Clinical performance of daily disposable soft contact lenses using sustained release technology

Purpose: Polyvinyl alcohol (PVA) is a successful tear film stabiliser and is widely used in comfort drops and some soft contact lens materials. A PVA-containing lens, nelfilcon A has been modified to include additional (non-functional) PVA in order to provide improved comfort. This study aims to examine the clinical performance of this nelfilcon A lens with AquaRelease™ (AquaRelease). Methods: Two contralateral, investigator masked, open label, subjective and objective evaluations were conducted. The first examined the effect of adding increased molecular weight PVA to nelfilcon A (n = 5), and the second compared this AquaRelease lens to ocufilcon B (n = 34). The principal measures were non-invasive break-up time (NIBUT) and subjective comfort, which were assessed at the beginning and end of a week of daily wear, and three times throughout 1 day at 8, 12 and 16 h. Results: All subjects successfully completed the daily wearing schedule of 16 h. On initial insertion, subjective comfort and NIBUT improved for AquaRelease than original nelfilcon A lenses (p < 0.05). Initial comfort was better for AquaRelease compared to ocufilcon B lenses (p = 0.01); however, NIBUT was not statistically different (11.7 ± 15.6 s versus 8.4 ± 6.8 s; p = 0.26). Subjective comfort decreased with time (p < 0.001), but there was no significant difference between AquaRelease and ocufilcon B lenses (p = 0.16). NIBUT was not significantly affected by time (p = 0.56) or between lenses (p = 0.33). At the end of a weeks' wear, subjective initial, end-of-day, overall comfort and vision were rated significantly better with AquaRelease than ocufilcon B (p < 0.01). Conclusions: Release of additional non-functionalised PVA from the nelfilcon A lenses appears to enhance comfortable contact lens wear. © 2006 British Contact Lens Association.

Ocular motor triad with single vision contact lenses compared to spectacle lenses

Aim: Theoretically myopes are required to exert more accommodation and vergence when wearing single vision contact lenses compared to glasses and hypermetropes less. This study aims to quantify the effects clinically. Method: Thirty subjects (21 female, nine male, average age 21.0 ± 2.2 years) with a range of refractive errors (-7.87 D to +3.50 D) viewed in a random order, static targets at 0.1, 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0 D accommodative demand that were matched for angular subtense. The subjects were fully corrected with spectacles and daily disposable contact lenses to their full prescription. Accommodation was monitored objectively with the PowerRefractor and Shin-Nippon SRW5000 and vergence and pupil size with the PowerRefractor. Results: Myopes exerted greater accommodative effort for viewing near targets with contact lenses than glasses and hypermetropes less (r2 = 0.35, p = 0.001 PowerRefractor). Myopes also exerted greater vergence effort for viewing near targets with contact lenses than glasses and hypermetropes less (r2 = 0.22, p < 0.01). Conclusion: Theoretical calculation of the accommodative and vergence requirements with glasses compared to contact lenses reflect clinical findings, although there is reasonable variability between individuals. © 2006 British Contact Lens Association.

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.

The application of counter immunoelectrophoresis (CIE) in ocular protein studies. Part I:time dependent deposition patterns of immunoregulatory proteins on anionic hydrogel contact lenses

This paper focuses on the effects of wear regime on the deposition pattern of important immunoregulatory proteins on FDA Group IV etafilcon-A lenses. Specifically, the aim was to assess the extent to which the daily disposable wear modality produces a different deposition of proteins from the conventional daily wear regime which is coupled with cleaning and disinfection. Counter immunoelectrophoresis (CIE) was employed to detect individual proteins in lens extracts from individual patients and focused on the analysis of five proteins, IgA, IgG, lactoferrin, albumin and kininogen. Deposition was monitored as a function of time; significantly lower deposition was detected on the daily disposable lenses. cr 2002 British Contact Lens Association. Published by Elsevier Science Ltd. All rights reserved.

The application of counter immunoelectrophoresis (CIE) in ocular protein studies. Part II:kinin activity in the lens wearing eye

The kinin family are a group of bioactive peptides that are closely involved in the modulation of vascular inflammation and local injury. We have demonstrated here, for the first time, a link between kinin activity and contact lens wear. Protein extracts from daily and extended wear etafilcon A, Group IV, Acuvue lenses (Vistakon), were analysed by counter immunoelectrophoresis. In this way, kinin activity associated with contact lens wear was detected. High molecular weight kininogen was used as the marker protein. In contrast, no kinin activity was detected in the non-lens wearing normal eye. © 2002 British Contact Lens Association. Published by Elsevier Science Ltd. All rights reserved.

