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

Sponsor
University Hospital, Motol
Study ID
NCT07149142
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-mydriatic fundus camera photography — DIAGNOSTIC_TEST
    Non-mydriatic fundus camera photography assessed by artificial intelligence software
  • Fundus ophtalmoscopy — DIAGNOSTIC_TEST
    Fundus opthalmoscopy assessed by an experienced ophtalmologist
  • Optic coherence tomography — DIAGNOSTIC_TEST
    Optic coherence tomography assessed by an experienced ophtalmologist
  • Confocal microscopy of the retina — DIAGNOSTIC_TEST
    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

Study Details

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.

Key Dates

First listed
Aug 29, 2025
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Study arm
    All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.

Primary Outcome Measure

Feasibility of AI for retinopathy screening [ Time Frame: Through study completion, on average 6 months. ]

Central Contacts

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