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COMPLETEDNCT04604002

Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

Lead sponsor: Heidelberg Engineering GmbH•1 U.S. locations•View source on ClinicalTrials.gov

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What this study is about

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Sponsors

Lead Sponsor

Heidelberg Engineering GmbH

The objectives of this study are: 1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types. 2\. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types. 3\. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All Populations:
•1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
•2. Age ≥ 22
•Normal Population:
•3\. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
•Pathology Population:
•3\. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

Exclusion Criteria

•All Populations:
•1. Subjects unable to read or write
•2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
•3. Subjects who cannot tolerate the imaging procedures
•4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 28, 2024Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment86

Start dateOct 2020

Last updatedFeb 28, 2024

Condition

Retinal Vascular Normal Eyes

Locations shown

Southeast Retina Center

Augusta, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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