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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02377154
Enrollment
150
Registered
2015-03-03
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

DEVICESlit lamp

Examination of cornea

Measurement of refraction

DEVICEIOLMaster 500

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

Measurement of white-to-white distance; Keratometry

DEVICELenStar LS900

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

DEVICEVERION Image Guided System

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

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Accuracy of repeatability of keratometry as performed by VERION Image Guided System3 immediate repetitions at study visit (study consists of 1 visit only)

Secondary

MeasureTime frame
Subjective comfort for test persons as evaluated by questionnaireImmediately after study visit (study consists of 1 visit only)
Duration of measurements of each keratometric device as taken by stopwatchDuring measurements from placement of head until completion
Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided SystemAt study visit (study consists of 1 visit only)
White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided SystemAt study visit (study consists of 1 visit only)
Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided SystemImmediately after measurement

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026