Beth T. Kinoshita

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.

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.

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.

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.

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.

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

Citation information: Yang N, Tai C, Sheedy JE, Kinoshita B, Lampa M & Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt 2012, 32, 412–420. doi: 10.1111/j.1475‐1313.2012.00922.x

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.

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

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.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.

Letter to the editor clarifying CLAY study group and published research findings

Dear Editor In the February 2016 issue of Contact Lens and Anterior Eye, we published a manuscript entitled Is purchasing lenses from the prescriber associated with better habits among soft contact lens wearers? [1] After the publication of this manuscript, the Coalition for Contact Lens Consumer Choice [2] (Coalition) misinterpreted this work in non-peer-reviewed open postings. We are writing to publicly correct those errors. First, the Coalition stated that the CLAY Group was “an optometric research organization formed by the AAO and the AOA, and funded by a grant from Alcon...” The Contact Lens Assessment and Youth (CLAY) study group was formed by the study team members at the jointly sponsored American Academy of Optometry (AAO) and American Optometric Association’s Council on Research (AOA) Summer Invitational Research Institute (the Institute). While the Institute brings together investigators with similar interests to discuss potential research topics, it does not generate research questions, oversee the execution of a project, or endorse research findings. The CLAY group independently sought funding from Alcon as an Investigator Initiated Trial. By definition, the Sponsor does not identify the research question, oversee the execution of a project, or endorse the research findings. As such, the CLAY group’s research findings are our own and are not attributable to the Institute or Sponsor. The Coalition also misinterpreted two findings in order to draw an unsupported conclusion. They correctly quoted a portion of the abstract which stated: “the purchase location of soft contact lens wearers had limited impact on known risk factors for soft contact lens-related complications...Closer access to the eye care provider through in-office soft contact lens purchase did not improve soft contact lens habits or reduce the prevalence of risk behaviors.” (emphasis added). While it is accurate that self-reported behaviors (e.g. replacement schedule, overnight wear) of wearers who purchased lenses from the internet were comparable to those of wearers who purchased lenses from their eye care provider or retail store, we also stated that “the findings from this cross-sectional survey of SCL wearers should not be construed to indicate that there is no increased risk of complications” with internet purchase (emphasis added) [1]. The study was neither designed nor analyzed to assess the risk of a red eye by purchase location. The study ONLY examined the relationship between purchase location and other risk taking behaviors. In another prospective, cross-sectional CLAY study which was not cited by the Coalition, we explored the risk of a having a contact lens related red eye event and found that patients with serious and significant red eye events were almost 5 times more likely to report purchasing lenses on the internet than those with non-serious red eye events (aOR 4.9, CI 1.6–15.1) [3]. Our results stand in agreement with earlier work by Stapleton and colleagues, who also found that purchase of contact lenses via mail order or internet was a risk factor for microbial keratitis [4], the most visionthreatening complication of contact lens wear. These scientific findings have important public health implications in that they suggest that internet purchasers, as compared to wearers who purchased lenses from their eye care provider or retail store, may be more likely to experience a serious red eye event. We believe that educating the contact lens wearer as they return for visits would be good practice, and may promote healthy behaviors and help prevent the occurrence of a serious red eye event. Further study is needed to better understand why this is so and how the self-described “alternate retailers” fit into the current health care delivery system and potentially are related to both patients’ wear and care behaviors AND their risk for complications.