NCT07680244 (CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
| NCT ID | NCT07680244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carl Zeiss Meditec-Dublin CoCe |
| Condition | Epiretinal Membrane |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-05-23 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07680244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epiretinal Membrane. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07680244 currently recruiting?
Yes, NCT07680244 is actively recruiting participants. Contact the research team at patricia.sha@zeiss.com for enrollment information.
Where is the NCT07680244 trial being conducted?
This trial is being conducted at Tucson, United States, Mountain View, United States, San Francisco, United States, Fort Lauderdale, United States and 2 additional locations.
Who is sponsoring the NCT07680244 clinical trial?
NCT07680244 is sponsored by Carl Zeiss Meditec-Dublin CoCe. The trial plans to enroll 400 participants.