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Switch from film to digital imaging of diabetic retinopathy may not affect study outcomes
Hubbard LD. Arch Ophthalmol. 2011;129(6):718-726.
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Switching from film to digital imaging for the assessment of diabetic retinopathy should not negatively affect research, a study suggested.
The masked, cross-sectional, comparison analysis was a sub-study of the Diabetes Control and Complications Trial (DCCT) and the Epidemiology of Diabetes Interventions and Complications Study (EDIC), which included 310 participants from 20 clinics with type 1 diabetes and a wide range of diabetic retinopathy.
Participants were imaged with film and digital media per the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol, and outcomes were compared. Overall, ETDRS severity levels, which were the major DCCT/EDIC outcomes, were shown to be similar, as were the conclusions drawn from these outcomes.
To date, all 28 clinics of the DCCT/EDIC Research Group have been transitioned to digital imaging. Despite the prevalence of optical coherence tomography in modern trials, the research group has opted not to include optical coherence tomography due to the low incidence of clinically significant macular edema in its cohort.
Few cases with severe nonproliferative diabetic retinopathy or severe or mild proliferative diabetic retinopathy were present, resulting in decreased power to examine differences between the two types of imaging in these categories, the study authors said.
Disclosure: The researchers report contributions from Abbott, Animas, Aventis, BD Bioscience, Bayer, Can-AM, Eli Lilly, Lifescan, Medtronic Minimed, Omron, Roche and OmniPod to the trial.
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