ForeseeHome NRich Registry

NCT05690880 | Active Not Recruiting FDA Device

• 1 other identifier: FSH-R-C2022.001
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)

  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 SD-OCT and to validate the predictive value of a non-NV-AMD FSH alerts.

  5 years

Interventions

Foresee Home DEVICE

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.).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 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 20,000 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.

You may qualify if:

• The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye.

You may not qualify if:

• Patients that are unable to establish a baseline

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (1)

NJ Retina

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)