Woods,J., Hutchings,N., Srinivasan,S., Jones,L. Geographic distribution of corneal staining in symptomatic dry eye Ocul Surf 2019;18(2):258-266 [ Show Abstract ]

Purpose
To describe the geographic distribution of corneal fluorescein staining across the five corneal zones, among non contact lens wearers who report symptoms of dry eye and determine which corneal zone most frequently exhibited the worst staining.

Methods
Prior studies conducted at the Centre for Ocular Research & Education, Canada, were reviewed for inclusion in the analysis. Each study assessed dry eye symptoms using OSDI and also assessed corneal fluorescein staining in five corneal zones. For each subject, the corneal zones were ranked 1–5 according to their relative staining grade, Rank-1 representing the highest grade.

Results
Data from 13 studies and 368 subjects were included. The total number of zones assigned Rank-1 (worst) staining was 449 (across 264 subjects). The inferior zone had the most Rank-1 counts of all zones at 193/43%, which involved 52.5% of all subjects. The nasal zone had 77/17% involving 20.9% of subjects, followed by the temporal (69/15.5%, 18.8% subjects) and superior zones (63/14%, 17.1% subjects). The central zone had the lowest count of Rank-1 designations, at only 47/10.5%, involving 12.8% of subjects. Bayesian analysis was used to generate distributions of the credible proportions of subjects likely to present with staining in a single peripheral zone, with or without central zone staining. It illustrated that staining in a peripheral zone without central staining was more credible. The worst single zone staining was most likely to present in the inferior zone (67.9%), followed by the nasal zone (11.3%), the superior zone (9.2%), and the temporal zone (5.6%).

Conclusion
In the presence of dry eye symptoms, the inferior zone typically presents the most severe grade of corneal staining, more likely without central zone staining. This knowledge is valuable when developing a strategy to treat dry eye signs, as the inferior corneal zone has the highest grade of staining thus has the potential to exhibit the greatest reduction in staining post-treatment.

Woods,J., Jones,D., Jones,L., Jones,S., Hunt,C., Chamberlain,P., McNally,J Ocular health of children wearing daily disposable contact lenses over a 6-year period Contact Lens Anterior Eye 2021;44(4):101391 [ Show Abstract ]

Purpose
To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression.

Methods
Children aged 8−12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1–3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4−6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0–4 grading scales; grade 0 represented no findings.

Results
144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%–1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear.

Conclusions
Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.

Woods,J., Jones,L. W. Pilot study to determine the effect of lens and eye rinsing on Solution-Induced Corneal Staining (SICS) Optometry and Vision Science 2016;93(10):1218-1227 [ Show Abstract ]

Purpose The main purpose of this study was to determine whether two interventions (rinsing the lens before lens insertion and rinsing the ocular surface post-lens removal) had any impact on solution-induced corneal staining (SICS). In addition, the presence of hyper-reflective epithelial cells in the presence of SICS was investigated. Methods Twenty subjects wore new balafilcon A lenses, which had been soaked overnight in a multipurpose care product containing polyhexamethylene biguanide for 2 hours. The study was conducted across three phases. In phase 1 (investigator and subject masked, randomized eye), one lens was rinsed with nonpreserved saline before lens insertion. In phase 2 (investigator masked, randomized eye), one eye was rinsed with nonpreserved saline after lens removal, before staining assessment. Corneal staining was recorded as the percentage area of the cornea exhibiting superficial punctate staining. In both phases, ocular comfort and presence of specific symptoms were captured. In phase 3, there was no randomized treatment; confocal images of the epithelium were obtained after 2 hours of wear. Results In phase 1 (lens-rinse), there was no significant difference in staining between the treated and untreated eyes (84 vs. 92%, respectively; p = 0.06). In phase 2 (eye-rinse), there was also no significant difference between the treated and untreated eye (86 vs. 86%, p = 0.92). Most subjects were asymptomatic. In phase 3, images of hyper-reflective cells were captured in 97% of the eyes imaged. Conclusions The two rinsing procedures did not affect the level of the SICS response. Hyper-reflective epithelial cells were found to be present in a significant number of eyes exhibiting SICS, and their presence warrants further investigation. © 2016 American Academy of Optometry.

Woods,J., Jones,L., Woods,C., Schneider,S., Fonn,D. Use of a photographic manipulation tool to assess corneal vascular response Optometry and Vision Science 2012;89(2):215-220 [ Show Abstract ]

Purpose. Corneal vasculature change in contact lens wearers has been linked to the level of hypoxia within the cornea. To assess the impact a treatment has on limbal vessels, a sensitive method of measurement and quantification is required. Methods. A group of 21 highly myopic, hydrogel wearers, with preexisting signs of corneal hypoxia, were enrolled into a study where they wore sifilcon A silicone hydrogel lenses (Dk/t = 117), on a daily wear basis for 9 months. At all scheduled visits, photographs were taken of the superior, inferior, temporal, and nasal limbal regions which were then imported into Adobe Photoshop. A red-free filter was applied to enhance the contrast of the blood columns. In each quadrant, the length of the longest visible blood column was measured and the blood columns that penetrated -0.5 mm into the cornea were counted. A control group of 11 non-lens wearers was recruited. Their photographs were taken at the beginning of the study and 9 months later. An independent, masked observer assessed the photographs. Results. There was a significant decrease in the maximum penetration of the blood column in all quadrants (p + 0.001) from baseline to the 9-month visit (e.g., superior: baseline 0.84 ± 0.39 mm; 9 months 0.63 ± 0.20 mm). There was also significant reduction in the number of visible blood columns longer than 0.5 mm in each quadrant (p + 0.001) from baseline to 9 months in all quadrants (e.g., superior: baseline 14.0 ± 8.2; 9 months 6.5 ± 6.0). The control group showed no change over time for the maximum blood column length (p = 0.638) or the number of columns >0.5 mm (p = 0.341). Conclusions. A group of highly myopic subjects exhibited reduction in the maximum length and number of blood columns in the cornea when refit with a highly permeable silicone hydrogel material. The use of photography, along with Adobe Photoshop software, provides a reliable way of measuring corneal vascular responses over time. (Optom Vis Sci 2012;89:215-220). © 2012 American Academy of Optometry.

