Surgical therapy in glaucoma 2019 - coavision.org Symposium... · Advances in Glaucoma Surgical...

1

Advances in Glaucoma Surgical Therapy

J. JAMES THIMONS, O.D.,FAAO

OPHTHALMIC CONSULTANTS OF CONNECTICUT

FAIRFIELD, CT

8/7/2019 1

Trends

Streamlining of existing procedures◦ Express Minishunt

◦ Use of Fibrin glue to reduce suturing

◦ Alternative tube placement techniques

Less invasive procedures◦ Canaloplasty

◦ Trabectome

◦ Gold Shunt

◦ Glaukos shunt

◦ ECP

Considerations

Impact of subsequent or prior procedures

Realistic expectations on intraocular pressure control and continuing medical therapy

Expected and tolerable side effects and complications

Trabecular Bypass Flow HypothesisZhou et al introduced a hypothesis that evaluated the effect of a theoretical channel created through the TM (a trabecular bypass) on the facility of outflow and IOP.◦ The authors established equations that govern the pressure and circumferential flow in Schlemm's canal

◦ Two types of bypasses permitting either unidirectional or bidirectional flow were incorporated to derive the facility of outflow and the reduced IOP.

Results:◦ In normal healthy eyes, the facility of outflow increased by 13% and 26% in the presence of a unidirectional and bidirectional bypass, respectively.

◦ Circumferential flow was significant only in the immediate quadrant to the bypass.

◦ In either case, the higher the baseline IOP, the greater the reduction.

Many glaucoma therapies focus on rerouting the aqueous humor around the conventional outflow pathway.◦ topical medications, filtration surgery, and implantation of glaucoma drainage devices

In response to high complication rates and/or lack of sustained efficacy of the available surgical therapies for glaucoma, a novel trabecular micro‐bypass stent (the iStent Trabecular Micro‐Bypass, Glaukos® Corporation) has been developed that can restore fully developed natural physiologic outflow in glaucomatous eyes.◦ Implantation into Schlemm’s canal allows aqueous humor to drain directly from the anterior chamber into Schlemm’s canal.

◦ The ab‐interno stent implantation procedure is straightforward, micro‐invasive, does not require a filtering bleb, and spares the conjunctiva, thus preserving all future therapeutic and surgical options for glaucoma patient care.

In this presentation, we will evaluate the available theoretical, in vitro, and clinical evidence that supports this new treatment modality.

Theoretical EvidenceGrant demonstrated in 1963 that 75% of resistance to aqueous outflow occurs in the trabecular meshwork (TM).1

Grant also found that the locus of abnormal (and normal) resistance to out‐flow of aqueous humor in primary open‐angle glaucoma(s) is at, or just proximal to, the inner wall of Schlemm's canal.

Johnson et al confirmed that the inner wall of TM is the site of greatest outflow resistance in the normal eye, as well as the increased outflow resistance in the glaucomatous eye.2

It follows that reducing trabecular meshwork resistance may be an effective way

to restore physiologic outflow

2

Current OAGTreatment Algorithm1

Drug therapy has been the standard of care in glaucoma for over 30 years.

Approximately 50% of patients are taking 2 or more medications increasing the disease management challenges of glaucoma and financial burden to patients and the healthcare system.2,3

1AAO Preferred Practice Pattern; Primary Open Angle Glaucoma. AAO committee 2003.2Stein J, Newman-Casey P, Niziol L, et. al. Association between the use of glaucoma medications and mortality. Arch Ophthalmol. 2010;128(2):235-245.3Market Scope Quarterly Glaucoma Report, 4th quarter 2013.

Add More Rx Therapy

Prescription Therapy(30 – 90 Days)

Invasive SurgeryTrabeculectomy

Switch orAdd Rx Therapy

Laser Trabeculoplasty

Newly Diagnosed POAG Patient

Top MIG”s in 2018Glaukos iStent

Xen Glaucoma Implant

CyPass

Canaloplasty

Trabectome

Trabeculectomywith Express Minishunt Express Mini‐shunt Advantages

Reduces operating time

Eyes appear to be quieter earlier in post‐op course

No iridectomy

Uniform opening

If hypotony occurs, tends to be less severe

8/7/2019 10

Express Mini‐shunt DisadvantagesNeeds some suturing as in trabeculectomy

Dependent on patient healing

Anti‐metabolites still routinely used

Patient has bleb

Hypotony possible

8/7/2019 11

Reasons to use the ExpressSimplify procedure

Shorten surgery time

Decrease tissue manipulation

Eliminate need for iridectomy

Decrease chance of ostium obstruction

Regulate flow in short term

Create less short term inflammation

3

Arguments Against

Expense

Foreign body

Metal in eye

Corneal contact

Patient SelectionSame as trabeculectomy

May work better in high risk patients

ICE patients

NV patients

Shallow/synechiae

Resident Surgery with Ex‐PRESS

No difference ◦ postoperative IOP

◦ proportional decrease in IOP

Ex‐PRESS group

◦ Significantly less medication to control IOP at 3 months

◦ No difference at 6 months or 1 year (P≥0.28)

◦More Ex‐PRESS patients had good IOP control without meds at 3 (P=0.057) and 6 months (P=0.076)

◦ No difference was found in the rates of sight‐threatening complications (P≥0.22)

8/7/2019Seider MI. Resident-performed Ex-PRESS Shunt Implantation Versus Trabeculectomy J Glaucoma. 2011 Apr 25. [Epub ahead of print]

Retrospective Case Series

Final percent IOP lowering was similar

Moorefields Bleb Grading System◦ Less vascularity and height but more diffuse area associated with the Ex‐PRESS blebs

Fewer cases of early postoperative hypotony and hyphema

Quicker visual recovery ◦ The Ex‐PRESS group required fewer postoperative visits compared with the trabeculectomy group (P < .000).

8/7/2019

Good TJ. Assessment of bleb morphologic features and postoperative outcomes after Ex-PRESSdrainage device implantation versus trabeculectomy. Am J Ophthalmol. 2011 Mar;151(3):507-13.e1. Epub 2011 Jan 13.

Ex‐PRESS in Prior Operated Eyes

Success complete in 60(60%) and qualified in 24 (24%) eyes

Mean IOP◦ 27.7 ± 9.2 mm Hg with 2.73 ± 1.1

◦ 14.02 ± 5.1 mm Hg with 0.72 ± 1.06 drugs (p < 0.0001)

Failure◦ Uncontrolled IOP (11%)

◦ bleb needling (4%)

◦ persistent hypotony (1%)

8/7/2019

Lankaranian D. Intermediate-term results of the Ex-PRESS(TM) miniature glaucoma implant under a scleral flap in previously operated eyes. Clin Experiment Ophthalmol. 2010 Dec 22.

5 year study Ex‐press vs Trabeculoectomy

EX‐PRESS more effective without medication◦ At year 1 12.8% of patients required IOP meds after EX‐PRESS implantation vs 35.9% after trabeculectomy

◦ At year 5 (41% versus 53.9%)

Responder rate was higher with EX‐PRESS

Time to failure was longer

Surgical interventions for complications were fewer after EX‐PRESS implantation

deJong et al. Five-year extension of a clinical trial comparing the EX-PRESS glaucomafiltration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-33. Epub 2011 Apr 29.

4

Results

The mean preoperative IOP was 23.7 ± 9.3 and the mean postoperative IOP on the last follow up day was 10.4 ± 4.5 (p<0.001) over a mean follow up period of 199 days (range 29‐608).

The mean number of medications used preoperatively was 2.83 ± 1.1 and postoperatively was 0.023 ± 0.1 (p<0.001).

Complications as hypotony, bleb leak, choroidal detachment, and transient hyphema were detected.

