Sheila Hickson-Curran

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance.

Purpose. To report on the development and validation of a short form of the Contact Lens Dry Eye Questionnaire (the CLDEQ-8) to enable it to reflect status of and change in overall opinion (“opinion”) of soft contact lenses (SCLs). Methods. Item reduction for the CLDEQ was achieved by correlation with overall opinion of SCLs at follow-up visits in a sample of 38 SCL wearers at one academic clinical site. The CLDEQ-8 score (frequency plus late day intensity of dryness, discomfort, and “blurry vision”; frequency of “closing eyes to rest them” and “removing CLs to relieve discomfort”) was then tested in 379 SCL wearers in a multicenter study with analysis stratified by opinion ratings at baseline and 2 weeks postrandomization to new silicone hydrogel SCLs. The sum of CLDEQ-8 scores (maximum 37) was correlated with opinion by Spearmans rank correlation coefficient and analyzed for change in opinion by analysis of variance (ANOVA). Results. The CLDEQ-8 scores in the validation sample were highly correlated with habitual baseline opinion (−0.44, p < 0.0001) and responsive to change in opinion postrandomization (−0.58, p < 0.0001). Baseline CLDEQ-8 scores by opinion status were as follows: Fair: 17.4 ± 8.7, Good 13.7 ± 6.4, Very Good 9.1 ± 4.7, and Excellent 6.4 ± 3.7 (ANOVA, F = 291.1, p < 0.0001). After 2 weeks, change in CLDEQ-8 scores by improvement status was as follows: Much Improved: −16.7 ± 10.0, Unchanged: −2.3 ± 5.0, to Much Worse +8.5 ± 5.8 (ANOVA, F = 16.5, p < 0.001). Conclusions. The CLDEQ-8 score significantly reflected baseline status and change in overall opinion after refitting with two types of silicone hydrogels. The CLDEQ-8 score is a valid outcome measure in SCL clinical trials to reflect opinion of SCLs.

The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Epidemiology

This report characterizes the neurobiology of the ocular surface and highlights relevant mechanisms that may underpin contact lens-related discomfort. While there is limited evidence for the mechanisms involved in contact lens-related discomfort, neurobiological mechanisms in dry eye disease, the inflammatory pathway, the effect of hyperosmolarity on ocular surface nociceptors, and subsequent sensory processing of ocular pain and discomfort have been at least partly elucidated and are presented herein to provide insight in this new arena. The stimulus to the ocular surface from a contact lens is likely to be complex and multifactorial, including components of osmolarity, solution effects, desiccation, thermal effects, inflammation, friction, and mechanical stimulation. Sensory input will arise from stimulation of the lid margin, palpebral and bulbar conjunctiva, and the cornea.

Patient attitudes and behavior regarding hygiene and replacement of soft contact lenses and storage cases

PURPOSE To review important aspects of contact lens compliance and to survey contact lens replacement frequency, steps in lens care and hygiene and replacement of the lens storage case via online surveys. METHODS Random US samples (n=645 and 787) of frequent replacement contact lens wearers answered questions on contact lens wear in online, sponsor-masked surveys. RESULTS Wearers of lenses prescribed by their practitioner for 2 weekly replacement reported that they replaced lenses as follows: within 2 weeks 45%, within 3 weeks (minor stretching) 68%, within 4 weeks 89%, ≥8 weeks (extreme stretching) 4%, compared to Monthly wearers who reported: within 4 weeks 37%, within 5 weeks (minor stretching) 57%, ≥8 weeks 23% (≥8 weeks extreme stretching, Chi-square p=0.001). Median frequency for cleaning lens storage case was 2-3 times per week, while 33% reported cleaning monthly or less often. Median lens storage case replacement was every 4-6 months, while 48% reported annual replacement or less often. Most patients cleaned their lens case with hot or cold tap water (72%). CONCLUSIONS These internet surveys revealed significant non-compliance with lens care steps, case hygiene and lens replacement schedule. More than half of the contact lens wearers surveyed were not compliant with their 2-weekly or monthly schedule. Lenses prescribed for longer replacement intervals can lead to more extreme stretching of lens life. To encourage better patient habits, eye care providers should reinforce their recommended frequency of replacement of lenses and storage cases and should reinforce care and hygiene steps at each patient visit.

Comparative evaluation of Asian and white ocular topography.