Woods,J., Varikooty,J., Fonn,D., Jones,L. A novel scale for describing corneal staining Clinical Ophthalmology 2018;12:2369-2375 [ Show Abstract ]

The assessment of corneal staining is a commonly conducted procedure in both clinical practice and as part of various research studies. Different grading scales are employed by many clinicians and researchers to undertake this procedure for corneal staining comparisons between eyes, products and over time. This paper describes the development and use of a grading scale for corneal staining undertaken at an academic research site. The scale involves assessment of three factors across five corneal zones: type, area and depth. Staining type and area are graded on a 0–100 scale, and depth is graded on a 0–4 scale. These factors can be combined to create a three- or two-factor staining grade, or the factors may be reported individually. An additional benefit of this scale is that the staining scores may be reported by zone as “zone staining scores” or the scores of zones may be combined to provide an overall corneal “global staining score”.

Woods,J., Woods,C. A., Fonn,D. Early symptomatic presbyopes-What correction modality works best? Eye and Contact Lens 2009;35(5):221-226 [ Show Abstract ]

Purpose: To compare the performance of a low-addition silicone hydrogel multifocal soft lens with other soft lens correction options in a group of habitual soft lens wearers of distance correction who are symptomatic of early presbyopia. METHOD: This clinical study was designed as a prospective, double-masked, randomized, crossover, dispensing trial consisting of four 1-week phases, one for each of the correction modalities: a low-addition silicone hydrogel multifocal soft lens, monovision, habitual correction, and optimized distance visual correction. The prescriptions of all modalities were finalized at a single fitting visit, and the lenses were worn according to a randomized schedule. All lenses were made from lotrafilcon B material. A series of objective vision tests were conducted: high- and low-contrast LogMAR under high- and low-room lighting conditions, stereopsis, and critical print size. A number of other data collection methods used were novel: some data were collected under controlled laboratory-based conditions and others under "real-world" conditions, some of which were completed on a BlackBerry hand-held communication device. RESULTS: All participants were able to be fit with all four correction modalities. Objective vision tests showed no statistical difference between the lens modalities except in the case of low-contrast near LogMAR acuity under low-lighting levels where monovision (+0.29 ± 0.10) performed better than the multifocal (+0.33 ± 0.11, P=0.027) and the habitual (+0.37 ± 0.12, P<0.001) modalities. Subjective ratings indicated a statistically better performance provided by the multifocal correction compared with monovision, particularly for the vision associated with driving tasks such as driving during the daytime (93.3 ± 8.8 vs. 84.2 ± 23.7, P=0.05), at nighttime (88.8 ± 11.7 vs. 74.9 ± 23.6, P=0.001), any associated haloes or glare (92.0 ± 10.6 vs. 78.0 ± 22.8, P=0.003), and observing road signs (90.1 ± 11.8 vs. 79.4 ± 20.2, P=0.027). Preference for the multifocal compared with monovision was also reported when watching television (95.0 ± 6.4 vs. 82.6 ± 20.1, P=0.001) and when changing focus from distance to near (87.0 ± 13.4 vs. 66.1 ± 32.2, P<0.001). CONCLUSIONS: For this group of early presbyopes, the AIR OPTIX AQUA MULTIFOCAL-Low Add provided a successful option for visual correction, which was supported by the results of subjective ratings, many of which were made during or immediately after performing such activities as reading, using a computer, watching television, and driving. These results suggest that making a prediction of "success or not" based on consulting room acuity tests alone is probably unwise. Copyright © Contact Lens Association of Ophthalmologists, Inc.

Woods,J., Woods,C., Fonn,D. Visual performance of a multifocal contact lens versus monovision in established presbyopes Optometry and Vision Science 2015;92(2):175-82 [ Show Abstract ]

PURPOSE: To compare subjective and objective visual performance of the Air Optix Aqua Multifocal lens to monovision in a group of subjects requiring a medium level of reading-addition power.

METHODS: Fifty participants with reading additions between 1.25 and 2.00 diopters (inclusive) were randomized into a prospective, crossover clinical trial. They wore monovision and multifocals for 2 weeks in a randomized order. High- and low-contrast logMAR (logarithm of the minimum angle of resolution) acuity and stereopsis were measured at the beginning and end of each period. During each phase, participants performed specific tasks followed by subjective rating surveys and also completed satisfaction rating surveys on days 3, 7, and 12; all were transferred in real time using BlackBerry smartphones. A general rating survey was completed at the dispensing and 2-week visits.

