Abstract:
:The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.
journal_name
Vis Neuroscijournal_title
Visual neuroscienceauthors
Drum Bdoi
10.1017/s0952523804213256subject
Has Abstractpub_date
2004-05-01 00:00:00pages
461-3issue
3eissn
0952-5238issn
1469-8714pii
S0952523804213256journal_volume
21pub_type
杂志文章abstract::Many diverse retinal disorders are characterized by retinal edema; yet, little experimental attention has been given to understanding the fundamental mechanisms underlying and contributing to these fluid-based disorders. Water transport in and out of cells is achieved by specialized membrane channels, with most rapid ...
journal_title:Visual neuroscience
pub_type: 杂志文章,评审
doi:10.1017/S0952523809090038
更新日期:2009-03-01 00:00:00
abstract::Population-based studies of retinal neurons have helped to reveal their natural types in mammals and teleost fishes. In this, the first such study in a frog, labeled ganglion cells of the mesobatrachian Xenopus laevis were examined in flatmounts. Cells with large somata and thick dendrites could be divided into three ...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s095252380001155x
更新日期:1997-09-01 00:00:00
abstract::A series of psychophysical tests examining early and later aspects of image-motion processing were conducted in a patient with bilateral lesions involving the posterior visual pathways, affecting the lateral parietal-temporal-occipital cortex and the underlying white matter (as shown by magnetic resonance imaging stud...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800000444
更新日期:1990-10-01 00:00:00
abstract::Natural scenes contain a variety of visual cues that facilitate boundary perception (e.g., luminance, contrast, and texture). Here we explore whether single neurons in early visual cortex can process both contrast and texture cues. We recorded neural responses in cat A18 to both illusory contours formed by abutting gr...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523807070113
更新日期:2007-01-01 00:00:00
abstract::AMPA-selective glutamate receptors play a major role in glutamatergic neurotransmission in the retina and are expressed in a variety of neuronal subpopulations. In the present study, immunocytochemical techniques were used to visualize the distribution of GluR2 and GluR4 subunits in the cat retina. Results were compar...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523899166100
更新日期:1999-11-01 00:00:00
abstract::The topographical distributions of the relative ratio of long- (L) and middle- (M) wavelength sensitive cone opsin messenger RNA (mRNA) in human and baboon retinas were mapped using real-time polymerase chain reaction. The L:M mRNA ratio increased in a central-to-peripheral gradient in both species, being quite pronou...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S095252380623325X
更新日期:2006-05-01 00:00:00
abstract::To test the hypothesis that light-evoked cone contraction in eye cups from Xenopus laevis is controlled through a direct mechanism initiated by the cone's own photopigment, we conducted spectral-sensitivity experiments. We estimate that initiation of contraction of red absorbing cones (611 nm) is 1.5 log units more se...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800002893
更新日期:1992-03-01 00:00:00
abstract::We examine the assumptions that the fovea contains equal numbers of inner (invaginating or ON) and outer (flat or OFF) midget bipolar cells and equal numbers of inner and outer diffuse bipolar cells. Based on reconstruction from electron photomicrographs of serial thin sections through the fovea of a macaque monkey, w...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523803202091
更新日期:2003-03-01 00:00:00
abstract::Adult teleost fish retinas can regenerate neurons following either surgical or pharmacological injury. The cellular milieu of the damaged retina within which regenerated neurons are produced might be different in these two model systems of retinal injury, and thus the phenotypic attributes of regenerated neurons in th...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800174115
更新日期:2000-07-01 00:00:00
abstract::Studies of the numbers of retinal ganglion cells and lateral geniculate nucleus (LGN) neurons in primates suggest that the numbers of both types of neurons may vary over a two-fold range from one individual to another. This raises the question of whether the numbers of ganglion cells and LGN neurons are related or var...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800007239
更新日期:1996-01-01 00:00:00
abstract::Single isolated photoreceptors can be taken through a visual cycle of light adaptation by bleaching visual pigment, followed by dark adaptation when supplied with 11-cis retinal. Light adaptation after bleaching is manifested by faster response kinetics and a permanent reduction in sensitivity to light flashes, presum...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800001735
更新日期:1994-03-01 00:00:00
abstract::The retinae of insectivores have been rarely studied, and their photoreceptor arrangements and expression patterns of visual pigments are largely unknown. We have determined the presence and distribution of cones in three species of shrews (common shrew Sorex araneus, greater white-toothed shrew Crocidura russula, dar...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800176138
更新日期:2000-11-01 00:00:00
abstract::The multi-input technique of Sutter and Tran (1992) yields multiple focal ERGs. The purpose here was to compare the components of this multifocal ERG to the components of the standard, full-field ERG. To record multifocal ERGs, an array of 103 hexagons was displayed on a monitor. Full-field (Ganzfeld) ERGs were elicit...
