Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517836
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Automated Screening Device to Detect MTMROP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation Study of i-ROP DL an Automated Screening Device to Detect More Than Mild Retinopathy of Prematurity MTMROP
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive care unit NICU setting to detect more than mild ROP MTMROP defined as type 2 or worse as defined by the Early Treatment for ROP ETROP study or pre-plus compared to an image-based reference standard diagnosis RSD
This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP e-ROP Study a National Institute of Health multicenter study
This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP e-ROP Study a National Institute of Health multicenter study
Detailed Description:
Retinopathy of prematurity is a disease that develops when babies are born prematurely before the retina has fully developed It is a leading cause of childhood blindness worldwide but blindness is usually avoidable with accurate diagnosis and timely treatment of babies with treatment-requiring disease The purpose of diagnostic eye exams therefore sometimes referred to as ROP screening examinations by clinicians is to identify severe disease that requires treatment and administer treatment to reduce the risk of blindness
Each country has accepted criteria for which babies require eye examinations for ROP In the United States all babies born less than 31 weeks post-menstrual age PMA or under 1500 grams require diagnostic eye examinations starting at 31 weeks PMA or 4 weeks after birth whichever is later Exams are repeated at 1-2 week intervals depending on the level of disease identified on examination
Diagnosis of ROP is made using either ophthalmoscopy in person examination at the bedside or using telemedicine with remote digital fundus imaging Telemedicine has become an acceptable standard of care for ROP diagnostic examinations and in most telemedicine workflows exams are repeated weekly to minimize the risk of missing ROP Whether exams occur in person or via telemedicine the ophthalmologist is responsible for documenting the presence or absence of ROP using the International Classification of ROP ICROP guidelines including documenting the presence and degree of zone stage and plus disease
The zone stage and plus disease classifications lead to overall disease severity categories as defined by the Early Treatment for ROP ETROP study see Table The ETROP study determined that urgent treatment within 48 hours should occur when babies develop type 1 ROP but was not indicated for babies with type 2 ROP or less Follow-up guidelines are determined by the responsible physician based on the level of disease although in telemedicine these typically occur weekly
ROP screening criteria are designed to be highly sensitive so that babies with any risk of developing type 1 ROP are captured in the screening population and receive diagnostic eye examinations As a result most babies who receive examinations do not have severe ROP on examination ROP examinations especially in person ophthalmoscopic examinations where scleral depression is utilized are stressful to the neonates and time consuming to the ophthalmologist and thus the current system is inefficient and exposes neonates to added stress which can have significant short and long-term consequences The ideal solution would be to reduce the number of in person examinations a baby receives without missing any cases of type 1 ROP and limit the number of diagnostic eye examinations an ophthalmologist needs to perform to those babies with more than mild ROP type 2 or worse
This scenario is directly analogous to diabetic retinopathy where the recommendation is for all diabetics to have an eye examination every year even though only a small minority will have treatment-requiring disease In diabetic retinopathy autonomous AI has provided an alternative care delivery model where screening examinations occur in the primary care office and only positive screens are sent for full ophthalmoscopic examination by an eye care provider
In this clinical study we are proposing to use the i-ROP DL system as an autonomous screening software as medical device for the detection of more than mild ROP MTMROP defined as type 2 or type 1 ROP using ETROP criteria Digital images can be acquired by a technician in a standardized fashion The system can analyze the images and output a positive or negative exam result
A positive result triggers a referral for telemedical review by an ophthalmologist using the same set of images does not require additional stress to babies The responsible clinician can document the level of ROP and recommend either in person examination for possible treatment or repeat screening examination or telemedical review at the appropriate interval
A negative result automatically triggers a scheduled follow-up appointment for repeated screening examination in 1 week
The i-ROP DL system was originally trained to diagnose plus disease at 3 levels no plus pre-plus or plus Subsequent work using the outputs for plus disease classification we developed the concept of a vascular severity score VSS as an output of the system The VSS is applied at the eye level from 1-9 and reflects the spectrum of vascular changes in pre-plus and plus disease Because pre-plus and plus disease develop in more severe ROP the VSS can be used as an objective assessment of ROP severity increasing with increasing stage of disease and overall category of ROP
Thus with the appropriate cut-point the VSS can be used for screening purposes ensuring nearly 100 sensitivity for detection of treatment-requiring type 1 ROP and high sensitivity for detection of type 2 or worse ROP The cut-point for this study will be 29
This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP e-ROP Study a National Institute of Health multicenter study
Importantly the e-ROP study was designed and executed prospectively to evaluate telemedical eye examinations compared to in person ophthalmoscopic examinations Digital fundus images were acquired using the Retcam Shuttle by trained technicians using a standardized protocol for image acquisition Images were then subsequently read by telemedical graders All babies received in person ophthalmological examinations by ophthalmologists who were masked to the images and were not part of the image acquisition process In other words the study was perfectly designed to evaluate an autonomous screening model for ROP where images are acquired by non-physicians using a defined protocol at the point of care and only positive exams are subsequently reviewed by the ophthalmologist
Each country has accepted criteria for which babies require eye examinations for ROP In the United States all babies born less than 31 weeks post-menstrual age PMA or under 1500 grams require diagnostic eye examinations starting at 31 weeks PMA or 4 weeks after birth whichever is later Exams are repeated at 1-2 week intervals depending on the level of disease identified on examination
Diagnosis of ROP is made using either ophthalmoscopy in person examination at the bedside or using telemedicine with remote digital fundus imaging Telemedicine has become an acceptable standard of care for ROP diagnostic examinations and in most telemedicine workflows exams are repeated weekly to minimize the risk of missing ROP Whether exams occur in person or via telemedicine the ophthalmologist is responsible for documenting the presence or absence of ROP using the International Classification of ROP ICROP guidelines including documenting the presence and degree of zone stage and plus disease
The zone stage and plus disease classifications lead to overall disease severity categories as defined by the Early Treatment for ROP ETROP study see Table The ETROP study determined that urgent treatment within 48 hours should occur when babies develop type 1 ROP but was not indicated for babies with type 2 ROP or less Follow-up guidelines are determined by the responsible physician based on the level of disease although in telemedicine these typically occur weekly
ROP screening criteria are designed to be highly sensitive so that babies with any risk of developing type 1 ROP are captured in the screening population and receive diagnostic eye examinations As a result most babies who receive examinations do not have severe ROP on examination ROP examinations especially in person ophthalmoscopic examinations where scleral depression is utilized are stressful to the neonates and time consuming to the ophthalmologist and thus the current system is inefficient and exposes neonates to added stress which can have significant short and long-term consequences The ideal solution would be to reduce the number of in person examinations a baby receives without missing any cases of type 1 ROP and limit the number of diagnostic eye examinations an ophthalmologist needs to perform to those babies with more than mild ROP type 2 or worse
This scenario is directly analogous to diabetic retinopathy where the recommendation is for all diabetics to have an eye examination every year even though only a small minority will have treatment-requiring disease In diabetic retinopathy autonomous AI has provided an alternative care delivery model where screening examinations occur in the primary care office and only positive screens are sent for full ophthalmoscopic examination by an eye care provider
In this clinical study we are proposing to use the i-ROP DL system as an autonomous screening software as medical device for the detection of more than mild ROP MTMROP defined as type 2 or type 1 ROP using ETROP criteria Digital images can be acquired by a technician in a standardized fashion The system can analyze the images and output a positive or negative exam result
A positive result triggers a referral for telemedical review by an ophthalmologist using the same set of images does not require additional stress to babies The responsible clinician can document the level of ROP and recommend either in person examination for possible treatment or repeat screening examination or telemedical review at the appropriate interval
A negative result automatically triggers a scheduled follow-up appointment for repeated screening examination in 1 week
The i-ROP DL system was originally trained to diagnose plus disease at 3 levels no plus pre-plus or plus Subsequent work using the outputs for plus disease classification we developed the concept of a vascular severity score VSS as an output of the system The VSS is applied at the eye level from 1-9 and reflects the spectrum of vascular changes in pre-plus and plus disease Because pre-plus and plus disease develop in more severe ROP the VSS can be used as an objective assessment of ROP severity increasing with increasing stage of disease and overall category of ROP
Thus with the appropriate cut-point the VSS can be used for screening purposes ensuring nearly 100 sensitivity for detection of treatment-requiring type 1 ROP and high sensitivity for detection of type 2 or worse ROP The cut-point for this study will be 29
This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP e-ROP Study a National Institute of Health multicenter study
Importantly the e-ROP study was designed and executed prospectively to evaluate telemedical eye examinations compared to in person ophthalmoscopic examinations Digital fundus images were acquired using the Retcam Shuttle by trained technicians using a standardized protocol for image acquisition Images were then subsequently read by telemedical graders All babies received in person ophthalmological examinations by ophthalmologists who were masked to the images and were not part of the image acquisition process In other words the study was perfectly designed to evaluate an autonomous screening model for ROP where images are acquired by non-physicians using a defined protocol at the point of care and only positive exams are subsequently reviewed by the ophthalmologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None