Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management.

SIGNIFICANCE: There are limited treatment options for myopia management of patients with moderate to high astigmatism. This work directly compares toric orthokeratology and soft toric multifocal lenses to show differences in visual acuity and patient satisfaction that could impact clinical care. Toric orthokeratology caused reduced visual acuity but was preferred subjectively for vision and overall. PURPOSE: This study aimed to quantify objective and subjective clinical differences between toric orthokeratology and soft toric multifocal contact lenses in the same cohort of myopic wearers with moderate to high astigmatism. METHODS: Thirty adults with refractive myopia (plano to -5.00 D) and astigmatism (1.25 to 3.50 D) were fitted empirically with both toric orthokeratology and soft toric multifocal contact lenses. Participants wore lenses for 10 days in random order, separated by a 14-day washout period. High-contrast visual acuity, low-contrast visual acuity, and glare logMAR visual acuity were measured. Surveys ascertained subject preference for comfort, vision, handling, and cost. Friedman, Wilcoxon signed rank, and χ2 tests were performed. RESULTS: A subset of participants (n = 17) who achieved good vision with both lens types was analyzed. High-contrast and glare acuity with toric orthokeratology were reduced by one line compared with soft toric multifocal lenses (both 0.00 vs. -0.10, P ≤ .003). Participants preferred toric orthokeratology for vision ( P ≤ .03) but soft toric multifocal lenses for handling ( P ≤ .006). When forced to choose between lens types, participants preferred toric orthokeratology for vision and overall (both P ≤ .007). CONCLUSIONS: Participants who achieved good vision with both lens types preferred toric orthokeratology over soft toric multifocal lenses, despite reduced high-contrast and glare visual acuity. Further research is needed to understand the relationship between visual performance and patient satisfaction.

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.

Soft toric contact lens wear improves digital performance and vision-A randomised clinical trial.

PURPOSE: To compare objective and subjective digital near visual performance and comfort in low to moderate astigmatic participants fitted with toric versus spherical equivalent silicone hydrogel daily disposable contact lenses. METHODS: This was a double-masked, randomised, crossover study. Participants aged 18 to 39 years with astigmatism of -0.75 to -1.50 D were recruited and fitted with toric and spherical contact lenses, in random order. Outcomes were measured at baseline and after 1 week of wear with each contact lens type after the follow-up visits. High- and low-contrast near logMAR visual acuity, automated visual acuity, zoom (%), contrast (%), reading distance (cm), critical print size (logMAR) and reading speed were assessed. Participants also completed the validated Near Activity Visual Questionnaire (NAVQ) and Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8) for each correction type. RESULTS: Twenty-three participants completed the study (74% female, average age 24.4 ± 4.2 years). When participants wore toric contact lenses, near high- and low-contrast visual acuity and automated visual acuity improved by 3-4 letters (all p < 0.03) and participants were able to read faster on an iPad (p = 0.02). Participants were also able to read with 8% less contrast on the iPad with toric lenses (p = 0.01). Participants reported better subjective vision on the overall NAVQ (p = 0.001) and better comfort on the CLDEQ-8 (p = 0.02) with toric lenses. Fewer participants reported difficulty with maintaining focus at near, reading small print, reading labels/instructions, reading the computer display/keyboard and reading post/mail with toric correction. CONCLUSIONS: Toric contact lenses improve comfort, subjective and objective visual performance with digital devices and other near tasks compared with the spherical equivalent correction in participants with low to moderate astigmatism.

Retrospective review of the effectiveness of orthokeratology versus soft peripheral defocus contact lenses for myopia management in an academic setting.