RESULTS: Forty-nine participants completed the study (mean age, 52 years). Distance and near high- and low-contrast acuities were significantly better (p < 0.05) with monovision at all visits. High-contrast intermediate acuity was only better (p < 0.05) with multifocals after 2 weeks. Stereopsis was equivalent after 2 weeks, but better (p < 0.05) with multifocals at dispensing. Subjective ratings were generally equivalent between modalities although there was a trend for multifocals to be rated higher for focus changing and driving, whereas monovision tended to be rated higher for near tasks. For both corrections, the satisfaction survey showed no significant change between days 3, 7, and 12, and the general survey showed that comfort was maintained but subjective vision ratings decreased significantly over the 2 weeks. Twenty-five participants (51%) preferred multifocals, 18 (37%) preferred monovision, and the remaining 6 (12%) declared both unacceptable.

CONCLUSIONS: In this cohort, distance and near acuities were better with monovision, whereas the subjective ratings tended to favor the Air Optix Aqua Multifocal, with the exception of near performance. Preference was statistically similar between both corrections, with a trend toward preferring the multifocal.

Wu,T.-Y., Huang,C.-C., Tsai,H.C., Lon,T.-K., Chen,P.-Y., Darge,H. F., Hong,Z.-X., Ham,H.-J., Lin,S.-Z., Lai,J.-Y., Chen,Y.-S. Mucin-mediated mucosal retention via end-terminal modified Pluronic F127-based hydrogel to increase drug accumulation in the lungs Biomaterials Advances 2024;Jan(156):213722 [ Show Abstract ]

Noninvasive lung drug delivery is critical for treating respiratory diseases. Pluronic-based copolymers have been used as multifunctional materials for medical and biological applications. However, the Pluronic F127-based hydrogel is rapidly degraded, adversely affecting the mechanical stability for prolonged drug release. Therefore, this study designed two thermosensitive copolymers by modifying the Pluronic F127 terminal groups with carboxyl (ADF127) or amine groups (EDF127) to improve the viscosity and storage modulus of drug formulations. β-alanine and ethylenediamine were conjugated at the terminal of Pluronic F127 using a two-step acetylation process, and the final copolymers were characterized using 1H nuclear magnetic resonance (1H NMR) and Fourier-transform infrared spectra. According to the 1H NMR spectra, Pluronic F127 was functionalized to form ADF127 and EDF127 with 85 % and 71 % functionalization degrees, respectively. Rheological studies revealed that the ADF127 (15 wt%) and EDF127 (15 wt%) viscosities increased from 1480 Pa.s (Pluronic F127) to 1700 Pa.s and 1800 Pa.s, respectively. Furthermore, the elastic modulus of ADF127 and EDF127 increased, compared with that of native Pluronic F127 with the addition of 5 % mucin, particularly for ADF127, thereby signifying the stronger adhesive nature of ADF127 and EDF127 with mucin. Additionally, ADF127 and EDF127 exhibited a decreased gelation temperature, decreasing from 33 °C (Pluronic F127 at 15 wt%) to 24 °C. Notably, the in vitro ADF127 and EDF127 drug release was prolonged (95 %; 48 h) by the hydrogel encapsulation of the liposome-Bdph combined with mucin, and the intermolecular hydrogen bonding between the mucin and the hydrogel increased the retention time and stiffness of the hydrogels. Furthermore, ADF127 and EDF127 incubated with NIH-3T3 cells exhibited biocompatibility within 2 mg/mL, compared with Pluronic F127. The nasal administration method was used to examine the biodistribution of the modified hydrogel carrying liposomes or exosomes with fluorescence using the IVIS system. Drug accumulation in the lungs decreased in the following order: ADF127 > EDF127 > liposomes or exosomes alone. These results indicated that the carboxyl group-modified Pluronic F127 enabled well-distributed drug accumulation in the lungs, which is beneficial for intranasal administration routes in treating diseases such as lung fibrosis.

Xu,M., Sivak,J. G., McCanna,D. J. Ocular toxicology: synergism of UV radiation and benzalkonium chloride
Cutaneous and Ocular Toxicology 2020;39(4):370-379 [ Show Abstract ]

Purpose: To investigate the combined toxic effect of ultraviolet (UV) radiation and benzalkonium chloride (BAK), a common preservative in ophthalmic eye drops, on human corneal epithelial cells (HCEC).

Methods: Cultured HCEC were exposed to different combined and separate UV (280-400 nm) and BAK solutions at relevant human exposure levels. Human exposure to UV can occur before, during, or after eye drop installation, therefore, three different orders of ocular exposures were investigated: UV and BAK at the same time, UV first followed by BAK, and BAK first followed by UV. Control treatments included testing HCEC exposed to BAK alone and also HCEC exposed to UV alone. In addition, phosphate-buffered saline (PBS) was used as a negative control. After exposure, cell metabolic activity of the cultures was measured with PrestoBlue, and cell viability was determined using confocal microscopy with viability dyes.

Results: BAK alone reduced the metabolic activity and cell viability of HCEC in a dose- and time-dependent manner. UV alone at a low dose (0.17 J/cm2) had little toxicity on HCEC and was not significantly different from PBS control. However, UV plus BAK showed combined effects that were either greater than (synergistic) or equal to (additive) the sum of their individual effects. The synergistic effects occurred between low dose UV radiation (0.17 J/cm2) and low concentrations of BAK (0.001%, 0.002%, 0.003%, and 0.004%).

Conclusions: This investigation determined that at relevant human exposure levels, the combination of UV radiation (280-400 nm) and BAK can cause synergistic and additive toxic effects on human corneal epithelial cells. This finding highlights the importance of considering the combined ocular toxicity of BAK and solar radiation in the risk assessment of BAK-preserved ophthalmic solutions.

