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.

Key biological issues in contact lens development

A contact lens is a medical device widely used as an alternative to spectacles in order to correct refractive vision problems. The evolution of polymeric biomaterials has heralded a continuous development in the materials used to produce contact lenses and maximize patient comfort and limit adverse events. Microbial keratitis (MK) is a relatively rare but potentially devastating condition associated with contact lens use, particularly with the extended wear of hydrogel lenses. It is the principal complication related to contact lens wear and the large population at risk make it a public health concern. Bacterial binding to the contact lens material is a precursor to the development of MK and is influenced by properties of the material and the bacteria. In order for bacteria to infiltrate the cornea there must be some degree of corneal damage, usually caused by trauma or hypoxia. The most recent materials available aim to allow the continuous wear of lenses while limiting corneal hypoxia, thus helping to prevent the development of MK. Limitations to the treatment of MK require that novel approaches may be necessary in order to limit bacterial adhesion to contact lens materials.

Effets du port continu de coquilles correctrices Invisalign® sur l’articulation temporo-mandibulaire et les muscles du complexe facial.

INTRODUCTION : L’articulation temporo-mandibulaire (ATM) est un système articulaire excessivement complexe. L'étiologie des désordres temporo-mandibulaires (DTM) est encore incertaine et le lien de cause à effet des traitements orthodontiques en tant que facteur de risque est une question qui a longuement été discutée. Cette étude clinique prospective vise à évaluer les effets à long terme du port continu de coquilles correctrices Invisalign® sur l’ATM et les muscles du complexe facial. MATÉRIELS ET MÉTHODES : L'étude incluait 43 adolescents et adultes âgés entre 13 et 51 ans (25 femmes et 18 hommes). Deux d'entre eux ont été exclus en raison de mauvaise coopération causant l’arrêt du traitement orthodontique. Les effets dans le temps des coquilles sur l'ATM et les muscles du complexe facial ont été évalués en utilisant l’examen du Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Le nombre de contractions musculaires durant le sommeil a été mesuré objectivement par enregistrements électromyographiques (EMG) et la fréquence de grincement et de serrement des dents à l’éveil a été rapportée subjectivement par les patients à l’aide de questionnaires. Des mesures répétées ont été effectuées aux temps suivants: avant le début du traitement pour les données contrôles (T1), deux semaines (T2), et six mois (T3) après le début du traitement. Les données numériques ont été analysées par l’analyse de variance (ANOVA) en mesures répétées et la méthode de Brunner-Langer, alors que les données nominales ont été évaluées par le test de Cochran-Mantel-Haenszel. Les résultats ont été considérés significatifs si p < 0.05. RÉSULTATS ET DISCUSSION : Le nombre de contractions musculaires par heure (index) durant le sommeil et leur durée moyenne n’ont pas été statistiquement différents entre les trois nuits d’enregistrement EMG (Brunner Langer, p > 0.005). Cependant, 67 % des participants ont rapporté avoir eu du grincement ou du serrement des dents la nuit au T2 et 64 % au T3 comparativement à 39 % au T1, ce qui était une augmentation significative (Cochran-Mantel-Haenszel, p = 0.0112). Quarante-quatre pour cent des patients ont signalé du grincement ou du serrement des dents pendant le jour au T1, tandis qu'un pourcentage nettement plus élevé de 66 % en a rapporté au T2 et 61 % au T3 (Cochran-Mantel-Haenszel, p = 0.0294). Au T1, 12 % des sujets ont indiqué qu'ils se sont réveillés avec une douleur musculaire, comparativement à 29 % au T2, ce qui était une augmentation significative (Cochran-Mantel-Haenszel, p = 0.0347). Au T2, il y avait une réduction significative des mouvements maximaux de la mandibule dans toutes les directions (ANOVA en mesures répétées, p < 0,05). De plus, il y a eu une augmentation significative du nombre de sites douloureux et de l'intensité de la douleur à la palpation de l'ATM et des muscles faciaux avec l'évaluation du RDC/TMD au T2 en comparaison aux T1 et T3 (Brunner Langer, p < 0,05). CONCLUSION : La présente étude n’a révélé aucun effet des coquilles sur l’activité oro-faciale durant le sommeil au fil du temps mesurée objectivement à l’aide des enregistrements EMG, mais une augmentation significative de la fréquence du grincement et du serrement des dents rapportée subjectivement par les patients au moyen des questionnaires aux T2 et T3. Au T2, il y avait une augmentation significative des symptômes de l'ATM et des muscles du complexe oro-facial, mais ces symptômes sont retournés au niveau initial avec le temps.

