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Target oriented selection of electrophysiological endpoints in preclinical and clinical trials
Author(s) -
ZRENNER E,
WILHELM B,
PETERS T,
KURTENBACH A
Publication year - 2009
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2009.3221.x
Subject(s) - clinical electrophysiology , clinical trial , selection (genetic algorithm) , quality (philosophy) , function (biology) , electrophysiology , computer science , medicine , neuroscience , medical physics , pathology , artificial intelligence , psychology , biology , philosophy , epistemology , evolutionary biology
Abstract Purpose The design of pre‐clinical and clinical studies, especially multi‐centre studies shall be discussed concerning the assessment of retinal function, retinal diseases and retinal circuitry as well as biochemistry and the selection of the proper electrophysiological “markers” for appropriate endpoints on the basis of knowledge on possible actions of particular compounds on visual function. Methods Quality has to be ensured by extended standard operating procedures and case report forms that implement also data that test the quality of procedures and calibrations. This includes harmonized quality standards, quality control, central reading and monitoring as well as data management. Results On the basis of standards and recommendations of International Society for Clinical Electrophysiology of Vision and EVI.CT.SE, extended protocols have been developed, targeted at rod and cone function, including sensitivity assessment of the retina by V‐log I‐functions, submicrovolt recording for clinical trials in patients with very small responses, ON and the OFF pathway differentiation. Additionally, ERG recovery after a strong bleach is recommended to target alterations in the visual cycle that involves photoreceptors as well as RPE cells. Conclusion First investigations with such refined standardized protocols have already been performed successfully showing a clear improvement of quality. Normative data are available for the various protocols.