Xu,M., Sivak,J. G., McCanna,D. J. Neutralization of the eye and skin irritant benzalkonium chloride using UVC radiation Cutaneous and Ocular Toxicology 2021;40(2):78-84 [ Show Abstract ]

Benzalkonium chloride (BAK) is a widely used disinfectant and preservative which is effective against a wide range of viruses (e.g. SARS-CoV and SARS-CoV-2), bacteria and fungi. However, it is toxic to the eye and skin. This study investigated the neutralization of BAK using ultraviolet C (UVC) radiation as an effort to reduce BAK toxicity potential.

Methods
BAK solutions were irradiated with a germicidal UVC lamp at various doses. Human corneal epithelial cells (HCEC) were then exposed to the UVC-irradiated BAK solutions for 5 minutes. After exposure, the cultures were assessed for metabolic activity using PrestoBlue; for cell viability using confocal microscopy with viability dyes; and for tight junction proteins using immunofluorescence staining for zonula occludens (ZO)-1.

Results
UVC radiation reduced BAK toxicity on cell metabolic activity in a dose-dependent manner. When the solution depth of BAK was 1.7 mm, the UVC doses needed to completely neutralize the toxicity of BAK 0.005% and 0.01% were 2.093 J/cm2 and 8.374 J/cm2, respectively. The cultures treated with UVC-neutralized BAK showed similar cell metabolic activity and cell viability to those treated with phosphate buffered saline (PBS) (p = 0.806 ∼ 1.000). The expression of ZO-1 was greatly disturbed by untreated BAK; in contrast, ZO-1 proteins were well maintained after exposure to UVC-neutralized BAK.

Conclusions
Our study demonstrates that the cell toxicity of BAK can be neutralized by UVC radiation, which provides a unique way of detoxifying BAK residues. This finding may be of great value in utilizing the antimicrobial efficacy of BAK (e.g. fighting against SARS-CoV-2) while minimizing its potential hazards to human health and the environment.

Yamasaki,K., Dantam,J., Sasanuma,K., Hisamura,R., Mizuno,Y., Hui,A., Jones,L. Impact of in vitro lens deposition and removal on bacterial adhesion to orthokeratology contact lenses Contact Lens Anterior Eye 2023;Online ahead of print [ Show Abstract ]

Purpose
The purpose of this study was to explore the impact of several contact lens (CL) care solutions on the removal of proteins and lipids, and how deposit removal impacts bacterial adhesion and solution disinfection.

Methods
Lysozyme and lipid deposition on three ortho-k (rigid) and two soft CL materials were evaluated using an ELISA kit and gas chromatography respectively. Bacterial adhesion to a fluorosilicone acrylate material using Pseudomonas aeruginosa with various compositions of artificial tear solutions (ATS), including with denatured proteins, was also investigated. The impact of deposition of the different formulations of ATS on biofilm formation was explored using cover slips. Finally, the lysozyme and lipid cleaning efficacy and disinfection efficacy against P. aeruginosa and Staphylococcus aureus of four different contact lens care solutions were studied using qualitative analysis.

Results
While maximum lysozyme deposition was observed with the fluorosilicone acrylate material (327.25 ± 54.25 µg/lens), the highest amount of lipid deposition was recorded with a fluoro-siloxanyl styrene material (134.71 ± 19.87 µg/lens). Adhesion of P. aeruginosa to fluorosilicone acrylate lenses and biofilm formation on cover slips were significantly greater with the addition of denatured proteins and lipids. Of the four contact lens care solutions investigated, the solution based on povidone-iodine removed both denatured lysozyme and lipid deposits and could effectively disinfect against P. aeruginosa and S. aureus when contaminated with denatured proteins and lipids. In contrast, the peroxide-based solution was able to inhibit P. aeruginosa growth only, while the two multipurpose solutions were unable to disinfect lenses contaminated with denatured proteins and lipids.

Conclusion
Bacterial adhesion and biofilm formation is influenced by components within artificial tear solutions depositing on lenses, including denatured proteins and lipids, which also affects disinfection. The ability of different solutions to remove these deposits should be considered when selecting systems to clean and disinfect ortho-k lenses.

Yamasaki,K., Drolle,E., Nakagawa,H., Hisamuare,R., Ngo,W., Jones,L. W. Impact of a low molecular weight hyaluronic acid derivative on contact lens wettability Cont Lens Anterior Eye 2021;44(3):101334 [ Show Abstract ]

Purpose
To investigate the interaction of a novel low molecular weight hyaluronic acid derivative containing hydrophobic groups with soft contact lenses and its effect on lens hydrophilicity compared with a conventional form of hyaluronic acid.

Methods
This investigation studied the uptake of fluorescently-labelled hyaluronic acid and a low molecular weight hyaluronic acid derivative to four types of contact lenses using fluorescent microscopy and confocal laser scanning microscopy. Further, the four lens types were used to compare efficacy in improving hydrophilicity, as well as maintenance of contact angle measurements, in commercially available multipurpose solutions that contained either hyaluronic acid, the low molecular weight hyaluronic acid derivative, or an alternative wetting agent.

Results
The low molecular weight hyaluronic acid derivative was found to sorb more readily to silicone hydrogel lenses and exhibit a greater accumulation over time than conventional hyaluronic acid. Multipurpose solutions containing the low molecular weight hyaluronic acid derivative showed an increase in lens hydrophilicity through decreases in contact angle measurements when compared with those obtained from lenses treated with multipurpose solutions containing conventional hyaluronic acid or alternative wetting agents. This increase in lens hydrophilicity associated with the low molecular weight hyaluronic acid derivative was also maintained over multiple cycles in phosphate buffered saline, while alternative solutions with conventional hyaluronic acid did not.

