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Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time. The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.

Purpose Alcohol delamination of the corneal epithelium (ADCE) is a therapeutic option for patients with recurrent corneal erosion (RCE) who do not respond to nonsurgical management of lubricants and extended wear contact lens. The aim of the study is to report on three-year efficacy and safety of ADCE for RCE of traumatic etiology. Methods This is a retrospective review of consecutive patients who underwent ADCE for traumatic RCE in a local hospital between January 2010 and January 2020. The outcomes at a 3-year follow-up review are included. Nonsurgical therapy used; intra- and postoperative complications were recorded. ADCE was only offered to those who remained symptomatic despite maximum topical lubrications and/or extended wear contact lens. Success was defined as the absence of recurrence of corneal erosion. Results Twenty-six eyes of 26 patients with RCE caused by trauma underwent ADCE. The mean age of patients was 39 years. The follow-up period was a minimum of 36 months. Three eyes (11.5%) had recurrence of corneal erosion after ADCE at the 3-year follow-up. Recurrence was noted at months 2, 23, and 36 postoperatively in these patients. All patients reported significant improvement in symptoms associated with recurrent erosion. Ten eyes (38.5%) stopped all topical lubricants postoperatively. No intra- or postoperative complications were noted in our study. Conclusion This study documents the long-term safety and efficacy of alcohol delamination of corneal epithelium at 3 years for patients with RCE of traumatic origin.

Most respirators employed in health care settings, and often in first responder and industrial settings, are intended for single-use: the user dons the respirator, performs a work activity, and then doffs and discards the respirator. However, in the current COVID-19 pandemic, in the presence of persistent shortages of personal protective equipment, extended use and reuse of filtering facepiece respirators are routinely contemplated by many health care organizations. Further, there is considerable current effort to understand the effect of sterilization on the possibility of reuse, and some investigations of performance have been conducted. While the ability of such a respirator to continue to provide effective protection after repeated sanitization cycles is a critical component of implementing its reuse, of equal importance is an understanding of the impact that reusing the respirator multiple times in a day while performing work tasks, and even extending its wear over multiple days, has on the workplace protective performance. In this study, we subjected a stockpiled quantitatively fitted surgical style N95 filtering facepiece respirator device to extreme reuse and extended wear conditions (up to 19 uses over a duration of 5 days) and measured its protective performance at regular intervals, including simulated workplace protection factor measurements using total inward leakage. With this respirator, it was shown to be possible to maintain protection corresponding to an assigned protection factor greater than 10 under extreme usage conditions provided an individual is properly trained in the use of, and expertly fitted in, the respirator. Other factors such as hygiene and strap breakage are likely to place limits on reuse.

Purpose The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis. Subjects and Methods A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria. Results The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05). Conclusion While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle.

Introduction Wearable sensors may be used for the assessment of behavioral manifestations of cigarette smoking under natural conditions. This paper introduces a new camera-based sensor system to monitor smoking behavior. The goals of this study were (1) identification of the best position of sensor placement on the body and (2) feasibility evaluation of the sensor as a free-living smoking-monitoring tool. Methods A sensor system was developed with a 5MP camera that captured images every second for continuously up to 26 hours. Five on-body locations were tested for the selection of sensor placement. A feasibility study was then performed on 10 smokers to monitor full-day smoking under free-living conditions. Captured images were manually annotated to obtain behavioral metrics of smoking including smoking frequency, smoking environment, and puffs per cigarette. The smoking environment and puff counts captured by the camera were compared with self-reported smoking. Results A camera located on the eyeglass temple produced the maximum number of images of smoking and the minimal number of blurry or overexposed images (53.9%, 4.19%, and 0.93% of total captured, respectively). During free-living conditions, 286,245 images were captured with a mean (±standard deviation) duration of sensor wear of 647(±74) minutes/participant. Image annotation identified consumption of 5(±2.3) cigarettes/participant, 3.1(±1.1) cigarettes/participant indoors, 1.9(±0.9) cigarettes/participant outdoors, and 9.02(±2.5) puffs/cigarette. Statistical tests found significant differences between manual annotations and self-reported smoking environment or puff counts. Conclusions A wearable camera-based sensor may facilitate objective monitoring of cigarette smoking, categorization of smoking environments, and identification of behavioral metrics of smoking in free-living conditions. Implications The proposed camera-based sensor system can be employed to examine cigarette smoking under free-living conditions. Smokers may accept this unobtrusive sensor for extended wear, as the sensor would not restrict the natural pattern of smoking or daily activities, nor would it require any active participation from a person except wearing it. Critical metrics of smoking behavior, such as the smoking environment and puff counts obtained from this sensor, may generate important information for smoking interventions.

Articular cartilage is critical for proper joint mobility as it provides a smooth and lubricated surface between articulating bones and allows for transmission of load to underlying bones. Extended wear or injury of this tissue can result in osteoarthritis, a degenerative disease affecting millions across the globe. Because of its low regenerative capacity, articular cartilage cannot heal on its own and effective treatments for injured joint restoration remain a challenge. Strategies in tissue engineering have been demonstrated as potential therapeutic approaches to regenerate and repair damaged articular cartilage. Although many of these strategies rely on the use of an exogenous three-dimensional scaffolds to regenerate cartilage, scaffold-free tissue engineering provides numerous advantages over scaffold-based methods. This review highlights the latest advancements in scaffold-free tissue engineering for cartilage and the potential for clinical translation. Impact statement Although scaffolds are often incorporated into cartilage tissue engineering strategies as a three-dimensional architecture conducive to tissue formation, scaffold-free approaches are increasingly recognized for their ability to better recapitulate the native tissue formation process. Recent advancements in scaffold-free tissue engineering and success in clinical trials demonstrate the potential of these techniques to serve as viable therapies for repairing and restoring damaged cartilage.

Since the seminal work of Wichterle in 1965 describing the first soft contact lenses and their potential for ocular drug delivery, the field has yet to realize his vision. Maintaining all lens commercial properties combined with a mechanism for controlled drug release of therapeutically relevant concentrations for duration of wear is a major challenge. Here, successful in vivo week-long sustained release of a small molecular weight therapeutic in rabbits from extended-wear silicone hydrogel contact lenses meeting all commercial specifications by utilizing a novel macromolecular memory strategy is reported for the first time. Lens-treated eyes show a continuous, therapeutically relevant bromfenac tear concentration of 256.4 ± 23.1 µg mL-1 for 8 days. Bromday (bromfenac ophthalmic solution, 0.09%, Bausch+Lomb) topical drops exhibit a quick peak concentration of 269.3 ± 85.7 µg mL-1 and 100 min duration. Bioavailability (AUC0-8days ) and mean residence time of lenses are 26 and 155 times higher than drops, respectively. Lenses are safe, well tolerated, and no corneal histological differences are observed. This work highlights the enormous potential of drug releasing lenses as a platform strategy, and offers a new dropless clinical strategy for post-cataract, uveitis, post-LASIK, and corneal abrasion treatment.

Objective: Most insulin infusion sets (ISs) are labeled for 2- or 3-days use. The Medtronic EWIS is designed to increase wear time up to 7 days. This study reports on EWIS survival and performance during the pivotal trial (ClinicalTrials.gov: NCT04113694). Method: This multi-center (15), single-arm, non-randomized, non-inferiority trial in 259 participants (18-80yrs) with T1D using the MiniMed™ 670G system (with Humalog™ or Novolog™ insulin) involved wearing a 2- or 3-day IS for 2 weeks (run-in) followed by 12 consecutive EWIS wears (study phase). The latter was worn for ≥174 hours or until set failure. Safety and performance (i.e., a priori target of Result: The EWIS survival rate was 74.8% versus the 67.7% rate of 2- or 3-day ISs (p Conclusion: The 7-day EWIS was safe and its performance was superior at ≥174 hours compared to the performance observed for 2- or 3-day infusion sets. Disclosure B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B. Horowitz: Research Support; Self; Abbott Laboratories, BD, Celgene, Crinetics Pharmaceuticals, Gan & Lee Pharmaceuticals, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Merck & Co., Inc., Novo Nordisk Inc. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. S. Huang: None. V. Chen: Employee; Self; Medtronic. G. Zhang: Employee; Self; Medtronic. S. Chattaraj: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. G. Grunberger: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. J. Thrasher: Advisory Panel; Self; Medtronic, Board Member; Self; Medtronic, Consultant; Self; Medtronic, Research Support; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan N. V., Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. A. Cavale: Research Support; Self; Eli Lilly and Company, Medtronic. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics.

