Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Heidelberg Engineering

Status: Completed

Conditions: Normal Eyes; Retinal Vascular

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03279939

S-2017-1

Details and patient eligibility

About

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

Full description

The objectives of this study are:

1. To compare the OCTA image quality between the SPECTRALIS and the predicate.
2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Enrollment: 88 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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

Trial design

88 participants in 2 patient groups

Subjects with Normal Eyes

Description:

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

Treatment:

Device: Fluorescein Angiography

Device: OCT Angiography

Device: Color Fundus Photography

Subjects with Pathology

Description:

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

Treatment:

Device: Indocyaine Green Angiography

Device: Fluorescein Angiography

Device: OCT Angiography

Device: Color Fundus Photography