Defining Daily Disposable Contact Lens Wear in a Clinical Study.

SIGNIFICANCE: The U.S. Food and Drug Administration regulates contact lenses as prescription medical devices and defines daily disposable lenses for single use; however, safety comparisons between daily disposable and reusable lenses rely on the lens-wearing regimen. When inappropriately discerned, studies may erroneously report replacement regimen, resulting in inaccurate risk rates. PURPOSE: This study aimed to explore different measures for defining daily disposable wearers in the context of a clinical study. METHODS: A secondary analysis of data from five multisite fieldings (n = 1059) from the Contact Lens Risk Survey was performed. Descriptive statistics were used to examine self-reported lens replacement, use of lens case, and manufacturer's recommended replacement frequency as defined by the participants' selection of their habitual lenses using a photographic aide. Daily disposable wearers were identified as reporting daily replacement (by self-report and lens identification) and not using a lens case. If there was a discrepancy among these three factors, the lens assignment was assessed as a majority response (two of three) or as missing if conflicting information was reported. RESULTS: The cohort was approximately two-thirds (68.7%) female and ranged from 12 to 33 years of age. A total of 154 participants (14.5%) were classified as daily disposable wearers and 896 (84.6%) as reusable wearers. Congruence was observed among all three daily disposable assignment factors for only 106 wearers (68.8%). The greatest discrepancy among daily disposable wearers was the report of using a lens case (n = 32 [20.8%]). In contrast, reusable lens wearers were more likely to report agreement across all three factors (n = 798 [89.1%], P < .001). CONCLUSIONS: This analysis suggests that the report of not using a lens case is a more conservative surrogate for true single-use lens wear, as one in five may be storing and reusing their daily disposable lenses.

Change in Risk Score and Behaviors of Soft Contact Lens Wearers After Targeted Patient Education.

OBJECTIVES: To determine if targeted education can influence the behaviors and scores of soft contact lens (SCL) wearers via the Contact Lens Risk Survey (CLRS). METHODS: This was a multicenter, prospective, case-control study. Cases were symptomatic red eye SCL wearers (age, 18-39 years), and controls were age , sex, and site matched. Participants completed the CLRS and were provided targeted patient education at three time points: baseline, one, and six months. Change in scores and behaviors were analyzed using the Wilcoxon signed rank test. RESULTS: Forty-one cases and 71 controls were analyzed. The mean risk score (mean±SE) from baseline to follow-up improved (reduced) for all participants (-1.96±0.73; P =0.01), mostly driven by the improvement among cases (-2.55±1.32; P =0.05). Case subjects reported a decrease in frequency of wearing lenses while showering (-0.32±0.07; P <0.0001), discarding lens solution (-0.13±0.06; P =0.03), and rinsing lenses with tap water (-0.19±0.08; P =0.02) after targeted education. CONCLUSIONS: Targeted patient education can influence some behaviors of SCL wearers, especially those who experienced a red eye event. Further study is needed to determine how to improve other risk behaviors and whether these changes are sustained long term.

Multicenter Testing of a Risk Assessment Survey for Soft Contact Lens Wearers With Adverse Events: A Contact Lens Assessment in Youth Study.

PURPOSE: To test the ability of responses to the Contact Lens Assessment in Youth (CLAY) Contact Lens Risk Survey (CLRS) to differentiate behaviors among participants with serious and significant (S&S) contact lens-related corneal inflammatory events, those with other events (non-S&S), and healthy controls matched for age, gender, and soft contact lens (SCL) wear frequency. METHODS: The CLRS was self-administered electronically to SCL wearers presenting for acute clinical care at 11 clinical sites. Each participant completed the CLRS before their examination. The clinician, masked to CLRS responses, submitted a diagnosis for each participant that was used to classify the event as S&S or non-S&S. Multivariate logistic regression analyses were used to compare responses. RESULTS: Comparison of responses from 96 participants with S&S, 68 with non-S&S, and 207 controls showed that patients with S&S were more likely (always or fairly often) to report overnight wear versus patients with non-S&S (adjusted odds ratio [aOR], 5.2; 95% confidence interval [CI], 1.4-18.7) and versus controls (aOR, 5.8; CI, 2.2-15.2). Patients with S&S were more likely to purchase SCLs on the internet versus non-S&S (aOR, 4.9; CI, 1.6-15.1) and versus controls (aOR, 2.8; CI, 1.4-5.9). The use of two-week replacement lenses compared with daily disposables was significantly higher among patients with S&S than those with non-S&S (aOR, 4.3; CI, 1.5-12.0). Patients with S&S were less likely to regularly discard leftover solution compared with controls (aOR, 2.5; CI, 1.1-5.6). CONCLUSIONS: The CLRS is a clinical survey tool that can be used to identify risky behaviors and exposures directly associated with an increased risk of S&S events.

Contact Lens Wearer Demographics and Risk Behaviors for Contact Lens-Related Eye Infections--United States, 2014.

Contact lenses provide safe and effective vision correction for many Americans. However, contact lens wearers risk infection if they fail to wear, clean, disinfect, and store their contact lenses as directed. Over the past decade, CDC has investigated several multistate outbreaks of serious eye infections among contact lens wearers, including Acanthamoeba keratitis. Each investigation identified frequent contact lens hygiene-related risk behaviors among patients. To guide prevention efforts, a population-based survey was used to estimate the number of contact lens wearers aged ≥18 years in the United States. A separate online survey of contact lens wearers assessed the prevalence of contact lens hygiene-related risk behaviors. Approximately 99% of wearers reported at least one contact lens hygiene risk behavior. Nearly one third of contact lens wearers reported having experienced a previous contact lens-related red or painful eye requiring a doctor's visit. An estimated 40.9 million U.S. adults wear contact lenses, and many could be at risk for serious eye infections because of poor contact lens wear and care behaviors. These findings have informed the creation of targeted prevention messages aimed at contact lens wearers such as keeping all water away from contact lenses, discarding used disinfecting solution from the case and cleaning with fresh solution each day, and replacing their contact lens case every 3 months.

Age, behavior, environment, and health factors in the soft contact lens risk survey.

PURPOSE: Previous studies have reported that the risk of corneal infectious and inflammatory events (CIEs) with soft contact lens (SCL) wear is highest in late adolescence and early adulthood. This study assesses the associations between patient age and other factors that may contribute to CIEs in young SCL wearers. METHODS: After ethics approvals and informed consent, a nonclinical population of young SCL wearers was surveyed in five US cities. Data from 542 SCL wearers aged 12-33 years were collected electronically. Responses were analyzed by age bins (12-14, 15-17, 18-21, 22-25, 26-29, and 30-33 years) using chi-square test. RESULTS: The cohort was 34% male and balanced across age bins. There were several significant associations between survey response and age (in bins). Wearers aged 18-21 years reported more recent nights with less than 6 hours of sleep (p < 0.001), more colds/flu (p = 0.049), and higher stress levels (p < 0.001). Wearers 18-21 and those 22-25 years were more likely to wear SCLs when showering (p < 0.001) and also reported more frequent naps with SCLs (p < 0.001). They reported sleeping in SCLs after alcohol use (p = 0.031), when traveling (p = 0.001), and when away from home (p = 0.024). Lower rates of regular hand washing before lens application (p = 0.054) was also associated with these groups. In addition, the relationship between reactive replacement and recommended replacement was dependent on age (p < 0.0001). CONCLUSIONS: Patient age influences lens wearing behaviors, environmental exposures, and other determinants of health that may contribute to increased CIEs in younger wearers. Targeted, age-specific education should be considered for both new and established SCL wearers.

Daily disposable soft lens sagittal depth and other lens parameter changes measured at room temperature (20 °C) and on-eye temperature (34 °C).

PURPOSE: To investigate the differences in contact lens sagittal depth (CL-SAG), base curve (BC), and overall lens diameter (OAD) of daily disposable (DD) SCLs at room temperature (20 °C) and on-eye (34 °C) temperature. METHODS: Twelve different spherical daily SCLs were analyzed (labeled power -3.00 D) at 20 °C and 34 °C. The posterior CL-SAG, BC, and OAD were measured directly using a spectral domain OCT-based instrument (Optimec is830). RESULTS: The CL-SAG range for the daily disposable lenses measured at 20 °C was 3468-4016 µm. At 34 °C, the DD CL-SAG of all lenses individually decreased compared to 20 °C (t = 7.78, p < 0.001), ranging from 3385 to 3913 µm. On average at the higher temperature, the measured overall lens diameter was smaller (t = 8.18, p < 0.001) and the BC was marginally steeper (t = 2.11, p = 0.058). CONCLUSIONS: Soft lens parameters change when equilibrated from room temperature (20 °C) to on-eye temperature (34 °C). All lenses shrink when going to on-eye temperature (both lens diameter and CL-SAG decreases), compared to lenses measured at room temperature by ISO standards. Higher water content materials tend to have greater changes to the lens parameters compared to lower water content material lenses.

Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance.

PURPOSE: To help maintain clear vision and ocular surface health, eye blinks occur to distribute natural tears over the ocular surface, especially the corneal surface. Contact lens wearers may suffer from poor vision and dry eye symptoms due to difficulty in lens surface wetting and reduced tear production. Sustained viewing of a computer screen reduces eye blinks and exacerbates such difficulties. The present study evaluated the wetting effect of lens care solutions (LCSs) on blink rate, dry eye symptoms, and vision performance. METHODS: Sixty-five adult habitual soft contact lens wearers were recruited to adapt to different LCSs (Opti-free, ReNu, and ClearCare) in a cross-over design. Blink rate in pictorial viewing and reading (measured with an eyetracker), dry eye symptoms (measured with the Ocular Surface Disease Index questionnaire), and visual discrimination (identifying tumbling E) immediately before and after eye blinks were measured after 2 weeks of adaption to LCS. Repeated measures anova and mixed model ancova were conducted to evaluate effects of LCS on blink rate, symptom score, and discrimination accuracy. RESULTS: Opti-Free resulted in lower dry eye symptoms (p = 0.018) than ClearCare, and lower spontaneous blink rate (measured in picture viewing) than ClearCare (p = 0.014) and ReNu (p = 0.041). In reading, blink rate was higher for ClearCare compared to ReNu (p = 0.026) and control (p = 0.024). Visual discrimination time was longer for the control (daily disposable lens) than for Opti-Free (p = 0.007), ReNu (p = 0.009), and ClearCare (0.013) immediately before the blink. CONCLUSIONS: LCSs differently affected blink rate, subjective dry eye symptoms, and visual discrimination speed. Those with wetting agents led to significantly fewer eye blinks while affording better ocular comfort for contact lens wearers, compared to that without. LCSs with wetting agents also resulted in better visual performance compared to wearing daily disposable contact lenses. These presumably are because of improved tear film quality.

Contact lens assessment in youth: methods and baseline findings.

PURPOSE: To describe the Contact Lens Assessment in Youth (CLAY) Study design and report baseline data for a multicenter, retrospective, observational chart review of children, teenagers, and young adult soft contact lens (SCL) wearers. METHODS: Clinical charts of SCL wearers aged 8 to 33 years were reviewed at six colleges of optometry. Data were captured retrospectively for eye care visits from January 2006 through September 2009. Patient demographics, SCL parameters, wearing schedules, care systems, and biomicroscopy findings and complications that interrupted SCL wear were entered into an online database. RESULTS: Charts from 3549 patients (14,276 visits) were reviewed; 78.8% were current SCL wearers and 21.2% were new fits. Age distribution was 8 to <13 years (n = 260, 7.3%), 13 to <18 years (n = 879, 24.8%), 18 to <26 years (n = 1,274, 36.0%), and 26 to <34 years (n = 1,136, 32.0%). The sample was 63.2% females and 37.7% college students. At baseline, 85.2% wore spherical SCLs, 13.5% torics, and 0.1% multifocals. Silicone hydrogel lenses were worn by 39.3% of the cohort. Daily wear was reported by 82.1%, whereas 17.9% reported any or occasional overnight wear. Multipurpose care systems were used by 78.1%, whereas another 9.9% indicated hydrogen peroxide solutions use. CONCLUSIONS: This data represent the SCL prescribing and wearing patterns for children, teenager, and young adult SCL wearers who presented for eye care in North American academic clinics. This will provide insight into SCL utilization, change in SCL refractive correction, and risk factors for SCL-related complications by age group.

Risk factors for interruption to soft contact lens wear in children and young adults.

