Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2021-09-29
2023-03-07
Brief Summary
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60 participants will be enrolled into this study. Participants need to have diabetic eye disease. This is a one-time study visit that lasts approximately 1 hour.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mild Non-Proliferative Diabetic Retinopathy (NPDR)
Presence of at least one retinal microaneurysm or hemorrhage as determined by clinician.
Topcon Camera
Standard 7 field imaging
Optos Camera
Ultrawide field imaging
Clarus Camera
Ultrawide field imaging
Moderate NPDR
Increasing hemorrhages and microaneurysms as well as cotton wool spots, venous beading (VB) or Intraretinal microvascular abnormalities (IRMA) to a mild degree as determined by clinician
Topcon Camera
Standard 7 field imaging
Optos Camera
Ultrawide field imaging
Clarus Camera
Ultrawide field imaging
Severe NPDR
"4-2-1" rule-that is, one has severe NPDR if hemorrhages or microaneurysms, or both, appear in all four retinal quadrants; venous beading appears in two or more retinal quadrants; or prominent IRMAs are present in at least one retinal quadrant as determined by clinician.
Topcon Camera
Standard 7 field imaging
Optos Camera
Ultrawide field imaging
Clarus Camera
Ultrawide field imaging
Proliferative Diabetic Retinopathy (PDR)
Neovascularization, either on or within one disc diameter (DD) of the optic disc (NVD) or elsewhere in the retina (NVE); a preretinal hemorrhage (PRH); or vitreous hemorrhage (VH) as determined by the clinician.
Topcon Camera
Standard 7 field imaging
Optos Camera
Ultrawide field imaging
Clarus Camera
Ultrawide field imaging
Interventions
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Topcon Camera
Standard 7 field imaging
Optos Camera
Ultrawide field imaging
Clarus Camera
Ultrawide field imaging
Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of diabetes.
* Willing to participate as evidenced by signing the written informed consent.
Exclusion Criteria
* Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
* Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
18 Years
90 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Barbara Blodi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UW Health - University Station Clinic
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A536000
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 4-22-2021
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0977
Identifier Type: -
Identifier Source: org_study_id
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