OutcomesStudies overall suggest compared to trabeculectomy‐◦ Less severe hypotony

◦ Less bleeding

◦ Less inflammation

◦ Faster visual recovery

◦ Similar long term IOP control

ECP/TCP ECP Advantages

Quick procedure, especially in cataract setting

Titratable

Can be done with outflow procedures

Hypotony unlikely

ECP DisadvantagesSome learning curve to avoid complications

Inflammation possible

IOP does not decrease rapidly

Difficult to do in some eyes

iStent® Indication for Use(US Label)

28

The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication

5

Distribution of Aqueous Veins(Among 409 Aqueous Veins)

29

De Vries 1947

Aqueous Veins

Aqueous Vein

Recipient EpiscleralVein

iStent® Surgical ProcedureiStent® rails are seated against scleral wall of Schlemm’s canal

iStent® Snorkel sits parallel to the iris plane

iStent® Surgery

Inject a viscoelastic into the anterior chamber. Use a miotic if desired to help open the angle.

Photo courtesy of Tom Samuelson, MD

US IDE Trial –Primary Endpoint

®

Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE, for the US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology 2011; 118:459–467.

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

Percent of Patients with IOP ≤21 mm HgWithout Medication Use

6

US IDE Trial –Secondary Endpoint

35

Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE, for the US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology 2011; 118:459–467.

®

• At 12 months, 66% of iStent® subjects with ≥ 20% IOP reduction without medication vs. 48% with cataract surgery alone (P=0.003)

Percent of Patients with IOP ≤20% Reduction in IOP Without Medication Use

iStent® Pivotal US IDE TrialSignificant IOP and Medication Reductions

At 12 months:

>30% reduction from baseline IOP◦ Similar outcome validated

adherence to study design (manage to threshold IOP)

For iStent subjects, IOP reduction with significantly less medication (P=0.001) ◦ 15% of iStent vs. 35% cataract

group on medication

15%

35%

Samuelson TW, Katz LJ, Wells JM, et al. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118:459-467 .

16.8±4.0 12.6±1.8

Results – All Eyes (n=104 eyes)Preop and 2-Year IOP and Medication

All Eyes with 2-Year Follow-up

2.3±1.0

1.0±1.2

Control and Reduced Medications Two Years Following Cataract Surgery (M. Gallardo)

Mark Gallardo, MD El Paso Eye Surgeons El Paso, TX. Presented at ASCRS 2017, Los Angeles, CA.

• At 2 years, 95% of eyes had an IOP ≤ 15 mmHg, 100% ≤ 18 mmHg

• 50% were on 0 medications, compared to 6% preop

Retrospective Case Series (Ferguson, Berdahl)

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

P<0.0001

• Large series (n=107)

• At 2 years, mean IOP reduction was 22% with a 56% reduction in mean medications

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

Retrospective Case Series (Ferguson, Berdahl)

• IOP reduction higher with higher baseline IOP

• Patients with pre-op IOP ≥ 26 achieved mean IOP reduction of 11.28 mm Hg

36%

Neuhann TH. Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results. J Cataract Refract Surg 2015; 41:2664–2671.

iStent® + Cataract Surgery Through 3 Years (T) . Neuhann

At 3 years mean IOP was < 15 mm Hg with an 86% reduction in medications

• Consecutive series of 62 eyes: decision to implant based on patient desire to reduce topical meds and intent to offer surgical treatment with favorable safety profile

7

Outcomes Through 48 Months After MIGS with 2 Trabecular Bypass Stents in Eyes with OAG Not Controlled on 1 MedicationERIC D. DONNENFELD, MD

OPHTHALMIC CONSULTANTS OF LONG ISLAND

CLINICAL PROFESSOR OF OPHTHALMOLOGY NYU

TRUSTEE DARTMOUTH MEDICAL SCHOOL

DEMOGRAPHICS AND PREOPERATIVE CHARACTERISTICS

39 subjects enrolled; 30 completed Month 48Gender (n)

22 male / 17 female

Race 100% Caucasian

Age (Mean ± SD)66.7 ± 10.0 years (Range 50-

90)

Lens Status (n) 35 phakic / 4 pseudophakic

Preoperative C/D Ratio (Mean ± SD) 0.7 ± 0.2

Preoperative Medicated IOP (Mean ± SD) 20.6 ± 2.0 mmHg

Preoperative Unmedicated (Post-washout) IOP (Mean ± SD) 24.1 ± 1.4 mmHg

# of Preoperative MedicationsAll subjects were on 1 med

Type of Medications (%, n)Beta-blocker

Carbonic anhydrase inhibitorProstaglandin analogue

Alpha agonist

56.4% (n=22)25.6% (n =10)15.4% (n =6)2.6% (n=1)

preop IOP after med washout

Mea

n ±

SD

IO

P (

mm

Hg

)

