Race, ethnicity, and considerations for data collection and analysis in research studies.

Research studies involving human subjects require collection of and reporting on demographic data related to race and ethnicity. However, existing practices lack standardized guidelines, leading to misrepresentation and biased inferences and conclusions for underrepresented populations in research studies. For instance, sometimes there is a misconception that self-reported racial or ethnic identity may be treated as a biological variable with underlying genetic implications, overlooking its role as a social construct reflecting lived experiences of specific populations.

Examining the impact of the QUARTET USA trial using the translational science benefits model.

Evaluation of benefits beyond quantitative academic outputs is essential in determining translational research value. We used the Translational Science Benefits Model (TSBM) to examine the impact of the QUARTET USA trial using 30 benefits across 4 domains: Clinical, Community, Economic, and Policy. We found that the QUARTET USA trial demonstrated impact in six areas within the Clinical, and Community domains and had potential impact in two additional areas within the Community and Economic domains.

Correction: Temporal changes in the systemic concentrations of retinoids in pregnant and postpartum women.

[This corrects the article DOI: 10.1371/journal.pone.

Proteomic Characterization of Corneal Epithelial and Stromal Cell-Derived Extracellular Vesicles.

Communication between the different layers of the cornea (epithelium and stroma) is a complex, yet crucial element in the corneal healing process. Upon corneal injury, it has been reported that the bi-directional cross talk between the epithelium and stroma via the vesicular secretome, namely, extracellular vesicles (EVs), can lead to accelerated wound closure upon injury. However, the distinct protein markers of EVs derived from human corneal epithelial (HCE) cells, keratocytes (HCKs), fibroblasts (HCFs), and myofibroblasts (HCMs) remain poorly understood.

Ocular tear fluid biomarkers collected by contact lenses.

Purpose: To collect tear fluid biomarkers from contact lenses (CLs) and determine the impact of CL wear duration.

Methods: Rabbits were fitted with commercial etafilcon A CLs, which were collected after 1 min, 4 and 8 h (n = 4/time point). Tear fluid proteins and cytokines were extracted from the CLs and quantified.

Corneal epithelial-stromal constructs to study differences associated with diabetes mellitus.

Diabetes mellitus (DM) is a common metabolic disease associated with severe macrovascular and microvascular complications that influence nearly every tissue in the body, including the anterior and posterior segments of the eye. In the cornea, DM is associated with recurrent epithelial erosion and reduced wound-healing capacity, which increases the risk of corneal scarring. We previously developed a co-culture model of the cornea consisting of immortalized human corneal epithelial cells (hCE-TJ) overlaying a self-assembled stromal layer generated by human corneal fibroblasts (hCFs) over a 4-week period.

A novel artificial intelligence model for diagnosing Acanthamoeba keratitis through confocal microscopy.

Purpose: To develop an artificial intelligence (AI) model to diagnose Acanthamoeba keratitis (AK) based on in vivo confocal microscopy (IVCM) images extracted from the Heidelberg Retinal Tomograph 3 (HRT 3).

Methods: This retrospective cohort study utilized HRT 3 IVCM images from patients who had received a culture-confirmed diagnosis of AK between 2013 and 2021 at Massachusetts Eye and Ear. Two cornea specialists independently labeled the images as AK or nonspecific finding (NSF) in a blind manner.

Development and Characterization of a Photocrosslinkable, Chitosan-Based, Nerve Growth Factor-Eluting Hydrogel for the Ocular Surface.

Purpose: Recombinant human nerve growth factor (rhNGF; cenegermin-bkbj, OXERVATE) is the first and only U.S. Food and Drug Administration-approved treatment for moderate to severe neurotrophic keratopathy.

Contact lenses as novel tear fluid sampling vehicles for total RNA isolation, precipitation, and amplification.

The tear fluid is a readily accessible, potential source for biomarkers of disease and could be used to monitor the ocular response to contact lens (CL) wear or ophthalmic pathologies treated by therapeutic CLs. However, the tear fluid remains largely unexplored as a biomarker source for RNA-based molecular analyses. Using a rabbit model, this study sought to determine whether RNA could be collected from commercial CLs and whether the duration of CL wear would impact RNA recovery.

