Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults

Обзор

Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting.

Подробное описание

Aim 1: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (Low Luminance Questionnaire) and to determine whether such differences are associated with life space.

Aim 2: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (objective measures of visual function) and to determine whether such differences are associated with life space.

Вмешательства

• Диагностический тест Life Space Questionnaire
  This 9-item questionnaire is interested in finding out how much a person gets out and about and the spatial extent of the person's typical life space, i.e., what is the usual range of places in which the person engages in activities within the designated time frame.
• Диагностический тест Low Luminance Questionnaire
  This 32-item questionnaire is interested in finding out problems that involve vision under different lighting conditions or feelings that people have about your vision under different lighting conditions.
• Диагностический тест Contrast sensitivity under dim illumination
  Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
• Диагностический тест Visual field under dim illumination (MAIA)
  Sensitivity in the central visual area will be assessed under dim illumination
• Диагностический тест Macular Pigment Optical Density (MPOD)
  Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
• Диагностический тест Dark Adaptation
  After adapting to a dark environment, participants will be exposed a bright flask of light. the time needed for them to recover their sensitivity will be measured.

Первичные конечные точки

• Assessment of life space measured with the Life Space Questionnaire [Срок оценки: Through study completion, an average of 1 year]
• Assessment of vision under low luminance conditions [Срок оценки: Through study completion, an average of 1 year]
• Differences in contrast sensitivity functions between controls and patients [Срок оценки: Through study completion, an average of 1 year]
• Differences in dark adaptation between controls and patients [Срок оценки: Through study completion, an average of 1 year]
• Differences in visual sensitivity under dim illumination between controls and patients [Срок оценки: Through study completion, an average of 1 year]
• Differences in Macular Pigment Optical Density between controls and patients [Срок оценки: Through study completion, an average of 1 year]
• Assessment of the relationship between each the measure of visual function and life space [Срок оценки: Through study completion, an average of 1 year]
• Assessment of the relationship between each the measure of visual function and self-reported visual function under dim illumination [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Inclusion Criteria (Patients):

• Participants that are enrolled in the Early Detection of Glaucoma Progression using a Novel Individualized Approach (IRB-300000301) or in the African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the Lamina Cribrosa in Progression (IRB-161115004).

Exclusion Criteria (Patients):

• Not being enrolled in one of the following two NIH-funded studies: 1. African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the lamina cribrosa in progression (EY026574) or 2. Early detection of glaucoma progression using a novel individualized approach (EY025756)

Inclusion Criteria (Controls):

• No diagnosis of eye disease

Exclusion Criteria (Controls):

• Cognitive impairment that would preclude ability to take the tests

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• University of Alabama Birmingham — Birmingham

Идентификаторы

NCT: NCT04396002 · 300001552 · 5P30AG022838-14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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