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- Naldi, L., et al.
(författare)
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Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: update of the EDEN Psoriasis Survey 2001-2006
- 2010
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Ingår i: British Journal of Dermatology. - : Oxford University Press (OUP). - 1365-2133 .- 0007-0963. ; 162:2, s. 384-389
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Tidskriftsartikel (refereegranskat)abstract
- Background Several new therapeutic options for psoriasis have been tested in clinical trials in recent years. Choice of comparator, study duration and outcome measures are critical for interpreting application of trial results to clinical practice. Objectives We examined whether these trial aspects have changed substantially in recent years in comparison with the past. Methods A systematic search and evaluation of all randomized controlled trials (RCTs) for psoriasis published from January 2001 up to December 2006 in 14 leading medical and dermatological journals, compared with those published from 1977 to 2000. Results There were 140 RCTs of psoriasis in the period 2001-2006 and 249 in the period 1977-2000. The proportion of placebo-controlled studies increased from 44.6% to 69.3%. The median study duration increased from 7 weeks to 12 weeks. The proportion of studies adopting the Psoriasis Area and Severity Index score as an outcome increased from 30.6% to 57.7%, while the number of studies incorporating a quality of life measure increased from only one (0.4%) to 12 studies (7.7%). The proportion of studies sponsored by pharmaceutical companies increased from 61.0% to 73.7%. Conclusions Despite the increased number of new options, the number of head-to-head comparative trials has decreased and most trials focus on short-term effects, probably reflecting the increased influence of industrial sponsorship on the research agenda.
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- Alahamami, Mastour A., et al.
(författare)
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Comparison of cysts in red and green images for diabetic macular edema
- 2014
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Konferensbidrag (refereegranskat)abstract
- Purpose: To improve the detection of macular cyst with photoscreening, we tested whether in a population of largely minority patients the red channel image from a color fundus camera visualizes cysts in diabetic macular edema better than the green channel image. In assessing diabetic retinas for clinically significant macular edema, the presence of cysts must be judged with respect to the central macula. Some grading programs use red free images, often derived from green channel images, to enhance visualization of retinal vessel damage or macular pigment, but some red and near infrared instruments have detected cysts better than short wavelength techniques. Methods: We evaluated macular cysts in 13 diabetic patients diagnosed with clinically significant macular edema, age range 33-68 years. Diabetic patients were selected from the screening study of >2000 underserved patients seen at Eastmont Wellness Center, Oakland, CA. Patients underwent photoscreening with a nonmydriatic color fundus camera (Canon Cr-DGi, Tokyo, Japan) and SD-OCT (iVue, Optovue Inc, Fremont, CA). The color fundus images for those patients were transformed into red and green channels to evaluate the appearance of macular cysts in red channel images and green channel images. The region of each cyst was compared SD-OCT scans (Adobe Photoshop CS5.1, San Jose, CA). Only cysts touching the central 1 mm around the fixation from the SD-OCT scans were sampled. Results: The average size of retinal cysts in red channel images, 124.57 µm (±106.96), was significantly greater than in green channel, 59.44 µm (±76.6), (p<0.006). Entire cysts could not be seen in 5 eyes in the green channel images. Conclusions: Our results indicate that the grading of cysts in the central macular might be improved by incorporating red channel images. There are a number of potential factors that could make cysts less visible in the green channel images, including poorer light penetration through to the deeper retina or macular pigment. Anterior segment issues impact more on green channel images. This population includes mostly minority patients who have dark fundi, and darker images.
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- Baskaran, Karthikeyan, et al.
