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NCT01625598 · ClinicalTrials.gov registry record
Computer Detection of Diabetic Retinopathy Compared to Clinical Examination
A clinical trial, sponsored by Digital Diagnostics.
- Completed
- Registry status
- 600
- Enrollment target
NCT01625598: Completed study, sponsored by Digital Diagnostics.
NCT01625598 is a clinical trial that has completed, run by Digital Diagnostics. The registered enrollment target is 600 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625598 has completed, sponsored by Digital Diagnostics.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
Study Summary
The hypothesis is that computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist.
Primary Outcome
If the interval excludes differences of 10% or more (IDx worse than clinical examination), then the IDx system will be considered non-inferior to clinical examination by ophthalmologists. If IDx is non-inferior to clinical examination, a two-sided test of the null hypothesis that the difference in sensitivities is 0 will be conducted to determine if the IDX is superior to clinical examination. 24 McNemar's test for paired proportions will be used to test the difference in proportions.
Interventions
- PROCEDURE Photography of the retina
- PROCEDURE Retinal photography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-04 |
What the finished NCT01625598 record still lists
NCT01625598 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Photography of the retina is the first listed.
NCT01625598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625598 about?
NCT01625598 is a clinical study titled "Computer Detection of Diabetic Retinopathy Compared to Clinical Examination". The hypothesis is that computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist.
What is the current status of trial NCT01625598?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2012-04. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01625598?
The interventions under investigation include: Photography of the retina (PROCEDURE), Retinal photography (PROCEDURE).
Who is sponsoring clinical trial NCT01625598?
This trial is sponsored by Digital Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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