Download ICCBBA Eye Banking Technical Advisory Group Ocular Tissue

ICCBBA Eye Banking Technical
Advisory Group
Ocular Tissue Nomenclature
(Revision following Public Consultation)
Participating Organizations
Ocular Tissue Nomenclature
2
TABLE OF CONTENTS
1
Introduction.................................................................................................................. 3
2
Summary of Changes .................................................................................................. 3
3
Proposed Nomenclature .............................................................................................. 4
3.1
Class .................................................................................................................... 4
3.2
Attribute Groups ................................................................................................... 4
3.3
Attribute Variables ................................................................................................ 5
4
Presentation of Information .......................................................................................... 8
5
Non-Coded Information ............................................................................................... 9
5.1
Additional Consent ............................................................................................... 9
5.2
Other Information.................................................................................................. 9
6
Participants................................................................................................................ 10
7
Appendix ................................................................................................................... 11
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Ocular Tissue Nomenclature
3
Ocular Tissue Nomenclature
1 Introduction
The proposed ocular tissue nomenclature was released for public consultation in May
2011. An excellent response was received with many very constructive comments. The
EBTAG has reviewed these comments and made appropriate adjustments to the
nomenclature.
The comments received, together with the response of the EBTAG, are attached in the
Appendix.
This document provides the updated version of the nomenclature.
2 Summary of Changes
The major changes that have been made as a result of the consultation are as follows:

Cornea has become a single Class value with the type of cornea now being
identified by a new Attribute group of “Corneal Graft”

Conjunctiva has been added as a new Class

A new Attribute group „Scleral Graft‟ has been added to define whether Whole or
Part sclera is being supplied

Corneal button has been added as a Corneal Graft Attribute value

The word „pre-cut‟ has been removed from the “Anterior layer” and “Posterior layer”
Corneal Graft Attribute values as this implied use of a microkeratome. This change
generalizes the definitions; for example, for „Posterior layer‟ all preparation
techniques for endothelial keratoplasty are now covered.

The definition of „Laser shaped‟ has been clarified to distinguish it from a posterior
layer cut by laser

The “Permitted Use” Attribute group has been withdrawn as it is recognized that
this information does not need to be coded, but see Section 5.1, Additional
Consent.

The “Recommended Clinical Use of Cornea” Attribute group has been withdrawn.

The “Additional Matching Information”, “Corneal thickness” and “Corneoscleral Disc
Diameter” Attribute groups have been withdrawn as it is recognized that this
information does not need to be coded, but see Section 5, Non-Coded Information.

The “Storage Conditions” Attribute group has been split into two new groups in
order to separate the storage state and the storage solutions. These Attribute
groups are named “Storage State” and “Storage Solutions”

A new Attribute group of “Pathogen Reduction” has been added
In addition to the above, some definitions have been changed. Please see the tables in
Section 3, Nomenclature for the fully revised version of the nomenclature.
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
4
3 Nomenclature
The nomenclature presented below will be used in standardized Product Description
Codes.
3.1
3.2
Class
Cornea
Transparent anterior part of the outer fibrous coat of the eye
bounded by an outer stratified epithelium and an inner
monolayer of endothelial cells. The major refractive
component of the eye.
Sclera
Fibrous white outer part of the eye remaining after excision of
the corneoscleral disc and removal of intraocular content and
extraneous surface tissue.
Limbal Tissue
Tissue bridging the junction between the cornea and sclera.
Conjunctiva
Transparent mucous membrane passing over the inner
surface of the eyelids and reflected over the front part of the
sclera.
Whole Eye
Whole eye which may include some conjunctiva
Attribute Groups
Corneal Graft
Specifies the type of corneal graft
Scleral Graft
Specifies the type of scleral graft
Storage State
Specifies the storage state of the tissue in the eye bank.
Delivery conditions may vary.
Storage Solution
Specifies the solution in which the tissue is stored in the
eye bank.
Endothelial Cell
Density
An indicator of whether the endothelial cell density is
included in the labeling
Pathogen Reduction
Describes the method of sterilization, disinfection or
decontamination of the product
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
3.3
5
Attribute Variables
Corneal Graft
Default: Not
applicable or
not specified
Either this attribute group does not apply (tissue class is not
Cornea) or the corneal graft type is not specified
Corneoscleral
disc
Cornea excised with scleral rim which may include some
conjunctiva
Corneal
button
Cornea with scleral rim removed
Anterior layer
Corneal stroma without endothelium. May include epithelium
Posterior
layer
Endothelium on Descemet‟s membrane with or without a
supporting layer of posterior stroma
Anterior and
posterior
layers
A pre-cut cornea where both the anterior and posterior layers are
present
Laser shaped
Full-thickness cornea shaped to a specific edge profile using
laser technology
Scleral Graft
Default: Not
applicable or
not specified
Whole sclera
Part sclera
Either this attribute group does not apply (tissue class is not
Sclera) or the scleral graft type is not specified
Complete sclera from one eye remaining after excision of
corneoscleral disc
A portion of the sclera from one eye
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
6
Storage State
Default: No
information
provided
No coded information about storage state is provided. Details
may appear in text on the tissue container label or in
accompanying documentation.
