Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

NCT03279939 | Completed FDA Device

• 1 other identifier: S-2017-1
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

Conditions

Retinal Vascular; Normal Eyes

Outcome Measures

Primary Outcomes (2)

• OCTA image quality

  Image quality grading results of study selected images

  day 1

• Clinically relevant findings on OCTA

  Clinically relevant grading results of study selected images

  day 1

Study Arms (2)

Subjects with Normal Eyes

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

Device: OCT Angiography; Device: Color Fundus Photography; Device: Fluorescein Angiography

Subjects with Pathology

OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.

Device: OCT Angiography; Device: Color Fundus Photography; Device: Fluorescein Angiography; Device: Indocyaine Green Angiography

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: 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

Fluorescein Angiography DEVICE

An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.

Also known as: FA

Subjects with Normal Eyes; Subjects with Pathology

Indocyaine Green Angiography DEVICE

An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.

Also known as: ICGA

Subjects with Pathology

Eligibility Criteria

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

Study Population

Subjects with Normal Eyes: * Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator * Corrected visual acuity ≥ 20/40 in each eye * No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye Subjects with Pathology: * Subjects with retinal conditions in at least one eye. * Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

You may qualify if:

• All subjects:
• Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
• Age ≥ 22
• Subjects with Normal Eyes:
• Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
• Corrected visual acuity ≥ 20/40 in each eye
• No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye
• Subjects with Pathology:
• Subjects with retinal conditions in at least one eye.
• Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

You may not qualify if:

• 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 with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
• Subjects with contraindication to pupillary dilation in study eye

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Fluorescein Angiography

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Study Officials

• David Brown, MD

  Retina Consultants Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 12, 2017
• Study Start: August 23, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)