Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637217
• Other study ID #: U1111-1249-7228
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2020
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Nerve Degeneration
• Neurodegeneration

Intervention

Diagnostic Test:
• Optical Coherence Tomography
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)

Locations

Country	Name	City	State
Romania	University of Medicine and Pharmacy " Iuliu Hatieganu"	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2018-2019
Primary	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	2018-2019
Secondary	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)	2018-2019
Secondary	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	2018-2019
Secondary	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.	2018-2019
Secondary	Correlation between choroidal parameters and diabetes control	Using HbA1c(Glycated haemoglobin) the investigators will analyze the choroidal's behaviour under different HbA1c levels.	2018-2019