Age Related Macular DegenerationHMPNCT00596388
Usage of the Home Macular Perimeter (HMP)
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device. 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
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Mar 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
- Age >50 years
- VA with habitual correction >20/60 in the study eye
- Ability to speak, read and understand instructions in 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
- Participation in another study with the exclusion of AREDS study
- Patients diagnosed with geographic atrophy (GA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study
Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.
Read the detailed description
The pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.
- Conditions
- Age Related Macular Degeneration
- Keywords
- HMP, AMD, CNV, PHP, HPHP
- 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 | Subjects diagnosed as intermediate AMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who manage to use the device as in a daily testing
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 posted17 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2013
- Study completionMar 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaron Mr Lang, MD, Principal investigator, Haemek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596388
- Sponsor's protocol ID
- HMP-PU1
- Other IDs
- 0197-07
- Acronym
- HMP
- Status last verified
- May 2013
- First submitted
- 7 Jan 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
- Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study
- ClinicalTrials.gov ID
- NCT00596388
- Acronym / sponsor ID
- HMP / HMP-PU1
- Conditions
- Age Related Macular Degeneration
- Keywords
- HMP, AMD, CNV, PHP, HPHP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 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.
Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.
Detailed description
The pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects diagnosed as intermediate AMD |
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
- Subjects diagnosed as intermediate AMD in at least one eye
- Age >50 years
- VA with habitual correction >20/60 in the study eye
- Ability to speak, read and understand instructions in Hebrew
Key exclusion criteria (5 listed)
- 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
- Participation in another study with the exclusion of AREDS study
- Patients diagnosed with geographic atrophy (GA)
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 manage to use the device as in a daily testing
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.
Yaron Mr Lang, MD principal investigator
Haemek Hospital
1 site 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 1 site 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 5 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 1 site 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 manage to use the device as in a daily testing (time frame: 6 month). 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.