Chemical Considerations Regarding the H-Value Methodology and Its Relation With Toxicity Determination

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.

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Chemical compounds causing severe acute toxicity in heavy liquids used for intraocular surgery

Srivastava

Andrés-Iglesias

Coco

et al. 2020

Regulatory Toxicology and Pharmacology

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Chemical Considerations Regarding the H-Value Methodology and Its Relation With Toxicity Determination

Cited by 4 publications

References 5 publications

Safety of perfluorocarbon liquids cannot be the retinologist’s responsibility

Safety of perfluorocarbon liquids cannot be the retinologist’s responsibility

A minimum specification dataset for liquid ocular endotamponades: recommendations by a European expert panel

Chemical compounds causing severe acute toxicity in heavy liquids used for intraocular surgery

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