Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year if Type II (and starting at 5th year after disease onset it Type I). However, majority of diabetic patients 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. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection this effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy v2.0, 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.
|Condition or Disease||Intervention/Treatment||Phase|
This study is a prospective, multicenter, observational study to assess the safety and efficacy of RETINA-AI Galaxy ("Galaxy") in screening for diabetic retinopathy in the primary care setting. The study design conforms to an Intent to Screen (ITS) paradigm . The Galaxy is a software medical device designed to analyze digital color fundus photographs and rapidly screen for the presence of more than mild diabetic retinopathy or vision-threatening diabetic retinopathy in the primary care setting.
The study will enroll up to 800 subjects after exclusions. Subjects who meet eligibility criteria will be recruited from Sites staffed by primary care providers. Eligibility will be assessed and informed consent obtained, after which digital color fundus photographs will be taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.
There will be a total of 3 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There will be a dedicated validation camera used in the Validation Reading Center Protocol part of the study. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training will operate the RETINA-AI Galaxy device and the screening cameras. The Retina Reading Center - certified professional ophthalmic photographers will operate the validation fundus cameras according the the 4W-D stereo protocol.
Arms and Interventions
Patients aged 22yrs or older who have diabetes will be recruited from primary care settings.
Diagnostic Test: Color fundus photograph
Subjects will undergo color fundus photography before and after pharmacological dilation of pupils.
Diagnostic Test: Optical Coherence Tomography (OCT) of the retina
Subjects will undergo OCT of the retina after pharmacological dilation of pupils.
Drug: Mydriatic Agent
Pharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects
Primary Outcome Measures
- To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 to detect more than mild diabetic retinopathy in the primary care setting [1 visit (1 day)]
To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 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.
- To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 to detect vision-threatening diabetic retinopathy in the primary care setting [1 visit (1 day)]
To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for detecting vision threatening diabetic retinopathy (vtDR) defined as severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema.
Patient age 22 or above
Patient with documented diagnosis of diabetes as defined by:
Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments
Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments
Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose
=200mg/dL (11.1 mmol/L)
- Per World Health Organization (WHO) or American Diabetes Association diabetes criteria
- Understanding of the Study and willingness and ability to sign informed consent
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 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).
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- RETINA-AI Health, Inc.
Study Documents (Full-Text)None provided.