Working memory and school readiness in preschool children with sickle cell disease compared to demographically matched controls.

Children diagnosed with sickle cell disease (SCD) are at risk of the development of neurobehavioural problems early in life. Specific impairments in executive function skills, including working memory, have been documented in school-aged children with SCD. These executive skills are known to strongly contribute to early academic skills and preparedness for entering kindergarten. This study examined working memory and school readiness in preschool children with SCD compared to a healthy control group matched for race, sex and parent education. A total of 84 patients diagnosed with SCD (61.9% haemoglobin [Hb]SS/HbSß0 -thalassaemia) and 168 controls completed testing. The mean (SD) ages of patients and controls at testing were 4.53 (0.38) and 4.44 (0.65) years respectively. The SCD group performed worse than controls on measures of executive function, working memory and school readiness (p < 0.01; Cohen's D range: 0.32-0.39). Measures of working memory were associated with school readiness after accounting for early adaptive development. Multiple linear regression models among patients diagnosed with SCD revealed that college education of the primary caregiver was positively associated with school readiness (p < 0.001) after controlling for sex, genotype, age and early adaptive development. These results highlight the need to implement school readiness interventions in young children diagnosed with SCD emphasising executive function skills.

[Practical aspects of ketamine treatment-Safety, combination treatment and comorbidities]. / Praktische Aspekte der Ketaminbehandlung ­ Sicherheit, Kombinationstherapien und Komorbiditäten.

BACKGROUND: Although multiple studies and meta-analyses have documented the rapid antidepressive efficacy of ketamine, there are numerous questions regarding the practical use in the clinical routine that are still unanswered. OBJECTIVE: Based on personal clinical experience, by comparison and supplementation of the current data situation, answers are given to questions regarding the practical use of ketamine for depression that have not yet been satisfactorily clarified. MATERIAL AND METHODS: The clinical experiences with antidepressive treatment using ketamine over more than 5 years were evaluated with respect to the questions at hand. This was followed by a qualitative comparison of these results with those of a narrative literature search. RESULTS: A total of 72 patients (unipolar depression n = 53, bipolar depression n = 16, schizoaffective depression n = 3) were included in the analysis of this cohort. A statistically significant reduction of depressive symptoms and suicidal ideation after S-ketamine treatment was found. Of the patients 61% suffered from at least one secondary diagnosis. A dose of 0.5 mg/kg body weight of S­ketamine at a frequency of three times per week was shown to be effective. The treatment appears to be safe with respect to urotoxic side effects, combination treatment with tranylcypromine and in comorbid posttraumatic stress disorder. CONCLUSION: Ketamine appears to be a safe and effective option for the treatment of unipolar and bipolar depression.

Maternal Plasma 25-Hydroxyvitamin D during Gestation Is Positively Associated with Neurocognitive Development in Offspring at Age 4-6 Years.

BACKGROUND: Vitamin D is critical to embryonic neuronal differentiation and other developmental processes that may affect future neurocognitive function. However, observational studies have found inconsistent associations between gestational vitamin D and neurocognitive outcomes. OBJECTIVES: We examined the association of gestational 25-hydroxyvitamin D [25(OH)D] with children's IQ at 4-6 y, and explored whether associations differed by race. METHODS: This study used data from the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early Childhood) cohort. Between 2006 and 2011, CANDLE recruited 1503 women in their second trimester of healthy singleton pregnancies. Inclusion criteria for this analysis were gestation of ≥34 wk and availability of 25(OH)D and IQ data. Associations between second-trimester 25(OH)D plasma concentration and Stanford-Binet IQ scores in offspring at 4-6 y were examined using multivariable linear regression; interaction terms were used to explore possible effect modification by race. RESULTS: Mean ± SD 25(OH)D concentration among 1019 eligible dyads was 21.6 ± 8.4 ng/mL, measured at a mean ± SD gestational age of 23.0 ± 3.0 wk. Vitamin D deficiency [25(OH)D < 20 ng/mL] was observed in 45.6%. Maternal 25(OH)D differed by race with a mean ± SD of 19.8 ± 7.2 ng/mL in Blacks sand 25.9 ± 9.3 ng/mL in Whites ( P  < 0.001). In adjusted models a 10-ng/mL increase in 25(OH)D was associated with a 1.17-point higher Full Scale IQ (95% CI: 0.27, 2.06 points), a 1.17-point higher Verbal IQ (95% CI: 0.19, 2.15 points), and a 1.03-point higher Nonverbal IQ (95% CI: 0.10, 1.95 points). We observed no evidence of effect modification by race. CONCLUSIONS: Second-trimester maternal 25(OH)D was positively associated with IQ at 4-6 y, suggesting that gestational vitamin D status may be an important predictor of neurocognitive development. These findings may help inform prenatal nutrition recommendations and may be especially relevant for Black and other dark-skinned women at high risk of vitamin D deficiency.

"Nobody Will Tell You. You've Got to Ask!": An Examination of Patient-Provider Communication Needs and Preferences among Black and White Women with Early-Stage Breast Cancer.

Patient-provider communication is a critical component of healthcare and is associated with treatment quality and outcomes for women with breast cancer. This qualitative study examines similarities and differences in patient perspectives of communication needs between Black and White breast cancer survivors. We conducted four focus groups (N = 28) involving women with early-stage breast cancer on adjuvant endocrine therapy (AET), stratified by race and length of time on AET (< 6 months and >6 months). Each group was moderated by a race-concordant moderator and analyzed by emergent themes. Participants expressed common patient-provider communication needs, namely increased sensitivity from oncologists during the initial cancer diagnosis, personalized information to facilitate treatment decisions, emotional support during the transition from active treatment to maintenance, and rapid provider responses to mobile app-based queries. Communication differences by race also emerged. Black women were less likely than White women to describe having their informational needs met. White women praised longstanding relationships with providers, while Black women shared personal stories of disempowered interactions and noted the importance of patient advocates. White women more often reported privacy concerns about technology use. Unlike White women, Black women reported willingness to discuss sensitive topics, both online and offline, but believed those discussions made their providers feel uncomfortable. Early-stage breast cancer patients on AET, regardless of race, have similar needs for patient-centered communication with their oncologists. However, Black women were more likely to report experiencing poorer communication with providers than White women, which may be improved by technology and advocates.

A randomised phase II trial of three dosing regimens of radium-223 in patients with bone metastatic castration-resistant prostate cancer.

BACKGROUND: Radium-223 prolongs overall survival and delays symptomatic skeletal events (SSEs) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. The approved radium-223 regimen is 55 kBq/kg every 4 weeks (q4w) for six cycles (standard dose). We investigated different radium-223 regimens in patients with mCRPC. PATIENTS AND METHODS: Patients were randomised 1 : 1 : 1 to radium-223 standard-dose, high-dose (88 kBq/kg q4w for six cycles) or extended-schedule arms (55 kBq/kg q4w for 12 cycles). The primary end point, SSE-free survival (SSE-FS), was compared in patients treated with a high- versus standard-dose regimen, or with a standard dose in an extended (>6 to 12 cycles) versus standard schedule (six cycles). RESULTS: A total of 391 patients were randomised; baseline characteristics were balanced between arms. On-treatment SSEs developed in 37/130 (28%), 42/130 (32%) and 48/131 (37%) patients in the standard-dose, high-dose and extended-schedule arms, respectively. There was no statistically significant difference in SSE-FS in the high- versus standard-dose arms [median 12.9 months versus 12.3 months; hazard ratio (HR) 1.06, 80% confidence interval (CI) 0.88-1.27, P = 0.70], and in the extended- versus standard-schedule arms (median 10.8 months versus 13.2 months; HR 1.26, 80% CI 0.94-1.69, P = 0.31). Overall survival in the three treatment arms was similar. As many as 370 (95%) patients received treatment (median of six cycles) in each arm. Grade ≥3 treatment-emergent adverse events (TEAEs) affected 34% of patients in the standard-dose, 48% in the high-dose and 53% in the extended-schedule arm, causing permanent discontinuation in 9%, 16% and 17% of patients, respectively. CONCLUSION: Radium-223 high-dose or extended-schedule regimens resulted in no change in SSE-FS or other efficacy end points and were associated with more grade ≥3 TEAEs. The extended-schedule regimen (beyond six doses) could not be implemented in a large proportion of patients due to disease progression. Therefore, the standard-dose schedule remains one of the standard therapies for patients with symptomatic mCRPC. TRIAL REGISTRATION: ClinicalTrials.govNCT02023697.

Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer.

BACKGROUND: In the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) events required for planned final OS analysis. Here, we report the results of a second pre-specified interim analysis (IA2). METHODS: One thousand two hundred and seven patients with nmCRPC were randomized 2 : 1 to apalutamide (240 mg daily) or placebo. The primary end point of the study was MFS. Subsequent therapy for metastatic CRPC was permitted. When the primary end point was met, the study was unblinded. Patients receiving placebo who had not yet developed metastases were offered open-label apalutamide. At IA2, pre-specified analysis of OS was undertaken, using a group-sequential testing procedure with O'Brien-Fleming-type alpha spending function. Safety and second progression-free survival (PFS2) were assessed. RESULTS: Median follow-up was 41 months. With 285 (67% of required) OS events, apalutamide was associated with an improved OS compared with placebo (HR 0.75; 95% CI 0.59-0.96; P = 0.0197), although the P-value did not cross the pre-specified O'Brien-Fleming boundary of 0.0121. Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45-0.68). At IA2, 69% of placebo-treated and 40% of apalutamide-treated patients had received subsequent life-prolonging therapy for metastatic CRPC. No new safety signals were observed. CONCLUSION: In patients with nmCRPC, apalutamide was associated with a 25% reduction in risk of death compared with placebo. This OS benefit was observed despite crossover of placebo-treated patients and higher rates of subsequent life-prolonging therapy for the placebo group.

A qualitative exploration of race-based differences in social support needs of diverse women with breast cancer on adjuvant therapy.

OBJECTIVE: Social support is a critical component of breast cancer care and is associated with clinical and quality of life outcomes. Significant health disparities exist between Black and White women with breast cancer. Our study used qualitative methods to explore the social support needs of Black and White women with hormone receptor-positive breast cancer on adjuvant endocrine therapy (AET). METHODS: We conducted four focus group (FG) interviews (N = 28), stratified by race (ie, Black and White) and time on AET. FGs were audiotaped, transcribed, and analyzed according to conventions of thematic analysis. RESULTS: Participants noted the importance of having their informational and emotional social support needs met by friends and family members. White participants reported support provided by others with breast cancer was crucial; Black women did not discuss other survivors as part of their networks. Notably, both White and Black participants used the FG environment to provide experiential social support to each other. CONCLUSIONS: White participants noted that having other breast cancer survivors in their support network was essential for meeting their social support needs. However, Black participants did not reference other breast cancer survivors as part of their networks. Cancer centers should consider reviewing patients' access to experiential support and facilitate opportunities to connect women in the adjuvant phase.

Atherosclerotic cardiovascular disease risk assessment and predictors of statin use in Filipino-American Women.

WHAT IS KNOWN AND OBJECTIVE: Race and gender disparities in the context of appropriate treatment with lipid-lowering therapies do exist. The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines outlined four groups, three for primary prevention and one for secondary prevention, whom would benefit from statin therapy to target atherosclerotic cardiovascular disease (ASCVD). The application of these recommendations in Filipino women living in the United States is unknown; however, this population is known to have elevated cardiovascular risk. Socio-economic and clinical characteristics that predict statin utilization of this Asian American subgroup need to be explored. METHODS: This was an exploratory analysis of data collected during a cross-sectional study of Filipino-American Women (FAW). The Pooled Cohort equation was used to estimate 10-year ASCVD risk. Bivariate analysis was employed to determine the association between statin treatment and clinical and socio-economic factors. Data were analysed using SAS® 9.4; statistical significance was set at P < 0.05. RESULTS AND DISCUSSION: A total of 384 women (mean age 56.3 years) were included in the original study, and the average 10-year ASCVD risk was 3.5 ± 3.7%. Upon applying the 2013 ACC/AHA guidelines, 97 FAW were categorized into one of the primary prevention groups. Women considered to benefit from a statin based on the guideline criteria but were not prescribed a statin were considered the not statin treated group (n = 55). From the original cohort, 93 FAW reported current statin therapy use and were categorized as statin treated. The clinical characteristics associated with not being statin treated were as follows: untreated blood pressure (P = 0.012), higher diastolic blood pressure (P = 0.015), higher total cholesterol (P < 0.001), higher triglycerides (P = 0.041), higher low-density lipoprotein (P < 0.001) and higher glucose (P = 0.011). The socio-economic factor associated with not being statin treated was having two or more insurance payers (P = 0.005). Overall, this population had a waist circumference and body mass index (BMI) that exceeds guidelines for Asian women (31.5 or 80 cm). WHAT IS NEW AND CONCLUSION: Predictors of statin utilization in FAW are not well documented in the literature. These findings emphasize room for improvement for the prescribing of statins in primary prevention for this study population. Applying culturally appropriate screening strategies to identify cardiovascular risk factors early such as BMI or waist circumference may assist with quantifying patients into one of the statin benefit groups if eligible.

Psychometric evaluation of the nursing child assessment teaching (NCAT) scale in a community-based sample.

The effect of the mother-child relationship on long-term child development has received research attention for decades. Because the quality and quantity of mother-infant interactions have been established as important predictors of the child's development, early identification of areas in the relationship requiring support and intervention is essential for promoting positive child outcomes. The Nursing Child Assessment Teaching Scale (NCAT) is an instrument long used to quantify the quality of interaction in the mother-child relationship during the first 36 months of a child's life. While the NCAT has been shown to be a reliable and valid instrument, limited evidence exists of the theoretical congruence between the Barnard Model it is based on and the NCAT scale. The psychometric properties of the NCAT scale and subscales were examined using item response theory in relation to characteristics of interactions in the Barnard Model using data collected during a clinic visit at 12 months of infant age in a sample of mothers and children (N = 1,121 dyads) from a community-based sample in Shelby County, TN. In this secondary analysis, descriptive statistics, reliabilities, and factor loadings for the NCAT were obtained using confirmatory factor analysis and augmented to form multiple indicators, multiple causes models, linking demographic predictors of the mothers and children to the NCAT subscales. Results supported scale abbreviation and theoretical congruence with the Barnard Model, which may provide researchers and practitioners with a more concise, reliable way of measuring maternal-child interaction in community settings.

Quality of Life and African American Women Who are Family Caregivers: A Literature Review with Implications for Psychiatric Mental Health Advanced Practice Registered Nurses.

PURPOSE: To identify factors affecting the quality of life (QOL) of African American women (AAW) family caregivers of individuals with kidney failure. METHODS: Ferrans' Conceptual Model of QOL provided the framework for this literature review. Included studies were (a) peer- reviewed, (b) published within the last ten years, (c) written in English, and (d) examined QOL of AAW family caregivers. Using CINAHL© and PubMed©, we found 14 studies that described factors associated with these caregivers' QOL. SCOPE: Few studies document the QOL of AAW who are family caregivers, especially in the context of kidney failure. Psychiatric Mental Health Advanced Practice Registered Nurses need to learn about the factors influencing the QOL of these caregivers. RESULTS: No studies were found within the last ten years that explored the QOL of AAW family caregivers of individuals with kidney failure. Findings reflected the QOL of AAW family caregivers in the context of other chronic conditions. Various factors such as stress, insomnia, and employment were linked to an impaired QOL. Implications for practice, research and education for PMH-APRNs are suggested. CONCLUSION: PMH-APRNs are uniquely trained to address many factors that affect the QOL of these caregivers and may provide holistic care aimed at promoting satisfactory QOL for these caregivers.

Maternal and Child Characteristics Associated With Mother-Child Interaction in One-Year-Olds.

Mothers' interactions with their young children have predicted later child development, behavior, and health, but evidence has been developed mainly in at-risk clinical samples. An economically and racially diverse sample of pregnant women who were not experiencing a high-risk pregnancy were recruited to participate in a community-based, longitudinal study of factors associated with child cognitive and social-emotional development during the first 3 years. The purpose of the present analysis was to identify associations between the characteristics of 1125 mothers and their 1-year-olds and the mothers' and children's scores on the Nursing Child Assessment Teaching Scale (NCATS). A multivariable approach was used to identify maternal and child characteristics associated with NCATS scores and to develop prediction models for NCATS total and subscale scores of mothers and children. Child expressive and receptive communication and maternal IQ, marital status, age, and insurance predicted NCATS Mother total score, accounting for 28% of the score variance. Child expressive communication and birth weight predicted the NCATS Child total score, accounting for 4% of variance. Child's expressive communication and mother's IQ and marital status predicted NCATS mother-child total scores. While these findings were similar to reports of NCATS scores in at-risk populations, no previous teams examined all of the mother and child characteristics included in this analysis. These findings support the utility of the NCATS for assessing mother-child interaction and predicting child outcomes in community-based, non-clinical populations. © 2017 Wiley Periodicals, Inc.

Male Caregivers of Persons with End Stage Renal Disease: A Qualitative Study.

This study explored experiences associated with burden, depressive symptoms, and perceived health in six male caregivers of persons with end stage renal disease (ESRD) using qualitative interviews. Analysis employed open coding and analysis to generate codes and categories. Eighty-three percent of the participants reported significant subjective and objective burden. Linkages occurred between sociodemographic characteristics, care recipient attributes, and caregiver-care recipient relationship, and caregivers' experience of burden and depressive symptoms. Findings suggest the need for intervention trials targeting new coping strategies to help improve the well-being of this population.

Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL.

BACKGROUND: Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial. PATIENTS AND METHODS: PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs). RESULTS: Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)]. CONCLUSIONS: Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls. CLINICAL TRIAL IDENTIFIER: NCT01212991, ClinicalTrials.gov.

Male Caregivers of Persons with End Stage Renal Disease: A Literature Review.

This literature review examined burden, depressive symptoms, and perceived health reported by male caregivers of persons with end stage renal disease. These studies suggest that male caregivers often experience negative outcomes. Compared to non-caregivers, male caregivers had higher levels of anxiety and depressive symptoms. Qualitative studies suggest depression is common and associated with conflict between caregiving responsibilities and work, poor caregiver health, and fears about the future outcomes of relatives for whom they provide care. Future research will assist healthcare providers to identify at-risk male caregivers and develop effective interventions to support this understudied caregiver population.

Epigenetic analysis of neurocognitive development at 1 year of age in a community-based pregnancy cohort.

Multiple studies show that molecular genetic changes and epigenetic modifications affect the risk of cognitive disability or impairment. However, the role of epigenetic variation in cognitive development of neurotypical young children remains largely unknown. Using data from a prospective, community-based study of mother-infant pairs, we investigated the association of DNA methylation patterns in neonatal umbilical cord blood with cognitive and language development at 1 year of age. No CpG loci achieved genome-wide significance, although a small number of weakly suggestive associations with Bayley-III Receptive Communication scales were noted. While umbilical cord blood is a convenient resource for genetic analyses of birth outcomes, our results do not provide conclusive evidence that its use for DNA methylation profiling yields epigenetic markers that are directly related to postnatal neurocognitive outcomes at 1 year of age.

