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Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes

NCT07149142 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-17

No results posted yet for this study

Summary

The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.

Each participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.

In subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.

The prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DIAGNOSTIC_TEST

Non-mydriatic fundus camera photography

Non-mydriatic fundus camera photography assessed by artificial intelligence software

DIAGNOSTIC_TEST

Fundus ophtalmoscopy

Fundus opthalmoscopy assessed by an experienced ophtalmologist

DIAGNOSTIC_TEST

Optic coherence tomography

Optic coherence tomography assessed by an experienced ophtalmologist

DIAGNOSTIC_TEST

Confocal microscopy of the retina

In a subset of participants over 18 years of age, confocal microscopy of the retina will be performed to assess the presence of diabetic neuropathy

Sponsors & Collaborators

  • University Hospital, Motol

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149142 on ClinicalTrials.gov