Download Richard L. Lindstrom, MD Adjunct Professor Emeritus: University of

Richard L. Lindstrom, MD
Adjunct Professor Emeritus:
University of Minnesota,
Department of
Ophthalmology
Founder and Attending
Surgeon: Minnesota Eye
Consultants
Brooks J. Poley, MD
Thomas W. Samuelson, MD
Attending Surgeon:
Minnesota Eye Consultants
Adjunct Associate Professor,
University of Minnesota
Acufocus, Inc. C,I,R
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*C=Consultant *I= Investor * MD= Medical Director
*R= Royalty
THIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR DEVICES
“This presentation represents the speaker’s professional experience.”
“Products/procedures not approved by the FDA and off label use of FDA approved products/procedures may be discussed.”
Cataract Surgery alone is the best currently
available procedure for the comprehensive
ophthalmologist in most patients with both
cataract and glaucoma
(or ocular hypertension)
A.  5 million Americans have cataracts.
B.  2.0 million Americans are visually impaired
from glaucoma.
C.  3.2 million Americans have cataract surgery
each year.
D.  10-15%of the patients have glaucoma
(or ocular hypertension)
E.  So…. 300,000 to 500,000 times per year in
the USA the Ophthalmic Surgeon must
decide how to treat the patient with
combined cataract and glaucoma/ocular
hypertension.
A.  Safety:
1. Incredible advances in the surgical
management of cataract.
B.  Efficacy:
1. Strong evidence that cataract surgery
alone produces a significant, sustained
reduction in IOP proportional to the
preoperative IOP.
C.  Equally impressive advances in the medical
management of glaucoma.
D.  The fact that modern clear corneal
cataract surgery does not interfere with
subsequent successful glaucoma surgery.
E.  Rapid visual rehabilitation: Stablemaximum vision in 2 weeks.
F.  Much better control of astigmatism with on
axis incision. No scleral flap sutures to
confound post op refraction as with
trabeculectomy.
A.  Comprehensive Ophthalmologist Glaucoma
1. Mild optic nerve damage and field loss
2. Well-controlled IOP on topical
medications
3. Compliant Patient
Early Cup
Shrinking Peripheral Field
B.  Consultative glaucoma specialist glaucoma
1. Severe optic nerve damage and
field loss.
2. Poor control of IOP on topical
medication or progression in spite
of maximum medical therapy.
3. Often poor compliance.
Advanced Cup
Tunnel Vision
A.  Minnesota Eye Consultants, Schulze Eye Surgery
1. 588 non-glaucoma eye (IOP: 9-31)
19 ocular hypertensive eyes ( IOP: 23-31)
a. Mean IOP drop – 6.5 mm Hg with
phaco/IOL alone
(Mean drop sustained for 9 years)
2. 124 glaucoma patients (IOP 5-29)
17 glaucoma eyes: (IOP 23-29)
with phaco/IOL alone
a. Mean IOP drop: 8.4 mm Hg.
(Mean drop sustained for 9 years)
(Cont’d) MN Eye Consultants, Schulze Eye Surgery
3. The average glaucoma patient required
1.3 drops daily before surgery, and 1.0
drop daily following phaco/IOL.
4. Failure: 1.1% in 4.1 years
a. OHTS non treated 9.5% in 5.0 years
b. OHTS treated: 4.4% in 5.0 years
The OHTS patients were studied in greater depth than
the typical patient in any study.
5. Postoperative complications: only those of
modern cataract surgery
(less than 5 % and rarely sight threatening)
B.  Shingleton:
1. 888 Pseudoexfoliation patients
a. Preop IOP 21 to 25: Mean 1 year IOP
drop: 5.8 mm Hg with phaco/IOL alone.
b. Preop IOP >25: Mean 1 year IOP drop:
11.0mm Hg with phaco/IOL alone.
2. 240 Pseudoexfoliation patients with glaucoma
a. Prep IOP 21- 25: Mean 1year drop:
5.1 mm Hg with phaco/IOL alone.
b. Preop IOP >25: Mean 1 year drop:
10.3mmHg with phaco/IOL alone.
C.  Others: ISSA, Brown, Tennen, Suzuki, John,
McGuigan, Tong, Hazaski, Mathahane.
 
 
Compare Safety and Efficacy:
iStent + Phacoemulsification / IOL
 
vs
 
Phacoemulsification / IOL
 
In Mild – Moderate OAG
Samuelson – 2009 AAO
74 yr old eye
Lens xchng
52 yr old eye
24 yr old eye
“Uveal tract returns to the
anterior/posterior position
“Anterior displacement of the
tract with age resulting from lens
of relative youth.”
Growth.”
 
Prospective, randomized,multicentered IDE trial
 
240 eyes
 
117 iStent + cataract surgery
 
123 cataract surgery only
 
29 investigational sites
 
Efficacy endpoints:
 
 
IOP ≤ 21 mmHg w/o medication at 1 year
 
IOP reduction ≥ 20%w/o medication at 1 year
Safety:
 
Adverse events/comps, BCVA, etc. through 2 years
Samuelson – 2009 AAO
iStent +
cataract
Cataract
only
(n=117)
(n=123)
IOP ≤ 21 mmHg w/o medication
72%
50%
p < 0.001
IOP reduction ≥ 20% w/o
medication
66%
48%
p = 0.003
Change in IOP (mmHg) from
washout baseline: mean (SD)*
- 8.4 (3.6)
- 8.5 (4.3)
NS
Percent of patients on meds*
15%
35%
p = 0.001
Significance
(P)
  Primary and secondary endpoints significantly higher in iStent group
  IOP reduction similar in both groups, as expected (patients managed
to threshold )
  Significantly less medications for iStent patients
* n=100 and 106 at one year for iStent and cataract groups, respectively
Samuelson – 2009 AAO
Samuelson – 2009 AAO
iStent + cataract
surgery (n=111)
Cataract surgery
only (n=122)
Anticipated early postoperative events
(transient events such as corneal
edema, trace folds, trace striae,
transient hypotony at 5-7 hours,
inflammation, epithelial defect and
discomfort as expected following
cataract surgery)
13%
12%
BCVA loss ≥ 1 line ≥ 3 months
5%
5%
Posterior capsular opacification
3%
7%
Blurry vision or visual disturbance
1%
5%
Iritis
1%
5%
Adverse Events*
•  Overall safety profile similar between groups
* ≥ 5% in either group
Samuelson – 2009 AAO
Mean IOP (mmHg) Terminal Washout at Month 16 17.917.3
14.815.7
16.6
19.2
p = 0.042 Cataract + iStent
Mean #Meds Cataract
2.0 1.9
p = 0.007 0.4 1.3
0
0
 At month 15, significantly greater reductions in meds with iStent
 1.6 fewer meds vs. 0.6 fewer meds = 1 full med reduction
 At month 16 (after medication washout), 3 mm Hg greater
reduction in IOP with iStent
 M16 IOP = 16.6 mm Hg vs. 19.2 mm Hg (p = 0.042)
Fea – 2010 JCRS
 
Cataract surgery and trabeculectomy each have
completely different mechanisms of IOP reduction
(trabecular vs trans-scleral), thus combining the
two procedures likely negates the effect of one or
the other on IOP reduction
 
iStent + Cataract Surgery share similar mechanism
of pressure reduction, i.e. both encourage
physiological outflow
Samuelson – 2009 AAO
A.  Tube versus Trabeculectomy (TVT) Study:
3-year results.
1. 107 Tube patients
a. Mean IOP drop: 13.0mm Hg
(Sustained for 3 years)
2. 105 Trabeculectomy patients
a. Mean IOP drop: 13.3 mmHg
(Sustained for 3 years)
(Cont’d) Tube versus Trabeculectomy (TVT)
Study: 3-year results.
3. The average patient required 1.2 drops
daily following surgery in both series.
4. Failure:
a. Tube 15.1% at 3years
b. Trabeculectomy 30.7% at 3 years
5. Postoperative complications
a. Tube: 39 % (Serious: 22%)
b. Trabeculectomy: 60% (Serious: 27%)
IOP > 17 mm Hg
IOP > 14 mm Hg
53.9%
p = 0.12
p = 0.056
35.0%
24.0
%
44.3
%
A.  IOP spikes should be treated
prophylactically .
1. Intracameral antihypertensives
(Carbachol)
2. Topical antihypertensives
3. Oral antihypertensives
B.  Vulnerable patients should have their IOP
checked 4-6 hours and 12-24 hours post-op.
A.  Effective: In patients with IOP greater than
25 mmHg one can achieve 10 mmHg drops
in IOP vs 13mm Hg for Tube and
Trabeculectomy.
B.  Safer: A complication rate well under 5% vs
40-60% for Tube and Trabeculectomy.
Severe complications under 1% vs 22-27 %
for Tube and Trabeculectomy.
C.  Phaco/IOL is synergistic with the superior
medical therapy available today.
D.  Phaco/IOL is compatible with the skill level of
the comprehensive ophthalmologist.
E.  And finally: Modern cataract surgery does not
reduce the success of subsequent glaucoma
surgery if required. We rarely perform two
interventions at the same time. We generally
intervene with one approach and reassess.
Cataract surgery should be considered an
incremental step in glaucoma management.
A.  Effectiveness: IOP lowering shown with less
medication use after iStent implantation.
B.  Safety: Overall safety profile similar for
cataract surgery alone or with iStent.
C.  Synergistic mechanism of action: iStent
and cataract surgery both enhance
trabecular outflow.
1. 
2. 
3. 
4. 
5. 
6. 
7. 
Long-term effects of phacoemulsification with intraocular lens
implantation in normotensive and ocular hypertensive eyes: Poley, et
al: JCRS May 2008;34:735-742.
Long term effects of phacoemulsification with intraocular lens
implantation in glaucoma eyes. Poley, et al: JCRS: In Press.
Effect of phacoemulsification on intraocular Pressure in eyes with
pseudoexfoliation. Single surgeon Series, Shingleton, BJ: JCRS Nov
2008;34:1834-1891.
Pseudoexfoliaton and the cataract surgeon: Preoperative,
intraoperative, and postoperative issues related to intraocular
pressure, cataract, and intraocular lenses. Shingleton, et al, JCRS
2009;35:1101-1120.
Three year follow-up of the Tube versus Trabeculectomy (TVT) Study.
Gedde, et al., AJO 2009;148:670-84.
Randomized evaluation of the trabecular micro-bypass stent with
phacoemulsification in patients with glaucoma and cataract.
Samuelson, et al., Ophthalmology 2010; in press.
Phacoemulsification vs. phacoemulsification with micro-bypass stent
implantation in primary open-angle glaucoma. Fea, AM, JCRS
2010;36:407-412.
Thank You!