Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO
NCT03841734
Arteritis, Arteritis, Giant Cell
Cannes, France
View Trial DetailsNCT Number: NCT00407901
The purpose of this research is to evaluate how accurately a proposed "Functionality Assessment Questionnaire" measures the differences between low-functioning and high-functioning visually challenged individuals who are legally blind.
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Notify Me18 year–80 year
All sexes
Observational
The specific aim of this research is to establish the scientific validity of an evaluation assessment tool that will measure the functional level of the visually challenged population. For this study a quantitative, self-evaluation tool has been designed to assess the functional skills at performing a variety of activities. It is called the Functional Assessment Questionnaire. The questionnaire is an innovative approach to measuring the level of these functional skills. It also includes critical benchmarks of real-world success that are not considered in assessing functional levels of the visually challenged, but are measures of evidence-based outcomes. It is a comprehensive measurement tool covering many areas of daily living, including:
Each of these categories include a progressive scale of 10 activities, 1 being the lowest level of functionality and 10 being the highest level of functionality. Most of the categories are easily self-evaluated, though some will require one-on-one discussion with the test administrator. At the completion of the Functional Assessment Questionnaire, a functionality score, ranging between 14 and 140 is tabulated for each individual.
In order to maintain scientific integrity of the Functional Assessment Questionnaire, certain non-identifiable information will be collected on each human subject. This information includes:
Comparative statistical analysis will be performed with the Functional Assessment Questionnaire results and the widely used SF-36 (36-Item Short Form Health Survey Instrument) and NEI-VFQ-25 with Appendix (National Eye Institute/Visual Function Questionnaire-25) questionnaires. The goal will be to check which questionnaire is more sensitive and accurate in measuring functional level outcomes both prior to (low-functioning individuals) and after (high functioning individuals) vision rehabilitation program participation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
George Washington University
Other
Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind
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