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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03912961
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
VisionQuest Biomedical LLC
Information provided by (Responsible Party):
Retina Global

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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Other: Picture of the retina with a handheld retinal camera

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Picture of the retina with a handheld retinal camera
    Patient with diabetes will have their undiluted and dilated images taken, with the images being centered on the macula and on the optic disc.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03912961

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Centro Medico Kolping Recruiting
Santa Cruz de la Sierra, Bolivia
Contact: Cristhian Diaz, MD    +591 78415225   
Clinica Incor Recruiting
Santa Cruz de la Sierra, Bolivia
Contact: Jimmy Borda, MD    +59178667446   
Hospital Universitario Japones Recruiting
Santa Cruz de la Sierra, Bolivia
Contact: Eva Dewi, MD    +59175534962   
Sponsors and Collaborators
Retina Global
VisionQuest Biomedical LLC
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Study Director: Rajat Agrawal, MD MS Retina Global

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Responsible Party: Retina Global Identifier: NCT03912961     History of Changes
Other Study ID Numbers: 2019-BOL-SC-DRAI
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases