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NCT03078231 · ClinicalTrials.gov registry record
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
A clinical trial, sponsored by Eyenuk.
- Completed
- Registry status
- 52
- Enrollment target
NCT03078231: Completed study, sponsored by Eyenuk.
NCT03078231 is a clinical trial that has completed, run by Eyenuk. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078231 has completed, sponsored by Eyenuk.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study Summary
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or 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 injections 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. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
Primary Outcome
The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.
Interventions
- PROCEDURE Color fundus photography
- DRUG Mydriatic Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2017-04-24 |
What the finished NCT03078231 record still lists
NCT03078231 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Color fundus photography is the first listed.
NCT03078231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078231 about?
NCT03078231 is a clinical study titled "Pilot 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 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...
What is the current status of trial NCT03078231?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2017-02-17. Estimated completion is 2017-04-24.
What interventions are being tested in trial NCT03078231?
The interventions under investigation include: Color fundus photography (PROCEDURE), Mydriatic Agent (DRUG).
Who is sponsoring clinical trial NCT03078231?
This trial is sponsored by Eyenuk, which has 4 total clinical trials registered on ClinicalTrials.gov.
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