Purpose To provide comparative ocular topography data from a substantial population of East Asian and white eyes. Methods This study evaluated 675 subjects from three ethnic groups: white (n = 255), Chinese (n = 299), and Japanese (n = 121) at investigational sites in four locations: Wenzhou, China; Melbourne, Australia; Tokyo, Japan; and Jacksonville, USA. Subjects underwent the same measurements of ocular topography using identical equipment and protocols. A videokeratoscope (Medmont E300) was used to measure apical corneal radius, simulated K-reading (K), corneal shape factor (CSF), and corneal sagittal height at 10 mm in the two principal meridians. Digital photography was also used to measure ocular parameters including horizontal visible iris diameter (HVID), vertical palpebral aperture (PA), the intercanthal angle (ICA), and upper and lower lid angles. Results Mean HVID measurements were significantly smaller for the Chinese and Japanese groups than whites: 11.26, 11.10, and 11.75 mm, respectively. Horizontal K was significantly steeper for the white than the Chinese and Japanese groups: 7.79, 7.86, and 7.92 mm, respectively. The Chinese eyes showed significantly higher mean vertical CSF (i.e., more prolate) than the other two groups. The Chinese group had significantly narrower PA and steeper ICA than the other two groups: the mean PA and ICA values were 9.71, 10.31, and 10.58 mm and 7.56, 6.32, and 6.27 degrees, for the Chinese, Japanese, and white groups, respectively. One-third of the Chinese (32%) and 31% of the Japanese subjects showed no apparent supratarsal fold (“single eyelid”). There were also significant differences between groups for corneal sagittal height at 10 mm and upper and lower lid angles, but no significant differences for vertical K and horizontal CSF. Conclusions This study has highlighted some differences in ocular topography between Chinese, Japanese, and white ethnic groups that may be relevant to soft contact lens fit.

Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry.

PURPOSE To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.).

Cutoff score and responsiveness of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a Large daily disposable contact lens registry.

PURPOSE To report (1) results of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among a large sample of SCL wearers before and during 1 year after fitting with one of 2 daily disposable (DD) lenses (etafilcon A or narafilcon B) in the TEMPO Registry, (2) the cut-off score to identify highly symptomatic SCL wearers and (3) the clinically important difference (CID) in the CLDEQ-8 score. METHODS Demographics, CL history and patterns of SCL use were documented. Construct validity of the CLDEQ-8 was tested versus overall opinion (OO) of habitual SCLs, eye dryness and eye sensitivity at baseline. Responsiveness to change in OO was tested. Cutoff score, CID, and predictive accuracy were analyzed with general linear mixed models, adjusting for clustering by site with Bonferoni correction for multiple comparisons. RESULTS Baseline CLDEQ-8 data from 977 habitual SCL wearers showed significant association with OO, eye dryness and sensitivity (p<0.0001, all). CLDEQ-8 scores improved significantly after refitting and reflected change in OO over time (p<0.0001). Diagnostic cutoff of≥12 and CID of 3 points performed best. CONCLUSIONS The CLDEQ-8 score of ≥12 points is proposed to identify SCL wearers who could benefit from clinical management of their CL-related symptoms. The clinically important difference was ±3 points. Refitting to these DD lenses in the TEMPO Registry provided significant and stable reduction in SCL-related symptoms across the year of follow-up. Use of the CLDEQ-8 in clinical practice and clinical research will help quantify and standardize symptom measures in SCL wearers.

Lid Wiper Epitheliopathy in Soft Contact Lens Wearers.

Purpose To evaluate lid wiper epitheliopathy (LWE) in soft contact lens (SCL) wearers on initial presentation and after using various SCL and solution combinations. Methods LWE was assessed in 253 habitual SCL wearers who attended a screening visit at one of three study sites. LWE was assessed using lissamine green and sodium fluorescein dyes (Korb scale); a final LWE grade was calculated as the averaged LWE grade of the two dyes. Eligible habitual wearers continued into the four study periods, during which they wore one of three SCL types (etafilcon A, galyfilcon A, or senofilcon A) while using each of four care solutions for 10 to 14 days in randomized order. Statistical analyses were performed using linear mixed models, testing for differences in LWE for subject characteristics and between three multipurpose (MPS) test solutions (BioTrue, OPTI-FREE PureMoist, RevitaLens OcuTec) compared to a hydrogen peroxide (Clear Care) control solution. Results LWE was present in 85% of habitual SCL wearers. LWE was not different for age (p = 0.28), sex (p = 0.99), race (p = 0.34), and comfort (p = 0.38) and not correlated with refractive error (r = 0.07). LWE was lower in habitual senofilcon A wearers (least-squares (LS) mean ± SE = 0.82 ± 0.19) compared to wearers of lotrafilcon B (1.34 ± 0.20; p < 0.02), comfilcon A (1.41 ± 0.21; p < 0.01), and other (1.18 ± 0.16; p < 0.03). Two hundred three participants completed all four study solutions with their assigned lens type; LWE was not different between the MPSs compared to the peroxide control solution across lens materials, except for less LWE for BioTrue (0.88 ± 0.17) versus Clear Care for participants wearing galyfilcon A (1.11 ± 0.18; p < 0.01). Conclusions On initial presentation, LWE was present in 85% of habitual wearers and found to be independent of age, sex, race, comfort, and refractive error but dependent on habitual SCL type. There were no clinically meaningful differences in LWE between the MPSs and hydrogen peroxide solution for the three lens types studied.

