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NCT02691312 · ClinicalTrials.gov registry record
Pediatric Type 1 Diabetes and Retinopathy
A clinical trial of Diabetic Retinopathy, sponsored by University of Florida.
- Completed
- Registry status
- 500
- Enrollment target
- 3
- Study locations
NCT02691312 is a study of Diabetic Retinopathy that has completed, run by University of Florida. The registered enrollment target is 500 participants, below the 1,668-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT02691312, a study of Diabetic Retinopathy, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 500 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Digital Retinography System
Study Locations (3)
Florida
- Florida Diabetes Camps - De Leon Springs
- Pediatrics Endocrinology/Diabetes at UF Health Medical Plaza and Children's Medical Services Building - Gainesville
- Children With Diabetes Friends For Life Conference - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2016-07 |
| Est. Completion | 2018-12-27 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02691312
The ClinicalTrials.gov registry entry for NCT02691312 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,668-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (70% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 1 intervention - of which Digital Retinography System is the first listed.
NCT02691312 reports 3 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02691312 about?
NCT02691312 is a clinical study titled "Pediatric Type 1 Diabetes and Retinopathy". 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, wh...
What is the current status of trial NCT02691312?
This trial is currently completed. The enrollment target is 500 participants. The study started on 2016-07. Estimated completion is 2018-12-27.
What conditions does trial NCT02691312 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT02691312?
The interventions under investigation include: Digital Retinography System (DEVICE).
Who is sponsoring clinical trial NCT02691312?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02691312 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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