N 39 39 39 39 39 39 39 39 30 29 29 29

*Excludes data after secondary surgery

Mean IOP ≤ 15.2 mmHg through M48 87% of eyes did not require ocular

hypotensive meds post-implantation

MEAN IOP OVER TIME POSTOPERATIVE IOP%

of

eye

s

* M36 and M48 excludes data after secondary surgery

Primary and secondary endpoints at 12 months were achieved by 92% of eyes

At month 48, both endpoints achieved by 90% of eyes

FAVORABLE SAFETY PROFILE

All subjects underwent uncomplicated implantation of 2 iStent devices

No device-related adverse events were observed and no subjects experienced hypotony

AEs mostly involved BCVA loss due to progression of pre-existing cataract

BCVA, C/D ratio, VF, and central corneal thickness generally stable over time

EventN=39

n (%)

BCVA loss due to progression of pre-existing cataract (1 of 4 subjects had cat surgery)

4 (10.3%)

Death 2 (5.1%)

Cataract progression 1 (2.6%)

Early post-op hyphema (same subject with initial cataract)

1 (2.6%)

Initial cataract (same subject with hyphema) 1 (2.6%)

Proliferative diabetic retinopathy 1 (2.6%)

Scar from age-related macular degeneration 1 (2.6%)

Secondary surgical intervention (cataract surgery)

1 (2.6%)

Total Adverse Events 12 (30.8%)

Total Subjects with Adverse Events 10 (25.6%)

Co‐Management CodingiStent implantation is described by CPT code 0191T

◦ 0191T is a Category III (new technology) code

◦ 0191T has no assigned Relative Value Units or Global Period

◦ There is no postop co‐management fee for any T‐code

◦ Medicare carriers will not recognize modifiers ‐54 & ‐55 for 0191T

Modifiers ‐54 & ‐55 can still be appended to CPT code 66984

◦ Modifier ‐54: surgical care only

◦ Modifier ‐55: all/part of outpatient postoperative care

◦ Surgeon MUST initiate the notification to Medicare by using modifier ‐54 with the claim

◦ In localities where Medicare has a higher physician payment for 0191T than for 66984 and where 66984 is reduced by 50%, payment for 66984‐550 will be reduced by 50%

8

8/7/2019 NOECKER 47 8/7/2019 NOECKER 48

8/7/2019 NOECKER 49 8/7/2019 NOECKER 50

Ivantis /Hydrus MicrostentThe FDA’s approval was based on the 24‐month results from the HORIZON trial, the largest MIGS study to date.

The study included 556 mild to moderate glaucoma patients randomly assigned to undergo cataract surgery with or without the microstent.

More than 77% of patients with the implant exhibited a significant decline in unmedicated IOP, compared with 58% of the control group.

On average, the device reduced IOP by 7.5 mmHg, approximately 2.3 mmHg more than the cataract surgery‐only group.

Hydrus Microstent

9

Hydrus Microstent Hydrus Microstent

Hydrus Microstent Overview

Hydrus Microstent Cypass: Suprachoroidal Stent

Cypass: Suprachoroidal Stent

10

CyPass

Initial Clinical Experience With the CyPassMicro‐Stent: Safety and Surgical Outcomes of a Novel SupraciliaryMicro‐stent.

Mean±SD follow‐up was 294±121 days.

Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP‐lowering medications was 2.0±1.1.

Cohort 1 ( >21 mmHg) showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage;

Cohort 2 ( < 21 mmHg) demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline).

Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes.

