Comparison Between an Electronic Mobile Device(DEM) and Optical Coherence Tomography (OCT) to Determine Cup-to-disc Ratio (C/D) Through a Non-inferiority Trial With Masked Data Analysis

Glaucoma is the second major cause of blindness in the world, lagging only behind cataract. However, unlike cataract, blindness caused by glaucoma is irreversible. Early diagnosis of the disease and progression monitoring is thus essential for proper treatment in order to avoid irreversible blindness. The most common screening exam for glaucoma diagnosis and monitoring is the eye fundus evaluation where Cup-to-Disc ratio (CDR) among other parameters are assessed. This kind of evaluation is performed by ophthalmologists based on their visual perception, requiring not only specific training but also some significant amount of time of eye examination.Objective measurement of CDR involves high cost equipment which in turn requires some specific training in order to use them. Currently, the Optical Coherence Tomography is used as the gold standard for CDR measurement. An OCT exam uses a high cost and complex equipment that most of the time is not affordable for low-income people. This study proposes a portable electronic device that captures eye fundus images, analyzes these images, performs CDR calculation and allows storing these images for further analysis. This low cost and portable device was developed to be used in several health services (public or private) and has low energy consumption, easing its mobility. Moreover, using this device is easy, not requiring any significant learning effort from ophthalmologists. In developing countries where screening programs for early diagnosis of glaucomatous neuropathy are adopted, an ever-growing number of researchers are putting a significant amount of effort to develop cost-benefit solutions that can reach low-income people and remote areas.