The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

Diabetic Retinopathy Clinical Trial

— SC-DRAI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912961
• Other study ID #: 2019-BOL-SC-DRAI
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: June 2020
• Source: Retina Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1034
• Est. completion date: October 15, 2019
• Est. primary completion date: April 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Bolivia	Centro Medico Kolping	Santa Cruz de la Sierra
Bolivia	Clinica Incor	Santa Cruz de la Sierra
Bolivia	Hospital Universitario Japones	Santa Cruz de la Sierra

Sponsors (2)

Lead Sponsor	Collaborator
Retina Global	VisionQuest Biomedical LLC

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects with gradable images taken by the hand held camera	Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts	3 months
Secondary	Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists	To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma	3 months