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

Purpose

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

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Subjects with absence of macular abnormalities 		Subjects with absence 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.
Other
Subjects with presence of macular abnormalities 		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.

Recruiting Locations

Retina Associates
Tucson, Arizona 85704
Contact:
Study Coordinator

Northern California Retina Vitreous Associates
Mountain View, California 94040
Contact:
Study Coordinator

Nova Southeastern University College of Optometry
Fort Lauderdale, Florida 33328
Contact:
Study Coordinator

Eyecare Medical Group
Portland, Maine 04102
Contact:
study coordinator

Moyes Eye Center
Kansas City, Missouri 64154
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
Carl Zeiss Meditec-Dublin CoCe

Study Contact

Patricia Sha, Optometrist
925-307-1588
patricia.sha@zeiss.com