Investigation of the performance of the menifocal Z gas-permeable bifocal contact lens during continuous wear

Purpose. The Menifocal Z is an alternating vision, concentric, bifocal gas-permeable (GP) contact lens; center distance is connected to near periphery by a smooth transition zone. The lens is produced using tisilfocon A (Menicon Z material), which is approved for up to 30 days of continuous wear (CW). The aim of this study was to evaluate the clinical performance of the Menifocal Z when worn for up to 30 days of CW for 6 months.

Methods. Thirty-five existing GP lens wearers were enrolled in the study. Subjects were fitted with Menifocal Z lenses and follow-up visits were conducted after 2 weeks of daily wear and 1 day, 1 week, 6 weeks, 3 and 6 months of CW. A range of objective and subjective clinical performance measures were assessed, including distance and near visual acuity, the physiological response to CW, and subjective evaluation of vision and comfort.

Results. Twenty-seven subjects (77%) completed the study and eight (23%) discontinued: five (14%) as a result of lens-related problems (four vision, one comfort) and three (9%) as a result of non-lens related reasons. Average CW time achieved by the subjects was 22 ± 2 days. Mean binocular logarithm of the minimum angle of resolution (logMAR) acuities at 6 months were: high contrast distance 0.03 (20/20-), low contrast distance 0.63 (20/80-), and high contrast near 0.26 (20/25, N4). Adverse responses and lens binding were minimal, and there were no significant increases in corneal staining, corneal vascularization, or superior palpebral conjunctival papillae over time (p > 0.05). Problems with night vision (distance and near) with the lenses were the most common difficulties reported by the subjects.

Conclusions. The Menifocal Z appears to be a promising option for presbyopic vision correction, providing successful correction of distance and near vision in a group of experienced GP lens wearers. The hyper Dk tisilfocon A (Menicon Z) material allowed for safe wear of the lenses on a CW basis.

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.

In vitro/In vivo assessment and mechanisms of toxicity of bioceramic materials and its wear particulates

With the progress in modern technological research, novel biomaterials are being largely developed for various biomedical applications. Over the past two decades, most of the research focuses on the development of a new generation of bioceramics as substitutes for hard tissue replacement. In reference to their application in different anatomical locations of a patient, newly developed bioceramic materials can potentially induce a toxic/harmful effect to the host tissues. Therefore, prior to clinical testing, relevant biochemical screening assays are to be performed at the cellular and molecular level, to address the issues of biocompatibility and long term performance of the implants. Along with testing strategies in the bulk material toxicity, a detailed evaluation should also be conducted to determine the toxicity of the wear products of the potential bioceramics. This is important as the bioceramics are intended to be implanted in patients with longer life expectancy and notwithstanding, the material will eventually release finer (mostly nanosized) sized debris particles due to continuous wear at articulating surfaces in the hostile corrosive environment of the human body. The wear particulates generated from a biocompatible bioceramic may act in a different way, inducing early/late aseptic loosening at the implant site, resulting in osteolysis and inflammation. Hence, a study on the chronic effects of the wear particulates, in terms of local and systemic toxicity becomes the major criteria in the toxicity evaluation of implantable bioceramics. In this broad perspective, this article summarizes some of the currently used techniques and knowledge in assessing the in vitro and in vivo cytotoxicity and genotoxicity of bioceramic implant materials. It also addresses the need to conduct a broad evaluation before claiming the biocompatibility and clinical feasibility of any new biomaterial. This review also emphasizes some of the case studies based on the experimental designs that are currently followed and its importance in the context of clinical applications.