PURPOSE: To evaluate the relative efficacy of peripheral defocus contact lenses (PDCLs) and orthokeratology (OK) in a real-world clinical population, and compare these results with previous randomised controlled clinical trials. METHODS: Records from a university practice were reviewed to identify children who were treated with OK or PDCLs. The analysed sample contained 273 visits from 77 patients. Annualised rates of axial length (AL) progression were calculated and used as the response variable in both linear mixed-effects (LME) and nonlinear regression models. RESULTS: On average, children were 10.7 years of age at baseline (p = 0.14 between treatments), and most patients were female. More Asian children wore OK lenses compared with PDCLs (p < 0.01). At baseline, children had ~3.00 D of myopia and 0.75 D of astigmatism in both treatment groups (p > 0.20 between treatments). LME regression models using only baseline covariates showed no evidence that the annualised change in AL differed between treatments, with or without the inclusion of age, race, sex, baseline AL or spherical equivalent refractive error. Across all possible subsets of models, age at baseline was the best predictor of annualised AL change. There was no statistical difference between parameters of an exponential decay model fitted within treatment using follow-up age as a time-varying predictor, indicating that the rate of annualised change in AL was similar for OK and PDCL. CONCLUSIONS: Retrospective analysis of real-world clinical data found no difference in annualised AL growth between PDCL and OK. Importantly, the AL progression from this clinical setting is consistent with that reported in randomised clinical trials. Therefore, continued research of real-world performance is warranted to understand the safety and efficacy of modern myopia control treatments in the broader population.

Examining daily disposable soft contact lens wearers' attitudes and beliefs using the Health Belief Model.

PURPOSE: To use the Health Belief Model (HBM) to understand daily disposable (DD) soft contact lens (SCL) wearers' attitudes and beliefs. METHODS: A convenience sample of DD SCL wearers (18-33 years) was enrolled at two sites. Participants were queried about demographics, SCL wear and HBM constructs. Rasch analysis was used to assess the psychometric properties of the survey instrument and generate scores for each HBM subscale. ANOVA was used to determine relationships among HBM constructs, subject demographics and DD SCL-related health behaviours. RESULTS: One hundred people participated (mean ± SD), age = 24.2 ± 3.9 years, 76% female. Thirty-seven percent reported sleeping in DD SCLs and 25% reported reusing DD SCLs. Self-report of reusing DD SCLs was associated with scores on the benefits: reuse (p = 0.02) and barriers (p = 0.007) subscales, and sleeping in lenses was associated with scores on the susceptibility (p = 0.05), benefits: wear behaviours (p = 0.006) and barriers (p = 0.01) subscales. Rasch analysis showed some subscales demonstrated multidimensionality. CONCLUSIONS: Selected health belief constructs were associated with DD SCL-related behaviours including reusing and overnight wear. Increased understanding of SCL attitudes and beliefs could inform patient education and interventions to decrease risks associated with improper SCL wear.

Impact of accommodative insufficiency and accommodative/vergence therapy on ciliary muscle thickness in the eye.

PURPOSE: Recent evidence suggests that the ciliary muscle apical fibres are most responsive to accommodative load; however, the structure of the ciliary muscle in individuals with accommodative insufficiency is unknown. This study examined ciliary muscle structure in individuals with accommodative insufficiency (AI). We also determined the response of the ciliary muscle to accommodative/vergence therapy and increasing accommodative demands to investigate the muscle's responsiveness to workload. METHODS: Subjects with AI were enrolled and matched by age and refractive error with subjects enrolled in another ciliary muscle study as controls. Anterior segment optical coherence tomography was used to measure the ciliary muscle thickness (CMT) at rest (0D), maximum thickness (CMTMAX) and over the area from 0.75 mm (CMT0.75) to 3 mm (CMT3) posterior to the scleral spur of the right eye. For those with AI, the ciliary muscle was also measured at increasing levels of accommodative demand (2D, 4D and 6D), both before and after accommodative/vergence therapy. RESULTS: Sixteen subjects with AI (mean age = 17.4 years, SD = 8.0) were matched with 48 controls (mean age = 17.8 years, SD = 8.2). On average, the controls had 52-72 µm thicker ciliary muscles in the apical region at 0D than those with AI (p = 0.03 for both CMTMAX and CMT 0.75). Differences in thickness between the groups in other regions of the muscle were not statistically significant. After 8 weeks of accommodative/vergence therapy, the CMT increased by an average of 22-42 µm (p ≤ 0.04 for all), while AA increased by 7D (p < 0.001). CONCLUSIONS: This study demonstrated significantly thinner apical ciliary muscle thickness in those with AI and that the ciliary muscle can thicken in response to increased workload. This may explain the mechanism for improvement in signs and symptoms with accommodative/vergence therapy.

Incidence of Corneal Adverse Events in Children Wearing Soft Contact Lenses.

OBJECTIVES: There is increasing interest in fitting children with soft contact lenses, in part due to the increase in prescribing of designs to slow the progression of myopia. This literature review summarizes large prospective and retrospective studies that include data on the incidence of microbial keratitis and corneal infiltrative events (CIEs) in children wearing soft contact lenses. METHODS: Peer-reviewed prospective and retrospective studies that report contact lens-related complications in children with at least one year of wear and at least 100 patient years of wear were identified. RESULTS: Seven prospective studies published between 2004 and 2022 were identified representing 3,752 patient years of wear in 1,756 children, nearly all of whom were fitted at age 12 years or younger. Collectively, they report one case of microbial keratitis and 53 CIEs, of which 16 were classified as symptomatic. The overall incidence of microbial keratitis was 2.7 per 10,000 patient years (95% CI: 0.5-15), and the incidence of symptomatic CIEs was 42 per 10,000 patient years (95% CI: 26-69). Two retrospective studies were identified representing 2,545 patient years of wear in 1,025 children, fitted at age 12 years or younger. One study reports two cases of microbial keratitis giving an incidence of 9.4 per 10,000 patient years (95% CI: 0.5-15). CONCLUSIONS: Accurate classification of CIEs is challenging, particularly in retrospective studies. The incidence of microbial keratitis in children wearing soft lenses is no higher than in adults, and the incidence of CIEs seems to be markedly lower.

Compounded 0.01% Atropine-What's in the Bottle?

OBJECTIVE: To describe the labeling, packaging practices, and characteristics of compounded 0.01% ophthalmic atropine. METHODS: A convenience sample of parents of children who had previously been prescribed low-concentration atropine for myopia management were randomized to obtain 0.01% atropine ophthalmic solution from one of nine compounding pharmacies. The products were analyzed for various important quality attributes. The main outcomes were labeling practices, concentration of atropine and degradant product tropic acid, pH, osmolarity, viscosity, and excipients in 0.01% atropine samples obtained from nine US compounding pharmacies. RESULTS: Twenty-four samples from nine pharmacies were analyzed. The median bottle size was 10 mL (range 3.5-15 mL), and eight of nine pharmacies used clear plastic bottles. Storage recommendations varied and were evenly split between refrigeration (33%), room temperature (33%), and cool, dark, dry location (33%). Beyond use dates ranged from 7 to 175 days (median, 91 days). Median pH of samples was 7.1 (range, 5.5-7.8). Median measured concentration relative to the prescribed concentration was 93.3% (70.4%-104.1%). One quarter of samples were under the 90% minimum target concentration of 0.01%. CONCLUSIONS: An inconsistent and wide variety of formulation and labeling practices exist for compounding 0.01% atropine prescribed to slow pediatric myopia progression.

Compounding of Low-Concentration Atropine for Myopia Control.

