This study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration.
Single-arm, prospective, ...multicenter clinical trial.
Thirty subjects were enrolled in the United States and Europe between June 6, 2007, and August 11, 2009. All subjects were followed up for a minimum of 6 months and up to 2.7 years.
The electronic stimulator and antenna of the implant were sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed, and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array then was tacked to the epiretinal surface.
The primary safety end points for the trial were the number, severity, and relation of adverse events. Principal performance end points were assessments of visual function as well as performance on orientation and mobility tasks.
Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications.
The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it.
The majority of infrarenal abdominal aortic aneurysm (AAA) repairs in the United States are performed with endovascular methods. Baseline aortoiliac arterial anatomic characteristics are fundamental ...criteria for appropriate patient selection for endovascular aortic repair (EVAR) and key determinants of long-term success. We evaluated compliance with anatomic guidelines for EVAR and the relationship between baseline aortoiliac arterial anatomy and post-EVAR AAA sac enlargement.
Patients with pre-EVAR and at least 1 post-EVAR computed tomography scan were identified from the M2S, Inc. imaging database (1999 to 2008). Preoperative baseline aortoiliac anatomic characteristics were reviewed for each patient. Data relating to the specific AAA endovascular device implanted were not available. Therefore, morphological measurements were compared with the most liberal and the most conservative published anatomic guidelines as stated in each manufacturer's instructions for use. The primary study outcome was post-EVAR AAA sac enlargement (>5-mm diameter increase). In 10 228 patients undergoing EVAR, 59% had a maximum AAA diameter below the 55-mm threshold at which intervention is recommended over surveillance. Only 42% of patients had anatomy that met the most conservative definition of device instructions for use; 69% met the most liberal definition of device instructions for use. The 5-year post-EVAR rate of AAA sac enlargement was 41%. Independent predictors of AAA sac enlargement included endoleak, age ≥ 80 years, aortic neck diameter ≥ 28 mm, aortic neck angle >60°, and common iliac artery diameter >20 mm.
In this multicenter observational study, compliance with EVAR device guidelines was low and post-EVAR aneurysm sac enlargement was high, raising concern for long-term risk of aneurysm rupture.
Retinal prosthetic implants are the only approved treatment for retinitis pigmentosa, a disease of the eye that causes blindness through gradual degeneration of photoreceptors. An array of ...microelectrodes triggered by input from a camera stimulates surviving retinal neurons, with each electrode acting as a pixel. Unintended stimulation of retinal ganglion cell axons causes patients to see large oblong shapes of light, rather than focal spots, making it difficult to perceive forms. To address this problem, we performed calcium imaging in isolated retinas and mapped the patterns of cells activated by different electrical stimulation protocols. We found that pulse durations two orders of magnitude longer than those typically used in existing implants stimulated inner retinal neurons while avoiding activation of ganglion cell axons, thus confining retinal responses to the site of the electrode. Multielectrode stimulation with 25-ms pulses can pattern letters on the retina corresponding to a Snellen acuity of 20/312. We validated our findings in a patient with an implanted epiretinal prosthesis by demonstrating that 25-ms pulses evoke focal spots of light.
Objective:This randomized controlled trial tested the efficacy of early intervention to prevent adult psychopathology and improve well-being in early-starting conduct-problem ...children.Method:Kindergarteners (N=9,594) in three cohorts (1991–1993) at 55 schools in four communities were screened for conduct problems, yielding 979 early starters. A total of 891 (91%) consented (51% African American, 47% European American; 69% boys). Children were randomly assigned by school cluster to a 10-year intervention or control. The intervention goal was to develop social competencies in children that would carry them throughout life, through social skills training, parent behavior-management training with home visiting, peer coaching, reading tutoring, and classroom social-emotional curricula. Manualization and supervision ensured program fidelity. Ninety-eight percent participated during grade 1, and 80% continued through grade 10. At age 25, arrest records were reviewed (N=817, 92%), and condition-blinded adults psychiatrically interviewed participants (N=702; 81% of living participants) and a peer (N=535) knowledgeable about the participant.Results:Intent-to-treat logistic regression analyses indicated that 69% of participants in the control arm displayed at least one externalizing, internalizing, or substance abuse psychiatric problem (based on self- or peer interview) at age 25, in contrast with 59% of those assigned to intervention (odds ratio=0.59, CI=0.43–0.81; number needed to treat=8). This pattern also held for self-interviews, peer interviews, scores using an “and” rule for self- and peer reports, and separate tests for externalizing problems, internalizing problems, and substance abuse problems, as well as for each of three cohorts, four sites, male participants, female participants, African Americans, European Americans, moderate-risk, and high-risk subgroups. Intervention participants also received lower severity-weighted violent (standardized estimate=−0.37) and drug (standardized estimate=−0.43) crime conviction scores, lower risky sexual behavior scores (standardized estimate=−0.24), and higher well-being scores (standardized estimate=0.19).Conclusions:This study provides evidence for the efficacy of early intervention in preventing adult psychopathology among high-risk early-starting conduct-problem children.
Social and emotional learning (SEL) has become more central to education because of demand from educators, parents, students, and business leaders alongside rigorous research showing broad, positive ...impacts for students and adults. However, all approaches to SEL are not equal. Systemic SEL is an approach to create equitable learning conditions that actively involve all Pre-K to Grade 12 students in learning and practicing social, emotional, and academic competencies. These conditions require aligned policies, resources, and actions at state and district levels that encourage local schools and communities to build the personal and professional capacities of adults to: implement and continuously improve evidence-based programs and practices; create an inclusive culture that fosters caring relationships and youth voice, agency, and character; and support coordinated school-family-community partnerships to enhance student development. Promoting social and emotional competencies-including the abilities to understand and manage emotions, achieve positive goals, show caring and concern for others, establish and maintain positive relationships, and make responsible decisions-are important for success at school and in life. In this article, we summarize key concepts and evidence for systemic SEL. Next, we explain interrelated Theories of Action and resources developed by the Collaborative for Academic, Social, and Emotional Learning (CASEL) to implement and continuously improve systemic SEL in schools, districts, and states. We discuss research on nested, interacting settings and processes involved in systemic SEL at proximal (classrooms, schools, families, and communities) and distal (districts, states, national, and international) ecological levels. We conclude with recommendations for future SEL research, practice, and policy.
Public Significance Statement
A systemic approach to social and emotional learning (SEL) creates equitable learning conditions that actively involve all Pre-K to Grade 12 students in developing social, emotional, and academic competencies. Decades of research shows these competencies lead to beneficial outcomes at school and in life. Creating these conditions requires aligned policies, resources, and actions at state and district levels to support a coordinated learning process through school-family-community partnerships to enhance student development.
Objective:
This article examines the impact of a universal social-emotional learning program, the Fast Track PATHS (Promoting Alternative Thinking Strategies) curriculum and teacher consultation, ...embedded within the Fast Track selective prevention model.
Method:
The longitudinal analysis involved 2,937 children of multiple ethnicities who remained in the same intervention or control schools for Grades 1, 2, and 3. The study involved a clustered randomized controlled trial involving sets of schools randomized within 3 U.S. locations. Measures assessed teacher and peer reports of aggression, hyperactive-disruptive behaviors, and social competence. Beginning in first grade and through 3 successive years, teachers received training and support and implemented the PATHS curriculum in their classrooms.
Results:
The study examined the main effects of intervention as well as how outcomes were affected by characteristics of the child (baseline level of problem behavior, gender) and by the school environment (student poverty). Modest positive effects of sustained program exposure included reduced aggression and increased prosocial behavior (according to both teacher and peer report) and improved academic engagement (according to teacher report). Peer report effects were moderated by gender, with significant effects only for boys. Most intervention effects were moderated by school environment, with effects stronger in less disadvantaged schools, and effects on aggression were larger in students who showed higher baseline levels of aggression.
Conclusions:
A major implication of the findings is that well-implemented multiyear social-emotional learning programs can have significant and meaningful preventive effects on the population-level rates of aggression, social competence, and academic engagement in the elementary school years.
Retinal prosthesis systems (RPS) are a novel treatment for profound vision loss in outer retinal dystrophies. Ideal prostheses would offer stable, long-term retinal stimulation and reproducible ...spatial resolution in a portable form appropriate for daily life.
We report a prospective, internally controlled, multicentre trial of the Argus II system. Twenty-eight subjects with light perception vision received a retinal implant. Controlled, closed-group, forced-choice letter identification, and, open-choice two-, three- and four-letter word identification tests were carried out.
The mean±SD percentage correct letter identification for 21 subjects tested were: letters L, T, E, J, F, H, I, U, 72.3±24.6% system on and 17.7±12.9% system off; letters A, Z, Q, V, N, W, O, C, D, M, 55.0±27.4% system on and 11.8%±10.7% system off, and letters K, R, G, X, B, Y, S, P, 51.7±28.9% system on and 15.3±7.4% system off. (p<0.001 for all groups). A subgroup of six subjects was able to consistently read letters of reduced size, the smallest measuring 0.9 cm (1.7°) at 30 cm, and four subjects correctly identify unrehearsed two-, three- and four-letter words. Average implant duration was 19.9 months.
Multiple blind subjects fitted with the Argus II system consistently identified letters and words using the device, indicating reproducible spatial resolution. This, in combination with stable, long-term function, represents significant progress in the evolution of artificial sight.
Vision loss due to retinitis pigmentosa affects an estimated 15 million people worldwide. Through collaboration between Second Sight Medical Products, Inc., and the Doheny Eye Institute, six blind ...human subjects underwent implantation with epiretinal 4 x 4 electrode arrays designed to directly stimulate the remaining cells of the retina, with the goal of restoring functional vision by applying spatiotemporal patterns of stimulation. To better understand spatiotemporal interactions between electrodes during synchronous and asynchronous stimulation, the authors investigated how percepts changed as a function of pulse timing across the electrodes.
Pulse trains (20, 40, 80, and 160 Hz) were presented on groups of electrodes with 800, 1600, or 2400 microm center-to-center separation. Stimulation was either synchronous (pulses were presented simultaneously across electrodes) or asynchronous (pulses were phase shifted). Using a same-different discrimination task, the authors were able to evaluate how the perceptual quality of the stimuli changed as a function of phase shifts across multiple electrodes.
Even after controlling for electric field interactions, subjects could discriminate between spatiotemporal pulse train patterns based on differences of phase across electrodes as small as 3 ms. These findings suggest that the quality of the percept is affected not only by electric field interactions but also by spatiotemporal interactions at the neural level.
During multielectrode stimulation, interactions between electrodes have a significant influence on the quality of the percept. Understanding how these spatiotemporal interactions at the neural level influence percepts during multielectrode stimulation is fundamental to the successful design of a retinal prosthesis.
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