Transcript MIGS: Minimally Invasive Glaucoma Surgery

MIGS:
Minimally Invasive Glaucoma
Surgery
Ilya Rozenbaum, MD
Matossian Eye Associates
June 2014
Disclosures
Speaker/Consultant:
Allergan
Alcon
Human Cost of Glaucoma
Glaucoma is the second leading cause of blindness worldwide
•Global estimates of glaucoma cases exceeded 60M in 2010 and are estimated to
grow to 78M by 2020
•Bilateral blindness is occurring at an alarming 7.5% of OAG cases globally,
growing from 4.4M to 6M patients between 2010 and 2020
•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 blind
•
1.Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 2006 March; 90(3): 262–267.
2.Congdon NG, De Jong PT, Klein BE et al.Glaucoma as a cause of blindness in the United States. American Glaucoma
Society Annual Meeting 2003; abstract.
3.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.
Problems with Glaucoma Meds

Future surgery success rate may be lower

Quality of life

Cost

Compliance

Side effects:

Death from beta-blockers

Fatal aplastic anemia (CAIs)

Severe allergic reactions

Retinal detachment (pilocarpine)

Irritation, redness, etc
Glaucoma: Surgical Disease
CIGTS:

Glaucomatous optic disc progression
is higher in patients on medical
treatment than surgical patients
Five-year Follow-up Optic Disc Findings of the Collaborative Initial Glaucoma
Treatment Study. Am J Ophthalmol 2009;147:717–724.
Glaucoma: Surgical Disease
Surgical options

Trabeculectomy or ExPress

Tube shunts
Ahmed,
Baerveldt, Molteno

Laser trabeculoplasty

Trans-scleral laser

Canaloplasty

MIGS
Glaucoma: Surgical Disease
Trabeculectomy 2014
Advantages
 Still the gold standard surgery
 No device needed - available, cost-effective
 Can achieve low IOPs

Disadvantages
 Less standardized (hasn’t significantly
changed in 50 years)
 Complications in up to 40%
 Failure in up to 50% at 5 years
 Cataract in 50% at 5 years

Gedde SJ, Schiffman JC, Feuer WJ, et al. Am J Ophthalmol. 2012;153:789-803 e2.
Glaucoma: Surgical Disease
TVT study: complications
Early postoperative complications:


21% (tube) and 37% (trab)
Late postoperative complications (up to 5 years after surgery):


34% (tube) and 36% (trab)
Cataract surgery:


54% of phakic tube eyes and 43% of phakic trab eyes
Reoperation for surgical complications:


22% (tube) and 18% (trab)
Gedde SJ, Herndon LW, Brandt JD, et al. Am J Ophthalmol. 2012;153:804-814 e1.
Bleb Leak
Evaluation must be done with high
concentration fluorescein

Cascading darker/clear fluid with fluorescent
edges is a leak

Endophthalmitis
Tube Erosion
Plate Erosion
Ideal glaucoma surgery?

As effective as trabeculectomy but safer

Reproducible/Predictable

No bleb

Easy to perform

Less post-operative effort

Cost-effective
Cataract surgery vs. controls from OHTS:
16.5% reduction in IOP sustained for 36 months
Mansberger SL, et al. Reduction in intraocular pressure after cataract extraction: the
ocular hypertension treatment study. Ophthalmology. 2012 Sep;119:1826-31.
Concomitant Cataract & Glaucoma
(US)
1 in 5 Cataract Eyes on OHT Medication
Centers for Medicare and Medicaid Services. 2002 – 2007.
Medicare Standard Analytical File. Baltimore, MD. 2007
.
SITA-Standard HVF 24-2
MIGS
Minimally
Invasive
Glaucoma
Surgery
Minimally Invasive Glaucoma Surgery
(MIGS)

Ab interno microincisional approach

Minimally traumatic to the target tissue

Safe and (at least modest) IOP reduction


Rapid recovery with minimal impact on the
patient’s quality of life
Typically indicated for mild to moderate POAG
Curr Opin Ophthalmol 2012, 23:96–104
iStent Trabecular Micro-Bypass Stent
(Glaucos)
1 mm x 0.33 mm
Snorkel: 0.25 mm x 120 µm (bore
diameter)
Snorkel
0.3 mm
Weight: 60 µg
Lumen 120 µm
Self-Trephining Tip
Surgical grade nonferromagnetic
titanium
Heparin-coated to promote selfpriming and facilitate outflow
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada
iStent
iStent: Indication

In conjunction with
cataract surgery

Mild to moderate openangle glaucoma

Currently treated with
ocular hypotensive
medication
For patients with
OAG/OHTN
who also need
cataract surgery
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada
iStent
Done with cataract surgery
iStent: Mechanism


