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Clinical Trials in the USA / NCT05690880
Active, not recruiting Observational

ForeseeHome NRich Registry

NCT05690880 · tracked via the Priya Life Science USA tracker
Sponsor
Notal Vision Inc.
Phase
Observational
Started
2022-12-15
Last updated
2023-02-15

Condition(s) studied

Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

Foresee Home

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.).

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients that are unable to establish a baseline

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
NJ Retina Toms River New Jersey
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05690880 on ClinicalTrials.gov ↗ ← All trials in the USA