Age-Related Macular Degeneration (AMD) – Beta Study Telemedicine Assessment
Overview
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.
Full Title of Study: “Age-Related Macular Degeneration (AMD) – Beta Study Telemedicine Assessment”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2010
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.
Interventions
- Device: FORESEE HOME
- Home Monitoring
Arms, Groups and Cohorts
- Dry AMD
- subjects diagnosed as intermediate AMD in at least one eye
Clinical Trial Outcome Measures
Primary Measures
- Subject compliance with Foresee HomeTM device
- Time Frame: 6 months
Secondary Measures
- Assessment of the Telemedicine infrastructure
- Time Frame: 6 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Notal Vision Ltd.
- Provider of Information About this Clinical Study
- Osnat Ehrman/Clinical manager, Notal Vision
- Overall Official(s)
- Daniel Roth, MD, Principal Investigator, Vitreos retina center – NJ
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