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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 © 2011 ICCBBA, All Rights Reserved www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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 www.iccbba.org 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. © 2011 ICCBBA, All Rights Reserved www.iccbba.org 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. www.iccbba.org 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. www.iccbba.org 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 www.iccbba.org 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. www.iccbba.org 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