Pediatric Type 1 Diabetes and Retinopathy

NCT02691312 | Completed

• 1 other identifier: IRB201501086
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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

Diabetic Retinopathy

Keywords

type 1 diabetes; retinopathy

Outcome Measures

Primary Outcomes (1)

• Number of participants diagnosed with retinopathy

  Using a CenterVue Digital Retinography System (DRS) the participants with a positive or inconclusive screen will be called with the results and recommended to undergo a dilated eye examination by a skilled ophthalmologist. The results from the ophthalmologist will be compared to the DRS results.

  Baseline

Study Arms (1)

Type 1 diabetes (T1D)

Pediatric patients with type 1 diabetes (T1D) will have an eye exam using the Digital Retinography System (DRS) taking non-mydriatic fundus images. If the test is positive or inconclusive, subjects will be notified and referred to an ophthalmologist for a dilated retinal exam. A chart review and questionnaire will be completed to evaluate for risk factors predisposing subjects to diabetic retinopathy.

Device: Digital Retinography System

Interventions

Digital Retinography System DEVICE

The DRS is a portable non-mydriatic fundus camera in which children place their chin on a chin rest and the camera, after auto-focusing, takes photographs of their retinas. These photographs will be examined by an ophthalmologist (specializing in retinal disease) to assess for evidence of diabetic retinopathy.

Also known as: CenterVue Digital Retinography System, DRS

Type 1 diabetes (T1D)

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes and a duration of 1 year or greater will be asked to participate. Potential participants will be approached at the Pediatric Endocrinology clinic visits, Florida Diabetes Camp and the Children With Diabetes annual meeting.

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

Florida Diabetes Camps

De Leon Springs, Florida, 32130, United States

Location

Pediatrics Endocrinology/Diabetes at UF Health Medical Plaza and Children's Medical Services Building

Gainesville, Florida, 32611, United States

Location

Children With Diabetes Friends For Life Conference

Orlando, Florida, 32821, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 1; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janet H Silverstein, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: July 1, 2016
• Primary Completion: January 20, 2018
• Study Completion: December 27, 2018
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

US (3)