Diabetic Retinopathy
Conditions
Brief summary
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.
Interventions
OTHERPicture of the retina with a handheld retinal camera
Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.
Sponsors
VisionQuest Biomedical LLC
Retina Global
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with gradable images taken by the hand held camera | 3 months | Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts |
| Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists | 3 months | To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma |
Countries
Bolivia
Outcome results
None listed