| Registry | NCT07680244 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: none, diagnostic |
| Enrollment | 400 (Estimated) |
| Sponsor | Carl Zeiss Meditec-Dublin CoCe (Industry) |
| Conditions | Epiretinal Membrane, Dry Age Related Macular Degeneration, Macular Abnormalities, Retina Disease, Vitreoretinal Abnormality, Intraretinal Hyporeflective Space, Subretinal Hyporeflective Space, IS/OS (Ellipsoid Zone) Disruption, Retinal Pigment Epithelium (RPE) Elevation, Retinal Pigment Epithelium (RPE) Atrophy |
| Interventions | PathFinder 1.0 on CIRRUS HD-OCT (Device) |
| Dates | start 2025-05-23, primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-07-02, last updated 2026-08-28 |
| Locations | 6 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Epiretinal Membrane All trials for Dry Age Related Macular Degeneration All trials of PathFinder 1.0 on CIRRUS HD-OCT
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Subjects with absence of macular abnormalities | Other | Device: PathFinder 1.0 on CIRRUS HD-OCT | Subjects with absence of macular abnormalities |
| Subjects with presence of macular abnormalities | Other | Device: PathFinder 1.0 on CIRRUS HD-OCT | Subjects with presence of macular abnormalities |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: 1. Able and willing to make the required study visits. 2. Able and willing to give written informed consent and follow study instructions. 3. Able and willing to complete ophthalmic imaging. 4. Adults 18 years of age or older. 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 1. Subjects with Disruption of the vitreoretinal interface (VRI) 2. Subjects with Intraretinal hyporeflective space (IRHS) 3. Subjects with Subretinal hyporeflective space (SRHS) 4. Subjects with IS/OS (Ellipsoid Zone) disruption 5. Subjects with Retinal Pigment Epithelium (RPE) elevation 6. Subjects with Retinal Pigment Epithelium (RPE) atrophy 7. Other abnormalities Exclusion Criteria: 1. Inability to undergo the required tests. 2. Unable to give consent or follow study instructions. 3. Inability to fixate that precludes obtaining acceptable macula scans in the study eye. 4. Visudyne (verteporfin) injection within the last 48 hours in the study eye. 5. Pilocarpine or Vuity use within the last 24 hours in the study eye. 6. Dense media opacity precluding adequate visualization of the retina in the study eye. 7. Vitreous floaters that preclude obtaining acceptable scans in the study eye.
| Facility | City | Country | Status |
|---|---|---|---|
| Retina Associates | Tucson, Arizona | United States | Recruiting |
| Northern California Retina Vitreous Associates | Mountain View, California | United States | Recruiting |
| Premier Eyecare of San Francisco | San Francisco, California | United States | Completed |
| Nova Southeastern University College of Optometry | Fort Lauderdale, Florida | United States | Recruiting |
| Eyecare Medical Group | Portland, Maine | United States | Recruiting |
| Moyes Eye Center | Kansas City, Missouri | United States | Recruiting |