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Study to Compare Kowa OCT Bi-μ and the Optovue iVue 100

NCT03505567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-09-10

No results posted yet for this study

Summary

This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Conditions

Interventions

DEVICE

KOWA OCT Bi-µ

Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.

DEVICE

Optovue iVue 100

U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • David Hosford, MD, Ph.D · Kowa Research Institute, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-21
Primary Completion
2018-09-01
Completion
2018-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505567 on ClinicalTrials.gov