An interventional study of PathFinder 1.0 on CIRRUS HD-OCT in Epiretinal Membrane, Dry Age Related Macular Degeneration and Macular Abnormalities, sponsored by Carl Zeiss Meditec-Dublin CoCe. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Carl Zeiss Meditec-Dublin CoCe (part of Carl Zeiss Meditec AG) · Not applicable, Interventional, and Diagnostic
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.
This study's planned enrollment of 400 is above the median of 51 across 79 interventional studies indexed under Epiretinal Membrane.
Browse Epiretinal Membrane studies →This is the only study on the registry with Carl Zeiss Meditec-Dublin CoCe as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The subject population will be comprised of two groups (all categories below pertain to the central 6x6 mm macula area):
Group A
1. Subjects with absence of macular abnormalities Group B
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with absence of macular abnormalities
Device: PathFinder 1.0 on CIRRUS HD-OCT
Subjects with presence of macular abnormalities
Device: PathFinder 1.0 on CIRRUS HD-OCT
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.
Sensitivity 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
Not enrolling at this site.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.