Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03852485

Enrollment

199

Registered

2019-02-25

Start date

2019-01-29

Completion date

2019-08-30

Last updated

2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Brief summary

Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed description

The purpose of this study is to compare with predicate device for the measurements of vascular structures and 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 compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Interventions

DEVICESD-OCT

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

IInclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Limits of agreement	Day 1	estimation of the interval within which a proportion of the differences between measurements lie

Secondary

Measure	Time frame	Description
Regression Analysis	Day 1	statistical process for estimating the relationships among variables

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026