7/15/11
Distribution Coaching Packet
By Christine A. Curcio, Ph.D., Director, Global Sight Network™
We at Global Sight Network™ are excited that you are interested in educating
surgeons in your service area about the value of GlycerolPlus Cornea for
glaucoma shunt coverage. We are sharing materials developed over the last
year, with a specific focus on the 2011 American Glaucoma Society meeting in
Dana Point CA. We offer these materials with the hope that your experiences will
help identify ways to improve our product and materials for the future. Please
review these 13 files/folders in the suggested order.
For general background see these websites:
1. For information about glaucoma
a. http://www.iopinc.com/patient_link/glaucoma.asp
2. For a drainage device:
a. http://www.ahmedvalve.com/ A GPC patch is used to cover the
tube and allow the eyelid to cover it smoothly.
Files for your review
00 DistributionPacketIntroduction.doc -- this file
01 GPC for GL Overview.doc – a brief review of glaucoma prevalence,
treatments, surgeries, biomaterials, GSN history
02 AGS 2011 Intro to GPC for GL.doc –what was said to doctors who came to
our table. Virtually all who came sought us out specifically. It took 2.5 minutes
to say, and I referred to the Girkin movie (above) and the Preparation Flyer (#5
below).
03 Glaucoma Ad Final.pdf – emailed to AGS members prior to the meeting.
04 GPC Brochure.pdf – given to every doctor who visited the table.
Global Sight Network™ – A Service of the Alabama Eye Bank
500 Jemison Road, Birmingham AL 35209
http://www.globalsightnetwork.org
Page 1 of 4
05 GPC preparation and usage in surgery (folder)—an instruction card and
video; to help doctors understand that GPC must be rehydrated, trimmed, deepithelized, and split to create 2 layers.
06 Product comparison, GL.doc – compare GPC for glaucoma shunt to other
popularly used materials, for internal use only.
07 Ordering GPC (folder) – includes order form and price sheet. Certificates are
EBAA certificates, licenses, etc, sometimes required for GSN to become a
trusted vendor for hospitals and ASC.
08 Package Inserts (folder)
09 Reporting requirements for human allografts (folder)
10 Tissue safety
11 References (folder) – for cornea in GL surgery, drainage device surgery
12 Template letters (folder) – includes follow-up letters after the AGS
FAQ for distribution
We can anticipate the following questions, based on our experience so far:
1. Why is GlycerolPlus Cornea good for glaucoma shunt coverage?
a. It is durable, and because it is clear, rather than opaque white, it is
cosmetically pleasing for patients who have shunts implanted in the
inferior nasal quadrant.
2. Who is the GSN representative in my area?
a. A partner eye bank, or if located outside a partner service area,
GSN direct.
3. How much does GlycerolPlus Cornea cost?
a. $325 for whole cornea, $275 for half (as of April 19, 2011). For
reference, Tutoplast Pericardium is $250.
4. How much tissue do I need for one shunt?
a. Half cornea is enough for one shunt.
5. Can I use one tissue for 2 patients?
a. Tissues are single use only (i.e., one cannot be used for 2
patients), according to the Eye Bank Association of America, our
regulating agency.
6. I’ve had trouble de-bulking (splitting to half-thickness) corneas I received
from my eye bank. What should I do?
a. When rehydrated as directed, GPC will swell somewhat and become
spongy and easier to handle than a fresh cornea from an eye bank.
As the video shows, Dr. Chris Girkin holds the cornea piece with
forceps and splits it into two layers with a blade. We’ve also learned
from Dr. Paul Palmberg of the Bascom Palmer Eye Institute that he
Global Sight Network™ – A Service of the Alabama Eye Bank
500 Jemison Road, Birmingham AL 35209
http://www.globalsightnetwork.org
Page 2 of 4
turns the corneal piece on its edge, makes a groove on that edge,
and pulls apart along the cleavage plane using two forceps. Either
anterior or posterior piece can work.
7. I had trouble getting the conjunctiva to grow over a corneal patch graft.
Am I doing something wrong?
a. GPC must be thoroughly stripped of epithelium by scraping with a
blade, in order to promote good in-growth of the conj. The video
shows that step well.
8. I usually use Tutoplast (dried) sclera. How will GPC differ?
a. Like sclera, GPC requires rehydration
9. I usually use Tutoplast pericardium. How will GPC differ?
a. GPC requires rehydration. GPC is thick and must be split
horizontally, unlike Tutoplast, which is folded to create enough
thickness.
10.How long does it take to prepare GPC for surgery?
a. We’ve learned from Dr. Girkin (on the video) that if he prepares the
cornea at the same time that the scrub tech prepares the patient,
both are ready at the same time, so there is no down time. We
recommend 20 min rehydration for GPC, and some surgeons use a
shorter time.
11.Are there published studies on the use of GPC for glaucoma?
a. Cornea has been used for glaucoma shunt coverage since 1996.
Please see papers by Rojanapongpun and Ritch, 1996, and Singh et
al., 2008, on this CD. Glycerol preserved cornea has been used by
surgeons at the Bascom Palmer Eye Institute for >5 yr. Positive
surgical outcomes have been reported by these doctors at national
meetings, but not yet published, since 2008. Patients seen at the
UAB Department of Ophthalmology by Christopher Girkin, MD,
MSPH with >12 mo post-operative follow-up are now part of a
retrospective study. Preliminary results are expected in May, 2011.
Prospective outcomes data specific to different biomaterials,
including those used by the BPEI surgeons, will be included in
upcoming follow-up reports from the Tube vs Trab Study, according
to S.J. Gedde, MD, Principal Investigator.
12.How do I know that cornea is safe?
a. Each GSN tissue is determined to be medically eligible by the
partner eye bank that contributes it. All donors are vetted by a
medical-social history questionnaire to rule out donors with highrisk behaviors or travel history. Blood samples from every donor
are determined to be free of the markers for transmissible disease
mandated by the EBAA and FDA.
13.My ASC/ hospital requires certificates (EBAA, state license, W-9) for a
tissue source to be considered a trusted vendor. How do I get these
documents?
a. These documents are available in pdf format at the GSN website.
They are also in this coaching packet.
14.Isn’t cornea expensive?
Global Sight Network™ – A Service of the Alabama Eye Bank
500 Jemison Road, Birmingham AL 35209
http://www.globalsightnetwork.org
Page 3 of 4
a. It may be expensive if bought fresh from an eye bank. GPC from
GSN or through your local eye bank is comparable to Tutoplast
pericardium in price.
15.My ASC wants to buy the cheapest graft material, currently Tutoplast.
How can I convince them to order GPC?
a. Your ASC purchasing agent may not be aware that GPC is similar in
price to Tutoplast.
16.How long is the shelf life of GPC?
a. 5 yr, same as the glycerol.
17.How can I set up regular shipments?
a. Just ask
18.What is the CPT code for GPC?
a. 67255 (same as scleral graft).
LISTEN LISTEN LISTEN
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Learn the doctor’s current experiences and meet them where they are.
Refer difficult questions. Don’t try to fake it.
Write down every question you can’t answer so that we can get an answer
for the distribution FAQ above.
The IPO Plan
Improved product
Precise processing
Outstanding customer service
Global Sight Network™ – A Service of the Alabama Eye Bank
500 Jemison Road, Birmingham AL 35209
http://www.globalsightnetwork.org
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