Status:
COMPLETED
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Lead Sponsor:
RETINA-AI Health, Inc.
Conditions:
Diabetic Retinopathy
Diabetic Eye Problems
Eligibility:
All Genders
22+ years
Brief Summary
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...
Detailed Description
This study is a prospective, multicenter, observational study to assess the safety and efficacy of RETINA-AI Galaxy in screening for diabetic retinopathy in the primary care setting. The study design ...
Eligibility Criteria
Inclusion
- Patient age 22 or above
- 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
- Understanding of the Study and willingness and ability to sign informed consent
Exclusion
- Persistent vision loss in one or both eyes
- Diagnosis with macula edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- History of retinal laser treatment or intraocular injections of other eye; or any prior history of retinal surgery.
- Current enrolled in another interventional study of an investigational device or drug and actively receiving investigational product for DR or DME
- 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)
- Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate
- Subject is contraindicated from fungus photography (e.g. subject is hypersensitivity to light).
Key Trial Info
Start Date :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04774822
Start Date
March 25 2021
End Date
August 31 2021
Last Update
September 16 2021
Active Locations (3)
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1
Biopharma Informatic, LLC
Houston, Texas, United States, 77043
2
Clinical Trial Network
Houston, Texas, United States, 77074
3
Biopharma Informatic LLC
Houston, Texas, United States, 77084