Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353542
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-21
Brief Title:
Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program BEGAS
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program BEGAS Artificial Intelligence Applied to Optic Nerve Retinographies for a Glaucoma Screening Program in a Primary-care Setting
Status:
RECRUITING
Status Verified Date:
2024-03
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:
BEGAS
Brief Summary:
Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care
Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit with an optic disc examination and intraocular pressure IOP
The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit IPU the patients will be allocated to one arm using an Artificial Intelligence AI reading software of the optic disc picture and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist
In both circuits an optic nerve head photography will be obtained and a masked reading center will be established to determine the ground truth for diagnosis
This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them
Secondary analyses will include potential diagnostic composite scores including other ancillary tests such as optical coherence tomography images that could maximize the screening process the identification of population and disease characteristics type of glaucoma intraocular pressure that could increase the effectivity and adherence to the screening process
Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit with an optic disc examination and intraocular pressure IOP
The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit IPU the patients will be allocated to one arm using an Artificial Intelligence AI reading software of the optic disc picture and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist
In both circuits an optic nerve head photography will be obtained and a masked reading center will be established to determine the ground truth for diagnosis
This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them
Secondary analyses will include potential diagnostic composite scores including other ancillary tests such as optical coherence tomography images that could maximize the screening process the identification of population and disease characteristics type of glaucoma intraocular pressure that could increase the effectivity and adherence to the screening process
Detailed Description:
The purpose of this study is twofold to validate in our population an Artificial Intelligence AI reading software of the optic disc picture after comparing the estimated result glaucomasuspectnormal to the ground truth and to conduct a clinical trial where the level of agreement between both systems and the cost-effectiveness of each of them will be tested
In the first phase a set of patients from our reference population will be selected A standard-of-care ophthalmic examination with the usual ancillary tests to confirm or rule out the presence of glaucoma including an optic disc retinography will be performed The patient and the test will be examined by a glaucoma specialist who will determine the status of the patient
Then the retinography will be analyzed by the AI software providing the estimated result glaucomasuspectnormal The level of agreement between the ground truth and the casted result will confirm the diagnostic accuracy
In the second phase a second set of patients will be recruited In this case the patients will be randomly allocated to either of the two arms of the study In arm A the ancillary tests including the retinography will be performed and the software will analyze the retinography therefore providing the glaucoma status result In arm B the patients and the test will be examined by a glaucoma specialist who will then determine the status of the patient
All the patients irrespective of the diagnosis and the arm of the study will be then explored by another glaucoma specialist reading center who will be blinded to where the diagnosis comes from AI software or glaucoma specialist to the determine the level of agreement between the two screening systems
In the first phase a set of patients from our reference population will be selected A standard-of-care ophthalmic examination with the usual ancillary tests to confirm or rule out the presence of glaucoma including an optic disc retinography will be performed The patient and the test will be examined by a glaucoma specialist who will determine the status of the patient
Then the retinography will be analyzed by the AI software providing the estimated result glaucomasuspectnormal The level of agreement between the ground truth and the casted result will confirm the diagnostic accuracy
In the second phase a second set of patients will be recruited In this case the patients will be randomly allocated to either of the two arms of the study In arm A the ancillary tests including the retinography will be performed and the software will analyze the retinography therefore providing the glaucoma status result In arm B the patients and the test will be examined by a glaucoma specialist who will then determine the status of the patient
All the patients irrespective of the diagnosis and the arm of the study will be then explored by another glaucoma specialist reading center who will be blinded to where the diagnosis comes from AI software or glaucoma specialist to the determine the level of agreement between the two screening systems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2301856 | OTHER | Institut dInvestigacions Biomèdiques August Pi i Sunyer | None |