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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Slit lamp
* Device: Autorefractor
* Device: IOLMaster 500
* Device: Pentacam HR
* Device: LenStar LS900
* Device: VERION Image Guided System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratometry, verion, iol, intraocular lens, iolmaster, lenstar, pentacam, IOL calculation, VERION Image Guided System