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ACTIVE NOT RECRUITING
NCT05690880

ForeseeHome NRich Registry

Sponsor: Notal Vision Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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