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Precision 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: NCT03859310
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Optovue

Brief Summary:
Precision of OCT- and OCTA-based Ocular Measurements

Condition or disease Intervention/treatment
Normal Eyes and Ocular Pathology Device: SD-OCT

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.

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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision of OCT and OCTA-based Ocular Measurements
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : August 30, 2019

Group/Cohort Intervention/treatment
Normal
no glaucoma or retinal pathology or corneal conditions
Device: SD-OCT
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Glaucoma
diagnosis of glaucoma
Device: SD-OCT
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
Device: SD-OCT
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
Device: SD-OCT
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures




Primary Outcome Measures :
  1. Repeatability and Reproducibility Standard Deviation of ocular measurements [ Time Frame: Day 1 ]
    calculated value minus the measured value


Secondary Outcome Measures :
  1. Repeatability and Reproducibility Coefficient of Variation of ocular measurements [ Time Frame: Day 1 ]
    maximum difference that is likely to occur between repeated measurements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Seeing eye doctor for routine care
Criteria

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.

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): NCT03859310


Locations
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United States, Ohio
AMA
Marysville, Ohio, United States, 43040
Sponsors and Collaborators
Optovue
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Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT03859310    
Other Study ID Numbers: 200-53770
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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