Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

NCT04637217 | Completed

• 1 other identifier: U1111-1249-7228
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Neurodegeneration

Keywords

optical coherence tomography; choroid; outer retina

Outcome Measures

Primary Outcomes (2)

• Correlation between choroid and outer retina using SD-OCT- based binarization technique

  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)

  2018-2019

• Correlation between neurodegeneration and retinal vessels characteristics

  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

  2018-2019

Secondary Outcomes (4)

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

  2018-2019

• Correlation between renal function and choroidal parameters

  2018-2019

• Correlation between sistemic factors and choroidal parameters

  2018-2019

• Correlation between choroidal parameters and diabetes control

  2018-2019

Study Arms (3)

Control

Diagnostic Test: Optical Coherence Tomography

Diabetes mellitus without Diabetic Retinopathy

Diagnostic Test: Optical Coherence Tomography

Diabetes mellitus with Diabetic Retinopathy

Diagnostic Test: Optical Coherence Tomography

Interventions

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)

Control; Diabetes mellitus with Diabetic Retinopathy; Diabetes mellitus without Diabetic Retinopathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy " Iuliu Hatieganu"

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Nerve Degeneration

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Ioana Damian, MD

  Iuliu Hatieganu University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the papers will be published.

Locations

RO (1)