(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000

Recruiting now · Not applicable

Conditions studied: 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

In brief

This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.

Key facts

Study ID

NCT07680244

Run by

Carl Zeiss Meditec-Dublin CoCe

People needed

400

Starts

2025-05-23

Expected to finish

2026-08-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able and willing to make the required study visits.
• Able and willing to give written informed consent and follow study instructions.
• Able and willing to complete ophthalmic imaging.
• 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
• Subjects with absence of macular abnormalities Group B
• Subjects with Disruption of the vitreoretinal interface (VRI)
• Subjects with Intraretinal hyporeflective space (IRHS)
• Subjects with Subretinal hyporeflective space (SRHS)
• Subjects with IS/OS (Ellipsoid Zone) disruption
• Subjects with Retinal Pigment Epithelium (RPE) elevation
• Subjects with Retinal Pigment Epithelium (RPE) atrophy
• Other abnormalities

You may not qualify if…

• Inability to undergo the required tests.
• Unable to give consent or follow study instructions.
• Inability to fixate that precludes obtaining acceptable macula scans in the study eye.
• Visudyne (verteporfin) injection within the last 48 hours in the study eye.
• Pilocarpine or Vuity use within the last 24 hours in the study eye.
• Dense media opacity precluding adequate visualization of the retina in the study eye.
• Vitreous floaters that preclude obtaining acceptable scans in the study eye.

Where it is running

• Retina Associates — Tucson, Arizona, United States (enrolling)
• Northern California Retina Vitreous Associates — Mountain View, California, United States (enrolling)
• Nova Southeastern University College of Optometry — Fort Lauderdale, Florida, United States (enrolling)
• Eyecare Medical Group — Portland, Maine, United States (enrolling)
• Moyes Eye Center — Kansas City, Missouri, United States (enrolling)
• Premier Eyecare of San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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