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.

Ocular biotribology and contact lens lubrication mechanisms

The work described in this thesis is concerned with mechanisms of contact lens lubrication. There are three major driving forces in contact lens design and development; cost, convenience, and comfort. Lubrication, as reflected in the coefficient of friction, is becoming recognised as one of the major factors affecting the comfort of the current generation of contact lenses, which have benefited from several decades of design and production improvements. This work started with the study of the in-eye release of soluble macromolecules from a contact lens matrix. The vehicle for the study was the family of CIBA Vision Focus® DAILIES® daily disposable contact lenses which is based on polyvinyl alcohol (PVA). The effective release of linear soluble PVA from DAILIES on the surface of the lens was shown to be beneficial in terms of patient comfort. There was a need to develop a novel characterisation technique in order to study these effects at surfaces; this led to the study of a novel tribological technique, which allowed the friction coefficients of different types of contact lenses to be measured reproducibly at genuinely low values. The tribometer needed the ability to accommodate the following features: (a) an approximation to eye lid load, (b) both new and ex-vivo lenses, (c) variations in substrate, (d) different ocular lubricants (including tears). The tribometer and measuring technique developed in this way was used to examine the surface friction and lubrication mechanisms of two different types of contact lenses: daily disposables and silicone hydrogels. The results from the tribometer in terms of both mean friction coefficient and the friction profiles obtained allowed various mechanisms used for surface enhancement now seen in the daily disposable contact lens sector to be evaluated. The three major methods used are: release of soluble macromolecules (such as PVA) from the lens matrix, irreversible surface binding of a macromolecule (such as polyvinyl pyrrolidone) by charge transfer and the simple polymer adsorption (e.g. Pluoronic) at the lens surface. The tribological technique was also used to examine the trends in the development of silicone hydrogel contact lenses. The focus of the principles in the design of silicone hydrogels has now shifted from oxygen permeability, to the improvement of surface properties. Presently, tribological studies reflect the most effective in vitro method of surface evaluation in relation to the in-eye comfort.

Biochemical markers and contact lens wear

The project objective was to develop a reliable selection procedure to match contact lens materials with individual wearers by the identification of a biochemical marker for assessment of in-eye performance of contact lenses. There is a need for such a procedure as one of the main reasons for contact lens wearers ceasing wearing contact lenses is poor end of day comfort i.e. the lenses become intolerable to the wearer as the day progresses. The selection of an optimal material for individual wearers has the potential benefit to reduce drop Qut, hence increasing the overall contact lens population, and to improve contact lens comfort for established wearers. Using novel analytical methods and statistical techniques, we were able to investigate the interactions between the composition of the tear film and of the biofilm deposited on the contact lenses and contact lens performance. The investigations were limited to studying the lipid components of the tear film; the lipid layer, which plays a key role in preventing evaporation and stabilising the tear film, has been reported to be significantly thinner and of different mixing characteristics during contact lens wear. Different lipid families were found to influence symptomatology, in vivo tear film structure and stability as well as ocular integrity. Whereas the symptomatology was affected by both the tear film lipid composition and the nature of the lipid deposition, the structure of the tear film and its stability were mainly influenced by the tear film lipid composition. The ocular integrity also appeared to be influenced by the nature of the lipid deposition. Potential markers within the lipid species have been identified and could be applied as follows: When required in order to identify a problematic wearer or to match the contact lens material to the contact lens wearer, tear samples collected by the clinician could be dispatched to an analytical laboratory where lipid analysis could be carried out by HPLC. A colorimetric kit based on the lipid markers could also be developed and used by clinician directly in the practice; such a kit would involve tear sampling and classification according to the colour into "Problem", "Border line" and "Good" contact lens wearers groups. A test kit would also have wider scope for marketing in other areas such as general dry-eye pathology.

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.

Development of a non-destructive fluorescence technique for analysis of contact lens deposition levels

The primary objective of this research has been to determine the potential of fluorescence spectroscopy as a method for analysis of surface deposition on contact lenses. In order to achieve this it was first necessary to ascertain whether fluorescence analysis would be able to detect and distinguish between protein and lipid deposited on a lens surface. In conjunction with this it was important to determine the specific excitation wavelengths at which these deposited species were detected with the greatest sensitivity. Experimental observations showed that an excitation wavelength of 360nm would detect lipid deposited on a lens surface, and an excitation wavelength of 280nm would detect and distinguish between protein and lipid deposited on a contact lens. It was also very important to determine whether clean unspoilt lenses showed significant levels of fluorescence themselves. Fluorescence spectra recorded from a variety of unworn contact lenses at excitation wavelengths of 360nm and 280nm indicated that most contact lens materials do not fluoresce themselves to any great extent. Following these initial experiments various clinically and laboratory based studies were performed using fluorescence spectroscopy as a method of analysing contact lens deposition levels. The clinically based studies enabled analysis of contact lenses with known wear backgrounds to be rapidly and individually analysed following discontinuation of wear. Deposition levels in the early stages of lens wear were determined for various lens materials. The effect of surfactant cleaning on deposition levels was also investigated. The laboratory based studies involved comparing some of the in vivo results with those of identical lenses that had been spoilt using an in vitro method. Finally, an examination of lysosyme migration into and out of stored ionic high water contact lenses was made.

