Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial.

Background: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.

Methods: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries.

Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial.

Background: Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg.

Methods: PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups.

Correlational analysis between salivary and blood glucose levels in individuals with and without diabetes mellitus: a cross-sectional study.

Objective: To estimate the association of patient-related demographic, socioeconomic status, physical activity, stress, and dietary factors influencing the relationship between salivary and blood glucose levels in individuals with and without diabetes mellitus (DM).

Method: This cross-sectional study was conducted on 166 participants with and without DM. Saliva and blood were collected to estimate the glucose levels.

Simulation of long-term impact of intravitreal anti-VEGF therapy on patients with severe non-proliferative diabetic retinopathy.

Objective: A simulation model was constructed to assess long-term outcomes of proactively treating severe non-proliferative diabetic retinopathy (NPDR) with anti-vascular endothelial growth factor (anti-VEGF) therapy versus delaying treatment until PDR develops.

Methods And Analysis: Simulated patients were generated using a retrospective real-world cohort of treatment-naive patients identified in an electronic medical records database (IBM Explorys) between 2011 and 2017. Impact of anti-VEGF treatment was derived from clinical trial data for intravitreal aflibercept (PANORAMA) and ranibizumab (RISE/RIDE), averaged by weighted US market share.

Development and Preliminary Validation of an Instrument to Measure Symptoms and Impacts in Patients with Proliferative Diabetic Retinopathy.

Introduction: Following a review of patient-reported outcome (PRO) instruments in the literature, existing PRO instruments may not adequately capture the experience of receiving treatment for proliferative diabetic retinopathy (PDR). Therefore, this study aimed to develop a de novo instrument to comprehensively assess the patient experience of PDR.

Methods: This qualitative, mixed-methods study comprised item generation for the Diabetic Retinopathy-Patient Experience Questionnaire (DR-PEQ), content validation in patients with PDR, and preliminary Rasch measurement theory (RMT) analyses.

The Patient Experience with Diabetic Retinopathy: Qualitative Analysis of Patients with Proliferative Diabetic Retinopathy.

Introduction: Few qualitative studies have explored the patient experience of daily life with proliferative diabetic retinopathy (PDR) and associated treatments. Herein, a conceptual model was developed to comprehensively examine symptoms, functional impacts, and treatment experiences in PDR.

Methods: A qualitative, mixed-methods study comprising a literature search and semi-structured interviews with clinicians and patients was conducted.

Venous Thromboembolism in Pregnancy and IVC Filter: A Case Report.

Introduction: Venous thromboembolism (VTE), composed of pulmonary embolism and deep venous thrombosis, can be a significant cause of morbidity and mortality during pregnancy. Underlying factors like thrombophillias can potentiate this risk many folds. Depending on these risks and peripartum stage, the benefits of thromboprophylaxis can outweigh potential side effects.

Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) for women with cardiovascular disease in a middle-income setting: A randomized controlled trial protocol.

Women are underrepresented in cardiac rehabilitation (CR) despite the benefits, and this is exacerbated in lower-resource settings where CR is insufficiently available. In this randomized controlled trial, the effectiveness of the Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) electronic cardiac rehabilitation (eCR) intervention on functional capacity, risk factors, quality of life, heart-health behaviors, symptoms, and morbidity will be tested among women with CVD in a middle-income country. Following a pilot study, a single-center, single-blinded, 2 parallel-arm (1:1 SNOSE) superiority trial comparing an eCR intervention (TaCT) to usual care, with assessments pre-intervention and at 3 and 6 months will be undertaken.

Comparison of surgical techniques for recurrent pterygium.

Objective: Although conjunctival autograft (CAU) and amniotic membrane grafting (AMG) with mitomycin-C (MMC) are most effective for the treatment of primary pterygium, the optimal surgical treatment of recurrent pterygium is not well established. We thus aimed to examine recurrence rates after recurrent pterygium excision surgery performed with CAU or AMG with or without MMC.

Methods: We performed a retrospective review of adult patients who underwent recurrent pterygium excision surgery at Boston Medical Center between January 1999 and July 2019.

Clinical and radiographic features of hydrolyzed MIRAgel scleral buckles: A comparative analysis.

The MIRAgel (hydrogel) scleral buckle, introduced in the 1980s, was a novel material to repair retinal detachments. It was later discontinued due to the frequency of long-term complications related to buckle hydrolysis and expansion. These complications included pain, limited extraocular motility, and more serious complications such as infection or scleral perforation, which ultimately necessitated surgical extraction as late as 20-30 years after placement.

Safety and efficacy of mifepristone versus dinoprostone gel in induction of labor: A randomized controlled trial.

Aim: The aim of this study was to evaluate the efficacy and safety of mifepristone for cervical ripening and induction of labor and compare the results with dinoprostone gel which is an established agent for labor induction.

