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NCT03112005 · ClinicalTrials.gov registry record

Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

A clinical trial of Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Eyenuk.

Completed
Registry status
942
Enrollment target
1
Study location

NCT03112005 is a study of Diabetic Macular Edema and Diabetic Retinopathy that has completed, run by Eyenuk. The registered enrollment target is 942 participants, below the 3,779-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03112005, a study of Diabetic Macular Edema and Diabetic Retinopathy, has completed, sponsored by Eyenuk.

COMPLETED
Registry status
942 participants
Enrollment target
1
Study location

Study Summary

More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.

Interventions

  • PROCEDURE Color fundus photography
  • DRUG Mydriatic Agent

Study Locations (1)

California

  • Los Angeles Biomedical Research Institute - Los Angeles

Trial Details

FieldValue
Enrollment Target 942 participants
Start Date 2017-04-17
Est. Completion 2018-05-31

Sponsor

Eyenuk

4 total trials

What the Registry Record Tells You About NCT03112005

The ClinicalTrials.gov registry entry for NCT03112005 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 942 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,779-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (75% lower). The listed sponsor is Eyenuk, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Color fundus photography is the first listed.

NCT03112005 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03112005 about?

NCT03112005 is a clinical study titled "Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool". More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommen...

What is the current status of trial NCT03112005?

This trial is currently completed. The enrollment target is 942 participants. The study started on 2017-04-17. Estimated completion is 2018-05-31.

What conditions does trial NCT03112005 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, Diabetic Retinopathy, Diabetic Eye Problems.

What interventions are being tested in trial NCT03112005?

The interventions under investigation include: Color fundus photography (PROCEDURE), Mydriatic Agent (DRUG).

Who is sponsoring clinical trial NCT03112005?

This trial is sponsored by Eyenuk, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03112005 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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