The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1034 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-10-15

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No