Traci E Clemons

The EMMES Corporation, Роквилл, Maryland, United States

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Publications (112)511.48 Total impact

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    ABSTRACT: Observational data have suggested that high dietary intake of saturated fat and low intake of vegetables may be associated with increased risk of Alzheimer disease. To test the effects of oral supplementation with nutrients on cognitive function. In a double-masked randomized clinical trial (the Age-Related Eye Disease Study 2 [AREDS2]), retinal specialists in 82 US academic and community medical centers enrolled and observed participants who were at risk for developing late age-related macular degeneration (AMD) from October 2006 to December 2012. In addition to annual eye examinations, several validated cognitive function tests were administered via telephone by trained personnel at baseline and every 2 years during the 5-year study. Long-chain polyunsaturated fatty acids (LCPUFAs) (1 g) and/or lutein (10 mg)/zeaxanthin (2 mg) vs placebo were tested in a factorial design. All participants were also given varying combinations of vitamins C, E, beta carotene, and zinc. The main outcome was the yearly change in composite scores determined from a battery of cognitive function tests from baseline. The analyses, which were adjusted for baseline age, sex, race, history of hypertension, education, cognitive score, and depression score, evaluated the differences in the composite score between the treated vs untreated groups. The composite score provided an overall score for the battery, ranging from -22 to 17, with higher scores representing better function. A total of 89% (3741/4203) of AREDS2 participants consented to the ancillary cognitive function study and 93.6% (3501/3741) underwent cognitive function testing. The mean (SD) age of the participants was 72.7 (7.7) years and 57.5% were women. There were no statistically significant differences in change of scores for participants randomized to receive supplements vs those who were not. The yearly change in the composite cognitive function score was -0.19 (99% CI, -0.25 to -0.13) for participants randomized to receive LCPUFAs vs -0.18 (99% CI, -0.24 to -0.12) for those randomized to no LCPUFAs (difference in yearly change, -0.03 [99% CI, -0.20 to 0.13]; P = .63). Similarly, the yearly change in the composite cognitive function score was -0.18 (99% CI, -0.24 to -0.11) for participants randomized to receive lutein/zeaxanthin vs -0.19 (99% CI, -0.25 to -0.13) for those randomized to not receive lutein/zeaxanthin (difference in yearly change, 0.03 [99% CI, -0.14 to 0.19]; P = .66). Analyses were also conducted to assess for potential interactions between LCPUFAs and lutein/zeaxanthin and none were found to be significant. Among older persons with AMD, oral supplementation with LCPUFAs or lutein/zeaxanthin had no statistically significant effect on cognitive function. Identifier: NCT00345176.
    JAMA The Journal of the American Medical Association 08/2015; 314(8):791-801. DOI:10.1001/jama.2015.9677 · 35.29 Impact Factor
  • Ophthalmology 08/2015; 122(8):e46-e47. DOI:10.1016/j.ophtha.2015.01.023 · 6.14 Impact Factor
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    ABSTRACT: To investigate progressive vision loss in patients with macular telangiectasia (MacTel) type 2 and to compare the ability to detect functional decline between microperimetry and visual acuity testing. Change of cumulative defect size (number of test points with absolute scotoma) on microperimetry testing and change in distance best-corrected visual acuity (BCVA) were evaluated in a prospective longitudinal observational study. The mean review period was 55.3 months (SD 17.3 months). In 58% of 71 eyes (40 patients) included for analysis, microperimetry revealed spread (n = 31) or new development (n = 10) of an absolute scotoma. At the same time, BCVA decreased more than two lines in only 17% (n = 12). Twenty-five (35%) eyes showed no change in visual function. Presence of an absolute scotoma at baseline, but not baseline BCVA, was predictive for functional decline on longitudinal microperimetry testing. Eyes with an absolute scotoma at baseline (n = 33) showed further growth of the scotoma in 94% (n = 31). In contrast, only 26% (n = 10) of eyes without an absolute scotoma at baseline (n = 38) developed an absolute scotoma de novo. Scotoma growth rate (new test points with an absolute scotoma per year) was 0.62 ± 0.10 for all eyes and 1.30 ± 0.12 for the subgroup of eyes with scotoma at baseline. Scotomata always first occurred in the quadrant temporal to the foveal center. A characteristic feature in patients with MacTel type 2 is progressive focal loss of macular sensitivity, preceding loss of visual acuity. Microperimetry is sensitive to detect such functional decline and thus may provide considerable power when being used as a functional outcome measure in future clinical trials.
