Clinical Trials Logo
  1. Home
  2. Diabetic Eye Problems
  3. NCT04774822

Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

Diabetic Retinopathy Clinical Trial

Official title:
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

Clinical Trial 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, 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.

Clinical Trial 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 conforms to an Intent to Screen (ITS) paradigm [1]. 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 360 subjects after exclusions. Subjects who meet eligibility criteria will be recruited from three 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 5 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04774822
Study type Observational
Source RETINA-AI Health, Inc.
Contact
Status Completed
Phase
Start date March 25, 2021
Completion date August 31, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A