Age-related Macular Degeneration (AMD)NCT02445313
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
An observational study of Age-related Macular Degeneration (AMD), run by Doheny Image Reading Center at 1 site in United States.
Trial summary
The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- Nidek MP-3
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 12 Feb 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohort A will consist of patients with AMD, recruited by PI when they come in to the clinic, with whom we will conduct medical record review and imaging procedures, using one of the research devices. Cohort B will consist of control subject with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.
Who may be able to join
- Normal, healthy participants and patients with AMD
Who cannot join
- Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
- Participants who are unable to maintain retinal fixation on a specified target
- Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
- Patients with media opacity which preclude high quality imaging will be excluded.
- Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.
Read the detailed description
To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Nidek MP-3
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nidek MP-3Device
Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal, healthy participants Receives: Device: Nidek MP-3 | |
| AMD | Age-related Macular Degeneration participants Receives: Device: Nidek MP-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographic Atrophy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJun 2015
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doheny Image Reading Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srinivas Sadda, Principal investigator, Doheny Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445313
- Sponsor's protocol ID
- NIDEKMP3
- Status last verified
- Feb 2019
- First submitted
- 13 May 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
- ClinicalTrials.gov ID
- NCT02445313
- Acronym / sponsor ID
- NIDEKMP3
- Conditions
- Age-related Macular Degeneration (AMD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Doheny Image Reading CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 15 May 2015 (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 investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.
Detailed description
To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Nidek MP-3Normal, healthy participants |
| AMD | – | Device: Nidek MP-3Age-related Macular Degeneration participants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort A will consist of patients with AMD, recruited by PI when they come in to the clinic, with whom we will conduct medical record review and imaging procedures, using one of the research devices. Cohort B will consist of control subject with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.
Key inclusion criteria (1 listed)
- Normal, healthy participants and patients with AMD
Key exclusion criteria (5 listed)
- Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
- Participants who are unable to maintain retinal fixation on a specified target
- Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
- Patients with media opacity which preclude high quality imaging will be excluded.
- Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.
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 |
|---|---|---|
| Nidek MP-3Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD | Device | AMD, Control |
Primary outcome
Geographic Atrophy
Time frame: 1 year
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 Feb 2019.
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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.
Srinivas Sadda principal investigator
Doheny Eye Institute
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 (AMD), run by Doheny Image Reading Center at 1 site in United States.
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 1 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 Feb 2019. 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 United States. 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?
Geographic Atrophy (time frame: 1 year). 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 Feb 2019.