    Investigative ophthalmology & visual science 06/2015; 56(6):3905-3912. DOI:10.1167/iovs.15-16915 · 3.40 Impact Factor
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    ABSTRACT: To evaluate whether dietary intake of luteiin/zeaxanthin and B vitamins is associated with cataract prevalence and incidence. Clinic-based, baseline cross-sectional and prospective cohort study designs. Three thousand one hundred fifteen patients (6129 eyes) enrolled in the Age-Related Eye Disease Study 55 to 80 years of age followed up for mean of 9.6 years. Participants completed baseline food frequency questionnaires. Baseline and annual lens photographs were graded centrally. Multivariate models controlling for previously identified risk factors for cataracts tested for the association of cataracts with reported dietary intake, using the lowest quintile as reference. Cataract surgery, cataract status (type and severity) at baseline, and development of cataracts. At baseline, increased dietary riboflavin and B12 were associated inversely with nuclear and cortical lens opacities. In comparisons of persons with and without cataract, persons with the highest riboflavin intake versus those with the lowest intake had the following associations: mild nuclear cataract: odds ratio (OR), 0.78; 95% confidence interval (CI), 0.63-0.97; moderate nuclear cataract: OR, 0.62; 95% CI, 0.43-0.90; and mild cortical cataract: OR, 0.80; 95% CI, 0.65-0.99. For B12, the results were: mild nuclear cataract: OR, 0.78; 95% CI, 0.63-0.96; moderate nuclear cataract: OR, 0.62; 95% CI, 0.43-0.88; and mild cortical cataract: OR, 0.77; 95% CI, 0.63-0.95. Highest dietary B6 intake was associated with a decreased risk of moderate nuclear lens opacity developing compared with the lowest quintile (OR, 0.67; 95% CI, 0.45-0.99). Highest dietary intake levels of niacin and B12 were associated with a decreased risk of development of mild nuclear or mild cortical cataracts in participants not taking Centrum (Pfizer, New York, NY) multivitamins. For participants taking multivitamins during the study, the highest intake of dietary folate was associated with an increased risk of mild posterior subcapsular lens opacity development. No statistically significant associations were found between lutein plus zeaxanthin intake and presence at baseline or development of nuclear or cortical lens opacity outcomes. These findings are consistent with earlier studies suggesting that dietary intake of B vitamins may affect the occurrence of age-related lens opacities. Further investigations are warranted. Published by Elsevier Inc.
    Ophthalmology 05/2015; 122(7). DOI:10.1016/j.ophtha.2015.04.007 · 6.14 Impact Factor
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    ABSTRACT: To investigate whether the 2-year change in lens opacity severity on the Age-Related Eye Disease Study (AREDS) lens grading scale predicts progression to cataract surgery or loss of visual acuity by 5 years. Prospective cohort study within a randomized clinical trial of oral supplements. The AREDS participants whose eyes were phakic at baseline and free of late age-related macular degeneration throughout the study. Baseline and annual lens photographs of AREDS participants (n = 3466/4757; 73%) were graded for severity of cataracts using the AREDS system for classifying cataracts from photographs. Clinical examinations conducted semiannually collected data on cataract surgery and visual acuity. Association of the change in lens opacities at 2 years with these outcomes at 5 years was analyzed with adjusted Cox proportional hazard models. Progression of lens opacities on stereoscopic lens photographs at 2 years, cataract surgery, and visual acuity loss of 2 lines or more at 5 years. The adjusted hazard ratios (HRs) for association of progression to cataract surgery at 5 years were: nuclear cataract increase of 1.0 unit or more compared with less than 1.0-unit change at 2 years, 2.77 (95% confidence interval [CI], 2.07-3.70; P < 0.001); cortical cataract increase of 5% or more in lens opacity in the central 5 mm of the lens compared with less than 5% increase at 2 years, 1.91 (95% CI, 1.27-2.87; P = 0.002); and posterior subcapsular cataract increase of 5% or more versus less than 5% in the central 5 mm of the lens, 8.25 (95% CI, 5.55-12.29; P < 0.001). Similarly, HRs of vision loss of 2 lines or more at 5 years for this degree of lens changes at 2 years were the following: nuclear, 1.83 (95% CI, 1.49-2.25; P < 0.001); cortical, 1.13 (95% CI, 0.78-1.65; P = 0.519); and posterior subcapsular cataract, 3.05 (95% CI, 1.79-5.19; P < 0.001). Two-year changes in severity of lens opacities on the AREDS lens grading scale are predictive of long-term clinically relevant outcomes, making them potential surrogate end points in follow-up studies. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