Conclusion
Overall, lens treatment using a low molecular weight hyaluronic acid derivative-based solution lead to improved in vitro lens hydrophilicity.

Yamasaki,K., Mizuno,Y., Kitamura,Y., McCanna,D. J., Ngo,W., Jones,L. W. The efficacy of povidone-iodine, hydrogen peroxide and a chemical multipurpose contact lens care system against Pseudomonas aeruginosa on various lens case surfaces Cont Lens Anterior Eye 2021;44(1):18-23 [ Show Abstract ]

Purpose
To determine the antimicrobial efficacy of a povidone-iodine system (PVP-I; cleadew, OPHTECS Corporation, Kobe, Japan), a peroxide system (AOSEPT Plus with HydraGlyde, Alcon, Fort Worth, TX), and a chemical multipurpose system (renu fresh, Bausch & Lomb, Rochester, NY) on contact lens case surfaces that are both in contact and not in contact with the solutions during lens disinfection.

Methods
The surfaces of the inner walls, underside of the lid, and lens holder (if applicable) of the cases were inoculated with P. aeruginosa ATCC 27853. The cases were disinfected with the solutions as per their manufacturer instructions. After disinfection, the inoculated surfaces were swabbed and the amount of surviving P. aeruginosa was determined. Following this experiment, separate cases were inoculated and disinfected as before. This time the cases were agitated after recommended disinfection time and the amount of P. aeruginosa in the disinfecting solution was quantified immediately, and again after resting for 7 days. Experiments were conducted in triplicate (n = 3).

Results
Units are expressed in log CFU. All three solutions significantly reduced P. aeruginosa on direct-contact surfaces (all p < 0.039). On non-contact surfaces, the reduction of P. aeruginosa in the PVP-I system (pre-disinfection: 6.8 ± 0.5, post-disinfection: 1.0 ± 0.0; p < 0.001) was significant, but not for the hydrogen peroxide system (pre-disinfection: 6.3 ± 0.6, post: 5.5 ± 0.5; p = 0.194) and the chemical multipurpose system (pre-disinfection: 6.6 ± 0.1, post-disinfection: 5.6 ± 0.8; p = 0.336). After 7 days post-disinfection, no P. aeruginosa regrowth was observed in the PVP-I system (Day 1: 1.0 ± 0.0, Day 7: 1.0 ± 0.0; p = 1) and the chemical multipurpose system (Day 1: 4.2 ± 0.2, Day 7: 1.8 ± 0.9; p = 0.012), however regrowth was observed in the hydrogen peroxide system (Day 1: 3.4 ± 0.6, Day 7: 6.1 ± 0.4; p = 0.003).

Conclusion
The PVP-I system was more effective against P. aeruginosa on non-contact surfaces than the hydrogen peroxide system or the chemical multipurpose system and is capable of inhibiting regrowth of P. aeruginosa for at least 7 days post-disinfection.

Yang,M., Luensmann,D., Fonn,D., Woods,J., Jones,D., Gordon,K., Jones,L. Myopia prevalence in Canadian school children: A pilot study Eye 2018;32(6):1042-1047 [ Show Abstract ]

Purpose: A pilot study to determine the prevalence of myopia, proportion of uncorrected myopia and pertinent environmental factors among children in a suburban region in Canada. Methods: Refraction with cycloplegia and ocular biometry were measured in children of two age groups. Myopia was considered at a spherical equivalent refraction (SER) ≤-0.50 D in at least one eye. Parents completed a questionnaire that captured the child's daily activities. Results: A total of 166 children completed the study (83 aged 6-8 and 83 aged 11-13). Myopia prevalence was 17.5% among the overall group, 6.0% among ages 6-8 and 28.9% among ages 11-13. Mean subjective SER in myopic children was -1.10 D (95% confidence interval (CI), -0.34 to -1.86 D) at ages 6-8 and -2.44 D (95% CI, -1.71 to -3.18 D) at ages 11-13. In this study, 34.5% of the myopic children were uncorrected, which represented 6.0% of the entire group of children. Mean axial length (AL) increased by 1.03 mm from ages 6-8 (mean 22.62 mm; 95% CI, 22.45 to 22.79 mm) to ages 11-13 (mean 23.65 mm; 95% CI, 23.45 to 23.84 mm; p < 0.01). The correlation coefficient between AL and SER was -0.618 (p < 0.01). Binary logistic regression between outdoor time and the prevalence of myopia showed that one additional hour of outdoor time per week lowered the odds of a child having myopia by 14.3% (p = 0.007). Conclusion: Myopia prevalence increased from 6% at ages 6-8 to 29% at ages 11-13. Thirty-five per cent of the myopes in this study were uncorrected. More time outdoors may be beneficial to protect against myopia onset.

Yang,M., Ngo,W., Srinivasan,S., Heynen,M. L., Dantam,J., Subbaraman,L. N., Jones,L., Senchyna,M. Optimization of goblet cell density quantification methods Experimental Eye Research 2021;207(June):108607 [ Show Abstract ]

The purpose of this study was to develop a standardized, accurate and efficient method for estimating conjunctival goblet cell density (GCD) via optimizing sample storage conditions and quantification methods. Conjunctival impression cytology (CIC) membranes were collected from both eyes of 32 participants and were randomized to two storage durations (2-3 weeks, 6-7 weeks) and two storage container types (microcentrifuge tube, flat histology cassette). The CIC membranes were stained and subdivided into 25 areas (5 mm × 5 mm) for imaging and the GCs were counted under 200X magnification using three different methods: (1) full CIC membrane GC count of the 25 images with cell-counting software ("full"; reference method), (2) partial membrane GC count of 9 images with cell-counting software ("partial"), and (3) manual counting of the 25 images ("manual"). In all cases, GCD was determined by dividing the GC count by the counting area. The average time required for quantification was recorded to gauge efficiency. Results showed no significant difference in GC count between the two storage durations (p = 0.745) or storage container types (p = 0.552). The median (interquartile range (IQR)) time required to quantify a CIC membrane for the full, partial, and manual methods of GC counting, was 14.8(17.6), 4.6(5.2) and 5.0 (5.0) minutes, respectively. The agreement of GCD values between the full and manual methods (bias: 0.4, 95% LOA: [-4.6, 5.5]) was stronger than that comparing the full and partial methods (bias: 0.5, 95% LOA: [-18, 17]). All together, through systematic examination of key procedural variables, an optimized method for GCD quantification within 7 weeks of sample collection was outlined. Adaption of procedures described in this paper to facilitate accurate and efficient GCD quantification may serve as a valuable step in clinical trials investigating DED pathophysiology and/or novel DED treatment strategies.

Yee,A., Chan,V., Heynen,M., Phan,C. M., Jones,L. Uptake and release of a multipurpose solution biocide (MAP-D) from hydrogel and silicone hydrogel contact lenses using a radiolabel methodology Eye & Contact Lens 2021;47(5):249-255 [ Show Abstract ]

Purpose:
The purpose of this study was to evaluate the uptake and release of radiolabelled myristamidopropyl dimethylamine (MAP-D) on reusable daily wear contact lenses (CLs) over 7 days.

Methods:
Three silicone hydrogel (SH) CL materials (lotrafilcon B, balafilcon A, senofilcon A) and two conventional hydrogel (CH) materials (etafilcon A, omafilcon A) were tested. A short-term (experiment 1, N=4) and a longer-term (experiment 2, N=3) study was conducted. In experiment 1, the CLs were incubated in 2 mL of phosphate buffered solution (PBS) containing 14C MAP-D (5 μg/mL) for 8 hrs. The release of 14C MAP-D was measured at t=0.25, 0.5, 1, 2, 4, 8, and 24 hr in PBS. In experiment 2, the CLs were incubated in the 14C MAP-D solution for 8 hrs followed by a 16-hr release in PBS. This cycle was repeated daily for 7 days. At the end of both experiments, lenses were extracted to determine the total uptake of MAP-D. The radioactivity was measured using a beta scintillation counter.

Results:
In experiment 1, all three SH lenses sorbed similar amounts of MAP-D (P=0.99), all of which were higher than the two CH materials (P<0.01). However, the CH materials released a greater amount of MAP-D than the SH materials (P<0.01). In experiment 2, the uptake of MAP-D in SH materials increased over 7 days, whereas the amount of MAP-D remained constant in the CH materials (P=0.99). Similar to experiment 1, the CH lenses released more MAP-D than SH lenses after 7 days (P<0.01).

Conclusion:
The SH materials absorbed greater amounts of MAP-D compared to CH materials. However, the CH materials released the greatest amount of MAP-D. Radioactive labelling of MAP-D offers a highly sensitive method of assessing the uptake and release profiles of biocides to CL materials.

Yee,A., Phan,C-M., Jones,L. Uptake and release of polyhexamethylene biguanide (PHMB) from hydrogel and silicone hydrogel contact lenses using a radiolabel methodology Contact Lens Anterior Eye 2022;45(5):101575 [ Show Abstract ]

Purpose
The purpose of this study was to evaluate the uptake and release of radiolabelled polyhexamethylene biguanide (PHMB) on reusable daily wear contact lenses (CLs) over 7 days.

Methods
Three silicone hydrogel (SH) contact lens materials (lotrafilcon B, balafilcon A, senofilcon A) and two conventional hydrogel (CH) materials (etafilcon A, omafilcon A) were examined. In experiment 1 (1-day study), CLs were soaked in 2 mL of phosphate buffered solution (PBS) containing radiolabelled 14C PHMB (1 µg/mL) for 8 h. The release kinetics of 14C PHMB from the CLs was measured at t = 0.25, 0.5, 1, 2, 4, 8, and 24 h in fresh 2 mL PBS. In experiment 2 (7-day study), the CLs were soaked in the 14C PHMB (1 µg/mL) solution for 8 h followed by a 16-hour release in 2 mL PBS. The lens cycle was repeated daily for 7 days. After both experiments, the residual amount of PHMB remaining within the lenses was extracted to determine the total uptake of PHMB.

Results
In experiment 1, the total uptake of PHMB for etafilcon A was significantly greater than senofilcon A (p = 0.01). There were no significant differences in total uptake of PHMB between other lens materials (p > 0.05). Etafilcon A released more PHMB compared to all other lens types over a 24-hr period (p < 0.001). In experiment 2, all CL materials continued to sorb more PHMB over time (p < 0.001). By day 7, the amount of PHMB sorbed by etafilcon A was significantly greater than senofilcon A (p = 0.02). After day 2, the CH materials released significantly more PHMB than the SH materials (p < 0.01).

Conclusion
The CL materials continued to sorb PHMB with no signs of saturation after 7 days. All lens materials released a consistent amount of PHMB each day. Radioactive labelling provides a sensitive method of assessing the uptake and release of PHMB from CL materials.

Yee,A., Walsh,K., Schulze,M., Jones,L The impact of patient behaviour and care system compliance on reusable soft contact lens complications Contact Lens Anterior Eye 2021;44(5):101432 [ Show Abstract ]

Reusable soft daily wear contact lenses (CLs) remain popular and were fit to just over half of all wearers in the most recent international CL prescribing survey. Unlike daily disposable CLs, reusables require cleaning and disinfecting after every use, along with storage in a CL case. These additional requirements add a number of steps to the daily wear and care routine, increasing the opportunities for CL wearers to exhibit non-compliant behaviour. The impact of non-compliance ranges from poor lens comfort through to potentially sight- threatening infective keratitis. The coronavirus pandemic has refocused the profession on the importance of hand hygiene in particular, and the need for promoting safe CL wear in general. This review summarises typical non-compliant behaviour related to reusable CLs, and examines strategies and opportunities to better support wearers. Patient education has a central role in encouraging compliant behaviour, although patient recall of information is low, and personal belief systems may result in continuation of non-compliant behaviour despite awareness of the risks. CL care solutions are required for the daily disinfection of lenses, however misuse of multipurpose solutions (MPS) and hydrogen peroxide (H2O2)-based care systems can challenge their ability to be fully efficacious. Standard efficacy testing is reviewed, with consideration of how well current protocols model real-world use of CL solutions. Although some recommendations are in place for the inclusion of additional variables such as lens cases, CL materials, organic soil and efficacy against Acanthamoeba, opportunity still exists to reevaluate global standards to ensure consistency of testing in all markets. Finally, potential future innovations are discussed which may further support increased safety in reusable lens wear through novel antimicrobial additions to both CL materials and cases

Yeu,E., Silverstein,S., Guillon,M., Schulze,M., Galaretta,D., Srinivasan,S., Manoj,V. Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial Clinical Ophthalmology 2020;14:2561-2570 [ Show Abstract ]

Purpose: To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropylguar (PG-HPG)-based nanoemulsion (Systane ® Complete) lubricant eye drops in participants with dry eye disease (DED).

Participants and Methods: In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED – subtyped into aqueous deficient, evaporative, and mixed dry eye – were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes. Results: A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: −17.3 [24.80]) for the overall cohort, −22.0 [21.73] for aqueous deficient, −17.6 [24.17] for evaporative and −13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study.

Conclusion: Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes. Keywords: aqueous deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant, mixed dry eye

Youn,H. -Y, McCanna,D. J., Sivak,J. G., Jones,L. W. In vitro ultraviolet-induced damage in human corneal, lens, and retinal pigment epithelial cells Molecular Vision 2011;17237-246

Young,G., Chalmers,R., Napier,L., Kern,J., Hunt,C., Dumbleton,K. Soft contact lens-related dryness with and without clinical signs Optometry and Vision Science 2012;89(8):1125-1132 [ Show Abstract ]

PURPOSE.: To report demographics, wearing patterns, and symptoms from soft contact lens (SCL) wearers with significant SCL-related dryness symptoms with and without significant ocular signs of dryness. METHODS.: In a multicenter, prospective observational clinical trial, symptomatic SCL wearers reported significant SCL-related dryness via self-administered questionnaire of frequency and intensity of dryness after a dry eye (DE) examination. DE etiology was assigned post hoc by an expert panel, and those with and without significant DE-related signs were analyzed by univariate logistic regression. Possible DE etiologies were aqueous tear deficiency, SCL-induced tear instability, meibomian gland dysfunction, or "other." Wearers without signs that qualified for any DE etiology were designated as No DE Signs (NDES). RESULTS.: Of the 226 SCL symptomatic wearers examined, 23% were without signs, 30% had aqueous tear deficiency, 25% had SCL-induced tear instability, 14% had meibomian gland dysfunction, and 8% had "other" diagnoses. The NDES wearers had significantly longer pre-lens break-up time (9.8 vs. 6.6 s, p < 0.0001), better lens wetting (3.4 vs. 2.4 0 to 4 scale, p < 0.0001), lower levels of film deposits on lenses (0.45 vs. 0.92, 0 to 4 scale, p < 0.0001), and of most slit lamp signs. The NDES wearers were significantly more likely to be male (36% vs.19%, p ≤ 0.013), were less likely to have deteriorating comfort during the day (81% vs. 97%, p ≤ 0.001), reported longer average hours of comfortable wear (11 ± 3 vs. 9 ± 4 h, p ≤ 0.014), had older contact lenses (18 ± 14 vs. 13 ± 12 days, p ≤ 0.029), and greater intensity of photophobia early and late in the day (p ≤ 0.043 and 0.021). CONCLUSIONS.: Symptoms of dryness in SCL wearers stem from a variety of underlying causes. However, nearly one-quarter of these symptomatic SCL wearers appear to be free of signs of dryness. The effective management of CL-related dryness requires a comprehensive range of clinical assessments and the use of a diverse range of management strategies. Copyright © 2012 American Academy of Optometry.