Moist chamber
Whole eye stored at 2 to 8°C in a humid environment.
Hypothermic
storage
Stored in a solution at 2 to 8°C
Ambient
storage
Stored in a solution at ambient temperature
Organ culture
Stored in a nutrient medium at 28 to 37°C
Frozen
Stored in the frozen state, but without additives specifically to
protect cells/matrix and/or without the controlled freezing
conditions required for cryopreservation.
Cryopreserved
Preserved by freezing or vitrification in the presence of a
cryoprotectant and using a method validated to maintain cellular
viability and/or preserve tissue matrix structure. The information
about the cryoprotectant may be specified using the storage
solutions attribute group or on the tissue container label or in
accompanying documentation.
Freeze dried
(Lyophilized) Preservation in the dried state achieved by
freezing followed by sublimation of water under vacuum to very
low residual moisture content.
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
7
Storage Solution
Default: Not
Specified
No coded information about the storage solution is provided.
Details about the storage solution may appear as text on the
tissue container label or in accompanying documentation.
None
No storage solution
Nutrient
medium
Tissue culture medium
Cryoprotectant
medium
Medium containing a cryoprotectant compound
Saline
Isotonic saline or balanced salt solution that may include
antibiotics
Ethanol
≥70% ethanol
Glycerol (High
Conc)
Sterile glycerol with a concentration of at least 85%
Endothelial Cell Density
Default: No
information provided
No information about the endothelial cell density is
provided
Information provided
Information about endothelial cell density is included in
the labeling
Pathogen Reduction
Default: No
Information
No information about pathogen reduction is provided
Pathogen Reduced:
Method NS
Tissue subjected to pathogen reduction process,
method not specified. Details about pathogen reduction
method may appear in text on the label.
No Pathogen
Reduction
No pathogen reduction steps have been performed.
Radiation Sterilization
Exposed to ionizing radiation in accordance with a
validated sterilization process.
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
8
4 Presentation of Information
The EBTAG also considered which of the nomenclature elements should be coded within
the ISBT 128 Product Description Code, which could be coded in an alternative data
structure within ISBT 128, and which should appear only as human readable text. The
reasoning behind these decisions is as follows:
Product Description Code: Information will be coded as part of the ISBT 128
Product Description Code where there is a benefit in being able to distinguish
distinct types of product through their coding, either to provide electronic support for
the management of the supply of product, or to categorize products for activity or
biovigilance reporting purposes. In addition to coding the information in the Product
Description Code Data structure, eye readable text on the label will be required as
indicated in Table 1.
Alternative Data Structure: Information may be coded in an alternative ISBT 128
data structure where specific information (such as an exact numerical value) is
required that is specific to a particular graft, and where electronic capture of this
information by the transplanting organization is desirable. In such cases a „flag‟ in
the product code can be used to alert the computer to the presence of this
additional electronically readable information. In addition to coding the information
in an alternative data structure, eye readable text on the label will be required as
indicated in Table 1.
Non-Coded Information: Some information has been identified that does not
require coding, but would benefit from standard usage. These recommendations
appear in Section 5 and apply to text based information carried on the affixed label
or accompanying documentation.
On the basis of these criteria, the recommendation for the presentation of information is
shown in Table 1.
Table 1 Presentation of Information
Information
Coded in
Product
Description
code
Coded in
alternative
data
structures
Class
Corneal Graft
Scleral Graft
Storage State
Storage Solution
Endothelial Cell Density (flag)
Pathogen Reduction
Endothelial Cell Density (value)
Additional Consent
Additional Donor Information
Corneal thickness
Corneoscleral disc diameter
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Optional
No
No
No
No
© 2011 ICCBBA, All Rights Reserved
Non-Coded
Information
(Eye
readable
text)
Yes
Yes
Yes
Yes
Yes
No
Yes
Optional
Optional
Optional
Optional
Optional
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Ocular Tissue Nomenclature
9
5 Non-Coded Information
5.1
Additional Consent
Labeled product is assumed to have been consented for clinical use. (It is
acknowledged that some countries have presumed consent where specific consent
to procure and use tissue is not required.) However, where known, it is beneficial to
provide information on additional consent and it is recommended that the additional
consent categories shown on Table 2 be used. This nomenclature (or similar
nomenclature in the appropriate language) should appear when needed on the
affixed label or accompanying documentation.
Table 2 Additional Consent Categories
5.2
No additional consent
Consent for surgical use but no additional consent has been
obtained.
Research
Additional consent has been obtained for research use
Educational use
Additional consent has been obtained for educational use
(includes surgical training)
For research or
educational use
Additional consent has been obtained for research and
educational use (includes surgical training)
Other Information
Where appropriate the following information should be included on the affixed label
or accompanying documentation:





Corneal thickness
Corneal disc diameter
Corneal opacity
Donor HLA type
Donor ABO group
© 2011 ICCBBA, All Rights Reserved
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Ocular Tissue Nomenclature
10
6 Participants
This document was prepared by representatives of professional societies and technical
experts.
International Eye Bank Technical Advisory Group Membership
Name
Affiliation
Country
John Armitage,
(Chair)
European Eye Bank Association
United
Kingdom
Paul Ashford
ICCBBA
United
Kingdom
Sam Barone
FDA Liaison
USA
Barbara Crow
Eye Bank Association of America
USA
Patricia Dahl
Eye Bank Association of America
USA
Jennifer DeMatteo
Eye Bank Association of America
USA
Pat Distler
ICCBBA
USA
Usha Gopinathan
Eye Bank Association of India
India
Peter Madden
Technical Expert
Australia
Mark Mannis
Asociacion Pan-Americana de Bancos de Ojos
USA
Louise Moffatt
Eye Bank Association of Australia and New
Zealand
New
Zealand
Diego Ponzin
European Eye Bank Association
Italy
Donald Tan
Asia Cornea Society and the Association of Eye
Banks of Asia
Singapore
Observers
Paul Derksen
Christina
Parsons
Canadian Blood Services
Canadian Blood Services
© 2011 ICCBBA, All Rights Reserved
Canada
Canada
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Ocular Tissue Nomenclature
11
7 Appendix
Comments and Responses from Consultation Ending 16 May 2011
From
Organization
Nomenclature
Comment
Response
1
Ellen Heck,
University of
Texas
Southwestern
EBAA
Class
I wonder if there should not be just a
definition of cornea without the cutting
information.
The class “Cornea” was created, with further information
in the Corneal Graft Attribute group.
2
Joel Sugar
University of
Illinois,
Chicago
Department of
Ophthalmology
and Visual
Sciences
EBAA
Class
Add "corneal disc" as corneas without
scleral rims are now being distributed.
Corneal button was added as a Corneal Graft Attribute
value.
3
Council
AEBA
Class
Propose to add 'Cornea Substitute' to
the class section with definition as
'Tissues used for temporary or
permanent substitute or appendix to
rebuild the function of cornea.
Examples are engineered corneal
tissues
This term can be added later, if requested. At that time,
consideration will be given to coding this as a Tissue
Engineered/Advanced Therapy Medicinal Product rather
than as ocular tissue.
4
Izabela
Tyszkiewicz
For Poland
Class
The term and the definition are more
or less OK for Polish Eye Banks.
“More or less” because the cornea
can be shaped not only by using the
laser but also by a corneal punch
(trephine).
A new attribute group, Corneal Graft, with an Attribute
variable, Corneal button, was added.
Martin Hermel
Board member
EEBA,
Surgeon
EEBA
Pre-cut anterior, pre-cut posterior and
laser-shaped cornea should be
attributes
These terms were moved into the Corneal Graft Attribute
group
5
Cornea - Laser
shaped
© 2011 ICCBBA, All Rights Reserved
Class
Cornea - Precut anterior
Cornea - Precut posterior
Cornea - Laser
shaped
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Ocular Tissue Nomenclature
From
12
Organization
Nomenclature
Comment
Response
6
Iva Dekaris
President
EEBA
Surgeon
EEBA
Class
Cornea – Precut Anterior
Pre-cut anterior cornea should
mention epithelium?
The definition was amended to „Corneal stroma without
endothelium, may include epithelium‟ to address this
concern.
7
David Glasser
Medical
Advisory
Board Chair
EBAA
Class
How "tight" are these definitions? Do
the above preclude inclusion of
Bowman membrane or epithelium?
Most anterior layers will include these
structures.
The Class “Cornea – Pre-cut Anterior” was changed. The
class is now “Cornea” and an attribute group, Corneal
Graft, has been added. “Anterior layer” is a variable
within the Corneal Graft group. The definition for
“Anterior layer” was changed to „Corneal stroma without
endothelium and that may include epithelium‟
Jackie Malling
Executive
Director
Minnesota
Lions Eye
Bank
EBAA
One thought for moving forward - it
would be nice to see keratolimbal
allograft listed (for example, page 5,
top chart).
The definition of Corneoscleral disc (in the Corneal Graft
Attribute group) was changed to indicate “may include
some conjunctiva”. This definition should now include
corneoscleral discs supplied for KLAL.
Jackie Malling
Executive
Director
Minnesota
Lions Eye
Bank
EBAA
And we are not sure if DMAEK and
DSAEK are covered (same example).
The word “pre-cut” was deleted from the Anterior and
Posterior layer terminology in order to generalize these
terms; e.g., posterior layer now covers DSAEK, DMAEK,
and DMEK, etc.
8
9
Cornea – Precut anterior
Class
Keratolimbal
allograft
© 2011 ICCBBA, All Rights Reserved
Class
Keratolimbal
allograft
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Ocular Tissue Nomenclature
From
13
Organization
Nomenclature
Comment
Response
10
Izabela
Tyszkiewicz
For Poland
Class - Limbal
Tissue
The term and the definition are OK for
Polish Eye Banks.
In Poland the donor-recipient blood
relationship is important in the case of
limbal tissue.
Following attributes have been
proposed: allogeneic, autologous or
allogeneic from family-related donor.
However taking into account our skin
discussion I rather would say:
autologous, allogeneic (without HLA
typing), allogeneic unrelated (HLA
tests confirmed no blood relationship
between the donor and the recipient)
and allogeneic related ((HLA tests
confirmed a blood relationship
between the donor and the recipient).
The intent of this term is merely to describe the supply of
Limbal tissue by an eye bank regardless of whether the
surgeon intends an autograft/allograft/matched graft.
These features cannot be coded as they would then
become invalid if the tissue is used in a different recipient.
Also, the final Limbal product may fall under cellular
therapy products where the relationship of recipient and
donor can be encoded. The general intent of all of the
codes is to describe the tissue as supplied, not the
intended use of the tissue.
11
Izabela
Tyszkiewicz
For Poland
Class - Sclera
The term and the definition are OK for
Polish Eye Banks.
Whole sclera is procured but in
Poland Eye Banks provided not the
whole sclera but ½ or ¼ of sclera. Is it
possible to take this into account?
A new Attribute group was proposed to distinguish whole
sclera from partial sclera. Division codes can be used to
indicate the number of divisions.
12
Manfred Dichtl
Linz, Austria
Class- Amnion
What about Amnion? I know that is
not ocular tissue, but is very often
processed in cornea banks. Wouldn´t
it make sense to include this tissue in
the debate?
Amnion already existed as an ISBT 128 tissue code and
therefore was not included here.
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Ocular Tissue Nomenclature
From
13
Izabela
Tyszkiewicz
14
Organization
Nomenclature
For Poland
Class
Corneoscleral
Disc
© 2011 ICCBBA, All Rights Reserved
Comment
All tissue banks agreed that
Corneoscleral Disc (CD) is what is
given to ophthalmologists in majority
of cases.
It is obvious for them that:
 CD can be either
recovered/procured directly
during recovery procedure or
excised from procured whole
eye.
 Procurement just a cornea
alone will
o cause the cornea
edema
o determine the final
diameter of the graft
Both issues are of course
undesired by end-users.
However all of them call that type of
graft "cornea" and only one is really
ready to accept it as CD.
Response
A new class, Cornea, was added. A new Attribute group,
Corneal Graft, was also added that should address these
issues.
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Ocular Tissue Nomenclature
From
14
15
15
Organization
Nomenclature
Comment
Response
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
Class
Corneoscleral
Disc
Not sure if it's clear if a pre-cut cornea
still falls under "corneoscleral disc" if
the cut layers are still together, cap
on, prior to separation/ removal of the
"pre-cut posterior or anterior layer" for
surgery. If the tissue is pre-cut, does it
remain a "corneoscleral disc" since all
pre-cut layers are present, with rim? I
specifically ask this because
"Recommended Clinical Use of
Cornea" is stated not to apply to the
pre-cut layers. I believe a
recommended clinical use should be
given when the tissue is pre-cut, so
that posterior is not utilized when only
the anterior layer is suitable, and viceversa. Perhaps adding the category
"Corneoscleral Disc- Pre-Cut" and
revising the other laser shaped to
"Corneoscleral Disc- Laser shaped"
remedies any confusion? The pre-cut
disc would be comprised of the precut layers. The Recommended
Clinical Use of Cornea could then
apply to classes Corneoscleral Disc,
Corneoscleral Disc- Laser shaped,
Corneoscleral Disc-Pre-cut, and
Whole Eye.
The Recommended Clinical Use group was withdrawn.
A new class, Cornea, and a new Attribute group, Corneal
Graft, were added. A variable was added to the Corneal
Graft group for „Anterior and posterior layers.‟
Manfred Dichtl
Linz, Austria
Some (in research, even clinically) are
working with cells, such as pigmentary
epithelial cells: Would it make sense
to include them? Actually I do not
need them, but maybe it is worth
discussing about, since there is a lot
of research.
This nomenclature can be added when requested. At that
time, consideration will be given to coding this as a
Tissue Engineered/Advanced Therapy Medicinal Product,
rather than as ocular tissue.
© 2011 ICCBBA, All Rights Reserved
Class Pigmentary
epithelial cells
The word “pre-cut” was removed from the nomenclature.
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Ocular Tissue Nomenclature
From
16
Organization
Nomenclature
Bradley
Tennant
Midwest
Eye-Banks
General
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
General
18
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
19
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
16
17
Response
Would it be possible to define
“labeling” or provide clarification in
regards to “labeling”? My
interpretation of labeling is the label
that is affixed to ocular tissue
containers. My concern is endothelial
cell density, corneal thickness and
corneoscleral disc diameter all
mention inclusion of this information in
the labeling. Label real estate can be
a real commodity for many eye banks.
Further guidance on labeling will be developed as a next
step by the EBTAG. At present, the term covers both
affixed and accompanying documentation.
Use of the term „labelling‟. SK asked
whether this refers to just to the tissue
container label or more generally to
the information sheets included with
the tissue.
Further guidance on labeling will be developed as a next
step by the EBTAG. At present, the term covers both
affixed and accompanying documentation.
Group
Corneoscleral
disc diameter
An indicator of whether the
corneoscleral disc diameter is
included in the labeling. A little
confused on whether the document is
actually defining the attribute group?
Does not define.
Recommend: "Corneoscleral disc
diameter: An indicator of whether the
measurement in microns of the
diameter of the cornea from limbus to
limbus is included in the labeling"
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
Group
Cornea
Thickness
A little confused on whether the
document is actually defining the
attribute group?
Does not define.
Recommend "Cornea Thickness: An
indicator of whether the calculation of
measurement in microns of the central
thickness of the cornea is included in
the labeling"
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
Definitions
Definitions
Labeling
© 2011 ICCBBA, All Rights Reserved
Comment
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Ocular Tissue Nomenclature
From
17
Organization
Nomenclature
Comment
Response
20
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
Group
Endothelial
Cell Density
A little confused on whether the
document is actually defining the
attribute group? Does not define.
Recommend "Endothelial Cell
Density: An indicator of whether the
calculation of endothelial cells/ mm² is
included in the labeling "
The group is used to define a flag to indicate whether the
endothelial cell density is provided. This can be used to
inform the receiving computer that there is another data
item to read. The actual measurement would be included
in the Dimensions Data Structure (a separate source of
electronic information) and would include the unit of
measure.
21
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
Group
Storage
Conditions Hypothermia
Recommend revising to "Short-Term
Preservation Medium: storage of
tissue in vitro in a nutrient medium <
14 days", as Hypothermia seems to
define the state the tissue is in, not
the medium, and encompasses any
refrigeration, such as WG.
This concern was addressed by separating storage state
from storage solutions.
22
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
Group
Storage
conditions Organ culture
Recommend to strike "This is the
principal storage method in the eye
bank and does not necessarily
describe the storage conditions during
delivery from the eye bank to the
operating room". Organ culture is not
the principal storage method in the
U.S., and I don't believe it's relevant to
the definition. If "Storage
Temperature" is added as an attribute
per above recommendation, the
proposed definition encompasses that
storage conditions do not necessarily
include transport.
This concern was addressed by splitting Storage
Conditions into two Attribute groups and amending
definitions, which now include the phrase: “Specifies the
storage state of the tissue in the eye bank. Delivery
conditions may vary.” (Note: The term „principal method‟
was not intended to imply national custom/practice but
rather referred simply to those individual eye banks,
regardless of country, that used organ culture as their
principal method of storage. Corneas stored by organ
culture are not necessarily delivered to the OR under the
exact same conditions as organ culture storage.)
23
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
Group
Permitted use. Default should be
„Surgical, research, education‟.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
© 2011 ICCBBA, All Rights Reserved
Permitted Use
Actual time of storage is intentionally not included since
this could change with new preservation solutions.
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Ocular Tissue Nomenclature
From
24
25
26
27
18
Organization
Nomenclature
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
Group
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
Edward J.
Holland, MD
Director,
Cornea
Service
Cincinnati Eye
Institute
Professor of
Ophthalmology
University of
Cincinnati
EBAA
David Glasser
Medical
Advisory
Board Chair
EBAA
Permitted Use
Group
Recommended
Clinical Use
Group
Recommended
Clinical Use of
Cornea Group
Comment
Response
Replace „or‟ with „and‟ in the permitted
use variables.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
Recommended clinical use. Important
information for the user, but not
needed in the code. The point is that
this information could be included in
the information included with the
tissue rather than as part of the code.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
There should be a listing for KLAL
tissue
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
KLAL was addressed in the new Corneal Graft Attribute
group. The definition of Corneoscleral disc was expanded
to include “may include some conjunctiva.”
© 2011 ICCBBA, All Rights Reserved
Group
Recommended
Clinical Use of
Cornea
The last sentence is unclear. What
does "group" refer to? Why would
recommended clinical use be limited
to the three categories listed? Why
couldn't it apply to any tissue? Is the
implication that banks will be required
to list a "recommended clinical use" or
is this just a definition? I have
additional concerns about the entire
concept of "recommended clinical
use" as noted below.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
www.iccbba.org
Ocular Tissue Nomenclature
From
19
Organization
Nomenclature
Comment
Response
28
David Glasser
Medical
Advisory
Board Chair
EBAA
Group
Recommended
Clinical Use of
Cornea Group:
Default: For
surgical use
only
Why would this be the default? There
is nothing wrong with making this the
default if that is most convenient for
eye banks, but most tissues eligible
for surgery would be eligible for all
three: surgery, research and
education.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
29
David Glasser
Medical
Advisory
Board Chair
EBAA
Group
Recommended
Clinical Use of
Cornea Group:
Default: DALK
only and
PK/DMEK
I have concerns with the entire
concept of "Recommended Clinical
Use."
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
© 2011 ICCBBA, All Rights Reserved
We tried to do this with the EBAA
Statistical report and it caused
numerous problems. In the examples I
cut and pasted above: some people
mount tissue on an artificial anterior
chamber for preparation of DALK or
DMEK. Techniques evolve and
different surgeons use different
techniques for the same procedure.
What is acceptable for one procedure
today may not be acceptable
tomorrow and vice versa. A cornea
with a stromal scar may indeed be
acceptable for ALK if it is laser cut first
to remove the scar, or if it is intended
for a tectonic non-optical graft. The
current nomenclature ignores the
tectonic non-optical category entirely.
It also ignores tissue for limbal stem
cell transplants. The possibilities are
extensive and can only be captured in
a standardized nomenclature if it is
much more detailed than what is listed
here, and if it is revised frequently to
keep up with changes in surgical
technique. With the current list, I
Limbal tissue was included as a Class
Conjunctiva was added as a new Class
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
20
Nomenclature
Comment
Response
suspect it will be easier for banks to
use the default "not specified" in many
cases.
What is the purpose of the
"Recommended Clinical Use"
section? Is it to make it easier for eye
banks to know how to place tissue?
Is it to facilitate statistical reporting of
how much tissue is available with
certain characteristics? It isn't for the
immediate benefit of the surgeon. It
could even increase medico legal risk
for surgeons who want to use tissue
for a clinical application other than the
one recommended by the eye bank.
For this reason alone, I would
recommend elimination of the term
"Recommended Clinical Use." If it is
decided to keep the current
categorization system, I would at least
rename this to something less
specific, maybe "frequent" or "typical"
clinical uses.
If the data is needed, I would replace
it with something like "Tissue
Characteristics" and make the
categories conform to tissue
characteristics rather than intended
use. This type of characterization
is what eye banks are used to doing.
Deciding appropriate clinical use of
tissue is part of the practice of
medicine and best left to the surgeon.
Instead of listing recommended
clinical use, consider separate
categories for the various
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
21
Nomenclature
Comment
Response
combinations of the following:
Endothelium - adequate vs.
inadequate
Who decides what the ECD cut-off is?
This is not addressed, and may differ
from one bank to another. Without a
uniform definition, does this have any
meaning?
Stroma - adequate vs. inadequate
Perhaps a more fine-grained grading
system is needed?
Cornea-scleral rim - adequate vs.
inadequate for AAC mounting
Who decides how big is big enough?
Limbal stem cell tissue
The current nomenclature ignores this
entirely. It is important in some cases.
Conjunctiva
The current nomenclature ignores this
entirely. It is important in some cases.
Banks can then set their own internal
guidelines for which types of
procedures to offer tissue for based
on the preferences of their surgeons.
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
30
Brian Philippy,
BSChE, BS,
CEBT
Director of
Transplant &
Research
Lions Medical
Eye Bank and
Research
Center of
Eastern
Virginia
22
Organization
Nomenclature
Comment
EBAA
Group
Recommended
Clinical Use of
Cornea group
This section is flawed.
We learned this lesson via our 2010
and previous statistical collection
models. You cannot predefine
groupings of tissue suitability. This
creates an inescapable logic problem.
There is no standard method for
evaluating tissue suitability. Since
each bank does this independently,
there may be criteria that makes a
cornea suitable for a procedure not
included in a grouping (e.g.
PK/DMEK/ALK or tectonic, etc.). It is
highly recommended that each
surgical suitability (clinical use
recommendation) be an independent
representation. This list should
include: EK, DALK/ALK, DMEK, PK,
KLA, Keratoprosthesis, nonkeratoplasty surgical use, and
Tectonic. The „tectonic‟ category is
best used for corneas that are
medically eligible, though less
desirable for any single technique.
Thereby the corneas are best used for
emergency situations, temporary
grafts that hold ocular stability, or for
use in parts of the world that wouldn‟t
receive tissue if lower quality tissue is
not made available. Non-keratoplasty
surgical use is for glaucoma shunt
patching, where cornea is used on the
scleral surface, so its use is not a
cornea surgery, but is a transplant.
Response
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
That‟s my two cents. Make each
suitability section independent and we
can all use the system.
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
23
Organization
Nomenclature
Comment
Response
31
David D
Verdier, MD
Verdier Eye
Center
Grand Rapids,
MI 49546
EBAA
Group
Recommended
Clinical Use of
Cornea Group
I would recommend another subset to
be included in the "Recommended
Clinical Use of Cornea Group":
DALK/PK. The rationale for this is to
provide for the rather common setting
in which a planned DALK procedure is
converted to a PK due to rupture of
Descemets membrane. Tissue for
these cases does not require
sufficient scleral rim for mounting in
an artificial anterior chamber, as
specified for the PK/EK/ALK/DMEK
subset.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
32
Beth Binnion
Cincinnati Eye
Bank
EBAA
Group
Recommended
Clinical Use of
Cornea Group
Four of the groups in this section
(DALK only, ALK/DALK, PK/DMEK,
and PK/EK/ALK/DMEK) use the
phrase "no stromal opacities" in
describing the tissue requirements for
use for these procedures.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
Many times, however, we can still use
a cornea with a stromal opacity for
ALK and PK procedures as long as
the opacity is outside of the button
required for the procedure (i.e. outside
of an 8.5mm button for the usual PK).