Designed to improve
aqueous outflow thru the
natural physiologic
pathway
Creates a bypass thru
trabecular meshwork to
Schlemm’s canal
iStent® is FDA approved in the U.S., C.E. marked in the E.U., and has Medical Device Approval in Canada
iStent
iStent Surgical Video
At 12 months:
68% of iStent subjects
with IOP ≤ 21 mm Hg
without medication vs.
50% with cataract
surgery alone (p=0.004)
Percent of Eyes With IOP ≤ 21 mm Hg Without Medication Use
100
80
60
40
20
0
Ophthalmology. 2011 Mar;118(3):459-67.
Cataract Surgery
iStent
Percent of Patients on Ocular Hypotensive Medication
At 12 months:
15% of iStent vs.
100
35% cataract group on
medication (p=0.001)
50
0
Cataract Surgery
Ophthalmology. 2011 Mar;118(3):459-67.
iStent
Complication
iStent + Cataract
Cataract
Surgery N = 111 Surgery N = 122
Anticipated early postoperative event
14(13%)
15(12%)
Stent obstruction by iris, vitreous, fibrous overgrowth,
fibrin, blood, and so forth
4(4%)
0(0%)
Posterior capsular opacification
3(3%)
8(7%)
Stent malposition
3(3%)
0(0%)
Subconjunctival hemorrhage
2(2%)
2(2%)
Elevated IOP, other
2(2%)
1(1%)
Epiretinal membrane
2(2%)
1(1%)
Iris atrophy
2(2%)
0(0%)
Blurry vision or visual disturbance
1(1%)
6(5%)
Iritis
1(1%)
6(5%)
Dry eye
1(1%)
2(2%)
Elevated IOP requiring treatment with oral or intravenous
medications or with surgical intervention
1(1%)
2(2%)
Macular edema
1(1%)
2(2%)
Foreign body sensation
0(0%)
3(2%)
Allergic conjunctivitis
0(0%)
2(2%)
Mild pain
0(0%)
2(2%)
Rebound inflammation from tapering steroids
0(0%)
2(2%)
iStent
Lower IOP
Fewer medications
No bleb!!
What's in the Pipeline?
2 “iStent inject” vs
latanoprost/timolol
Endoscopic Cyclo Photocoagulation
(ECP) - EndoOptiks
ECP
ECP




ECP is the selective ablation of aqueous
producing ciliary processes via an ab
interno approach
Inhibits aqueous production, therefore
reducing IOP and medication use
ECP has been performed globally for over
12 years
More than 50,000 patients treated to date
ECP Indications

Mild to moderate glaucoma (any type)
or

Refractory glaucoma (after multiple failed
glaucoma surgeries)
Phaco-ECP: Combined ECP and Cataract
Surgery
Lindfield D, Ritchie RW, Griffith MF. BMJ Open 2012
ECP COLLABORATIVE STUDY GROUP
SAFETY STUDY: COMPLICATIONS
5824 PATIENTS
IOP Spike
Hemorrhage
Serous Choroidal Effusion
IOL Dislocation
CME
RD
Massive Choroidal Hemorrhage
Hypotony or Phthisis
NLP Vision
Cataract
Acute Graft Rejection
Chronic Graft Rejection
Chronic Inflammation
Flat AC
Endophthalmitis
Diplopia
Wound Leak
Bleb Complications
14.5%
3.8%
0.36%
0.36%
1.03%
0.27%
0.09%
0.12%
0.12%
24.5%
5.3%
0
0
0
0
0
0
0
Trabectome (Neomedix)
Trabectome
Ablates and removes
a strip of trabecular
meshwork and reestablishes access
to the eye’s natural
drainage pathway
38
Review of 115 Trabectome patients vs. 102
trab-MMC patients.
Success rates (IOP<21 mmHg or >20%
reduction) at 2 years:
22.4% for trabectome and 76.1% for trab
(P=0.001)
Ophthalmology. 2012 Jan;119(1):36-42.
Trabectome had 100% hyphema POD #1, plus
4.3% other complications, compared to 35.3%
complication rate for trabeculectomy (P=.001)
Ophthalmology. 2012 Jan;119(1):36-42.
Trabectome
Side Effects and Complications

Descemet’s injury

Ciliary body injury

Reflux bleeding, hyphema

Zonule injury
The ICE Procedure
Cataract Extraction
iStent
ECP
What is ICE?
16.5% IOP lowering
at 3 years
Mansberger. Ophthal. 2012;
119:1826-31.
33% IOP lowering
with cataract
extraction
Samuelson. Ophthal.
2011;118:459-67.
43% IOP lowering with cataract extraction
Kahook; J Glaucoma. 2007;16:527-30.
Mechanisms of ICE?
? Angle widening
? Decreased
aqueous
production
Increased
trabecular
outdlow
Decreased aqueous production
Preoperative vs. Month 3-6 IOP Reduction
% of eyes
(n=48)
% of eyes
Preoperative vs. Month 3-6 IOP
What about Cost?
Projected cost savings at 6 years in $:
1 drop
2 drops
3 drops
iStent
-20.77
1272.55
2124.71
ECP
779.23
2072.55
2924.71
Trabectome
279.23
1572.55
2424.71
Iordanous Y et al. J Glaucoma. 2014 Feb;23(2):e112-8.
Summary




Appreciation for the risks and complications
associated with traditional glaucoma surgery
has ignited the MIGS revolution
MIGS, combined with cataract surgery,
provides safe new options for IOP reduction
Lots of options, data is forthcoming
Trabeculectomy and tube shunt surgery for
significant IOP reduction
Thank you!
Hopewell office 609-882-8833
Doylestown office 215-230-9200
Cell 646-263-3045