Analytical techniques for the study of soft contact lens spoilation

Soft contact lens wear has become a common phenomenon in recent times. The contact lens when placed in the eye rapidly undergoes change. A film of biological material builds up on and in the lens matrix. The long term wear characteristics of the lens ultimately depend on this process. With time distinct structures made up of biological material have been found to build up on the lens. A fuller understanding of this process and how it relates to the lens chemistry could lead to contact lenses that are better tolerated by the eye. The tear film is a complex biological fluid, it is this fluid that bathes the lens during wear. It is reasonable to suppose that it is material derived from this source that accumulates on the lens. To understand this phenomenon it was decided to investigate the make up and conformation of the protein species that are found on and in the lens. As inter individual variations in tear fluid composition have been found it is important to be able to study the proteins on a single lens. Many of the analytical techniques used in bio research are not suitable for this study because of the lack of sensitivity. Work with poly acrylamide electrophoresis showed the possibility of analyzing the proteins extracted from a single lens. The development of a biotin avidin electro-blot and an enzyme linked aniibody electro-blot, lead to the high sensitivity detection and identification of the proteins present. The extraction of proteins from a lens is always incomplete. A method that analyses the proteins in situ would be a great advancement. Fourier transform infra red microscopy was developed to a point where a thin section of a contact lens could yield information about the proteins present and their conformation. The three dimensional structure of the gross macroscopic structures termed white spots was investigated using confocal laser microscopy.

Visual comparison of multifocal contact lens to monovision

Purpose. To compare visual function with the Bausch & Lomb PureVision multifocal contact lens to monovision with PureVision single vision contact lenses. Methods. Twenty presbyopic subjects were fitted with either the PureVision multifocal contact lens or monovision with PureVision singlevision lenses. Aftera 1-month trial, the following assessments of visual function were made: (a) distance, intermediate, and near visual acuity (VA); (b) reading ability; (c) distance and near contrast sensitivity function (CSF); (d) near range of clear vision; (e) stereoacuity; and (f) subjective evaluation of near vision ability with a standardized questionnaire. Subjects were then refitted with the alternative correction and the procedure was repeated. All measurements were compared between the two corrections, whereas the ``low addition'' multifocal lens was also compared with the ``high addition'' alternative. Results. Distance and near VA were significantly better with monovision than with the multifocal option (p < 0.05). Intermediate VA (p = 0.13) was similar with both corrections, whereas there was also no significant difference in distance and near CSF (p = 0.29 on both occasions). Reading speeds (p = 0.48) and the critical print size (p = 0.90) were not significantly different between the two contact lens corrections, but stereoacuity (p < 0.01) and the near range of clear vision (p < 0.05) were significantly better with the multifocal option than with monovision. Subjective assessment of near ability was similar for both types of contact lens (p = 0.52). The high addition multifocal lens produced significantly poorer distance and near CSF, near VA, and critical print size compared with the low addition alternative. Conclusions. Monovision performed better than a center-near aspheric simultaneous vision multifocal contact lens of the same material for distance and near VA only. The multifocal option provides better stereoacuity and near range of clear vision, with little differences in CSF, so a better balance of real-world visual function may be achieved due to minimal binocular disruption. (Optom Vis Sci 2009;86:98-105)

Some clinical aspects of the eye in extended contact lens wear

The limbal vascular response to extended contact lens wear was examined in a group comparative study initially intended to last eighteen months. After six months all patients wearing contact lenses had presented with micro-epithelial cysts. This unanticipated occurrence of the micro-epithelial-cysts necessitated termination of the study, and limited the quantity of data collected. However, sufficient results were available to allow a limited description of •the vascular response to this form of contact lens wear. Interpretations of the date collected ore discussed in relation to suggested vasostimulating factors in the cornea. The micro-epithelial cysts observed after extended wear were classified and their rate of recovery recorded. A further clinical study was undertaken to observe cysts in both contact lens - and non contact lens-wearing eyes. Cysts were observed in every category of patient, although the characteristic patterns varied. These observations of micro-epithelial cysts are discussed with respect to the aetiopathogeneses of corneal epithelial cystic disorders. Subsequently, attempts were made to induce cysts in rabbit corneae by extended contact lens wear. Clinical observations revealed cyst-like appearances. Histological sections did not contain cysts but did exhibit signs characteristic •of cystic disorders of the corneal epithelium. In general, the results from the study indicate that extended wear is subjectively acceptable to contact lens wearers. However, the objective findings of significant vascular changes, micro-epithelial cysts and cases of acute red eye response cast considerable doubt on the recommendation of extended wear contact lenses for purely cosmetic applications.

Another angle on contact lens surface analysis

Purpose: Dynamic contact angle (DCA) methods have advantages over other contact angle methodologies, not least that they can provide more than single contact angle values. Here we illustrate the use of DCA analysis to provide “fingerprint” characterisation of contact lens surfaces, and the way that different materials change in the early stages of wear. Method: The DCA method involves attaching to a microbalance weighted strips cut from a lens. The strips are then cyclically inserted into and removed from an aqueous solution. Conventionally, readings of force taken from linear portions of the resultant dipping curves are translated into advancing (CAa) and receding contact (CAr) angles. Additionally, analysis of the force versus immersion profile provides a “fingerprint” characterisation of the state of the lens surface. Results: CAa and CAr values from DCA traces provide a useful means of differentiating gross differences in hydrophilicity and molecular mobility of surfaces under particular immersion and emersion conditions, such as dipping rate and dwell times. Typical values for etafilcon A (CAa:63.1; CAr:37) and balafilcon B (CAa:118.4; CAr:36.4) illustrate this. Surface modifications induced in lens manufacture are observed to produce not only changes in these value, which may be small, but also changes in the DCA “fingerprint” (slope, undulations, length of plateau). Interestingly, similar changes are induced in the first few hours of lens wear with some lens-patient combinations. Conclusions: Although single parameter contact angles are useful for material characterisation, information of potential clinical interest can be obtained from more detailed analysis of DCA traces.