Two subjects demonsrated mild transient hyphema, and

None exhibited prolonged inflammation, persistent hypotony, or hypotonymaculopathy

Alcon Voluntarily Withdraws CyPass Micro-Stent For Surgical Glaucoma From MarketAugust 29, 2018, 01:21:00 AM EDT By RTT News

•

Shutterstock photo(RTTNews.com) - Alcon, the eye care unit of Novartis ( NVS ), announced Wednesday an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. Alcon also advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon.The move is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The COMPASS-XT study was designed to collect safety data on the subjects who participated in the COMPASS study for an additional three years, with analysis of the completed data set at five years post-surgery. At five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.The US Food and Drug Administration or FDA approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study.The COMPASS study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone.At two years post- surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.Stephen Lane, Chief Medical Officer, Alcon, said, "Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future."The voluntary market withdrawal applies to all versions of the CyPass Micro- Stent.

Preliminary ASCRS CyPassWithdrawal Consensus StatementASCRS CyPass Withdrawal Task Force

Leads: Douglas Rhee, MD; Nathan Radcliffe, MD; and Francis Mah, MD

Glaucoma: Leon Herndon, MD; Marlene Moster, MD; Thomas Samuelson, MD; Steven Vold, MD

Cornea: Ken Beckman, MD, FACS; John Berdahl, MD; Marjan Farid, MD; Preeya Gupta, MD

Purpose

On August 29th, 2018, Alcon voluntarily withdrew the CyPass device from the market due to safety concerns reportedly based on 5‐year data from the COMPASS XT study which indicate a higher rate of endothelial cell loss (ECL) in patients receiving cataract extraction (CE) plus CyPass versus CE alone. This ASCRS task force was convened to develop an understanding of the data and a preliminary consensus on monitoring and treatment options.

8/7/2019

CyPass Recall

8/7/2019

CyPass Recall

8/7/2019 NOECKER 64

11

CyPass Recall

8/7/2019 NOECKER 65

‐1% % 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 11% 12% 13% 14% 15%

Endothelial Cell Loss Rate per Year

CyPass, 3 rings visible, n=6

Materials

Permanent, collagen derived, gelatin implant, 6 mm long

Implant is soft, compressible, and flexible when hydrated

Material and design mitigate traditional implant issues◦ Absence of Migration◦ Tissue‐conforming◦ Non‐inflammatory

Methods

Pre‐loaded, disposable Inserter

Handles like IOL inserter

Straightforward procedure

With or without cataract surgery

Removable and/or repeatable

Mild, Moderate & Refractory Glaucoma

© COPYRIGHT 2012. AQUESYS AND XEN GLAUCOMA IMPLANT ARE REGISTERED TRADEMARKS OF AQUESYS, INC. *AQUESYS IS NOT APPROVED FOR SALE IN THE UNITED STATES. IDE APPROVED INVESTIGATIVE STATUS. CONFIDENTIAL

XEN Glaucoma Implant™ Materials and Methods

Allergan:XENAb Interno Sub‐Conjunctival Drainage

Surgical “Gold Standard” IOP reduction in minimally invasively procedure

Clinically proven outflow pathway

Bypasses all potential outflow obstructions

Conjunctiva sparing: alternative surgical options remain

Single implant delivers desired effectiveness

© COPYRIGHT 2012. AQUESYS AND XEN GLAUCOMA IMPLANT ARE REGISTERED TRADEMARKS OF AQUESYS, INC. *AQUESYS IS NOT APPROVED FOR SALE IN THE UNITED STATES. IDE APPROVED INVESTIGATIVE STATUS. CONFIDENTIAL

XEN Glaucoma Implant™ Mechanism of Action

Gelatin Material is Tissue Conforming

POAG Only

*Mean preoperative IOP is best medicated. Patients were not washed out prior to surgery.

Summed patients: primary, combined and refractory

Initial Clinical Results: From A Multi‐Center Study on Early Moderate Stage Population

* Washout IOP calculated at +30% from medicated

N = 62Pre op

IOP 21.8 ± 3.5 mmHg Meds 2.612M(N=37)

18M(N=14)

24M(N=8)

Mean IOP mmHgStd. Dev.

