Pediatric Type 1 Diabetes and Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus, Type 1
Study type: Observational

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.
    

Detailed description: 
      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.
    

Intervention name(s): Digital Retinography System
Intervention type(s): Device
Intervention description(s): 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 name(s): CenterVue Digital Retinography System; DRS
Observational model: Case-Only
Time perspective: Cross-Sectional
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.
      
Keywords: type 1 diabetes; retinopathy