Aim: To identify IPISF occurrence and troubleshooting methods, determine habits and perceptions of diabetes technology use, and assess the history and satisfaction of education in those who utilize CSII. Methods: A 57-item online survey was constructed and included demographic questions, assessment with Likert scales, and open-ended questions regarding infusion sets. Participants were recruited via the T1D Exchange online community database. Statistical analysis was performed using R and JMP. Results: A total of 715 individuals were surveyed including 639 people with diabetes (PwD) and 76 caretakers among 49 states and territories from 09/2020 - 11/2020. Demographics: PwD age 51.6±15.1 years, caretaker age 46.1±7.6 years (dependent PwD age 15.2±11.2 year), 99.6% type 1 diabetes, 69% female, 92% white, CSII use for 14.1±8.5 years, 44% use AID, HbA1c 6.8±0.97%, TIR 72.3±16.1%, TIR3 days. 97% of participants experience IPISF with 41% reporting ≥1 IPISF/month. Following IPISF, participants administered correction boluses using their pump with (41%) and without (44%) changing their failed infusion set. 61% of subjects had not received IPISF education in over a year and 19% had never received IPISF education. For users who experience ≥1 IPISF/month, hyperglycemia and related symptoms were more likely to alert users of IPISF than pump alarms (n=259, p=0.0355). Respondents with ≥1 IPISF/month were also more likely to both feel burned out by their diabetes technology (p Conclusion: Developing technologies that reduce and mitigate IPISF should be a critical focus, especially as extended wear infusion sets become available. Disclosure J. H. Wilcox: Employee; Self; Diatech Diabetes, Inc. J. C. Gray: Employee; Self; Diatech Diabetes, Inc. N. R. Cooper: Employee; Self; Diatech Diabetes, Inc. L. E. Blanco: Employee; Self; Diatech Diabetes, Inc. R. Kelleher: Employee; Self; Diatech Diabetes, Inc. L. M. Vanengelen: Employee; Self; Diatech Diabetes, Inc. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool.

Objective: Most insulin infusion sets (ISs) are labeled for 2- or 3-days use. The Medtronic EWIS is designed to increase wear time up to 7 days, and demonstrated a 74.8% survival rate (77.8%, excluding inadvertent early removal) in the pivotal trial (ClinicalTrials.gov: NCT04113694). This study reports on study participant satisfaction during the EWIS pivotal trial. Method: This multi-center (15), single-arm, non-randomized, non-inferiority trial in 259 participants (18-80yrs) with T1D using the MiniMed™ 670G system (with Humalog™ or Novolog™ insulin) involved wearing a 2- or 3-day IS for 2 weeks (run-in) followed by 12 consecutive EWIS wears (study phase). The latter was worn for ≥174 hours or until set failure. Participants completed a Medtronic Likert-based questionnaire at baseline and study exit. The averaged paired change in score at study-baseline was determined (Wilcoxon signed-rank test). Result: Reported satisfaction data during 2- or 3-day IS versus EWIS wear (Figure) show that ease and convenience of use, comfort, wear duration and time required to change a set were significantly improved with EWIS (p Conclusion: These findings point to significantly greater satisfaction with the EWIS when compared with a 2- or 3-day IS, which may result in reduced care burden and improved adherence. Disclosure R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. B. Horowitz: Research Support; Self; Abbott Laboratories, BD, Celgene, Crinetics Pharmaceuticals, Gan & Lee Pharmaceuticals, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Merck & Co., Inc., Novo Nordisk Inc. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. S. Huang: None. V. Chen: Employee; Self; Medtronic. G. Zhang: Employee; Self; Medtronic. S. Chattaraj: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. G. Grunberger: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. A. Cavale: Research Support; Self; Eli Lilly and Company, Medtronic. J. Thrasher: Advisory Panel; Self; Medtronic, Board Member; Self; Medtronic, Consultant; Self; Medtronic, Research Support; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan N. V., Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care.

Purpose: To demonstrate the therapeutic benefit of extended wear bandage contact lens (BCL) use in patients with epidermolysis bullosa (EB) suffering from recurrent, painful, and slow-to-heal corneal epithelial defects.Methods: Case reports of three patients.Results: We report ophthalmic treatment of three pediatric patients, two with recessive dystrophic EB (RDEB) and one with junctional EB (JEB), who suffered frequently recurrent corneal abrasions and were treated with 30-day extended-wear bandage contact lenses (BCLs), replaced every month for at least 1 year. Pain and frequency of corneal abrasions improved immediately, and the BCLs were well tolerated. Vision was maintained or improved in all cases. Corneal ulcers did not occur while on antibiotic prophylaxis.Conclusions: Continuous and prolonged BCL therapy in patients with EB can be an effective way to immediately alleviate pain, prevent recurrent abrasions, and improve patient quality of life.

A new category of hearing technology has emerged that comprises devices inserted deep into the ear canal. Although not implanted, they represent an extension of what is expected of a traditional hearing aid. There are advantages to these devices, but they are not suited for all individuals with hearing loss. This category consists of 2 devices currently available in the United States: Lyric (Phonak AG, Stafa, Switzerland) and Earlens (Earlens, Menlo Park, CA, USA).

Objectives To report the successful treatment of persistent corneal epithelial defects that failed to respond to alternative treatment methods using extended wear of three different rigid gas-permeable scleral lenses. Methods Eight eyes of eight patients with persistent corneal epithelial defects were treated with Blanchard Onefit 2.0 Scleral lens, BostonSight Scleral lens, and BostonSight PROSE device and were observed for defect resolution and improvement in best-corrected visual acuity over the duration of treatment. Results All eyes observed complete re-epithelialization with a mean time of 11.1 ± 5.5 days. At the conclusion of the treatment, visual acuity improved in all but one patient. No complications were observed during treatment. Conclusions Scleral lenses provide the corneal epithelium with hydration, oxygen permeation, and protection from mechanical forces; thereby facilitating healing of persistent corneal epithelial defects. This case series demonstrates the successful use of continuous wear scleral lenses in a number of patients for the treatment of persistent epithelial defects refractory to other interventions.

Oxygen permeability or transmissibility is a crucial parameter for contact lenses to ensure that extended wear will not induce corneal hypoxia. This work tests a new method of using the oxidation of cysteamine, an oxygen-sensitive chemical, to quantify the oxygen transmissibility of current commercial contact lenses and contact lenses loaded with vitamin E.3D printing was used to modify eye drop bottles and quartz cuvettes to create systems that allowed insertion of a contact lens in between the cysteamine solution and air. Both systems were exposed to atmospheric conditions where the only path of entry for oxygen was through the contact lens. The entering oxygen reacted with cysteamine, and the rate of cysteamine oxidation was measured using UV-vis spectrophotometry. The rate was then stoichiometrically related to oxygen transmissibility.The eye drop method predicted transmissibility values within 9% of established, commercial values. The cuvette method predicted values within 10% of established values for silicone hydrogel lenses without any correction factor and within 11% for poly-hydroxyethyl-methacrylate lenses after correcting for oxygen entering the system. Incorporation of 20% (w/w) vitamin E into Acuvue® Oasys® lenses did not have a significant impact on the oxygen transmissibility.Both methods presented in this work can reliably measure oxygen transmissibility of contacts lenses or other materials. Further improvements in manufacturing could lead to improved accuracy and reliability, allowing wider use of this method for quantifying the oxygen transport in contact lenses.

This study used the framework of esthetic response to analyze student perceptions of outerwear coats as one apparel product considered for its potential for extended wear. Through a pilot, six coat...

