---
title: Retinal Neurodegenerative and Vascular Changes in Diabetic Patients
nct_id: NCT04637217
overall_status: COMPLETED
sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
study_type: OBSERVATIONAL
primary_condition: Diabetic Retinopathy
countries: Romania
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04637217.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04637217"
ct_last_update_post_date: 2020-11-19
last_seen_at: "2026-05-12T06:02:29.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

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

**NCT ID:** [NCT04637217](https://clinicaltrials.gov/study/NCT04637217)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 97
- **Lead Sponsor:** Iuliu Hatieganu University of Medicine and Pharmacy
- **Conditions:** Diabetic Retinopathy, Neurodegeneration
- **Start Date:** 2018-07-01
- **Completion Date:** 2019-07-01
- **CT.gov Last Update:** 2020-11-19

## 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.

## Eligibility

- **Sex:** 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
```

## Arms

- **Control**
- **Diabetes mellitus without Diabetic Retinopathy**
- **Diabetes mellitus with Diabetic Retinopathy**

## 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)

## Primary Outcomes

- **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)
- **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

- **Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)** _(time frame: 2018-2019)_
- **Correlation between renal function and choroidal parameters** _(time frame: 2018-2019)_
- **Correlation between sistemic factors and choroidal parameters** _(time frame: 2018-2019)_
- **Correlation between choroidal parameters and diabetes control** _(time frame: 2018-2019)_

## Locations (1)

- University of Medicine and Pharmacy " Iuliu Hatieganu", Cluj-Napoca, Romania

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of medicine and pharmacy " iuliu hatieganu"|cluj-napoca||romania` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04637217.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04637217*  
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