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Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

I

Iuliu Hatieganu University of Medicine and Pharmacy

Status

Completed

Conditions

Neurodegeneration
Diabetic Retinopathy

Treatments

Diagnostic Test: Optical Coherence Tomography

Study type

Observational

Funder types

Other

Identifiers

NCT04637217
U1111-1249-7228

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

97 participants in 3 patient groups

Control
Treatment:
Diagnostic Test: Optical Coherence Tomography
Diabetes mellitus without Diabetic Retinopathy
Treatment:
Diagnostic Test: Optical Coherence Tomography
Diabetes mellitus with Diabetic Retinopathy
Treatment:
Diagnostic Test: Optical Coherence Tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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