The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study


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.

Full Title of Study: “Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar’s Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 14, 2019


  • Other: Picture 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
    • Time Frame: 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 Measures

  • Number of subjects with gradable images taken by the hand held camera
    • Time Frame: 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
    • Time Frame: 3 months
    • To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Global
  • Collaborator
    • VisionQuest Biomedical LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rajat Agrawal, MD MS, Study Director, Retina Global

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.