Recruiting NCT07680244
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PathFinder 1.0 on CIRRUS HD-OCT.
- Who it may be relevant to
- Registry conditions: Epiretinal Membrane, Dry Age Related Macular Degeneration, Macular Abnormalities, Retina Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
Interventions
- Device 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 measures
- 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)]
Secondary outcome measures (5)
- Sensitivity and specificity by clinical diagnosis [Time frame: Baseline]
- Sensitivity by macular abnormality type [Time frame: Baseline]
- Positive Predictive Value and Negative Predictive Value [Time frame: Baseline]
- Rate of acceptable versus unacceptable B-scans [Time frame: Baseline]
- Algorithm repeatability (precision) [Time frame: Baseline]
Eligibility criteria
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
1\. 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 6 centers
- Retina Associates — Tucson
- Northern California Retina Vitreous Associates — Mountain View
- Premier Eyecare of San Francisco — San Francisco
- Nova Southeastern University College of Optometry — Fort Lauderdale
- Eyecare Medical Group — Portland
- Moyes Eye Center — Kansas City
Identifiers
NCT: NCT07680244 · CIRRUS-2023-1