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

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ClinicalTrials.gov Identifier: NCT02391558
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

Study Description
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Brief Summary:
Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace fluorescein angiography.

Condition or disease
Diabetic Retinopathy

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.
Study Design
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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with clinical indication for fluorescein angiography will be invited to perform OCT angiography in the same day during a period of 6-8 months.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391558


Locations
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Portugal
Aibili - Cec
Coimbra, Portugal
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT02391558    
Other Study ID Numbers: 4C-2015-07
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases