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Doctors of Optometry | Course Notes

OD6 – 1CE Minimally Invasive Glaucoma Surgery Updates

Saturday, February 17, 2018 10:55 am – 11:50 am Plaza C – 2nd Fl

Presenter: Dr. Walt Whitley Walter Whitley, OD, MBA, FAAO serves as the Director of Optometric Services and Residency Program Supervisor at Virginia Eye Consultants in Norfolk, Virginia where his practice encompasses ocular surface disease, glaucoma, surgical co-management, clinical research and the supervision of an extensive referral network. He is a frequent lecturer and author on ocular disease, surgical comanagement and practice management topics. Dr. Whitley is the co-chief medical editor of CollaborativeEye and serves on the editorial boards for the Review of Optometry and Optometry Times. On the state level, Dr. Whitley is the current legislative chair for the Virginia Optometric Association and serves on the board of trustees. He was named the 2012 Young OD of the Year and the 2015 Keyperson of the Year for the Virginia Optometric Association.

Course Description

This course will provide attendees updates on minimally invasive glaucoma surgery and their role with or without cataract surgery. There have been numerous advances in ophthalmic surgery from laser cataract surgery, expanded presbyopic IOLs, advanced monofocal options and minimally invasive glaucoma procedures to provide our patients improved quality of vision and quality of life.

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Doctors of Optometry | Course Notes

NOTES:

1/24/2018

1

Minimally Invasive Glaucoma Surgery Updates

COPE#51843-GL

Walter O. Whitley, OD, MBA, FAAO

Director of Optometric Services - Virginia Eye Consultants

Affiliated Residency Supervisor – Pennsylvania College of Optometry

Disclosures - Walter O. Whitley, OD, MBA, FAAO has received consulting fees, honorarium or research funding from:

• Alcon

• Allergan

• Bausch and Lomb

• Biotissue

• Beaver-Visitec

• Carl Zeiss Meditec

• Glaukos

• Collaborative Eye – Co-Chief Medical Editor

• Review of Optometry – Contributing Editor

• Optometry Times – Editorial Advisory Board

• J&J Vision

• Ocusoft

• Science Based Health

• Shire

• Sun Pharmaceuticals

• TearLab Corporation

• Tearscience

Virginia Eye Consultants Tertiary Referral Eye Care Since 1963

• John D. Sheppard, MD, MMSc

• Stephen V. Scoper, MD

• David Salib, MD

• Elizabeth Yeu, MD

• Thomas J. Joly, MD, PhD

• Dayna M. Lago, MD

• Constance Okeke, MD, MSCE

• Jay Starling, MD

• Samantha Dewundara, MD

• Rohit Adyanthaya, MD

• Albert Cheung, MD

• Walter O. Whitley, OD, MBA, FAAO

• Cecelia Koetting, OD, FAAO

• Christopher Kruthoff, OD, FAAO – Pending

• Kelsey Butler, OD

Glaucoma Can Be Devastating

• Glaucoma is the second leading cause of blindness worldwide

• 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 blind1

1. 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.

Standard Treatment Options for Glaucoma

• Standard Treatment Options – Glaucoma Medications

– Laser Trabeculoplasty

– Invasive Surgery

• Trabeculectomy / Shunt

• Challenges – Long-term exposure to glaucoma

medication can cause corneal surface damage

– Non-compliance to medication

• More than 90% of patients are non-adherent, and nearly 50% stop taking their medications before 6 months1

– Less durability in laser treatments

– Risks associated with invasive surgery

– Cost burden to patients & system

1. Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:598-596

MIGS offers cataract patients with glaucoma a new option that can relieve eye pressure and may reduce reliance on medication

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Glaucoma Considerations

• When COMPLIANCE with drops is low

• When MEDICAL THERAPY FAILS

• When the PROGRESSION continues to WORSEN

• Treatment options

– More medications

– Laser therapy

– Surgical intervention

Patient Compliance and Dosing

• Literature review of 76 studies show – Compliance increases with

decreased dosage regimen and complexity1

– 79% compliance with QD regimen vs 51% for QID regimens (p=0.001)1

– Simpler, less-frequent dosing results in better compliance in a variety of therapeutic classes1

Co

mp

lian

ce

Dosing (Times/day)

1. Claxton et al. Clinical Therapeutics. 2001; 23:1296-1310.

Poor Adherence To Glaucoma Therapy

• By one year after first eye drop Rx, less than 50% are still filling prescription

• Among New Jersey Medicaid seniors, 25% never filled the second prescription

• Average number of treated days = 70

Reardon, Schwartz, Mozaffari. Clin Therap 2003;25:1172 Gurwitz et al. Am J Public Health 1993;83:711-6.

Nordstrom, Friedman, et al. Ophthalmology 2005

How Adherent are Glaucoma Patients with QD Medication?

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Case Presentation

• CC: vision cloudy OS>OD

• HPI: 68 yo WM presents for cataract evaluation with h/o controlled moderate OAG OS>OD

• Current meds: Levobunolol QD OU, Travatan qhs OU, Optive

• POHx: SLT OU 2007

• FamHx: mother with glaucoma

Case Presentation

• BCVA : 20/40 OD, 20/50 OS

• Present Rx: OD -0.50+1.00 x 075 OS -1.00 +0.75 x 110

• Keratometry: OD 43.67/44.00 x 055 OS 43.25/44.37 x 85

• IOP: OD 14, OS 14 (GAT)

• CCT: OD 527, OS 512

• Tmax: OD 20; OS 24

• Gonioscopy: OU open to scleral spur

• SLE 2+ NS OU

Case Presentation

• Dilated Fundus Exam:

• Optic Nerve: CDR OD: vert 0.55 horiz 0.5

(thin rim infer/sup)

CDR OS: vert 0.7 horiz 0.65

• Macula: OU Flat

• Vessels: WNL

• Periphery: WNL

Case Presentation

• Diagnosis: VS Cataract OU, Controlled Glaucoma

• Type of Glaucoma: open angle glaucoma

– Stage of Glaucoma: Moderate to severe OS>OD

– What is the target pressure? Low teens OU

– Is current treatment adequate? Yes

How Do Patients Feel about their Drop Usage?

• 54% stated their drops were expensive

• 72% were suffering from side effects

• 91% said medical therapy represented minimal/no inconvenience

• 82% were interested in learning about procedures that could reduce or possible eliminate their need for drops

VEC Internal Survey

68 glaucoma pts

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Concomitant Cataract & Glaucoma Patients - US

79.5% Cataract Only

20.5% Cataract +

Minimum of 1 OHT Med

3.5M US Cataract Procedures

Cataract Pts Cataract Pts w/ Glaucoma

718K

19 Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File. Baltimore, MD. 2007 .

Significant Treatment Opportunity

One in five Cataracts Eyes on OHT Medication

PN: 400-0122-2013-US Rev 0 Release Date: 04/26/2013

QUALITY-OF-LIFE ISSUES

• Improved quality of vision

• Less dependence on glasses / contact lenses

• Patients now

• More demanding

• More knowledgeable

• More sophisticated

• More informed

Patients looking for better outcomes

and quality of life - your practice can offer this!

Cataract and Glaucoma

• How to position the cataract operation in the management scheme of the patient’s glaucoma condition?

• Is it better to choose one sequence and type of surgery before the other, or to combine two procedures?

• STRESS the IMPORTANCE of visual fields PRIOR to cataract surgery

Who is an MIGS Candidate?

• Patients undergoing cataract surgery with mild to moderate open-angle glaucoma

• Need for better control of IOP

• Decrease risk of IOP fluctuations

• Compliance / adherence issues

• Avoid the risks of more invasive procedures

• Cost

• Side effects of medications

Diagnostic Testing for MIGS

• Manifest refraction and brightness acuity testing

• Careful slit lamp examination

– Presence of PXF or PDS??

• Full glaucoma workup

– Visual fields

– OCT

– Pachymetry

– Gonioscopy

“The new MIGS procedures are to trabeculectomy what phacoemulsification was to intracapsular cataract extraction or

LASIK was to RK.”

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Pathway for Trabecular Bypass Devices

• Shunting the canal

– Express MiniShunt (Alcon)

• Stenting the canal

– iStent (Glaukos Corp)

• Reduce aqueous production

– Endocyclophotocoagulation

• Dilating the canal

– Visco 360 / Ab-Interno Canaloplasty (ABIC)

• Divert aqueous into the suprachoroidal space

– Cypass Microshunt (Alcon)

• Divert aqueous into the subconjunctival space

– Xen Gen Stent (Allergan)

Gonio, Gonio, Gonio!!!

http://www.studyblue.com/notes/note/n/angle-structures/deck/1857080

MIGS ADVANTAGES Safer

Faster recovery Gentler

Combined with cataract sx

Less glaucoma meds Reduction of IOP

Less OR time

Avoids serious complications

Spares the conjunctiva

Decreased IOP fluctuations

No Bleb

Good for contact lens wearers

Fewer follow-up appointments

Are Patients Interested in MIGS?

• 28pts

• 79% did not mind instilling drops

• 64% did not mind wearing glasses

• 86% were interested in reducing their need for topical medications

Trabectome Video by Constance Okeke, MD Trabectome - IOP & Glaucoma Medication Use Outcome

Mean pre-op IOP

Mean IOPs with standard deviations at various intervals after surgery over 72 months

Mean pre-op medication use

Mean medication use after surgery over 72 months

IOP (mmHg)

Glaucoma Medication Use

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Istent Video Courtesy of Constance Okeke, MD, MSCE

US IDE Trial - Primary Endpoint

32

At 12 months, 72% of iStent® subjects with IOP ≤ 21 mm Hg without medication vs. 50% with cataract surgery alone (P<0.001)

0

20

40

60

80

100

Cataract Surgery iStent

Percent of Patients With IOP ≤21 mm Hg Without Medication Use

50%

72%

®

Caution: Investigational device limited by Federal (U.S.) law to investigational use only.

iStent + Phaco Ferguson, Berdahl, Schweitzer et. al

Retrospective Case Series

n=107 at 2 years

Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of trabecular microbypass stents with phacoemulsification in patients with open-angle glaucoma

and cataract. Clinical Ophthalmology 2016:10 1767-1773

iStent + Phaco Ferguson, Berdahl, Schweitzer et. Al. Retrospective Case

Series

IOP reduction higher with higher baseline IOP

Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of trabecular microbypass stents with phacoemulsification in patients with open-angle glaucoma

and cataract. Clinical Ophthalmology 2016:10 1767-1773

Our Solution Portfolio

Transformational Shift to Micro-Scale Injectable Therapy

RESTORE FLOW FURTHER ENHANCE FLOW COMBINATION DRUG & FLOW

iStent Inject, iStent Supra and iDose are not approved by the FDA. iStent Inject and iStent Supra are currently being evaluated in IDE clinical trials; iDose is currently being evaluated in Phase II IND clinical trial.

iStent Inject®

Injectable 2-stent therapy

for combo-cataract and

standalone procedures

iStent®

Used in

combination with

cataract surgery

iStent Supra®

Designed to access

secondary outflow

pathway

iDoseTM

Targeted injectable drug-

delivery implant;

sustained drug therapy

Injectable Flow Platform Injectable Drug Delivery

Precision solutions for complete range of glaucoma disease states & progression

The iStent is approved in the European Union and certain other international markets for use either in combination with cataract surgery or as a standalone procedure in phakic and pseudophakic eyes. In the United States, the iStent is indicated for use in

conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication.

ICE, ICE Baby Video Courtesy of John Berdahl, MD and Justin Schweitzer, OD

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The XEN® Gel Stent

• A glaucoma implant designed to reduce

intraocular pressure in eyes suffering from

refractory glaucoma1

• 6-mm length, 45-micron inner diameter—

about the length of an eyelash1,2

• Composed of gelatin, cross-linked with

glutaraldehyde1

1. XEN® Directions for Use; 2. Vogt et al. In: Blume-Peytavi et al, eds. Hair Growth and Disorders. 2008.

The XEN® Procedure

1. XEN® Directions for Use.

In the clinical investigation, standard ophthalmic surgery techniques, viscoelastic, and mitomycin C (0.2 mg/mL) were used before injection.1

Established Effectiveness at 12 Months

1. XEN® Directions for Use.

76.3% (95% CI = 65.8%, 86.8%); using observed

data and failures for subjects with glaucoma-related secondary surgical intervention and multiple

imputations for missing data (N = 65).1

-6.4 ± 1.1 (95% CI = -8.7, -4.2); using observed data and

worst within-eye IOP for subjects with glaucoma-related secondary surgical intervention and multiple imputations for

missing data (N = 65).1

Established Effectiveness at 12 Months

1. XEN® Directions for Use.

Baseline 25.1 ( ± 3.7) mm Hg;

