Controlled Surgical Trial. Clinical & Surgical Ophthalmology 28:10, 2010 27

Trabectome and PCE vs. PCE Alone –

Matched Pairs (IOP, AGE) N=10

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Trabectome and PCE vs. PCE Alone –

Matched Pairs IOP Trends

PCE Only

Baseline for both groups

Trabectome+PCE

Matched Pairs IOP Trends

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Trabectome and PCE vs.

PCE Alone – Survival Curve

PCE alone 45%

Trabectome+PCE 80%

Success definition:IOP ≥20% reduction of pre-op

IOP <21 mmHgNo Secondary Surgery

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Trabectome and Phaco vs.

Trabeculectomy and Phaco

• Prospective, non-randomized, comparative trial

• Consecutive patients, 1 surgeon

• 2 Groups:

– Trabectome + PCE (N=89)

– Trabeculectomy + PCE (N=23)

Francis B.A., Winarko J. Combined Trabectome and

Cataract Surgery versus Combined Trabeculectomy

and Cataract Surgery in Open-Angle Glaucoma. Clinical & Surgical Ophthalmology 29:2/3, 2011 31

IOP Comparison

Trabectome + PCE Trabeculectomy + PCE

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Medication Use

Comparison

Trabectome + PCE Trabeculectomy + PCE

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Survival Curve Comparison

Trabeculectomy+PCE 83%

Trabectome+PCE 95%

Success definition:IOP ≥20% reduction of pre-op

and IOP <21 mmHgand No Secondary Surgery

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Trabectome vs.Trabectome

and Phaco

• Consecutive patients of three (3) surgeons

• 2 Groups:

– Trabectome (N=538)

– Trabectome and PCE (N=290)

Mosaed S, Rhee DJ, Filippopoulos T, Tseng H,

Deokule S, Weinreb RN. Experience With

Trabectome in Adult Open Angle Glaucoma Patients Followed for At Least One Year. Clinical & Surgical

Ophthalmology 28:8, 2010.35

IOP

Trabectome and PCE Trabectome Alone

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Medication Use

Trabectome and PCE Trabectome Alone

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Trabectome vs. Trabectome

with PCE: Survival Curve

Trabectome alone

64.9%

Trabectome and PCE

86.9%

Success definition:No additional glaucoma surgery and

IOP reduction ≥20% from pre-op and IOP <21 mmHglast 2 follow ups, after 3 months post-op

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The New Glaucoma Triple?

From American Academy of Ophthalmology ONE Editor’s Choice.

http://www.aao.org/clinical-video/glaucoma-triple-procedure. Rahul T. Pandit, 39

iStentiStentiStentiStent

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iStent – 2 Year Data

• Prospective randomized controlled multicenter clinical trial (29 US sites)

• Eyes with mild to moderate glaucoma

• Unmedicated intraocular pressure (IOP) between 22 mmHg and 36 mmHg

• Randomly assigned to have cataract surgery with iStent trabecular micro-bypass stent implantation (stent group) or cataract surgery alone (control group).

• Followed for 24 months postoperatively.

Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year

follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45.

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iStent – 2 Year Data

• At 24 months, more patients had IOP ≤ 21 mm Hg without ocular hypotensive medications in the stent group vs. controls (P=.036).

• Stent Group Control Group

IOP at 12 Months 17.0 mm Hg 17.1 ± 2.9 mm

IOP at 24 Months 17.0 ± 3.1 17.8 ± 3.3

• Ocular hypotensive medication was statistically significantly lower in the stent group at 12 months (not significant at 24 months)

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Using multiple iStents in

cataract patients

• Comparative case series of 53 eyes with OAG (47

patients)

– 28 with implantation of 2 stents

– 25 with implantation of 3 stents

• Follow-up through 1 year.

• Efficacy measures were intraocular pressure (IOP)

and topical ocular hypotensive medication use.

• Safety assessment included complications and

corrected distance visual acuity (CDVA).

Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD, Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD. J Cataract Refractive Surg. 2012 (Nov) Volume 38, Issue 11 , Pages 1911-1917.

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Using multiple iStents in

cataract patients

• Mean IOP 14.3 (significant reduction, p<0.001)

• Target IOP achieved in a significantly higher proportion of eyes at 1 year versus preoperatively (77% versus 43%; P<.001).

• 83% of eyes had decrease in topical medications at 1 year, with a 74% decrease in the mean number of medications (2.7 to 0.7) at 1 year (P<.001).

Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD, Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD. J Cataract Refractive Surg. 2012 (Nov) Volume 38, Issue 11 , Pages 1911-1917.

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Using multiple iStents in

cataract patients

• Mean IOP (mm Hg) at each visit through 12 months stratified by number of stents. Bars represent the standard deviation (IOP = intraocular pressure).

Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD, Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD. J Cataract Refractive Surg. 2012 (Nov) Volume 38, Issue 11 , Pages 1911-1917.

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Using multiple iStents in

cataract patients

• 3-stent group

on significantly fewer topical

medications

than 2-stent

group at 1 year

(0.4 versus 1.0; P=.04).

(∗P=.009; φP=.04).

Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD, Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD. J Cataract Refractive Surg. 2012 (Nov) Volume 38, Issue 11 , Pages 1911-1917.

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Theoretic Potential Cost

Savings of MIGS

• At 6 years

– Trabectome offered a cumulative cost savings of

$279.23, $1572.55, and $2424.71 per patient versus

monodrug, bidrug, and tridrug therapy, respectively.

– iStent offered a cumulative cost difference of -$20.77,

$1272.55, and $2124.71 per patient when comparing versus monodrug, bidrug, and tridrug

therapy, respectively.

– ECP yielded a cost savings of $779.23, $2072.55, and

$2924.71 per patient versus monodrug, bidrug, and

tridrug therapy, respectively.

Iordanous Y, Kent JS, Hutnik CM, Malvankar-Mehta MS. Projected Cost Comparison of Trabectome, iStent, and Endoscopic Cyclophotocoagulation Versus Glaucoma Medication in the Ontario Health Insurance Plan. J Glaucoma. 2014 Feb;23(2):e112-8.

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Investigational Investigational Investigational Investigational

MicroMicroMicroMicro----StentsStentsStentsStents

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Supra-ciliary and

Other Micro-Stents

• Various devices under investigation– CyPass Micro-Stent (Transcend Medical; Menlo Park, CA)

– Gold Micro Shunt Plus (GMS+) (SOLX Inc.; Waltham, MA)

– XEN Gel stent (Aquesys/Allergan)

– iStent Supra (Glaukos Corporation; Laguna Hills, CA)

• Bypasses normal trabecular meshwork outflow and Schlemm’scanal

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM390338.pdf52

CyPass Micro-Stent

Transcend Medical• Biocompatible, nonresorbable polyimide tube

– 6.3 mm in length, 510-µm external diameter

– placed through 1.5 mm incision, drains into the suprachoroidal space

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CyCLE multicenter

European trial

• 136 patients, 2-year follow-up, 15 European sites

• Safety study

• All patients had open-angle glaucoma and underwent phacoemulsification and implantation of the micro-stent.

• Patients were divided into two cohorts:– Cohort 1 (51 patients) had

uncontrolled IOP of 21 mm Hg or greater at baseline.

– Cohort 2 (85 patients) had controlled IOP of less than 21 mm Hg. 54

CyCLE multicenter

European trial

• Cohort 1

– mean IOP decreased from 25.5 mmHg baseline to between 16.9 and 15.8 mmHg at 24 months.

– medications decreased from a mean of 2.2 to 1.

• Cohort 2– stable IOP, from 16.4 mmHg at baseline to a low of 15.2 at 6

months and 16.1 at 24 months.

– medications decreased from a mean of 2 to 1.1.

Received CE Mark

Currently available in select locations in Europe.

Compass clinical trial in U.S.

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SOLX Gold Shunt

• Multi-center clinical trial

• Currently approved in Canada and some European

countries

Key features: • No bleb (ie, suprachoroidal

drainage)• Highly biocompatible

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SOLX Gold Shunt

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XEN Gel Stent

(ab interno subconjunctival)

• AqueSys XEN Gel Stent has CE mark

• Minimally invasive subconjunctival approach bypasses all potential aqueous outflow obstructions

• Soft gelatin material minimizes complications related to synthetic materials

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XEN Gel Stent

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Other Investigational Procedures

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Deep Wave

Trabeculoplasty

• Developed by Malik

Kahook, M.D. (U of

Colorado, Denver)

• Reduced IOP by 26%

in an initial clinical

investigation

• Clinical Trial

terminated (funding)

From Ophthalmology Times 2014 Jan 15. Image courtesy of OcuTherix

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Deep Wave

Trabeculoplasty

• Non-invasive, focal, mechanical oscillation to the limbalregion at a low amplitude and frequency– Targets the trabecular meshwork to restore outflow function.

– Conforming nose cone ensures proper placement of the oscillating tip on the limbus and limits scleral deflection.

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Summary

• Features of MIGS

– ab interno

– avoids disruption of conjunctiva

– often combined with cataract surgery

– minimal alteration of normal ocular anatomy/physiology

– low risk

– quick recovery time

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Summary

• Various MIGS surgery modalities

– Decrease production of aqueous

– Increase aqueous outflow

• through traditional pathway (trabecular meshwork / Schlemm’s

canal)

• through alternative pathway (suprachoroidal space)

• through sclera into subconjunctival space

• Similar skill sets required for all except ECP

• Geared toward comprehensive anterior segment

surgeons

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QUESTIONS