Patient Perceptions of Illness Causes and Treatment Preferences for Obsessive-Compulsive Disorder: A Mixed-Methods Study.

Obsessive-compulsive disorder (OCD) is a condition with high patient morbidity and mortality. Research shows that eliciting patient explanations about illness causes and treatment preferences promotes cross-cultural work and engagement in health services. These topics are in the Cultural Formulation Interview (CFI), a semi-structured interview first published in DSM-5 that applies anthropological approaches within mental health services to promote person-centered care. This study focuses on the New York City site of an international multi-site study that used qualitative-quantitative mixed methods to: (1) analyze CFI transcripts with 55 adults with OCD to explore perceived illness causes and treatment preferences, and (2) explore whether past treatment experiences are related to perceptions about causes of current symptoms. The most commonly named causes were circumstantial stressors (n = 16), genetics (n = 12), personal psychological traits (n = 9), an interaction between circumstantial stressors and participants' brains (n = 6), and a non-specific brain problem (n = 6). The most common treatment preferences were psychotherapy (n = 42), anything (n = 4), nothing (n = 4), and medications (n = 2). Those with a prior medication history had twice the odds of reporting a biological cause, though this was not a statistically significant difference. Our findings suggest that providers should ask patients about illness causes and treatment preferences to guide treatment choice.

Minimally invasive hallux valgus surgery using 3D printed patient specific instrumentation.

In this technical report study, we describe technique for performing the osteotomy and screw passage in minimally invasive fourth-generation hallux valgus surgery with transverse and akin extra-articular metaphyseal osteotomy (META) using a 3D-printed patient-specific surgical instrumentation guide. In an effort to minimize the learning curve and address the variability associated with technical corrections and screw placement, we have initiated the creation of personalized patient-specific instrumentation guides using 3D printing. Our hypothesis is that this approach will enhance safety, precision, decrease surgical time, and reduce exposure to radiation. Level of Evidence: Level V, expert opinion.

Technique Tip: Medial prominence bone spur resection in the third-generation percutaneous Chevron-Akin Osteotomy Technique (PECA) for hallux valgus correction.

The third-generation percutaneous chevron and Akin osteotomy (PECA) technique for surgical management of hallux valgus has shown improvement in clinical and radiographic outcomes. During this procedure, lateral translation and fixation of the first metatarsal head results in the formation of a bony prominence on the medial side of the distal aspect of the first metatarsal which can cause pain and discomfort to the patient. We describe two techniques to address this bony prominence; either i) excision osteotomy and removal of the fragment or ii) a dorsal closing wedge osteotomy retaining the bony fragment. LEVEL OF EVIDENCE: Level V, expert opinion.

The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts.

BACKGROUND: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data. METHODS: Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. "East" and "West" cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm. RESULTS: The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95% CI 0.11-0.16). Propensity score-adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95% CI 0.13-0.18). CONCLUSIONS: In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.

Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale.

OBJECTIVE: To assess consensual validity, interrater reliability, and criterion validity of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale, a new functional outcome scale intended to capture the severity of oropharyngeal dysphagia, as represented by the degree of diet texture restriction recommended for the patient. DESIGN: Participants assigned International Dysphagia Diet Standardisation Initiative Functional Diet Scale scores to 16 clinical cases. Consensual validity was measured against reference scores determined by an author reference panel. Interrater reliability was measured overall and across quartile subsets of the dataset. Criterion validity was evaluated versus Functional Oral Intake Scale (FOIS) scores assigned by survey respondents to the same case scenarios. Feedback was requested regarding ease and likelihood of use. SETTING: Web-based survey. PARTICIPANTS: Respondents (N=170) from 29 countries. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Consensual validity (percent agreement and Kendall τ), criterion validity (Spearman rank correlation), and interrater reliability (Kendall concordance and intraclass coefficients). RESULTS: The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed strong consensual validity, criterion validity, and interrater reliability. Scenarios involving liquid-only diets, transition from nonoral feeding, or trial diet advances in therapy showed the poorest consensus, indicating a need for clear instructions on how to score these situations. The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed greater sensitivity than the FOIS to specific changes in diet. Most (>70%) respondents indicated enthusiasm for implementing the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. CONCLUSIONS: This initial validation study suggests that the International Dysphagia Diet Standardisation Initiative Functional Diet Scale has strong consensual and criterion validity and can be used reliably by clinicians to capture diet texture restriction and progression in people with dysphagia.

