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

NCT04604002 | Completed FDA Device

• 1 other identifier: S-2020-5
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Vascular; Normal Eyes

Outcome Measures

Primary Outcomes (4)

• Image quality score

  Graded 0-2 (0 = poor, 1 = average, 2 = good)

  through study completion, an average of 1 day

• Visibility of OCTA key anatomical vascular structures quality score

  Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities

  through study completion, an average of 1 day

• Identification of vascular abnormalities on OCTA

  Graded Yes, No, or Unable to Grade based on pre-specified abnormalities

  through study completion, an average of 1 day

• Adverse Events

  All AEs

  through study completion, an average of 1 day

Study Arms (2)

Subjects with Normal Eyes

OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology

Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography

Subjects with Pathology

OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology

Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography

Interventions

OCT Angiography DEVICE

OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.

Also known as: Optical Coherence Tomography Angiography, OCTA

Subjects with Normal Eyes; Subjects with Pathology

Color Fundus Photography DEVICE

Non-contact white light photography

Also known as: CFP

Subjects with Normal Eyes; Subjects with Pathology

Optical Coherence Tomography DEVICE

A non-contact test that uses light waves to take cross-sectional pictures of the retina

Also known as: OCT

Subjects with Normal Eyes; Subjects with Pathology

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology

You may qualify if:

• All Populations:
• Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
• Age ≥ 22
• Normal Population:
• \. 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:
• \. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Dennis Marcus, MD

  Southeast Retina Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 27, 2020
• Study Start: October 15, 2020
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)