Overview

This trial is active, not recruiting.

Condition diabetic retinopathy
Sponsor Association for Innovation and Biomedical Research on Light and Image
Start date September 2015
End date April 2016
Trial size 62 participants
Trial identifier NCT02391558, 4C-2015-07

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional

Primary Outcomes

Measure
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).
time frame: Single Visit

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Association for Innovation and Biomedical Research on Light and Image.