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Optos P200TE Agreement and Precision Study

NCT03868462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2019-10-15

No results posted yet for this study

Summary

This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Conditions

Interventions

DEVICE

Predicate Device

The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

DEVICE

Optos P200TE

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Sponsors & Collaborators

  • Optos, PLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2019-09-16
Completion
2019-09-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03868462 on ClinicalTrials.gov