Age Related Macular DegenerationUU2NCT00748384
Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 2 sites in Israel.
Trial summary
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2009to May 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed as Intermediate AMD
Who may be able to join
- Capable and willing to sign a consent form and participate in the study
- Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)
- Age more than 50 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- Familiar with computer usage
Who cannot join
- Evidence of macular disease other than AMD or glaucoma in the study eye
- Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
- Never been tested on the PHP device
- Participation in another study with the exclusion of AREDS study
- Patients diagnosed with geographic atrophy (GA)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
Read the detailed description
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.
- Conditions
- Age Related Macular Degeneration
- Keywords
- HMP, CNV, AMD, PHP, HPHP, foresee
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Self trained subjects | |
| 2 | supervised trained subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who managed to set the device
Measured: 6 months
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training
Measured: 6 month
Number of device malfunctions
Measured: 6 month
Average use of the device
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionMar 2013
- Study completionMay 2013
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haya Morori Katz, M.D., Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748384
- Sponsor's protocol ID
- HMP-UU2
- Acronym
- UU2
- Status last verified
- May 2013
- First submitted
- 4 Sep 2008
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT00748384
- Acronym / sponsor ID
- UU2 / HMP-UU2
- Conditions
- Age Related Macular Degeneration
- Keywords
- HMP, CNV, AMD, PHP, HPHP, foresee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Sep 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 purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
Detailed description
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Self trained subjects |
| 2 | – | –supervised trained subjects |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed as Intermediate AMD
Key inclusion criteria (6 listed)
- Capable and willing to sign a consent form and participate in the study
Key exclusion criteria (6 listed)
- Evidence of macular disease other than AMD or glaucoma in the study eye
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 managed to set the device
Time frame: 6 months
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training
Time frame: 6 month
Number of device malfunctions
Time frame: 6 month
Average use of the device
Time frame: 6 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 15 May 2013.
- sponsor siteLink provided by the sponsor.
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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.
Haya Morori Katz, M.D. principal investigator
Kaplan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 2 sites in Israel.
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 6 inclusion and 6 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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 managed to set the device (time frame: 6 months). The study lists 4 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 15 May 2013.