- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592826
HMP (Home Macular Perimeter) -Usability Trial
April 13, 2015 updated by: Notal Vision Ltd.
Phase III Study of the Usability of the HMP Device
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 .
Study Overview
Status
Completed
Conditions
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
Study Type
Observational
Enrollment (Actual)
25
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be recruited in community centers and clinics and will include up to 25 people aged >50 years (Age-related Macular Degeneration age group).
The group will be heterogeneous in terms of education, age, ethnic background, and gender.
The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects who successfully set up the device
Time Frame: 1 month
|
1 month
|
Proportion of subjects who successfully pass the training program (successful calibration module)
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with reliable tests results
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam Mr Weinstein, MD, Kidney Health Center of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
January 1, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T3
- WIRB Pr. No.: 20071980
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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