NCT03279939

Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 88 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Retinal Vascular
• Normal Eyes

Interventions

Type	Name	Description
DEVICE	OCT Angiography	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.
DEVICE	Color Fundus Photography	Non-contact white light photography.
DEVICE	Fluorescein Angiography	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.
DEVICE	Indocyaine Green Angiography	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.

Timeline

• Start date: 2017-08-23
• Primary completion: 2018-01-12
• Completion: 2018-01-12
• First posted: 2017-09-12
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study