Relaxing descemetotomy: microscope-integrated OCT-guided technique for acute corneal hydrops.

Introduction: 3 cases are used to illustrate the technique of Descemet membrane (DM) relaxing incisions followed by air descemetopexy for the management of patients with acute corneal hydrops.

Patients And Clinical Findings: In each case, anterior-segment optical coherence tomography (OCT) demonstrated taut DM detachments and hydrops was refractory to conservative medical management and intracameral air injection.

Diagnosis Intervention And Outcomes: To facilitate the reapproximation of DM and potentiate corneal deturgescence, intraoperative OCT-guided descemetotomy was performed with bent surgical scissors and a bent 30-gauge needle.

Suppression of Neovascularization by Topical and Subconjunctival Bevacizumab After High-Risk Corneal Transplantation.

Purpose: To assess the effectiveness of topical and subconjunctival bevacizumab in suppressing vascularization in graft and host bed after high-risk corneal transplantation.

Design: Secondary analysis of prospective, randomized, double-blind, placebo-controlled multicentric clinical trial.

Participants: The study includes patients aged > 18 years who underwent high-risk penetrating keratoplasty, which was defined as corneal vascularization in ≥ 1 quadrants of the corneal graft and host bed, excluding the limbus.

Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA).

Background: This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management.

Methods And Results: A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews.

Bilastine 0.6% Preservative-Free Eye Drops as an Effective Once-Daily Treatment for the Signs and Symptoms of Allergic Conjunctivitis: A Pooled Analysis of 2 Randomized Clinical Trials.

Background And Objectives: Allergic conjunctivitis is the most common type of ocular allergy. The objective of this study was to evaluate the efficacy of a new once-daily, preservative-free, bilastine 0.6% eye drop formulation for the treatment of allergic conjunctivitis.

Rationale and design for Healthy Hearts for Michigan (HH4M): A pragmatic single-arm hybrid effectiveness-implementation study.

Background: The burden of cardiovascular disease (CVD) is particularly high in several US states, which include the state of Michigan. Hypertension and smoking are two major risk factors for mortality due to CVD. Rural Michigan is disproportionally affected by CVD and by primary care shortages.

Guidance on interim analysis methods in clinical trials.

Interim analyses in clinical trials can take on a multitude of forms. They are often used to guide Data and Safety Monitoring Board (DSMB) recommendations to study teams regarding recruitment targets for large, later-phase clinical trials. As collaborative biostatisticians working and teaching in multiple fields of research and across a broad array of trial phases, we note the large heterogeneity and confusion surrounding interim analyses in clinical trials.

Recurrent keratoconus: an analysis of breaks in Bowman's layer in corneal grafts.

Objective: To study in a masked fashion whether an objective histological feature associated with keratoconus (KCN) occurs in donor corneas in eyes originally receiving a corneal graft for KCN.

Methods: Two ocular pathologists performed a retrospective masked histological analysis of slides from donor buttons recovered from 21 eyes with a history of KCN undergoing repeat penetrating keratoplasty (failed-PK-KCN), 11 eyes that underwent their first PK due to KCN (primary KCN), and 11 eyes without history of KCN which underwent PK for other conditions (failed-PK-non-KCN). Breaks/gaps in Bowman's layer served as the pathological feature indicative of recurrent KCN.

Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial.

Importance: Dry eye disease (DED) is a common public health problem with significant impact on vision-related quality of life and well-being of patients. Medications with rapid onset of action and a good tolerability profile remain an unmet need.

Objective: To assess efficacy, safety, and tolerability of a water-free cyclosporine ophthalmic solution, 0.

Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis.

Background And Objective: Bilastine is a second-generation antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The present trial evaluated the efficacy and safety of a new bilastine 0.6% preservative-free eye drop formulation for the symptomatic treatment of allergic conjunctivitis.