Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children

Diabetic Retinopathy Clinical Trial

Official title:

Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615740
• Other study ID #: 03_RVO-FNOs_2022
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of the project is to create a normative database from data collected from a healthy pediatric population. A secondary aim is to compare normative data with data from pediatric patients with pre-existing type 1 diabetes mellitus.

Description:

Diabetic retinopathy, or damage to the retina caused by diabetes, is one of the most common complications in all patients with newly diagnosed diabetes mellitus of both types. These are mainly pathological changes affecting the vascular supply of the retina, which precede changes affecting the peripheral nervous system.

Children and in general patients with type I diabetes mellitus are around 0.6% of the population in the long term. the first changes in the retinal vessels can usually be expected after 2-5 years from the first detection of the disease. These changes are diagnosed using a biomicroscopic examination of the fundus.

Until recently, the only possible examination method was fluorescein angiography (FAG). It is an invasive examination with a fluorescein solution administered into a peripheral vein through a cannula and further photo documentation of the flow dynamics through the vascular bed in blue (cobalt) light. The flow time in individual phases of filling is recorded.

The disadvantage is the necessary cooperation of the child, the need to establish peripheral venous access, the risk of an allergic reaction to the contrast material, and the duration of the examination lasting two or more hours.

These disadvantages disappeared with the advent of optical coherence tomography and the angiographic mode - OCTA.

OCTA can detect the passage of individual blood elements (mostly erythrocytes) through capillaries and larger vessels in real-time and thus compile maps of individual vascular networks in the retina and choroid. The advantage is that the examination is not invasive, it is not necessary to inject a dye into the patient's bloodstream and no special preparation is required. The device is classified as a Class 1 laser, which is safe for the human eye. The examination is not painful or uncomfortable.

Due to the relatively short period of use in practice, there is still a lack of data from findings in a healthy population. In the past, normative databases of adult patients were compiled for comparing the state of the healthy central area of the eye using OCTA. Data for the child population, especially the Central European one, is missing or has been collected on a small sample only.

The primary goal of the project is to create a normative database from data collected from a healthy pediatric population. A secondary aim is to compare normative data with data from pediatric patients with pre-existing type 1 diabetes mellitus.

It is anticipated that 100-150 children aged 6-15 will be enrolled at the Centre for Visually Impaired Children of the University of Ostrava as part of regular check-ups. Depending on the degree of cooperation of the child, the examination takes around two minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• emmetropia

• slight refractive error

• best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes

Exclusion Criteria:

• general disease that by its nature affects or can affect the retina and the vascular system of the eye

• concomitant vascular or other retinal diseases

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Diagnostic Test:
• Optical coherence tomography (OCTA)
OCTA can detect the passage of individual blood elements (mostly erythrocytes) through capillaries and larger vessels in real-time

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular density in central and peripheral retina - healthy subjects	The primary goal of the project is measurement of vascular density in central and peripheral retina in healthy subjects using OCT Spectralis (Heidelberg Engineering, Germany). Vascular density is ratio between areas with and without vascular tissue. Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from healthy individuals 6-15 years old.	3 years
Secondary	Vascular density in central and peripheral retina - diabetic patients	The secondary goal of the project is measurement of vascular density in central and peripheral retina in diabetic patients using OCT Spectralis (Heidelberg Engineering, Germany). Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from diabetic patients 6-15 years old shortly after being diagnosed and compared with results obtained in the healthy group.	3 years