Clinical trial NCT04637217: Retinal Neurodegenerative and Vascular Changes in Diabetic Patients
Official title: Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Neurodegeneration
Keywords: optical coherence tomography
choroid
outer retina
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants were recruited between July 2018 and July 2019 at Department of Ophthalmology, Emergency County Hospital Cluj, Romania. Healthy subjects were recruited from patients scheduled for routine ocular examination at Department of Ophthalmology, Emergency County Hospital Cluj, Romania

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.

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

Primary outcomes:
measure: Correlation between choroid and outer retina using SD-OCT- based binarization technique
timeFrame: 2018-2019
measure: Correlation between neurodegeneration and retinal vessels characteristics
timeFrame: 2018-2019
Secondary outcomes:
measure: Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)
timeFrame: 2018-2019
measure: Correlation between renal function and choroidal parameters
timeFrame: 2018-2019
measure: Correlation between sistemic factors and choroidal parameters
timeFrame: 2018-2019
measure: Correlation between choroidal parameters and diabetes control
timeFrame: 2018-2019
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: University of Medicine and Pharmacy " Iuliu Hatieganu"
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Ioana Damian, MD
role: PRINCIPAL_INVESTIGATOR
References: