We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083147
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : September 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Device: FORESEE HOME

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 Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Subject compliance with Foresee HomeTM device [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Assessment of the Telemedicine infrastructure [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
intermediate AMD
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083147


Locations
United States, New Jersey
Vitreos retina center
Tom's river, New Jersey, United States
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Daniel Roth, MD Vitreos retina center - NJ
More Information

Responsible Party: Osnat Ehrman/Clinical manager, Notal Vision
ClinicalTrials.gov Identifier: NCT01083147     History of Changes
Other Study ID Numbers: ForeseeHome-US3
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010

Keywords provided by Notal Vision Ltd:
Intermediate AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases