Preventing advanced diabetic retinopathy in children
Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
This study is trying to see if using a new eye scan can help doctors spot early signs of eye problems in children with type 1 diabetes before they get worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT05615740 on ClinicalTrials.gov |
What this trial studies
This project aims to create a normative database using data from healthy children to better understand diabetic retinopathy in pediatric patients. It will compare this normative data with that from children diagnosed with type 1 diabetes mellitus. The study utilizes advanced optical coherence tomography (OCTA) to assess retinal changes, which is less invasive than traditional fluorescein angiography. By identifying early changes in retinal vascular supply, the study hopes to improve early detection and intervention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are children with type 1 diabetes mellitus who have not yet developed significant retinal changes.
Not a fit: Patients with general diseases affecting the retina or those with existing retinal vascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for diabetic retinopathy in children.
How similar studies have performed: While the use of OCTA is becoming more common, this specific approach to creating a normative database for pediatric diabetic retinopathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * emmetropia * slight refractive error * best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes Exclusion Criteria: * general disease that by its nature affects or can affect the retina and the vascular system of the eye * concomitant vascular or other retinal diseases
Where this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Principal investigator: Michal Koubek, MD — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.