Conjunctival epithelial flaps with 18 months of silicone hydrogel contact lens wear

Purpose. To report differences in the incidence of conjunctival epithelial flaps (CEFs) found in a group of neophyte contact wearers using two different silicone hydrogel contact lenses on a daily- and continuous-wear basis during an 18-month period. Methods. Sixty-one subjects were initially examined, and 53 were eligible to participate in the study. Eligible subjects were randomly assigned to wear one of two silicone hydrogel materials, lotrafilcon A or balafilcon A, on a daily- or continuous-wear basis. After an initial screening, subjects were monitored weekly for the first month and then after 3, 6, 12, and IS months. The incidence of CEFs in each of the four contact lens groups was recorded. Results. Five of the 53 subjects enrolled in the study showed bilateral CEFs. A higher incidence of CEFs was found in subjects wearing lotrafilcon A lenses (n = 4) compared to balafilcon A lenses (it = 1) (chi(2) = 4.37, P=0.04). Differences in the incidence of CEFs between subjects wearing lenses on a daily-wear basis (n = 1) versus a continuous-wear basis (it = 4) showed a weak statistical significance (chi(2) = 3.03, P=0.08). Conclusions. Lotrafilcon A lenses were associated with a higher incidence of CEFs than balafilcon A lenses were, and this difference may be attributed to differences in the edge design, material, or modulus of rigidity between the two lens types. Subjects wearing lenses on a daily-wear basis showed fewer adverse events than did subjects wearing lenses on a continuous-wear basis. The longer wearing times of subjects wearing lenses on a continuous-wear basis are likely to exacerbate the incidence of CEFs.

The tear film and contact lens wear

Contact lenses have become a popular method of vision correction for millions of people globally. As with all devices designed for use within the body, interactions occur between the implanted material and the surrounding biological fluid. A common complaint of lens wearers is that they often experience symptoms of dry eye whilst wearing lenses. This sensation is often heightened towards the end of the day. Through the course of this study, various analytical techniques have been utilised including one dimensional electrophoresis and Western Blotting to study the protein profiles of tear samples. By studying the tears of non-contact lens wearers, it was possible to analyse what could be considered normal, healthy, individuals. A clinical study was also undertaken which followed a population of individuals from the neophyte stage to one whereby they were accustomed lens wearers. Tears were monitored at regular intervals throughout the course of this study and worn contact lenses were also analysed for proteins that had been deposited both on and within the lens. Contact lenses disrupt the tear film in a physical manner by their very presence. They are also thought to cause the normal protein profile to deviate from what would be considered normal. The tear film deposits proteins and lipids onto and within the lens. The lens may therefore be depriving the tear film of certain necessary components. The ultimate aim of this thesis was to discover how, and to what extent, lenses affected tear proteins and if there were any proteins in the tear fluid that had the potential to be used as biochemical markers. Should this be achievable it may be possible to identify those individuals who were more likely to become intolerant lens wearers. This study followed the changes taking place to the tear film as an effect of wearing contact lenses. Twenty-eight patients wore two different types of silicone hydrogel lenses in both a daily wear and a continuous wear regime. The tear protein profiles of the lens-wearers were compared with a control group of non-lens wearing individuals. The considerable amount of data that was generated enabled the clearly observable changes to the four main tear proteins to be monitored.

Evidence of lipid degradation during overnight contact lens wear:gas chromatography mass spectrometry as the diagnostic tool

Purpose. We investigated structural differences in the fatty acid profiles of lipids extracted from ex vivo contact lenses by using gas chromatography mass spectrometry (GCMS). Two lens materials (balafilcon A or lotrafilcon A) were worn on a daily or continuous wear schedule for 30 and 7 days. Methods. Lipids from subject-worn lenses were extracted using 1:1 chloroform: methanol and transmethylated using 5% sulfuric acid in methanol. Fatty acid methyl esters (FAMEs) were collected using hexane and water, and analyzed by GCMS (Varian 3800 GC, Saturn 2000 MS). Results. The gas chromatograms of lens extracts that were worn on a continuous wear schedule showed two predominant peaks, C16:0 and C18:0, both of which are saturated fatty acids. This was the case for balafilcon A and lotrafilcon A lenses. However, the gas chromatograms of lens extracts that were worn on a daily wear schedule showed saturated (C16:0, C18:0) and unsaturated (C16:1 and C18:1) fatty acids. Conclusions. Unsaturated fatty acids are degraded during sleep in contact lenses. Degradation occurred independently of lens material or subject-to-subject variability in lipid deposition. The consequences of lipid degradation are the production of oxidative products, which may be linked to contact lens discomfort. © 2014 The Association for Research in Vision and Ophthalmology, Inc.

Adverse events and discontinuations during 18 months of silicone hydrogel contact lens wear

PURPOSE. To report differences in the incidence of adverse events and discontinuations found in a group of neophyte contact wearers using two different silicone hydrogel contact lenses on a daily- and continuous-wear basis during an 18-month period. METHODS. Sixty-one subjects were initially examined, and 53 were eligible to participate in the study. Eligible subjects were randomly assigned to wear one of two silicone hydrogel materials: lotrafilcon A or balafilcon A lenses on a daily- or continuous-wear basis. After an initial screening, subjects were monitored weekly for the first month and then after 3, 6, 12, and 18 months. The incidence of adverse events, including corneal infiltrative events, superior epithelial arcuate lesions, and contact lens-induced papillary conjunctivitis, and discontinuations in each of the four contact lens groups were recorded. RESULTS. Twenty-two adverse events were found. A higher incidence of adverse events was found in subjects wearing lotrafilcon A lenses than in those wearing balafilcon A lenses (χ = 4.40, P=0.04). There were fewer adverse events in subjects wearing lenses on a daily-wear basis than in those wearing lenses on a continuous-wear basis (χ = 5.98, P=0.01). Eight subjects discontinued from the study as a result of recurrent corneal infiltrative events (one), vision problems (two), excessive ocular discomfort (one), relocation (one), noncompliance with the study protocol (one), and being lost to follow-up (two). No significant differences were found in the number of discontinuations between the two lens types (χ = 0.66, P=0.42) and wearing regimens (χ = 0.08, P=0.78). CONCLUSIONS. Lotrafilcon A lenses were associated with a higher incidence of adverse events than balafilcon A lenses were, and this difference is attributed to the difference in the incidence of corneal infiltrative events. Subjects wearing lenses on a daily-wear basis had fewer adverse events than did subjects wearing lenses on a continuous-wear basis. Both lens types and wearing regimens showed a similar incidence of discontinuations. © 2007 Lippincott Williams & Wilkins, Inc.

Changes in ocular physiology, tear film characteristics, and symptomatology with 18 months silicone hydrogel contact lens wear

Purpose. The purpose of this study was to evaluate the longitudinal changes in ocular physiology, tear film characteristics, and symptomatology experienced by neophyte silicone hydrogel (SiH) contact lens wearers in a daily-wear compared with a continuous-wear modality and with the different commercially available lenses over an 18-month period. Methods. Forty-five neophyte subjects were enrolled in the study and randomly assigned to wear one of two SiH materials: lotrafilcon A or balafilcon A lenses on either a daily- (LDW; BDW) or continuous-wear (LCW; BCW) basis. Additionally, a group of noncontact lens-wearing subjects (control group) was also recruited and followed over the same study period. Objective and subjective grading of ocular physiology were carried out together with tear meniscus height (TMH) and noninvasive tear breakup time (NITBUT). Subjects also subjectively rated symptoms and judgments with lens wear. After initial screening, subsequent measurements were taken after 1, 3, 6, 12, and 18 months. Results. Subjective and objective grading of ocular physiology revealed a small increase in bulbar, limbal, and palpebral hyperemia as well as corneal staining over time with both lens materials and regimes of wear (p < 0.05). No significant changes in NITBUT or TMH were found (p > 0.05). Subjective symptoms and judgment were not material- or modality-specific. Conclusions. Daily and continuous wear of SiH contact lenses induced small but statistically significant changes in ocular physiology and symptomatology. Clinical measures of tear film characteristics were unaffected by lens wear. Both materials and regimes of wear showed similar clinical performance. Long-term SiH contact lens wear is shown to be a successful option for patients. Copyright © 2006 American Academy of Optometry.

