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NCT Number: NCT07680244

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

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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Key information

Conditions

Epiretinal Membrane Atrophy Dry Age Related Macular Degeneration Eye Diseases IS/OS (Ellipsoid Zone) Disruption Intraretinal Hyporeflective Space Macular Abnormalities Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Retina Disease Retinal Diseases Retinal Pigment Epithelium (RPE) Atrophy Retinal Pigment Epithelium (RPE) Elevation Subretinal Hyporeflective Space Vitreoretinal Abnormality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Retina Associates, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Sensitivity and specificity by clinical diagnosis

    Time frame: Baseline

    Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group.

  2. Sensitivity by macular abnormality type

    Time frame: Baseline

    Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.

  3. 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.

  4. 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".

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Sha, Optometrist

CONTACT

[email protected]

925-307-1588

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec-Dublin CoCe

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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