    Ophthalmology 02/2015; 122(5). DOI:10.1016/j.ophtha.2014.12.037 · 6.14 Impact Factor
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    ABSTRACT: To evaluate the safety and tolerability of intraocular delivery of ciliary neurotrophic factor (CNTF) using an encapsulated cell implant for the treatment of macular telangiectasia type 2. An open-labeled safety trial conducted in 2 centers enrolling 7 participants with macular telangiectasia type 2. The participant's more severely affected eye (worse baseline visual acuity) received the high dose implant of CNTF. Patients were followed for a period of 36 months. The primary safety outcome was a change in the parameters of the electroretinogram (ERG). Secondary efficacy outcomes were changes in visual acuity, en face measurements of the optical coherence tomography of the disruption in the ellipsoid zone, and microperimetry when compared with baseline. The ERG findings demonstrated a reduction in the amplitude of the scotopic b-wave in 4 participants 3 months after implantation (month 3). All parameters returned to baseline values by month 12 and remained so at month 36 with no clinical impact on dark adaptation. There was no change in visual acuity compared with baseline. The area of the defect as measured functionally by microperimetry and structurally by the en face OCT imaging of the ellipsoid zone loss appeared unchanged from baseline. The intraocular delivery of CNTF in the encapsulated cell implant appeared to be safe and well tolerated in eyes with macular telangiectasia type 2. Further evaluation in a randomized controlled clinical trial is warranted to test for efficacy. Copyright © 2014 Elsevier Inc. All rights reserved.
    American Journal of Ophthalmology 12/2014; 159(4). DOI:10.1016/j.ajo.2014.12.013 · 3.87 Impact Factor
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    ABSTRACT: Macular telangiectasia Type 2 is a bilateral, progressive potentially blinding retinal disease characterized by both vascular and neurodegenerative signs that have been documented using different imaging techniques. The correlation between macular telangiectasia Type 2 signs from various imaging modalities is unknown. Our aim was to investigate the relationship of various macular telangiectasia Type 2 signs using fundus fluorescein angiography, optical coherence tomography and dual-wavelength autofluorescence images. Participants were selected from the macular telangiectasia Type 2 Natural History Observation Study, based on a confirmed diagnosis and the availability of images. Signs in fundus fluorescein angiography, dual-wavelength autofluorescence, and optical coherence tomography images were graded according to standardized categories, and agreement among the multimodel imaging was assessed statistically. One hundred and ninety-one eyes of 96 patients were examined. Significant correlations were found between early and late fundus fluorescein angiography (ρ = 0.82, P < 0.0001), luteal pigment loss and early/late fundus fluorescein angiography signs (ρ = 0.52, P < 0.0001 and ρ = 0.62, P < 0.0001, respectively), inner and outer segment break length and pigment loss (Class 1 vs. 2/3, P < 0.0001; Class 2 vs. 3, P = 0.04). Correlation between pigment loss and retinal spaces/atrophic retinal restructuring was fair (κ = 0.25-0.33). Bilateral symmetry was slight to substantial (κ = 0.18-0.62). Our data demonstrate the relative extent of neurodegenerative and vascular signs; it may be useful for designing systems for staging disease severity using multimodal imaging and may also provide clues to the pathogenesis of the disease.
    Retina (Philadelphia, Pa.) 11/2014; 35(4). DOI:10.1097/IAE.0000000000000365 · 3.24 Impact Factor
  • Ophthalmology 11/2014; 122(1). DOI:10.1016/j.ophtha.2014.10.012 · 6.14 Impact Factor
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    ABSTRACT: Objective To determine whether genotypes at 2 major loci associated with late age-related macular degeneration (AMD), complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2), influence the relative benefits of Age-Related Eye Disease Study (AREDS) supplements. Design Unplanned retrospective evaluation of a prospective, randomized, placebo-controlled clinical trial of vitamins and minerals for the treatment of AMD. Subjects AREDS participants (mean age, 69 years) who were at risk of developing late AMD and who were randomized to the 4 arms of AREDS supplement treatment. Methods Analyses were performed using the Cox proportional hazards model to predict progression to late AMD (neovascular or central geographic atrophy). Statistical models, adjusted for age, gender, smoking status, and baseline AMD severity, were used to examine the influence of genotypes on the response to therapy with 4 randomly assigned arms of AREDS supplement components: placebo, antioxidants (vitamin C, vitamin E, β-carotene), zinc or a combination. Main Outcome Measures The influence of the genotype on the relative treatment response to the randomized components of the AREDS supplement, measured as progression to late AMD. Results Of the 1237 genotyped AREDS participants of white ethnicity, late AMD developed in 385 (31.1%) during the mean follow-up of 6.6 years. As previously demonstrated, CFH genotype (P = 0.005), ARMS2 (P< 0.0001), and supplement were associated individually with progression to late AMD. An interaction analysis found no evidence that the relative benefits of AREDS supplementation varied by genotype. Analysis of (1) CFH rs1061170 and rs1410996 combined with ARMS2 rs10490924 with the 4 randomly assigned arms of AREDS supplement and (2) analysis of the combination of CFH rs412852 and rs3766405 with ARMS2 c.372_815del443ins54 with the AREDS components resulted in no interaction (P = 0.06 and P = 0.45, respectively, before multiplicity adjustment). Conclusions The AREDS supplements reduced the rate of AMD progression across all genotype groups. Furthermore, the genotypes at the CFH and ARMS2 loci did not statistically significantly alter the benefits of AREDS supplements. Genetic testing remains a valuable research tool, but these analyses suggest it provides no benefits in managing nutritional supplementation for patients at risk of late AMD.
    Ophthalmology 11/2014; 121(11). DOI:10.1016/j.ophtha.2014.05.008 · 6.14 Impact Factor
  • James M Chamberlain · Traci Clemons
    JAMA The Journal of the American Medical Association 09/2014; 312(9):963. DOI:10.1001/jama.2014.8755 · 35.29 Impact Factor
  • Emily Y Chew · Traci E Clemons
    Jama Ophthalmology 08/2014; 132(8):1031-2. DOI:10.1001/jamaophthalmol.2014.2009 · 3.32 Impact Factor
  • Emily Y Chew · Traci E Clemons
    Jama Ophthalmology 07/2014; 132(7):904-905. DOI:10.1001/jamaophthalmol.2014.1783 · 3.32 Impact Factor
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    ABSTRACT: Objective To evaluate visual acuity outcomes after cataract surgery in persons with varying degrees of severity of age-related macular degeneration (AMD). Design Cohort study. Participants A total of 1232 eyes of 793 participants who underwent cataract surgery during the Age-Related Eye Disease Study 2, a prospective, multicenter, randomized controlled trial of nutritional supplements for treatment of AMD. Methods Preoperative and postoperative characteristics of participants who underwent cataract extraction during the 5-year trial were analyzed. Both clinical data and standardized red-reflex lens and fundus photographs were obtained at baseline and annually. Photographs were graded by a centralized reading center for cortical and posterior subcapsular lens opacities and for AMD severity. Cataract surgery was documented at annual study visits or by history during the 6-month telephone calls. Analyses were conducted using multivariate repeated-measures regression. Main Outcome Measures Change in best-corrected visual acuity (BCVA) after cataract surgery compared with preoperative BCVA. Results Adjusting for age at time of surgery, gender, interval between preoperative and postoperative visits, and type and severity of cataract, the mean changes in visual acuity were as follows: eyes with mild AMD (n = 30) gained 11.2 letters (95% confidence interval [CI], 6.9–15.5), eyes with moderate AMD (n = 346) gained 11.1 letters (95% CI, 9.1–13.2), eyes with severe AMD (n = 462) gained 8.7 letters (95% CI, 6.7–10.7), eyes with noncentral geographic atrophy (n = 70) gained 8.9 letters (95% CI, 5.8–12.1), and eyes with advanced AMD (central geographic atrophy, neovascular disease, or both; n = 324) gained 6.8 letters (95% CI, 4.9–8.8). The visual acuity gain across all AMD severity groups was statistically significant from preoperative values (P < 0.0001). Conclusions Mean visual acuities improved significantly after cataract surgery across varying degrees of AMD severity.
    Ophthalmology 06/2014; 121(6). DOI:10.1016/j.ophtha.2013.12.035 · 6.14 Impact Factor
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    ABSTRACT: Background: Regression occurs in 22%-41% of children with Autism Spectrum Disorder (ASD) at the average age of 20-23 months. At present, no clear contributors to regression have been identified. Increased levels of several immune cytokines have been reported in the subgroup of regressive autism, but no studies have examined the role of oxidative stress in this process. Objectives: To compare biomarkers of oxidative stress and immune cytokines in children with ASD, with and without regression. Methods: Three sites in the Autism Speaks Autism Treatment Network: Toronto, ON; Baltimore, MD; and Little Rock, AS, recruited children, aged 18-42 months with ASD, with regression (ASD-R) (n=25), and without regression (ASD-NR) (n=24). The two groups were compared with regards to oxidative stress markers (free reduced glutathione, oxidized glutathione, homocysteine, cysteine, 3-nitrotyrosine and 3-chlorotyrosine) and immune cytokines (interleukin 1, macrophage chemoattractant protein 1, macrophage inflammatory protein 1A, interferon gamma, TNF alpha, and CD 40L). Regression was defined as having established a skill for at least one month, followed by a significant loss of that skill (more than 90% for language, and 75% for social) for more than 1 month. Regression was operationalized using a modified Regression Validation Interview and inter rater reliability for the assessment of “definite” or “no” regression was 89%. The ASD-R group completed a standardized medical investigation including screening for metabolic and genetic disorders. Children met criteria for an ASD according to the Autism Diagnostic Observation Schedule and the DSM-IV. Results: The mean ages of the ASD-R and ASD-NR groups were similar, 2.5 and 2.6 years respectively. The mean age of regression in the ASD-R group was 1.9 ± 0.4 years and the duration from when regression was definitively noted to plasma analysis was 8.0 ± 4.5 months. The ASD-R group had a significantly lower mean free reduced glutathione level (1.71 ± 0.13) compared to the ASD-NR group (1.86 ± 0.20) (p=0.006). There was also an increase in a marker for protein oxidative damage, 3-nitrotyrosine (p=0.04) in the ASD-R (74.19 ± 17.14) compared to the ASD-NR (64.78 ± 12.30) group. There were no differences in other oxidative stress markers or immune cytokines between groups. Conclusions: In this pilot study, ASD and recent regression in young children was associated with decreased free glutathione and increased 3-nitrotyrosine, supporting evidence of decreased antioxidant potential and increased oxidative damage in plasma, compared to young children with ASD and no regression. There were no group differences in other biomarkers of oxidative stress. Lower free glutathione levels may be a risk factor for regression in a subgroup of children with ASD and regression. This study was limited by a small sample size and the analysis of oxidative stress biomarkers and cytokine levels was limited to plasma. Future studies should examine oxidative stress biomarkers in the plasma and cerebrospinal fluid in young children with ASD and recent regression to assess for possible differences in oxidative stress and damage in the central nervous system.
    2014 International Meeting for Autism Research; 05/2014
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    ABSTRACT: Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication. To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus. This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam. Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered. The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration. Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%). Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition. Identifier: NCT00621478.
    JAMA The Journal of the American Medical Association 04/2014; 311(16):1652-60. DOI:10.1001/jama.2014.2625 · 35.29 Impact Factor
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    ABSTRACT: The aim of this study was to determine whether typical abnormalities seen on autofluorescence (AF) imaging in patients with macular telangiectasia (MacTel) type 2 are correlated with visual acuity at presentation and with progression of visual loss over a 2-year follow-up period. A subgroup of 218 patients (413 eyes) enrolled in the MacTel study that underwent AF imaging was included in the present study. Images were graded at the Moorfields Eye Hospital Reading Center. Recorded AF abnormalities at baseline and at 2 years included the presence of increased AF because of loss of masking at the central macula, localized decreased AF at the end of a retinal vessel, and large area of decreased AF. Best-corrected visual acuity was measured using the Early Treatment for Diabetic Retinopathy chart at baseline and after 2 years. Statistical associations were sought by means of a generalized linear model. Presence of increased macular AF (P = 0.004), a large area of decreased AF (P < 0.001), or decreased AF at the end of a retinal vessel (P < 0.001) at baseline were significantly associated with worse best-corrected visual acuity. Presence of increased macular AF (P < 0.001) or of localized decreased AF at the end of a retinal vessel (P < 0.001) and the absence of a large area of decreased AF (P < 0.001) were predictive of a subtle but significant drop in best-corrected visual acuity at 2 years. Increased central AF at baseline heralds worse best-corrected visual acuity and predicts further subtle visual loss in a period of 2 years, which, however, does not stand out from the overall slowly progressive natural history of the disease.
    Retina (Philadelphia, Pa.) 04/2014; 34(8). DOI:10.1097/IAE.0000000000000110 · 3.24 Impact Factor
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    ABSTRACT: IMPORTANCE Dietary supplements have been proposed as a mechanism to improve health and prevent disease. OBJECTIVE To determine if supplementing diet with long-chain ω-3 polyunsaturated fatty acids or with macular xanthophylls results in a reduced rate of cardiovascular disease (CVD). DESIGN, SETTING, AND PARTICIPANTS The Cardiovascular Outcome Study (COS) was an ancillary study of the Age-Related Eye Disease Study 2 (AREDS2), a factorial-designed randomized clinical trial of 4203 participants recruited from 82 US academic and community ophthalmology clinics, who were followed up for a median of 4.8 years. Individuals were eligible to participate if they were between the ages of 50 and 85 years, had intermediate or advanced age-related macular degeneration in 1 eye, and were willing to be randomized. Participants with stable, existing CVD (>12 months since initial event) were eligible to participate. Participants, staff, and outcome assessors were masked to intervention. INTERVENTIONS Daily supplementation with long-chain ω-3 polyunsaturated fatty acids (350-mg docosahexaenoic acid [DHA] + 650-mg eicosapentaenoic acid [EPA]), macular xanthophylls (10-mg lutein + 2-mg zeaxanthin), combination of the two, or matching placebos. These treatments were added to background therapy of the AREDS vitamin and mineral formulation for macular degeneration. MAIN OUTCOMES AND MEASURES A composite outcome of myocardial infarction, stroke, and cardiovascular death with 4 prespecified secondary combinations of the primary outcome with hospitalized heart failure, revascularization, or unstable angina. RESULTS Study participants were primarily white, married, and highly educated, with a median age at baseline of 74 years. A total of 602 cardiovascular events were adjudicated, and 459 were found to meet 1 of the study definitions for a CVD outcome. In intention-to-treat analysis, no reduction in the risk of CVD or secondary CVD outcomes was seen for the DHA + EPA (primary outcome: hazard ratio [HR], 0.95; 95% CI, 0.78-1.17) or lutein + zeaxanthin (primary outcome: HR, 0.94; 95% CI, 0.77-1.15) groups. No differences in adverse events or serious adverse event were seen by treatment group. The sample size was sufficient to detect a 25% reduction in CVD events with 80% power. CONCLUSIONS AND RELEVANCE Dietary supplementation of long-chain ω-3 polyunsaturated fatty acids or macular xanthophylls in addition to daily intake of minerals and vitamins did not reduce the risk of CVD in elderly participants with age-related macular degeneration. TRIAL REGISTRATION Identifier: NCT00345176.
    JAMA Internal Medicine 03/2014; 174(5). DOI:10.1001/jamainternmed.2014.328 · 13.12 Impact Factor
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    ABSTRACT: Although children with Autism Spectrum Disorders (ASD) are thought to experience sleep problems at a much higher rate than typically developing peers, the relationship between sleep disturbance and Health-Related Quality of Life (HRQoL) has not been explored within this pediatric population. Further, little is understood about the HRQoL of children with ASD in general. This study assessed the HRQoL and sleep health of a sample of children with ASD and investigated the relationship between HRQoL and overall sleep problems within the context of key clinical characteristics. Study participants included 86 parents of children with ASD between the ages of 4 and 12 years. Subjects were recruited from 3 autism specialty clinics at large academic medical centers and asked to proxy-report on their children's HRQoL and sleep habits. Adjusted regression models showed a consistent negative relationship between sleep disturbance and HRQoL, with greater overall sleep problems being associated with poorer total, physical, and psychosocial HRQoL. Sleep duration and sleep anxiety were also found to be negatively associated with HRQoL. These findings suggest that treatments that are effective in treating sleep disturbances may improve children's HRQoL.
