Health TrialsbyHealthPanel

(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000

ConditionsEpiretinal MembraneDry Age Related Macular DegenerationMacular AbnormalitiesRetina DiseaseVitreoretinal AbnormalityIntraretinal Hyporeflective SpaceSubretinal Hyporeflective SpaceIS/OS (Ellipsoid Zone) DisruptionRetinal Pigment Epithelium (RPE) ElevationRetinal Pigment Epithelium (RPE) Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarl Zeiss Meditec-Dublin CoCe

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • PathFinder 1.0 on CIRRUS HD-OCT

    Device

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Subjects with absence of macular abnormalitiesOther 1 intervention
Group B: Subjects with presence of macular abnormalitiesOther 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of PathFinder 1.0

Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.

Time frame
Baseline (single study visit OCT acquisition)
2

Specificity of PathFinder 1.0

Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.

Time frame
Baseline (single study visit OCT acquisition)

Secondary outcomes

1

Sensitivity and specificity by clinical diagnosis

Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group.

Time frame
Baseline
2

Sensitivity by macular abnormality type

Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.

Time frame
Baseline
3

Positive Predictive Value and Negative Predictive Value

Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0.

Time frame
Baseline
4

Rate of acceptable versus unacceptable B-scans

Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable".

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carl Zeiss Meditec-Dublin CoCe

Lead sponsor

Source ClinicalTrials.gov
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