Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2016-07-31
2018-12-27
Brief Summary
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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.
Detailed Description
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As part of their informed consent, all participants will be asked as part of their informed consent to allow study staff to contact their local ophthalmologist for their eye exam results following a positive or inconclusive portable retinal screening. Participants or their guardians will also be asked to fill out a study questionnaire during the screening visit. When available, the study subjects' medical record will be accessed to identify their BMI, time since T1D diagnosis, previous hemoglobin A1c (HbA1c) levels over the last 12 months (or longer if available), insulin regimen, Tanner staging, serum lipids, urine microalbumin:creatinine, presence or absence of hypertension, and previous diagnoses of diabetic retinopathy, microalbuminuria, hyperlipidemia or hypertension.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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.
Digital Retinography System
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.
Interventions
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Digital Retinography System
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration of diabetes 1 year or greater
Exclusion Criteria
* Age \< 9 years and \>26 years of age
9 Years
26 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Janet H Silverstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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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
Countries
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Study Documents
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Document Type: FDA 501(k)
View DocumentOther Identifiers
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IRB201501086
Identifier Type: -
Identifier Source: org_study_id