Diabetic Retinopathy Clinical Trial
Official title:
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Verified date | September 2021 |
Source | RETINA-AI Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.
Status | Completed |
Enrollment | 397 |
Est. completion date | August 31, 2021 |
Est. primary completion date | May 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 1. Patient age 22 or above 2. Patient with documented diagnosis of diabetes as defined by: A. Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments B. Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments C. Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water. D. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose >=200mg/dL (11.1 mmol/L) E. Per World Health Organization (WHO) or American Diabetes Association diabetes criteria 3. Understanding of the Study and willingness and ability to sign informed consent Exclusion Criteria: 1. Persistent vision loss in one or both eyes 2. Diagnosis with macula edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion 3. History of retinal laser treatment or intraocular injections of other eye; or any prior history of retinal surgery. 4. Current enrolled in another interventional study of an investigational device or drug and actively receiving investigational product for DR or DME 5. Subject has a condition that in the principal investigator's opinion would preclude participation in the study (e.g it may confound study results or result in ungradable photographs for clinical reference standard) 6. Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate 7. Subject is contraindicated from fungus photography (e.g. subject is hypersensitivity to light). |
Country | Name | City | State |
---|---|---|---|
United States | Biopharma Informatic LLC | Houston | Texas |
United States | Biopharma Informatic, LLC | Houston | Texas |
United States | Clinical Trial Network | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
RETINA-AI Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the sensitivity and specificity of RETINA-AI Galaxy to detect more than mild diabetic retinopathy in the primary care setting | To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting more than mild diabetic retinopathy (mtmDR) defined as moderate non-proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema. | 1 visit (1 day) | |
Primary | To determine the sensitivity and specificity of RETINA-AI Galaxy to detect vision-threatening diabetic retinopathy in the primary care setting | To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting vision threatening diabetic retinopathy (vtDR) defined as severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema. | 1 visit (1 day) |
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