Prevalence of early retinal vasculoneurodegenerative alterations in children and adolescents with Type 1 Diabetes

• Conditions: H35.0; Type 1 Diabetes mellitus; Background retinopathy and retinal vascular changes

• Registration Number: DRKS00024728
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Type 1 Diabetes (T1D), T1D, for a duration 2 years, Age 10-18 years, at time of T1D onset living in Vienna

Exclusion Criteria

severe visual impariement
light sensitive epilepsy
hyperopia/myopia ±5.5 Dioptries

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetic retinopathy Ophthalmological findings through manual evaluation of the Fundus photography and funduscopy - (categorical):<br>- Retinopathy (visually threatening, moderate, mild - in summary)<br>- no retinopathy <br><br>This is collected as part of study visits 1, study visits 2 (12 months later) and study visits 3 (24 months later).

Secondary Outcome Measures

Name	Time	Method
Secondary target parameters<br>• Central retinal thickness<br>• Morphological biomarkers in OCT (fluid, microaneurysms, detailed analysis of the thickness of the individual retinal layers) and OCT-A (retinal ischemia and vascular density in different retinal layers)<br>• photoreceptors (number)<br>• Central vessels (measurement of the lumen and wall thickness)<br>• Diabetic retinopathy through automated evaluation of the IDxDR fundus photo (categorical):<br> -- Visually threatening retinopathy = macular edema, severe non-proliferative or proliferative retinopathy<br> -- Moderate retinopathy<br> -- Mild retinopathy = non-proliferative retinopathy or no retinopathy