Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial.

SIGNIFICANCE: After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations. PURPOSE: The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication. METHODS: In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points. RESULTS: Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide). Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was -1.69 mm and was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05). At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs. 38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours. CONCLUSIONS: Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic blockers) with a tolerable safety profile.

Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial.

PURPOSE: Phentolamine mesylate ophthalmic solution (PMOS), applied to the eye topically, was shown previously to have beneficial effects in patients with dim light vision disturbances (DLD), including decreased pupil diameter (PD), improved best-corrected distance visual acuity (BCDVA), as well as lower intraocular pressure (IOP). The ORION-1 trial evaluated the long-term safety and efficacy of PMOS in a glaucomatous, presbyopic population. PATIENTS AND METHODS: In this randomized, double-masked, multi-center, placebo-controlled, multiple-dose Phase 2b trial, 39 patients with elevated IOP were randomized to receive one evening dose of study medication or placebo for 14 days. The primary outcome measure was mean change in diurnal IOP, and the key secondary outcome measures included changes in PD, distance-corrected near visual acuity (DCNVA), and conjunctival hyperemia. RESULTS: Use of 1% PMOS did not lead to a statistically significant decrease in diurnal IOP compared to placebo (P = 0.89) but trended toward a greater decrease in patients with lower IOP baselines. PMOS produced a statistically significant mean 20% PD reduction under both photopic and mesopic conditions that was sustained for 36 hours post-dosing. A statistically significant number of patients with PMOS compared to placebo demonstrated ≥1 line of improvement in photopic DCNVA at day 8 (P = 0.0018), day 15 (P = 0.0072), and day 16 (P = 0.0163), with a trend for 2- and 3-line improvements at all time points. There was no statistical difference in conjunctival hyperemia compared to placebo. CONCLUSION: Although mean IOP was not lowered significantly, daily evening dosing of 1% PMOS was found to be well tolerated with no daytime conjunctival redness and demonstrated improvement in DCNVA with sustained PD reduction in a glaucomatous and presbyopic population. Smaller pupil size can have beneficial effects in improving symptoms of presbyopia and DLD, which will be the focus of further studies.

What is appropriate to post on social media? Ratings from students, faculty members and the public.

OBJECTIVES: The purpose of this study was to ascertain what medical students, doctors and the public felt was unprofessional for medical students, as future doctors, to post on a social media site, Facebook(®) . The significance of this is that unprofessional content reflects poorly on a student, which in turn can significantly affect a patient's confidence in that student's clinical abilities. METHODS: An online survey was designed to investigate the perceptions of University of Michigan medical students, attending physicians and non-health care university-wide employees (that serves as a subset of the public) regarding mock medical students' Facebook(®) profile screenshots. For each screenshot, respondents used a 5-point Likert scale to rate 'appropriateness' and whether they would be 'comfortable' having students posting such content as their future doctors. RESULTS: Compared with medical students, faculty members and public groups rated images as significantly less appropriate (p < 0.001) and indicated that they would be less comfortable (p < 0.001) having posting students as future doctors. All three groups rated screenshots containing derogatory or private information about patients, followed by images suggesting marijuana use, as least appropriate. Images conveying intimate heterosexual couples were rated as most appropriate. Overall, the doctor group, females and older individuals were less permissive when compared with employee and student groups, males and younger individuals, respectively. CONCLUSIONS: The most significant conclusion of our study is that faculty members, medical students and the 'public' have different thresholds of what is acceptable on a social networking site. Our findings will prove useful for students to consider the perspectives of patients and faculty members when considering what type of content to post on their social media sites. In this way, we hope that our findings provide insight for discussions, awareness and the development of guidelines related to online professionalism for medical students.

Changing practice: implementation of a venous thromboembolism prophylaxis protocol at an academic medical center.

