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ForeseeHome NRich Registry
Sponsor: Notal Vision Inc.
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
20000
Start Date
2022-12-15
Completion Date
2027-12-15
Last Updated
2023-02-15
Healthy Volunteers
No
Conditions
Interventions
Foresee Home
The ForeseeHome Monitoring System, a non-significant risk device, is prescribed by eye care providers to patients as part of their clinical care. Notal Vision Monitoring Center (NVMC) is an independent diagnostic testing facility responsible for clinical monitoring of FSH data. The NVMC communicates with the patients (for training on the use of the device, troubleshooting of device issues, adherence monitoring, etc.) and with the patients' eyecare providers (for reporting FSH alerts, monitoring of clinical outcomes to assess device functionality and ongoing need for the device, etc.).
Locations (1)
NJ Retina
Toms River, New Jersey, United States