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Evidence Based Case Studies: Minimally Invasive Glaucoma Surgery

Walter O. Whitley, OD, MBA, FAAO

Director of Optometric Services - Virginia Eye Consultants

Affiliated Residency Supervisor – Pennsylvania College of Optometry

Disclosures

• Alcon

• Allergan

• Bausch and Lomb

• Biotissue

• Beaver-Visitec

• Publications

– Advanced Ocular Care – Co-Chief Medical Editor

– Review of Optometry – Editorial Advisory Board, Monthly Columnist

– Optometry Times – Editorial Advisory Board

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

• Ocusoft

• Science Based Health

• Shire

• Sun Pharma

• TearLab Corporation

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

• Esther Chang, MD

• Jay Starling, MD

• Samantha Dewundara, MD

• Walter O. Whitley, OD, MBA, FAAO

• Cecelia Koetting, OD, FAAO

• Christopher Kuc, OD, FAAO

• Leanna Olennikov, OD

• Christopher Kruthoff, OD

• Jillian Janes, OD

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.

How Adherent are Glaucoma Patients with QD Medication?

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How Do Patients Feel about their Drop Usage?

• 68 glaucoma pts

• 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

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 (Applanation)

• 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

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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

What Do You Get When You Add?

+

Great Candidate for MIGS/PHACO

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

16 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

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

LASIK was to RK.”

Minimally Invasive Glaucoma Surgery (MIGS)

Ab Externo

• Canaloplasty

• Stegmann Canal Expander

• Gold Microshunt

Ab Interno

• Glaukos iStent

• Neomedix Trabectome

• Excimer laser trabeculotomy

• Hydrus Microstent

• Cypass Microstent***

• Kahook Dual Blade

• Xen Gel Stent***

Trabecular Bypass Devices

• These procedures facilitate the flow of aqueous into Schlemm’s canal by: – Shunting the canal

• Express MiniShunt (Alcon)

– Stenting the canal • iStent (Glaukos Corp)

– Divert aqueous into the suprachoroidal space • Cypass Microshunt (Alcon)

– Divert aqueous into the subconjunctival space • Xen Gen Stent (Allergan)

PN: 400-0135-2013-US Rev. 0 Release Date: 08/27/2013

Trabectome

Photo accessed from http://www.downstate.edu/ophthalmology/patient-info/patient-info-glaucoma.html on 11/4/16

Anatomical Considerations

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

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Trabectome 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

Istent

• Titanium, L-shaped, trabecular microbypass stent

• Snorkle through TM

• Use Gonio to place it

US IDE Trial - Primary Endpoint

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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.

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

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The XEN® Procedure Creates a Low-Lying, Ab-interno Bleb in Refractory Glaucoma1

• Example of elevated, cystic bleb2

1. Dapena and Ros. Revista Española de Glaucoma e Hipertensión Ocular. 2015; 2. Errico et al. Clin Ophthalmol. 2011.

Ab-Externo Bleb

Suture wounds2

Dissected tenon

capsule layer2

Diffuse, mildly

elevated bleb2

Ab-Interno Bleb

• Low-lying and diffuse1

Controlled flow through lumen restriction1

Tenon capsule

adhesions intact1

Undistrubed, low-lying

drainage space1

XEN® Ab-interno Bleb Examples

Post-op day 1 Post-op month 12 Post-op month 18

Actual patient. Images courtesy of: Francisco Millan, MD, and Vanessa Vera, MD.

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

Why Target the Uveoscleral Outflow Pathway?

• Uveoscleral outflow: considered pressure independent and contributes up to 50% of total aqueous outflow.2

• Aqueous percolates through the ciliary body and exits into the suprachoroidal space, primarily through the sclera and choroidal blood vessels.3

• The highest point of resistance is the ciliary body, which is thought to regulate this drainage.3

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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

unmedicate

d

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.

Demonstrated safety as compared to cataract surgery alone

Intraoperative adverse events

A total of 25 intraoperative were reported in 20 out of 374 CyPass subjects (5.3%)

Incidence of postoperative adverse events

39% of CyPass® Micro-Stent patients

36% of Control patients

Postoperative AEs were generally manageable and transient and did not negatively affect functional outcomes such as visual acuity

Adverse Event, % CyPass® Micro-

Stent + Phaco

n=374

Phaco only

n=131

Blepharitis 1.9% 0.0%

Corneal abrasion 1.9% 1.5%

Corneal edema 3.5% 1.5%

Conjunctivitis 1.1% 2.3%

Cyclodialysis cleft 1.9% 0.0%

Hyphema, intraoperative 2.7% 0.0%

Hypotony IOP <6 mmHg 2.9% 0.0%

IOL complication 1.1% 0.0%

IOP elevation, ≥10 mmHg above baseline 4.3% 2.3%

Iritis 8.6% 3.8%

Loss of BCVA; ≥10 letters read 8.8% 15.3%

Maculopathy/retinopathy

(cystoid, diabetic, other) 3.2% 3.1%

Microstent obstruction 2.1% N/A

Subconjunctival hemorrhage 2.1% 0.8%

Surgical reintervention 5.1% 5.3%

Worsening of ocular symptoms 5.6% 3.1%

Visual field loss progression 6.7% 9.9%

Safety Population, events occurring at rate of 1.0% or greater

And There’s More

Ab interno canaloplasty

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

– Early to Moderate – iStent, xen, Cypass

– ? multiple iStents off label

– iStent inject shows promise

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 THANK YOU WWHITLEY@VEC2020.COM