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VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:
1. Primary Objective:
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
2. Secondary Objective:
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Validation Ancillary Endpoints
1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.
Observational Model: Case-Crossover, Time Perspective: Prospective
St. Luke's Roosevelt Hospitals
St. Luke's-Roosevelt Hospital Center
Published on BioPortfolio: 2014-08-27T03:13:08-0400
To evaluate health related quality of life (HRQoL) of low-vision patients and their care givers undergoing low-vision rehabilitation program (LVRP).
This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving...
The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.
The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with cent...
1. Purpose a. Examination on Efficacy of Retina Projection System 2. Patients a. Low vision patients 3. Methods 1. Vision aids ...
Veterans with low vision who live in rural communities have limited access to low-vision rehabilitation services, unless they are able to travel several miles to a specialty low-vision clinic. A low-v...
Systematic lighting assessments should be part of low vision evaluations. The LuxIQ has gained popularity as an assessment tool, but its reliability has not been examined independently and is necessar...
Older adults with low vision are a growing population with rehabilitation needs including support with community mobility to enable community participation. Some older adults with low vision choose to...
The prevalence of irreversible vision impairment in the United States is expected to increase by 2050. Vision rehabilitation is the primary treatment option. Clinical trials have established its effic...
The use of self-reported vision is an integral part of most population surveys and is primarily used for healthcare monitoring. Since the patient's assessment is not always consistent with the objecti...
Vision considered to be inferior to normal vision as represented by accepted standards of acuity, field of vision, or motility. Low vision generally refers to visual disorders that are caused by diseases that cannot be corrected by refraction (e.g., MACULAR DEGENERATION; RETINITIS PIGMENTOSA; DIABETIC RETINOPATHY, etc.).
Application of tests and examinations to identify visual defects or vision disorders occurring in specific populations, as in school children, the elderly, etc. It is differentiated from VISION TESTS, which are given to evaluate/measure individual visual performance not related to a specific population.
Defects of color vision are mainly hereditary traits but can be secondary to acquired or developmental abnormalities in the CONES (RETINA). Severity of hereditary defects of color vision depends on the degree of mutation of the ROD OPSINS genes (on X CHROMOSOME and CHROMOSOME 3) that code the photopigments for red, green and blue.
Type of vision test used to determine COLOR VISION DEFECTS.
Failure or imperfection of vision at night or in dim light, with good vision only on bright days. (Dorland, 27th ed)
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...