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

NCT07680244 — Not applicable, Recruiting, 400 participants, Carl Zeiss Meditec-Dublin CoCe

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RegistryNCT07680244
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, single group, masking: none, diagnostic
Enrollment400 (Estimated)
SponsorCarl Zeiss Meditec-Dublin CoCe (Industry)
ConditionsEpiretinal 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
InterventionsPathFinder 1.0 on CIRRUS HD-OCT (Device)
Datesstart 2025-05-23, primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-07-02, last updated 2026-08-28
Locations6 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Epiretinal Membrane All trials for Dry Age Related Macular Degeneration All trials of PathFinder 1.0 on CIRRUS HD-OCT

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Subjects with absence of macular abnormalitiesOtherDevice: PathFinder 1.0 on CIRRUS HD-OCTSubjects with absence of macular abnormalities
Subjects with presence of macular abnormalitiesOtherDevice: PathFinder 1.0 on CIRRUS HD-OCTSubjects with presence of macular abnormalities
  • 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.

+Outcome measures

Primary outcomes

  • Sensitivity of PathFinder 1.0 [Baseline (single study visit OCT acquisition)]: Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
  • Specificity of PathFinder 1.0 [Baseline (single study visit OCT acquisition)]: Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (6)

FacilityCityCountryStatus
Retina AssociatesTucson, ArizonaUnited StatesRecruiting
Northern California Retina Vitreous AssociatesMountain View, CaliforniaUnited StatesRecruiting
Premier Eyecare of San FranciscoSan Francisco, CaliforniaUnited StatesCompleted
Nova Southeastern University College of OptometryFort Lauderdale, FloridaUnited StatesRecruiting
Eyecare Medical GroupPortland, MaineUnited StatesRecruiting
Moyes Eye CenterKansas City, MissouriUnited StatesRecruiting