15.73.5

14.72.9

14.92.8

Mean Post Op MedsMean Meds % Reduction

0.9‐65%

1.0‐61%

1.0‐61%

% IOP reduction from Best RxFrom Washout IOP*

‐28%‐45%

‐33%‐48%

‐32%‐47%

% <21 mmHg and/or ‐20%

100% 100% 100%


100% 86% 100%

% <16 mmHgand/or ‐30%

84% 86% 63%

12

Initial Clinical Results: From A Multi‐Center Study on Severe/Refractory Population

* Washout IOP calculated at +30% from medicated

N = 39Pre op

IOP 22.6 ± 4.3 mmHg Meds 3.112M(N=29)

18M(N=12)

24M(N=12)

Mean IOP mmHgStd. Dev.

13.94.6

12.93.4

13.74.7

Mean Post Op MedsMean Meds % Reduction

1.1‐66%

1.1‐66%

1.3‐57%

% IOP reduction from Best RxFrom Washout IOP*

‐38%‐52%

‐43%‐55%

‐39%‐53%


100% 100% 100%


97% 100% 100%

% <16 mmHgand/or ‐30%

79% 92% 83%

Canaloplasty

72

Similar to Interventional Cardiology

Canaloplasty: akin to Angioplasty“Canaloplasty is hydraulic angioplasty of Schlemm’s Canal with implantation of a suture stent”

Ultrasound imaginglocate the target

Microcatheter cannulate the canal, inject viscoelastic, place suture

Ultrasound imaging examine results

Angiography

locate the obstruction

PTCA/Stent Catheteradvance to expand and stent the vascular lesion

Angiography assess the results

How does Canaloplasty work?Restores normal outflow physiology by

internal filtration of aqueous

By stretching the trabecular meshwork

Thereby increasing the permeability of the trabecular meshwork

Preventing collapse of Schlemm’s Canal, thereby

Preventing blockage of outflow channels

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 BasicsViscoelastic injection ◦ Dilates the canal◦ May increase permeability of the trabecular meshwork ◦ Dilates the ostia of the collector channels

Multipurpose 10‐0 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

13

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

Canaloplasty, Suture Tension

Histology (H&E staining) Close-up of suture

Distension of Trabecular Meshwork Histology (ex-vivo)

UBM Imaging

Rejuvenate the outflow system in patients with glaucoma

Restore a healthy IOP◦ Without penetrating the eye◦ Without creating a bleb or fistula◦ Without undue postoperative care

Preoperative, occluded canal

Dilation of Schlemm’s canal

Effects of Suture TensionEx-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)

Canaloplasty, Suture Tension

Grade 0- No distension Grade 1 – Good distension Grade 2 – Maximum desired distension

Distension of Trabecular Meshwork visualized with UltraSound Imaging

Canaloplasty

8/7/2019 NOECKER 82

IOP All Enrolled Eyes

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

Baseline 1D 1W 1M 3M 6M 12M 18M 24M

IOP

[m

m H

g]

14

Canaloplasty Multicenter StudyProspective 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, exfoliative glaucoma, or POAG with narrow but not occludable angles after laser iridectomy

Exclusion criteria◦ More than 2 laser trabeculoplasty

◦ Chronic uveitis

◦ PAS or history of angle closure

Results16 Centers

184 eyes◦ 161 (88.0%) Successful Dilation◦ 154 (84.0%) Successful Suture Placement◦ 46 (25.0%) Combined with Cataract Surgery

◦ 2 (0.9%) Failed to Complete Procedure◦ 11 (6.0%) Converted to Trabeculectomy/Tube Shunt◦ 2 (1.0%) Surgically Revised◦ 46 (25%) Combined Canaloplasty Cataract

Lost to Follow‐up◦ 4 (2.0%) Reported deceased◦ 1 ( 0.5%) Patient withdrew from study◦ 6 (3.0%) Lost to Follow‐up

Baseline 3 Months 6 Months 12 Months 18 Months 24 Months

IOP Avg 24.1 16.0 15.7 15.5 15.9 15.7

IOP SD 5.0 5.0 4.0 4.0 4.0 3.5

N 184 155 149 132 114 92

Mean IOP drop 35%

IOP All Enrolled Eyes

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0


IOP

[m

m H

g]

15.7

Canaloplasty Combined with Phacoemulsification Cataract Surgery

A subset of eyes in the prospective, international multi‐center study of canaloplasty to treat open angle glaucoma also presented with visually significant cataract and were treated with combined surgery.


IOP Avg 24.4 14.3 12.9 14.0 14.0 14.0

IOP SD 5.7 3.6 3.0 4.1 4.1 3.9

N 50 41 43 36 36 26

IOP Avg 24.3 16.6 16.9 16.6 16.2 16.4

IOP SD 4.9 5.2 4.5 5.2 4.0 3.2

N 147 126 108 108 88 66

Combined Procedure ResultsIOP Combined Surgery vs Canaloplasty Alone

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0


IOP [m

m H

g]

Combined Canaloplasty Alone

Combined

Mean IOP Drop 43%

Canaloplasty

Mean IOP Drop 33%

Combined Procedure ResultsMedication Results

-0.5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5


# M

edic

atio

ns

Combined Canaloplaslty Alone


Meds/Pt 1.5 0.1 0.1 0.2 0.2 0.2

Meds SD 1.0 0.3 0.4 0.4 0.4 0.4

N 50 41 43 36 26 26

Meds/Pt 2.0 0.4 0.5 0.6 0.6 0.8

Meds SD 0.9 0.7 0.7 0.8 0.8 0.9

N 146 126 118 108 88 66

Combined

Mean Meds Drop: 87%

Canaloplasty Alone

Mean Meds Drop: 61.4%

0.8

0.2

15

Combined Procedure Results

Average visual acuity improved by approximately 2 lines (0.18 LogMAR) at 24 months follow-up.

VA Results

0.00

0.20

0.40

0.60

0.80

1.00

Baseline 3M 6M 12M 18M 24M

BC

VA

[L

og

MA

R]

Baseline 6 Months 12 Months 18 Months 24 Months

Avg 0.38 0.21 0.21 .16 .20

SD 0.34 .35 .34 .17 .28

N 54 46 39 29 28

Trabectome

8/7/2019 NOECKER 90

Trabectome AdvantagesQuick procedure

Hypotony unlikely

Ab interno approach eliminates dependence on dissection

Can do in many types of glaucoma

8/7/2019 NOECKER 91

Trabectome DisadvantagesNeed to be able to visualize angle

Bleeding common

Very low IOPs unlikely

Cannot do in eyes with canaloplasty

8/7/2019 NOECKER 92

gof Trabectome surgeryYildrum,Y etal Int. Ophthalmology 2016

A total of 70 eyes followed up with a diagnosis of open‐angle glaucoma (OAG) and undertaken trabectome surgery were included in the study.

The criteria of success were accepted as an IOP value ≤21 mmHg or ≥30 % reduction in IOP and no need for a second operation.

Mean IOP was decreased by 38 % from a preoperative value of 28.77 ± 5.34 to 17.62 ± 2.81 mmHg at the end of 18 months.

Likewise, mean drug usage was decreased by 48 % from a preoperative value of 3.3 ± 1.01 to 1.7 ± 1.16 at the end of 18 months. Both decreases were statistically significant (p < 0.05).

Postoperative success rates were:

1. 82.8 % in the 6th month



4. 470 % in the 18th month.

Most common complication observed was intraoperative reflux hemorrhage and no serious complication was observed.

SOLX GMS Plus+Gold Micro Shunt

IOP Reduction Without a Bleb

16

External Device Comparison

GMS Plus+ +

Consistency

9 o’clock position

Blebless Drainage Gold Shunt

98

Shunt in Proper Position UBM of Gold Shunt

17

Telemetrics: The Future of Medicine

Launch Point Technologies

IOL Tonometry

http://www.launchpnt.com/portfolio/biomedical/intraocular‐pressure‐sensor

There’s an App for That

Nature Medicine 2014◦Yossi Mandel, Bar‐Ilan/ Stephen Quake, Stanford

◦Utilizes a variable float tube in the IOL

◦Smart Phone app allows acquisition of data

◦ In development

There’s an App for That

Surgical therapy in glaucoma 2019 - coavision.org Symposium... · Advances in Glaucoma Surgical...

Documents

Transcript of Surgical therapy in glaucoma 2019 - coavision.org Symposium... · Advances in Glaucoma Surgical...