12-month

15.9 (± 5.2) mm Hg.1

Baseline 3.5 (± 1.0) medications; 12-

month average

1.7 (± 1.5) medications.1

Cypass Microstent

• Ab-interno insertion into the supraciliary space

• Fenestrated microstent made of biocompatible polyimide material

• Magnetic resonance safe

CyPass® Micro-Stent: Enhanced Aqueous Outflow The supraciliary space has a negative pressure

gradient that drives aqueous outflow and reduction of intraocular pressure1

The uveoscleral pathway bypasses Schlemm’s canal and collector channels, which may be atrophic in glaucoma patients2

The CyPass® Micro-Stent utilizes the same outflow pathway as first line prostaglandin analogues3

1. Saheb H, Ianchulev T, Ahmed I. Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open-angle glaucoma. Br

J Ophthalmol. 2012;98:19–23. 2. Fellman. Episcleral venous fluid wave correlates with the type and extent of canal-based surgery. AGS 2014 abstract.

3. Weinreb RN, Toris CB, Gabelt BT, et al. Effects of prostaglandins on the aqueous humor outflow pathways. Surv Ophthalmol. 2002;47(Suppl 1):S53–S64.

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Clinical Data Delivers superior, long-term IOP-lowering efficacy

Two-year COMPASS Trial is the largest MIGS randomized controlled trial completed to date Landmark FDA study with two-year follow-up on >500 patients with baseline/terminal washout

• 72.5% of

eyes

achieved a

≥20%

reduction in

unmedicated

diurnal IOP

at 2 years*

• 61.2% of eyes

maintained an

unmedicated

diurnal IOP

range between

6 and 18

mmHg

at 24 months

(a 41%

increase)*

*Prospective, randomized, multicenter clinical trial in patients (n=505) with open-angle glaucoma undergoing cataract surgery randomized to microstent (n=374) or phacoemulsification (n=131).

Primary outcome measure was unmedicated diurnal IOP reduction at 24 months versus cataract surgery alone at baseline. Secondary outcomes measures included mean change in 24 month

DIOP from baseline and 24 month unmedicated mean IOP (between 6 mmHg to 18 mmHg) versus cataract surgery alone. Medication use at 24 months was also analyzed. The primary and

secondary effectiveness analyses were performed using intent to treat (ITT) population.

And There’s More

• Canaloplasty

• Glaukos Istent Supra

• Glaukos Istent Inject

• Allergan Bimatoprost SR

• Ocular Therapeutix SR Travaprost

Solx Gold Shunt

Kahook Dual Blade

How To Choose Which Procedure?

• Discuss with your surgeon which procedures they perform?

• Based on Stage and Severity

– Moderate to advanced cases – Trabectome, Xen

– Early to Moderate – iStent, Cypass

– Multiple iStents off label??

Post-operative Cataract IOP Spikes in Glaucoma Patients

• Adequate control prior to surgery

– Additional drops

– SLT prior

• Consideration of combined glaucoma and cataract procedures

• Aggressive treatment perioperatively

– Diamox at the end of the case, early post-op

• Closer follow-up post-operatively

Express the Benefits of MIGS to Your Patients

• You play in an important role in the patient’s decision about MIGs and they trust you and want your guidance

• May be covered by Medicare and most private insurance companies

• Implanted at the same time of cataract surgery with an excellent overall safety profile

• Proven outcomes

• Proven to reduce IOP and may reduce

glaucoma medication usage

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Patient Education

▸ Practical tips for the Doctor Patient Discussion

▸ Expectations – Under-promise but over-deliver

▸What is my goal??

▸ Is this realistic to achieve?

▸ Presenting the Option of MIGS to the Patient

▸ Sink drain analogy

Where to Start?

▸ See a glaucoma patient and ask yourself:

▸ Are they stable?

▸ Are they with a visually significant cataract?

▸ Are they non-compliant and progressing?

▸ Have they had SLT?

Gonio, Gonio, Gonio

▸ Perfect your gonioscopy skills in the clinic

▸ Avoid the common pitfalls – not performing enough gonioscopy

▸ Look for secondary signs and contra-indications

▸ Financial bottom line

Educate and Refer

▸ Tell your MIGS/cataract or MIGS alone candidate that there are options

▸ Give them hope of the possibility of less invasive ways to gain better control and/or less drops

▸ Remember to undersell, so can over-deliver

▸ Be MIGS general so can have flexibility when evaluating

Constance Okeke, MD, MSCE

• More MIGS Success Secrets Revealed in this book

THANK YOU WWHITLEY@VEC2020.COM