Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 4
- 主要终点
- Primary outcome measures are the percent of eyes developing CNV, mean change in visual acuity, and change in drusen volume, area of GA and photoreceptor layer thickness from SDOCT centered on the fovea.
研究概览
简要总结
The purpose of this study is to identify whether changes in age-related macular degeneration (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging, can be used to predict vision loss and the advancement of AMD in people at moderate to high risk for progression.
详细描述
The primary objective of this study is to identify whether SDOCT patterns such as: drusen size, OCT reflectivity within drusen, photoreceptor (PR)change over drusen, microfoci of subretinal fluid (SRF), or retinal thickening are predictive of vision loss, progression of drusen, progression of photoreceptor loss over drusen, development of choroidal neovascularization (CNV), or development of geographic atrophy (GA).
The secondary objectives of this study are:
- To define the relationship between SDOCT imaging, autofluorescence (AF)imaging, and color photographic or other fundus imaging of AREDS 2 patients in both a cross-sectional study of baseline data and a longitudinal study in data collected over the 5 year AREDS 2 study.
- To compare the extent of geographic atrophy on SDOCT versus color photographs and autofluorescence.
- To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AMD subjects and controls
- •Men and women between the ages of 50 and 85 years
- •AMD subjects
- •Enrollment in the AREDS 2 trial;
- •Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye
排除标准
- •Ocular media not clear enough to allow good fundus photography.
结局指标
主要结局
Primary outcome measures are the percent of eyes developing CNV, mean change in visual acuity, and change in drusen volume, area of GA and photoreceptor layer thickness from SDOCT centered on the fovea.
时间窗: 2 years and 5 years
次要结局
- Measurement of area of GA from SDOCT images versus color fundus photos versus AF images.(2 years and 5 years)
- Drusen area measured from SDOCT versus from color fundus photographs. Mean change in drusen area reproducibility of measurements using these techniques.(2 years and 5 years)
- Grading of drusen type, presence or absence of fluid, photoreceptor loss or retinal thickening from SDOCT versus from color fundus photographs at each timepoint.(2 years and 5 years)
- Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy.(2 years and 5 years)
- To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.(5 years)