Purpose To document contact lens prescribing trends in the United Kingdom over the past quarter of a century. Methods An annual survey of contact lens prescribing was conducted each year from 1996 to 2020, inclusive, by asking a random selection of optometrists and contact lens opticians to provide information relating to 10 consecutive contact lens fits between January and March. Results Over the 25 year survey period, 2,671 practitioners returned survey forms, reporting a total of 25,575 contact lens fits. The mean (± standard deviation) age of lens wearers was 35 ± 15 years, of which 64 % were female. Over the survey period, rigid lens new fits decreased from 22 % to 2%. The prescribing of silicone hydrogel lenses has increased steadily since their introduction towards the end of the 1990s, and now represent 80 % of soft lens fits. Soft toric lens prescribing has gradually increased to 47 % – a value at which astigmatism ≥ 0.75DC is theoretically corrected in all contact lens wearers. Daily disposable prescribing increased steadily over the survey period and now represents 63 % of lenses prescribed. Extended wear fits remain at very low levels, except for some prescribing for overnight orthokeratology. Multi-purpose lens care solutions are ubiquitous; peroxide and other systems are now seldom prescribed. Rigid lenses and monthly replacement soft lenses are predominantly worn on a full time basis, whereas daily disposable soft lenses are mainly worn part time. Conclusions This report documents the evolution of contact lens fitting in the United Kingdom over the past 25 years. The most likely lens fit is a spherical design silicone hydrogel daily disposable contact lens prescribed for a 35 year old female and worn on a part-time basis.

Continuous subcutaneous insulin infusion (CSII) is becoming increasingly used for achieving target glycemic control as well as providing flexibility in lifestyle. In a widely used version of CSII, the insulin pump itself is attached to one end of an insulin infusion set (IIS), which delivers insulin via a thin flexible plastic tube to the patient’s body via a cannula or needle that is inserted under the skin at the other end of the IIS. Despite the increased use of CSII by patients with diabetes, there have been few recent advances in IIS technology, especially when compared to the many recent advances made in insulin pump technology and in insulin pharmacokinetics. To discuss recent developments in, and future plans for IIS development, Diabetes Technology Society virtually hosted the Advances in Insulin Pump Infusion Sets Symposium on December 1, 2020. This symposium featured experts in the field of IISs, including representatives from Medtronic and ConvaTec (which are two manufacturers that are currently developing IISs), Stanford University, Steno Diabetes Center Copenhagen, and Science Consulting in Diabetes. The webinar’s six speakers covered (1) patient burden, (2) extended wear technology, and (3) future directions in IIS development.

The purpose of this article is to compare the insulin cost-savings of the Medtronic Extended Infusion Set (or EIS, a.k.a. Extended Wear Infusion Set) designed and labeled for up to 7-day use with rapid-acting insulins to the current standard of care, 2- to 3-day infusion sets. There are three major improvements (reducing insulin waste, plastic waste, and adverse events) with the extended duration of infusion set wear. This analysis focuses on cost savings from reduced insulin wastage during set changes. Studies published on insulin infusion set survival and EIS clinical trial data (NCT04113694) were used to estimate device lifetime performance using a Markov chain Monte Carlo model, including the assessment of adverse effects and device failure. Total costs associated with infusion set change or failure were systematically found in published literature or estimated based on physical usage, and the direct impact on insulin costs was calculated. Based on the model and clinical data, EIS users can expect to change their infusion sets about 75 fewer times than standard set users each year. The costs related to unrecoverable insulin during an infusion set and reservoir change in the US were estimated to range from $19.79 to $22.48, resulting in approximately $1324 to $1677 in annual cost-savings for the typical user from minimizing insulin wastage. The study only assessed devices used within a monitored setting, that is, clinical trials. In addition, the variability associated with healthcare standards and costs and individual treatment variability including insulin dosages, contribute to the uncertainties with the calculations. Our analysis demonstrates that by extending the duration of infusion set wear, there may be substantial cost savings by reducing insulin wastage.

In the outbreak of COVID-19, the extended wear of single-use, disposable respirators was inevitable due to limited supplies. As a respirator is front-line protection against particulate matter, including bioaerosol and droplets, a comprehensive understanding for the reuse strategy is needed. In this study, eight different disinfection methods commonly applied for the reuse of respirators were compared for their influence on the filtration and bactericidal/bacteria removal performance, with in-depth discussion on the cause of effects. Treatments including oven-dry, ultraviolet irradiation (UV), microwaving, laundering with and without detergent, and immersion in hypochlorite, isopropanol, and ethanol were performed to respirators. Immersion in ethanol or isopropanol was effective for inactivation and removal of bacteria, yet such a treatment significantly deteriorated the filtration efficiency in about 20&ndash, 28%, dissipating the surface charges. Laundering, while effective in removing the attached bacteria, triggered physical damage, leading to a possible reduction of filtration performance. A short-term oven-dry, UV irradiation, and microwaving mostly preserved the filtration performance, yet the drawback lied in the incomplete bactericidal efficiency. This study would contribute to the public health and safety by providing scientific background on the effect of disinfection treatment methods for respirators.

The purpose of this study was to investigate the effect of Mel4 antimicrobial peptide-coated contact lenses (MACL) on the microbiota of the conjunctiva and lenses during three months of extended wear.One hundred and seventy-six participants were recruited into a randomised, contralateral, double masked, biweekly extended wear MACL and uncoated control lens trial. At the one month and 3-month visit, the conjunctival microbiota was sampled using sterile cotton swabs and contact lenses were collected aseptically. Standard microbiological procedures were employed for culture of the swabs and contact lenses and identification of the isolated microorganisms.Gram-positive bacteria (predominantly coagulase-negative staphylococci) were the most frequently isolated microbes from both contact lenses and conjunctiva. There was no difference in the frequency of isolation of most bacteria or fungi from the conjunctival swabs of eyes wearing either MACL or control lenses. The only exception was a higher frequency of eyes harbouring Staphylococcus arlettae when wearing control lenses (5%) versus MACL (1%) (p = 0.002). There was no significant difference in the frequency of microbes isolated from MACL or control contact lenses. There were also no differences between lens types in the frequency of isolation of1 microbial type per sampling occasion for either conjunctiva swabs or contact lenses.MACL wear did not change the conjunctival microbiota during extended wear, and the types of microbes isolated from MACL were similar to those isolated from control lenses.

The film-forming, friction and wear properties of a range of model and commercial ashless P and P/S antiwear additives have been studied. A method has been developed for removing the tribofilms formed by such additives in order to effectively quantify mild wear. In general the P/S additives studied formed thinner tribofilms but gave lower wear than the S-free P ones. In extended wear tests, three P/S additives gave wear as low, or lower, than a primary zinc dialkyldithiophosphate (ZDDP). For almost all lubricants tested the wear rate measured in short tests was considerably higher than that in long tests due to the greater contribution of running-in wear in the former. This highlights the importance of basing antiwear additive choice on reasonably long tests, where running-in becomes only a small component of the wear measured. It has been found that for both P and P/S ashless additives the addition of oil-soluble metal compounds based on Ti and Ca boosts tribofilm formation and can lead to very thick films, comparable to those formed by ZDDP. However, this thick film formation tends to be accompanied by an increase in mixed friction and also does not appear to reduce wear but may even increase it.

This was a randomized double blinded study of a novel infusion set with and without heparin, hypothesizing that small doses of heparin would decrease thrombosis and subcutaneous inflammation. The MiniMed™ Quick-set™ infusion set was modified with a new tubing connector from current P-Cap. The P-Cap was modified to contain a foam (F) or a foam with heparin (F+H) connector. Visibly the sets appeared identical. Each participant wore two F and two F + H sets for 7 days or until set failure. The order of infusion set wear was randomly assigned. Infusion set failure was determined by unexplained hyperglycemia >250mg/dL with a failed correction dose, ketones >0.6mmol/L, evidence of infection, occlusion alarms, or adhesive failure. Infused set survival was compared to similar published 1-week studies using standard Quick-sets. There were 20 participants (mean age 29.5±8 years). Each set was worn 40 times. Length of wear and causes of failure are shown below. Length of wear was not different between the F and F+H groups, but both had improved length of wear compared to historical Quick-sets (p There was no difference in overall duration of wear between the F and F+H groups. Both infusion set groups intended for extended wear had significantly better survival than the historical Quick-Set™ group. Further studies are planned with the F group. Disclosure B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. Marcal: None. L. Hoffman: None. G. Musolino: None. L. Ekhlaspour: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic. Funding Medtronic Diabetes

