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

Официальное название

Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes

Обзор

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.

Вмешательства

• Диагностический тест Non-mydriatic fundus camera photography
  Non-mydriatic fundus camera photography assessed by artificial intelligence software
• Диагностический тест Fundus ophtalmoscopy
  Fundus opthalmoscopy assessed by an experienced ophtalmologist
• Диагностический тест Optic coherence tomography
  Optic coherence tomography assessed by an experienced ophtalmologist
• Диагностический тест 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

Первичные конечные точки

• Feasibility of AI for retinopathy screening [Срок оценки: Through study completion, on average 6 months.]

Вторичные конечные точки (3)

• Examination satisfaction [Срок оценки: Through study completion, on average 6 months.]
• Prevalence of diabetic retinopathy [Срок оценки: Through study completion, on average 6 months.]
• Prevalence of diabetic neuropathy [Срок оценки: Through study completion, on average 6 months.]

Критерии участия

Критерии включения

• Type 1 diabetes diagnosed according to the ADA 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

Критерии исключения

• Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Чехия · 1 центр

• University Hospital Motol — Prague

Идентификаторы

NCT: NCT07149142 · PAIRS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