The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study (SC-DRAI)

Retina Global

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Other: Picture of the retina with a handheld retinal camera

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03912961

2019-BOL-SC-DRAI

Details and patient eligibility

About

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.

Enrollment: 1,034 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
3. Subjects who have been diagnosed with Type I or Type II diabetes mellitus.

Exclusion criteria

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
3. Subject blind in one eye due to any cause
4. Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.