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

Completed
Conditions
Diabetic Retinopathy
Registration Number
NCT02391558
Lead Sponsor
Association for Innovation and Biomedical Research on Light and Image
Brief Summary

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

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Aibili - Cec

🇵🇹

Coimbra, Portugal

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