Impact in contact lenses and the anterior eye:challenges prevailing in 2015

As we settle into a new year, this second issue of Contact Lens and Anterior Eye allows us to reflect on how new research in this field impacts our understanding, but more importantly, how we use this evidence basis to enhance our day to day practice, to educate the next generation of students and to construct the research studies to deepen our knowledge still further. The end of 2014 saw the publication of the UK governments Research Exercise Framework (REF) which ranks Universities in terms of their outputs (which includes their paper, publications and research income), environment (infrastructure and staff support) and for the first time impact (defined as “any effect on, change or benefit to the economy, society, culture, public policy or services, health, the environment or quality of life, beyond academia” [8]). The REF is a process of expert review, carried out in 36 subject-based units of assessment, of which our field is typically submitted to the Allied Health, Dentistry, Nursing and Pharmacy panel. Universities that offer Optometry did very well with Cardiff, Manchester and Aston in the top 10% out of the 94 Universities that submitted to this panel (Grade point Average ranked order). While the format of the new exercise (probably in 2010) to allocate the more than £2 billion of UK government research funds is yet to be determined, it is already rumoured that impact will contribute an even larger proportion to the weighting. Hence it is even more important to reflect on the impact of our research. In this issue, Elisseef and colleagues [5] examine the intriguing potential of modifying a lens surface to allow it to bind to known wetting agents (in this case hyaluronic acid) to enhance water retention. Such a technique has the capacity to reduced friction between the lens surface and the eyelids/ocular surface, presumably leading to higher comfort and less reason for patients to discontinue with lens wear. Several papers in this issue report on the validity of new high precision, fast scanning imaging and quantification equipment, utilising techniques such as Scheimpflug, partial coherence interferometry, aberrometry and video allowing detailed assessment of anterior chamber biometry, corneal topography, corneal biomechanics, peripheral refraction, ocular aberrations and lens fit. The challenge is how to use this advanced instrumentation which is becoming increasingly available to create real impact. Many challenges in contact lenses and the anterior eye still prevail in 2015 such as: -While contact lens and refractive surgery complications are relatively rare, they are still too often devastating to the individual and their quality of life (such as the impact and prognosis of patients with Acanthmoeba Keratitis reported by Jhanji and colleagues in this issue [7]). How can we detect those patients who are going to be affected and what modifications do we need to make to contact lenses and patient management prevent this occurring? -Drop out from contact lenses still occurs at a rapid rate and symptoms of dry eye seem to be the leading cause driving this discontinuation of wear [1] and [2]. What design, coating, material and lubricant release mechanism will make a step change in end of day comfort in particular? -Presbyopia is a major challenge to hassle free quality vision and is one of the first signs of ageing noticed by many people. As an emmetrope approaching presbyopia, I have a vested interest in new medical devices that will give me high quality vision at all distances when my arms won’t stretch any further. Perhaps a new definition of presbyopia could be when you start to orientate your smartphone in the landscape direction to gain the small increase in print size needed to read! Effective accommodating intraocular lenses that truly mimic the pre-presbyopic crystalline lenses are still a way off [3] and hence simultaneous images achieved through contact lenses, intraocular lenses or refractive surgery still have a secure future. However, splitting light reaching the retina and requiring the brain to supress blurred images will always be a compromise on contrast sensitivity and is liable to cause dysphotopsia; so how will new designs account for differences in a patient's task demands and own optical aberrations to allow focused patient selection, optimising satisfaction? -Drug delivery from contact lenses offers much in terms of compliance and quality of life for patients with chronic ocular conditions such as glaucoma, dry eye and perhaps in the future, dry age-related macular degeneration; but scientific proof-of-concept publications (see EIShaer et al. [6]) have not yet led to commercial products. Part of this is presumably the regulatory complexity of combining a medical device (the contact lens) and a pharmaceutical agent. Will 2015 be the year when this innovation finally becomes a reality for patients, bringing them an enhanced quality of life through their eye care practitioners and allowing researchers to further validate the use of pharmaceutical contact lenses and propose enhancements as the technology matures? -Last, but no means least is the field of myopia control, the topic of the first day of the BCLA's Conference in Liverpool, June 6–9th 2015. The epidemic of myopia is a blight, particularly in Asia, with significant concerns over sight threatening pathology resulting from the elongated eye. This is a field where real impact is already being realised through new soft contact lens optics, orthokeratology and low dose pharmaceuticals [4], but we still need to be able to better predict which technique will work best for an individual and to develop new techniques to retard myopia progression in those who don’t respond to current treatments, without increasing their risk of complications or the treatment impacting their quality of life So what will your New Year's resolution be to make 2015 a year of real impact, whether by advancing science or applying the findings published in journals such as Contact Lens and Anterior Eye to make a real difference to your patients’ lives?

