Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

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