The effect of contact lens wear on dynamic ocular surface temperature

Aim: To determine the dynamic emitted temperature changes of the anterior eye during and immediately after wearing different materials and modalities of soft contact lenses. Method: A dynamic, non-contact infrared camera (Thermo-Tracer TH7102MX, NEC San-ei) was used to record the ocular surface temperature (OST) in 48 subjects (mean age 21.7 ± 1.9 years) wearing: lotrafilcon-A contact lenses on a daily wear (LDW; n = 8) or continuous wear (LCW; n = 8) basis; balafilcon-A contact lenses on a daily wear (BDW; n = 8) or continuous wear (BCW; n = 8) basis; etafilcon-A contact lenses on a daily disposable regimen (EDW; n = 8); and no lenses (controls; n = 8). OST was measured continuously five times, for 8 s after a blink, following a minimum of 2 h wear and immediately following lens removal. Absolute temperature, changes in temperature post-blink and the dynamics of temperature changes were calculated. Results: OST immediately following contact lens wear was significantly greater compared to non-lens wearers (37.1 ± 1.7 °C versus 35.0 ± 1.1 °C; p < 0.005), predominantly in the LCW group (38.6 ± 1.0 °C; p < 0.0001). Lens surface temperature was highly correlated (r = 0.97) to, but lower than OST (by -0.62 ± 0.3 °C). There was no difference with modality of wear (DW 37.5 ± 1.6 °C versus CW 37.8 ± 1.9 °C; p = 0.63), but significant differences were found between etafilcon A and silicone hydrogel lens materials (35.3 ± 1.1 °C versus 37.5 ± 1.5 °C; p < 0.0005). Ocular surface cooling following a blink was not significantly affected by contact lens wear with (p = 0.07) or without (p = 0.47) lenses in situ. Conclusions: Ocular surface temperature is greater with hydrogel and greater still with silicone hydrogel contact lenses in situ, regardless of modality of wear. The effect is likely to be due to the thermal transmission properties of a contact lens. © 2004 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

The development of biomaterials for contact lens applications:effects of wear modality on materials design

The successful design of polymers for contact lens applications depends on the ability to provide a balance of properties appropriate to the ocular environment. Principal relevant aspects of the anterior eye are the tear film, eyelid and cornea, which govern the requirements for surface properties, modulus and oxygen permeability, respectively. Permeability requirements and the developing view of the needs of the cornea, in terms of oxygen consumption and the particular roles of fluorine and silicon in the design of silicone hydrogels, which have proved to be the most successful family of materials for this demanding application, are discussed. The contact lens field is complicated by the fact that contact lenses are used in a range of wear modalities, the extremes of which can conveniently be classified as lenses that are disposed of at the end of a single period of daily wear and those used for 30. days of successive day-and-night periods, frequently referred to as extended or continuous wear. As silicone hydrogels developed, in the decade following their launch there has been a progressive trend in properties taking both modulus and water content closer to those of conventional hydrogels. This is particularly evident in the family of daily disposable contact lenses that have appeared since 2008.

Contact Lens Practice, 2nd Edition

Thoroughly revised and updated, this popular book provides a comprehensive yet easy to read guide to modern contact lens practice. Beautifully re-designed in a clean, contemporary layout, this second edition presents relevant and up-to-date information in a systematic manner, with a logical flow of subject matter from front to back. This book wonderfully captures the ‘middle ground’ in the contact lens field … somewhere between a dense research-based tome and a basic fitting guide. As such, it is ideally suited for both students and general eye care practitioners who require a practical, accessible and uncluttered account of the contact lens field. Contents Part 1 Introduction Historical perspective. The anterior eye Visual optics Clinical instruments Part 2 Soft contact lenses Soft lens materials Soft lens manufacture Soft lens optics Soft lens measurement Soft lens design and fitting Soft toric lens design and fitting Soft lens care systems Part 3 Rigid contact lenses Rigid lens materials Rigid lens manufacture Rigid lens optics Rigid lens measurement Rigid lens design and fitting Rigid toric lens design and fitting Rigid lens care systems Part 4 Lens replacement modalities Unplanned lens replacement Daily soft lens replacement Planned soft lens replacement Planned rigid lens replacement Part 5 Special lenses and fitting considerations Scleral lenses Tinted lenses Presbyopia Continuous wear Sport Keratoconus High ametropia Paediatric fitting Therapeutic applications Post-refractive Surgery Post-keratoplasty Orthokeratology Diabetes Part 6 Patient examination and management History taking Preliminary examination Patient education Aftercare Complications Digital imaging Compliance Practice management Appendices Index