Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes
NCT ID: NCT07149142
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2026-01-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Non-mydriatic fundus camera photography
Non-mydriatic fundus camera photography assessed by artificial intelligence software
Fundus ophtalmoscopy
Fundus opthalmoscopy assessed by an experienced ophtalmologist
Optic coherence tomography
Optic coherence tomography assessed by an experienced ophtalmologist
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
Interventions
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Non-mydriatic fundus camera photography
Non-mydriatic fundus camera photography assessed by artificial intelligence software
Fundus ophtalmoscopy
Fundus opthalmoscopy assessed by an experienced ophtalmologist
Optic coherence tomography
Optic coherence tomography assessed by an experienced ophtalmologist
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
Eligibility Criteria
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Inclusion Criteria
* Age over 11.0 years or duration of diabetes over 2 years
* Signed written informed consent by both the CwD and their parent/caregiver
Exclusion Criteria
11 Years
19 Years
ALL
No
Sponsors
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University Hospital, Motol
OTHER
Responsible Party
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Vit Neuman
MD, PhD
Locations
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University Hospital Motol
Prague, Prague 5, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PAIRS
Identifier Type: -
Identifier Source: org_study_id
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