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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