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Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
NCT03112005 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- PROCEDURE Color fundus photography
- DRUG Mydriatic Agent
Study Locations (1)
California
- Los Angeles Biomedical Research Institute — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 942 participants |
| Start Date | 2017-04-17 |
| Est. Completion | 2018-05-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03112005
The ClinicalTrials.gov registry entry for NCT03112005 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 942 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eyenuk, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03112005 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03112005?
The interventions under investigation include: Color fundus photography (PROCEDURE), Mydriatic Agent (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03112005?
This trial is sponsored by Eyenuk, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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