Predicted tear layer oxygen tensions under two designs of silicone hydrogel toric lenses

Introduction

The goal of this study was to apply a theoretical analysis of the relationship between contact lens oxygen transmissibility and tear layer oxygen tension to silicone hydrogel toric lenses and thereby model the success of such lenses in decreasing corneal hypoxia.

Method

Lens thickness was measured at different points along the vertical meridian of one prism-ballasted, one dynamic-stabilized silicone hydrogel toric lens design, and one control “traditional” hydrogel toric lens design. Using lens thickness measurements and the nominal oxygen permeability values of these three lens designs, the subsequent oxygen tension in the tear layer trapped between the contact lens and the anterior cornea (P2) were calculated for both open- and closed-eye conditions using a single corneal chamber model with a personal computer program.

Results

We found that cylindrical powers, regardless of lens materials, did not have a statistically significant effect on lens thickness (F = 0.30, p = 0.5834) to the limitation of our measurements, while contact lens type, spherical power, location on lens, and axis of cylindrical power were all found to do so. When multi-factor ANOVA was applied to the lens thickness and P2 data, contact lens location had a statistically significant effect on P2 values for both prism-ballasted (F = 640.16, p < 0.0001) and dynamic-stabilized toric lenses (F = 352.85, p < 0.0001). When the same statistical methodology was used to compare the relative performance of all three lenses on P2 during daily wear, the average P2 values for the three different lens brands were all statistically significantly different, while under closed-eye conditions the average P2 values for both silicone hydrogel toric lenses were no longer statistically significantly different (F = 1.00, p = 0.3178).

Conclusion

Assuming that the critical P2 was 100 mmHg, we predicted that silicone hydrogel toric soft lenses would provide reasonable anterior corneal oxygenation, certainly much enhanced over the environment predicted under traditional hydrogel designs, especially during daily (e.g. open eye) wear. Substantial corneal hypoxia continued to be predicted during extended wear of all lenses, but especially so with the use of traditional hydrogels.     

BCLA CLEAR - Contact lens wettability,cleaning, disinfection and interactions with tears

Contact lens materials have undergone significant changes over the past 20 years, particularly with respect to the introduction of silicone hydrogel materials. Whilst this development addressed hypoxic issues, other important areas relating to contact lens success, notably comfort, require further research.Contact lens wettability remains a crucially important part of biocompatibility. Contact lenses can be made more wettable by incorporation of surfactants into blister packs, internal wetting agents, surface treatments or care solutions. However, there remains no clear association between contact lens wettability and comfort, making it challenging to determine the potential for these approaches to be of significant clinical benefit. Most contact lenses are used on a daily wear, reusable basis, which requires them to be disinfected when not worn. The ideal disinfecting solution would also improve comfort during wear. However, balancing these requirements with other factors, including biocompatibility, remains a challenge. Soft lens materials invariably take up and subsequently release certain components of disinfecting solutions onto the ocular surface. This may affect tear film stability and the normal ocular microbiome, and further research is needed in this area to determine whether this has any affect on comfort. Finally, contact lens materials sorb components of the tear film, and these interactions are complex and may change the biochemistry of the tear film, which in turn may affect their comfort.In conclusion, the interaction between lens materials, tear film and disinfection solution plays an important role in the biocompatibility of lenses. However, the exact role and whether this can be altered to improve biocompatibility and comfort during wear remains debatable. This report summarises the best available evidence to examine this complex relationship and the opportunities for practitioners to enhance in-eye comfort of contemporary lenses, along with providing suggestions for areas of study that may provide further information on this topic.     

