Evaluating an approach for communicating integrated risk scores for melanoma.

Integrated risk scores (polygenic and non-genetic risk factors) can facilitate risk-stratification, to inform targeted melanoma screening. This mixed-methods pilot study assessed satisfaction, attitudes, and psychosocial impact of a protocol for communicating integrated risk for melanoma using questionnaires (baseline and 1-month post-results) and semi-structured interviews. Affected and unaffected adults enroled in ongoing melanoma studies were recruited to receive their integrated risk booklets and attend a genetic counselling appointment.

Nationwide, Couple-Based Genetic Carrier Screening.

Background: Genomic sequencing technology allows for identification of reproductive couples with an increased chance, as compared with that in the general population, of having a child with an autosomal recessive or X-linked genetic condition.

Methods: We investigated the feasibility, acceptability, and outcomes of a nationwide, couple-based genetic carrier screening program in Australia as part of the Mackenzie's Mission project. Health care providers offered screening to persons before pregnancy or early in pregnancy.

Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons.

Purpose: Long-term survival in high-risk neuroblastoma (HRNB) is approximately 50%, with mortality primarily driven by relapse. Eflornithine (DFMO) to reduce risk of relapse after completion of immunotherapy was investigated previously in a single-arm, phase II study (NMTRC003B; ClinicalTrials.gov identifier: NCT02395666) that suggested improved event-free survival (EFS) and overall survival (OS) compared with historical rates in a phase III trial (Children Oncology Group ANBL0032; ClinicalTrials.

Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation.

Introduction: Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes.

Methods: This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract.

Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) for Postoperative Pain After Photorefractive Keratectomy.

Purpose: Evaluation of safety and efficacy of topical ocular SAF312 (Libvatrep) in post-photorefractive keratectomy (PRK) pain.

Methods: In this placebo (vehicle)-controlled, participant- and investigator-masked study, 40 participants were randomized (1:1) to two treatment sequences in a bilateral PRK crossover design (SAF312 2.5% followed by vehicle [or vice versa], one eye drop, four times daily for 72 hours after PRK).

Efficacy of lofexidine for mitigating opioid withdrawal symptoms: results from two randomized, placebo-controlled trials.

Fear of opioid withdrawal syndrome (OWS) often dissuades opioid discontinuation. Lofexidine is an FDA-approved, alpha-adrenergic receptor agonist for treatment of OWS. Pivotal trial results from the per-protocol statistical analyses have been published.

Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial.

Objectives: To investigate the safety and efficacy of lofexidine for treating opioid withdrawal syndrome (OWS) and facilitating completion of opioid withdrawal.

Methods: A multicenter, double-blind, placebo-controlled study was conducted at 18 US centers from June 2013 to December 2014. Participants (n = 603) aged ≥18 years, dependent on short-acting opioids, and seeking withdrawal treatment, randomized 3:3:2 to receive lofexidine 2.

Apomorphine Subcutaneous Injection for the Management of Morning Akinesia in Parkinson's Disease.

Background: In patients with motor fluctuations complicating Parkinson's disease (PD), delays in time-to-ON with levodopa are common. This open-label study aimed to assess the effect of apomorphine on time-to-ON in PD patients with morning akinesia.

Methods: The safety population included 127 enrolled patients, and the full analysis set (FAS) included 88 patients.

Psychometric evaluation of the 10-item Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) in patients undergoing opioid detoxification.

Introduction: The Short Opiate Withdrawal Scale (SOWS)-Gossop is a 10-item questionnaire developed to evaluate opioid withdrawal symptom severity. The scale was derived from the original 32-item Opiate Withdrawal Scale in order to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The objective of this study was to examine the psychometric properties and provide score interpretation guidelines for the SOWS-Gossop 10-item version.

Randomized, placebo-controlled trial of trimethobenzamide to control nausea and vomiting during initiation and continued treatment with subcutaneous apomorphine injection.

Background: Nausea and vomiting can occur in Parkinson's disease (PD) patients initiated on apomorphine subcutaneous injections and antiemetic prophylaxis is recommended per product labeling. Data suggest long-term antiemetic prophylaxis may not be needed, although this has not been systematically studied.

Methods: We evaluated coadministered trimethobenzamide with apomorphine in 182 PD subjects using a randomized, double-blind, placebo-controlled design, with phased withdrawal of subjects from trimethobenzamide to placebo.

Safety of besifloxacin ophthalmic suspension 0.6% in cataract and LASIK surgery patients.

Purpose: The aim of the study was to evaluate the safety of besifloxacin ophthalmic suspension 0.6% as antibacterial prophylaxis in the surgical setting.

Methods: Two prospective safety surveillance studies were conducted-one in the cataract surgery setting and the other in the laser-assisted in situ keratomileusis (LASIK) surgery setting.

A multicenter, open-label, exploratory dose-ranging trial of intranasal hydromorphone for managing acute pain from traumatic injury.

