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Pilot Study of OCT Versus Fluorescein Angiography in DME

NCT01876914 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-04-06

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Oregon Clinical and Translational Research Institute

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Andreas Lauer, M.D. · Oregon Health & Science Universtiy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-12-23
Completion
2017-12-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01876914 on ClinicalTrials.gov