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NCT02391558 Clinical Trial

Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography

Diabetic Retinopathy Clinical Trial

— OCTA  

Official title:
Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02391558
Other study ID # 4C-2015-07
Secondary ID
Status Completed
Phase N/A
First received March 12, 2015
Last updated March 9, 2017
Start date September 2015
Est. completion date April 2016

Study information
Verified date March 2017
Source Association for Innovation and Biomedical Research on Light and Image
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace fluorescein angiography.

Description:

Fluorescein angiography (FA) is the standard and generally accepted method to identify vascular features in the retina, detecting capillary dropout and neovessel growth. Its value is undeniable and is a routine ophthalmological examination. However, it requires intravenous injection of fluorescein, which can cause nausea, vomiting and, rarely, anaphylaxis and death. New OCT angiography methods can detect, noninvasively red blood cells flow and, therefore, identify well the retinal vasculature. It is crucial and of major interest to evaluate the clinical utility of this new methodology comparing this information with the one obtained from fluorescein angiography.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- All patients with clinical indication for fluorescein angiography in their clinical practice

Exclusion Criteria:

- Subjects with a pacemaker of similarly critical electronic device

- Subjects with severe ocular media opacities

- Subjects with corneal abnormalities

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal Aibili - Cec Coimbra

Sponsors (1)
Lead Sponsor Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison between examination techniques on the detection of morphological changes in the retina (such as vessels morphology, vascular ischemia, retinal neovascularization, choroidal neovascularization, and other vascular abnormalities). Single Visit
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