- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05368623
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Study Overview
Status
Detailed Description
This study was a prospective, multicenter, observational study to assess the safety and efficacy of the RETINA-AI Galaxy™ v2.0 ("Galaxy™") in screening for diabetic retinopathy in the primary care setting. The study design conformed to an Intent to Screen (ITS) paradigm. The Galaxy™ is a Software-as-a-Medical-Device designed to analyze digital color fundus photographs and rapidly screen for diabetic retinopathy in the primary care setting.
Subjects who met eligibility criteria were recruited from Sites in the United States staffed by primary care providers. Eligibility was assessed and informed consent was obtained, after which digital color fundus photographs were taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.
There were a total of 3 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There was a dedicated validation camera used in the Validation Reading Center Protocol part of the study at each Site. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training operated the RETINA-AI Galaxy v2.0 device and the screening cameras. The Retina Reading Center (RRC)- certified professional ophthalmic photographers operated the validation fundus cameras according the the 4W-D stereo protocol, and obtained OCT images of the macula.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 92844
- Clinical Research Organization
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Illinois
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Chicago, Illinois, United States, 60402
- Clinical Research Organization
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Texas
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Houston, Texas, United States, 77074
- Clinical Research Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
INCLUSION CRITERIA
- Patient age 22 or above
Patient with a documented diagnosis of diabetes as defined by any of the following:
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-hour 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. Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
- Understanding of the Study and willingness and ability to sign informed consent
EXCLUSION CRITERIA:
- Persistent vision loss in one or both eyes
- Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
- Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME).
- Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate.
- Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Sequential Enrollment
Patients aged 22yrs or older who have diabetes will be recruited from primary care settings.
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Subjects will undergo color fundus photography before and after pharmacological dilation of pupils.
Subjects will undergo OCT of the retina after pharmacological dilation of pupils.
Pharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for diabetic retinopathy screening in the primary care setting.
Time Frame: 1 visit (1 day)
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1 visit (1 day)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Mydriatics
Other Study ID Numbers
- RETINA-AI-CT2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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