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NCT01876914 · ClinicalTrials.gov registry record
Pilot Study of OCT Versus Fluorescein Angiography in DME
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 20
- Enrollment target
NCT01876914: Completed study, sponsored by Oregon Health and Science University.
NCT01876914 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01876914 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when fluid and proteins collect in the macula (the yellow central area of the retina). The fluid can cause swelling which in turn can lead to worsening central vision. The purpose of this study is to see if the study device (Swept Source Optical Coherence Tomography or SS-OCT) is able to diagnose DME as well as an already approved imaging procedure called fluorescein angiography (FA). FA is standard of care and would be conducted regardless of study participation. The dye used in FA, which can cause allergic reactions in some patients and is not used in pregnant women, is not needed with the study device. Another purpose of the study is to avoid the risk of administering the FA dye if possible.
Primary Outcome
Total retinal blood flow, as measured by Doppler OCT, is correlated with visual acuity and the area of macular ischemia as evaluated by FA. This will be performed by the following analysis: 1. Pearson's correlation test of total retinal blood flow with logMAR visual acuity; 2. Pearson's correlation test of total retinal blood flow with the area of macular ischemia on FA.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-12-23 |
What the finished NCT01876914 record still lists
NCT01876914 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01876914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01876914 about?
NCT01876914 is a clinical study titled "Pilot Study of OCT Versus Fluorescein Angiography in DME". Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when fluid and proteins collect in the macula (the yellow central area of the retina). The fluid can cause swelling which in turn can lead to worsening central vision. The purpose of this study is to see if the stud...
What is the current status of trial NCT01876914?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2013-06. Estimated completion is 2017-12-23.
Who is sponsoring clinical trial NCT01876914?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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