PURPOSE: The purpose of this study was to describe age and other risk factors for ocular events that interrupt soft contact lens (SCL) wear in youth. METHODS: A retrospective chart review of SCL wearers aged 8 to 33 years at the first observed visit was conducted at six academic eye care centers in North America. Data were extracted from all visits during the observation period (>3 years). Clinical records that documented conditions resulting in an interruption of SCL wear "events" were scanned, masked for age and SCL parameters, and then adjudicated to consensus diagnosis. Generalized estimating equations were used to examine the effect of selected covariates, including age, on the risk of an event. RESULTS: Chart review of 3549 SCL wearers yielded 522 events among 426 wearers (12%). The risk of an event increased from ages 8 to 18 years, showed modest increases between ages 19 and 25 years, and then began to decline after age 25 years. New lens wearers (<1 year) were less likely to experience events (p = 0.001). Lens replacement schedule and material were also predictive of interruptions to SCL wear with the lowest risk in daily replacement and hydrogel lens wearers (both p < 0.0001). CONCLUSIONS: These results suggest that the risk of events that interrupt SCL wear peaks in late adolescence and early adulthood and reflects risk factors identified in prospective contact lens studies. Relative to older teens and young adults, patients younger than 14 years presented with significantly fewer events resulting in interrupted lens wear.

Variation in sag values in daily disposable, reusable and toric soft contact lenses.

PURPOSE: While knowledge of the ocular surface sagittal height (OC-SAG) is increasing with newer instrumentation, understanding of soft lens sag values (CL-SAG) in daily clinical practice is limited. This study aimed to report the differences in CL-SAG of a large collection of daily disposable (DD), reusable (2-week and 4-week replacement) and toric lens designs. METHODS: 12 different spherical DD and 15 reusable lens types were analysed (labelled power -3.00D); 17 different toric lens types analysed (6 DD and 11 reusable) in -3.00D =C 0.75 × 180. Posterior CL-SAG was measured directly using a spectral domain OCT-based instrument (Optimec is830). RESULTS: The range in CL-SAG for DDs was 3,398-3,912 microns, for reusable lenses 3,372-4,004 microns and for toric lenses 3,536-4,157 microns. Lens diameter and BC together influence CL-SAG values. For lenses with the same labelled base curve (BC), the maximum difference in the DD group was 264 microns, in the reusable group 418 microns and in the toric group 345 microns. Three lens designs within the DD group and five in the reusable group offer two BCs, with an average variation (±SD) in CL-SAG of 276 ± 39 microns; one toric lens with two BCs showed a 377-micron difference. CONCLUSIONS: Marked differences in CL-SAG values were found in this study, also between lenses of the same BC. While ECPs should be aware that diameter and BC together influence CL-SAG, this also indicates that lens substitution based on BC alone could result in substantial differences in CL-SAG, with a potential impact on lens fit. Lens designs offering two BCs showed a somewhat narrow band in absolute terms in CL-SAG, and switching from a spherical to a toric lens of the same lens manufacturer could result in a significant change in CL-SAG.

Development of a contact Lens risk survey.

PURPOSE: To describe the development and report psychometric properties of the Contact Lens Risk Survey (CLRS) to identify patients at risk for soft contact lens-related complications. METHODS: Psychometric properties of the CLRS, a web-based survey with branching logic, were determined using data from 5 multi-site fieldings (n = 1059), including re-fielding to sub groups. Responses from participants with and without an active red eye were used to identify risk factors of a red eye event and calculate an overall risk score. A 6th fielding of the CLRS (n = 171) was used to assess discriminate validity. RESULTS: Participants needed 11-12 min to complete the survey with a negligible difference by age. Internal consistency was excellent (Cronbach's α ≥ 0.70) for 3 of the 5 constructs identified by factor analysis. Twelve of the 17 survey items exhibited excellent within-subject repeatability (Kappa ≥ 0.61). Between-subject agreement, assessed in 18-25 year olds, was high for the majority of items, suggesting good generalizability across different populations of SCL wearers. The ability of the model using individual items of the CLRS to discriminate Controls and participants with a red eye was good with an area under the curve of 0.779. CONCLUSION: The CLRS tool is a repeatable and valid instrument to standardize documentation of demographic, behavior, and exposure factors which appear to drive the greatest risk of a contact lens related red eye event.

