Phase 0 Observational Study of a Computer-based Screening Algorithm for Detection of Diabetic Retinopathy

Sensitivity of retinal screening for risk stratification of DR using digital fundus photographs with and without the assistance of the RiskAnalyzer

Sensitivity and specificity of retinal screening for risk stratification of DR using digital fundus photographs and the RiskAnalyzer

Clinical Trial Methods and Research Design: A total of 10,000 subjects will be recruited to participate in this study. These subjects will be enrolled through two parallel collaborators, Extension for Community Healthcare Outcomes (Project ECHO) and CommuniCare Health Centers. Each clinic will obtain approximately 50% of the cases per year or an average of 50 cases per week. Subjects will be identified from clinics, CommuniCare Health Centers of San Antonio, TX and Project ECHO, New Mexico. CommuniCare has two associated sites, the Barrio Family Health Center in Southeast San Antonio, TX and the Dr. Frank Bryant Health Center also in San Antonio. CommuniCare serves approximately 45,000 subjects a year of which it is estimated that 5000 are requiring diabetic care. Project ECHO in conjunction with the University of New Mexico collaborates with over 20 rural clinics in New Mexico to provide service to underserved areas in New Mexico. A recruitment flyer and consent forms will be provided to each site. Clinic staff will recruit subject for the study during scheduled visits. Subject will be given a flyer containing information about the study and the informed consent document. Subjects who are interested in being enrolled in the study will be referred to a photographer within the site for Retinal imaging. Subjects will not receive a payment or stipend for participation in this study.

There are no screening requirements for subjects to participate in this trial. Subjects must be diagnosed as a person with pre-diabetes or diabetes by a medical professional. There is no requirement or solicitation for information regarding prior or concomitant therapy. There are no criteria set forth for subjects to exit or be discontinued from the study once the retinal screening is performed. Subjects will not be withdrawn from the study once retinal screening has occurred. Once the subject completes retinal screening, the period of subject participation is concluded. Images taken from subjects may not be used in the study due to inadequate image quality. The number of images found to be inadequate will be tracked and reported at the completion of the study. Retinal screening marks both the beginning and the end of subject participation in this study.

For each eye, a minimum of two posterior pole images will be collected. One image will be centered on the fovea and the second on the optic disc. A third image will be collected of the anterior segment (front of the eye). Subjects will not be pharmacologically dilated. Imaging will rely on natural dilation due to adaptation to darkness in the imaging room. More than two images per eye will be collected only when the imager (photographer) identifies any given image of insufficient quality for reading. Poor quality images are typically due to physiological reasons, such as blinking or small pupils and will not be used as part of this study. The retinal photographer will attempt up to 3 times to acquire images of a subject's eyes in order to complete the imaging protocol. The study coordinator will conduct weekly audits of the imaging procedure in order to ensure and document compliance with the study protocol.