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NCT01083147 Clinical Trial

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

Age-Related Macular Degeneration Clinical Trial

— AMD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01083147
Other study ID # ForeseeHome-US3
Secondary ID
Status Completed
Phase N/A
First received March 7, 2010
Last updated September 22, 2010
Start date October 2009
Est. completion date September 2010

Study information
Verified date September 2010
Source Notal Vision Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• FORESEE HOME
Home Monitoring

Locations
Country Name City State
United States Vitreos retina center Tom's river New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subject compliance with Foresee HomeTM device 6 months No
Secondary Assessment of the Telemedicine infrastructure 6 months No
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