Effects of lysosomal deposition on the friction coefficient of hydrogel contact lenses

When a contact lens is in contact with the eyelid and the cornea, tear proteins start to be accumulated on the lens and may subsequently undergo conformational changes. Protein adsorption or conformational changes on the lens may lead to discomfort, red eye, or even inflammatory reactions. Although measuring the friction coefficient of contact lens has been linked to comfort degree in vivo, there is not much research about the effects of tear protein deposition on the friction coefficient of the contact lens. Therefore, we investigated the friction coefficient of three distinct materials of contact lenses in two different lysosomal concentrations. We also studied lysozyme deposition on the lens without the influence of friction. The results demonstrated that although the amount of lysozyme deposition was high on all the materials we tested, it was not corresponded to higher friction coefficient. In addition, we investigated the effect of the contact lens care solution we developed on friction coefficient and lysozyme deposition of three different materials of contact lenses. The results showed that the care solution could reduce the increased friction coefficient caused by high lysosomal concentration. Therefore, we proposed a potential mechanism of why lysosomal deposition may result in high friction coefficient for certain types of hydrogel contact lenses.     

Is contact lens "T" still important?

We studied oxygen supply to the contact lens covered cornea by means of a complex calculation method. We measured lens thicknesses, both centrally and at a 3mm peripheral location, of a range of optical powers of two different spherical silicone hydrogel contact lens designs (manufactured by Ciba Vision and Bausch & Lomb) and one "traditional" hydrogel. Using the measured values of lens thickness and the nominal oxygen permeabilities of these three plastics, we calculated the oxygen tension level in the tear layer posterior to the contact lens and anterior to the cornea and the oxygen flux through these contact lenses, under both open- and closed-eye conditions. We conclude that variable thicknesses of the silicone hydrogel contact lenses does not significantly affect the oxygen tension in the entrapped tear layer, given their high oxygen diffusion coefficients, under open-eye conditions, and probably only minimally under closed-eye conditions as well.     

Randomized crossover trial of silicone hydrogel contact lenses

PurposeThe aim of the current study is to assess, using new technologies, the interaction of four monthly silicone hydrogel contact lenses on the ocular surface and the comfort over 15 days of use.MethodsProspective cross-over, randomized and double-masked study including four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3). Clinical examination was performed in the following order: tear meniscus height, first break-up of the tear film, the average time of all tear film breakup incidents, bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining. Finally, subjective comfort was obtained from Contact Lens Dry Eye Questionnaire-8.ResultsThe impact of contact lens wear on the ocular surface didn’t show statistically significant changes over time except for corneal and conjunctival staining grades on day 15 compared to day 1 for the comfilcon A group (P = .003 and P = .01, respectively). Contact lens stability and impact on the ocular surface during contact lens wear didn’t show statistically significant changes over time except in the case of the comfilcon A material with respect to the irritation item (P = .01).ConclusionsThese results suggest that the impact of monthly silicone hydrogel contact lens materials on the ocular surface after and during contact lens wear, contact lens stability over time, and subjective comfort did not reveal any significant changes over 15 days of use for any of the materials.     

Compatibility of phospholipid liposomal spray with silicone hydrogel contact lens wear

Purpose

To assess the effects of two weeks of regular phospholipid liposomal spray application on lipid layer grade, tear film stability, subjective comfort, visual acuity, and lipid deposition in silicone hydrogel contact lens wearers.

Use of silicone hydrogel material for daily wear.

