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CompletedNCT03859310Updated Sep 3, 2019

Precision of OCT and OCTA-based Ocular Measurements

An observational study in Normal Eyes and Ocular Pathology, sponsored by Optovue. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by Optovue · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years and older
Sex
All
01

Study summary

Precision of OCT- and OCTA-based Ocular Measurements

Read the 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.

02

Conditions studied

  • Normal Eyes and Ocular Pathology
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In context

Lead sponsor

Optovue is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Seeing eye doctor for routine care

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal

    no glaucoma or retinal pathology or corneal conditions

    Device: SD-OCT

  • Glaucoma

    diagnosis of glaucoma

    Device: SD-OCT

  • Retina

    diagnosis of AMD, DR or other retinal pathology

    Device: SD-OCT

  • Cornea

    wear contact lens or prior refractive surgery or having dry eye or KCN

    Device: SD-OCT

Interventions

  • DeviceSD-OCT

    Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

06

What researchers measure

Primary outcomes

  1. Repeatability and Reproducibility Standard Deviation of ocular measurements

    calculated value minus the measured value

    Time frame: Day 1

Secondary outcomes

  1. Repeatability and Reproducibility Coefficient of Variation of ocular measurements

    maximum difference that is likely to occur between repeated measurements

    Time frame: Day 1

07

Study locations

1 site
  • AMA
    Marysville, Ohio 43040, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03859310
Lead sponsor
Optovue
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Jan 29, 2019
Primary completion
Jul 10, 2019
Completion
Aug 30, 2019
Last update
Sep 3, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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