An observational study in Type 1 Diabetes and Diabetic Retinopathy, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by Odense University Hospital · Observational
The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 132 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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This study includes a cohort of type 1 diabetic patients, who originally were identified in 21 paediatric departments and studied in 1986. This group initially consisted of 1033 children and was estimated to involve around 80 percent of all Danish type 1 diabetic patients below the age of 18. In 1995 further examinations were performed on the cohort; this time 339 chose to participate.
In this study we will invite the participants from 1995 who also participated in the eye examinations, n=324, to participate in yet another follow-up examination.
Exclusion Criteria:
This is an observational study with no interventions.
Incidence of diabetic retinopathy and proliferative diabetic retinopathy
Using the ETDRS grading protocol the degree of retinopathy in 2011 will be assessed by grading 7-field fundus photographs taken at follow-up examination. This will be related to the degree of retinopathy found in the patients in 1995, where the last study of the cohort took place.
Time frame: 16 years
Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Using the computer software named IVAN we will assess the average vessel diameters around the optic disc on fundus photos from 1995. This we will relate to the degree of retinopathy in 2011 to see if vessel diameters predicts diabetic eye complications.
Time frame: 16 years
Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Using the computer software named Fractal Analyzer we will assess the fractal dimension around the optic disc on fundus photos from 1995. This we will relate to the degree of retinopathy in 2011 to see if fractals can help predict diabetic eye complications.
Time frame: 16 years
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Odense University Hospital