Silicone hydrogel contact lenses were initially developed to optimise oxygen transmissibility for extended wear use. The concerns with such contact lenses have been their higher elastomeric and hydrophobic characteristics associated with the incorporation of silicone type monomers. The use of silicone hydrogel has most recently been suggested for daily wear to eliminate all hypoxic related problems. The primary aim of the investigation was to test in vivo wetting performance and subjective acceptance of the first silicone hydrogel contact lens developed for daily wear, ACUVUE ADVANCE with HYDRACLEAR (galyfilcon A), compared to a conventional hydrogel contact lens for the same application SofLens 66 (alphafilcon A). The investigation was a randomised, subject masked bilateral cross over investigation testing of the two contact lens materials over their approved replacement periods (galyfilcon A 2 weeks and alphafilcon A 2 weeks (USA) and 4 weeks (Europe)). In all cases ReNu Multiplus lens care system was used. The investigation carried out on 24 contact lens wearers showed that: (i) in vivo wettability was superior for galyfilcon A which had a thicker lipid layer (thin layer incidence: galyfilcon A 54%; alphafilcon A 70-86%, p<0.05), a thicker aqueous layer (thick layer incidence: galyfilcon A 88%; alphafilcon A 35-64%, p<0.05) and a more stable tear film (galyfilcon A 7.8s; alphafilcon A 2 weeks 5.6s, p=0.022; 4 weeks 7.4s, p=0.276); (ii) for the intended replacement period, comfort was better with galyfilcon A (2 weeks) compared to alphafilcon A (4 weeks) at insertion (p=0.001) and, throughout the day (daytime and evening p=0.008). Contact lenses made from galyfilcon A and replaced two weekly achieved better in vivo wettability than contact lenses made from alphafilcon A and replaced either two and four weekly; the better wettability was associated with an overall better comfort for galyfilcon A.     

Trends in the use of silicone hydrogel contact lenses for daily wear

Although the first silicone hydrogel contact lenses introduced onto the world contact lens market in 1999 held approval for both daily wear and extended wear use, the latter modality was promoted much more heavily by the manufacturers. The first silicone hydrogel lenses specifically promoted for daily wear were introduced in 2003. Data that we have gathered from annual contact lens fitting surveys demonstrate an immediate increase in market share whereby this lens type now represents more than one-third of soft lens fits in the United Kingdom. The success of this lens category is attributed to the health and safety benefits of silicone hydrogel materials and the positive impact of lens manufacturers by way of the effective marketing and distribution of these products.     

Thirty years of ‘quiet eye’ with etafilcon A contact lenses

Frequent replacement contact lenses made from the etafilcon A hydrogel lens material were introduced onto the market over 30 years ago, and etafilcon A remains the most widely used hydrogel lens material today. Although the prescribing of silicone hydrogel lenses is increasing, millions of lens wearers globally have been wearing hydrogel lenses for many years and exhibit a physiologically-stable ‘quiet eye’, with a low profile of adverse events. Hydrogel lenses are demonstrated to maintain a low inflammatory response and infection risk profile during daily wear, which in the case of etafilcon A, may be related to its low modulus, and the naturally-protective, anti-microbial, non-denatured lysozyme absorbed into the lens from the tear fluid. Although improved corneal physiology from decreased hypoxia with silicone hydrogel lenses is well accepted, equivalent levels of corneal oxygenation are maintained during daily wear of low to medium powered hydrogel lenses, which do not impede the daily corneal de-swelling process, and do not induce clinically significant changes in ocular health. Therefore, hydrogel lenses remain an important alternative for daily wear in modern contact lens practice.     

Factors influencing the prescribing of hydrogel contact lenses

Despite the current market popularity of silicone hydrogel contact lenses, conventional hydrogel lenses still represent a significant proportion of the overall contact lens market. Data gathered from annual UK contact lens fitting surveys over the past 13 years indicate that 64% of hydrogel lenses prescribed during this period were of low/medium water content (≤60% water). Whereas, in the past, practitioners would choose the water content of a hydrogel lens to meet specific clinical needs, this choice appears today to be largely governed by product availability.     

Surface versus bulk activity of lysozyme deposited on hydrogel contact lens materials in vitro

Purpose

To determine and compare the levels of surface versus bulk active lysozyme deposited on several commercially available hydrogel contact lens materials.