    Research in Autism Spectrum Disorders 03/2014; 8(3):292–303. DOI:10.1016/j.rasd.2013.12.015 · 2.96 Impact Factor
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    ABSTRACT: To evaluate the effects of a home-monitoring device with tele-monitoring compared with standard care in detection of progression to choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), the leading cause of blindness in the US. Patients and methods Participants, aged 53 to 90years, at high risk of developing CNV associated with AMD were recruited to the HOme Monitoring of Eye (HOME) Study, an unmasked, multi-center, randomized trial of the ForeseeHome (FH) device plus standard care vs. standard care alone. The FH device utilizes preferential hyperacuity perimetry and tele-monitoring to detect changes in vision function associated with development of CNV, potentially prior to symptom and visual acuity loss. After establishing baseline measurements, subsequent changes on follow-up are detected by the device, causing the monitoring center to alert the clinical center to recall participants for an exam. Standard care consists of instructions for self-monitoring visual changes with subsequent self-report to the clinical center. The primary objective of this study is to determine whether home monitoring plus standard care in comparison with standard care alone, results in earlier detection of incident CNV with better present visual acuity. The primary outcome is the decline in visual acuity at CNV diagnosis from baseline. Detection of CNV prior to substantial vision loss is critical as vision outcome following anti-angiogenic therapy is dependent on the visual acuity at initiation of treatment. HOME Study is the first large scale study to test the use of home tele-monitoring system in the management of AMD patients.
    Contemporary clinical trials 02/2014; 37(2). DOI:10.1016/j.cct.2014.02.003 · 1.94 Impact Factor
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    ABSTRACT: Objective To determine whether home monitoring with the ForeseeHome device (Notal Vision Ltd, Tel Aviv, Israel), using macular visual field testing with hyperacuity techniques and telemonitoring, results in earlier detection of age-related macular degeneration–associated choroidal neovascularization (CNV), reflected in better visual acuity, when compared with standard care. The main predictor of treatment outcome from anti-vascular endothelial growth factor (VEGF) agents is the visual acuity at the time of CNV treatment. Design Unmasked, controlled, randomized clinical trial. Participants One thousand nine hundred and seventy participants 53 to 90 years of age at high risk of CNV developing were screened. Of these, 1520 participants with a mean age of 72.5 years were enrolled in the Home Monitoring of the Eye study at 44 Age-Related Eye Disease Study 2 clinical centers. Interventions In the standard care and device arms arm, investigator-specific instructions were provided for self-monitoring vision at home followed by report of new symptoms to the clinic. In the device arm, the device was provided with recommendations for daily testing. The device monitoring center received test results and reported changes to the clinical centers, which contacted participants for examination. Main Outcome Measures The main outcome measure was the difference in best-corrected visual acuity scores between baseline and detection of CNV. The event was determined by investigators based on clinical examination, color fundus photography, fluorescein angiography, and optical coherence tomography findings. Masked graders at a central reading center evaluated the images using standardized protocols. Results Seven hundred sixty-three participants were randomized to device monitoring and 757 participants were randomized to standard care and were followed up for a mean of 1.4 years between July 2010 and April 2013. At the prespecified interim analysis, 82 participants progressed to CNV, 51 in the device arm and 31 in the standard care arm. The primary analysis achieved statistical significance, with the participants in the device arm demonstrating a smaller decline in visual acuity with fewer letters lost from baseline to CNV detection (median, −4 letters; interquartile range [IQR], −11.0 to −1.0 letters) compared with standard care (median, −9 letters; IQR, −14.0 to −4.0 letters; P = 0.021), resulting in better visual acuity at CNV detection in the device arm. The Data and Safety Monitoring Committee recommended early study termination for efficacy. Conclusions Persons at high risk for CNV developing benefit from the home monitoring strategy for earlier detection of CNV development, which increases the likelihood of better visual acuity results after intravitreal anti-VEGF therapy.
    Ophthalmology 02/2014; 121(2):535–544. DOI:10.1016/j.ophtha.2013.10.027 · 6.14 Impact Factor

Publication Stats

2k Citations
511.48 Total Impact Points


  • 2003–2015
    • The EMMES Corporation
      Роквилл, Maryland, United States
  • 2009
    • National Institutes of Health
      Maryland, United States
  • 2005–2009
    • National Eye Institute
      Maryland, United States
  • 2004
    • Johns Hopkins Medicine
      Baltimore, Maryland, United States
  • 2001
    • University of Wisconsin–Madison
      • Department of Ophthalmology and Visual Sciences
      Madison, Wisconsin, United States