HMP (Home Macular Perimeter) -Usability Trial
Completed
- Conditions
- Age Related Macular Degeneration
- Registration Number
- NCT00592826
- Lead Sponsor
- Notal Vision Ltd.
- Brief Summary
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 .
- Detailed Description
Stage I:
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Age >50 years
- Familiar with computer usage
- Capable and willing to sign a consent form and participate in the study
- Ability to speak, read and understand instructions in English
Exclusion Criteria
- Subject already participating in another study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who successfully set up the device 1 month Proportion of subjects who successfully pass the training program (successful calibration module) 1 month
- Secondary Outcome Measures
Name Time Method Proportion of subjects with reliable tests results 1 month