Status:
COMPLETED
Pilot Study of OCT Versus Fluorescein Angiography in DME
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Oregon Clinical and Translational Research Institute
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Diabetic macular edema (DME) is one of the most common causes of visual loss in patients with diabetes and a leading cause of blindness in the working age population. In DME, excess fluid from blood ...
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus (type 1 or type 2).
Exclusion
- Inability to give informed consent.
- Inability to complete study tests within a 30 day period.
- Inability to maintain stable fixation for OCT imaging.
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A prior history of reaction to fluorescein or other dyes.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to treatment.
- Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 23 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01876914
Start Date
June 1 2013
End Date
December 23 2017
Last Update
April 6 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science University
Portland, Oregon, United States, 97239