MedTrace Logo

P200TE and Predicate Agreement and Precision Study

NCT05624593 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-11-22

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 P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Conditions

Interventions

DEVICE

P200TE

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

DEVICE

Predicate

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.

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
2022-11-04
Primary Completion
2023-03-31
Completion
2023-03-31
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 NCT05624593 on ClinicalTrials.gov