Use of silicone hydrogel contact lenses by Australian optometrists

Background: Prior to the launch of silcone hydrogel (Si-H) materials in Australia in 1999, only 1.6 per cent of lenses were prescribed on a continuous wear basis.

Methods: One thousand surveys were distributed randomly to practitioners in Australia during January 2000, 2001 and 2002 (total surveys 3,000). Each anonymous survey requested data about the next 10 patients fitted with contact lenses, including date, age, gender, new fitting or refitting, lens material type, lens design, frequency of replacement, modality of wear, uses per week and care regimen.

Results: Twenty per cent (599) were returned, reporting data on 5,976 fittings. A total of 710 fittings used Si-H contact lenses (11.9 per cent), which represented 18.6 per cent of all soft lens fittings. During the three years, the proportion of practitioners prescribing Si-H lenses increased from 42.2 to 52.5 per cent. In 2000, 43.8 per cent were daily wear, which decreased to 32.2 per cent by 2002. The solution system of choice for daily wear lenses was multipurpose solutions (98.4 per cent); the only alternative was hydrogen peroxide systems. Continuous wear represented 11.7 per cent of all fittings, ofwhich 85.7 per cent were Si-H, 3.0 per cent RGP lenses and 11.3 per cent conventional hydrogels. For continuous wear, 79.0 per cent of fittings were to existing wearers, whereas for daily wear, 59.4 per cent were existing wearers. More males were prescribed Si-H continuous wear contact lenses, while females were more likely to be prescribed Si-H on a daily wear basis.

Discussion: Si-H contact lenses were introduced to the Australian market as a continuous wear contact lens, yet many practitioners use this product for daily wear with multipurpose solutions. By 2002, more practitioners were prescribing Si-H contact lenses for continuous wear than in 2000, suggesting a growing confidence in that product for that mode of wear. A comparison with an earlier survey shows there is an increase in continuous wear from 1.6 per cent to 11.7 per cent over a five-year period.

A seven year survey of the contact lens prescribing habits of Canadian optometrists

Purpose. Little is known about the contact lens prescribing habits of optometrists in North America. The purpose of this survey was to obtain data on the types of lenses and solutions prescribed by Canadian optometrists.

Methods. One thousand Canadian optometrists were surveyed annually over seven consecutive years (2000 to 2006; n = 7000) on their contact lens prescribing preferences. Each survey requested a range of information about the contact lenses prescribed to the first 10 patients after its receipt.

Results. Over this time period, 1008 (14.4%) of the surveys were returned, providing data on 9383 fits. During the seven-year period, the ratio of male:female fits was 1:2 (3123:6217, 43 not reported), with a mean age of 31.3 ± 13.6 years (range 2 to 82 years). The ratio of new fits to refits was 2:3 (3780:5518, 85 not reported), with 91.3% of all fits being soft contact lenses (SCL). Of the SCL fits, 59.5% were spherical, 28.5% toric, 9.7% multifocal, and 2.3% cosmetic tints. Gas permeable (GP) fits were 46.6% spherical, 18.6% toric, 19.5% multifocal, and 6.6% were for orthokeratology (OK). Over the seven-year period, SCL prescribed for continuous wear (CW) increased from 3.2% to 14.3% between 2000 and 2004 and reduced to 8.1% in 2006, for all fits. The use of mid-water content (MWC) materials decreased from 34.6% to 2.7% and the use of silicone hydrogel (SH) lenses increased from 61.4% to 96.2%, for all CW fits. GP lens continuous wear increased from 0.7% to 30.6% of all GP lens fits by 2006. Daily wear (DW) of SH lenses decreased from 49.6% (2000) to 33.7% (2004) and then increased to 86.1% in 2006, for SH fits. MWC SCL fit on a monthly planned replacement (PR) basis reduced in popularity over the seven-year period (75.0% to 39.9%) and in 2006 more patients were fit overall with SH lenses (42.9%). The use of non-PR SCL declined from 20.5% to 4.5% of all fits. Fitting of low-water content lenses also declined (15.1% to 7.0%). High-water content (5.4% to10.2%) and SH lenses (5.4% to 42.9%) both increased. By 2006, the majority of GP lenses fit were with high Dk (HDK) materials (50.3%).

Conclusions. The preferred contact lens modality for Canadian optometrists appears to be DW SCL, which are replaced monthly. The proportion of lenses used for CW peaked in 2004, with SH SCL being the preferred material. The market share for GP lenses remains relatively unchanged, with an increasing proportion used for OK and CW. The launch of DW SH lenses in 2004 resulted in a marked increase in their reported fits, with a similar effect following the launch of a HDK GP lens material for CW.

