Transcript EX-PRESS® Device

Glaucoma Surgery 2011:
Why am I Still Doing a
Trabeculectomy?
Garry P Condon, MD
Associate Professor Ophthalmology
Drexel University College of Medicine
Chairman Dept Ophthalmology
Allegheny General Hospital
Pittsburgh PA
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EX-PRESS® Device Brief Statement
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients
where medical and conventional surgical treatments have failed.
GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to
compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate
version is according to the doctor's discretion.
CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:
· Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
· Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative
complications following implantation of the device.
· Patients diagnosed with angle closure glaucoma.
WARNINGS/PRECAUTIONS:
· The surgeon should be familiar with the instructions for use.
· The integrity of the package should be examined prior to use and the device should not be used if the package is
damaged and sterility is compromised.
· This device is for single use only.
· MRI of the head is permitted, however not recommended, in the first two weeks post implantation.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions,
complications and adverse events.
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Why do I still do some form of
Trabeculectomy?
Experience
…stood the test of time
It works
Can repeat it
Doing it better
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Collaborative Initial Glaucoma Treatment
Study (CIGTS)
• 465 trabeculectomies (300 patients)
• Pre-op IOP: 27 mmHg
• Post-op IOP: 15 mmHg
– 44% reduction
• 5 years follow-up
Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001;
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What counts in glaucoma
surgery…
“Is Scoring With Efficacy”
IOP Reduction of
30% and More…
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Trab: Nothing else stacks up!
Failed Contenders
Viscocanalostomy
Deep sclerectomy
Deep sclerectomy with
Aquaflow
Sinusotomy
Thermal sclerostomy
Iridencleisis
Laser sclerostomy
Internal sclerectomy
Cyclodialysis
Trabeculotomy
Goniotomy
Cyclophotocoagulation
Transscleral
Endoscopic
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Trab’s Two Biggest Contenders:
Tube Shunts
Canaloplasty
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Trabeculectomy
…a life after TVT?
Tube vs Trab Study
A new Star?
Or tubes just on a Power Play?
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Trabeculectomy
…a life after TVT?
• Study limitations
– Preliminary data
– More data being published
• 5yr results presented at AGS
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TUBE VS TRAB:
SOME BOOTH COMMENTARY…
Listen to me...
I’m a Canadian!
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TVT Probability of Failure
30.7%
p=
0.010
15.1%
Gedde SJ et al. TVT 3 yr follow up, AJO 2009
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TVT Probability of Failure
30.7%
p=
0.010
15.1%
Gedde SJ et al. TVT 3 yr follow up, AJO 2009
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The Fight Wasn’t Fair!
While all eyes were good candidates for a tube
….Failed trab eyes not good cases for another
trab
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And yet…The Overtime Period!
Trab was ‘effective’ in 70% of cases
And on fewer meds!
… available options down the road
Needling / revision
Trab again!
Gedde SJ et al. TVT 3 yr follow up, AJO 2009
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TVT: The Off Sides
Tube first … Big Bloody Operation
One Good Shot
Trab after a tube??
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TVT: The Penalty Box!
New motility problems in tube group 10%
Gedde SJ et al. TVT 3 yr follow up, AJO 2009
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Replay… what can we say?
• Do TVT results to date favor tubes?
• Yes – In patients with previous conj surgery
But…
• In Clear corneal pseudophakes?
• In Primary glaucoma surgery??
We just don’t know.
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Canaloplasty?
Best study: 89 patients 3-year F/U
Pre-op IOP: 23.5 mmHg
Post-op IOP:15.5 mmHg
34% reduction
Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011
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Canaloplasty: Problems
No independent data…
Uncontrolled, non-randomized study
from i-Science
And…
15% of cases surgeons couldn’t
complete the operation!!
Find the canal
Pass the Microcatheter
Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011
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Canaloplasty vs Trabeculectomy
Sponsor
Patients
(#)
F/U (yrs)
i-Science CIGTS
NIH
89
465
3
IOP
34%
reduction
5
44%
Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011
Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001;
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So for that super-LOW IOP
In Primary Virgin Eyes
For now…
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Trabeculectomy is the Gold Standard!
Trab…
The
Winning
play!!!
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…but live with this!?
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…and this
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… We CAN DO IT BETTER!
Surgery 1 year apart
OS limbal based
OD fornix based
Fornix based flap
Broader MM-C application
Bullet-proof Conj closure
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Mastering water-tight closure
Condon Conj Closure video: Eyetube.net
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EX-PRESS® Device Indication
The EX-PRESS® Glaucoma Filtration Device
is intended to reduce intraocular pressure in
glaucoma patients where medical and
conventional surgical treatments (SLT/ALT)
have failed.
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More precision?
More control?
EX-PRESS® device under scleral flap
Maris, Ishida and Netland. J Glaucoma, Jan 2007
Hearndon and Marzette. AGS 2008
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Trab-what I hated
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EX-PRESS® device titled 220
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EX-PRESS® Device: P-50
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EX-PRESS® device P-50 DETAIL
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My Flap Technique
Conj flap technique:
LimbusBased
<2001
FornixBased
>2001
Number of consec eyes:
(min 4 wk f/up)
107
199
wound leaks req surg repair:
2
2
wound leaks req surg repair %
1.9
1.0
Video:
‘Closing the Conjunctival Flap’
www.Eyetube.net
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1 mo
1 yr
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Assessment of Bleb Morphology and Postoperative Outcomes After
EX-PRESS® device Versus Trabeculectomy
(Good & Kahook, AJO 2011)
• Retrospective Consecutive Case Control
Series
• Seventy Patients (n=35 each group) with
Mean of ~28 months of follow up
• Also assessed time to visual recovery
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Post-operative Outcomes After
EX-PRESS® device Versus Trabeculectomy
Final IOP decreased by 45.15% and 48.45% from baseline
in the EX-PRESS® device and Trabeculectomy groups respectively
(p=0.209)
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Assessment of Visual Recovery
EX-PRESS® device Versus Trabeculectomy
* Best Corrected
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EX-PRESS® Glaucoma
Filtration Device
Remarkably Biocompatible
A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of
the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma.
2003 Jun; 12(3):275-80
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De Feo etal. 2009
• 2 yr postop EX-PRESS® device in one eye
(postmortem)
• No difference in corneal endothelial cell density
between the two eyes
F. De Feo, S. Jacobson, A Nyska, P. Pagani, C.E Traverso. Histological Biocompatibility of a Stainless Steel Miniature
Glaucoma Drainage Device in Humans: A Case Report. Toxicologic Pathology, 37: 512-516, 2009
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We can do BETTER than this!
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And this…
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Let’s raise the bar…
No… Let’s Raise a Glass at the Bar!
More correct and effective standard surgery
New approaches to enhance current techniques
Smoother more favorable outcomes
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Thank-you
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