Test-retest variability of microperimetry in geographic atrophy.

PURPOSE: Microperimetry (MP) allows for measurement of retinal sensitivity at precise locations and is now commonly employed as a clinical trial endpoint. Test-retest reliability is important when evaluating treatment effects in patients with geographic atrophy (GA). This study aimed to determine the test-retest variability of MP in patients with moderate to severe GA using the MAIA MP device. METHODS: In this prospective study, patients with a confirmed diagnosis of foveal-involving GA were enrolled. Participants performed three MP assessments of a selected eye over two visits with the Macular Integrity Assessment (MAIA) 2 instrument (Centervue, Padova, Italy) utilizing a wide 30° grid, consisting of 93 stimuli (Goldmann III) using a 4-2 representation strategy, encompassing the entire area of GA and beyond. Mean retinal sensitivity (MS) was expressed as an average threshold value (dB) for the entire field tested. Coefficients of Repeatability at a 95% level (CoR95) were calculated for Point Wise Sensitivity (PWS). Fixation stability (FS) was assessed by evaluating the area of an elliptical representation encompassing 95% of the cloud of fixation points (CFP) dataset generated by the MAIA MP, known as the bivariate contour ellipse area (BCEA). RESULTS: A total of 8 subjects were enrolled (21 tests), with six subjects completing 3 MP assessments. BCVA in these patients ranged from 20/100 to 20/800. The mean area of GA was 18.7 ± 12.3 mm2. The average time to complete one MP assessment was 13 min 9 s and mean BCEA@95% was 38.5 ± 19.3°2. The MS was 14.3 ± 4.5 dB. No significant increase in MS was noted between testing pairs 1&2 and 2&3. The preferred retinal locus was maintained in the same quadrant on successive tests. The mean CoR95 for PWS were similar for testing pairs 1&2 (± 3.50 dB) and 2&3 (± 3.40). CONCLUSION: Microperimetry using a wide grid can be reliably performed in a reasonable amount of time in patients with moderate and severe vision loss secondary to GA. There was no learning effect seen between sequential assessments when analyzing MS or PWS. A change of approximately 4 dB in PWS provides a threshold for considering a true change in this patient cohort.

Safety and Efficacy of Subretinally Administered Palucorcel for Geographic Atrophy of Age-Related Macular Degeneration: Phase 2b Study.

PURPOSE: To evaluate safety and successful use of a novel subretinal delivery system and suprachoroidal surgical approach and safety and activity of human umbilical tissue-derived cells (palucorcel) via a novel delivery system in patients with geographic atrophy (GA). DESIGN: Multicenter, open-label phase 2b study. PARTICIPANTS: Participants were 55 to 90 years with GA secondary to age-related macular degeneration (AMD) and best-corrected visual acuity (BCVA) of 20/80 to 20/800. Exclusion criteria included neovascular AMD in the intervention eye, glaucoma with intraocular pressure of 25 mmHg or more, or other significant ophthalmologic conditions. METHODS: Participants received a subretinal injection of palucorcel, 3.0 × 105 cells in 50 µl, using the custom-designed delivery system and surgical procedure. MAIN OUTCOME MEASURES: Safety assessments included treatment-emergent adverse events (AEs), immunologic assessments, and ophthalmologic evaluations. Efficacy was evaluated as change in mean number of BCVA letters from baseline, proportion of participants gaining 15 BCVA letters or more, and growth rate of GA lesions at 12 months. RESULTS: Surgery and palucorcel administration were performed in 21 participants at 8 sites by 8 different surgeons. At baseline, median total area of GA was 13.4 mm2 and median BCVA was 43 letters in the intervention eye. Eye-related AEs occurred in 76% of participants (16/21), including conjunctival hemorrhage (n = 5), retinal hemorrhage (n = 4), and vitreous floaters (n = 4). Most AEs were mild and resolved within 1 month. No serious AEs, no retinal detachment or perforation, and no significant changes in intraocular pressure occurred. At month 12, mean change in BCVA from baseline was -5.9 letters correct (standard deviation, 13.0 letters correct) in the intervention eye and -3.7 letters correct (standard deviation, 9.0 letters correct) in the fellow eye. No participants showed improvement of 15 letters or more in the intervention eye, and 3 participants lost more than 15 letters by month 1. No apparent effect of treatment was observed. CONCLUSIONS: Palucorcel was delivered successfully to the targeted subretinal site using a novel delivery system and suprachoroidal approach for most participants; however, improvement in GA area, retardation of growth, or visual acuity were not demonstrated.

Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry.

