Table 3 Study exclusion criteria

From: Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices

unable to understand the study

unable to or unwilling to sign the informed consent

indicate persistent vision loss, blurred vision, or floaters

previously diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion

history of laser treatment of the retina or injections into either eye, or any history of retinal surgery;

currently participating in another investigational eye study or actively receiving investigational product for DR or DME

a condition that, in the opinion of the investigator, would preclude participation in the study;

contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity

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