Ignite Creation Date:
2024-05-06 @ 8:15 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02691312
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2016-02-22
Brief Title:
Pediatric Type 1 Diabetes and Retinopathy
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Prevalence and Characterization of Retinopathy in Children With Type 1 Diabetes Using a Non-mydriatic Fundus Camera
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 httpwwwcentervuecomproducta556htmlid637 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 microalbumincreatinine presence or absence of hypertension and previous diagnoses of diabetic retinopathy microalbuminuria hyperlipidemia or hypertension
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 microalbumincreatinine presence or absence of hypertension and previous diagnoses of diabetic retinopathy microalbuminuria hyperlipidemia or hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None