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

June 29, 2026 updated by: Carl Zeiss Meditec-Dublin CoCe
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Retina Associates
        • Contact:
          • Study Coordinator
    • California
      • Mountain View, California, United States, 94040
        • Recruiting
        • Northern California Retina Vitreous Associates
        • Contact:
          • Study Coordinator
      • San Francisco, California, United States, 94110
        • Completed
        • Premier Eyecare of San Francisco
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • Recruiting
        • Nova Southeastern University College of Optometry
        • Contact:
          • Study Coordinator
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Eyecare Medical Group
        • Contact:
          • Study Coordinator
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • Moyes Eye Center
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of PathFinder 1.0
Time Frame: Baseline (single study visit OCT acquisition)
Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
Baseline (single study visit OCT acquisition)
Specificity of PathFinder 1.0
Time Frame: Baseline (single study visit OCT acquisition)
Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.
Baseline (single study visit OCT acquisition)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity by clinical diagnosis
Time Frame: Baseline
Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group.
Baseline
Sensitivity by macular abnormality type
Time Frame: Baseline
Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.
Baseline
Positive Predictive Value and Negative Predictive Value
Time Frame: Baseline
Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0.
Baseline
Rate of acceptable versus unacceptable B-scans
Time Frame: Baseline
Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable".
Baseline
Algorithm repeatability (precision)
Time Frame: Baseline
Repeatability of PathFinder 1.0 results, expressed as the consistency of the proportion of abnormal B-scans per macular cube across repeated scans.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec-Dublin CoCe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRRUS-2023-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epiretinal Membrane

Clinical Trials on PathFinder 1.0 on CIRRUS HD-OCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe