View clinical trials related to ROP.
Filter by:In this study, the investigators aim to improve image acquisition and preprocessing pipeline for FDA application. Our previous research has used various methodologies to identify images to input into the algorithm. The investigators aim to evaluate the effect of image quality and field of view on the output of the device in addition to performing a precision study to evaluate the effect of different camera operators on image selection and device output. Additionally the investigators aim to assist conducting pivotal clinical study for assistive diagnosis. Based on two previous meetings with the FDA, the clinical study will test the following hypothesis: use of the i-ROP DL VSS improves the accuracy of plus disease diagnosis among clinicians performing telemedical review of images. The investigators also aim to assist in conducting pivotal clinical study of autonomous ROP screening. Preliminary data suggests that the i-ROP DL system could achieve 100% sensitivity for detection of severe ROP. The investigators will perform a clinical study to support a revised indication for use as an autonomous AI screening device. Output of the i-ROP DL system will be compared to masked telemedicine grading for identification of referral-warranted and treatment-requiring ROP.
The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants. The main question it aims to answer are: • To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.
To validate new screening instruments for eye disease, increase eye care access in underserved communities, and provide a scientifically implemented method to set up programs for eye disease screening.