Comparison of fitting stability of the different soft toric contact lenses

Purpose: To compare lens orientation and rotational recovery of five currently available soft toric lenses. Methods: Twenty subjects were recruited and trialed with each of the study lenses in a random order. Study lenses were PureVision® Toric (B&L), Air Optix® for Astigmatism (Alcon), Biofinity® Toric (CooperVision), Acuvue® Advance for Astigmatism (Vistakon), and Proclear® Toric (CooperVision). Lens orientation in primary position to determine the lens rotation form the vertical position and rotational recovery to primary gaze orientation following a 45° manual misorientation for the different lenses was compared. Results: The Biofinity Toric showed the lowest rotation from the vertical position and the Proclear Toric the highest. Also, the highest and the lowest reorientation speed were related to the Biofinity Toric and the Acuvue Advance for Astigmatism, respectively. The Repeated Measures ANOVA showed a significant difference in the lens rotation (P=. 0.004) and rotational recovery (P<. 0.001) among different contact lenses and the performed multiple comparisons indicated differences in rotation and also in reorientation speed were only seen between the Biofinity Toric when compared to four other lenses (P<. 0.05). Conclusion: Although there was appropriate fitting, based upon lens orientation and reorientation speed, with each of the study lenses it would appear that the optimized ballast technique used in the design of the Biofinity Toric helps reduce lens rotation and improve rotational recovery compared to others.

Optical quality and visual performance with customised soft contact lenses for keratoconus

Purpose: This study investigated how aberration-controlling, customised soft contact lenses corrected higher-order ocular aberrations and visual performance in keratoconic patients compared to other forms of refractive correction (spectacles and rigid gas-permeable lenses). Methods: Twenty-two patients (16 rigid gas-permeable contact lens wearers and six spectacle wearers) were fitted with standard toric soft lenses and customised lenses (designed to correct 3rd-order coma aberrations). In the rigid gas-permeable lens-wearing patients, ocular aberrations were measured without lenses, with the patient's habitual lenses and with the study lenses (Hartmann-Shack aberrometry). In the spectacle-wearing patients, ocular aberrations were measured both with and without the study lenses. LogMAR visual acuity (high-contrast and low-contrast) was evaluated with the patient wearing their habitual correction (of either spectacles or rigid gas-permeable contact lenses) and with the study lenses. Results: In the contact lens wearers, the habitual rigid gas-permeable lenses and customised lenses provided significant reductions in 3rd-order coma root-mean-square (RMS) error, 3rd-order RMS and higher-order RMS error (p ≤ 0.004). In the spectacle wearers, the standard toric lenses and customised lenses significantly reduced 3rd-order RMS and higher-order RMS errors (p ≤ 0.005). The spectacle wearers showed no significant differences in visual performance measured between their habitual spectacles and the study lenses. However, in the contact lens wearers, the habitual rigid gas-permeable lenses and standard toric lenses provided significantly better high-contrast acuities compared to the customised lenses (p ≤ 0.006). Conclusions: The customised lenses provided substantial reductions in ocular aberrations in these keratoconic patients; however, the poor visual performances achieved with these lenses are most likely to be due to small, on-eye lens decentrations. © 2014 The College of Optometrists.

Randomized crossover trial of silicone hydrogel presbyopic contact lenses

PURPOSE: To assess the performance of four commercially available silicone hydrogel multifocal monthly contact lens designs against monovision. METHODS: A double-masked randomized crossover trial of Air Optix Aqua multifocal, PureVision 2 for Presbyopia, Acuvue OASYS for Presbyopia, Biofinity multifocal, and monovision with Biofinity contact lenses was conducted on 35 presbyopes (54.3 ± 6.2 years). After 4 weeks of wear, visual performance was quantified by high- and low-contrast visual acuity under photopic and mesopic conditions, reading speed, defocus curves, stereopsis, halometry, aberrometry, Near Activity Visual Questionnaire rating, and subjective quality of vision scoring. Bulbar, limbal, and palpebral hyperemia and corneal staining were graded to monitor the impact of each contact lens on ocular physiology. RESULTS: High-contrast photopic visual acuity (p = 0.102), reading speed (F = 1.082, p = 0.368), and aberrometry (F = 0.855, p = 0.493) were not significantly different between presbyopic lens options. Defocus curve profiles (p <0.001), stereopsis (p <0.001), halometry (F = 4.101, p = 0.004), Near Activity Visual Questionnaire (F = 3.730, p = 0.007), quality of vision (p = 0.002), bulbar hyperemia (p = 0.020), and palpebral hyperemia (p = 0.012) differed significantly between lens types, with the Biofinity multifocal lens design principal (center-distance lens was fitted to the dominant eye and a center-near lens to the nondominant eye) typically outperforming the other lenses. CONCLUSIONS: Although ocular aberration variation between individuals largely masks the differences in optics between current multifocal contact lens designs, certain design strategies can outperform monovision, even in early presbyopes.

