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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Carl Zeiss Meditec-Dublin CoCe
Study ID
NCT07680244
Status
Recruiting
Apply to this trial

Conditions

  • Dry Age Related Macular Degeneration
  • Epiretinal Membrane
  • IS/OS (Ellipsoid Zone) Disruption
  • Intraretinal Hyporeflective Space
  • Macular Abnormalities
  • Retina Disease
  • Retinal Pigment Epithelium (RPE) Atrophy
  • Retinal Pigment Epithelium (RPE) Elevation
  • Subretinal Hyporeflective Space
  • Vitreoretinal Abnormality

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PathFinder 1.0 on CIRRUS HD-OCT — DEVICE
    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.

Study Details

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 Dates

Start date
May 23, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Subjects with absence of macular abnormalities
    Subjects with absence of macular abnormalities
  • Other: Subjects with presence of macular abnormalities
    Subjects with presence of macular abnormalities

Primary Outcome Measure

Sensitivity of PathFinder 1.0 [ Time Frame: Baseline (single study visit OCT acquisition) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Retina AssociatesTucsonArizona85704
Study Coordinator
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040
Study Coordinator
Premier Eyecare of San FranciscoSan FranciscoCalifornia94110-
Nova Southeastern University College of OptometryFort LauderdaleFlorida33328
Study Coordinator
Eyecare Medical GroupPortlandMaine04102
study coordinator
Moyes Eye CenterKansas CityMissouri64154
Study Coordinator

Find similar trials in Tucson, AZ

By research site
Retina Associates· Tucson, AZNorthern California Retina Vitreous Associates· Mountain View, CAPremier Eyecare of San Francisco· San Francisco, CANova Southeastern University College of Optometry· Fort Lauderdale, FLEyecare Medical Group· Portland, MEMoyes Eye Center· Kansas City, MO

Related Studies