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

This study has been completed.
Information provided by:
Notal Vision Ltd Identifier:
First received: March 7, 2010
Last updated: September 22, 2010
Last verified: September 2010
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Condition Intervention
Age-Related Macular Degeneration Device: FORESEE HOME

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

Resource links provided by NLM:

Further study details as provided by Notal Vision Ltd:

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

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

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
subjects diagnosed as intermediate AMD in at least one eye
Home Monitoring

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.

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01083147

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

Responsible Party: Osnat Ehrman/Clinical manager, Notal Vision Identifier: NCT01083147     History of Changes
Other Study ID Numbers: ForeseeHome-US3
Study First Received: March 7, 2010
Last Updated: September 22, 2010

Keywords provided by Notal Vision Ltd:
Intermediate AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on August 18, 2017