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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00709319 |
The study is designed as a prospective cohort study to assess changes in visual acuity and retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic macular edema.
The study also aims to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain data that can be used to plan a randomized trial.
Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy surgery. The vitrectomy procedure will be performed based on the investigators usual care and is not considered part of the research although the procedure performed will be collected.
Condition |
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Diabetic Retinopathy Diabetic Macular Edema |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of Vitrectomy for Diabetic Macular Edema Study |
Enrollment: | 241 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Primary
Subjects vitreomacular traction, visual acuity 20/63 to 20/400, retinal thickness >300 microns in the central subfield on OCT, and cataract extraction not being performed in conjunction with vitrectomy.
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Secondary
Subjects not meeting criteria for primary cohort
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
adults with diabetic macular edema
Subject-level Inclusion Criteria
To be eligible, the following inclusion criteria (1-3) must be met:
Able and willing to provide informed consent.
Subject-level Exclusion Criteria
A patient is not eligible if any of the following exclusion criteria (4-6) are present:
Study Eye Criteria
To be a study eye, all of the inclusion criteria (a-e) and none of the exclusion criteria (f-m) listed below must be met. A patient can have only one study eye. If both eyes are eligible and undergoing vitrectomy, the first eye having surgery will be the study eye.
The eligibility criteria for a study eye are as follows:
Inclusion
Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
Exclusion
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Director ) |
Study ID Numbers: | NEI-125 |
Study First Received: | July 1, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00709319 |
Health Authority: | United States: Federal Government |
Diabetic retinopathy Diabetic macular edema dme vitrectomy |
Eye Diseases Vascular Diseases Diabetes Mellitus Edema Endocrine System Diseases Macular Degeneration Retinal Degeneration Diabetic Angiopathies |
Macular Edema Signs and Symptoms Diabetic Retinopathy Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
Cardiovascular Diseases |