PathFinder 1.0 detects retinal abnormalities on macular OCT scans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates how well PathFinder 1.0 identifies retinal abnormalities within the central macula using CIRRUS HD-OCT images. It measures sensitivity and specificity across participants with and without macular pathology in the central 6x6 mm area. Participants will undergo ophthalmic imaging with PathFinder 1.0 applied to CIRRUS scans, comparing automated findings to clinical references. Eligible adults will include two groups: those without macular abnormalities and those with specific macular disruptions, including VRI disruption, IRHS, SRHS, ellipsoid zone disruption, RPE changes, and other abnormalities. The trial is sponsored by Carl Zeiss Meditec and will be conducted at three U.S. retina clinics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Retina Associates
  Tucson, Arizona, United States Recruiting
• Northern California Retina Vitreous Associates
  Mountain View, California, United States Recruiting
• Nova Southeastern University College of Optometry
  Fort Lauderdale, Florida, United States Recruiting
• Eyecare Medical Group
  Portland, Maine, United States Recruiting
• Moyes Eye Center
  Kansas City, Missouri, United States Recruiting
• Premier Eyecare of San Francisco
  San Francisco, California, United States Completed

Study contacts

• Study coordinator: Patricia Sha, Optometrist
• Email: patricia.sha@zeiss.com
• Phone: 925-307-1588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.