Objective: Current real-time continuous glucose monitoring (CGM) sensors are approved for 7-14 days of wear, whereas insulin infusion sets are indicated for 2-3 days of wear. Development of a closed-loop control system with the same duration of wear for its CGM and insulin infusion consumables necessitates an infusion set with greater longevity. This study assessed the safety and performance of a newly designed Extended Wear Infusion Set (EWIS) for up to 7 days. Method: A single-center feasibility study targeted the recruitment of 26 adult subjects (between 22 and 75 years of age) This was a 1-center, prospective, open label one arm study, with each subject being asked to wear 4 trial devices until the infusion set failed or 7-day use was reached. Result: There were twenty-one participants of whom 20 completed the study, resulting in 82 insertions and 78 wear counts. At 7 days of wear, the overall failure rate for the EWIS was 19.5%, which was comparable to that after 3-day use for a 3-day infusion set (∼23%) (MiniMed™ Quick-set), as previously reported. (Patel et al. Diabetes Technol Ther. 2014; 16:15-19). Over time, EWIS use for 7 days did not significantly increase hyperglycemia (mean SG value Day 3: 150 ± 56 mg/dL; Day 6: 160 ± 50 mg/dL; target < 250 mg/dL) or total daily insulin requirements (TDI at Day 1: 41±17 U/Day; Day 3: 40±17 U/Day; Day 7: 43 ±20 U/Day) There were no events of infusion set blockage or diabetic ketoacidosis during the study. Conclusion: The performance of the EWIS across 7 days of use was equivalent to the performance reported for a 3-day infusion set during 3 days of use. Safety outcomes during EWIS use were acceptable for the intended subcutaneous insulin infusion by an external pump for 7 days. Disclosure J. Ilany: Research Support; Self; Medtronic. O. Cohen: Employee; Self; Medtronic. N. Konvalina: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic. Funding Medtronic

Objective: The durability of wearable devices, e.g., insulin infusion sets (IIS), is challenged by external factors such as friction, movement, stretch, moisture, and skin viscoelasticity. Such factors are difficult to investigate in non-clinical settings. We assessed 3 new adhesive patches and compared them to those used with current Medtronic infusion sets to determine which would be suitable for an extended wear infusion set with intended wear time of up to 7 days. Method: Seventy-five adults were recruited in 3 studies to wear 2 patch variants each on conventional IIS sites, for up to 8 days. Non-functional Medtronic pumps were used to simulate use conditions. The primary outcome was wear time. Secondary outcomes included edge lift and descriptive user feedback (e.g., appearance, comfort, irritation score, residue upon removal, and removal discomfort). Results: The results (Figure 1) demonstrated that the 7-day survival rate for existing IIS patches varied from ∼70% to ∼90%. These data indicated that the hub form factor played an insignificant role in the adhesive patch wear time. Two of three new adhesive patches had a 7-day survival rate ≥95% without significantly impacting user experience (i.e., wear comfort or skin reactions). Conclusion: In the simulated-use studies, two new adhesive patches met the primary and secondary outcomes for use with an extended wear infusion set. Disclosure G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic. E. Anselmo: Employee; Self; Medtronic. L. Hoffman: None. M. Tran: None. S. Bondy: Employee; Self; Medtronic. Stock/Shareholder; Self; Medtronic.

Background: There is limited evidence supporting a replacement interval of infusion sets for continuous subcutaneous insulin infusion (CSII). The aim of this study was to investigate if steel and s...

What you need to know More than 140 million people worldwide wear contact lenses.1 Contact lens wearers are more prone to ocular surface problems, particularly those who use extended wear contact lenses.23 Patients may present to the general practitioner, pharmacist, or optometrist in approximately 42% of cases.4 Clinicians in acute care need to be able to identify sight threatening conditions such as microbial keratitis, and advise on more common problems such as a retained contact lens or contact lens discomfort. This article outlines the common eye conditions associated with contact lens wear and an approach that non-specialists can use to identify and manage them. Accurate diagnosis and treatment of contact lens related problems in the non-specialist setting is challenging. Firstly, in the case of someone presenting with a red eye, the wide differential diagnosis of the red eye has to be considered in addition to the specific contact lens related complications described in this article.5 Secondly, a slit lamp is required to confirm the diagnosis in most cases. As such, in primary care an assessment may be limited to identifying a likely cause, and making a judgment about the risk of a serious or sight threatening complications and need for urgent eye specialist assessment. Forming this judgment is summarised in figure 1. We recommend that if a clinician is uncertain about the diagnosis, they should seek further advice from an eye specialist. Advise patients to abstain from using contact lenses while awaiting specialist …