OBJECTIVES: Low-concentration atropine is commonly prescribed to slow myopia progression in children but is not Food and Drug Administration-approved for that indication and is only available in the United States from compounding pharmacies. The purpose of this study was to ascertain its reported compounding and labeling in the United States. METHODS: US compounding pharmacies were identified through a survey of eye doctors, social media, conferences, and web search. Twenty-eight pharmacies were identified and contacted through telephone and asked a standard set of questions about their methods to compound and label low-concentration atropine. RESULTS: Twenty-six pharmacies across 19 states provided responses, with 21 answering all nine items (81%) and a mean of 8.7 of nine responses. The most frequently reported bottle size was 5 mL (interquartile range [IQR]: 3.5-10). For storage, 10 pharmacies (38%) recommended refrigeration and 16 (62%) stated room temperature was sufficient. The median beyond-use date provided was 65 days (IQR: 45-158). For preparation, 12 pharmacies (50%) used commercially available 1% solution, 9 (38%) used powdered atropine, 2 (8%) used both, and 1 (4%) stated their approach was proprietary. For the added excipients, 11 (42%) used artificial tears only, 6 (23%) added 0.9% saline only, 7 (27%) used more than one ingredient, and 2 (8%) were proprietary. Only two pharmacies mentioned adding boric acid and two mentioned "pH-adjusted" saline. CONCLUSIONS: There were a wide variety of formulation methods in the United States, which may affect atropine stability and potency. Similarly, there are a wide variety of storage and beyond-use recommendations. Further research is needed to assess how these variations may affect the efficacy and safety of low-concentration atropine and of myopia control.

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.

In-person and online escape rooms for individual and team-based learning in health professions library instruction.

Background: A growing body of research demonstrates that adapting the popular entertainment activity "escape rooms" for educational purposes as an innovative teaching method can improve the learning experience. Escape rooms promote teamwork, encourage analytical thinking, and improve problem solving. Despite the increasing development and use of escape rooms in health sciences programs and academic libraries, there is little literature on the use of this method in health sciences libraries with health professions students. Case Presentation: Staff at a health sciences library collaborated with faculty to incorporate escape rooms into library instruction in a variety of settings (in-person, hybrid, online) and formats (team, individual) with health professions students from various disciplines (optometry, pharmacy, medicine). The escape rooms described in this paper offered unique experiences for students through active learning. Discussion: Important considerations when planning escape rooms for health sciences library instruction include deciding on team-based or individual design, calculating potential costs in time and money, deciding on an in-person, hybrid, or online format, and determining whether grades should be assigned. Escape rooms can be an effective strategy for library instruction in the health sciences, working in multiple formats to bring game-based learning to a variety of health professions students.

Greater higher order aberrations induced by toric orthokeratology versus soft toric multifocal contact lens wear.

PURPOSE: Spherical orthokeratology and soft multifocal contact lenses are commonly used for myopia control and correction, but have been shown to increase spherical aberration, coma and total higher order root mean square (HORMS) aberrations. There are limited myopia control contact lens options for patients with moderate to high astigmatism. The purpose of this study was to quantify changes in higher order aberrations (HOA) in myopic astigmatic eyes fitted with toric orthokeratology (TOK) and soft toric multifocal (STM) contact lenses. METHODS: Ocular wavefront aberrations were measured in both eyes of 30 adult subjects and are reported through the 6th radial order over a 5 mm, dilated pupil. All eyes met refractive criteria of myopia (-5.00 D to plano) and cylinder (-3.50 to -1.25 D). Three measurements were taken at baseline and after 10 ± 2 days of lens wear (TOK, STM). Sixteen subjects achieved logMAR high contrast visual acuity of 0.30 or better in both eyes and were included in this analysis. Repeated measures analysis of variance and post-hoc paired t-tests were used, as appropriate, with Benjamini-Hochberg correction. RESULTS: Higher order root mean square, spherical aberration (C12), and coma RMS (C7, C8) increased with TOK (0.641 [0.222], 0.409 [0.157], 0.426 [0.187] µm, respectively) and STM (0.481 [0.107], 0.223 [0.139], 0.320 [0.130] µm, respectively) from baseline (all p < 0.001). TOK was elevated compared to STM for HORMS (p = 0.03), spherical aberration (p = 0.001) and coma RMS (p = 0.04). CONCLUSIONS: Toric orthokeratology induced more HORMS, spherical aberration and coma RMS than STM in myopic astigmats; however, both lens types showed an increase in HOA compared to baseline, which placed patients outside the age and pupil size matched normative ranges. While the optical changes that accompany these modalities are helpful for myopia management, the induction of HOAs may have unintended consequences on visual performance.

Corneal Elevation, Power, and Astigmatism to Assess Toric Orthokeratology Lenses in Moderate-to-High Astigmats.

OBJECTIVES: Fitting philosophies for toric orthokeratology are based on elevation or corneal astigmatism, but it is unclear which is more effective. The purpose of this analysis was to further understand corneal shape and the relationship between peripheral elevation and central astigmatism in moderate-to-high astigmats. METHODS: Corneal tomography was measured three times on the right eyes of 25 moderate-to-high refractive myopic astigmatic adults. Corneal astigmatism and elevation were calculated at 4-, 6-, and 8-mm chords. Subjects were fitted with toric orthokeratology lenses following the manufacturer's guidelines based on elevation. Twenty subjects completed 10 days of wear. A masked examiner assessed movement and centration via slitlamp videos and quantified treatment zone and decentration from tangential power difference tomography maps. Correlations between variables were assessed. RESULTS: Average corneal astigmatism was 2.20±0.70 DC and peripheral elevation was 50.88±18.92 µm and they were strongly correlated (4 mm R2=0.96, 6 mm R2=0.92, 8 mm R2=0.86, all P<0.001). Each diopter of astigmatism equated to 25 µm of elevation at an 8-mm chord. Via slitlamp, average treatment zone area was 12.73±4.62 mm2 and 13 lenses decentered. From tomography, average treatment zone area was 7.16±2.56 mm2 and 17 were decentered. Tomography treatment zone area was negatively correlated with central corneal astigmatism (R2=0.60) and elevation at an 8-mm chord (R2=0.64, both P<0.001). CONCLUSIONS: For tomography images, central corneal astigmatism was highly correlated with peripheral elevation and may be a more expedient measure for clinical use. Treatment area decreased as corneal astigmatism and elevation increased.

Pediatric Microbial Keratitis With Overnight Orthokeratology in Russia.

OBJECTIVES: To estimate the incidence of microbial keratitis in children wearing overnight orthokeratology lenses in Moscow, Russia. METHODS: To estimate the number of children wearing overnight orthokeratology lenses in 2018, 1,368 patient records from 13 Doctors Lens clinics were selected at random and extrapolated to the entire patient base. To identify cases of microbial keratitis, all episodes of infiltrative keratitis from Morozovskaya City Children's Clinical Hospital in 2018 were recorded and adjudicated by three experienced ophthalmologists. Incidence was calculated as the number of cases divided by the estimated number of wearers. RESULTS: There were 23,049 overnight orthokeratology fits between 2010 and 2018. Among the 1,368 records surveyed, 1,078 (79%) were younger than 18 years at initial fitting. Based on a 7% or 10% annual discontinuation rate, the estimated number of children wearing lenses in 2018 was 10,307 or 9,422, respectively. During 2018, there were 139 cases of corneal infiltrative keratitis in children and 45 were adjudicated as microbial keratitis (32%). Of these, 20 cases were associated with contact lens wear (44%): 15 soft lens wearers (33%) and 5 overnight orthokeratology wearers (11%). Based on the 5 cases and assuming a 7% or 10% discontinuation rate, the annual incidence is 4.9 (95% confidence interval[CI]: 2.1-11.4) or 5.3 (95% CI: 2.3-12.4) per 10,000 patient years. CONCLUSION: The incidence of microbial keratitis in children wearing overnight orthokeratology is lower than a previous United States study and similar to rates associated with use of daily wear soft contact lenses.

Randomized Clinical Trial of Near Visual Performance with Digital Devices Using Spherical and Toric Contact Lenses.