journal_title:Visual neuroscience
pub_type: 临床试验,杂志文章
doi:10.1017/s0952523800012190
更新日期:1997-05-01 00:00:00
abstract::The objective of this study was to evaluate the maturity of three inhibitory mechanisms (end-inhibition, side-inhibition, and cross-orientation inhibition) in the striate cortex of kittens at 4 weeks postnatal. To accomplish this, we made extracellular recordings from area 17 neurons while presenting visual stimuli co...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800007756
更新日期:1996-11-01 00:00:00
abstract::The human visual system is remarkably tolerant to degradation in image resolution: human performance in scene categorization remains high no matter whether low-resolution images or multimegapixel images are used. This observation raises the question of how many pixels are required to form a meaningful representation o...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523808080930
更新日期:2009-01-01 00:00:00
abstract::Nucleus rotundus and nucleus dorsolateralis posterior (DLP) are the thalamic components of two parallel pathways within the tectofugal division of the pigeon visual system. An earlier study (Hodos, Weiss & Bessette, 1986) had shown that lesions in direct telencephalic recipients of projections from rotundus and DLP pr...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800001036
更新日期:1988-01-01 00:00:00
abstract::Visual perception is not instantaneous; the perceptual representation of our environment builds up over time. This can strongly affect our responses to visual stimuli. Here, we study the temporal dynamics of visual processing by analyzing the time course of priming effects induced by the well-known Ebbinghaus illusion...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523816000134
更新日期:2016-01-01 00:00:00
abstract::The period of susceptibility for binocular depth vision was studied in kittens by subjecting them to periods of monocular deprivation beginning at different ages. In an initial study, we found that normally reared kittens can learn a depth-discrimination task much more rapidly when tested binocularly than monocularly,...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800000341
更新日期:1990-09-01 00:00:00
abstract::Reduction of blood flow to the rat retina was achieved by either clamping both carotid arteries briefly (24 min) or combining clamping of the carotid arteries with permanent occlusion of the vertebral arteries. Analysis of retinas 6 days after operations showed that GFAP immunoreactivity is expressed throughout the re...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800010427
更新日期:1991-12-01 00:00:00
abstract::Immunohistochemical techniques were used to survey the distribution of several conventional transmitters, receptors, and neuropeptides in the pigeon nucleus of the basal optic root (nBOR), a component of the accessory optic system. Amongst the conventional neurotransmitters/modulators, the most intense labeling of fib...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800005964
更新日期:1989-11-01 00:00:00
abstract::Absorbance spectra of cone outer segments and oil droplets were recorded microspectrophotometrically in the retina of the red-eared turtle, Trachemys scripta elegans. There are four cone visual pigments, with lambda(max) = 617 nm (red sensitive), 515 nm (green sensitive), 458 nm (blue sensitive), and 372 nm (UV-sensit...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523801185081
更新日期:2001-09-01 00:00:00
abstract::Although galvanic vestibular stimulation (GVS) is known to affect the speed and accuracy of visual judgments, the underlying electrophysiological response has not been explored. In the present study, we therefore investigated the effect of GVS on the N170 event-related potential, a marker commonly associated with earl...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523812000235
更新日期:2012-09-01 00:00:00
abstract::Agrin is a large extracellular matrix protein that directs the accumulation of acetylcholine receptors at the neuromuscular junction. Recent evidence suggests that agrin may be involved in organizing synapses in the visual system as well. Focussing on the pathway that controls accommodation and pupilloconstriction, th...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800007537
更新日期:1996-03-01 00:00:00
abstract::During their complex life history, anguilliform eels go through a major metamorphosis when developing from a fresh water yellow eel into a deep-sea silver eel. In addition to major changes in body morphology, the visual system also adapts from a fresh water teleost duplex retina with rods and cones, to a specialized d...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523808080152
更新日期:2008-05-01 00:00:00
abstract::The outer plexiform layer of the retina contains a neural circuit in which cone synaptic terminals are electrically coupled and release glutamate onto wide-field and narrow-field horizontal cells. These are also electrically coupled and feed back through a GABAergic synapse to cones. In cat this circuit's structure is...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800008440
更新日期:1995-05-01 00:00:00
abstract::We have investigated the effects of inactivation of localized sites in area 17 on the visual responses of cells in visuotopically corresponding regions of area 18. Experiments were performed on adult normal cats. The striate cortex was inactivated by the injection of nanoliters of lidocaine hydrochloride or of gamma-a...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800001826
更新日期:1992-12-01 00:00:00
abstract::A new tissue slice preparation of the cuttlefish eye is described that permits patch-clamp recordings to be acquired from intact photoreceptors during stimulation of the retina with controlled light flashes. Whole-cell recordings using this preparation, from the retinas of very young Sepia officinalis demonstrated tha...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/S0952523805223106
更新日期:2005-05-01 00:00:00
abstract::Rod and cone photoresponses in a variety of species have been accurately described with linear multistage filter models. In this study, the response latency and initial coding of intensity at two higher levels of visual processing are related to such photoreceptor responses. One level is the retinal output (spiking di...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800012499
更新日期:1989-07-01 00:00:00
abstract::Visually guided saccadic eye movements to singly presented stationary targets form a bimodal distribution. After superior colliculus lesions, the so called "express saccades" that form the first mode of the distribution are no longer obtained. The aim of this study was to determine what role several other neural syste...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800001590
更新日期:1994-03-01 00:00:00
abstract::We have described the currents flowing across the presynaptic membranes of the four median photoreceptors of the giant barnacle, Balanus nubilus, using a quasi-voltage clamp arrangement. Membrane potential, measured in the terminal region of one photoreceptor, was controlled in all four terminals by feedback current s...
journal_title:Visual neuroscience
pub_type: 杂志文章
doi:10.1017/s0952523800003667
更新日期:1993-03-01 00:00:00