Epiretinal MembraneNCT07680244
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
A study testing PathFinder 1.0 on CIRRUS HD-OCT in people with Epiretinal Membrane and Dry Age Related Macular Degeneration, run by Carl Zeiss Meditec-Dublin CoCe at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiretinal Membrane, Dry Age Related Macular Degeneration, Macular Abnormalities
- What is being tested?
- PathFinder 1.0 on CIRRUS HD-OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 May 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Nova Southeastern University College of Optometry
Fort Lauderdale, Florida, 33328
Study Coordinator
- Recruiting
Moyes Eye Center
Kansas City, Missouri, 64154
Study Coordinator
- Recruiting
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Study Coordinator
- Recruiting
Eyecare Medical Group
Portland, Maine, 04102
study coordinator
- Completed
Premier Eyecare of San Francisco
San Francisco, California, 94110
- Recruiting
Retina Associates
Tucson, Arizona, 85704
Study Coordinator
About this study
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, Intraretinal Hyporeflective Space
- Being tested
- PathFinder 1.0 on CIRRUS HD-OCT
- Medical subject headings
- Epiretinal Membrane, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PathFinder 1.0 on CIRRUS HD-OCTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with absence of macular abnormalities | Other | Subjects with absence of macular abnormalities Receives: Device: PathFinder 1.0 on CIRRUS HD-OCT |
| Subjects with presence of macular abnormalities | Other | Subjects with presence of macular abnormalities Receives: Device: PathFinder 1.0 on CIRRUS HD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of PathFinder 1.0
Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
Measured: Baseline (single study visit OCT acquisition)
Specificity of PathFinder 1.0
Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.
Measured: Baseline (single study visit OCT acquisition)
Secondary outcomes (5)
Sensitivity and specificity by clinical diagnosis
Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group.
Measured: Baseline
Sensitivity by macular abnormality type
Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.
Measured: Baseline
Positive Predictive Value and Negative Predictive Value
Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0.
Measured: Baseline
Rate of acceptable versus unacceptable B-scans
Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable".
Measured: Baseline
Algorithm repeatability (precision)
Repeatability of PathFinder 1.0 results, expressed as the consistency of the proportion of abnormal B-scans per macular cube across repeated scans.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start23 May 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec-Dublin CoCe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680244
- Sponsor's protocol ID
- CIRRUS-2023-1
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
- ClinicalTrials.gov ID
- NCT07680244
- Acronym / sponsor ID
- CIRRUS-2023-1
- Conditions
- Epiretinal Membrane, Dry Age Related Macular Degeneration, Macular Abnormalities, Retina Disease, Vitreoretinal Abnormality, Intraretinal Hyporeflective Space
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Carl Zeiss Meditec-Dublin CoCeIndustry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with absence of macular abnormalities | Other | Device: PathFinder 1.0 on CIRRUS HD-OCTSubjects with absence of macular abnormalities |
| Subjects with presence of macular abnormalities | Other | Device: PathFinder 1.0 on CIRRUS HD-OCTSubjects with presence of macular abnormalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PathFinder 1.0 on CIRRUS HD-OCTParticipants undergo standard OCT imaging on CIRRUS HD-OCT systems, and the investigational PathFinder software analyzes the images for macular abnormalities without influencing clinical care. | Device | Subjects with absence of macular abnormalities, Subjects with presence of macular abnormalities |
Primary outcome
Sensitivity of PathFinder 1.0
Time frame: Baseline (single study visit OCT acquisition)
Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
Specificity of PathFinder 1.0
Time frame: Baseline (single study visit OCT acquisition)
Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PathFinder 1.0 on CIRRUS HD-OCT in people with Epiretinal Membrane and Dry Age Related Macular Degeneration, run by Carl Zeiss Meditec-Dublin CoCe at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Sha, Optometrist (925-307-1588, patricia.sha@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of PathFinder 1.0 (time frame: Baseline (single study visit OCT acquisition)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.