SIGNIFICANCE: Visual demands today incorporate a significant amount of time using digital devices. Results of this randomized crossover study of spherical and toric contact lenses demonstrated that participants were able to read smaller print size more comfortably and preferred toric contact lenses when using digital devices. PURPOSE: The purpose of this study was to assess how toric contact lens correction affects subjective and objective outcomes of astigmatic patients using real-world digital devices. METHODS: Adult participants, aged between 20 and 38 years with -0.75 to -1.50 D of astigmatism were enrolled in this double-masked randomized crossover 10-day study of Alcon Dailies Aqua Comfort Plus Sphere and Toric (Alcon, Geneva, Switzerland) contact lenses. Electronic high- and low-contrast near logMAR visual acuity and contrast sensitivity were tested. Reading performance was assessed using custom iPad applications; one used a reading sentences test, whereas the other analyzed zoom, contrast, and distance with website-based articles. Participants completed the Near Activity Visual Questionnaire and stated their preferred contact lens correction. RESULTS: Thirty seven participants were screened, 35 participants were enrolled, and 34 participants completed the study. Toric lens correction improved near high- and low-contrast visual acuity by 0.5 to 1 full line (P < .0001) and allowed participants to read one line smaller text on the iPad (P = .01). Participants increased the zoom 11% (P = .004) and the contrast 4% (P = .006) more with spherical lenses while reading articles. Participants held the iPad at approximately the same distance, about 33 cm (P = .63). Eighty five percent of participants preferred the toric correction (P < .0001). Participants reported improved satisfaction with toric lens correction (P = .0002) and noticed the most benefit with tasks such as reading small print and labels/instructions. CONCLUSIONS: This study used digital devices to demonstrate realistic benefits of toric contact lens designs for astigmatic patients.

Myopia Control 2020: Where are we and where are we heading?

PURPOSE: This review arms practitioners with the evidence-based information they need to fully manage myopia. RECENT FINDINGS: The recent peer-reviewed literature is critically evaluated to provide a comprehensive analysis of the safety and efficacy of behavioural, optical and pharmaceutical myopia management. Importantly, the paper addresses not only who to treat, but how to treat them, and when to stop or modify treatments. Finally, the paper discusses expectations for treatment and why slowing myopia by even 1 dioptre improves long term health outcomes. SUMMARY: The management of an individual child should be underpinned by the evidence-based literature and clinicians must stay alert to ongoing myopia research that will undoubtedly result in an evolution of the standard of care for the myopic and pre-myopic child.

Functional retinal outcomes in patients with prediabetes and type 2 diabetes.

PURPOSE: Type 2 diabetes (T2DM) is a leading cause of visual impairment. Its precursor, prediabetes (preDM), is growing in numbers every year. While it is well known that T2DM causes changes in retinal function early in the disease process, it is likely that some of these changes emerge during the preDM stage. This study evaluates retinal function measures in patients with preDM to determine if there are differences in colour vision, contrast sensitivity (CS), and multifocal electroretinogram (mfERG) measures present before T2DM is diagnosed. METHODS: The L'Anthony desaturated D-15 test, Mars Chart CS test, and mfERG were administered on the right eye of 43 participants; 15 controls (HbA1c ≤ 5.6%), 17 with preDM (HbA1c 5.7%-6.4%), and 11 with T2DM (either physician diagnosed or with untreated HbA1c ≥ 6.5%). HbA1c values were measured at the time of the other tests. Colour vision confusion scores (CVCS) were calculated from the D-15 using the method developed by Torok. Multivariate regression (which controlled for age differences) was used to evaluate the relationship of HbA1c and functional measures. Kruskal-Wallis tests were also used to evaluate differences between groups with post-hoc analysis. RESULTS: CVCSs were significantly different between the three groups (p = 0.009). There was an association between higher CVCS and higher HbA1c values across all groups as well as specifically within the preDM group when controlling for age (R2  = 0.29, p = 0.01 and R2  = 0.39, p = 0.02 respectively). Multivariate regression of all of the functional tests together and HbA1c found only colour vision remained significant, indicating that the functional examination metrics may provide redundant data, with similar changes in prediabetes where colour vision may be the strongest indicator early in the process. CONCLUSIONS: Patients with prediabetes have functional changes that can be measured in the retina before the diagnosis of diabetes, with the L'Anthony D-15 colour vision test providing the strongest association with glucose dysregulation in this population. This has important implications for follow up and screening for diabetes within optometric practices. Further studies are needed to follow these patients over time to see how and when these metrics change.

