NCT07680244NARecruitingAccepts Healthy Volunteers
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Carl Zeiss Meditec-Dublin CoCe
Start Date
5/23/2025
Completion Date
8/1/2026
Summary
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
PathFinder 1.0 on CIRRUS HD-OCT
Conditions
Epiretinal MembraneDry Age Related Macular DegenerationMacular AbnormalitiesRetina DiseaseVitreoretinal AbnormalityIntraretinal Hyporeflective SpaceSubretinal Hyporeflective SpaceIS/OS (Ellipsoid Zone) DisruptionRetinal Pigment Epithelium (RPE) ElevationRetinal Pigment Epithelium (RPE) Atrophy
Locations
Retina Associates
Tucson, Arizona 85704
United States
Northern California Retina Vitreous Associates
Mountain View, California 94040
United States
Premier Eyecare of San Francisco
San Francisco, California 94110
United States
Nova Southeastern University College of Optometry
Fort Lauderdale, Florida 33328
United States
Eyecare Medical Group
Portland, Maine 04102
United States
Moyes Eye Center
Kansas City, Missouri 64154
United States