The contact Lens risk survey to assess risk of soft contact lens-related inflammatory events.

PURPOSE: To test the Contact Lens Assessment in Youth Contact Lens Risk Survey (CLRS) scoring algorithm in soft contact lens (SCL) wearers presenting with SCL-related adverse events and healthy matched controls. METHODS: This prospective case-control study compared CLRS responses in SCL wearers presenting with symptomatic red eyes (Cases) with age-, sex- and site-matched healthy SCL wearers (Controls) at six locations across North America. Responses to individual questions from Cases and Controls were analyzed using either the Pearson, Mantel-Haenszel chi-square, or Fisher's exact test. Differences in the CLRS scores were compared using t-tests. RESULTS: A total of 171 SCL wearers were enrolled (n = 57 Cases, 114 Controls). Cases were adjudicated to consensus and classified as contact lens-related serious and significant (S&S) or non-serious events. S&S Cases scored significantly higher on the CLRS (56.1 ±â€¯11.1) than either their matched Controls (44.3 ±â€¯11.1) (P <  0.001) or the non-Serious Cases (44.8± 12.8 P =  0.002). Scores of non-serious Cases were not significantly different than scores of their Controls (43.4 ± 10.7, P = 0.33) CONCLUSIONS: The CLRS scoring algorithm discriminated between SCL wearers presenting with S&S CL-related adverse events from healthy SCL wearers and those with non-serious events. This survey and scoring system could help practitioners identify patients at greatest risk for CL-related adverse events and support targeted interventions aimed at reducing risk behaviors.

Water Exposure is a Common Risk Behavior Among Soft and Gas-Permeable Contact Lens Wearers.

PURPOSE: To understand soft contact lens (SCL) and gas-permeable (GP) lens wearers' behaviors and knowledge regarding exposure of lenses to water. METHODS: The Contact Lens Risk Survey (CLRS) and health behavior questions were completed online by a convenience sample of 1056 SCL and 85 GP lens wearers aged 20 to 76 years. Participants were asked about exposing their lenses to water and their understanding of risks associated with these behaviors. Chi-square analyses examined relationships between patient behaviors and perceptions. RESULTS: GP lens wearers were more likely than SCL wearers to ever rinse or store lenses in water (rinsing: 91% GP, 31% SCL, P < 0.001; storing: 33% GP, 15% SCL P < 0.001). Among SCL wearers, men were more likely to store (24% vs. 13%, P = 0.003) or rinse (41% vs. 29%, P = 0.012) their lenses in water. Showering while wearing lenses was more common in SCL wearers (86%) than GP lens wearers (67%) (P < 0.0001). Swimming while wearing lenses was reported by 62% of SCL wearers and 48% of GP lens wearers (P = 0.027). Wearers who rinsed (SCL; P < 0.0001, GP; P = 0.11) or stored lenses in water (SCL; P < 0.0001, GP P = 0.007) reported that this behavior had little or no effect on their infection risk, compared with those who did not. Both SCL (P < 0.0001) and GP lens wearers (P < 0.0001) perceived that distilled water was safer than tap water for storing or rinsing lenses. CONCLUSIONS: Despite previously published evidence of Acanthamoeba keratitis' association with water exposure, most SCL, and nearly all GP lens wearers, regularly expose their lenses to water, with many unaware of the risk.

Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls.

PURPOSE: The purpose of this study was to assess risk factors associated with soft contact lens (SCL)-related corneal infiltrative events (CIEs). METHODS: This was a single-visit, case-control study conducted at five academic centers in North America. Cases were defined as current SCL wearers with a symptomatic CIE. For each case, three age- and sex-matched controls were enrolled. Subjects completed the Contact Lens Risk Survey (CLRS), a standardized scripted medical interview, supplied a recent health history, and underwent an ocular examination. Microbial culturing of the ocular surface, SCL, and lens storage case was conducted for all cases and one of the three matched controls. Univariate and multivariate logistic regression modeling were used to assess the risk of developing a CIE. RESULTS: Thirty cases and 90 controls 13 to 31 years of age completed the study. Corneal infiltrative event diagnosis included contact lens-associated red eye, infiltrative keratitis, and contact lens peripheral ulcer. Subjects with symptomatic CIEs were more likely to harbor substantial levels of gram-negative bioburden on the ocular surface and contact lens. Significant risk factors for developing a CIE were overnight wear of SCLs, use of multipurpose solution, rinsing SCLs with water, lens storage case older than 6 months, previous "red eye" event, use of ocular drops in the past week, and illness during the past week. CONCLUSIONS: This pilot study demonstrated feasibility of enrolling a representative pool of SCL wearers with an untreated, symptomatic CIE and assessing CIE risk factors by using standardized methods. A larger sample size is needed to determine relationships between patient-reported behaviors and exposures, microbial bioburden, and CIE development.

