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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Slit lamp; Device: Autorefractor; Device: IOLMaster 500; Device: Pentacam HR; Device: LenStar LS900; Device: VERION Image Guided System

• Registration Number: NCT02377154
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Primary Completion: 2015-05
• Study Completion: 2016-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opthalmologically healthy individuals	IOLMaster 500	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Opthalmologically healthy individuals	Slit lamp	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Opthalmologically healthy individuals	Pentacam HR	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Opthalmologically healthy individuals	Autorefractor	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Opthalmologically healthy individuals	LenStar LS900	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Opthalmologically healthy individuals	VERION Image Guided System	Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of ophthalmology, University of Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany