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Lookup NU author(s): Professor David SteelORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2023, The Author(s). Purpose: To propose a minimum specification dataset to characterize liquid ocular endotamponades (OEs), namely silicone oil (SO), heavy SO (HSO), perfluorodecalin (PFD), and perfluoro-octane (PFO), in terms of physicochemical properties, purity and available evidence of safety, in line with ISO16672:2020. Methods: An evidence-based consensus using the expert panel technique was conducted. Two facilitators led a committee of 11 European experts. Facilitators prepared a dataset for each compound including the list of specifications relevant for the safety, identified by the group members on the basis of expertise and a comprehensive literature review. Each item was ranked by each member using a 9-point scale from 1 “absolutely to not include” to 9 “absolutely to include” in two rounds followed by discussion. Only items reaching consensus (score ≥ 7 from ≥ 75% of members) were included in the final datasets. Results: For all OEs, consensus was reached to include manufacturer, density, refractive index, chemical composition, dynamic viscosity, interfacial and surface tension, endotoxins, in vitro cytotoxicity assessment, and any evidence from ex vivo and/or in vivo tests for safety assessment. Additional specifications were added for SO (molecular weight distribution, content of oligosiloxanes with MW ≤ 1000 g/mol, spectral transmittance) and PFD/PFO (% of pure PFD/PFO in the final product, vapor pressure, chemical analyses performed for safety assessment). Conclusion: The proposed evidence-based minimum specification datasets for SO, HSO, PFD, and PFO have the potential to provide surgeons and health service purchasers with an easily available overview of the most relevant information for the safety assessment of OEs. [Figure not available: see fulltext.]
Author(s): Ferrara M, Steel DH, Romano MR, European Intraocular Tamponades Study Group
Publication type: Article
Publication status: Published
Journal: Graefe's Archive for Clinical and Experimental Ophthalmology
Year: 2024
Volume: 262
Pages: 1141-1149
Print publication date: 01/04/2024
Online publication date: 01/12/2023
Acceptance date: 19/10/2023
Date deposited: 23/01/2024
ISSN (print): 0721-832X
ISSN (electronic): 1435-702X
Publisher: Springer Nature
URL: https://doi.org/10.1007/s00417-023-06289-6
DOI: 10.1007/s00417-023-06289-6
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