Is purchasing lenses from the prescriber associated with better habits among soft contact lens wearers?

PURPOSE: To compare the habits of United States (US) soft contact lens (SCL) wearers who bought SCLs from their eye care practitioner (ECP), on the internet/telephone, or at retail (not where they were examined) to test the effect of proximity to the prescriber on SCL wear and care practices. METHODS: Adult SCL wearers completed an adapted Contact Lens Risk Survey (CLRS) online that queried items related to risk factors for SCL-related complications. Responses from subjects who purchased at the ECP, via the internet/telephone, or at a retail store were compared (Chi-Square). RESULTS: Purchase sources were: ECP 646 (67%, 44±12 yrs, 17% male), Retail 104 (11%, 45±13 yrs, 28% male), and Internet/telephone 218 (23%, 45±12 yrs, 18% male); age (p=0.51), gender (p=0.021). Internet purchasers had fewer annual eye exams (79% ECP, 83% retail, 66% internet/telephone, p=0.007), purchased more hydrogel SCLs (34% ECP, 29% retail, 45% internet/telephone, p=0.0034), and paid for SCLs with insurance less often (39% ECP, 29% retail, 19% internet/telephone, p<0.0001). Other behaviors were similar across groups (p>0.05). CONCLUSIONS: In this sample, the purchase location of SCL wearers had limited impact on known risk factors for SCL-related complications. Internet purchasers reported less frequent eye exams and were more likely to be wearing hydrogel SCLs. Closer access to the ECP through in-office SCL purchase did not improve SCL habits or reduce the prevalence of risk behaviors.

Rate of change and predictive factors for increasing minus contact lens powers in young myopes.

BACKGROUND: Understanding the factors associated with myopic progression is critical to properly recruit subjects into clinical trials for control of myopia. The purpose of this study is to describe the rate of change in soft contact lens (SCL) power and the associated predictive factors in a young clinical population from the Contact Lens Assessment in Youth study. METHODS: Data from a retrospective chart review of myopic SCL wearers aged eight to 22 years were analysed for rate of progression of myopia and associated characteristics using multivariate methods. RESULTS: Myopic subjects (n = 912) with at least six months of follow-up were observed (4,341 visits, mean follow-up 25 months, 37 per cent hydrogel and 63 per cent silicone hydrogel SCLs). During observation, 36 per cent of subjects experienced a change in soft contact lens power of -0.50 D or more. Significant predictors of future increase in minus lens power were: ages eight to 13 years, shorter time to the first increase in minus power and hydrogel soft contact lens material. The mean annualised increase in minus decreased with age (-0.31D per year for eight to 13 year olds to -0.10 D per year for 20 to 22 year olds, p < 0.0001). Increases in minus were less common among users of silicone hydrogel materials than hydrogel daily disposable lenses after controlling for age (p = 0.039). CONCLUSION: In this retrospective chart review of young soft contact lens wearers, the mean annualised rate of increase in minus soft contact lens power decreased with age, longer time to first increase in power and was greater with hydrogel soft contact lenses. The rates observed were similar to progression rates in prospective myopia clinical trials that employed cylcoplegic autorefraction.

Geographic and temporal risk factors for interruptions to soft contact lens wear in young wearers.

