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Data Collection of OCT and OCTA-based Ocular Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887104
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Optovue

Study Description
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Brief Summary:
Data Collection of OCT and OCTA-based Ocular Measurements

Condition or disease Intervention/treatment
Eyes Without Ocular Pathology Device: SD-OCT

Detailed Description:
The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.
Study Design
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Study Type : Observational
Actual Enrollment : 482 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection of OCT and OCTA-based Ocular Measurements
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : August 30, 2019
Groups and Cohorts
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Intervention Details:
  • Device: SD-OCT
    Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Outcome Measures
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Primary Outcome Measures :
  1. Retinal thickness [ Time Frame: Day 1 ]
    micrometers


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Persons having eyes without ocular pathology
Criteria

Inclusion Criteria:

  • No glaucoma
  • No retinal pathology
  • No systemic disorders impacting the eye
  • No ocular surgery or medical treatment of ocular condition

Exclusion Criteria:

  • High IOP
  • Poor vision
  • Clinical findings consistent with pathology
  • Unable to complete the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887104


Locations
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United States, California
Eye Care Center
Pomona, California, United States, 91766
United States, Florida
Eye Care Institute
Fort Lauderdale, Florida, United States, 33312
United States, New Jersey
IOVS
Newark, New Jersey, United States, 07103
United States, Ohio
AMA Eye Physicians & Surgeons
Marysville, Ohio, United States, 43040
United States, Oklahoma
College of Optometry
Tahlequah, Oklahoma, United States, 74464
Sponsors and Collaborators
Optovue
More Information
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Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT03887104    
Other Study ID Numbers: 200-53771
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes