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To Investigate the Precision and Agreement of SS-1000 and Pentacam in a Repeatability and Reproducibility Trial

NCT02077790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-03-04

No results posted yet for this study

Summary

This study is to support the substantial equivalence of the SS-1000 to the predicate device Pentacam.

Primary Objective -The primary objective of the trial is to evaluate the precision of the SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.

Secondary Objectives

* To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
* To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
* To investigate the agreement between SS-1000 and Pentacam in measuring the anterior segment parameters in an eye

Study design

-The trial design is a prospective precision trial with the following factors: The trial will be conducted at one investigational site. The site will have three SS-1000 devices and three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are confounded with instrument effect. All participants will have one visit and undergo the same set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).

Conditions

  • Evaluate the Agreement and Precision of Device SS-1000 and the Predicate Device the Pentacam in a Reproducibility and Repeatability Trial

Interventions

DEVICE

CASIA Cornea/Anterior Segment OCT SS-1000

The SS-1000 is a three-dimensional, non-contact, non-invasive high resolution optical coherence tomography imaging device based on the principal of "Swept Source" OCT. The system achieves high resolution imaging of 10 μm (Axial) and 30 μm (Transverse) and high speed scanning of 30,000 A-scans per second.

Sponsors & Collaborators

  • Tomey Corporation

    lead INDUSTRY

Principal Investigators

  • Atsushi Shiraishi, M.D., Ph.D. · Ehime University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

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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 NCT02077790 on ClinicalTrials.gov