OBJECTIVES: This was a secondary analysis of an existing dataset of soft contact lens wearers age 8-33 years, who received eye care outside of a clinical trial. The aim was to identify geographical and temporal factors associated with interruptions to contact lens wear. METHODS: Data from six academic centers in North America captured 522 events in 3549 patients. Cases were analyzed overall and in subcategories of allergic, and serious and significant adverse events. General estimating equations were used to model the effect of geographic (Northwest, West, Central, Northeast, Southeast) and temporal (season, month, day of the week) factors, along with previously identified risk factors associated with interruptions in lens wear (patient age, contact lens material, overnight wear, lens care system, replacement schedule, and years of contact lens wear). RESULTS: After controlling for established risk factors, both region and temporal factors disrupted the patients' ability to maintain contact lens wear. About 4% of all visits had complications that led to an interruption in wear. Allergic events were highest in the Central region. Serious and significant adverse events peaked in the Southeast during the Autumn and Winter months (September, October, December). Day of the week was not significant in any model. CONCLUSIONS: This study provides evidence of seasonal and regional challenges to contact lens wear. As the use of soft contact lenses expands for both cosmetic and medical reasons, practitioners must examine ways to maintain continuous, safe, and healthy use of contact lenses across all patients.

Age and other risk factors for corneal infiltrative and inflammatory events in young soft contact lens wearers from the Contact Lens Assessment in Youth (CLAY) study.

PURPOSE: To describe age and other risk factors for corneal infiltrative and inflammatory events (CIEs) in young, soft contact lens (SCL) wearers and to model the age-related risk. METHODS: A multicenter, retrospective chart review of 3549 SCL wearers (8-33 years at first observed visit, +8.00 to -12.00D, oversampling <18 years) captured CIEs from January 2006 to September 2009. The review noted age, sex, SCL worn, use of lens care products, and SCL wearing history. Event diagnoses were adjudicated to consensus by reviewers masked to wearer identity, age, and SCL parameters. Significant univariate risk factors for CIEs were subsequently tested in multivariate generalized estimating equations. RESULTS: Charts from 14,305 visits observing 4,663 SCL years yielded 187 CIEs in 168 wearers. Age was a significant nonlinear risk factor, peaking between 15 and 25 years (P < 0.008). Less than 1 year of SCL use was protective versus longer years of wear (P < 0.0003). Use of multipurpose care products (2.86×), silicone hydrogels (1.85×), and extended wear (2.37×) were significantly associated with CIEs in the multivariate model (P < 0.0001 each). CONCLUSIONS: Patient age, years of lens wear, use of multipurpose care products, silicone hydrogels, and extended wear were all significantly associated with CIEs with SCL wear. Use of SCLs in young patients aged 8 to 15 years was associated with a lower risk of infiltrative events compared with teens and young adults. In terms of safety outcomes, SCLs appear to be an acceptable method of delivering optics designed to manage myopia progression in children and young teens in the future.

Characterization of patients who report compliant and non-compliant overnight wear of soft contact lenses.

PURPOSE: To describe compliant and non-compliant overnight wear (EW) of soft contact lenses from a large observational study. METHODS: A retrospective chart review of 3211 SCL patients with known EW status (aged 8-33yrs, SCL power +8.00 to -12.00D) captured data from 10,516 clinical visits (2006-2009). Status of EW was either daily wear (DW), compliant EW (overnight wear of US Food & Drug Administration (US FDA) EW-approved lenses), non-compliant EW (overnight wear of DW-approved lenses). The effect of demographic and clinical characteristics on the likelihood of reporting EW was examined using logistic regression. Additionally, the effect of these same characteristics on the likelihood of non-compliant EW was assessed with logistic models. RESULTS: Eight-hundred and eight patients (25.2%) reported EW. Non-compliant EW was reported by 6% of wearers (13 hydrogel, 2 silicone hydrogel brands) In multivariate models, patient age and lens replacement schedule were significant factors for EW (vs. DW) and for non-compliant (vs. compliant) EW (p<0.0001). Other factors significantly related to EW were gender, smoking, lens material, sphere power, and years of CL wear (p≤0.007, all). CONCLUSIONS: Young people (ages 18-25yrs), males, smokers, myopes, silicone hydrogel lens wearers and patients with >1yr of CL wear were significantly more likely to report EW. Non-compliant EW occurred often in young people and daily disposable wearers, though many brands had non-compliant EW use. Understanding who is likely to wear EW and non-compliant EW will help clinicians pointedly counsel patients more at risk on best practices with EW.