Absorption and Extraction of Inflammatory Mediators From Contact Lens Materials.

OBJECTIVES: This report aimed to explore whether certain inflammatory mediators were absorbed, extracted, or bound by various contact lens materials. METHODS: Comfilcon A, balafilcon A, omafilcon A, and etafilcon A were soaked in 500 and 100 pg/mL of interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), or interleukin-1 receptor antagonist (IL-1Ra), and also in combined solutions of inflammatory mediators (500 pg/mL or 100 pg/mL) separately. Lenses were then extracted in 1:1 2% trifluoroacetic acid:acetonitrile. The extracted and residual concentrations of inflammatory mediators were determined using enzyme-linked immunosorbent assays. Absorbed (control-residual) and firmly bound (absorbed-extracted) concentrations were calculated for analysis. RESULTS: More MMP-9 was absorbed by omafilcon A (466±9 pg/mL) than balafilcon A (P=0.006; 437±11 pg/mL) or etafilcon A (P=0.001; 428±13 pg/mL) when soaked in 500 pg/mL, but no differences in 100 pg/mL. More MMP-9 remained firmly bound to omafilcon A (P=0.03; 174±3 pg/mL), comfilcon A (P=0.049; 168±34 pg/mL), and balafilcon A (P=0.01; 186±14 pg/mL) than etafilcon A (128±22 pg/mL). There were no differences in IL-8 absorption between lenses; however, more IL-8 remained firmly bound to omafilcon A (P=0.01; 336±25 pg/mL) than etafilcon A (106±133 pg/mL) when soaked in 500 pg/mL. No differences were found in concentrations of absorbed or firmly bound IL-1Ra between materials. When the mediators were combined, IL-8 was absorbed more in etafilcon A (P=0.03) than in other lens materials, but the absorbed IL-8 did not remain firmly bound. CONCLUSIONS: The uptake and extraction of inflammatory mediators from contact lenses was affected by competitive binding between the mediators.

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.

Accommodation and Phoria in Children Wearing Multifocal Contact Lenses.

PURPOSE: To determine the effect of multifocal contact lenses on accommodation and phoria in children. METHODS: This was a prospective, non-dispensing, randomized, crossover, single-visit study. Myopic children with normal accommodation and binocularity and no history of myopia control treatment were enrolled and fitted with CooperVision Biofinity single vision (SV) and multifocal (MF, +2.50D center distance add) contact lenses. Accommodative responses (photorefraction) and phorias (modified Thorington) were measured at four distances (>3 m, 100 cm, 40 cm, 25 cm). Secondary measures included high- and low-contrast logMAR acuity, accommodative amplitude, and facility. Differences between contact lens designs were analyzed using repeated measures regression and paired t-tests. RESULTS: A total of 16 subjects, aged 10 to 15 years, completed the study. There was a small decrease in high (SV: -0.08, MF: +0.01) and low illumination (SV: -0.03, MF: +0.08) (both P < .01) visual acuity, and contrast sensitivity (SV: 2.0, MF: 1.9 log units, P = .015) with multifocals. Subjects were more exophoric at 40 cm (SV: -0.41, MF: -2.06 Δ) and 25 cm (SV: -0.83, MF: -4.30 Δ) (both P < .01). With multifocals, subjects had decreased accommodative responses at distance (SV: -0.04; MF: -0.37D, P = .02), 100 cm (SV: +0.37; MF: -0.35D, P < .01), 40 cm (SV: +1.82; MF: +0.62D, P < .01), and 25 cm (SV: +3.38; MF: +1.75D, P < .01). There were no significant differences in accommodative amplitude (P = .66) or facility (P = .54). CONCLUSIONS: Children wearing multifocal contact lenses exhibited reduced accommodative responses and more exophoria at increasingly higher accommodative demands than with single vision contact lenses. This suggests that children may be relaxing their accommodation and using the positive addition or increased depth of focus from added spherical aberration of the multifocals. Further studies are needed to evaluate other lens designs, different amounts of positive addition and aberrations, and long-term adaptation to lenses.