This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
Participants undergo standard OCT imaging on CIRRUS HD-OCT systems, and the investigational PathFinder software analyzes the images for macular abnormalities without influencing clinical care.
Retina Associates
Tucson, Arizona, United States
RECRUITINGNorthern California Retina Vitreous Associates
Mountain View, California, United States
RECRUITINGPremier Eyecare of San Francisco
San Francisco, California, United States
COMPLETEDNova Southeastern University College of Optometry
Fort Lauderdale, Florida, United States
RECRUITINGEyecare Medical Group
Portland, Maine, United States
RECRUITINGMoyes Eye Center
Kansas City, Missouri, United States
RECRUITINGSensitivity of PathFinder 1.0
Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
Time frame: Baseline (single study visit OCT acquisition)
Specificity of PathFinder 1.0
Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.
Time frame: Baseline (single study visit OCT acquisition)
Sensitivity and specificity by clinical diagnosis
Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group.
Time frame: Baseline
Sensitivity by macular abnormality type
Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.
Time frame: Baseline
Positive Predictive Value and Negative Predictive Value
Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0.
Time frame: Baseline
Rate of acceptable versus unacceptable B-scans
Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable".
Time frame: Baseline
Algorithm repeatability (precision)
Repeatability of PathFinder 1.0 results, expressed as the consistency of the proportion of abnormal B-scans per macular cube across repeated scans.
Time frame: Baseline
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