NCT07680244

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 17, 2026

Last Update Submit

June 29, 2026

Conditions

Subretinal Hyporeflective SpaceRetinal Pigment Epithelium (RPE) AtrophyIntraretinal Hyporeflective SpaceEpiretinal MembraneDry Age Related Macular DegenerationMacular AbnormalitiesRetina DiseaseVitreoretinal AbnormalityIS/OS (Ellipsoid Zone) DisruptionRetinal Pigment Epithelium (RPE) Elevation

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of PathFinder 1.0

    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

    Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.

    Baseline (single study visit OCT acquisition)

Secondary Outcomes (5)

  • Sensitivity and specificity by clinical diagnosis

    Baseline

  • Sensitivity by macular abnormality type

    Baseline

  • Positive Predictive Value and Negative Predictive Value

    Baseline

  • Rate of acceptable versus unacceptable B-scans

    Baseline

  • Algorithm repeatability (precision)

    Baseline

Study Arms (2)

Subjects with absence of macular abnormalities

OTHER

Subjects with absence of macular abnormalities

Device: PathFinder 1.0 on CIRRUS HD-OCT

Subjects with presence of macular abnormalities

OTHER

Subjects with presence of macular abnormalities

Device: PathFinder 1.0 on CIRRUS HD-OCT

Interventions

PathFinder 1.0 on CIRRUS HD-OCTDEVICE

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.

Subjects with absence of macular abnormalitiesSubjects with presence of macular abnormalities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Retina Associates

Tucson, Arizona, 85704, United States

RECRUITING

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

RECRUITING

Premier Eyecare of San Francisco

San Francisco, California, 94110, United States

COMPLETED

Nova Southeastern University College of Optometry

Fort Lauderdale, Florida, 33328, United States

RECRUITING

Eyecare Medical Group

Portland, Maine, 04102, United States

RECRUITING

Moyes Eye Center

Kansas City, Missouri, 64154, United States

RECRUITING

MeSH Terms

Conditions

Epiretinal MembraneAtrophy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Sha, Optometrist

CONTACT

925-307-1588patricia.sha@zeiss.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 2, 2026

Study Start

May 23, 2025

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(6)