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NCT02088229 · ClinicalTrials.gov registry record
Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 35
- Enrollment target
NCT02088229: Completed study, sponsored by University of Michigan.
NCT02088229 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088229 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
Study Summary
This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescein angiography, in addition to retinal layer integrity and thickness using high resolution optical coherence tomography. Also, functional assessments such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation, perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and compared with historical controls to ensure that currently accepted interventions are safe. Finally, potential confounding variables for DME including those related to the eye, systemic factors, and patient demographics will be recorded to assess the influence of these variables on treatment response. The primary objective is to develop hypotheses that might better explain the retinal structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in eyes receiving treatment for diabetic macular edema (DME).
Primary Outcome
Rod intercept (minutes)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-07 |
What the finished NCT02088229 record still lists
NCT02088229 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02088229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02088229 about?
NCT02088229 is a clinical study titled "Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema". This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescei...
What is the current status of trial NCT02088229?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2012-09. Estimated completion is 2015-07.
Who is sponsoring clinical trial NCT02088229?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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