Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

Completed

• Conditions: Neurodegeneration; Diabetic Retinopathy
• Interventions: Diagnostic Test: Optical Coherence Tomography

• Registration Number: NCT04637217
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus without Diabetic Retinopathy	Optical Coherence Tomography	-
Diabetes mellitus with Diabetic Retinopathy	Optical Coherence Tomography	-
Control	Optical Coherence Tomography	-

Primary Outcome Measures

Name	Time	Method
Correlation between choroid and outer retina using SD-OCT- based binarization technique	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	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 Outcome Measures

Name	Time	Method
Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)	2018-2019	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)
Correlation between renal function and choroidal parameters	2018-2019	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
Correlation between choroidal parameters and diabetes control	2018-2019	Using HbA1c(Glycated haemoglobin) the investigators will analyze the choroidal's behaviour under different HbA1c levels.
Correlation between sistemic factors and choroidal parameters	2018-2019	The investigators will document if the presence of High Blood pressure(yes/no) and current smoking(yes/no) influences choroidal thickness or CVI.

Trial Locations

Locations (1)

University of Medicine and Pharmacy " Iuliu Hatieganu"; 🇷🇴 Cluj-Napoca, Romania