Comparability of Keratometry of VERION Image Guided System With Established Measuring Devices

NCT ID: NCT02377154

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.

In addition the comfort and duration of examination in the different devices is evaluated.

Detailed Description

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Conditions

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Healthy

Keywords

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keratometry verion iol intraocular lens iolmaster lenstar pentacam IOL calculation VERION Image Guided System

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Opthalmologically healthy individuals

Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System

Group Type OTHER

Slit lamp

Intervention Type DEVICE

Examination of cornea

Autorefractor

Intervention Type DEVICE

Measurement of refraction

IOLMaster 500

Intervention Type DEVICE

Measurement of axial length and white-to-white distance; Keratometry; IOL calculation

Pentacam HR

Intervention Type DEVICE

Measurement of white-to-white distance; Keratometry

LenStar LS900

Intervention Type DEVICE

Measurement of axial length and white-to-white distance; Keratometry; IOL calculation

VERION Image Guided System

Intervention Type DEVICE

Measurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500

Interventions

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Slit lamp

Examination of cornea

Intervention Type DEVICE

Autorefractor

Measurement of refraction

Intervention Type DEVICE

IOLMaster 500

Measurement of axial length and white-to-white distance; Keratometry; IOL calculation

Intervention Type DEVICE

Pentacam HR

Measurement of white-to-white distance; Keratometry

Intervention Type DEVICE

LenStar LS900

Measurement of axial length and white-to-white distance; Keratometry; IOL calculation

Intervention Type DEVICE

VERION Image Guided System

Measurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All interested individuals
* Full legal capacity

Exclusion Criteria

* Pre-existing or actual ocular disease or pathology, history of ocular surgery
* Contact lens wear 2 weeks before examination
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Mike P. Holzer

Ophthalmologist, FEBO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mike P Holzer, MD, FEBO

Role: PRINCIPAL_INVESTIGATOR

Department of opthalmology, University of Heidelberg

Locations

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Department of ophthalmology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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S-532/2014

Identifier Type: -

Identifier Source: org_study_id