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.
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: 1. 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. 2. To compare the extent of geographic atrophy on SDOCT versus color photographs and autofluorescence. 3. To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.
Study Type
OBSERVATIONAL
Enrollment
470
Emory University Eye Center
Atlanta, Georgia, United States
National Eye Institute
Bethesda, Maryland, United States
Duke University Eye Center
Durham, North Carolina, United States
Devers Eye Center
Portland, Oregon, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years and 5 years
Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy.
Time frame: 2 years and 5 years
Measurement of area of GA from SDOCT images versus color fundus photos versus AF images.
Time frame: 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.
Time frame: 5 years
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