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CompletedNCT04637217

Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study

Status
Completed
Phase
Study type
Observational
Enrollment
97 (actual)
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.

Detailed description

Relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. Since OCT is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. In the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. Moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOptical Coherence TomographySpectral Domain Optical Coherence Tomography(SD-OCT) examination will be performed for every patient: posterior pole scan, EDI-OCT(enhanced depth imaging-OCT) and peripapillary RNFL(retinal nerve fiber layer)

Timeline

Start date
2018-07-01
Primary completion
2019-07-01
Completion
2019-07-01
First posted
2020-11-19
Last updated
2020-11-19

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT04637217. Inclusion in this directory is not an endorsement.

Retinal Neurodegenerative and Vascular Changes in Diabetic Patients (NCT04637217) · Clinical Trials Directory