If the draft language is intended to
refer only to the central cornea
“button”, then this should not be a
problem. However, if the draft
language is referring to the entire
cornea, then many corneas would
inappropriately be recommended as
unsuitable for these procedures.
33
Ruth Phinney
Lions Eye
Bank of
Oregon
© 2011 ICCBBA, All Rights Reserved
Group
Recommended
Clinical Use of
I did not see, under the
“Recommended Clinical Use of
Cornea Group”, any designation for
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling. KLAL was addressed by the
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
24
Nomenclature
Comment
Cornea Group
keratolimbal allograft (KLAL) surgery.
Response
definition of Corneoscleral disc, which indicates it “may
include conjunctiva.”
There are two ways to view surgical
tissue: the patient‟s point of view, and
the eye bank‟s point of view:
From the patient‟s point of view the
tissue transplanted for a KLAL would
be Limbal Tissue. From the eye
bank‟s point of view, however, the
tissue provided for a KLAL is a
Corneoscleral Disc and it is the
surgeon who dissects the central
corneal tissue from the limbal tissue in
the OR, thus providing the actual
limbal-tissue transplant.
It is within the realm of possibility that
an eye bank would furnish limbal
tissue alone for a KLAL, but I am
unaware of this happening in the
United States. My own eye bank, The
Lions Eye Bank of Oregon, has
provided only Corneoscleral Discs for
KLAL. From our point of view, it is
advantageous to be able to designate
a cornea as suitable or not suitable for
KLAL as well as for specific corneal
surgeries, as specified in the
Recommended Clinical Use of Cornea
Groups. If the cornea is not accepted
for a KLAL surgery, it can then go on
to be placed as a corneal disc graft of
some sort.
If the Classes are not mutually
exclusive, then it would be possible to
make this designation by assigning
both the Corneoscleral Disc and the
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
25
Nomenclature
Comment
Response
Limbal Tissue classes to a suitable
cornea. If the Classes are mutually
exclusive, then clinical use of cornea
groups designating acceptability for
KLAL use need to be generated.
The particular tissue parameters
qualifying a Corneoscleral Disc for
use in KLAL are not the same as the
tissue parameters used to determine
the appropriate Recommended
Clinical Use of Cornea Group for any
cornea under consideration. Essential
KLAL parameters include a relatively
intact epithelium and procurement of
sufficient protective conjunctiva to
give the surgeon confidence the cells
of the limbal tissue will perform
satisfactorily upon transplantation.
If the rim-size considerations of the
DALK only and PK/DMEK
recommended use groups are
considered applicable to KLAL, and
rule-out tissues in those groups for
KLAL, then adding KLAL suitability or
lack thereof to the remaining groups
would result in an additional three
groups in the Recommended Clinical
Use of Cornea Groups.
If the rim-size considerations of the
current Recommended Clinical Use of
Cornea Groups are not considered
consonant with KLAL parameters,
then adding KLAL suitability or lack
thereof to all groups would double the
number of groups, resulting in a total
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
26
Nomenclature
Comment
Response
of ten Recommended Clinical Use of
Cornea Groups.
34
Garret Locke
Iowa Lions
Eye Bank
Group
Recommended
Clinical Use of
Cornea Group
Recommended Clinical Use of Cornea
Group” section: the section for
PK/DMEK highlights a reason for this
classification as “insufficient scleral
rim for mounting on an artificial
anterior chamber”. This language
pigeon-holes DMEK processing into
technologies that are 12-18 months
old. Likely, in initial drafts, this was
written at a time when the SCUBA
technique was widely thought to be
the method of tissue preparation.
Now, with the bubble technique, this
processing utilizes an anterior
chamber for a DSAEK type
processing as part of the DMEK
processing. It would be best to limit
classifications here strictly to
structural qualities and not necessarily
to attributes that may have a differing
impact on future processing
technologies.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
35
Joel Sugar
University of
Illinois,
Chicago
Department of
Ophthalmology
and Visual
Sciences
EBAA
Group
Recommended
clinical use of
cornea group:
under EK only
It would probably be wise to not
specify what is in the parentheses as
other forms of tissue processing are
certain to arise and some present one
such as DSEK (not automated) are
still likely done, as well as hybrid
preparations like DMEK tissue with
posterior stroma in the periphery, etc.
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
36
John Glasser
Medical
Advisory
Board Chair
EBAA
Group
Why limit this to HLA and ABO
typing? It might be found in the future
that some other typing is useful.
Perhaps this would be better written
This Attribute group was withdrawn. The information can
be included as text on either the affixed label or the
supplementary labeling.
