- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806402
Evaluation of OCT Measurements
January 20, 2014 updated by: Optovue
Evaluation of the Precision and Accuracy of OCT Measurements in Retinal and Glaucoma Patients
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.
Study Overview
Status
Completed
Detailed Description
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology.
There will be a series of measurements acquired from one eye on at least 2 different OCT devices.
All testing will be completed in one visit.
Study Type
Observational
Enrollment (Actual)
135
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
-
-
California
-
Daly City, California, United States, 94015
- Pacific Eye Specialists
-
Petaluma, California, United States, 94954
- North Bay Eye Associates
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Walnut Creek, California, United States, 94596
- West Coast Retinal Medical Group
-
-
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
Patients will have retina pathology or glaucoma.
Description
Inclusion Criteria:
Inclusion Criterea:
- At least 18 years of age
- Able and willing to provide consent
- Willing to complete the required examinations and visits
- Best corrected visual acuity equal or better than 20/100
- Retina subject must have clinical diagnosis of retinal pathology
- Glaucoma subjects must have clinical diagnosis of glaucoma
Exclusion Criteria:
- Unable to complete the required examinations and visits
- Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment
- Confounding pathology requiring surgical treatment or medical intervention
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
Cohorts and Interventions
Group / Cohort |
---|
Retina
Having clinical diagnosis of retina pathology
|
Glaucoma
Having clinical diagnosis of glaucoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retina thickness
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 5, 2013
First Submitted That Met QC Criteria
March 5, 2013
First Posted (Estimate)
March 7, 2013
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20130104
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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