Background The aim of this study was to assess the validity of rebound tonometry measurements obtained over eyes wearing extended-wear bandage contact lenses with the highest oxygen transmissibility (Dk/t) value of 175 @ -3.00 D. Methods A total of 151 normal eyes were included in this prospective pretest-posttest study. A rebound tonometer (iCare PRO) was used to collect intraocular pressure readings from “naked” eyes (eyes without contact lenses) and the same eyes wearing extended-wear lotrafilcon A bandage contact lenses (Alcon Air Optix Night & Day Aqua Contact Lenses). The mean pre- and post-application values were pooled and compared using the paired t-test. Results The application of extended-wear lotrafilcon A contact lenses over normal eyes did not cause a statistically significant change in the intraocular pressure measurements obtained using an iCare PRO tonometer (13.74 ± 2.15 mm Hg vs. 13.77 ± 2.26 mm Hg, p-value = 0.6506). Conclusion Based on this study conducted on normal eyes, the removal of extended-wear bandage contact lenses is not necessary when taking intraocular pressure measurements using the iCare PRO rebound tonometer.

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

PURPOSE: To understand long-term contact lens prescribing habits of Canadian optometrists.METHODS: One thousand optometrists were surveyed annually from 2000 to 2015. Information was requested on the first ten patients examined after receiving the survey.RESULTS: Over the 16-year survey period, 1987 optometrists provided information on 19,143 patients. Mean age of the patients was 32.7±14.4years. Ratio of females to males was 2:1, the ratio of new fits to refits was 2:3. Soft contact lenses represented 94.5% of all fits. Rigid lenses were more often used as a refit compared to a new fit. Over the 16 years, market share for silicone hydrogel materials grew from 0% to 69.6%, mid-water content materials declined from 75.7% to 14.1%. The multifocal market share grew at the expense of spherical designs, with no change in toric lens fitting. Monthly soft lens replacement remained the preferred option at 48.2%, followed by daily disposable at 40.8%; two-weekly replacement declined to less than10% of patients by 2015. Extended wear was likely used to refit and only to a small proportion of wearers, representing 2.6% of SCL by 2015. The lens care system of choice throughout the period was multipurpose solutions, although the proportion for peroxide systems more than doubled by 2015 from 9.6%, to 21.1%.CONCLUSIONS: Over the 16-year period, SCL material preference changed to silicone hydrogels with monthly replacement being preferred; daily disposables replacing 2-weekly as the alternate. Lens care preference continued to be multipurpose solutions. Rigid lenses appear to be sustained for specialist fitting.

Intracorneal haemorrhage is a rare complication of modern contact lens wear. While a limited number of reports have described intracorneal haemorrhages (typically stromal) associated with the extended wear of soft contact lenses with limited oxygen permeability for the correction of aphakia, this case report documents the management and resolution of a significant intraepithelial corneal haemorrhage associated with long-term rigid contact lens wear for keratoconus and high myopia.

Purpose The relative risks of ocular pathology with increasing myopia have been described; the absolute lifetime risk of vision impairment from myopia is yet to be compared to the childhood and lifetime risks of contact lens wear for myopia control. Methods Using peer-reviewed data, the absolute risks of microbial keratitis (MK) in daily disposable soft, reusable soft and orthokeratology contact lens (CL) wear were calculated over both a childhood (age 8–18) and a lifetime (age 8–65) of CL wear. This was compared to the previously published cumulative risk of vision impairment by age 75 based on increasing myopia and axial length. Data were converted utilizing the Council of International Organizations of Medical Sciences (CIOMS) classification system for frequency of adverse events, with 95 % confidence intervals included. Results The lifetime risk of vision impairment in axial lengths over 26 mm and more than 6D of myopia is greater than the lifetime risk of MK in any CL modality, except for adult SCL extended wear. If axial length is below 26 mm and myopia lower than 3D, a lifetime of CL wear is more risky in comparison, except in the case of daily disposable wear. Ten years of childhood CL wear of any modality presents lower likelihood of MK than any comparable risk of vision impairment. Conclusion The comparative lifetime risks of contact lens wear commenced at age 8 for myopia control are less than the lifetime risks of vision impairment with myopia more than 6D or axial length more than 26 mm. When only childhood CL wear is considered, the risk comparison is clearly skewed towards the positive impact of CL wear, especially in daily disposable wear. Clinicians should be confident to proactively recommend myopia control CL wear to younger children, as both the safety profile and potential preventative ocular health benefits are evident.