Heidi Wagner

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.

Variables affecting rigid contact lens comfort in the collaborative longitudinal evaluation of keratoconus (CLEK) study.

Purpose. To identify factors associated with rigid contact lens comfort in keratoconus. Methods. Baseline data from the 16 Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study clinical sites were analyzed for all patients wearing a rigid contact lens in their more severely keratoconic eye (as determined by steep keratometry). Corneal transplant patients, patients who did not wear a rigid contact lens in either eye, patients who did not wear a rigid lens in their worse eye, and patients with missing contact lens comfort data were excluded from the sample. A total of 751 eyes were included. Variables assessed included measures of disease severity, visual acuity through the patients’ habitual rigid contact lenses, contact lens wearing time, the apical fitting relationship of the contact lens, the degree of peripheral clearance, and the presence of corneal scarring and staining. Comfort was measured by asking the patients “In general, how comfortable are your contact lenses?” (1 = very comfortable through 5 = very irritating). Results. Measures of disease severity (steep keratometry and the first definite apical clearance lens) were not associated with lens comfort. There was no difference in self-reported contact lens comfort between patients fitted with apical touch vs. apical clearance. Patients with a peripheral clearance rating of “minimal unacceptable” (more common among patients with milder keratoconus) were approximately half as likely to report good contact lens comfort compared with patients with “average” peripheral clearance (unadjusted odds ratio, 0.39; 95% confidence interval, 0.19 to 0.79). There was no association between contact lens comfort and the other peripheral clearance ratings compared with ratings of average. Conclusions. There does not appear to be an association between decreasing patient-reported rigid lens comfort and increasing disease severity as measured by steep keratometry or first definite apical clearance lens in this sample. The apical fitting relationship (flat vs. steep) does not appear to be associated with patient-reported comfort. Minimal peripheral clearance may contribute to decreased rigid contact lens comfort in keratoconus.

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.

The Influence of Gender and Hormone Status on the Severity and Progression of Keratoconus

Purpose: To assess the effects of gender and hormone status on the severity and progression of keratoconus in patients enrolled in the Collaborative Longitudinal Evaluation of Keratoconus Study. Methods: The severity and progression of keratoconus in both men (M) and women were evaluated over a 4-year period that encompassed menopausal transition for hormone-active women (HA) and hormone-inactive women (HI). Four outcome measures were selected as indicators of the severity of keratoconus: high-contrast best-corrected visual acuity, low-contrast best-corrected visual acuity, the steep keratometric measurement, and corneal scarring (yes/no). Results: There were no statistically significant differences among the 3 groups (M, HA, and HI) in race, history of atopic disease, family history of keratoconus, or rigid contact lens wear in the right and left eyes. At baseline, there were no significant differences among the 3 groups in high-contrast best-corrected visual acuity, low-contrast best-corrected visual acuity, or steep keratometric reading. Progression of keratoconus, as assessed by changes in these 3 continuous variables, was equal for the 3 groups. M had more corneal scarring than did HA or HI; however, there was no progression of scarring for any of the groups. Conclusion: Keratoconus progressed in both men and women, aged 48-59 years; however, there were no differences among the groups in progression.

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.

Sex- and gender-based differences in healthy and diseased eyes

PURPOSE The aim of this study was to identify sex- and gender-based differences in ocular anatomy, physiology, and disease susceptibility or manifestation. METHODS Review of current indexed literature was conducted. RESULTS Sex and sex hormones influence the lacrimal system, eyelids and blinking, corneal anatomy and disease, aqueous humor dynamics and glaucoma, crystalline lens and cataract, uveitis and retinal disease, ocular circulation, and optic nerve anatomy and disease. Systemic conditions, particularly autoimmune disease, and conditions that are unique to women, such as pregnancy and menopause, further illustrate the effects of sex hormones on the eye. Gender-based differences in ocular conditions and disease should be considered within the context of the underlying physical and social environment. CONCLUSIONS Many sex- and gender-based differences exist in healthy and diseased eyes.

Eye on Diabetes: A Multidisciplinary Patient Education Intervention

PURPOSE The purpose of this study is to compare the efficacy of usual care to an intervention emphasizing patient education targeted at a multicultural adult patient population with diabetes seeking eye care in an academic health center. METHODS Ninety patients were randomized to usual care or to the intervention. All patients received a comprehensive eye health and vision examination and completed a demographic survey, a patient satisfaction survey, and a diabetes eye health pretest and posttest administered by a masked examiner at 1 week and 3 months. A multidisciplinary (optometry, pharmacy, endocrinology) patient education curriculum was developed for patients randomized to the intervention. Because the dependent variable was measured at 3 points on a nominal scale, a binary generalized estimating equation was employed. RESULTS The assessment of patient knowledge at baseline revealed misconceptions about diabetic eye disease. While most patients recognized that people with diabetes should have regularly scheduled eye examinations through dilated pupils (90.0%), most patients incorrectly reported that diabetic eye disease usually has early warning signs (75.6%). While controlling for age, gender, race, education, and HbA1c level, subjects who participated in the intervention were 2 times more likely to score higher on the posttest (chi(2) = 45.51, P > .00). No differences between pretest and posttest scores were found for patients who did not participate in the intervention (chi(2) = 11.67, P > .11). CONCLUSIONS Patients who participated in the educational intervention demonstrated an increase in knowledge across time. Patients may benefit from education emphasizing the importance of dilated eye examinations in the absence of ocular symptoms.

Visual acuity and "balanced progressive" simultaneous vision multifocal contact lenses.

Objectives. To investigate how add power affects binocular distance visual acuity in subjects wearing simultaneous vision, balanced progressive, multifocal contact lenses. Methods. Twenty-five young normally sighted subjects were fit binocularly, according to the manufacturers’ fitting nomogram, with CooperVision Proclear Multifocal contact lenses. A multifactorial experimental design was used to study distance visual acuity measured to the single letter with repeated measures on add power (+1.00, +1.50, +2.00, +2.50), light level (photopic and mesopic), and Bailey-Lovie chart contrast (high and low). Results. The relationship between add power and visual acuity was analyzed by linear regression for each of the 4 test conditions. The corresponding mean decrease in equivalent Snellen visual acuity from 20/16 to 20/17 between the +1.00 and +2.50 add powers for the photopic light level, high contrast test condition was not significant (F = 3.068, P=0.083). However, the change in visual acuity from 20/24 to 20/27 between the same add powers for the low contrast, photopic test condition was significant (P=0.048), as was the loss in visual acuity from 20/24 to 20/28 for the high contrast, mesopic test condition (P=0.005) and the reduction from 20/45 to 20/61 for the low contrast, mesopic light level test condition (P=1.5 × 10−5). Pupil diameter averaged 3.9 ± 0.07 mm and 6.2 ± 0.12 mm under photopic and mesopic light levels, respectively. Conclusions. Distance visual acuity averaged better than 20/20 for all add powers under high contrast, high illumination test conditions and decreased by a small, but significant amount, under other testing conditions.