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Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

NCT ID: NCT04637217

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-01

Brief Summary

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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

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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.

Conditions

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Diabetic Retinopathy Neurodegeneration

Keywords

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optical coherence tomography choroid outer retina

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Optical Coherence Tomography

Intervention Type 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)

Diabetes mellitus without Diabetic Retinopathy

Optical Coherence Tomography

Intervention Type 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)

Diabetes mellitus with Diabetic Retinopathy

Optical Coherence Tomography

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Ioana Damian

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioana Damian, MD

Role: PRINCIPAL_INVESTIGATOR

Iuliu Hatieganu University of Medicine and Pharmacy

Locations

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University of Medicine and Pharmacy " Iuliu Hatieganu"

Cluj-Napoca, , Romania

Site Status

Countries

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Romania

Other Identifiers

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U1111-1249-7228

Identifier Type: -

Identifier Source: org_study_id