© 2011 ICCBBA, All Rights Reserved
Additional
matching
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
27
Nomenclature
Comment
information
as "An indicator of whether donor
tissue typing has been
performed (e.g. HLA, ABO)."
Response
37
Joel Sugar
University of
Illinois,
Chicago
Department of
Ophthalmology
and Visual
Sciences
EBAA
Group
Storage
Conditions
Add gamma irradiated
A new Attribute group, Irradiated, was added
38
Ellen Heck,
University of
Texas
Southwestern
EBAA
Group
Storage
Conditions
I am not certain the preservation
media or technique would be covered
as it is defined. I am concerned it
might only lead some to think of
refrigerated or room temperature and
not the media or method. Should that
also be specified?
This concern was addressed by splitting Storage
Conditions into two Attribute groups, Storage Solutions
and Storage State.
© 2011 ICCBBA, All Rights Reserved
www.iccbba.org
Ocular Tissue Nomenclature
From
39
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
28
Organization
Nomenclature
EBAA
Group
Storage
Conditions
Comment
A description of storage conditions of
the tissue. Same comment as above.
Does not define. The list of the
different "Storage Conditions" listed
on page 6 actually appears to be a
blend of preservation media type, and
the state the cornea is in. For
instance, Glycerol and Hypothermia
do not seem to be in the same
category. May clarify to split out into
two distinct categories.
Response
This concern was addressed by splitting Storage
Conditions into two Attribute groups, Storage Solutions
and Storage State.
Recommendation: Revise Storage
Conditions to "Preservation Method:
A description of the method/ type of
media utilized to preserve the tissue
for use." Include new Attribute Group
"Storage Temperature: A description
of the storage temperature range
recommended for the specific
preservation type. Does not
necessarily define non-storage
transport conditions".
40
Amanda
Nerone
Quality
Assurance
Specialist
Heartland
Lions Eye
Banks
EBAA
Group
Storage
Conditions
Recommend revising per comments
above to "Preservation Method".
Remove temperature requirements
from the definitions of method types.
This concern was addressed by splitting Storage
Conditions into two Attribute groups, Storage Solutions
and Storage State.
41
Garret Locke
Iowa Lions
Eye Bank
Group
I know there are some eye banks
which preserve sclera in triple
antibiotic solution and some that
irradiate it. I don‟t know if there was
any consideration for this or not during
other reviews, but it would probably
A new Attribute group for irradiation was added.
© 2011 ICCBBA, All Rights Reserved
Storage
Conditions
”Saline” was added as a variable in the Storage Solution
Attribute group. Its definition indicates it “may include
antibiotics.”
www.iccbba.org
Ocular Tissue Nomenclature
From
Organization
29
Nomenclature
Comment
Response
be worthwhile to research all of the
different options being used out there
and include them in this list.
42
43
44
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
Stefan Ek
Board
member,
EEBA
Eye Banker
EEBA
Council
AEBA
Group
Storage
Conditions
Group
Storage
Conditions
Group
Storage
Conditions
45
David Glasser
Medical
Advisory
Board Chair
EBAA
© 2011 ICCBBA, All Rights Reserved
Group
Storage
Conditions
Storage conditions. SK raised the
issue that organ cultured corneas are
delivered to the OR in a different
medium.
The definition of the Storage State group was expanded
to indicate, “Specifies the storage state of the tissue in
the eye bank. Delivery conditions may vary.”
Sclera can be stored in balanced salt
solution and BSS should therefore be
added to the list of storage conditions.
The definition of “Saline” in the new Attribute group
Storage Solutions was expanded to read, “Isotonic saline
or balanced salt solution that may include antibiotics.”
Propose to add one more mode of
storage as they now have irradiated
corneal tissue that is stored in albumin
at room temperature. This may
become increasingly popular as
storage duration is 1 year.
A new Attribute group for Irradiation was added.
The delivery temperature disclaimer
should apply to hypothermia,
cryopreserved and moist chamber
storage as well as organ tissue.
The definition of the Storage State group was expanded
to indicate, “Specifies the storage state of the tissue in
the eye bank. Delivery conditions may vary.”
In the new Attribute group Storage Solutions, “Not
specified” can be used for solutions not currently in
common use. The actual solution can be indicated in eye
readable text on the affixed label or accompanying
documentation.
www.iccbba.org
Ocular Tissue Nomenclature
30
Comment received on draft version created after initial comment period.
From
1
David Glasser
Medical
Advisory
Board Chair
Organization
Nomenclature
Comment
EBAA
Corneal Graft
Attribute Group
I think there is still the potential for
ambiguity here. This section
mixes both anatomical definitions
and the means by which a graft is
prepared. For example, one could
categorize a laser-cut anterior
lamellar graft as either anterior
layer or laser shaped. Solutions
could include a separate section
for categorizing preparation
techniques or expanding this
section to include more
distinct/unique
anatomical/preparation
combinations.
© 2011 ICCBBA, All Rights Reserved
Response
Altered the definition to “Full-thickness cornea
shaped to a specific edge profile using laser.”
www.iccbba.org