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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Diagnostic test: Optical coherence tomography (OCTA)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy pediatric patients; Healthy pediatric patients will undergo optical coherence tomography.	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
Active Comparator: Children with diabetes mellitus; Children with diabetes mellitus will undergo optical coherence tomography.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Michal Koubek, MD, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): November 30, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: optical coherence tomography; diabetic retinopathy; diabetes mellitus; fluorescein angiography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Nutritional and Metabolic Diseases; Diabetic Retinopathy; Diabetes Mellitus; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: 03_RVO-FNOs_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. These may be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No