Crossover evaluation of silicone hydrogel daily disposable contact lenses

PURPOSE: To assess the surface tear breakup time and clinical performance of three daily disposable silicone hydrogel contact lenses over 16 hours of wear. METHODS: Thirty-nine patients (mean [±SD] age, 22.1 [±3.5] years) bilaterally wore (narafilcon A, filcon II-3, and delefilcon A) contact lenses in a prospective, randomized, masked, 1-week crossover clinical trial. Tear film was assessed by the tear meniscus height (TMH), ocular/contact lens surface temperature dynamics, and lens surface noninvasive breakup time at 8, 12, and 16 hours of wear. Clinical performance and ocular physiology were assessed by subjective questionnaire, by high-/low-contrast logMAR (logarithm of the minimum angle of resolution) acuity, and through bulbar and limbal hyperemia grading. Corneal and conjunctival staining were assessed after lens removal. RESULTS: Delefilcon A demonstrated a longer noninvasive breakup time (13.4 [±4.4] seconds) than filcon II-3 (11.6 [±3.7] seconds; p < 0.001) and narafilcon A (12.3 [±3.7] seconds; p < 0.001). A greater TMH (0.35 [±0.11] mm) was shown by delefilcon A than filcon II-3 (0.32 [±0.10] seconds; p = 0.016). Delefilcon A showed less corneal staining after 16 hours of lens wear (0.7 [±0.6] Efron grade) than filcon II-3 (1.1 [±0.7]; p < 0.001) and narafilcon A (0.9 [±0.7]; p = 0.031). Time was not a significant factor for prelens tear film stability (F = 0.594, p = 0.555) or TMH (F = 0.632, p = 0.534). Lens brand did not affect temperature (F = 1.220, p = 0.308), but it decreased toward the end of the day (F = 19.497, p < 0.001). Comfort, quality of vision, visual acuity and contrast acuity, and limbal grading were similar between the lens brands but decreased with time during the day (p < 0.05). CONCLUSIONS: The tear breakup time over the contact lens surface differed between lens types and may have a role in protecting the ocular surface.

The measurement of intraocular pressure over positive soft contact lenses by rebound tonometry

Purpose - To investigate if the accuracy of intraocular pressure (IOP) measurements using rebound tonometry over disposable hydrogel (etafilcon A) contact lenses (CL) is affected by the positive power of the CLs. Methods - The experimental group comprised 26 subjects, (8 male, 18 female). IOP measurements were undertaken on the subjects’ right eyes in random order using a Rebound Tonometer (ICare). The CLs had powers of +2.00 D and +6.00 D. Measurements were taken over each contact lens and also before and after the CLs had been worn. Results - The IOP measure obtained with both CLs was significantly lower compared to the value without CLs (t test; p < 0.001) but no significant difference was found between the two powers of CLs. Conclusions - Rebound tonometry over positive hydrogel CLs leads to a certain degree of IOP underestimation. This result did not change for the two positive lenses used in the experiment, despite their large difference in power and therefore in lens thickness. Optometrists should bear this in mind when measuring IOP with the rebound tonometer over plus power contact lenses.

Contrast sensitivity evaluation with filter contact lenses in patients with retinitis pigmentosa: a pilot study

Purpose: the aim of this pilot study was to test whether retinitis pigmentosa patients would benefit from filter contact lenses as an effective optical aid against glare and photophobia. Methods: fifteen subjects with retinitis pigmentosa were enrolled in this study. All of them were evaluated with filter soft contact lenses (MaxSight), filter glasses (CPF 527) and without filters (control). All patients were assessed for the three aid conditions by means of best corrected visual acuity (BCVA), contrast sensitivity (without glare and with central and peripheral glare)(CSV-1000) and a specific subjective questionnaire about quality of vision. Results: BCVA was slightly better with filters than without filter but the differences were not statistically significant. Contrast sensitivity without glare improved significantly with the contact lenses (p<0.05). The central glare had significant differences for the frequencies of 3 cpd and 18 cpd between the contact lens filter and the control group (p=0.021 and p=0.044, respectively). For the peripheral glare contrast sensitivity improved with contact lens versus control group for highest frequencies, 12 and 18 cpd (p<0.001 and p=0.045, respectively). According to the questionnaire the contact lens filter gave them more visual comfort than the glasses filter under the scenarios of indoors glare, outdoors activities and indoors comfort. Conclusion: the filter contact lenses seem to be a good option to improve the quality of vision of patients with retinitis pigmentosa.