BACKGROUND: The Institute of Medicine has identified a "quality chasm" between existing evidence and actual clinical practice. The Venous Thromboembolism Prevention Study has shown that enoxaparin prophylaxis is a safe and effective way of preventing postoperative venous thromboembolism. This article presents a "how-to" guide for implementation of a venous thromboembolism prophylaxis protocol. METHODS: The Venous Thromboembolism Prevention Study prophylaxis protocol included provision of postoperative, prophylactic dose enoxaparin for the duration of inpatient stay. Compliance was considered at the individual patient level and defined as appropriate provision of protocol-appropriate enoxaparin prophylaxis. Multiple simultaneous interventions to improve protocol compliance were undertaken. Both physician and physician assistant "champions" were identified. Interventions included staff and surgeon educational sessions, discussion of venous thromboembolism-themed articles at journal club, and monthly e-mail reminders specific to the protocol, among others. Compliance rates over time were compared using the chi-square test. RESULTS: The authors reviewed medical records from 945 consecutive admissions to the plastic surgery service who met Venous Thromboembolism Prevention Study eligibility criteria over a 30-month period. Initial education sessions significantly increased compliance over baseline (55 percent versus 10 percent; p<0.001). After formal protocol adoption, compliance increased steadily over the first 9 months and peaked by 1 year. In the absence of any direct intervention, compliance remained stable at 90 percent for the final 12 months of the study. This was significantly increased when compared with the period of time immediately following protocol adoption (90 percent versus 77 percent; p<0.001). CONCLUSION: This article provides readers with a practical approach for implementation of a venous thromboembolism prophylaxis protocol at their hospital.

Validation of the Caprini risk assessment model in plastic and reconstructive surgery patients.

BACKGROUND: The Venous Thromboembolism Prevention Study (VTEPS) Network is a consortium of 5 tertiary referral centers established to examine venous thromboembolism (VTE) in plastic surgery patients. We report our midterm analyses of the study's control group to evaluate the incidence of VTE in patients who receive no chemoprophylaxis, and validate the Caprini Risk Assessment Model (RAM) in plastic surgery patients. STUDY DESIGN: Medical record review was performed at VTEPS centers for all eligible plastic surgery patients between March 2006 and June 2009. Inclusion criteria were Caprini score ≥3, surgery under general anesthesia, and postoperative hospital admission. Patients who received chemoprophylaxis were excluded. Dependent variables included symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within the first 60 postoperative days and time to DVT or PE. RESULTS: We identified 1,126 historic control patients. The overall VTE incidence was 1.69%. Approximately 1 in 9 (11.3%) patients with Caprini score >8 had a VTE event. Patients with Caprini score >8 were significantly more likely to develop VTE when compared with patients with Caprini score of 3 to 4 (odds ratio [OR] 20.9, p < 0.001), 5 to 6 (OR 9.9, p < 0.001), or 7 to 8 (OR 4.6, p = 0.015). Among patients with Caprini score 7 to 8 or Caprini score >8, VTE risk was not limited to the immediate postoperative period (postoperative days 1-14). In these high-risk patients, more than 50% of VTE events were diagnosed in the late (days 15-60) postoperative period. CONCLUSIONS: The Caprini RAM effectively risk-stratifies plastic and reconstructive surgery patients for VTE risk. Among patients with Caprini score >8, 11.3% have a postoperative VTE when chemoprophylaxis is not provided. In higher risk patients, there was no evidence that VTE risk is limited to the immediate postoperative period.

Early fasciotomy in electrically injured patients as a marker for injury severity and deep venous thrombosis risk: an analysis of the National Burn Repository.

By using the National Burn Repository, the authors sought to identify markers for injury severity and deep venous thrombosis (DVT) risk after electrical injury. They identified adult patients in the National Burn Repository who were admitted with an electrical injury between 1995 and 2007 (n = 1469). Patients who died within 24 hours or were admitted for less than 1 day and hospitals reporting no complications were excluded. Independent variables included TBSA burned, duration of intensive care unit stay and hospital admission, duration of mechanical ventilation, the number of operative procedures, amputation, and early fasciotomy. Early fasciotomy was defined as fasciotomy performed on a patient's first trip to the operating room and was used as a proxy for severity of electrical injury. DVT and death were the dependent variables. Among electrically injured patients, 10.4% had early fasciotomy. Patients who had early fasciotomy had significantly prolonged intensive care unit stays (10.3 vs 4.8 days, P < .001), hospital days (36.7 vs 17.1 days, P < .001), amputations (49.0 vs 4.6%, P < .001), and a number of operative codes (17.6 vs 5.4, P < .001). DVT incidence was 0.9%. Electrically injured patients who had early fasciotomy were significantly more likely to have a DVT when compared with patients who did not have early fasciotomy (7.55 vs 0.95%, P = .002). Early fasciotomy after electrical injury is a marker for increased injury severity. Among patients who underwent early fasciotomy after electrical injury, 7.5% develop DVT, and 49% require amputation during their initial hospitalization.