The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

NCT03912961 | Completed

• 1 other identifier: 2019-BOL-SC-DRAI
• Study Type: observational
• Target: 1,034
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Retinopathy

Outcome Measures

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

  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

  3 months

Secondary Outcomes (2)

• Number of subjects with gradable images taken by the hand held camera

  3 months

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retina Global: lead
• VisionQuest Biomedical LLC: collaborator

Study Sites (3)

Centro Medico Kolping

Santa Cruz de la Sierra, Bolivia

Location

Clinica Incor

Santa Cruz de la Sierra, Bolivia

Location

Hospital Universitario Japones

Santa Cruz de la Sierra, Bolivia

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Rajat Agrawal, MD MS

  Retina Global

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 11, 2019
• Study Start: January 21, 2019
• Primary Completion: April 14, 2019
• Study Completion: October 15, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BO (3)