Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774822
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-02-24
Brief Title:
Validation Study of RETINA-AI Galaxy an Automated Diabetic Retinopathy Screening Device
Sponsor:
RETINA-AI Health Inc
Organization:
RETINA-AI Health Inc
Study Overview
Official Title:
Validation Study of RETINA-AI Galaxy an Automated Diabetic Retinopathy Screening Device
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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 US 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 eg 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
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 US 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None