Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Not Applicable

Completed

• Conditions: Normal Eyes; Retinal Vascular
• Interventions: Device: OCT Angiography; Device: Color Fundus Photography; Device: Fluorescein Angiography; Device: Indocyaine Green Angiography

• Registration Number: NCT03279939
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-08-23
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects with Normal Eyes	Color Fundus Photography	OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology.
Subjects with Normal Eyes	Fluorescein Angiography	OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology.
Subjects with Pathology	OCT Angiography	OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.
Subjects with Pathology	Color Fundus Photography	OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.
Subjects with Pathology	Indocyaine Green Angiography	OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.
Subjects with Normal Eyes	OCT Angiography	OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology.
Subjects with Pathology	Fluorescein Angiography	OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.

Primary Outcome Measures

Name	Time	Method
Clinically relevant findings on OCTA	day 1	Clinically relevant grading results of study selected images
OCTA image quality	day 1	Image quality grading results of study selected images

Trial Locations

Locations (1)

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States