Pediatric Type 1 Diabetes and Retinopathy



Status:Completed
Conditions:Ocular, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:9 - 26
Updated:1/6/2019
Start Date:July 2016
End Date:December 27, 2018

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Prevalence and Characterization of Retinopathy in Children With Type 1 Diabetes Using a Non-mydriatic Fundus Camera

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.

The study will be a prospective cross-sectional study of pediatric participants who have had
T1D for one year or more. Pediatric participants will be recruited at the Florida Diabetes
Camps, the Children With Diabetes Friends for Life Orlando Conference, and the University of
Florida Pediatric Endocrinology Clinics. The participants will be tested for diabetic
retinopathy using a Digital Retinography System (DRS)
(http://www.centervue.com/producta556.html?id=637). The DRS is a portable non-mydriatic
fundus camera in which the participants places their chins on the chin-rest and the device
takes a digital image of their eyes for evaluation by an ophthalmologist remotely. These
photographs will be examined by an ophthalmologist (specializing in retinal disease) to
assess for evidence of diabetic retinopathy.

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.

Inclusion Criteria:

- Diagnosis of type 1 diabetes

- Duration of diabetes 1 year or greater

Exclusion Criteria:

- Diabetes less than 1 year duration

- Age < 9 years and >26 years of age
We found this trial at
3
sites
Gainesville, Florida 32611
Principal Investigator: Janet H Silverstien, MD
Phone: 352-273-9259
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De Leon Springs, Florida 32130
Principal Investigator: Janet H Silverstein, MD
Phone: 352-273-9259
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Orlando, Florida 32821
Principal Investigator: Janet H Silverstein, MD
Phone: 352-273-9259
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Orlando, FL
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