Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690880
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-01-10
Brief Title:
ForeseeHome NRich Registry
Sponsor:
Notal Vision Inc
Organization:
Notal Vision Inc
Study Overview
Official Title:
ForeseeHome NRich Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
This registry will compare functional and structural data of progression of Intermediate AMD iAMD and conversion to neovascular AMD NV-AMD while monitored at home with the ForeseeHome Monitoring System FSH and during routine care with Spectral Domain Optical Coherence Tomography SD-OCT and to validate the predictive value of a non-NV-AMD FSH alerts
Detailed Description:
The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 2060 or better that establish a valid baseline in at least one eye The process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing The aim of the registry is to collect data up to 20000 patients on the ForeseeHome program for at least one year The data will be collected for approximately a period of 5 years
The registry will include clinics that provide direct care to the patients on the ForeseeHome device and Notal Vision Monitoring Center The registry aims to collect data from about 200 referring physicians
The registry will include structural and functional data for the patients active on the ForeseeHome device The details of data points to be collected are mentioned below
Data from participating sites will be collected in a de-identified manner and collected in the registry Patients will be assigned a patient ID and will be collected in a sequential manner from each site No data shall be acquired outside standard of care Not all data points for each patient are expected to be present The following data points shall be shared in the registry
From Notal Vision Monitoring Center
1 Patient ID Date of Birth DOB gender and testing eye From prescribing physician
2 Visual Acuity Visual acuity as measured during regular examination in a period when the patient is active on the ForeseeHome program shall be shared in the registry Maximum 2 visual acuity measurements shall be shared during one calendar year
3 Structural OCT Images OCT images volume scans acquired following a ForeseeHome alert shall be shared in the registry
4 OCT Angiography OCT-A Images OCT-A images acquired following a ForeseeHome alert shall be shared in the registry
5 Fluorescein Angiography FA FA images acquired following a ForeseeHome Alert visit shall be shared in the registry
6 Diagnosis of wet-AMD in case of ForeseeHome alert The diagnosis related to status of patients macular degeneration in both eyes shall be shared in the registry in case of an alert
7 Status of the eye after exiting the ForeseeHome program regarding conversion to wet-AMD and its timing
The registry will include clinics that provide direct care to the patients on the ForeseeHome device and Notal Vision Monitoring Center The registry aims to collect data from about 200 referring physicians
The registry will include structural and functional data for the patients active on the ForeseeHome device The details of data points to be collected are mentioned below
Data from participating sites will be collected in a de-identified manner and collected in the registry Patients will be assigned a patient ID and will be collected in a sequential manner from each site No data shall be acquired outside standard of care Not all data points for each patient are expected to be present The following data points shall be shared in the registry
From Notal Vision Monitoring Center
1 Patient ID Date of Birth DOB gender and testing eye From prescribing physician
2 Visual Acuity Visual acuity as measured during regular examination in a period when the patient is active on the ForeseeHome program shall be shared in the registry Maximum 2 visual acuity measurements shall be shared during one calendar year
3 Structural OCT Images OCT images volume scans acquired following a ForeseeHome alert shall be shared in the registry
4 OCT Angiography OCT-A Images OCT-A images acquired following a ForeseeHome alert shall be shared in the registry
5 Fluorescein Angiography FA FA images acquired following a ForeseeHome Alert visit shall be shared in the registry
6 Diagnosis of wet-AMD in case of ForeseeHome alert The diagnosis related to status of patients macular degeneration in both eyes shall be shared in the registry in case of an alert
7 Status of the eye after exiting the ForeseeHome program regarding conversion to wet-AMD and its timing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None