Unlabelled: We conducted a prospective multicenter, open-label, escalating dose-range trial to compare, across patients, single intranasal doses (2, 4, 6, 8, and 10 mg) of hydromorphone HCl in the treatment of acute trauma pain The main outcome measure of pain-intensity reduction was derived from serial Numerical Pain-Rating Scores and calculated as the summed pain-intensity difference over 3 hours (SPID 3). Nasal examinations, vital signs, and adverse events were reported as safety outcomes. The mean decrease in pain intensity from baseline to 30 minutes was 39 to 44% for the 4-, 6-, 8- and 10-mg doses (n = 19, 33, 28, and 19 per group) and only 24% reduction for the 2-mg dose (n = 14).

Changes in posterior corneal elevation after laser in situ keratomileusis enhancement.

Purpose: To evaluate changes in posterior corneal elevation using the Pentacam topographer (Oculus) in patients having laser in situ keratomileusis (LASIK) enhancement.

Setting: Private practice, Chevy Chase, Maryland, USA.

Methods: The Pentacam device was used to evaluate the changes in posterior corneal elevation above the best-fit sphere before LASIK enhancement and after LASIK enhancement in 24 eyes.

A novel mutation of the Keratin 12 gene responsible for a severe phenotype of Meesmann's corneal dystrophy.

Purpose: To determine if a mutation within the coding region of the keratin 12 gene (KRT12) is responsible for a severe form of Meesmann's corneal dystrophy.

Methods: A family with clinically identified Meesmann's corneal dystrophy was recruited and studied. Electron microscopy was performed on scrapings of corneal epithelial cells from the proband.

Infectious and noninfectious keratitis after laser in situ keratomileusis Occurrence, management, and visual outcomes.

Purpose: To retrospectively review the occurrence, treatment, and visual outcomes associated with various etiologies of keratitis as a postoperative complication of laser in situ keratomileusis (LASIK) at an academic surgical center.

Setting: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

Development and validation of a short global dry eye symptom index.

ABSTRACT we have developed and evaluated the repeatability of a short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome (DES). The "Symptom Assessment iN Dry Eye" (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation. Fifty-two subjects with DES were prospectively enrolled and followed-up at 2 and 4 months with repeated administrations of the SANDE questionnaire and clinical ocular surface evaluation.

Pharmacokinetics and pharmacodynamics of a new intranasal midazolam formulation in healthy volunteers.

We evaluated the pharmacokinetics and pharmacodynamics of single 5-mg doses of midazolam after administration of a novel intranasal (IN) formula, IM, and IV midazolam in an open-label, randomized, 3-way cross-over study in 12 healthy volunteers. IN doses were delivered as 0.1-mL unit-dose sprays of a novel formulation into both naris.

Results of late flap removal after complicated laser in situ keratomileusis.

Purpose: To evaluate the effect of flap removal on complications after laser in situ keratomileusis (LASIK).

Setting: Three university-based referral centers and 1 private practice.

Methods: This retrospective interventional case series comprised 6 eyes of 6 patients at 4 centers.

Removal of INTACS for myopia.

Objective: To evaluate the safety and efficacy of the removal of INTACS.

Design: Subgroup analysis from a nonrandomized comparative interventional trial.

Participants: Four hundred fifty-two patients with best spectacle-corrected visual acuity of 20/20 or better and myopia (1.

Sloughing of corneal epithelium and wound healing complications associated with laser in situ keratomileusis in patients with epithelial basement membrane dystrophy.

Purpose: To report sloughing of corneal epithelium during laser in situ keratomileusis and subsequent wound healing complications in patients with epithelial basement membrane dystrophy.

Methods: In a retrospective study, the surgical procedures, postoperative course, and visual acuities of 16 eyes of nine patients with epithelial basement membrane dystrophy who underwent laser in situ keratomileusis complicated with epithelial sloughing at three centers were reviewed. The mean follow-up period was 23 weeks (range, 4 to 52 weeks).

Comparison of visual results in initial and re-treatment laser in situ keratomileusis procedures for myopia and astigmatism.

Purpose: To report the results of initial and re-treatment laser in situ keratomileusis procedures for myopia and astigmatism.

Methods: A total of 1161 consecutive inital and retreatment laser in situ keratomileusis procedures in 697 patients performed between September 19, 1996, and June 20, 1998, were retrospectively analyzed. Baseline and postoperative best spectacle-corrected visual acuity, uncorrected visual acuity, spherical and cylindrical refractions, computerized video keratography, and biomicroscopy were measured or performed on each eye.

Penetrating keratoplasty for keratoconus: a long-term review of results and complications.

Purpose: To study the long-term complications of penetrating keratoplasty (PKP) to evaluate current recommendations to patients with keratoconus.

Setting: John Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

Methods: Retrospective study of all PKP procedures for keratoconus performed by 4 surgeons during a 312 year period.

Tarsal fibroma.

Purpose: To report a case of an isolated tarsal fibroma.

Methods: Case report. Excisional biopsy and histopathological evaluation were performed on a solid lesion originating from the tarsal conjunctival surface of an upper eyelid.