Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients (UU2)
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
Age Related Macular Degeneration
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients|
- Proportion of subjects who managed to set the device [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Number of device malfunctions [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Average use of the device [ Time Frame: 6 month ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Self trained subjects
supervised trained subjects
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.