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

BackgroundThere is a need for clinical tools to identify cultural issues in diagnostic assessment.AimsTo assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice.MethodMixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored.ResultsMixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time.ConclusionsThe CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool.

Development of International Terminology and Definitions for Texture-Modified Foods and Thickened Fluids Used in Dysphagia Management: The IDDSI Framework.

Dysphagia is estimated to affect ~8% of the world's population (~590 million people). Texture-modified foods and thickened drinks are commonly used to reduce the risks of choking and aspiration. The International Dysphagia Diet Standardisation Initiative (IDDSI) was founded with the goal of developing globally standardized terminology and definitions for texture-modified foods and liquids applicable to individuals with dysphagia of all ages, in all care settings, and all cultures. A multi-professional volunteer committee developed a dysphagia diet framework through systematic review and stakeholder consultation. First, a survey of existing national terminologies and current practice was conducted, receiving 2050 responses from 33 countries. Respondents included individuals with dysphagia; their caregivers; organizations supporting individuals with dysphagia; healthcare professionals; food service providers; researchers; and industry. The results revealed common use of 3-4 levels of food texture (54 different names) and ≥3 levels of liquid thickness (27 different names). Substantial support was expressed for international standardization. Next, a systematic review regarding the impact of food texture and liquid consistency on swallowing was completed. A meeting was then convened to review data from previous phases, and develop a draft framework. A further international stakeholder survey sought feedback to guide framework refinement; 3190 responses were received from 57 countries. The IDDSI Framework (released in November, 2015) involves a continuum of 8 levels (0-7) identified by numbers, text labels, color codes, definitions, and measurement methods. The IDDSI Framework is recommended for implementation throughout the world.

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

BACKGROUND: The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation. OBJECTIVE: The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up. METHODS: Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. CONCLUSION: Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs.

An Open-Label Pilot Study of Duloxetine in Patients With Irritable Bowel Syndrome and Comorbid Major Depressive Disorder.

Major depressive disorder (MDD) and irritable bowel syndrome (IBS) frequently co-occur, yet treating their comorbid presentation is challenging. Low-dose tricyclic antidepressants are efficacious for IBS, but higher doses to treat depressive symptoms present tolerability problems, whereas selective serotonin reuptake inhibitors are more tolerable but show inconsistent efficacy for IBS. If efficacious, serotonin-norepinephrine reuptake inhibitors like duloxetine would provide a useful alternative. We explored efficacy, tolerability, and time to onset of action of duloxetine in comorbid IBS-MDD in an open-label, 12-week trial. Repeated-measures mixed-effects regression analysis with the intent-to-treat sample assessed rate of change of the clinician-administered Gastrointestinal Symptoms Rating Scale, Montgomery-Åsberg Depression Rating Scale, and other clinician-administered and self-report scales. Seventeen Hispanic adults with current MDD and comorbid IBS meeting Rome III criteria entered the study. Medical and laboratory assessment ruled out alarm symptoms and signs inconsistent with IBS. Duloxetine led to significant improvement in Gastrointestinal Symptoms Rating Scale and Montgomery-Åsberg Depression Rating Scale scores and 71.4% and 64.3% intent-to-treat response rates for IBS and MDD, respectively. Abdominal pain severity decreased by 56%. Contrary to expectation of rapid analgesic effects, based on duloxetine studies for neuropathic pain, both IBS and MDD symptoms improved gradually; differences in slopes of improvement were nonsignificant. Duloxetine was moderately well tolerated at a mean endpoint dose of 60 mg/d. Study limitations include the lack of placebo control, modest sample size, single ethnic group, and high attrition rate. Duloxetine efficacy for comorbid IBS-MDD should be studied under placebo-controlled conditions with larger and more diverse samples.

How Do Clinicians Prefer Cultural Competence Training? Findings from the DSM-5 Cultural Formulation Interview Field Trial.

OBJECTIVE: This study's objective is to analyze training methods clinicians reported as most and least helpful during the DSM-5 Cultural Formulation Interview field trial, reasons why, and associations between demographic characteristics and method preferences. METHOD: The authors used mixed methods to analyze interviews from 75 clinicians in five continents on their training preferences after a standardized training session and clinicians' first administration of the Cultural Formulation Interview. Content analysis identified most and least helpful educational methods by reason. Bivariate and logistic regression analysis compared clinician characteristics to method preferences. RESULTS: Most frequently, clinicians named case-based behavioral simulations as "most helpful" and video as "least helpful" training methods. Bivariate and logistic regression models, first unadjusted and then clustered by country, found that each additional year of a clinician's age was associated with a preference for behavioral simulations: OR = 1.05 (95 % CI: 1.01-1.10; p = 0.025). CONCLUSIONS: Most clinicians preferred active behavioral simulations in cultural competence training, and this effect was most pronounced among older clinicians. Effective training may be best accomplished through a combination of reviewing written guidelines, video demonstration, and behavioral simulations. Future work can examine the impact of clinician training satisfaction on patient symptoms and quality of life.

Progressive MS: from pathophysiology to drug discovery.

Progressive multiple sclerosis (MS) will be a major area of research interest for years to come. No treatments exist and success in the field will generalise to other neurological conditions where neurodegeneration coexists with neuroinflammation. The issue is complex, and interdisciplinary approaches - uniting scientists with different competences (neurobiology, immunogenetics, etc.) and 'mindsets' (academia and industry) - will be decisive. The International Progressive MS Alliance is catalysing this process through various initiatives, the most recent of which was a meeting where scientists from academia (also outside the MS field) and from industry reviewed data and strategies to determine the next steps towards the translation of current knowledge into effective therapies.Key findings are:(i). Concerted efforts are essential to prioritise pathogenetic mechanisms according to impact on the disease and druggability.(ii). Combination therapies will probably be needed, possibly early in the disease, along with new trial designs and treatment schedules.(iii). Drug screenings are a pragmatic approach hopefully enriched by the use of neural and oligodendrocyte progenitors differentiated from induced pluripotent stem cells (iPSCs).(iv). The field of network biology will increase our ability to predict therapeutic targets.(v). Genome-wide association studies (GWAS) must try to identify variants associated with disease progression.

Perspectives of family members participating in cultural assessment of psychiatric disorders: findings from the DSM-5 International Field Trial.

Despite the important roles families play in the lives of many individuals with mental illness across cultures, there is a dearth of data worldwide on how family members perceive the process of cultural assessment as well as to how to best include them. This study addresses this gap in our knowledge through analysis of data collected across six countries as part of a DSM-5 Field Trial of the Cultural Formulation Interview (CFI). At clinician discretion, individuals who accompanied patients to the clinic visit (i.e. patient companions) at the time the CFI was conducted were invited to participate in the cultural assessment and answer questions about their experience. The specific aims of this paper are (1) to describe patterns of participation of patient companions in the CFI across the six countries, and (2) to examine the comparative feasibility, acceptability, and clinical utility of the CFI from companion perspectives through analysis of both quantitative and qualitative data. Among the 321 patient interviews, only 86 (at four of 12 sites) included companions, all of whom were family members or other relatives. The utility, feasibility and acceptability of the CFI were rated favourably by relatives, supported by qualitative analyses of debriefing interviews. Cross-site differences in frequency of accompaniment merit further study.

The influence of food texture and liquid consistency modification on swallowing physiology and function: a systematic review.

Texture modification has become one of the most common forms of intervention for dysphagia, and is widely considered important for promoting safe and efficient swallowing. However, to date, there is no single convention with respect to the terminology used to describe levels of liquid thickening or food texture modification for clinical use. As a first step toward building a common taxonomy, a systematic review was undertaken to identify empirical evidence describing the impact of liquid consistency and food texture on swallowing behavior. A multi-engine search yielded 10,147 non-duplicate articles, which were screened for relevance. A team of ten international researchers collaborated to conduct full-text reviews for 488 of these articles, which met the study inclusion criteria. Of these, 36 articles were found to contain specific information comparing oral processing or swallowing behaviors for at least two liquid consistencies or food textures. Qualitative synthesis revealed two key trends with respect to the impact of thickening liquids on swallowing: thicker liquids reduce the risk of penetration-aspiration, but also increase the risk of post-swallow residue in the pharynx. The literature was insufficient to support the delineation of specific viscosity boundaries or other quantifiable material properties related to these clinical outcomes. With respect to food texture, the literature pointed to properties of hardness, cohesiveness, and slipperiness as being relevant both for physiological behaviors and bolus flow patterns. The literature suggests a need to classify food and fluid behavior in the context of the physiological processes involved in oral transport and flow initiation.

