GlaucomaNCT03318705
Testing Latest Version of NidekRS3000Adv
An observational study of Glaucoma, 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?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- RS3000Adv
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 28 Mar 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control subjects 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
- Healthy participants
- 18 years old or older
Who cannot join
- Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
- subjects who are unable to maintain retinal fixation on a specified target
- subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
- subjects with media opacity which preclude high quality imaging will be excluded.
- vulnerable subjects
- subjects under 18
Show all 10Show fewer
- pregnant subjects
- economically and educationally disadvantaged subjects
- decision impaired subjects
- homeless subjects
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.
- Conditions
- Glaucoma
- Being tested
- RS3000Adv
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS3000AdvDevice
Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular vascularization
Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants
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 posted24 Oct 2017
- Study start1 Feb 2018
- Primary completion28 Mar 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Principal investigator, Kenneth Marion, Doheny Image Reading Center
- Investigators
- Srinivas Sadda, MD, Principal investigator, Doheny Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318705
- Sponsor's protocol ID
- NIDEKRS3000ADV
- Status last verified
- Jul 2018
- First submitted
- 19 Oct 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Latest Version of NidekRS3000Adv
- ClinicalTrials.gov ID
- NCT03318705
- Acronym / sponsor ID
- NIDEKRS3000ADV
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Doheny Image Reading CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control subjects with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.
Key inclusion criteria (2 listed)
- Healthy participants
- 18 years old or older
Key exclusion criteria (10 listed)
- Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
- subjects who are unable to maintain retinal fixation on a specified target
- subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
- subjects with media opacity which preclude high quality imaging will be excluded.
- vulnerable subjects
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 |
|---|---|---|
| RS3000AdvNidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants | Device | – |
Primary outcome
Ocular vascularization
Time frame: 1 year
Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants
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 9 Jul 2018.
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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, MD 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 Glaucoma, 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 2 inclusion and 10 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 9 Jul 2018. 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?
Ocular vascularization (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 9 Jul 2018.