Transition from pediatric to adult care in sickle cell disease: perspectives on the family role.

Transition from pediatric to adult care poses challenges for adolescents with sickle cell disease (SCD). This study explored the transition perspectives of adolescents with SCD, their siblings, and caregivers. Focus groups were conducted with 12 African American families. Adolescents, siblings, and caregivers demonstrated awareness of transition and need for disease management responsibility. Siblings' and caregivers' concerns included adolescent medication adherence. Family concerns included leaving the pediatric environment and adult providers' lack of knowledge. Families recommended more transition preparation opportunities. Family members' perspectives are valuable in informing transition planning. Family-focused interventions designed to prepare and support families during transition are necessary.

[History of cancer and chemotherapy before chemotherapy]. / Histoire du cancer et de la chimiothérapie avant la chimiothérapie.

Chemotherapy stands today for cancer. In 1909, Paul Ehrlich (1854-1915) advocates the use of arsphenamine by infusion. So, he is considered as the father of chemotherapy. In fact, the first to have thought through chemotherapy was Sir Christopher Wren (1632-1723). In 1676, ideas and experiments on animals had sufficiently progressed to allow Michel Ettmuller (1644-1683) to publish the first edition of his book and several others were printed until 1753. In this book, he describes the first intravenous treatment, it sets the first indications, dosages and different products which can be used. However this method has been forgotten until the late 19th century.

From Reactive to Proactive - The Future Life Design to Promote Health and Extend the Human Lifespan.

Disease treatment and prevention have improved the human lifespan. Current studies on aging, such as the biological clock and senolytic drugs have focused on the medical treatments of various disorders and health maintenance. However, to efficiently extend the human lifespan to its theoretical maximum, medicine can take a further proactive approach and identify the inapparent disorders that affect the gestation, body growth, and reproductive stages of the so-called "healthy" population. The goal is to upgrade the standard health status to a new level by targeting the inapparent disorders. Thus, future research can shift from reaction, response, and prevention to proactive, quality promotion and vigor prolonging; from single disease-oriented to multiple dimension protocol for a healthy body; from treatment of symptom onset to keep away from disorders; and from the healthy aging management to a healthy promotion design beginning at the birth.

Exudation in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System or Monthly Injections.

PURPOSE: To evaluate for the presence, severity, and type of exudation at each study visit for a subgroup of patients with neovascular age-related macular degeneration from the Archway and Portal trials. DESIGN: Retrospective analysis of prospectively obtained data. METHODS: Spectral-domain optical coherence tomography scans from each study visit of 44 patients from the Port Delivery System (PDS) arm and 32 patients from the monthly injection arm of Archway were evaluated, and composites of horizontal scans through the fovea were created. Each composite was graded for the presence, type, and severity of exudation and impact on best-corrected visual acuity. RESULTS: After PDS implantation, 20 of 44 eyes (45%) never showed any exudation in the fovea, 2 (5%) never showed exudation in the fovea but had several missed visits, whereas 15 (34%), 3 (7%), and 4 (9%) showed mild, moderate, or severe exudation at 1 or more study visits, respectively. When exudation was present, it was most commonly subretinal fluid (50%). Of 32 patients randomized to monthly injections, 15 (47%) had no exudation in the fovea during monthly injections or after PDS implantation. Fluctuation of exudation in the fovea over time was seen in some patients after PDS implantation or during monthly injections with little or no identifiable impact on best-corrected visual acuity. In the 7 eyes with moderate or severe exudation in the fovea after PDS implantation, final vision was good in 5 (20/25 in 3, 20/40 in 1, and 20/50 in 1) and 2 had reduced vision from submacular hemorrhage. CONCLUSIONS: The PDS provides excellent control of exudation in the fovea in patients with neovascular age-related macular degeneration, and when exudation occurs, it often resolves without a negative impact on vision.