Age Related Macular DegenerationNCT00592826
HMP (Home Macular Perimeter) -Usability Trial
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Subject already participating in another study.
About this study
Official title: 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 .
Read the 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
- Conditions
- Age Related Macular Degeneration
- Keywords
- PHP, HMP, HPHP, AMD, CNV
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who successfully set up the device
Measured: 1 month
Proportion of subjects who successfully pass the training program (successful calibration module)
Measured: 1 month
Secondary outcomes (1)
Proportion of subjects with reliable tests results
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Mr Weinstein, MD, Principal investigator, Kidney Health Center of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592826
- Sponsor's protocol ID
- T3
- Other IDs
- WIRB Pr. No.: 20071980
- Status last verified
- Apr 2015
- First submitted
- 1 Jan 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of the Usability of the HMP Device
- ClinicalTrials.gov ID
- NCT00592826
- Acronym / sponsor ID
- T3
- Conditions
- Age Related Macular Degeneration
- Keywords
- PHP, HMP, HPHP, AMD, CNV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subject already participating in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects who successfully set up the device
Time frame: 1 month
Proportion of subjects who successfully pass the training program (successful calibration module)
Time frame: 1 month
1 secondary outcome
Proportion of subjects with reliable tests results
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Mr Weinstein, MD principal investigator
Kidney Health Center of Maryland
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who successfully set up the device (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015; AzTrials last refreshed its copy on 1 Nov 2026.