A naturally shaped silicone ventricle evaluated in a mock circulation loop : a preliminary study

Mock circulation loops are used to evaluate the performance of cardiac assist devices prior to animal and clinical testing. A compressible, translucent silicone ventricle chamber that mimics the exact size, shape and motion of a failing heart is desired to assist in flow visualization studies around inflow cannulae during VAD support. The aim of this study was therefore to design and construct a naturally shaped flexible left ventricle and evaluate its performance in a mock circulation loop. The ventricle shape was constructed by the use of CT images taken from a patient experiencing cardiomyopathic heart failure and used to create a 3D image and subsequent mould to produce a silicone ventricle. Different cardiac conditions were successfully simulated to validate the ventricle performance, including rest, left heart failure and VAD support.

Twenty first century trends in silicone hydrogel contact lens fitting : an international perspective

Silicone hydrogel contact lenses were introduced into the market in 1999. To assess prescribing trends of this lens type since then, up to 1000 survey forms were sent to contact lens fitters in Australia, Canada, Japan, the Netherlands, Norway, the UK and the USA each year between 2000 and 2008. Practitioners were asked to record data relating to the first 10 contact lens fits or refits performed after receiving the survey form. Analysis of returned forms revealed a rapid increase in the prescribing of silicone hydrogel lenses over the survey period. In 2008, silicone hydrogel lenses represented 36% of all soft lenses prescribed. The categorization of the majority of lenses prescribed as ‘refits’ is primarily attributed to the mass conversion of lens wearers from hydrogel to silicone hydrogel lenses. Silicone hydrogels may soon represent the majority of soft contact lenses prescribed.

Clinical investigation of asmofilcon A silicone hydrogel lenses

Purpose. To investigate the clinical and subjective performance of asmofilcon A, a new third generation silicone hydrogel contact lens during 6-night extended wear (EW) over 6 months. Methods. A prospective, randomized, single-masked study was conducted. Sixty experienced daily wear soft contact lens wearers were randomly assigned to wear either asmofilcon A or senofilcon A contact lenses bilaterally for 6 months on an EW basis. Evaluations were conducted at contact lens delivery and after 1 week, 4 weeks, 3 and 6 months of EW. Results. Fifty subjects (83%) successfully completed the study. Two subjects experienced adverse events; one unilateral red eye with asmofilcon A and one asymptomatic infiltrate with senofilcon A. There were no significant differences in high or low contrast distance visual acuity between asmofilcon A and senofilcon A; however, low contrast distance visual acuity decreased significantly over time with both contact lens types (p < 0.05). The two lens types did not vary significantly with respect to any of the objective and subjective measures assessed (p > 0.05). Superior palpebral conjunctival injection showed a statistically significant increase over time with both lens types (p < 0.05). Both lens types were rated highly with respect to overall comfort, with subjects reporting 14 or 15 h of comfortable lens wearing time per day at each of the study visits (p > 0.05). Overall satisfaction ratings were also very high at all visits, with median scores of 95 (86 to 99) for asmofilcon A and 90 (85 to 96) for senofilcon A at 6 months (p > 0.05). Conclusions. Over 6 months of EW, the asmofilcon A contact lens performed in a similar manner to senofilcon A with respect to visual acuity, ocular health, and contact lens performance measures. Longer-term EW studies are required to investigate the changes over time observed with both lens types.

Reinforced hydrogels for silicone copolymer delivery for scar remediation

Hypertrophic scars are formed by collagen overproduction in wounded areas and often occur in victims of severe burns. There are several methods for hypertrophic scar remediation and silicone gel therapy is one of the more successful methods. Research by others has shown that the activity of these gels may be due to migration of amphiphilic silicone oligomers from the gel and into the dermis, down-regulating production of collagen by fibroblasts. Normal silicone oil (PDMS) does not produce the same effect on fibroblasts. The main purpose of this project is the introduction of a particular amphiphilic silicone rake copolymer into an appropriate network which can absorb and release the silicone copolymer on the scarred area. Hydrogels are polymeric crosslinked networks which can swell in water or a drug solution, and gradually release the drug when applied to the skin. The application of gel enhances the effectiveness of the therapy, reduces the period of treatment and can be comfortable for patients to use. Polyethylene glycol (PEG) based networks have been applied in this research, because the amphiphilic silicone rake copolymer to be used as a therapy has polyethylene oxide (PEO) as a side chain. These PEO side chains have very similar chemical structure to a PEG gel chain so enhancing both the compatibility and the diffusion of the amphiphilic silicone rake copolymer into and out of the gel. Synthesis of PEG-based networks has been performed by two methods: in situ silsesquioxane formation as crosslink with a sol-gel reaction under different conditions and UV curing. PEG networks have low mechanical properties which is a fundamental limitation of the polymer backbone. For mechanical properties enhancement, composite networks were synthesized using nano-silica with different surface modification. The chemical structure of in situ silsesquioxane in the dry network has been examined by Solid State NMR, Differential Scanning Calorimetry (DSC) and swelling measurements in water. Mechanical properties of dry networks were tested by Dynamic Mechanical Thermal Analysis (DMTA) to determine modulus and interfacial interaction between silica and the network. In this way a family of self-reinforced networks has been produced that have been shown to absorb and deliver the active amphiphilic silicone- PEO rake copolymer.

Pre-clinical evaluation of amphiphilic silicone oligomers for scar remediation

The formation of hypertrophic scars is a frequent outcome of wound repair and often requires further therapy with treatments such as silicone gel sheets (SGS; Perkins et al., 1983). Although widely used, knowledge regarding SGS and their mechanism of action on hypertrophic scars is limited. Furthermore, SGS require consistent application for at least twelve hours a day for up to twelve consecutive months, beginning as soon as wound reepithelialisation has occurred. Preliminary research at QUT has shown that some species of silicone present in SGS have the ability to permeate into collagen gel skin mimetics upon exposure. An analogue of these species, GP226, was found to decrease both collagen synthesis and the total amount of collagen present following exposure to cultures of cells derived from hypertrophic scars. This silicone of interest was a crude mixture of silicone species, which resolved into five fractions of different molecular weight. These five fractions were found to have differing effects on collagen synthesis and cell viability following exposure to fibroblasts derived from hypertrophic scars (HSF), keloid scars (KF) and normal skin (nHSF and nKF). The research performed herein continues to further assess the potential of GP226 and its fractions for scar remediation by determining in more detail its effects on HSF, KF, nHSF, nKF and human keratinocytes (HK) in terms of cell viability and proliferation at various time points. Through these studies it was revealed that Fraction IV was the most active fraction as it induced a reduction in cell viability and proliferation most similar to that observed with GP226. Cells undergoing apoptosis were also detected in HSF cultures exposed to GP226 and Fraction IV using the Tunel assay (Roche). These investigations were difficult to pursue further as the fractionation process used for GP226 was labour-intensive and time inefficient. Therefore a number of silicones with similar structure to Fraction IV were synthesised and screened for their effect following application to HSF and nHSF. PDMS7-g-PEG7, a silicone-PEG copolymer of low molecular weight and low hydrophilic-lipophilic balance factor, was found to be the most effective at reducing cell proliferation and inducing apoptosis in cultures of HSF, nHSF and HK. Further studies investigated gene expression through microarray and superarray techniques and demonstrated that many genes are differentially expressed in HSF following treatment with GP226, Fraction IV and PDMS7-g-PEG7. In brief, it was demonstrated that genes for TGFβ1 and TNF are not differentially regulated while genes for AIFM2, IL8, NSMAF, SMAD7, TRAF3 and IGF2R show increased expression (>1.8 fold change) following treatment with PDMS7-g-PEG7. In addition, genes for αSMA, TRAF2, COL1A1 and COL3A1 have decreased expression (>-1.8 fold change) following treatment with GP226, Fraction IV and PDMS7-g-PEG7. The data obtained suggest that many different pathways related to apoptosis and collagen synthesis are affected in HSF following exposure to PDMS7-g-PEG7. The significance is that silicone-PEG copolymers, such as GP226, Fraction IV and PDMS7-g-PEG7, could potentially be a non-invasive substitute to apoptosis-inducing chemical agents that are currently used as scar treatments. It is anticipated that these findings will ultimately contribute to the development of a novel scar therapy with faster action and improved outcomes for patients suffering from hypertrophic scars.

The effect of hydrogel and silicone hydrogel contact lenses on the measurement of intraocular pressure with rebound tonometry

Purpose: To assess the accuracy of intraocular pressure(IOP) measurements using rebound tonometry over disposable hydrogel (etafilcon A) and silicone hydrogel (senofilcon A) contact lenses (CLs) of different powers. Methods: The experimental group comprised 36 subjects (19 male, 17 female). IOP measurements were undertaken on the subject’s right eyes in random order using a rebound tonometer (ICare). The CLs had powers of +2.00D, −2.00D and−6.00D. Six measurements were taken over each contact lens and also before and after the CLs had been worn. Results: A good correlation was found between IOP measurements with and without CLs (all r≥0.80; p < 0.05). Bland Altman plots did not show any significant trend in the difference in IOP readings with and without CLs as a function of IOP value. A two-way ANOVA revealed a significant effect of material and power (p < 0.01) but no interaction. All the comparisons between the measurements without CLs and with hydrogel CLs were significant (p < 0.01). The comparisons with silicone hydrogel CLs were not significant. Conclusions: Rebound tonometry can be reliably performed over silicone hydrogel CLs. With hydrogel CLs, the measurements were lower than those without CLs. However, despite the fact that these differences were statistically significant, their clinical significance was minimal.

Clinical performance of a new silicone hydrogel contact lens over 6 months of extended wear

Purpose: Silicone hydrogel contact lenses (CLs) are becoming increasingly popular for daily wear (DW), extended wear (EW) and continuous wear (CW), due to their higher oxygen transmissibility compared to hydrogel CLs. The aim of this study was to investigate the clinical and subjective performance of asmofilcon A (Menicon Co., Ltd), a new surface treated silicone hydrogel CL, during 6-night EW over 6 months (M). Methods: A prospective, randomised, single-masked, monadic study was conducted. N=60 experienced DW soft CL wearers were randomly assigned to wear either asmofilcon A (test: Dk=129, water content (WC)=40%, Nanogloss surface treatment) or senofilcon A (control: Dk=103, WC=38%, PVP internal wetting agent, Vistakon, Johnson & Johnson Vision Care) CLs bilaterally for 6 M on an EW basis. A PHMB-preserved solution (Menicon Co., Ltd) was dispensed for CL care. Evaluations were conducted at CL delivery and after 1 week (W), 4 W, 3 M and 6 M of EW. At each visit, a range of objective and subjective clinical performance measures were assessed. Results: N=50 subjects (83%) successfully completed the study, with the majority of discontinuations due to loss to follow-up (n=3) or moving away/travel (n=5). N=2 subjects experienced adverse events; n=1 unilateral red eye with asmofilcon A and n=1 asymptomatic infiltrate with senofilcon A. There were no significant differences in high or low contrast distance visual acuity (HCDVA or LCDVA) between asmofilcon A and senofilcon A; however, LCDVA decreased significantly over time with both CL types (p<0.05). The two CL types did not vary significantly with respect to any of the objective and subjective measures assessed (p>0.05); CL fitting characteristics and CL surface measurements were very similar and mean bulbar and limbal redness measures were always less than grade 1.0. Superior palpebral conjunctival injection showed a statistically, but not clinically, significant increase over time with both CL types (p<0.05). Corneal staining did not vary significantly between asmofilcon A and senofilcon A (p>0.05), with low median gradings of less than 0.5 observed for all areas assessed. There were no solution-related staining reactions observed with either CL type. The asmofilcon A and senofilcon A CLs were both rated highly with respect to overall comfort, with medians of 14 or 15 hours of comfortable lens wearing time per day reported at each of the study visits (p>0.05). Conclusions: Over 6 months of EW, the asmofilcon A and senofilcon A CLs performed in a similar manner with respect to visual acuity, ocular health and CL performance measures. Some changes over time were observed with both CL types, including reduced LCDVA and increased superior palpebral injection, which warrant further investigation in longer-term EW studies. Asmofilcon A appeared to be equivalent in performance to senofilcon A.

Amphiphilic silicone archtectures via anaerobic thiol - ene chemistry

Despite broad application, few silicone-based surfactants of known structure or, therefore, surfactancy have been prepared because of an absence of selective routes and instability of silicones to acid and base. Herein the synthesis of a library of explicit silicone-poly(ethylene glycol) (PEG) materials is reported. Pure silicone fragments were generated by the B(C(6)F(5))(3)-catalyzed condensation of alkoxysilanes and vinyl-functionalized hydrosilanes. The resulting pure products were coupled to thiol-terminated PEG materials using photogenerated radicals under anaerobic conditions.

Power-law viscous materials for analogue experiments: New data on the rheology of highly-filled silicone polymers

The selection of appropriate analogue materials is a central consideration in the design of realistic physical models. We investigate the rheology of highly-filled silicone polymers in order to find materials with a power-law strain-rate softening rheology suitable for modelling rock deformation by dislocation creep and report the rheological properties of the materials as functions of the filler content. The mixtures exhibit strain-rate softening behaviour but with increasing amounts of filler become strain-dependent. For the strain-independent viscous materials, flow laws are presented while for strain-dependent materials the relative importance of strain and strain rate softening/hardening is reported. If the stress or strain rate is above a threshold value some highly-filled silicone polymers may be considered linear visco-elastic (strain independent) and power-law strain-rate softening. The power-law exponent can be raised from 1 to ~3 by using mixtures of high-viscosity silicone and plasticine. However, the need for high shear strain rates to obtain the power-law rheology imposes some restrictions on the usage of such materials for geodynamic modelling. Two simple shear experiments are presented that use Newtonian and power-law strain-rate softening materials. The results demonstrate how materials with power-law rheology result in better strain localization in analogue experiments.

The epidemiology of microbial keratitis with silicone hydrogel contact lenses

It was widely anticipated that after the introduction of silicone hydrogel lenses, the risk of microbial keratitis would be lower than with hydrogel lenses because of the reduction in hypoxic effects on the corneal epithelium. Large-scale epidemiological studies have confirmed that the absolute and relative risk of microbial keratitis is unchanged with overnight use of silicone hydrogel materials. The key findings include the following: (1) The risk of infection with 30 nights of silicone hydrogel use is equivalent to 6 nights of hydrogel extended wear; (2) Occasional overnight lens use is associated with a greater risk than daily lens use; (3) The rate of vision loss due to corneal infection with silicone hydrogel contact lenses is similar to that seen in hydrogel lenses; (4) The spectrum of causative organisms is similar to that seen in hydrogel lenses, and the material type does not impact the corneal location of presumed microbial keratitis; and (5) Modifiable risk factors for infection include overnight lens use, the degree of exposure, failing to wash hands before lens handling, and storage case hygiene practice. The lack of change in the absolute risk of disease would suggest that exposure to large number of pathogenic organisms can overcome any advantages obtained from eliminating the hypoxic effects of contact lenses. Epidemiological studies remain important in the assessment of new materials and modalities. Consideration of an early adopter effect with studies involving new materials and modalities and further investigation of the impact of second-generation silicone hydrogel materials is warranted.

An early assessment of silicone hydrogel safety : pearls and pitfalls, and current status

The contact lens industry has evolved and now provides many choices, including continuous wear, overnight orthokeratology, frequent-replacement lenses, daily-disposable lenses, and many alternatives in systems of care and maintenance. Epidemiologic studies to date have shown that how a lens is worn, particularly if worn overnight, can increase the risk of microbial keratitis. However, the risk of silicone hydrogel contact lenses worn on a continuous-wear basis has been evaluated only recently. This article summarizes the recent research data on extended-wear silicone hydrogel lenses and discusses the challenges of early evaluations of silicone hydrogel lens safety. Finally, the relevance of this information is discussed to practitioners and contact lens wearers making choices about the risks and benefits of different products and how they are used.

In response: Changes in ultraviolet transmittance of hydrogel and silicone hydrogel contact lenses induced by wear

We thank Dr Shedden and Dr Pall for their insightful comments and the opportunity to clarify a number of points from our work.1 The “protection factor” (PF) expressed as the inverse of the transmittance of contact lens (CL) material (1/Tλ), where T is the percentage transmittance of ultraviolet radiation (UVR) in a given waveband (UVC, UVB or UVA) of the UV spectrum for contact lenses is the standard method for reporting PF values and as such there should not be any controversy. We have calculated the PF for each wavelength across the entire UV spectrum (UVC, UVB, UVA) as presented in figure 3 of our previous publication.1 In that article, we were simply stating the observation when transmission in the UVC spectra band is considered especially because appreciable amounts of potentially carcinogenic short UV wavelengths was shown to be present in sunlight in our region three decades ago2 and these short wavelength photons are reported to be more biologically damaging to ocular tissues.3 In addition, the depletion of the Ozone layer is still continuing. Nevertheless, we understand the concern of the authors that the results of the PF might be confusing to those who are not familiar with the science of UVR and as such we have made some revisions to the findings of the calculated PF...

Persistent anterior chamber silicone oil and myopia

A 60-year-old male experienced a marked unilateral myopic shift of 20 D following attempted removal of intravitreal heavy silicone oil (HSO) used in the treatment of inferior proliferative vitreous retinopathy following retinal detachment. Examination revealed HSO adherent to the corneal endothelium forming a convex interface with the aqueous, obscuring the entire pupil, which required surgical intervention to restore visual acuity. This case highlights the potential ocular complications associated with silicone oil migration into the anterior chamber, which include corneal endothelial decompensation and a significant increase in myopia.

Studies on the Tracking and Erosion Resistance of RTV Silicone Rubber Nanocomposite

One of the problems associated with outdoor polymeric insulators is tracking and erosion of the weathershed which can directly influence the reliability of the power system. Flame retardants are added to the base material to enhance its tracking and erosion resistance. Hydroxide fillers are regarded as the best flame retardants. This paper deals with studies related to nano - sized magnesium dihydroxide (MDH) and micron-sized Alumina Trihydrate (ATH) fillers as flame retardants in RTV silicone rubber. Tracking and erosion resistance studies were carried out on MDH and ATH silicone rubber composites using an inclined plane tracking and erosion (IPT) resistance tester. The MDH filled (5% by wt) composites performed much better than ATH composites in terms of eroded mass, depth of erosion, width and length of erosion. The eroded mass of MDH composite is 49.8 % that of ATH composite which can be attributed to high surface area and higher thermal stability of MDH nanofillers.