Young,G., Keir,N., Hunt,C., Woods,C. A. Clinical evaluation of long-term users of two contact lens care preservative systems Eye and Contact Lens 2009;35(2):50-58 [ Show Abstract ]

PURPOSE: To clinically evaluate long-term users of two different contact lens care preservative systems and to investigate whether prolonged use is associated with an increase in the prevalence of dry eye. METHODS: Eighty-nine wearers of group IV hydrogel or silicone hydrogel lenses participated in this one-visit, investigator-masked study. Subjects were required to have consistently used a polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) based solution for 2 years. Consistent use was defined as 80% for the past 2 years and 100% for the past year. Clinical assessments included: average and comfortable wear time; overall and end-of-day comfort; signs of dryness, discomfort, burning or stinging, grittiness or scratchiness and visual changes; non-invasive and fluorescein break-up-time; pre-ocular tear film lipids, tear meniscus height, Schirmer and fluorescein clearance tests; limbal and bulbar hyperemia; palpebral roughness; corneal and conjunctival staining; lens front surface wetting; and lens film deposits. RESULTS: Significantly more grittiness or scratchiness was reported by subjects using a PHMB-containing system (67% vs. 44%; P = 0.02). Palpebral roughness and hyperemia were significantly greater in the PHMB group wearing group IV lenses (P = 0.01 and P = 0.05, respectively). Corneal staining was significantly higher in the PHMB users in all four peripheral sectors (P < 0.01). Nasal and temporal conjunctival staining was also significantly higher for users of PHMB-containing systems (P < 0.05). Front surface lens wettability was significantly better for group IV PQT users compared to PHMB users (P = 0.008), with 84% vs. 72%, respectively, with lenses graded by the investigator as having "good" or "excellent" wettability. Significantly higher levels of lens front surface film deposits were noted with PHMB users (P = 0.007), with 58% of group IV lenses treated with PHMB compared with 38% of group IV lenses treated with PQT showing some lens front surface film deposition. No significant differences between the two preservative system groups were noted for the range of dry eye evaluations nor the remaining clinical assessments. CONCLUSIONS: Differences in both ocular and lens characteristic were observed between long-term users of two preservative systems used in many contact lens multi-purpose solutions. The findings from this study did not support the hypothesis that prolonged use of PHMB-containing solutions leads to dry eye. Additional studies including a larger sample size and perhaps longer use of the systems could help to further elucidate differences in clinical performance between systems.

Young,G., Veys,J., Pritchard,N., Coleman,S. A multi-centre study of lapsed contact lens wearers Ophthalmic and Physiological Optics 2002;22(6):516-527 [ Show Abstract ]

Purpose: Discontinuation from contact lens wear has been identified as a contributing factor in the lack of growth of contact lens use in Europe. The purpose of this study was to determine the proportion of lapsed contact lens wearers that can be refitted successfully with contact lenses and to evaluate the reasons for discontinuation from contact lens wear. Methods: This was a multi-site clinical study involving 15 UK investigators and 236 lapsed contact lens wearers who had previously tried contact lenses and discontinued. The reasons for discontinuation were assessed by subjects, who were then refitted with contact lenses. Investigators subsequently evaluated factors associated with their initial discontinuation. Short-term success was defined as the successful completion of 1 month of contact lens wear with absence of complications that would prevent further wear. Subjects were interviewed by telephone 6 months after being refitted to determine whether they were still wearing contact lenses. Those who were not wearing lenses were questioned about the reasons for discontinuation and their likelihood of resuming lens wear. Results: A majority of subjects (51%) cited discomfort as the principal reason for having previously given up contact lens wear. Problems with vision were the second most common reason (13%), either with reading (6%) or general vision (7%). The most common type of discomfort was dryness (40%). In almost all cases (97%), the investigator's assessment of the reasons for discontinuation agreed with the subject's own assessment but investigators also cited product-related and practitioner-related factors as contributing to previous failure. The short-term success rate for refitting lapsed wearers was found to be 77% (CI: 70-82%). The highest short-term success rates were for 2-weekly/monthly soft spherical lenses (91%) and daily disposable lenses (89%). Lower success rates were found for soft toric (69%) and soft bifocal (53%) lenses. At the 6-month stage, 73% of those who continued in lenses after the 1-month visit were still wearing contact lenses and a further 18% indicated that they were either 'very likely' or 'likely' to resume lens wear. Conclusions: A high proportion of lapsed contact lens wearers can be successfully refitted with contact lenses. The prime reason for previous discontinuation from contact lenses is discomfort and, in particular, dryness-related discomfort. In many cases, previous contact lens failure is product or practitioner-related rather than because of patient-specific problems. Once refitted with contact lenses, lapsed wearers cite vision problems rather than discomfort as the most common reason for discontinuing. This finding suggests that recent advances in contact lens material, design, replacement frequencies and care systems have improved the prospects for avoiding lens-related discomfort and for continuing contact lens wear. © 2002 The College of Optometrists.

Zaidi,A., Seo,J., McCanna,D.J., Mahil,A., Jones,L. Molecular biology of two common ophthalmic viruses: Relevance to clinical practice Optometry in Practice 2023;24(1): [ Show Abstract ]

Due to the coronavirus pandemic, viruses have suddenly become a prominent topic of discussion. As such, it
is important to understand the life cycle and, ultimately, the process of inactivating viruses. To inactivate them
it is important to block the mechanisms that they use to induce infection. Due to their ability to survive on
various surfaces, appropriate cleaning practices to prevent viral spread and contamination of medical devices,
practice equipment and surfaces are paramount. Depending on the type of virus and genome configurations,
various mechanisms are used to induce a viral infection. Understanding the susceptibility of the viral outer
coating is crucial to preventing viral spread, whether through droplet transmission or while on surfaces (fomite
transmission). Knowledge of how viral receptors and proteins interact to facilitate the recognition, attachment
and entry of a virus into the host cell is vital for an understanding of how disinfectants and antivirals can be
effective. Viral replication, transcription and translation are also major targets of antivirals. This paper will
review the physiology of two major ophthalmic viruses: adenovirus and herpes simplex.