Chinese and Caucasian ocular topography and soft contact lens fit

The aim was to evaluate the effect of ocular topography on soft contact lens fit in Chinese and Caucasians.

Eyelid Margin and Meibomian Gland Characteristics and Symptoms in Lens Wearers.

Purpose To describe the lid margin characteristics of contact lens wearers and relate them to comfort during lens wear. Methods Three study sites enrolled habitual contact lens wearers. Subjects completed the Comfort domain of the Contact Lens User Experience (CLUE) questionnaire, and each eye was graded for the presence of mucocutaneous junction (MCJ) displacement, lid margin irregularity, and lid margin vascularity. Examiners counted the number of meibomian gland (MG) orifices in the central centimeter of the lower eyelid and the number of those that showed pouting/plugging and vascular invasion. MG expressibility was graded according to the Shimazaki schema. Subjects were grouped based on presence/absence of each characteristic, total number of orifices (≥5 vs. <5), and expressibility (grade 0 vs. >0). Descriptive statistics are reported. A linear model was used to assess the fixed effect of each characteristic on combined CLUE score and each CLUE statement, if the effect on combined CLUE score showed p < 0.10. Results The study included 203 subjects (67.5% female) with mean age (±SD) of 30.3 ± 9.6 years. The most commonly observed characteristics were orifice pouting/plugging, compromised MG expressibility, and lid margin vascularity (35.0, 30.3, and 20.4%, respectively). MCJ displacement and MG expressibility had an effect on the combined CLUE score such that individual CLUE statements were analyzed (p = 0.01 and p = 0.06, respectively). MCJ displacement had an effect on comfort upon insertion (p = 0.01), comfort after 5 minutes (p = 0.03), end-of-day comfort (p = 0.01), and ability to maintain ocular moisture (p = 0.030). MG expressibility had a significant effect on general comfort (p = 0.01), comfort throughout the day (p = 0.02), and the ability to maintain ocular moisture (p = 0.02). Conclusions MCJ displacement and MG expressibility have an effect on contact lens comfort.

Eye sensitivity in soft contact lens wearers.

Purpose To estimate the prevalence of self-reported “sensitive eyes” (SEs) in soft contact lens (CL) wearers, evaluate the clinical characteristics of patients with SEs, and examine the effect of refitting them with silicone hydrogel lenses. Methods After self-assessment, 2154 CL wearers were separated into SE and non-SE patients. Demographics, biometric data, wearing time, symptoms, and signs were compared between the two populations. Sixty-three SE patients were randomized into senofilcon A (senA) lenses and 65 into a non–senA arm (lotrafilcon B, omafilcon A, and balafilcon A lenses). The performance of senA lenses was compared against habitual and non-senA lenses 2 weeks later. Results A total of 12.2% of CL wearers reported SEs with their habitual CLs. No significant differences were noticed between SE and non-SE patients in sex, age, or refraction. The prevalence of dryness (43 vs 19%, p < 0.0001), irritation (25 vs 11%, p < 0.0001), redness (20 vs 6%, p < 0.0001), and stinging (6 vs 1%, p < 0.0001) was higher in SE patients. Average wearing time (13.0 vs 14.1 hours, p < 0.0001) was lower in this group. Limbal/bulbar hyperemia and corneal/conjunctival staining were not significantly different between the two populations. Senofilcon A increased the number of patients reporting no dryness (habitual vs senA, 20 vs 44%, p < 0.0003), irritation (22 vs 37%, p = 0.015), redness (52 vs 76%, p =0.009) and stinging (58 vs 77%, p = 0.012) but did not significantly affect clinical signs. Senofilcon A was significantly more efficient than non-senA lenses in improving dryness (scale of 0 to 3: senA vs non-senA, 0.64 vs 1.02, p = 0.0056), irritation (0.72 vs 1.16, p = 0.0015), and stinging (0.18 vs 0.53, p = 0.0049). Conclusions A substantial proportion of CL wearers report SEs with their habitual lenses. These patients are characterized by a high prevalence of additional symptoms, which are not reflected in clinical signs. Senofilcon A, or lenses with similar properties, may help reduce these symptoms in SE patients.