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

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01083147
First received: March 7, 2010
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • Subject compliance with Foresee HomeTM device [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the Telemedicine infrastructure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Dry AMD
subjects diagnosed as intermediate AMD in at least one eye
 Device: FORESEE HOME
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Osnat Ehrman/Clinical manager, Notal Vision
ClinicalTrials.gov Identifier: NCT01083147     History of Changes
Other Study ID Numbers: ForeseeHome-US3
Study First Received: March 7, 2010
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
Intermediate AMD

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

ClinicalTrials.gov processed this record on May 23, 2013