Methods: A total of 100 patients were enrolled in a prospective study and assigned to one of two treatment protocols. After the exclusion of 10 patients, there were 46 patients in the mifepristone group and 44 in the dinoprostone group.

Prosthetic Replacement of the Ocular Surface Ecosystem Treatment for Ocular Surface Disease in Pediatric Patients With Stevens-Johnson Syndrome.

Purpose: To report the outcomes of prosthetic replacement of the ocular surface ecosystem (PROSE) treatment in pediatric patients with chronic ocular surface disease associated with Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).

Design: Retrospective, interventional case series.

Methods: Patients aged 18 years or younger seen in consultation for PROSE treatment at a single center between January 1992 and December 2016 with a history of SJS/TEN were reviewed.

Descemet Membrane Endothelial Keratoplasty After Failed Descemet Stripping Without Endothelial Keratoplasty.

Purpose: To describe the clinical course, surgical experience, and postoperative outcomes of 3 patients with Fuchs endothelial dystrophy who underwent Descemet membrane endothelial keratoplasty (DMEK) after failed Descemet stripping without endothelial keratoplasty.

Methods: Three patients who underwent DMEK for management of persistent corneal edema after deliberate Descemet stripping in the setting of Fuchs endothelial dystrophy were identified. Patients were examined at day 1, week 1, and months 1, 3, and 6 after DMEK.

Current trends in the management of thyroid eye disease.

Purpose Of Review: The present review summarizes the body of literature concerning the medical and surgical treatment of thyroid eye disease (TED) from 1 January 2014 through 30 March 2015.

Recent Findings: Corticosteroids continue to be the primary medical therapy for TED. Recent research has offered insight into potential differences between oral corticosteroid and intravenous corticosteroid treatment regimens in terms of efficacy and side-effect profiles.

Open repair versus fenestrated endovascular aneurysm repair of juxtarenal aneurysms.

Background: Open repair is the gold standard management for juxtarenal aneurysms. Fenestrated endovascular aneurysm repair (FEVAR) is indicated for high-risk patients. The long-term outcomes of FEVAR are largely unknown, and there is no Level I comparative evidence.

Participation in clinical research: perspectives of adult patients and parents of pediatric patients undergoing hematopoietic stem cell transplantation.

Despite major improvements over the past several decades, many patients undergoing hematopoietic stem cell transplantations (HSCT) continue to suffer from significant treatment-related morbidity and mortality. Clinical research studies (trials) have been integral to advancing the standard of care in HSCT. However, 1 of the biggest challenges with clinical trials is the low participation rate.

Magnetic systems for tarsorrhaphy.

Purpose: Paralytic lagophthalmos can cause exposure keratopathy. Current treatments have difficulties: extrusion, migration, allergic reaction, anatomical disruption, and technically difficult surgeries. The goal of this study was to design, create, and assess a new method for eyelid closure using magnets.

Optic Nerve Head and Retinal Nerve Fiber Layer Differences Between Caribbean Black and African American Patients as Measured by Spectral Domain OCT.

Purpose: There are well-established differences in optic nerve morphology between patients of African and European descent. Spectral domain optical coherence tomography (OCT) scanning has demonstrated these differences with respect to optic disc area (DA), average cup-disc ratio, cup volume, and nerve fiber layer thickness. However, the term "African descent" describes a heterogenous group with considerable variability.

Plus disease in retinopathy of prematurity: diagnostic impact of field of view.

Purpose: To examine the impact of retinal field of view and magnification on interexpert reliability of plus disease diagnosis in retinopathy of prematurity.

Methods: Fifteen wide-angle images from infants with retinopathy of prematurity were cropped and adjusted in magnification to create 2 additional image categories: medium angle (40°-50°) and narrow angle (20°-30°). These 45 images were uploaded to a Web-based system and interpreted independently by 13 experts of retinopathy of prematurity using a 3-level (plus, preplus, neither) and 2-level (plus, not plus) classification.

Pulmonary endothelial permeability is increased by fluid from packed red blood cell units but not by fluid from clinically-available washed units.

Background: Massive transfusions are a risk factor for acute respiratory distress syndrome (ARDS) in severely injured patients. Neutrophil priming has been proposed to be an integral part of the early inflammatory response to trauma. To complement that work, we studied another major cell type involved in inflammation: the endothelial cell.

Breast cancer pseudometastasis in a sentinel lymph node with cytokeratin-positive debris.

We report extensive pseudometastasis detected by immunohistochemical (IHC) staining within a sentinel lymph node. An 83-year-old woman underwent simple mastectomy and sentinel lymph node biopsy (SLNB) for infiltrating ductal carcinoma. Intraoperative frozen section of the SLNB specimen appeared histologically negative for metastasis.