Erratum to: The Influence of Food Texture and Liquid Consistency Modification on Swallowing Physiology and Function: A Systematic Review.

Erratum to: Dysphagia DOI 10.1007/s00455-014-9578-x. In the original version of this article, Fig. 1 was published incorrectly. The corrected figure is given below.

Impact of Sesamoid Coverage on Clinical Foot Function Following Fourth-Generation Percutaneous Hallux Valgus Surgery.

Background: The impact of pronation and sesamoid coverage on clinical outcomes following percutaneous hallux valgus surgery are not currently known. The aim of this study was to investigate if sesamoid coverage was associated with worse clinical outcomes at 12-month follow-up following percutaneous hallux valgus surgery. Methods: Retrospective comparative observational study of clinical and radiographic outcomes based on a previously published prospective dataset. Patients were stratified into 3 cohorts based on the degree of sesamoid coverage (normal, mild, or moderate) on 12-month weightbearing radiographs following fourth-generation percutaneous hallux valgus surgery. Primary outcome was a validated patient-reported outcome measure (PROM), the Manchester-Oxford Foot Questionnaire (MOXFQ). Secondary outcomes included Euroqol-5D, VAS Pain, and radiographic deformity correction. Results: Forty-seven feet underwent primary fourth-generation HV surgery and were stratified into 3 cohorts. There were 19, 16, and 12 feet in the normal, mild, and moderate cohorts respectively. There was no significant difference in either pre- or postoperative foot function (all MOXFQ domains, P > .05) or health-related quality of life (EQ-5D Index or VAS, P > .05). The MOXFQ Index preoperatively was as follows: normal cohort, 56.1 ± 26.9; mild cohort, 54.1 ± 17.9; and severe cohort, 49.6 ± 23.8; and postoperatively was as follows: normal cohort, 15.6 ± 21.5; mild cohort, 11.4 ± 15.5; and severe cohort, 11.4 ± 13.6 (P = .737-.908). There was significantly worse hallux valgus angle (HVA) and intermetatarsal angle (IMA) between the cohorts (P < .01). Although HVA and IMA were corrected to normal parameters following surgery in all cohorts, there was a significantly worse postoperative HVA in the moderate sesamoid coverage (5.3 ± 3.9 vs 7.9 ± 5.3 vs 11.4 ± 3.7, P < .01); however, IMA was not significantly different (3.4 ± 2.2 vs 4.1 ± 2.7 vs 5.2 ± 2.9, P = .168). Conclusion: This study found that cases where the sesamoids were not reduced had a poorer correction and had worse preoperative deformity. Clinical outcomes and foot function following fourth-generation percutaneous hallux valgus surgery were not affected by sesamoid coverage at the 12-month follow-up. The long-term implications in the difference in radiographic deformity between the 3 cohorts are not known, and further work should explore the relationship of first ray pronation and sesamoid position, particularly with regard to recurrence. Level of evidence: Level III, retrospective comparative study of prospectively collected data.

Validation of the IDDSI funnel for liquid flow testing.

In 2017, the International Dysphagia Diet Standardisation Initiative (IDDSI) introduced the IDDSI flow test which enables patients, clinicians, caregivers, food service professionals and researchers to classify liquid thickness into five levels based on the volume of liquid remaining in a standard 10 mL slip tip syringe after 10 s of flow under gravity. Within a few months of publishing the IDDSI flow test instructions, several barriers emerged: (1) the preferred model of syringe (BD 303134) was not equally accessible around the world, causing some users to perform flow tests with alternate models of syringe; (2) differences in syringe geometry across models led to variations in IDDSI flow test results; and (3) the need to use a second syringe for sample loading added complexity and cost to end users. To address these barriers, IDDSI designed the IDDSI funnel, a novel device, which combines the geometry of the BD 303134 syringe with a kitchen funnel to facilitate easy loading of liquid samples without need for a second syringe. In this report, we compare the IDDSI flow test results across two devices: syringe BD 303134 and IDDSI funnel. IDDSI level classifications were in complete agreement with the syringe reference test results in 67/73 (92%) of the test fluids and temperature conditions with mean difference of residual liquid across devices of 0.2 (2% full scale). These results demonstrate excellent correspondence between the two devices.

