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Evaluation of PathFinder 1.0 Software for Detecting Macular Abnormalities Using CIRRUS 6000 and 5000 OCT Systems in Adults
Led by Carl Zeiss Meditec-Dublin CoCe · Updated on 2026-07-02
400
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of PathFinder 1.0 software in detecting retinal abnormalities using OCT B-scans from CIRRUS 6000 and 5000 imaging systems. The study aims to measure the sensitivity and specificity of this diagnostic tool in adults with and without various macular abnormalities affecting the central macula. Participants will undergo standard OCT imaging on CIRRUS HD-OCT systems. The PathFinder 1.0 software will analyze these images to identify macular abnormalities such as vitreoretinal interface disruption, hyporeflective spaces within or beneath the retina, ellipsoid zone disruption, and retinal pigment epithelium changes. This is a device study with two groups subjects with no macular abnormalities and subjects with specific retinal changes. The software analysis does not affect clinical care. Participants will attend a single study visit for OCT image acquisition. The study will assess the softwares ability to correctly identify abnormalities by calculating sensitivity, specificity, positive and negative predictive values, rate of acceptable scans, and algorithm repeatability. Participants must be able to complete ophthalmic imaging and comply with study instructions. The total participation involves just this baseline imaging visit with no treatment intervention or follow-up required.
CONDITIONS
Brief Title
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Subjects without macular abnormalities or with specified macular abnormalities including vitreoretinal interface disruption, intraretinal hyporeflective space, subretinal hyporeflective space, ellipsoid zone disruption, retinal pigment epithelium elevation or atrophy, and other abnormalities in the central 6x6 mm macula area
You will not qualify if you...
- Inability to undergo the required tests
- Unable to give consent or follow study instructions
- Inability to fixate that prevents obtaining acceptable macula scans in the study eye
- Visudyne (verteporfin) injection within the last 48 hours in the study eye
- Use of pilocarpine or Vuity within the last 24 hours in the study eye
- Dense media opacity that prevents adequate visualization of the retina in the study eye
- Vitreous floaters that prevent obtaining acceptable scans in the study eye
Research Team
P
Patricia Sha, Optometrist
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