Fast versus gradual adaptation of soft monthly contact lenses in neophyte wearers

AimTo determine if a gradual adaptation period is necessary for neophytes when fitted with modern hydrogel or silicone hydrogel reusable disposable contact lenses.MethodAcross four sites, 74 neophytes (18–28 years) were randomly assigned to a reusable lens cleaned nightly with Opti-Free® Puremoist® multi-purpose contact lens solution: Proclear® (hydrogel) or Biofinity® (silicone hydrogel) and an adaptation schedule: fast (10 h wear from the first day) or gradual (4 h on the first day, increasing their wear time by 2 h on each subsequent day until they had reached 10 h). Masked investigators graded ocular surface physiology and non-invasive tear breakup time (NIBUT) and a range of comfort, vision and lens handling subjective ratings (0–100 visual analogue scales) were recorded at the baseline visit and after 10 h of lens wear, 4–6 days and 12–14 days after lens fitting. Subjective scores were also repeated after 7 days.ResultsThere was no difference (p > 0.05) in ocular surface physiology or NIBUT between fast and gradual adaptation groups at any time point in either lens type with the exception of increased corneal staining (p = 0.019) in the silicone hydrogel fast adaptation group after 4–6 days, but was similar by 12–14 days. Subjective scores were also similar across the visits and lens types with the exception of ‘lens awareness’ (p = 0.019) which was less in the gradual versus the fast adaptation silicone hydrogel lens group at 12–14 days.ConclusionThere seems to be no clinical benefit for recommending a gradual adaptation period in new wearers fitted with modern soft reusable disposable contact lenses. The findings of this work add to a growing body of evidence suggesting that such advice is unnecessary in regular soft contact lens wear, which has important ramifications for the initial clinical management of these patients.     

In vitro analysis of the interaction of tear film inflammatory markers with contemporary contact lens materials

PurposeSeveral clinical studies have suggested that reusable silicone hydrogel contact lens materials exhibit a two-times increased rate of corneal infiltrative events compared to reusable hydrogels. One potential factor contributing to this complication relates to the differential uptake of tear film-based pro-inflammatory cytokines. The purpose of this study was to use an in vitro assay to investigate whether four pro-inflammatory cytokines differed in their uptake onto six contemporary contact lens materials.MethodsConventional hydrogel (etafilcon A, omafilcon A) and silicone hydrogel (balafilcon A, comfilcon A, senofilcon A, somofilcon A) contact lens materials were soaked in solutions containing pro-inflammatory cytokines IL-1β, IL-6, IL-8 and TNF-α. Samples of the soaking solutions were collected over various time points and analyzed using the Meso Scale Discovery system, which served as a measurement of cytokine uptake onto the contact lens materials.ResultsBoth conventional hydrogels (etafilcon A, omafilcon A) and two of the four silicone hydrogels tested (balafilcon A, comfilcon A), exhibited some uptake of IL-1β, IL-8 or TNF-α (p < 0.05). Senofilcon A and somofilcon A did not exhibit uptake of any of these cytokines (p > 0.05). There was no uptake of IL-6 onto any of the contact lens materials investigated (p > 0.05).ConclusionThe contact lens materials tested did not exhibit any uptake of IL-6 and furthermore, did not exhibit more than 10 ± 3 % to 25 ± 12 % uptake of IL-1β, IL-8 or TNF-α. Numerous factors could contribute to the reported increase in corneal infiltrative events with reusable silicone hydrogel materials, however, based on these results, it appears that uptake of these four cytokines are unlikely to contribute to this finding.     