OBJECTIVES: To describe the patient-reported wearing experience over time among wearers of hydrogel daily disposable (HydDD) contact lenses (CLs) in the TruEye and Moist Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Registered wearers older than 40 years who were recently fit with 1-DAY ACUVUE MOIST HydDDs completed self-administered questionnaires four times during a year-long Registry. Overall opinion of CLs, replacement schedules, Contact Lens Dry Eye Questionnaire (CLDEQ-8), and compliance were queried. Data were analyzed with analysis of variance and signed rank tests. RESULTS: A total of 86 subjects (24% men, age 50.2±7.1 years) completed the Registry. Approximately 76% were new to daily disposable lenses, and 8% were neophytes. Overall opinion of CLs improved significantly after refitting with HydDDs (baseline 57% excellent/very good vs. 69%-79% at follow-ups, P<0.05 all vs. baseline). Changing to HydDDs maintained average and comfortable wear time (P>0.05), and it did significantly improve CLDEQ-8 scores at all follow-ups (baseline, 11.2±7.3 vs. 2 weeks, 7.8±5.8, P<0.0001; 4 months, 8.6±6.5, P=0.0006; 12 months, 9.3±6.5, P=0.01). Self-assessment of compliance was excellent/very good for 80% at baseline, and improved to 92% to 98% at follow-ups (P<0.0001). More than 90% never slept in their HydDDs, although compliance to daily replacement diminished from 2-week to 4-month surveys (93% vs. 84%, P=0.007). CONCLUSIONS: After refitting with HydDDs, older wearers reported significantly higher overall opinions of their lenses, better CLDEQ-8 symptom scores, and most were compliant with proper daily disposable lens use. Diminishing daily replacement rates from 2 weeks to 4 months indicate a need to reinforce that recommendation. Wearers of HydDD CLs older than 40 years experienced many benefits from refitting with these daily disposable lenses.

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.

Subjective Comfort and Physiology with Modern Contact Lens Care Products.

PURPOSE: To compare subjective comfort and ocular physiology with three multipurpose solutions (MPSs) to that of a peroxide-based system with three different soft contact lens materials. METHODS: Habitual soft contact lens wearers (n = 236) were enrolled at three sites and completed a washout period with no contact lens solution for ≥4 days. Subjects were randomly assigned to one of three lens types: etafilcon A, galyfilcon A, or senofilcon A. A new lens of the assigned type was worn for 10 to 14 days each while using one of four care solutions, in random order (A-polyaminopropyl biguanide + polyquaternium, B-POLYQUAD + Aldox, C-alexidine + polyquaternium-1, and D-hydrogen peroxide) with a washout period (≥4 days) between each solution. After each care solution, biomicroscopy was performed and subjective comfort was assessed using the Contact Lens User Experience (CLUE) questionnaire and other instruments including comfortable wear time (CWT). Linear mixed models were used for analysis. Comfort and biomicroscopy signs with each MPS were compared to that of the peroxide solution. RESULTS: Subjective CLUE Comfort score across all lens types with each MPS was not significantly different than with the peroxide solution (p = 0.98). There were no differences in CWT between each MPS and the peroxide solution for any lens type (range of differences: -0.8 to 0.8 h; all p ≥ 0.13). Six MPS/material combinations had no clinically meaningful change in corneal staining versus peroxide (<0.5 units); three combinations could increase staining by up to 0.57 units. Staining was

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.

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.

Chinese and Caucasian ocular topography and soft contact lens fit.

BACKGROUND: The aim was to evaluate the effect of ocular topography on soft contact lens fit in Chinese and Caucasians. METHOD: This study evaluated 547 subjects from two ethnic groups, Caucasian (n = 250) and Chinese (n = 297), at investigational sites in three locations: Wenzhou, China, Melbourne, Australia and Jacksonville, USA. Subjects underwent measurement of a range of ocular topographic variables using identical equipment and protocols, including: apical corneal radius (CR), corneal shape factor (CSF) in the two principal meridians, horizontal visible iris diameter (HVID), vertical palpebral aperture (PA), upper lid angle (ULA) and inter-canthal angle (ICA). Subjects were fitted with a spherical lens in two base curves (BCs) (1·Day ACUVUE, 8.50, 9.00 mm) and a toric soft lens (Accelerated Stabilization Design). RESULTS: The steeper base curve (8.50 mm) spherical lenses gave an acceptable overall lens fit with 98 per cent or more of subjects in both groups, while the flatter lens (9.00 mm) was acceptable in a significantly higher proportion of the Chinese compared to Caucasian group (96 versus 82 per cent, p < 0.0001) . The main difference in fit between groups was for centration; there was significantly less decentration with the Chinese group (8.50 BC: 39 versus 72 per cent, p < 0.0001; 9.0 BC: 63 versus. 85 per cent, p = 0.02). The 8.5 mm base curve showed good centration (none or slight decentration) for 97 per cent of Caucasian eyes and 96 per cent of Chinese eyes. With both groups, there were some significant correlations between lens fit and ocular topographic variables, most notable between upper lid angle and toric lens orientation with the Chinese subjects. Regression analysis also showed key predictive values relating to lens fit. CONCLUSIONS: Detailed ocular measurements suggest anatomical differences between Chinese and Caucasian populations that should be considered in soft lens design. The spherical and toric lenses tested in this study fitted a large proportion of both Chinese and Caucasian eyes and are robust to the ocular differences noted.

