At a glance
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Analyzing the Performance of Automated Software in the Identification of Malarial Retinopathy in Digital Retinal Images of Cerebral Malaria Patients
In Brief
A clinical study evaluating Automated software for malarial retinopathy detection for Cerebral Malaria and Malarial Retinopathy. Completed, enrolled 834 participants across 1 site.
Detailed Summary
The focus of the study is performance validation of ASPIRE software device in processing mydriatic retinal images of a patient with clinically diagnosed Cerebral Malaria (CM), to detect malarial retinopathy (MR). The outcome expected is the sensitivity and specificity of ASPIRE in detecting MR in patients with clinical diagnosis of CM, who may be addressed by a physician or ophthalmic specialist with follow-up and/or treatment. The reference standard for detection of MR is based on an adjudicated diagnoses by a panel of three ophthalmic graders (ophthalmologists) trained in the detection of MR in retinal images.
Study Details
Timeline
Interventions
ASPIRE mobile application (App) software is intended to perform computer-aided detection of malarial retinopathy (MR) in digital retinal images of clinically diagnosed cerebral malaria (CM) patients under 21 years of age, to be used by a healthcare provider (user) with basic training, in primary care settings such as healthcare clinics and hospitals. The mobile Application hosts a software module developed using Deep-Learning algorithms to analyze digital retinal images of diagnosed CM patients for features suggestive of malarial retinopathy. ASPIRE requires at least four adequate quality retinal images (as determined by the image quality analysis software) captured from a patient to process it for MR detection. ASPIRE outputs a screening result of "Malarial retinopathy detected" or "Malarial retinopathy not detected" to the user. ASPIRE software is designed and validated to perform at clinically acceptable sensitivity and specificity in the detection of MR.