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Clinical Trial Summary

Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. While the visual impairment caused by EMD is variable, its early treatment can improve visual acuity and quality of life. The objective of this project is to use the new OCT-angiography technology, which evaluates macular capillary network without the need of intravenous injection of contrast, to assess macular microcirculatory network in its response to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be helpful in understanding the pathophysiology of visual loss associated with DME and in determining prognosis.


Clinical Trial Description

Patients who participate in this study will be selected among adults treated at the Retina Clinic and Ocular Oftalmologia clinics and will be aware of all stages of the research, formalizing the approval of their participation by informed consent term. The tests will be performed after pupillary dilation with 2 eye drops of tropicamide 1% (Mydriacyl, Alcon Laboratories), in Cirrus 5000 HD-OCT devices (Carl Zeiss Meditec - Dublin USA). Image acquisition protocols Optic Disc Cube 200x200 and 512x128 Macular Cube will be used, with analysis by RNFL protocols and NGO Analysis Report and Macular Cube Analysis Report, respectively. Subjective analysis of the examinations will be performed by the three authors of this project independently and then compared between them. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02870803
Study type Observational
Source Retina Clinic, Sao Paulo, Brazil
Contact Gabriel Andrade, M.D.
Phone (11) 3058-2020
Email drgabrielandrade@gmail.com
Status Recruiting
Phase N/A
Start date July 2016
Completion date April 2018

See also
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