Safety of silicone oils as intraocular medical device: An in vitro cytotoxicity study

Romano, Mario R.; Ferrara, Mariantonia; Gatto, Claudio; Giurgola, Laura; Zanoni, Michele; Angi, Martina; Rinaldi, Michele; Borgia, Alfredo; Sorrentino, Tania; Tóthová, Jana DʼAmato

doi:10.1016/j.exer.2020.108018

Cited by 25 publications

(29 citation statements)

References 20 publications

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“…PDMS is synthesized from the octamethylcyclotetrasiloxane (D4) monomer. According to the European Chemical Agency (ECHA), D4 monomer is a toxic substance [ 5 ]. Several studies reported that D4 monomer has been shown to cause severe inflammation in rabbit and human eyes by penetrating ocular tissue [ 5 , 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

“…According to the European Chemical Agency (ECHA), D4 monomer is a toxic substance [ 5 ]. Several studies reported that D4 monomer has been shown to cause severe inflammation in rabbit and human eyes by penetrating ocular tissue [ 5 , 6 , 7 ]. D4 monomer caused acute ocular toxicity in the form of severe corneal edema and opacification [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

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Physical Characterization and In Vitro Toxicity Test of PDMS Synthesized from Low-Grade D4 Monomer as a Vitreous Substitute in the Human Eyes

Auliya

Setiadji

Fitrilawati

et al. 2022

JFB

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Polydimethylsiloxane (PDMS) is one of the most superior materials and has been used as a substitute for vitreous humor in the human eye. In previous research, we have succeeded in producing PDMS with low and medium viscosity using octamethylcyclotetrasiloxane (D4) monomer with a low grade of 96%. Both have good physical properties and are comparable to commercial product PDMS and PDMS synthesized using D4 monomer with a high grade of 98%. An improvement of the synthesis process is needed to ensure that PDMS synthesized from a low-grade D4 monomer under specific synthesis conditions can repeatedly produce high-quality PDMS. Apart from good physical properties, the PDMS as a substitute for vitreous humor must also be safe and not cause other disturbances to the eyes. Here, we reported the process of synthesizing and characterizing the physical properties of low- and medium-viscosity PDMS using a low-grade D4 monomer. We also reported for the first time the in vitro toxicity test using the Hen’s Egg Test Chorioallantoic Membrane (HET-CAM) test method. We have succeeded in obtaining PDMS with viscosities of 1.15 Pa.s, 1.17 Pa.s, and 1.81 Pa.s. All samples have good physical properties such as refractive index, surface tension, and functional groups that are similar to commercial PDMS. The HET-CAM test results showed that all samples did not show signs of irritation indicating that samples were non-toxic. From the results of this study, it can be concluded that PDMS synthesized from a low-grade D4 monomer under specific synthesis conditions by the ROP method is very safe and has the potential to be developed as a substitute for vitreous humor in human eyes.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Physical Characterization and In Vitro Toxicity Test of PDMS Synthesized from Low-Grade D4 Monomer as a Vitreous Substitute in the Human Eyes

Auliya

Setiadji

Fitrilawati

et al. 2022

JFB

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“…A recent in vitro study evaluated the short-term cytotoxicity of LMWCs to human ocular cell lines [ 18 ]. However, potential limitations were present in the experimental setup and the types of LMWC used, causing the results of the work to be less translatable [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

“…To address these limitations [ 18 ], in this study, an in vitro transwell cell culture system was used. This system allows the retinal cells to be in direct contact with the LMWCs on the apical side, while receiving nutrients from culture media on their basolateral side [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

What Is the Cause of Toxicity of Silicone Oil?

Chen

Zhou

et al. 2021

Materials

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Purpose: To investigate the toxicity of the low-molecular-weight components (LMWCs) in ophthalmic silicone oils (SilOils) on retinal cell lines. Methods: The toxicity of six types of LMWCs were studied and compared with conventional SilOil 1000 cSt. In vitro cytotoxic tests of LMWCs, in both liquid and emulsified forms, on three retinal cell lines (Müller cells (rMC-1), photoreceptor cells (661W) and retinal pigment epithelial cells (ARPE-19)) were conducted using a transwell cell culturing system. The morphology and viability of cells were assessed by light microscopy and Cell Counting Kit-8 (CCK-8) assay at different time points (6, 24 and 72 h). The ARPE-19 apoptotic pathway was investigated by Mitochondrial Membrane Potential/Annexin V Apoptosis Kit at different time points (6, 24 and 72 h). Results: Apart from dodecamethylpentasiloxane (L5), all liquid LMWCs showed varying degrees of acute cytotoxicity on retinal cell lines within 72 h. Emulsified LMWCs showed comparable cytotoxicity with liquid LMWCs on retinal cell lines. Cyclic LMWCs, octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) had significantly higher cytotoxicity when compared with their linear counterparts decamethyltetrasiloxane (L4) and L5 with similar molecular formula. Using ARPE-19 cells as an example, we showed that LMWCs induce the apoptosis of retinal cells. Conclusions: Most LMWCs, in both liquid and emulsified forms, can induce acute cytotoxicity. In addition, cyclic LMWCs are suspected to have higher cytotoxicity than their linear counterparts. Therefore, LMWCs are suspected to be the main cause of the long-term toxicity of ophthalmic SilOil, due to their toxicity and propensity to cause ophthalmic SilOil to emulsify. The amount of LMWCs should be considered as the paramount parameter when referring to the quality of SilOil.

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“…The use of silicones in medical industry is well established. In addition to their common use in breast implants for decades, silicones continue to be considered for a variety of new medical applications [50][51][52][53][54] .…”

Section: Biocompatibilitymentioning

confidence: 99%

Flexible thermoelectric generator with liquid metal interconnects and low thermal conductivity silicone filler

et al. 2021

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Harvesting body heat using thermoelectricity provides a promising path to realizing self-powered, wearable electronics that can achieve continuous, long-term, uninterrupted health monitoring. This paper reports a flexible thermoelectric generator (TEG) that provides efficient conversion of body heat to electrical energy. The device relies on a low thermal conductivity aerogel–silicone composite that secures and thermally isolates the individual semiconductor elements that are connected in series using stretchable eutectic gallium-indium (EGaIn) liquid metal interconnects. The composite consists of aerogel particulates mixed into polydimethylsiloxane (PDMS) providing as much as 50% reduction in the thermal conductivity of the silicone elastomer. Worn on the wrist, the flexible TEGs present output power density figures approaching 35 μWcm−2 at an air velocity of 1.2 ms−1, equivalent to walking speed. The results suggest that these flexible TEGs can serve as the main energy source for low-power wearable electronics.

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Safety of silicone oils as intraocular medical device: An in vitro cytotoxicity study

Cited by 25 publications

References 20 publications

Physical Characterization and In Vitro Toxicity Test of PDMS Synthesized from Low-Grade D4 Monomer as a Vitreous Substitute in the Human Eyes

Physical Characterization and In Vitro Toxicity Test of PDMS Synthesized from Low-Grade D4 Monomer as a Vitreous Substitute in the Human Eyes

What Is the Cause of Toxicity of Silicone Oil?

Flexible thermoelectric generator with liquid metal interconnects and low thermal conductivity silicone filler

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