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.).

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.

The use of daily disposable lenses in problematic reusable contact lens wearers.

PURPOSE: Replacing soft contact lenses (CLs) on a daily basis brings a number of advantages, most notably, reduced exposure to deposits, disinfectants, allergens, and other contaminants. This retrospective study estimated the prevalence of problems in current wearers of reusable soft CLs and tested the effect of refitting "problem" patients with daily disposable (DD) hydrogel lenses. METHODS: Prevalence was estimated from 398 current reusable CL wearers for: frequent/constant discomfort or dryness, ≥2 h of uncomfortable wear, ≥grade 2 conjunctival hyperaemia (0-4), or ≥grade 3 corneal staining (0-15). In the second part of the study, 217 reusable CL wearers classified as problem patients were randomly refitted with DD lenses manufactured from one of two materials: etafilcon A (n=96) or nelfilcon A (n=121) and reassessed 1 week later. RESULTS: Thirty-nine percent (154/398) had some qualifying criterion: reduced comfortable wearing time (CWT), 20%; dryness, 20%; irritation, 5%; corneal staining, 8%; and hyperaemia, 7%. After refitting with DDs, the prevalence of reduced CWT was decreased from 65% to 51% (P=0.0039), dryness from 60% to 41% (P < 0.0001) and corneal staining from 28% to 21% (P=0.04). There was no significant change in the prevalence of irritation, or hyperaemia. Some differences were noted between the two lens materials. CONCLUSIONS: A high proportion of reusable soft lens wearers encounter clinically relevant signs or symptoms with their current CLs. This study provides evidence that refitting with DD lenses is a useful strategy for alleviating some of the common problems of CL wear.

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.

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 Spearman's 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.

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.

Struggle with hydrogel CL wear increases with age in young adults.

PURPOSE: To report the symptoms and experiences associated with habitual hydrogel (Hyd) and silicone hydrogel (SiHy) contact lenses (CLs) among young adults and measure their association with age. METHODS: Questionnaire responses from 699 Hyd and 183 SiHy wearers were analyzed to test the association of age with features indicating struggle with CL wear. Prevalence by age was compared between groups with Pearson's chi-square and within groups with Spearman's correlation coefficient. RESULTS: Hyd and SiHy groups were similar for sex and age distribution. Diagnosis of dry eye increased with age in the Hyd wearers from 10.6% to 21.1% (18-24 vs. 30-35 years), but was approximately 19% in the SiHy wearers across age. Adverse environments caused more discomfort with Hyd than SiHy lenses and Hyd wearers' discomfort increased with age (smoky (p=0.0001), dry air environments (p=0.002), after napping or sleeping (p=0.004). More Hyd wearers considered discontinuation of CL wear with age, from 4.6% to 14.2% (18-24 vs. 30-35 years, p<0.04), but the proportion remained steady at 9% across age for SiHy wearers (p=0.46). CONCLUSIONS: From 18 to 35 years, hydrogel CL wearers reported increasing struggle with CL wear and more negative ratings compared to SiHy wearers. Older hydrogel CL wearers were also more likely to consider discontinuing CL wear compared with younger hydrogel or silicone hydrogel CL wearers in general. Young adult CL wearers should be routinely queried directly about specific aspects of CL wear in order to determine whether different lens types should be prescribed to avoid abandonment of CL wear.

Clinical evaluation of toric soft lens reproducibility.

PURPOSE: The manufacturing variability of frequent replacement toric soft lenses is such that some resulting variation in clinical performance can be expected. The purpose of this study was to evaluate the effect of manufacturing variability on the clinical performance of three frequent replacement toric soft contact lenses. METHODS: This was a three-part study in which 12 to 14 subjects were enrolled for each part. In each part, subjects were preadapted to the lens type 1 month prior to the assessment visits. Subjects wore a total of 12 test lenses in one eye and, in each case, the clinical performance was compared with a control lens of the same type worn in the other eye that was removed between assessments but not replaced. The study lenses were Acuvue Toric (Vistakon), Focus Toric (Ciba Vision) and FreshLook Toric (Wesley lessen). RESULTS: Two lens types (Focus Toric and FreshLook Toric) showed significantly greater variability with the test lenses compared with the nonreplaced control lenses with several variables: lens fit, visual acuity, and subjective vision quality. One lens (Focus Toric) also showed greater variability of orientation position, and another (Acuvue Toric) showed greater variability in subjective vision quality. CONCLUSIONS: The study demonstrated variability in aspects of clinical performance, which appear to be linked to variability of manufacturing output. With toric soft lenses used on a frequent replacement basis, better reproducibility is needed if consistent clinical performance is to be maintained.