Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Retinal Vascular Clinical Trial

Official title:

Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279939
• Other study ID #: S-2017-1
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: February 2019
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Eyes
• Retinal Vascular

Intervention

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.
• Color Fundus Photography
Non-contact white light photography.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Retina Consultants of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCTA image quality	Image quality grading results of study selected images	day 1
Primary	Clinically relevant findings on OCTA	Clinically relevant grading results of study selected images	day 1