- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318705
Testing Latest Version of NidekRS3000Adv
July 6, 2018 updated by: Kenneth Marion, Doheny Image Reading Center
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 Overview
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Pasadena, California, United States, 91105
- Doheny Eye Centers UCLA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Control subjects with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.
Description
Inclusion Criteria:
- Healthy participants
- 18 years old or older
Exclusion Criteria:
- 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
- pregnant subjects
- economically and educationally disadvantaged subjects
- decision impaired subjects
- homeless subjects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular vascularization
Time Frame: 1 year
|
Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Srinivas Sadda, MD, Doheny Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
March 28, 2018
Study Completion (Actual)
March 28, 2018
Study Registration Dates
First Submitted
October 19, 2017
First Submitted That Met QC Criteria
October 19, 2017
First Posted (Actual)
October 24, 2017
Study Record Updates
Last Update Posted (Actual)
July 9, 2018
Last Update Submitted That Met QC Criteria
July 6, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDEKRS3000ADV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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