HMP (Home Macular Perimeter) -Usability Trial
The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .
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|