2. Purpose

a. Modules The purpose of an ISCEV Module is to specify parameters, settings of stimulation and recording as well as data evaluation procedures for certain purposes, patient populations or compounds in clinical trials, in order to complement the ISCEV standard by addition of modules that allow recording of particular retinal responses (such as OFF and S-Cone responses) or functional alterations ( e.g. by “submicrovolt recordings”) that are not part of the standard itself. The list of modules (by Sept.1, 2008), examples of which are shown in fig.1, is as follows

ISCEV Standard modules (*), according to 2008 standard 1: Scotopic 0.01 ERG 5: Photopic 3.0 ERG 2: Scotopic 3.0 ERG 6: Photopic 3.0 flicker 3: Scotopic 3.0 oscillatory potentials 4: Scotopic 10 ERG New modules (being developed by ISCEV) 11: ROD b-wave series 31: Cone b-wave series 41: Focal ERG 12: ROD b-wave V-log(I) 32: S-Cone 13: a-wave analysis 33: ON-OFF response 14: small amplitude ERG 34: Photopic negative response 15: recovery after bleaching 41: Photopic Frequency series

(*) ISCEV Standard for clinical electroretinography (2008 update). Marmor MF, Fulton A, Holder GE, Miyake Y (Chair), Brigell M, Bach M (for the International Society for Clinical Electrophysiology of Vision).

b. Protocols

Protocols are documents that precisely describe each of the modules (presently under development by a small group of ISCEV members appointed for each module at Morgantown meeting). ISCEV has approved a template for the general structure of a protocol which includes: 1. Scope To be defined in all modules 2. Identification 2.1. Number 2.2. Version number 2.3. Date of approval) To be defined in all modules 3. Protocol use(s) 3.1 Patient population To be defined in all modules 4. Technical issues 4.1. Equipment and facilities 4.2. Staff expertise and responsibilities 4.3. Procedure 4.4. Patient Information Include definitions that are not exactly defined in the ISCEV Standard or in the section “general definitions” of this document 5. Response evaluation (with example) To be defined in all modules 6. Reporting and storage Include definitions that are not exactly defined in the ISCEV Standard or in the section “general definitions” of this document 7. Calibration Include definitions that are not exactly defined in the ISCEV Standard or in the section “general definitions” of this document 8. Protocol Specifications To be defined in all modules 9. Relevant References To be defined in all modules

c. Module sequences

After modules have defined, ISCEV will propose sequences of modules to be used in clinical trials’ protocols, as shown in fig.1, bottom; the sequences are named A, B, C…. and are designed such as to minimize the effect of preceeding modules on the response of a certain module, with respect to state of adaptation and strength of preceeding light stimulation. Module sequences will be defined in a matrix including all modules defined in the ISCEV standard as well as new modules that are defined by the ISCEV committees.

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