NCT02377154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

February 13, 2015

Last Update Submit

December 11, 2017

Conditions

Healthy

Keywords

keratometryverioniolintraocular lensiolmasterlenstarpentacamIOL calculationVERION Image Guided System

Outcome Measures

Primary Outcomes (1)

  • Accuracy of repeatability of keratometry as performed by VERION Image Guided System

    3 immediate repetitions at study visit (study consists of 1 visit only)

Secondary Outcomes (5)

  • Subjective comfort for test persons as evaluated by questionnaire

    Immediately after study visit (study consists of 1 visit only)

  • Duration of measurements of each keratometric device as taken by stopwatch

    During measurements from placement of head until completion

  • Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System

    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

    At study visit (study consists of 1 visit only)

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

    Immediately after measurement

Study Arms (1)

Opthalmologically healthy individuals

OTHER

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

Device: Slit lampDevice: AutorefractorDevice: IOLMaster 500Device: Pentacam HRDevice: LenStar LS900Device: VERION Image Guided System

Interventions

Slit lampDEVICE

Examination of cornea

Opthalmologically healthy individuals
AutorefractorDEVICE

Measurement of refraction

Opthalmologically healthy individuals
IOLMaster 500DEVICE

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

Opthalmologically healthy individuals
Pentacam HRDEVICE

Measurement of white-to-white distance; Keratometry

Opthalmologically healthy individuals
LenStar LS900DEVICE

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

Opthalmologically healthy individuals
VERION Image Guided SystemDEVICE

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

Opthalmologically healthy individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All interested individuals
  • Full legal capacity

You may not qualify if:

  • Pre-existing or actual ocular disease or pathology, history of ocular surgery
  • Contact lens wear 2 weeks before examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ophthalmology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Intraocular Lymphoma

Interventions

Slit Lamp

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsEye NeoplasmsNeoplasms by SiteLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OphthalmoscopesDiagnostic EquipmentEquipment and Supplies

Study Officials

  • Mike P Holzer, MD, FEBO

    Department of opthalmology, University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist, FEBO

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

DE(1)