The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03912961
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-21
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Primary Completion: 2019-04-14
• Study Completion: 2019-10-15
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

Clinica Incor; 🇧🇴 Santa Cruz de la Sierra, Bolivia

Centro Medico Kolping; 🇧🇴 Santa Cruz de la Sierra, Bolivia

Hospital Universitario Japones; 🇧🇴 Santa Cruz de la Sierra, Bolivia