The short-term effect of contact lens wear on blink characteristics

PurposeThe aim of this pilot study was to investigate the initial effect of contact lens wear on spontaneous blink characteristics.MethodsThis was a randomised, crossover pilot study. Spontaneous blinking was recorded using a high-speed infrared camera in ten subjects with three different soft contact lenses (spherical hydrogel, spherical silicone hydrogel and toric hydrogel), one rigid contact lens and without contact lenses. Custom semi-automated software was used to determine palpebral aperture height, interblink interval (IBI), blink speed, blink completeness and blink duration.ResultsThe IBI was significantly greater for non-lens wear compared with the silicone hydrogel [ratio (95% CI): 1.34 (1.16, 1.55), p < 0.0001], toric hydrogel [1.28 (1.10, 1.48), p = 0.0001] and rigid corneal lenses [1.48 (1.27, 1.73), p < 0.0001]. The spherical silicone hydrogel lens showed greater closing-phase speed than non-lens wear [mean difference (95% CI): 27.4 (5.6, 49.1) mm/s, p = 0.006]. Shorter total blink duration was found for non-lens wear compared with any of the lens types [spherical hydrogel: ratio 0.89 (0.81, 0.98), p = 0.01; spherical silicone hydrogel: 0.87 (0.80, 0.95), p = 0.0001; toric hydrogel: 0.90 (0.83, 0.98), p = 0.004; and rigid corneal: 0.88 (0.82, 0.96), p = 0.0004]. Opening-phase speed (p = 0.12) and blink completeness metrics (all p > 0.5) were not influenced by wearing condition.ConclusionThis work showed that short-term contact lens wear influenced the palpebral aperture height, IBI, speed and duration of the blink, and the effect is dependent on the contact lens type. The completeness of the blink was not altered by contact lens wear. Future work should be conducted to assess the effect of long-term wear of different contact lens types on blink characteristics. The measurement of spontaneous blinking characteristics represents an immediate, sensitive and non-invasive evaluation of the impact of a contact lens on the ocular surface.     

The influence of surface treatment on hydrophobicity, protein adsorption and microbial colonisation of silicone hydrogel contact lenses.

PURPOSE: To evaluate the influence of surface treatment of silicone-hydrogel CL on lens hydrophobicity, protein adsorption and microbial colonisation by studying several silicone hydrogel contact lenses (CL) with and without surface treatment. The lenses used in this study were Balafilcon A, Lotrafilcon A, Lotrafilcon B and Galyfilcon A. A conventional hydrogel CL (Etafilcon A) was also tested. METHODS: Hydrophobicity was determined through contact angle measurement using the advancing type technique on air. The type and quantity of proteins adsorbed were assessed through SDS-PAGE and fluorescence spectroscopy, respectively. Microbial colonisation was studied by removing the microbes from the lenses through sonication, and counting the colony-forming units on agar plates. RESULTS: Regarding hydrophobicity, both surface and non-surface-treated silicone hydrogel CL were found to be hydrophobic, and the conventional hydrogel CL was found to be hydrophilic. Concerning protein adsorption, different protein profiles were observed on the several lenses tested. Nevertheless, the presence of proteins with the same molecular weight as lysozyme and lactoferrin was common to all lenses, which is probably related to their abundance in tears. In terms of total protein adsorption, silicone hydrogel CL did not exhibit any differences between themselves. However, the conventional hydrogel Etafilcon A adsorbed a larger amount of proteins. Regarding microbial colonisation, Balafilcon A exhibited the greatest amount of colonising microbes, which can be due to its superior hydrophobicity and higher electron acceptor capacity. CONCLUSION: This study suggests that silicone hydrogel lenses adsorb a lower amount of proteins than the conventional hydrogel lenses and that this phenomenon is independent of the presence of surface treatment. Concerning microbial colonisation, the surface treated Balafilcon A, exhibited a greater propensity, a fact that may compromise the lens wearer's ocular health.     

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.     

A comparison of regimen methods for the removal and inactivation of bacteria, fungi and Acanthamoeba from two types of silicone hydrogel lenses

Purpose

To compare the antimicrobial efficacy of commercial contact lens solutions when used according to the manufacturers’ recommended regimens with two types of silicone hydrogel lenses.

Methods

Four multipurpose contact lens care solutions were examined, representing manufacturer recommended regimens of “rub & rinse”, “no rub, rinse” or “no rub, no rinse”. Test organisms were Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Fusarium solani, Candida albicans and Acanthamoeba castellanii (trophozoites and cysts). Organisms, in the presence of organic soil, were inoculated on to Acuvue Oasys or Air Optix lenses and subjected to the solution manufacturer's recommended regimen. The number of surviving organisms on the lenses and in the soak solution was enumerated in accordance with ISO 14729.

Results

ISO 14729 dictates that for a given organism the combined average number of surviving microbes from the lenses and disinfectant soaking solution must be ≤10 colony forming units (cfu)/ml. By this criterion, only Complete Easy Rub (“rub & rinse” regimen) gave satisfactory results for all bacteria, fungi and Acanthamoeba with both lens types. Solutions employing “no rub, rinse” were less satisfactory but significantly better than “no rub, no rinse”. Significant differences were found in organism survival on the lenses with greater numbers remaining on the Air Optix compared to Oasys (p < 0.01-0.0001).

Conclusion

The findings of this study demonstrate that the use of a manual rubbing step is more effective than rinsing or soaking alone in removing pathogenic microbes from silicone hydrogel lenses. Accordingly, it would seem prudent to recommend that contact lens care systems include a rub step as part of the hygiene regimen.     

Rigid gas permeable contact lenses: Out in the cold

Introduction

Rigid gas permeable (RGP) contact lens wearers may experience episodes of lens fracture during handling. In this paper, we report the case of a keratoconic contact lens wearer whose lens fractured whilst being handled at sub-zero temperatures. Subsequent studies illustrate how PMMA and RGP contact lenses behave when exposed to sub-zero temperatures.

Methods

Using a previously validated custom-built strain gauge we have measured the force required to invert RGP contact lenses (Fluroperm, DK30-DK151, PMMA and Aquasil; dioptric power −2.00DS) under different temperature conditions.

Results

It was found that RGP lenses, frozen to −7 °C, required on average 15% less force to cause inversion than when stored at room temperature, regardless of material. It was also found that without due care, lenses of all materials fractured more easily after having been frozen, than lenses kept at room temperature. Fracture rates rose from 8% to 83% if lenses were stored wet (at −7 °C) as opposed to dry.

Conclusion

The authors conclude that practitioners should consider inappropriate contact lens storage and handling as a possible reason for otherwise unexplained acute RGP contact lens fracture.     

Non-invasive pre-lens tear film assessment with high-speed videokeratoscopy

Purpose

To evaluate the effect of two types of daily contact lenses (delefilcon A and omafilcon A) on the tear film and establish whether it is dependent on pre-corneal tear film characteristics using a new method to analyse high-speed videokeratoscopy recordings, as well as to determine the sensitivity of the method in differentiating between contact lens materials on eye.

Long-term effects of tear film component deposition on the surface and optical properties of two different orthokeratology lenses

PurposeTo understand the effects of long-term deposition of tear film components on the surface and optical properties of orthokeratology (ortho-k) lenses, two different lenses, Brighten 22 and Optimum Extra, were tested here.MethodsOrtho-k lenses were immersed in artificial tears and cleaned with a commercial care solution repeatedly for up to 90 days. Both the daily and accumulated lysozyme deposition amounts using an Enzyme-Linked ImmunoSorbent Assay were then analyzed. The base curve, central thickness, power, and transmission of visible light, ultraviolet A, and ultraviolet B were analyzed before and after repeated tear film component deposition procedures. The surface roughness using atomic force microscopy was observed and an energy dispersive spectrometer was used to analyze the composition of the deposits.ResultsThe highest levels of lysozyme were adsorbed on both lens materials during the first four days of the procedure and became saturated by day 6. For both lens materials, contamination on the lenses was easily observed by day 30, and the degree of surface roughness was higher. The transmission levels of different light spectrums were reduced showing that the optical characteristics of both lenses were also affected.ConclusionsThe results provide in vitro evidence that lysozyme could not be completely removed from orthokeratology lenses. Both surface and optical properties were affected by the deposition of tear film components. However, only one commercial multipurpose care solution was used to clean the lens in this study when the main ingredient was a surfactant, and the results might be different when other care regimens with other key ingredients are used. In addition, whether tear film component deposition might result in increased risks of infection or corneal abrasion will require further investigation.