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NCT Number: NCT04637217

Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Nerve Degeneration Neurodegeneration Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Medicine and Pharmacy " Iuliu Hatieganu"

Cluj-Napoca, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography

Diagnostic Test

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)

Primary outcomes

  1. 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)

  2. 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

  1. Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)

    Time frame: 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)

  2. Correlation between renal function and choroidal parameters

    Time frame: 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

  3. Correlation between sistemic factors and choroidal parameters

    Time frame: 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.

  4. Correlation between choroidal parameters and diabetes control

    Time frame: 2018-2019

    Using HbA1c(Glycated haemoglobin) the investigators will analyze the choroidal's behaviour under different HbA1c levels.

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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