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

December 11, 2017 updated by: Prof. Dr. med. Mike P. Holzer, Heidelberg University

Comparability of Keratometry and Intraocular Lens (IOL) Calculation of VERION Image Guided System With Established Measuring Devices in Ophthalmologically Healthy Individuals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Department of ophthalmology, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Device: Slit lamp
Examination of cornea
Device: Autorefractor
Measurement of refraction
Device: IOLMaster 500
Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
Device: Pentacam HR
Measurement of white-to-white distance; Keratometry
Device: LenStar LS900
Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
Device: VERION Image Guided System
Measurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of repeatability of keratometry as performed by VERION Image Guided System
Time Frame: 3 immediate repetitions at study visit (study consists of 1 visit only)
3 immediate repetitions at study visit (study consists of 1 visit only)

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective comfort for test persons as evaluated by questionnaire
Time Frame: Immediately after study visit (study consists of 1 visit only)
Immediately after study visit (study consists of 1 visit only)
Duration of measurements of each keratometric device as taken by stopwatch
Time Frame: During measurements from placement of head until completion
During measurements from placement of head until completion
Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Time Frame: At study visit (study consists of 1 visit only)
At study visit (study consists of 1 visit only)
White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Time Frame: At study visit (study consists of 1 visit only)
At study visit (study consists of 1 visit only)
Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System
Time Frame: Immediately after measurement
Immediately after measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Mike P Holzer, MD, FEBO, Department of opthalmology, University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-532/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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