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

NCT05615740 | Active Not Recruiting

• 1 other identifier: 03_RVO-FNOs_2022
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; optical coherence tomography; fluorescein angiography; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vascular density in central and peripheral retina - diabetic patients

  3 years

Study Arms (2)

Healthy pediatric patients

ACTIVE COMPARATOR

Healthy pediatric patients will undergo optical coherence tomography.

Diagnostic Test: Optical coherence tomography (OCTA)

Children with diabetes mellitus

ACTIVE COMPARATOR

Children with diabetes mellitus will undergo optical coherence tomography.

Diagnostic Test: Optical coherence tomography (OCTA)

Interventions

Optical coherence tomography (OCTA) DIAGNOSTIC_TEST

OCTA can detect the passage of individual blood elements (mostly erythrocytes) through capillaries and larger vessels in real-time

Children with diabetes mellitus; Healthy pediatric patients

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• emmetropia
• slight refractive error
• best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michal Koubek, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled into two groups - healthy pediatric population and children with diabetes mellitus.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 14, 2022
• Study Start: May 2, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)