Recruiting

PathFinder 1.0

Sponsor:

Carl Zeiss Meditec-Dublin CoCe

Code:

NCT07680244

Conditions

Epiretinal Membrane

Dry Age Related Macular Degeneration

Macular Abnormalities

Retina Disease

Vitreoretinal Abnormality

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PathFinder 1.0 on CIRRUS HD-OCT

Study Details

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.

Conditions

Epiretinal Membrane

Dry Age Related Macular Degeneration

Macular Abnormalities

Retina Disease

Vitreoretinal Abnormality

Study ID

NCT07680244

Start date

May 23, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Patricia Sha, Optometrist

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

Locations

Retina Associates

Recruiting

Tucson, Arizona, United States, 85704

Northern California Retina Vitreous Associates

Recruiting

Mountain View, California, United States, 94040

Nova Southeastern University College of Optometry

Recruiting

Fort Lauderdale, Florida, United States, 33328

Eyecare Medical Group

Recruiting

Portland, Maine, United States, 04102

Moyes Eye Center

Recruiting

Kansas City, Missouri, United States, 64154

More Information

Sponsor

Carl Zeiss Meditec-Dublin CoCe

Last update posted

Aug 28, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Carl Zeiss Meditec-Dublin CoCe on 2026-08-28.