Statistical considerations for cardiovascular clinical trials straddling the continuum of pandemic phases.

In 2020, the NIH and FDA issued guidance documents that laid the foundation for human subject research during an unprecedented pandemic. To bridge these general considerations to actual applications in cardiovascular interventional device trials, the PAndemic Impact on INTErventional device ReSearch (PAIINTERS) Working Group was formed in early 2021 under the Predictable And Sustainable Implementation Of National CardioVascular Registries (PASSION CV Registries). The PAIINTER's Part I report, published by Rymer et al. [5], provided a comprehensive overview of the operational impact on interventional studies during the first year of the Pandemic. PAIINTERS Part II focused on potential statistical issues related to bias, variability, missing data, and study power when interventional studies may start and end in different pandemic phases. Importantly, the paper also offers practical mitigation strategies to adjust or minimize the impact for both SATs and RCTs, providing a valuable resource for researchers and professionals involved in cardiovascular clinical trials.

Interface Fluid Syndrome Masquerading as Diffuse Lamellar Keratitis After Small Incision Lenticule Extraction.

A 34-year-old male with no past medical or ocular history underwent bilateral uncomplicated small incision lenticule extraction (SMILE). On day 1, uncorrected distance visual acuity (UDVA) was 20/25 in the right eye (OD) and 20/20 in the left eye (OS). The intraocular pressure (IOP) was 12 mmHg in both eyes (OU). On day 17, UDVA was 20/70 OD and 20/30+2 OS. Slit-lamp examination (SLE) revealed diffuse 2+ haze at the interface suspicious for diffuse lamellar keratitis (DLK). Topical difluprednate was added twice a day (BID). Vision decreased by day 20 with a significant myopic shift and 3+ interface haze OU. A washout of the interface was performed. Topical steroids were increased with oral prednisone. One day after the washout, vision and interface haze improved. On day 3 status post washout, UDVA decreased to 20/70 OD and 20/50 OS. IOP was 42 mmHg OU. A diagnosis of interface fluid syndrome (IFS) was confirmed. All steroids were stopped while adding ocular hypotensive medication. One month later, visual acuity was 20/20 OU with a complete resolution of interface haze. Only a handful of IFS has been documented in SMILE, an incidence that may increase as SMILE becomes more common. Among all SMILE cases, IFS was most commonly associated with steroid-induced ocular hypertension and a myopic shift around 21 days postoperatively. A fluid cleft at the interface may not always be visible with SLE, masquerading as DLK. Scheimpflug densitometry and anterior segment optical coherence tomography (AS-OCT) may aid in quantifying interface edema needed to confirm a diagnosis when IOP is unclear. A corneal washout can immediately improve corneal edema, but the preferred treatment is discontinuing all steroid medication and starting glaucoma drops.

Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®.

Aim: To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet®. Patients & methods: In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (∼8 µl) or two sprays (∼16 µl) of TR-PH FC to both eyes in randomly assigned order. Results: At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: NCT04907474 (ClinicalTrials.gov).

Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet^®. The Optejet^® is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (∼8 µl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). Rapid dilation was observed at 15 min, and the proportions of eyes that achieved a pupil diameter of ≥6.0 mm were 74% and 83% of patients at 15 min with one spray and two sprays, respectively. The mydriatic agent was well tolerated with the delivery system even in the absence of topical anesthetic, with no ocular or system adverse events reported. Mydriasis is a vital component of routine eye healthcare, and the current standard-of-care mydriatic eye drops potentially have limitations, including contamination, spillage and burning/stinging. Delivery of a mydriatic with the Optejet^® may improve patient care flow in the clinical office setting.