(författare)
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Stability of fixation in diabetes patients with and without clinically significant macular edema
- 2014
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Konferensbidrag (refereegranskat)abstract
- Purpose - Eye diseases affecting central vision impair fixation and interfere with day-to-day tasks such as reading. Diabetic retinopathy and clinically significant macular edema (CSME) are leading causes of visual impairment in diabetes patients. The aim of this study is to find whether diabetic patients with CSME have poorer fixation stability compared to patients without CSME, by analyzing the fundus images obtained from the Laser Scanning Digital Camera (LSDC).Methods - Two hundred underserved, diabetic patients were screened for diabetic retinopathy at the Eastmont Wellness Center within the EyePACS telemedicine network, using LSDC. One eye of each patient who had diabetic retinopathy was included in this study. Non-mydriatic color fundus photos were classified for presence of CSME by two independent, certified EyePACS graders. The first 50 patients (25 males & 25 females) with CSME were selected and 50 (27 males & 23 females) diabetic patients without CSME were selected as controls. Mean age was 59 (±9) years for patients with CSME and was 55 (±10) years for patients without CSME. The subjects included 53% Hispanics, 26% African Americans and 21% other. A series of 20 images (36 deg field, 1024 X 1024 pixels, and 850 nm) were acquired at 11 fps. Eye positions were obtained by selecting a region of interest in the first image of each series and aligning the remaining images to that region by cross-correlation. The bi-contour ellipse area (BCEA) and the standard deviation of the Euclidean distance (SDED) were used to quantify fixation stability.Results - The fixation stability for patients with CSME was significantly worse than for those without CSME (t test: p < 0.001, 0.007 for BCEA and SDED, respectively). The mean fixation stability obtained by the BCEA metric was 2.74 (±0.40) log(minArc2) and 2.34 (±0.42) log(minArc2) for patients with and without CSME, respectively. For SDED the mean was 48.4 (±28.8) microns and 34.6 (±20.4) microns for patients with and without CSME, respectively. The correlation with age was not significant for either group (R2 = 0.052, 0.011).Conclusions - Diabetic patients with CSME had poorer fixation stability than patients without CSME for both metrics. Fixation stability is a potential tool for assessing macular function and could be used for tracking the treatment and progression of macular edema.The LSDC images provide one method to quantify fixation stability rapidly.
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- Green, Jason J. A., et al.
(författare)
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Retina Artery to Vein Intensity Ratio as a Function of Wavelength and Dark-Field Offset With Low Cost Ophthalmoscope
- 2014
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Konferensbidrag (refereegranskat)abstract
- PurposeTo quantify light return from retinal vessels for oxygenation status. To use a low-cost Digital Light Ophthalmoscope (DLO) based on a novel structured light pattern Digital Light Projector for quantitative retinal imaging. MethodsFive normal subjects of ages 27-63 and various eye colors were imaged without mydriasis. The DLO produced a progressively scanning 6 pixel wide stripe, 96 stripe illumination pattern (85 μm stripe width at retina) with LEDs at 635 +/- 25nm (Red) and 535 +/- 70nm (Green) with a constant fixation target location across tests. The illumination was synchronized to a 13.2 Hz rolling shutter CMOS sensor (11 μm resolution at retina). To collect the light return from the retina at varying light multiply scattered levels, aperture offset was varied in position with respect to the illumination centerline: dark-field mode was obtained with large offsets and confocal mode had small offsets, where offset was varied from -517 μm (row start 30) to 1353 μm (row start 200). Multiple images of 12 bit dynamic range were captured in sequence, aligned with translational cross correlation, then time averaged to reduce noise. The artery and vein gray scale intensity level was measured at vessel centers for: 1) both vessels over background retina and 2) artery over the optic disc and vein over background. Mean-to-mean intensity ratios were then compared. ResultsWith an aperture width of 704 μm, intensity varied by 2.60 bits (a factor of 4.5) for each subject per condition: red, green, artery, and vein, 3.39 bits if same subject and condition (2.3% Red A/V ratio CoV σ/μ), and by 5.07 bits over all tests. Yet, the ratio (Red/Green Artery)/(Red/Green Vein) was close to unity across offsets and linear fits had an R^2 regression of, for case 1: 0.72, 0.06, 0.25, 0.18, and 0.49, and case 2: 0.0005, 0.89, 0.75, 0.50, and 0.18. The Artery/Vein ratio trend slopes, intercept points, and inversions varied between subjects, i.e. contrast reversals were observed. ConclusionsThe DLO can be utilized electronically to effectively perform quantitative fundus imaging at both Red and Green wavelengths, which is a step towards performing oximetry. 77 is zero offset
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