Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

NCT01083147 — Completed, 50 participants, Notal Vision Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT01083147, acronym AMD
Status	Completed
Study type	Observational
Enrollment	50 (Actual)
Sponsor	Notal Vision Ltd. (Industry)
Conditions	Age-Related Macular Degeneration
Interventions	FORESEE HOME (Device)
Dates	start 2009-10-01, primary completion 2010-03-01, completion 2010-09-01, first posted 2010-03-09, last updated 2010-09-23
Locations	1 site in United States

-Summary

The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Expand all sections · Collapse all

+Detailed description

This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.

+Arms and interventions

Arm	Type	Interventions	Description
Dry AMD		Device: FORESEE HOME	subjects diagnosed as intermediate AMD in at least one eye

FORESEE HOME (Device): Home Monitoring

+Outcome measures

Primary outcomes

Subject compliance with Foresee HomeTM device [6 months]

Secondary outcomes

Assessment of the Telemedicine infrastructure [6 months]

+Eligibility

Sex: All, ages: 50 Years to any

Inclusion Criteria:

* Subjects who successfully completed participation in ForeseeHome-US2 study
* Patients with ability to comprehend and sign the informed consent/authorization

Exclusion Criteria:

* Subjects who failed to complete participation in ForeseeHome-US2 study

+Locations (1)

Facility	City	Country	Status
Vitreos retina center	Toms River, New Jersey	United States

+Investigators

Daniel Roth, MD, Principal investigator, Vitreos retina center - NJ