Health beliefs affect the correct replacement of daily disposable contact lenses:predicting compliance with the Health Belief Model and the Theory of Planned Behaviour

Purpose: To assess the compliance of Daily Disposable Contact Lenses (DDCLs) wearers with replacing lenses at a manufacturer-recommended replacement frequency. To evaluate the ability of two different Health Behavioural Theories (HBT), The Health Belief Model (HBM) and The Theory of Planned Behaviour (TPB), in predicting compliance. Method: A multi-centre survey was conducted using a questionnaire completed anonymously by contact lens wearers during the purchase of DDCLs. Results: Three hundred and fifty-four questionnaires were returned. The survey comprised 58.5% females and 41.5% males (mean age 34. ±. 12. years). Twenty-three percent of respondents were non-compliant with manufacturer-recommended replacement frequency (re-using DDCLs at least once). The main reason for re-using DDCLs was "to save money" (35%). Predictions of compliance behaviour (past behaviour or future intentions) on the basis of the two HBT was investigated through logistic regression analysis: both TPB factors (subjective norms and perceived behavioural control) were significant (p. <. 0.01); HBM was less predictive with only the severity (past behaviour and future intentions) and perceived benefit (only for past behaviour) as significant factors (p. <. 0.05). Conclusions: Non-compliance with DDCLs replacement is widespread, affecting 1 out of 4 Italian wearers. Results from the TPB model show that the involvement of persons socially close to the wearers (subjective norms) and the improvement of the procedure of behavioural control of daily replacement (behavioural control) are of paramount importance in improving compliance. With reference to the HBM, it is important to warn DDCLs wearers of the severity of a contact-lens-related eye infection, and to underline the possibility of its prevention.

Effect of third-order aberrations on dynamic accommodation

We investigate the potential for the third-order aberrations coma and trefoil to provide a signed cue to accommodation. It is first demonstrated theoretically (with some assumptions) that the point spread function is insensitive to the sign of spherical defocus in the presence of odd-order aberrations. In an experimental investigation, the accommodation response to a sinusoidal change in vergence (1–3 D, 0.2 Hz) of a monochromatic stimulus was obtained with a dynamic infrared optometer. Measurements were obtained in 10 young visually normal individuals with and without custom contact lenses that induced low and high values of r.m.s. trefoil (0.25, 1.03 μm) and coma (0.34, 0.94 μm). Despite variation between subjects, we did not find any statistically significant increase or decrease in the accommodative gain for low levels of trefoil and coma, although effects approached or reached significance for the high levels of trefoil and coma. Theoretical and experimental results indicate that the presence of Zernike third-order aberrations on the eye does not seem to play a crucial role in the dynamics of the accommodation response.

Effect of presbyopic vision corrections on perceptions of driving difficulty

Objectives: As the population ages, more people will be wearing presbyopic vision corrections when driving. However, little is known about the impact of these vision corrections on driving performance. This study aimed to determine the subjective driving difficulties experienced when wearing a range of common presbyopic contact lens and spectacle corrections.----- Methods: A questionnaire was developed and piloted that included a series of items regarding difficulties experienced while driving under daytime and night-time conditions (rated on five-point and seven-point Likert scales). Participants included 255 presbyopic patients recruited through local optometry practices. Participants were categorized into five age-matched groups; including those wearing no vision correction for driving (n = 50), bifocal spectacles (n = 54), progressive spectacles (n = 50), monovision contact lenses (n = 53), and multifocal contact lenses (n = 48).----- Results: Overall, ratings of satisfaction during daytime driving were relatively high for all correction types. However, multifocal contact lens wearers were significantly less satisfied with aspects of their vision during night-time than daytime driving, particularly regarding disturbances from glare and haloes. Progressive spectacle lens wearers noticed more distortion of peripheral vision, whereas bifocal spectacle wearers reported more difficulties with tasks requiring changes of focus and those who wore no optical correction for driving reported problems with intermediate and near tasks. Overall, satisfaction was significantly higher for progressive spectacles than bifocal spectacles for driving.----- Conclusions: Subjective visual experiences of different presbyopic vision corrections when driving vary depending on the vision tasks and lighting level. Eye-care practitioners should be aware of the driving-related difficulties experienced with each vision correction type and the need to select corrective types that match the driving needs of their patients.