Ocular response to silicone-hydrogel contact lenses

The thesis investigates the ocular response to silicone-hydrogel (SiH) contact lens wear, a relatively new contact lens material that has a higher modulus of rigidity and different surface coating than used in conventional hydrogel materials. The properties of SiH materials differ significantly from conventional hydrogels and, using subjective and objective means of assessment, the thesis examines how these properties affect reflection and biometry, ocular physiology, tear film characteristics, symptomatology, adverse events and complications. A range of standard and newly designed investigative techniques were employed, and latter involving novel imaging techniques, for the objective assessment of physiological changes which occur with contact lens wear. The study is the first to combine these techniques with biochemical analyses of the tear film composition. Forty-seven subjects were fitted with SiH lenses and randomly allocated to one of the two materials currently on the market (Lotrafilcon A or Balafilcon A) on an either daily or continuous wear basis. An additional control group of 14 age-matched non-contact lens wearers were monitored over the same period. Measurements were taken before and 1, 3, 6, 12 and 18 months after initial fitting. The findings reported in this thesis will enable contact lens practitioners and manufacturers to understand further the optical, physiological and biochemical nature of the ocular response to SiH contact lenses and hence facilitate the development of this important generation of contact lens material.

The effect of care solutions on the bulk and surface properties of soft contact lenses

Purpose: Soft contact lenses for continuous wear require the use of cleaning regimes which utilise hydrogen peroxide systems or multipurpose cleaning solutions (MPS). The compositions of MPS are becoming increasingly complex and often include disinfectants, cleaning agents, preservatives, wetting agents, demulcents, chelating and buffering agents. Recent research on solution–lens interactions has focused on specific ocular parameters such as corneal staining. However the effect of a solution on the lens, particularly silicone hydrogel lenses, itself has received less attention. The purpose of this work was to establish and understand the effects that care solutions have on selected bulk and surface material properties. Methods: Selected bulk and surface properties of each material (etafilcon A, vifilcon A, balafilcon A, senofilcon A, lotrafilcon A and lotrafilcon B, galyfilcon A) were measured after a 24 h soak in a variety of care solutions. Additionally the lenses were soaked for 24 h in hyperosmolar (680 mOsm L-1) and hyposmolar (170 mOsm L-1) PBS. A bulk property parameter the total diameter (TD) was measured using an Optimec contact lens analyser. The surface property related CoF of soaked lenses was measured on a nano-tribometer with conditions of load 30 mN, at a distance of 20 mm and speed 30 mm/min. Results: In terms of bulk properties, change is related to the EWC of the lens, the higher the EWC of the lens the greater the TD changes. Silicone hydrogel lenses have EWCs of <47% and little or no TD changes were observed; lotrafilcon A exhibited no change irrespective of the cleaning solution. Conventional contact lenses have higher EWCs (58% for etafilcon A and 55% for vifilcon A) and the TD was seen to change to a greater extent, for example the etafilcon A material in ReNu MPS had an increase to 14.45± 0.07 mm from the cited 14.2 mm. Other lenses increased or decreased in TD depending on the solution used. The osmolarity of the solution although important is not the only factor governing change in the TD, for example soaking senofilcon A in hyperosmolar PBS (680 mOsm L-1) for 24 h increased the TD of the lens (+0.25 ± 0.07 mm), however when the same lens type was soaked for 24 h in a MPS with a lower osmolarity there was a similar effect. Biotribology measurements demonstrated that some solution–lens combinations can reduce the CoF by 55%, when compared with biotribology with the native packing solution. An increase in the CoF was observed for other solution–lens combinations. Conclusions: There is a dramatic difference in bulk and surface performance of specific lens materials with particular care solutions. Individual components of the care solutions have effects on the bulk and surface properties of contact lenses. The affects are not as great with the silicone hydrogel as compared with conventional hydrogels.

Refractive and biometric changes with silicone hydrogel contact lenses

Purpose. This study reports data from an 18-month longitudinal study of neophyte contact lens wearers and compares changes in ocular refraction and biometry induced by daily wear and continuous wear of two different silicone hydrogel (SiH) materials. Methods. Forty-five subjects were enrolled in the study and randomly assigned to wear one of the two silicone hydrogel materials: Lotrafilcon A or Balafilcon A lenses on either a daily or continuous wear basis. Measurements of objective refraction, axial length, anterior chamber depth, corneal curvature, and the rate of peripheral corneal flattening were performed before and 1, 3, 6, 12, and 18 months after initial fitting. Results. Mean spherical equivalent refractive error increased in the myopic direction in all contact lens groups across time (p < 0.001). Axial length was the main biometric contributor to the development of myopia. After 18 months of lens wear, subjects in the Lotrafilcon A group showed the greater mean increase in myopia (i.e., -0.50 D). Conclusions. The results of this study show that increases in myopia, similar if not higher than those found to occur normally in young adult noncontact lens wearers, still occur with silicone hydrogel contact lens wear. The main biometric contributor to the progression of myopia was an increase in axial length. Differences between our results and those of previous studies with silicone hydrogel contact lenses could be attributed to the differing populations used in which both age and occupation may have played a role. Copyright © 2005 American Academy of Optometry.

Friction and wear behaviour of continuous fibre as cast Kevlar-phenolic resin composite

A compression moulded Kevlar-phenolic resin composite consisting of 30 wt% continuous fibres was slid against a steel disc such that the fibre axis was normal to the sliding plane. The sliding experiments were conducted in a normal pressure range of 0.47–4.27 MPa and at a sliding speed of 0.5 ms–1. The initial sliding interaction is abrasive. With further sliding, as patches of polymer transfer film develop on the polymer pin and counterface, the interaction becomes adhesive and steady-state friction is established. The wear resistance of the polymer was found to be related to the stability of this film.

Effect of sliding speed on friction and wear of uni-directional aramid fibre-phenolic resin composite

A previous study on the tribological performance of a compression-moulded aramid fibre-phenolic resin composite, containing 30% continuous fibre, showed that this composite provides a reasonable combination of the friction coefficient and wear rate to be used as a friction component, such as a brake shoe. In the present work, the effect of sliding speed on the friction and wear behaviour of this composite has been investigated. The sliding experiments were conducted in a speed range of 0.1-6 m s(-1) at two normal pressure levels of 1.0 and 4.9 MPa. The coefficient of friction was found to be stable over a wide range of sliding speeds and normal pressures. The wear of the composite was found to be insensitive to changes in the speed in the higher speed range. The results have been supplemented with scanning electron micrographs to help understand possible friction and wear mechanisms.

INFLUENCE OF ATMOSPHERIC HUMIDITY ON THE ABRASIVE WEAR OF METALS.

A pin-on-disc apparatus has been used to obtain continuous simultaneous measurements of the wear and friction (sliding force) behaviour of metals on bonded silicon carbide abrasive paper under conditions of controlled humidity. Iron, mild steel, and copper exhibit qualitatively similar wear behaviour; the wear rate decreases progressively with the number of passes over the same track. In contrast, the wear rate of titanium remains constant. Variation in atmospheric humidity has little effect on the wear rates of copper or titanium, although a slight effect was found in mild steel and iron. Refs.

Scanning Electron Microscopy Studies on Tear and Wear Failure of Short Kevlar Fiber-Thermoplastic- Polyurethane Composite

Tear and wear properties of short kevlar fiber, thermoplastic polcurethane (TPU) composite with respect to fiber loading-and fiber onentation has been studied and the fracture surfaces were examined under scanning electron microscope (SEM). Tear strength first decreased up to 20 phr fiber loading and then gradually increased with increasing fiber loading. Anisotropy in tear strength was evident beyond a fiber loading of 20 phr. Tear fracture surface of unfilled TPU showed sinusoidal folding characteristics of high strength matrix. At low fiber loading the tear failure was mainly due to fibermatrix failure whereas at higher fiber loading the failure occurred by fiber breakage. Abrasion loss shows a continuous rise with increasing fiber loading, the loss in the transverse orientation of fibers being higher than that in the longitudinal orientation. The abraded surface showed lone cracks and ridges parallel to the direction of abrasion indicating an abrasive wear mechanism. In the presence of fber the abrasion loss was mainly due to fiber low.

Wear of permanent incisors with age on commercial Australian Angora goat farms

OBJECTIVE: To quantify if, and to what extent, permanent incisor wear differed with age of goat and farm of origin on commercial Australian Angora goat farms. DESIGN: Observations were made on three Angora goat farms in the wheat-sheep zone of Victoria, each managed according to the farmer's practices. Farmers provided a representative flock of does. METHODS: The proportion and pattern of wear of permanent incisors were recorded and percentage wear calculated. After log(y + 10) transformation, a parsimonious general linear model was developed to relate wear to farm and age, with age considered as a continuous variate. RESULTS: The range in wear of the permanent incisors was 0-100%. For each farm, the most parsimonious model for permanent first incisor wear and average wear of all permanent incisors was a separate straight line relating the transformed incisor wear to the age of doe. The models accounted for 66-73% of variance. On each farm the incisor wear was similar and low for ages up to approximately 4 years. On all farms, the amount of incisor wear increased dramatically with age, although the rate of increase differed with each farm. CONCLUSIONS: Permanent incisor wear increased with age of goat and differed with farm of origin. Angora goat farmers need to be aware of the potential for incisor wear to affect doe production and health.