- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03859310
Precision of OCT and OCTA-based Ocular Measurements
August 30, 2019 updated by: Optovue
Precision of OCT- and OCTA-based Ocular Measurements
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess precision of measurements of vascular structures and the anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to assess measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.
Study Type
Observational
Enrollment (Actual)
144
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
-
-
Ohio
-
Marysville, Ohio, United States, 43040
- AMA
-
-
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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Seeing eye doctor for routine care
Description
Inclusion Criteria:
- Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
- Glaucoma - Have glaucoma and no history of other retinal pathology.
- Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
- Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.
Exclusion Criteria:
- Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
- Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
- Retina - Unable to complete required exams.
- Cornea - Unable to complete required exams.
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 |
Intervention / Treatment |
---|---|
Glaucoma
diagnosis of glaucoma
|
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
|
Normal
no glaucoma or retinal pathology or corneal conditions
|
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
|
Retina
diagnosis of AMD, DR or other retinal pathology
|
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
|
Cornea
wear contact lens or prior refractive surgery or having dry eye or KCN
|
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeatability and Reproducibility Standard Deviation of ocular measurements
Time Frame: Day 1
|
calculated value minus the measured value
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeatability and Reproducibility Coefficient of Variation of ocular measurements
Time Frame: Day 1
|
maximum difference that is likely to occur between repeated measurements
|
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 (ACTUAL)
January 29, 2019
Primary Completion (ACTUAL)
July 10, 2019
Study Completion (ACTUAL)
August 30, 2019
Study Registration Dates
First Submitted
February 22, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (ACTUAL)
March 1, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 3, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 200-53770
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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