Pediatric Type 1 Diabetes and Retinopathy
Completed
Conditions studied: Diabetic Retinopathy
In brief
Diabetic retinopathy (DR) causes more new cases of blindness among young adults than any other disease. More than 90% of individuals with type 1 diabetes (T1D) will have some form of DR by 20 years after their diagnosis. DR is associated with long-term hyperglycemia and blood glucose variability, which induces vascular endothelial dysfunction and destruction in the retina, eventual retinal ischemia, and in the end, widespread neovascularization of the retina and optic disk. When these fragile vessels bleed, they can cause vitreous hemorrhage and loss of vision. Eventually the friable vessels fibrose and can result in retinal detachment or further retinal ischemia. Major risk factors for the development of diabetic retinopathy are time since diagnosis, age at diagnosis, and severity of hyperglycemia. Retinopathy most commonly occurs at least three years after diagnosis and most cases are diagnosed more than five years after the onset of T1D. Current guidelines from the American Diabetes Association (ADA) and American Academy of Ophthalmology (AAO) recommend that patients with T1D undergo an initial comprehensive dilated fundoscopic evaluation once the individual has had diabetes for 3-5 years and has either reached puberty or 10 years of age, whichever is earlier. These patients should receive a yearly exam thereafter, or every two years based upon the recommendation of an eye care professional. However, the prevalence of retinopathy in children is unknown and adherence to these guidelines, especially in youth, has proven difficult. Thus, it is important to make these guidelines more evidence based, as retinopathy is often asymptomatic until vision loss occurs. The first step in this process is the determination of the prevalence of retinopathy in a general population of youth with diabetes. This should be followed by determining which children are most at risk, so the guidelines can provide realistic and pertinent guidance to practitioners.
Key facts
- Study ID
- NCT02691312
- Run by
- University of Florida
- People needed
- 500
- Starts
- 2016-07-01
- Expected to finish
- 2018-12-27
- Last updated by the study team
- 2019-12-12
Who can join
Age: 9 and older, up to 26. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of type 1 diabetes
- Duration of diabetes 1 year or greater
You may not qualify if…
- Diabetes less than 1 year duration
- Age < 9 years and >26 years of age
Where it is running
- Florida Diabetes Camps — De Leon Springs, Florida, United States
- Pediatrics Endocrinology/Diabetes at UF Health Medical Plaza and Children's Medical Services Building — Gainesville, Florida, United States
- Children With Diabetes Friends For Life Conference — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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