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Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04637217
Enrollment
97
Registered
2020-11-19
Start date
2018-07-01
Completion date
2019-07-01
Last updated
2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Neurodegeneration

Keywords

optical coherence tomography, choroid, outer retina

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.

Interventions

DIAGNOSTIC_TESTOptical 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)

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between choroid and outer retina using SD-OCT- based binarization technique2018-2019starting 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 characteristics2018-2019using 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

MeasureTime frameDescription
Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)2018-2019The 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 parameters2018-2019Using 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 sistemic factors and choroidal parameters2018-2019The investigators will document if the presence of High Blood pressure(yes/no) and current smoking(yes/no) influences choroidal thickness or CVI.
Correlation between choroidal parameters and diabetes control2018-2019Using HbA1c(Glycated haemoglobin) the investigators will analyze the choroidal's behaviour under different HbA1c levels.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026