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Completed

NCT Number: NCT03912961

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Medico Kolping, Santa Cruz de la Sierra, Bolivia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
  • Subjects who have been diagnosed with Type I or Type II diabetes mellitus.

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
  • Subject blind in one eye due to any cause
  • 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.

Treatment and study plan

Picture of the retina with a handheld retinal camera

Other

Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Retina Global

Other

Collaborators

  • VisionQuest Biomedical LLC

Registry information

Official study title

Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera

Acronym: SC-DRAI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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