HMP (Home Macular Perimeter) -Usability Trial
Age Related Macular Degeneration
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Phase III Study of the Usability of the HMP Device|
- Proportion of subjects who successfully set up the device [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Proportion of subjects who successfully pass the training program (successful calibration module) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Proportion of subjects with reliable tests results [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- Receive a packed HMP device.
- Unpack the device and install it, using a set-up guide
- Use an interactive tutorial to learn the task
- Calibrate the sensitivity of the test
This stage will be completed within 1 to 5 visits, depending on personal progress rate.
Subjects who have successfully completed stage I will be recruited to stage II.
Those subjects will:
• Perform 3 tests , each test in a different day
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592826
|Principal Investigator:||Adam Mr Weinstein, MD||Kidney Health Center of Maryland|