Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

Impact of Video Describing Cataract Surgical Simulator Training on Patients' Perceptions of Resident Involvement in Cataract Surgery.

Purpose The aim of this article is to investigate the impact of a 1-minute video describing resident training with a cataract surgical simulator on patients' perceptions regarding resident involvement in cataract surgery and to identify factors associated with patient willingness to have cataract surgery performed by a resident. Design Cross-sectional survey. Methods An anonymous Likert-style survey was conducted among 430 consecutive adult patients who presented for eye examination at the Penn State Health Eye Center. The survey included questions regarding demographics, understanding of the medical training hierarchy, and patient willingness to have a resident perform their cataract surgery. There were six questions regarding patient willingness to have residents perform their cataract surgery and the second question in this set informs the patient that residents are supervised by an experienced cataract surgeon. Patients were randomly assigned to one of two groups: patients in Group 1 completed the survey only, while patients in Group 2 watched a 1-minute video describing resident training with a cataract surgical simulator prior to completing the survey. Results Four hundred fourteen of the 430 patients (96.3%) completed the survey. Overall, 24.7% ( n = 102) of respondents expressed willingness to allow an ophthalmology resident to perform their cataract surgery, and that proportion increased to 54.0% ( n = 223) if the patient was informed that the resident would be supervised by an experienced cataract surgeon. Patients in Group 2 were twice as likely compared with patients in Group 1 to express willingness to allow an ophthalmology resident to perform their cataract surgery (odds ratio 1.92 [1.18-3.11], p = 0.009). Conclusions A thorough informed consent process including information regarding attending supervision and a brief video detailing resident training with a cataract surgery simulator may increase patient willingness to allow resident participation in cataract surgery.

Practice Patterns Among Eye Care Providers at US Teaching Hospitals With Regard to Assessing and Educating Patients About Smoking.

PURPOSE: To investigate practice patterns of eye care providers at academic medical centers in the United States (US) with regard to assessing patients' smoking status and exposure, educating patients regarding ocular risks of smoking, and counseling patients about smoking cessation. DESIGN: Cross-sectional survey. METHODS: An anonymous survey including multiple choice and Likert-style questions was constructed on http://www.surveymonkey.com and emailed to the coordinators of all 113 US ophthalmology residency programs, with a request to forward to all faculty, fellows, residents, and optometrists at their institution. Main outcome measures include proportion of eye care providers who assess patients' smoking status, educate patients regarding ocular risks of smoking, and discuss with patients smoking cessation options. RESULTS: Of the 292 respondents, 229 (78%) "always" or "periodically" ask patients about their smoking status, 251 (86%) "seldom" or "never" ask patients about secondhand smoke exposure, 245 (84%) "always" or "periodically" educate patients about ocular diseases associated with smoking, 142 (49%) "seldom" or "never" ask patients who smoke about their willingness to quit smoking, and 249 (85%) "seldom" or "never" discuss potential methods and resources to assist with smoking cessation. CONCLUSIONS: Most eye care providers assess patients' smoking status and educate patients regarding ocular risks of smoking. However, approximately half do not ask, or seldom ask, about patients' willingness to quit smoking, and most do not discuss smoking cessation options.

Severity of end-organ damage as a predictor of outcomes after implantation of left ventricular assist device.

The optimal timing of left ventricular assist device (LVAD) implantation in the management of advanced heart failure remains controversial. We hypothesize that in patients with cardiogenic shock, the severity of end-organ dysfunction as determined by the sequential organ failure assessment (SOFA) score is a determinant of outcomes after LVAD implantation. We determined the preoperative SOFA score and short- and long-term outcomes of 97 consecutive patients who received HeartMate II or HeartWare LVAD at our institution since January 2007. Kaplan-Meier analysis was used to compare long-term survival across SOFA score subgroups. The overall 30 day mortality was 10.1%, with no significant difference among SOFA score subgroups. Patients with scores ≥9 had significantly longer hospital stay (26 ± 6 vs. 18 ± 10 days, p = 0.03). One-year survival for SOFA scores 0-2, 3-5, 6-8, and ≥9 was 94%, 75%, 64%, and 29%, respectively. SOFA score was significantly lower in survivors at 6, 9, 12, 24, and 36 months. SOFA score did not predict adverse outcomes of bleeding, cerebrovascular events, infection, or pump exchange. These results show that preoperative SOFA score is a powerful predictor of outcomes after LVAD implantation. Long-term outcomes can be significantly improved by early intervention before emergence of end-organ dysfunction.

The intramolecular allenolate Rauhut-Currier reaction.

An intramolecular Rauhut-Currier reaction utilizing alkynoates as the initial conjugate acceptor affords densely functionalized 5- and 6-membered rings from ynoate-enoate, ynoate-enenitrile, and alkynyl sulfone-enenitrile substrates. Trialkylphosphines catalyze the reaction, and TMSCN serves as a pronucelophile to effect turnover of the catalyst and the formation of a second C-C bond. Because of the highly electrophilic alkyne acceptor, this reaction yields products that cannot be easily accessed from the traditional Rauhut-Currier reaction.