再現性試験においてSS-1000とPentacamの精度と一致性を調査する

基本情報

NCT ID

NCT02077790

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

66

治験依頼者名

Tomey Corporation

概要

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).

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)