An observational study in Diabetic Retinopathy, sponsored by Retina Global. Completed at 3 sites in Bolivia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by Retina Global · Observational
In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's enrollment of 1,034 is above the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →This is the only study on the registry with Retina Global as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.
Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists
Time frame: 3 months
Number of subjects with gradable images taken by the hand held camera
Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts
Time frame: 3 months
Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists
To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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