Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

Iuliu Hatieganu University of Medicine and Pharmacy97 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Retinopathy Neurodegeneration

Interventions

Optical Coherence TomographyDIAGNOSTIC_TEST

Spectral 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)

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * history of type 1DM for more than 1 year * history of type 2 DM for more than 3 months * diagnosis of no DR or mild Non-proliferative diabetic retinopathy(NPDR) Exclusion Criteria: * DR with more than NPDR , * Diabetic macular oedema, * media opacities such as corneal or lens opacities that could preclude appropriate OCT imaging, * presence of other retinal diseases such as Age-related macular degeneration, Vitreo-macular traction, Macular hole, Epiretinal membrane, Retinal vein occlusion, Macular scars, * Glaucoma, Optic neuropathies or Neurodegenerative diseases, * history of ocular trauma, * Refractive errors of more than ±6 diopters (spherical equivalent), * previous ocular surgery, focal laser, panretinal photocoagulation or anti-VEGF intravitreal injection

Locations (1)

University of Medicine and Pharmacy " Iuliu Hatieganu"

Cluj-Napoca, Romania

Outcomes

Primary Outcomes

Correlation between choroid and outer retina using SD-OCT- based binarization technique

starting from EDI-OCT scans the investigators will analyze choroidal parameters such as Luminal area, Stromal area, Total choroidal area, Chorodial vascularity index and correlate them with retinal pigment epithelium (RPE),outer nuclear layer(ONL) and photoreceptors' thickness (PR)

Time frame: 2018-2019

Correlation between neurodegeneration and retinal vessels characteristics

using full width at half maximum method, the investigators will measure peripapillary arteries and veins' diameters, their wall thickness and correlate them with RNFL and ganglion cell layer(GCL) thickness

Time frame: 2018-2019

Secondary Outcomes

Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)

The investigators will analyze if changes in the choroid will influence patients' visual acuity. For statistical reasons, visual acuity will be converted to logMAR(logarithm of the minimum angle of resolution)

Time frame: 2018-2019

Correlation between renal function and choroidal parameters

Using estimated glomerular filtration rate(eGFR-mL/min/1.73 m2) the investigators will analyze if a decreased eGFR will produce changes in choroidal architecture

Time frame: 2018-2019

Correlation between sistemic factors and choroidal parameters

The investigators will document if the presence of High Blood pressure(yes/no) and current smoking(yes/no) influences choroidal thickness or CVI.

Time frame: 2018-2019

Correlation between choroidal parameters and diabetes control

Data from ClinicalTrials.gov

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