Skip to main content
OpenTrials
Completed

NCT Number: NCT03852485

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IOVS, Newark, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SD-OCT

Device

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

Primary outcomes

  1. Limits of agreement

    Time frame: Day 1

    estimation of the interval within which a proportion of the differences between measurements lie

Secondary outcomes

  1. Regression Analysis

    Time frame: Day 1

    statistical process for estimating the relationships among variables

Sponsors and collaborators

Lead sponsor

Optovue

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.