Phase
Condition
Diabetic Retinopathy
Retina
Treatment
handheld fundus camera
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
22 years of age or older
Documented diagnosis of diabetes mellitus, as per any of the following:
Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
Hemoglobin A1c (HbA1c) ≥ 6.5%
Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucosedose dissolved in water
Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
Ability to understand and the willingness to sign a written informed consentdocument
Exclusion
Exclusion Criteria:
Currently participating in an interventional eye study
Has a known allergy to or contraindication for the use of Tropicamide 1% or othermydriatic eye drops
Has a condition that, in the opinion of a licensed clinical team member orinvestigator, would preclude participation in the study (e.g., unstable medicalstatus including blood pressure or glycemic control, microphthalmia or previousenucleation)
Pregnancy
Self-report of visual symptoms including vision loss or blurred vision that cannotbe corrected (e.g., with eyeglasses) or floaters
History of laser treatment of the retina, injections into either eye, or any historyof retinal surgery
Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severenon-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, orretinal vein occlusion)
Any condition that is contraindicated for the use of the study camera
Contraindication for imaging by devices used in the study due to any of thefollowing:
Subject is hypersensitive to light
Subject recently underwent photodynamic therapy (PDT)
Subject is taking medication that causes photosensitivity
Study Design
Study Description
Connect with a study center
Infinity Clinical Research
Norco, California 92860
United StatesSite Not Available
Dream Team
Pomona, California 91767
United StatesSite Not Available
East Cost Institute for Research
Jacksonville, Florida 32216
United StatesSite Not Available
Ocean Wellness Center
Miami Gardens, Florida 33169
United StatesSite Not Available
Olive Branch Family Medical Center
Olive Branch, Mississippi 38654
United StatesSite Not Available
Logan Health
Kalispell, Montana 59901
United StatesSite Not Available
Lillestol Research, LLC
Fargo, North Dakota 58104
United StatesSite Not Available
Allure Health
Friendswood, Texas 77546
United StatesSite Not Available
Mt. Olympus Medical Research
Sugar Land, Texas 77479
United StatesSite Not Available
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