Age Related Macular DegenerationAMDNCT00963339
Age-Related Macular Degeneration (AMD) - Usability Study
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd..
Trial summary
The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Foresee Home
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2010
- 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: Intermediate AMD
Who may be able to join
- Subjects diagnosed as intermediate AMD in at least one eye
- Visual Acuity (VA) with habitual correction <20/60 in the study eye
- Qualified in the clinic to use the device
- Ability to speak, read and understand instructions in English
- Subjects with ability to comprehend and sign the informed consent/authorization
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
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
About this study
The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.
Read the detailed description
The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Foresee Home
- 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.
Foresee HomeDevice
Home Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Dry AMD | subjects diagnosed as intermediate AMD in at least one eye Receives: Device: Foresee Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful unpacking and installation
Measured: 3 months
Successful self tutorial performance
Measured: 3 months
Ability of the subjects to operate the device as define by a successful test completion
Measured: 3 months
Secondary outcomes (1)
Evaluate the success rate of the interactive tutorial as defined by a reliable test result.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionSep 2010
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Roth, MD, Principal investigator, Vitreos retina center - NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963339
- Sponsor's protocol ID
- US02
- Acronym
- AMD
- Status last verified
- Sep 2010
- First submitted
- 20 Aug 2009
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Macular Degeneration (AMD) - Usability Study
- ClinicalTrials.gov ID
- NCT00963339
- Acronym / sponsor ID
- AMD / US02
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Aug 2009 (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 purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.
Detailed description
The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry AMD | – | Device: Foresee Homesubjects diagnosed as intermediate AMD in at least one eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intermediate AMD
Key inclusion criteria (5 listed)
- Subjects diagnosed as intermediate AMD in at least one eye
- Visual Acuity (VA) with habitual correction <20/60 in the study eye
- Qualified in the clinic to use the device
- Ability to speak, read and understand instructions in English
- Subjects with ability to comprehend and sign the informed consent/authorization
Key exclusion criteria (3 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
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foresee HomeHome Monitoring | Device | Dry AMD |
Primary outcome
Successful unpacking and installation
Time frame: 3 months
Successful self tutorial performance
Time frame: 3 months
Ability of the subjects to operate the device as define by a successful test completion
Time frame: 3 months
1 secondary outcome
Evaluate the success rate of the interactive tutorial as defined by a reliable test result.
Time frame: 3 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 23 Sep 2010.
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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.
Daniel Roth, MD principal investigator
Vitreos retina center - NJ
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 5 inclusion and 3 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 23 Sep 2010. 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?
Successful unpacking and installation (time frame: 3 months). The study lists 3 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 23 Sep 2010.