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

September 22, 2010 updated by: Notal Vision Ltd.
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Tom's river, New Jersey, United States
        • Vitreos retina center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

intermediate AMD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dry AMD
subjects diagnosed as intermediate AMD in at least one eye
Device: FORESEE HOME
Home Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject compliance with Foresee HomeTM device
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the Telemedicine infrastructure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

  • Principal Investigator: Daniel Roth, MD, Vitreos retina center - NJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 7, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ForeseeHome-US3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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