Age Related Macular DegenerationNCT00776451
Usability of the PreView PHP for Home Use in Intermediate AMD Patients
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Mar 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Dry AMD subjects
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 ≥65 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- Qualified to use the device by health care professional
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 or macular 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: Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.
Read the detailed description
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD
- Medical subject headings
- Macular Degeneration
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 with Dry AMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
Measured: 2 clinic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionMar 2009
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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Neil Bressler, Prof., Principal investigator, JHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776451
- Sponsor's protocol ID
- PHP-US-01
- Status last verified
- Jun 2009
- First submitted
- 20 Oct 2008
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT00776451
- Acronym / sponsor ID
- PHP-US-01
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Oct 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.
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.
Detailed description
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects diagnosed with Dry AMD |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Dry AMD subjects
Key inclusion criteria (5 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 ≥65 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- Qualified to use the device by health care professional
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 or macular 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
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
Time frame: 2 clinic visits
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 3 Jun 2009.
- sponsor web 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.
Neil Bressler, Prof. principal investigator
JHMC
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 5 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 3 Jun 2009. 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?
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment (time frame: 2 clinic visits). 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 3 Jun 2009.