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Completed

NCT Number: NCT02377154

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

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.

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Key information

Conditions

Healthy Eye Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intraocular Lymphoma Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ophthalmology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slit lamp

Device

Examination of cornea

Autorefractor

Device

Measurement of refraction

IOLMaster 500

Device

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

Pentacam HR

Device

Measurement of white-to-white distance; Keratometry

LenStar LS900

Device

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

VERION Image Guided System

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Subjective comfort for test persons as evaluated by questionnaire

    Time frame: Immediately after study visit (study consists of 1 visit only)

  2. Duration of measurements of each keratometric device as taken by stopwatch

    Time frame: During measurements from placement of head until completion

  3. 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)

  4. 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)

  5. Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System

    Time frame: Immediately after measurement

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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