RTVue
Cirrus
Spectralis
Study sites
6 USA
3 Japan
1 India
1 England
6 USA
1 China
1 Germany
# Subjects
480
264
201
Subject Ethnicity
Caucasian
African descent
Asian
Indian
Other
European descent
Chinese
European descent
Hispanic
Caucasian
Subject age
18-84
19-84
18-78
Measures
RNFL thickness
GCC
Macular retinal thickness
Peripapillary RNFL
RNFL thickness for ON
Head scan cube
ON parameters
Macular ganglion cell +IPL thickness
Macular retinal thickness
RNFL thickness
Denice Barsness, CRA, COMT, ROUB, CDOS, FOPS
Ophthalmic Diagnostic Center
CPMC Department of Ophthalmology
2100 Webster Street Suite 212
San Francisco CA 94115
(415) 600-3937 FAX (415) 600-6563
From: optimal-bounce@xxxxxxxxxxxxx [mailto:optimal-bounce@xxxxxxxxxxxxx] On ;
Behalf Of Dave Clark
Sent: Thursday, September 22, 2016 6:36 AM
To: optimal@xxxxxxxxxxxxx
Subject: [External] [optimal] Re: Heidelberg RNFL scans
Darrin,
In short...."No!" So here is my reasoning.
I'm not sure, but I would think that they had to label this in accordance
with either the FDA clearance or some other entity(possibly European)
guidelines. Certain countries, like Japan, are the only ones with a true pure
ethnic sampling for data. It would be very difficult to obtain a true "pure"
sampling. Even "Caucasian" as a qualifier is suspect to me. We have people
running around thinking they are Caucasian and in fact they have DNA of
Hispanic, American Indian or some other ethnic class. I do not think the
reference data bases should be relied upon as much as our US doctors do.
In my opinion there should be no diagnosis based solely on the RNFL data
obtained from the patients first scan. The RNFL scan should be used only as one
of many criteria for glaucoma and is a better tool to be used in the monitoring
of progression or effective management of the glaucoma patient.
I admit that I have promoted the fact that reference data is important but
only on the first visit to see how a patient compares to known "normals".
Sorry for the dissertation but I talk to so many doctors about this all the
time. I am pretty sure this reference data base importance was over emphasized
by cooperate America to differentiate one instrument over another.
Warm Regards,
David Clark
Daveclark86@xxxxxxxxx<mailto:Daveclark86@xxxxxxxxx>
Cell: 551-579-1062
Sent from my iPhone
On Sep 22, 2016, at 9:03 AM, Darrin Landry
<darrin@xxxxxxxxxxxxxxxx<mailto:darrin@xxxxxxxxxxxxxxxx>> wrote:
So I've been using Heidelberg Spectralis since 2007, and it was just pointed
out to me that on the bottom of the RNFL analysis, it says "Results valid for
Caucasian eyes only".
Now, because Maine is 97.3% Caucasian, this has not been much of a problem.
Does anyone feel that this restriction would produce false analysis on a
non-Caucasian patient?
thanks
Darrin
Darrin A Landry, CRA, OCT-C
Ophthalmic Consultant
Bryson Taylor, Inc.
207-838-0961
www.brysontaylor.com<mailto:Darrin@xxxxxxxxxxxxxxxx>
