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NCT01614327 · ClinicalTrials.gov registry record
Computer-based Screening for Diabetic Retinopathy
A clinical trial, sponsored by VisionQuest Biomedical.
- Completed
- Registry status
- 19,199
- Enrollment target
NCT01614327 is a clinical trial that has completed, run by VisionQuest Biomedical. The registered enrollment target is 19,199 participants.
The verdict
NCT01614327 has completed, sponsored by VisionQuest Biomedical.
- COMPLETED
- Registry status
- 19,199 participants
- Enrollment target
Study Summary
The study is an Observational, Phase 0 designed to establish that the risk for diabetic retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any reader and it decreases the inter-reader variability. Objectives: Objectives one, two, and three are arranged chronologically and in an increasing level of complexity as a three tiered approach to support the primary and secondary endpoint of the trial. Objective one is to test fully each system components of the study limited to a single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the risk of Diabetic Retinopathy in comparison to the gold standard. Objective three is to demonstrate that the reader's accuracy in grading images is improved when risk levels assigned by the RiskAnalyzer are made available to the reader while performing the grading of the images which is the primary endpoint of the trial Methods and Research Design: A network of clinical study sites will be established to meet the required number of cases needed as calculated by statistical analysis. Male and Female Subjects between the ages of 18-65 who are either pre-diabetic or diabetics will be eligible for participation in this study. Subjects will be recruited, consented, photographed and their images graded by two trained readers and analyzed by the RiskAnalyzer . The risk levels that are obtained from the RiskAnalyzer will be compared to the current gold standard practice, manual grading of each case by a reader. Data collected during this clinical trial will be reported to the referring physician in the form of a retinal screening report completed and signed by a licensed Ophthalmic professional and delivered to their attending physician. Risk levels for diabetic retinopathy obtained by use of the RiskAnalyzer will not be given to the attending physician under any circumstances in order to preserve standard of care for the patient. The sensitivity, specificity, receiver operating
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19,199 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-02-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01614327
The ClinicalTrials.gov registry entry for NCT01614327 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 19,199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VisionQuest Biomedical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01614327 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01614327 about?
NCT01614327 is a clinical study titled "Computer-based Screening for Diabetic Retinopathy". The study is an Observational, Phase 0 designed to establish that the risk for diabetic retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any reader and it decreases the inter-reader variability. Objectives: Objectives one, two, and three are arranged chronol...
What is the current status of trial NCT01614327?
This trial is currently completed. The enrollment target is 19,199 participants. The study started on 2012-08. Estimated completion is 2015-02-24.
Who is sponsoring clinical trial NCT01614327?
This trial is sponsored by VisionQuest Biomedical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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