Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Retinopathy
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Correlation between choroid and outer retina using SD-OCT- based binarization technique
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Ioana Damian
Assistant Professor
Iuliu Hatieganu University of Medicine and Pharmacy
Eligibility Criteria
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
Outcomes
Primary Outcomes
Correlation between choroid and outer retina using SD-OCT- based binarization technique
Time Frame: 2018-2019
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)
Correlation between neurodegeneration and retinal vessels characteristics
Time Frame: 2018-2019
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
Secondary Outcomes
- Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)(2018-2019)
- Correlation between renal function and choroidal parameters(2018-2019)
- Correlation between choroidal parameters and diabetes control(2018-2019)
- Correlation between sistemic factors and choroidal parameters(2018-2019)